New and updated

Does removing more or fewer lymph nodes improve outcomes in women who have endometrial cancer?

Moffatt J;Webster KE;Dwan K;Frost JA;Morrison J — Tue, 10 Jun 2025 00:00:00 +0200

New

Authors:

Moffatt J, Webster KE, Dwan K, Frost JA, Morrison J

Key messages

Not removing pelvic lymph nodes (which are part of the immune system and in the lower tummy) probably does affect survival compared with removing all pelvic lymph nodes in women without obvious disease spread and may reduce the risk of disease coming back.
Not removing pelvic lymph nodes, or removing only the first draining lymph nodes (called sentinels), probably greatly reduces the risk of developing swelling in the legs after surgery compared with removing all pelvic nodes, or pelvic/para-aortic (which are higher in the tummy) nodes.

What is endometrial cancer and how is it treated?

Endometrial cancer affects the lining of the womb (uterus), known as the endometrium. It is the sixth most common cancer in females worldwide. In 2022, there were 420,242 cases of womb cancer, causing 97,704 deaths worldwide.

Most women with endometrial cancer have early-stage disease at diagnosis (only in the womb). Treatment involves hysterectomy (surgical removal of the womb and neck of womb) and removal of the fallopian tubes (which transport the egg from the ovaries to the womb) and ovaries (which produce eggs). Removal of lymph nodes (lymphadenectomy) in the pelvis (lower tummy) or para-aortic areas (area around the main blood vessels in the upper tummy) (or both), is performed to see if further treatment with anticancer medicine (chemotherapy) or high-dose x-rays (radiotherapy) is needed to reduce the risk of recurrence.

Why is this important for women with endometrial cancer?

The rate of lymph node involvement in early-stage disease is low and may be predicted by examining the womb under a microscope and running further tests following hysterectomy. Lymphadenectomy carries a risk of long-lasting lymphoedema (swelling in parts of the lower body). New techniques for detecting and removing just the first draining lymph nodes from each side of the womb (sentinel lymph node biopsy) can replace lymphadenectomy in detecting involved nodes accurately, but we do not know if sentinel lymph node biopsy is beneficial to women, despite it being widely used.

What did we want to find out?

We wanted to know if removing all pelvic, just sentinel or no apparently normal lymph nodes from pelvic/para-aortic areas was beneficial to women with presumed early-stage endometrial cancer and if there were any unwanted effects.

What did we do?

We searched for studies comparing removal of all pelvic, just sentinel or no apparently normal nodes from pelvic/para-aortic areas in women with presumed early-stage endometrial cancer. We compared and summarised the results, and rated our confidence in the evidence, based on factors including study methods and the number of women in the studies.

What did we find?

We found five studies (one is continuing) with 2074 women with endometrial cancer conducted in the UK, South Africa, Poland, New Zealand, Chile, Italy, Egypt and Brazil, and published between 2008 and 2023.

Pelvic lymphadenectomy versus no lymphadenectomy

Women with no lymphadenectomy are probably as likely to survive up to three years (146/1000 deaths with pelvic lymphadenectomy versus 126/1000 deaths with no lymphadenectomy).
Women with no lymphadenectomy are less likely to have recurrent disease by three years (205/1000 women with pelvic lymphadenectomy versus 164/1000 women with lymphadenectomy).
Women with no lymphadenectomy may have fewer complications from surgical injury (38/1000 women with pelvic lymphadenectomy versus 26/1000 women with no lymphadenectomy) and probably have fewer complications due to surgery (e.g. infection/blood clots; 13/1000 women with pelvic lymphadenectomy versus 4/1000 women with no lymphadenectomy).
Women with no lymphadenectomy probably have a much lower rate of lymphoedema by three years (61/1000 women with pelvic lymphadenectomy versus 7/1000 women with no lymphadenectomy) and likely have fewer lymph collections (cysts; 14/1000 women with pelvic lymphadenectomy versus 3/1000 women with no lymphadenectomy).

Sentinel lymph node biopsy versus pelvic/para-aortic lymphadenectomy

Preliminary data from one study are very uncertain about deaths, surgical complications and quality of life.
Sentinel lymph node biopsy probably reduces lymphoedema rates (92/1000 women with sentinel lymph node biopsy versus 306/1000 women with pelvic/para-aortic lymphadenectomy).

No lymphadenectomy versus pelvic/para-aortic lymphadenectomy

We are very uncertain about deaths, surgical complications and quality of life.
Pelvic/para-aortic lymphadenectomy may reduce lymphoedema (18/1000 women with no lymphadenectomy versus 250/1000 women with pelvic/para-aortic lymphadenectomy).

What are the limitations of the evidence?

Some studies were published before the modern classification of endometrial tumours, and more of these women would now be offered chemotherapy/radiotherapy, even without confirmed lymph node involvement. This may have affected the results.

We hoped to rank the effectiveness of these treatments, but there were not enough studies or results to do this. Further data from 10 ongoing studies are awaited.

How up to date is the evidence?

The review is current to 22 March 2024.

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Gonadotropin-releasing hormone (GnRH) analogues for treating premenstrual syndrome (PMS)

Naheed B;Kuiper JH;O'Mahony F;O'Brien PMS — Tue, 10 Jun 2025 00:00:00 +0200

New

Authors:

Naheed B, Kuiper JH, O'Mahony F, O'Brien PMS

Review question

What are the benefits and risks of using medication known as gonadotropin-releasing hormone (GnRH) agonists and antagonists in the management of premenstrual syndrome (PMS)?

Key messages

• We found reliable evidence that GnRH agonists without add-back improve PMS symptoms compared to placebo, but also that menopausal side effects are common, and women taking GnRH agonists without add-back are more likely to stop their treatment than women taking placebo.

• We are moderately confident that PMS symptoms may improve when comparing GnRH agonists with add-back versus placebo. There was not enough evidence to decide if GnRH agonists with add-back improves PMS symptoms compared to GnRH alone, or if dosage of add-back hormones has an effect on PMS symptoms.

• Further studies known as 'randomised controlled trials' of GnRH agonists with add-back and long-term follow-up are needed.

What is premenstual syndrome?

Premenstrual syndrome (PMS) comprises a range of physical, psychological and behavioural symptoms that occur after release of an egg from the ovary (ovulation), disappear by the end of a woman's period and cause substantial distress or impairment to daily life, including work, school, social activities, hobbies and interpersonal relationships. Stopping ovulation using GnRH analogues may suppress those symptoms, but the downside is that they may cause menopause-like side effects, such as hot flushes, and - in the long term - osteoporosis. To counteract these side effects, another hormone (most often oestrogen or progestogen) can be added to the treatment; this is known as add-back.

What did we want to find out?

Gonadotropin-releasing hormone (GnRH) analogues are peptides (proteins) with a structure related to GnRH that are widely used to prevent ovulation. They are a group of drugs that influence the part of the brain containing the hypothalamus and pituitary gland. GnRH analogues have two types: agonists and antagonists. GnRH agonists initially stimulate GnRH production but with longer use suppress GnRH production. GnRH antagonists immediately suppress GnRH production. We wanted to find out if they were effective and safe. We searched a type of study known as a 'randomised controlled trial', in which people are assigned to one of two (or more) groups randomly, with less risk of bias in the results.

Study characteristics

We found 11 studies (randomised controlled trials) of the use of GnRH analogues in the management of PMS, enroling a total of 265 women who were clinically diagnosed with PMS. We used these RCTs in four comparisons: GnRH agonists without add-back versus placebo (9 studies, 173 women), GnRH agonists with add-back versus placebo (1 study, 31 women), add-back versus placebo during GnRH agonist treatment (2 studies, 60 women) and a comparison of different doses of add-back (1 study, 15 women). No study reported quality of life or long-term risks such as osteoporosis.

Key results

We found reliable evidence that GnRH agonists without add-back improve overall premenstrual symptoms, compared to placebo. However, women using GnRH agonists are more likely to withdraw from treatment due to negative side effects (such as menopause-like symptoms).

We found low-certainty evidence that GnRH agonists with add-back may improve global symptoms compared to placebo, while insufficient evidence was found about negative side effects.

The evidence for add-back versus placebo during GnRH agonist treatment and about different doses of add-back hormones was too imprecise to decide which worked best.

None of the included studies reported on quality of life or on long-term risks such as osteoporosis.

What are the limitations of the evidence?

The main limitations of the evidence are the small number of women included in most of the studies, and the women in the studies sometimes being aware of the treatment they were getting. We are confident about the results of GnRH agonists without add-back compared to placebo, but have little confidence in the results of the other three comparisons.

How up to date is the evidence?

The evidence is based on searches of healthcare databases that were run up to May 2023.

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In adults and adolescents with HIV, is using two different rapid tests together ('parallel testing') to diagnose tuberculosis (TB) disease more accurate than using only one?

Tue, 10 Jun 2025 00:00:00 +0200

New

Authors:

Bjerrum S, Yang B, Åhsberg J, Olbrich L, Damkjær MW, Nathavitharana RR, Broger T, Olaru ID, Sweetser B, Poore H, Razid A, Kay AW, Denkinger CM, Schiller I, Dendukuri N, Jaganath D, Lundh A, Shah M

This review looked at adults and adolescents with HIV who have signs and symptoms of tuberculosis (TB) disease. Diagnosis can be done using respiratory samples (fluids or mucus collected by coughing or using tubes to remove fluid from the throat, lungs, or stomach) or urine. We wanted to know whether using two rapid tests together - an automated test on a respiratory sample (LC-aNAAT) and a urine strip test (LF-LAM) - is better than using LC-aNAAT alone. Using these two tests together is called parallel testing.

Key messages

- Parallel testing finds more cases of TB than using just the LC-aNAAT alone.

- However, parallel testing may also lead to more false TB diagnoses in people who do not actually have TB, and this undesirable effect is likely more pronounced in settings where TB is less common.

- In places where TB is common, the benefit of parallel testing (i.e. detecting more people who actually have TB) may outweigh the harms (i.e. misdiagnoses, unnecessary treatment, and delayed diagnosis of other illnesses).

Why is it important to improve the diagnosis of TB amongst people with HIV?

People with HIV are at a higher risk of developing TB than those without HIV. TB in patients with HIV often presents with non-specific symptoms, and detecting the bacteria (Mycobacterium tuberculosis) with standard sputum (spit) tests can be difficult. This is partly due to challenges in coughing up a sputum sample, which may contain very few bacteria, and because TB may occur in parts of the body other than the lungs. As a result of delayed or missed diagnoses, TB is the leading cause of hospital admission and death amongst people living with HIV worldwide.

What is parallel testing?

Parallel testing refers to using more than one test at the same time. If any one of the tests returns a positive test result, we consider the parallel testing to have a positive test result. We studied parallel testing using LC-aNAAT on respiratory samples in combination with LF-LAM on urine.

What did we want to find out?

- How accurate is parallel testing for all forms of TB in adults and adolescents (aged 10 years and older) with HIV who have signs or symptoms of TB?

- How accurate is parallel testing for identifying TB compared to using respiratory LC-aNAAT alone?

What did we do?

We searched for studies that had investigated the accuracy of both respiratory LC-aNAAT and urine LF-LAM for TB in adults and adolescents living with HIV, and we combined the results of these studies.

What did we find?

The review included 27 studies that involved 12,651 participants, of whom 2368 (19%) had confirmed TB.

The included participants were from 19 low- and middle-income countries where HIV and TB are common. Many studies were from countries in sub-Saharan Africa. One study was conducted with adolescents, but the other studies were of adults.

Accuracy of parallel testing

The results of these studies indicate that in a group of 1000 people, of whom 200 (20%) actually have TB, then:

- parallel testing would correctly identify 155 as having TB, but would miss 45; for the remaining 800 people who do not have TB, parallel testing would correctly identify 715 as not having TB, but would misdiagnose 85 as having TB.

Parallel testing compared to respiratory LC-aNAAT alone

The results of these studies indicate that if a parallel test strategy was used instead of a respiratory LC-aNAAT test alone, in a group of 1000 people, of whom 200 (20%) actually have TB, then:

- parallel testing would accurately diagnose 13 more patients who actually have TB who would have been missed by LC-aNAAT on respiratory samples used alone (i.e. 13 fewer 'false negatives' with parallel testing). On the other hand, using parallel testing would misdiagnose 54 more people who do not have TB (54 more 'false positives' with parallel testing), compared to LC-aNAAT alone.

What are the limitations of the evidence?

The evidence for parallel testing in adolescents is limited. Although we included a large number of adults from different settings, only a small number of adolescents were part of this review.

Some studies in this review excluded patients who could not produce a sputum or urine sample. This may have resulted in an underestimation or overestimation of the accuracy of parallel testing.

Because it is difficult to detect TB in patients with HIV, the method for verifying whether a person truly has TB or not (what we call the 'reference standard') may not be perfect. This means that we might have underestimated or overestimated the accuracy of parallel testing. Some studies using a different reference standard (called a 'composite reference standard') showed different results, though these results were very uncertain.

How up to date is this evidence?

The evidence is based on searches conducted up to 3 November 2023.

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Which is safer after removing the tail of the pancreas: stapler or handsewn closure?

Probst P;Hüttner FJ;Klaiber U;Knebel P;Ulrich A;Büchler MW;Diener MK — Tue, 10 Jun 2025 00:00:00 +0200

Updated

Authors:

Probst P, Hüttner FJ, Klaiber U, Knebel P, Ulrich A, Büchler MW, Diener MK

Key messages

• There is likely little or no difference in leaks from the pancreas (pancreatic fistula) and may be little or no difference in deaths after surgery, whether the pancreas is closed with a stapler or sewn by hand.

• Surgeons may choose the method they are more comfortable with or that best suits the patient’s situation.

• More research should focus on other ways to prevent leaks after pancreas surgery, as the best method is still not known.

What is the pancreas, and why is it removed?

The pancreas is an organ in the belly that helps with digestion and controls blood sugar. Sometimes, the end part of the pancreas (called the 'tail') has to be removed, for example because of a tumour. This operation is called a distal pancreatectomy.

One common problem after this surgery is a pancreatic fistula, which is when digestive juices leak from the cut end of the pancreas into the belly. This can cause pain, infections, and bleeding. Closing the pancreas properly after surgery is important to reduce this risk.

How is the pancreas closed after surgery?

There are two main ways to close the pancreas after the tail is removed:

• handsewn closure: the surgeon cuts the pancreas with a knife and sews it closed by hand;

• stapler closure: a device is used to cut and seal the pancreas in one step.

It is unclear which method is better for preventing problems after surgery.

What did we want to find out?

We wanted to know if stapler closure or handsewn closure works better to:

• reduce the number of leaks (pancreatic fistulas);

• lower the chance of dying after the operation;

• reduce other complications.

What did we do?

We looked for studies that compared stapler closure and handsewn closure in people who had surgery to remove the tail of the pancreas. We summarised the findings and judged how confident we are in the results.

What did we find?

We found three high-quality studies with 515 adults who had surgery to remove the tail of their pancreas. These studies took place in different countries and included people with various pancreas diseases.

There was likely little or no difference between the stapler and handsewn groups in how often a leak happened after surgery and other problems after surgery, and may be little or no difference in how many people died after the operation.

What are the limitations of the evidence?

The studies were not very large, and a few details were not reported clearly. Also, there were problems with the study methods that could have affected our conclusions. Because of this, we are not certain of the results. More research should explore other ways to prevent pancreatic fistula.

How up-to-date is this evidence?

The evidence is current to October 2023.

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Benefits and risks of combining local antibiotics and steroids to treat chronic suppurative otitis media

Brennan-Jones CG;Head K;Chong LY;Daw J;Veselinović T;Schilder AGM;Bhutta MF — Mon, 09 Jun 2025 00:00:00 +0200

Updated

Authors:

Brennan-Jones CG, Head K, Chong LY, Daw J, Veselinović T, Schilder AGM, Bhutta MF

Key messages

- We are uncertain about the effectiveness of topical (i.e. delivered as drops, sprays or creams) antibiotics with steroids for improving the resolution of ear discharge in participants with an ear condition known as chronic suppurative otitis media (CSOM).

- We found no evidence that the addition of steroids to topical antibiotics affects the resolution of ear discharge when measured at one to two weeks, and no results were available for longer-term outcomes.

- There is low-certainty evidence that some types of topical antibiotics (without steroids) may be better than topical antibiotic-steroid combinations for improving resolution of discharge.

- There is uncertainty about the relative effectiveness of different types of antibiotics; it is not possible to determine whether a family of antibiotics known as quinolones are better, worse or the same as antibiotics known as aminoglycosides. These two groups of compounds are believed to have different harmful effects, but there is insufficient evidence from the studies included in the review to make any comment about possible harms. In general, harmful effects were poorly reported.

What did we study in the review?

Chronic suppurative otitis media (CSOM) is an inflammation and infection of the middle ear that lasts for two weeks or more. People with CSOM usually experience recurrent or persistent ear discharge – pus that leaks out from a hole in the eardrum – and hearing loss.

CSOM is commonly treated with a combination of antibiotics (medicines that fight bacterial infections) and steroids (medicines that work by reducing inflammation in the body). These medicines are referred to as 'topical' treatments when they are administered as ear drops, sprays or creams put directly into the ear. Often, topical antibiotics and topical steroids are combined to treat CSOM. We reviewed the evidence from research studies to find out how effective this combination is, and whether it causes unwanted effects.

What was the aim of the review?

We searched for all relevant studies in the medical literature, compared their results and summarised the evidence from all the studies. The studies evaluated different combinations of antibiotics plus steroids, and compared them with either no treatment, a fake treatment (placebo), the same antibiotic without steroids or different antibiotics without steroids. We also assessed how certain we were about the evidence, taking into account factors such as study size and the way studies were conducted. Based on our assessments, we categorised the evidence as being of very low, low, moderate or high certainty.

This is the first update of a review published in 2020, which contained 17 studies.

What are the main results of the review?

We found two new studies. Overall, the review included 19 studies involving over 2024 people with CSOM. None of the studies measured one of our outcomes: health-related quality of life.

1. Topical antibiotics plus steroids versus placebo (fake treatment) or no treatment (three studies, 210 people)

Our primary outcome, stopping ear discharge, was not measured at the time point of one to two weeks.

We do not know whether antibiotics plus steroids are better or worse than placebo or no treatment for:

- stopping ear discharge (when measured after four weeks);

- hearing; or

- causing unwanted effects (such as ear pain or serious complications).

This evidence is of very low certainty.

2. Topical antibiotics plus steroids versus the same topical antibiotic used alone (four studies, 475 people)

Topical antibiotics plus steroids may make little or no difference to stopping ear discharge after one to two weeks (low-certainty evidence). The outcome was not measured at the 'after four weeks' time point.

We do not know whether antibiotics plus steroids are better or worse than the same topical antibiotic used alone for:

- hearing; or

- causing unwanted effects (such as ear pain or serious complications).

This evidence is of very low certainty.

3. Topical antibiotics other than quinolones plus steroids versus topical quinolone antibiotics alone (10 studies, 1056 to 1096 people)

Non-quinolone antibiotics (specifically, antibiotics known as aminoglycosides) plus steroids may not be as effective as a family of antibiotics known as quinolones used alone for stopping ear discharge at one to two weeks (low-certainty evidence).

We do not know whether non-quinolone antibiotics plus steroids are better or worse than quinolone antibiotics alone for:

- stopping ear discharge after four weeks;

- hearing; or

- causing unwanted effects (such as ear pain or serious complications).

This evidence is of very low certainty.

4. Other comparisons

Results for 10 other comparisons are presented in the full review.

What are the limitations of the evidence?

Too few robust studies have been conducted for us to know whether adding steroids to topical antibiotics affects the effectiveness of the antibiotic or impacts the risk of harmful effects from the treatment. The evidence is also limited by the age of the studies and the lack of information on certain population groups.

How up to date is this review?

The evidence in this Cochrane review is based on searches of medical literature up to June 2022.

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Do antibiotics taken orally or given as an injection help people with chronic suppurative otitis media?

Mon, 09 Jun 2025 00:00:00 +0200

Updated

Authors:

Chong LY, Head K, Webster KE, Daw J, Strobel NA, Richmond PC, Snelling T, Bhutta MF, Schilder AGM, Brennan-Jones CG

Key messages

- We do not know if antibiotics taken by mouth or given as an injection (systemic antibiotics) are effective treatments for chronic suppurative otitis media (CSOM; a type of long-term ear infection), and whether they lead to unwanted effects. Evidence about unwanted effects is particularly limited.

- Future studies should be larger, use rigorous methods, include groups at particular risk of CSOM, follow participants for at least six months, and assess outcomes that are important to patients and healthcare professionals.

What is chronic suppurative otitis media?

Chronic suppurative otitis media (CSOM) is an inflammation and infection of the middle ear that lasts for two weeks or more. People with CSOM usually experience recurrent or persistent discharge – fluid that leaks out from a hole or tear in the eardrum – and hearing loss.

How is CSOM treated?

CSOM can be treated with antibiotics (medicines that fight bacterial infections), taken orally or given as an injection (i.e. systemic treatment in which the whole body is treated). Systemic antibiotics can be used:

- alone;
- in combination with antibiotics in the form of drops, sprays, ointments, or creams (topical, i.e. localised surface treatment); or
- in combination with other treatments such as steroids (anti-inflammation medicines) or antiseptics (substances that stop or slow down the growth of micro-organisms).

What did we want to find out?

We aimed to find out how effective systemic antibiotics are for treating CSOM. In particular, we wanted to know whether systemic antibiotics stopped ear discharge, improved health-related quality of life, or affected people's hearing. We also wanted to know if systemic antibiotics caused pain, discomfort or irritation in the ear, unwanted effects (such as dizziness or ear bleeding), or any serious complications.

What did we do?

We searched for studies that compared systemic antibiotics to no treatment, placebo (an inactive or 'dummy' medicine), or another systemic antibiotic in people of any age. We compared and summarised the results of the studies and rated our confidence in the evidence, based on factors such as study methods and sizes.

What did we find?

This is an update of a review first published in 2021. We found 21 studies that involved a total of 2525 people with CSOM. People were followed for up to one year after treatment. Four studies provided information about funding and other support: two studies were publicly funded, and pharmaceutical companies supplied medicine in the other two studies.

The studies compared systemic antibiotics:

- to no treatment (one study);
- plus topical antibiotics to topical antibiotics alone (seven studies);
- plus other treatments (other than topical antibiotics alone), against these same treatments without systemic antibiotics (four studies);
- to different systemic antibiotics (10 studies).

Main results

Systemic antibiotics alone against no treatment

We do not know if systemic antibiotics alone are better or worse than no treatment.

Systemic antibiotics plus topical antibiotics against topical antibiotics alone

Systemic antibiotics plus topical antibiotics may have little to no effect on whether discharge stops after one to two weeks compared to topical antibiotics alone (three studies). We do not know if systemic antibiotics added to topical antibiotics have any other positive or negative effects.

Systemic antibiotics plus other treatments (other than topical antibiotics alone), against these same treatments without systemic antibiotics

We do not know if systemic antibiotics are effective or lead to harmful events when added to treatments other than topical antibiotics only.

Comparisons between different systemic antibiotics

We do not know whether some systemic antibiotics are better than others.

In general, the evidence was limited, which made it difficult to determine whether there were potentially harmful effects of systemic antibiotics. However, it is known more broadly that systemic antibiotics can have unwanted effects, such as diarrhoea or nausea, and also carry a risk of systemic allergic reactions such as a skin rash. The risk of these events is expected to be similar to that of treating other infections with comparable doses and treatment duration to CSOM. There is also a broader concern associated with the overuse of systemic antibiotics and the increasing resistance to antibiotics.

What are the limitations of the evidence?

We had little to no confidence in the evidence because: there were too few studies; most studies were small; some studies used methods likely to introduce errors in their results; and some reported little information.

How current is this review?

The evidence is current to June 2022.

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What are the benefits and harms of antibiotics given directly into the ear compared to antibiotics given to the whole body to treat chronic suppurative otitis media?

Mon, 09 Jun 2025 00:00:00 +0200

Updated

Authors:

Chong LY, Head K, Webster KE, Daw J, Strobel NA, Richmond PC, Snelling T, Bhutta MF, Schilder AGM, Brennan-Jones CG

Key messages

– Topical quinolone antibiotics (given directly into the ear) may be slightly more effective than systemic antibiotics (given to the whole body) at resolving ear discharge.

– We do not know whether topical or systemic antibiotics are better for improving hearing.

What is chronic suppurative otitis media?

Chronic suppurative otitis media, also known as chronic otitis media, is an inflammation and infection of the middle ear that lasts for two weeks or more. People with chronic suppurative otitis media usually experience recurrent or persistent discharge (fluid that leaks out from a hole or tear in the eardrum) and hearing loss.

Antibiotics (medicines that fight bacterial infections) are the most common treatment for chronic suppurative otitis media. Antibiotics can:

– be applied to part of the body (locally) in the form of drops, sprays, ointments, or creams (topical antibiotics); or

– treat the whole body (systemic antibiotics) when injected or taken orally (by mouth).

What was the aim of this review?

We aimed to find out how effective topical and systemic forms of the same antibiotic, or one topical antibiotic versus a different systemic antibiotic, were in people with chronic suppurative otitis media, and whether they cause unwanted effects. In particular, we wanted to know whether topical or systemic antibiotics stopped ear discharge, and whether they affected health-related quality of life (a measure of a person's satisfaction with their life and health), or hearing. We also wanted to know if they caused pain, discomfort, or irritation in the ear; unwanted effects such as dizziness or ear bleeding; or any serious complications. We compared and summarised the results of the studies and rated our confidence in the evidence, based on factors such as study methods and consistency of results.

What are the main results of the review?

This is the first update of a review published in 2021. The update found no new studies. Overall, we found six studies that involved 445 people.

Quinolone ear drops versus oral quinolone tablets

Four studies (325 people) assessed this comparison. Compared to oral quinolone, quinolone ear drops may slightly increase the chances of ear discharge resolving after one to two weeks (2 studies, 210 people). Three studies (265 people) reported that they did not suspect ototoxicity (when a person develops hearing or balance problems due to a medicine) in any person, but it was unclear how this was measured, so the evidence is very uncertain. No studies reported ear pain, serious complications, or health-related quality of life. No studies reported results for hearing, despite it being measured in three studies.

Quinolones ear drops versus injected aminoglycosides

One study (60 people) assessed this comparison. Resolution of ear discharge was not measured at one to two weeks. The study did not report any "side effects," which we assume meant there was no ear pain, ototoxicity, or serious complications, but the evidence is very uncertain. The evidence was very uncertain for hearing.

We do not know if quinolone ear drops are better or worse than injected aminoglycosides for treating chronic suppurative otitis media. Only one study investigated this and it provided insufficient evidence.

Quinolones ear drops versus oral penicillin with clavulanic acid (a beta-lactamase inhibitor)

We do not know if ofloxacin ear drops are better or worse than oral amoxicillin-clavulanic acid for treating chronic suppurative otitis media. Only one study investigated this and it provided insufficient evidence. No study reported information about the effects of different treatments on ear discharge after four weeks or health-related quality of life.

What are the limitations of the evidence?

We need more information about different types of topical antibiotics. We need more evidence from well-designed studies to be able to compare the effects of topical and systemic antibiotics on aspects such as health-related quality of life or ear pain. We also need more information about harmful effects. There was a lack of recent data, and limited information on groups of people who are more likely to have chronic suppurative otitis media or different antibiotics.

How up to date is this review?

The evidence is current to June 2022.

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What are the benefits and harms of ear cleaning to treat inflammation and infection of the middle ear?

Bhutta MF;Head K;Chong LY;Daw J;Schilder AGM;Brennan-Jones CG — Mon, 09 Jun 2025 00:00:00 +0200

Updated

Authors:

Bhutta MF, Head K, Chong LY, Daw J, Schilder AGM, Brennan-Jones CG

Key messages

– We do not know how effective ear cleaning is for people with inflammation and infection of the middle ear (called chronic suppurative otitis media), and whether it causes unwanted effects.

– We are very uncertain about the evidence within the very few studies on this topic. Unwanted effects were not well reported in the studies we found. We need researchers to conduct studies that compare ear cleaning to no cleaning, and compare different cleaning techniques and frequency, so that we can assess the benefits and harms of ear cleaning for people with chronic suppurative otitis media.

What is chronic suppurative otitis media?

Chronic suppurative otitis media, which is also known as chronic otitis media, is an inflammation and infection of the middle ear that lasts for two weeks or more. People with chronic suppurative otitis media usually have recurrent or persistent ear discharge (pus that leaks out from a hole in the eardrum) and hearing loss.

How can chronic suppurative otitis media be treated?

There are a few approaches to clean the affected ears and remove discharge. These include:

– using cotton wool or tissue paper (called dry mopping);
– sucking out pus and fluid that is blocking the ear with a small device (usually done under a microscope); or
– washing out the ear (called irrigation).

What is the aim of this review?

We wanted to know how effective ear cleaning is in treating people with chronic suppurative otitis media, and whether it causes unwanted effects. In particular, we wanted to know whether ear cleaning stopped ear discharge, and whether it affected people's quality of life or hearing. We also wanted to know if it caused pain, discomfort, or irritation in the ear; unwanted effects such as dizziness or ear bleeding; or any serious complications. We compared and summarised the results of the studies and rated our confidence in the evidence, based on factors such as study methods and consistency of results.

What are the main results of the review?

This is the first update of a review published in 2020, which did not find any new studies. Overall, we found three studies that involved 431 people with chronic suppurative otitis media. Two studies included only children, while the third included both children and adults. One study recruited people from the Solomon Islands, who were considered to be a high-risk Indigenous group. People were followed for between six weeks and six months after treatment.

Daily dry mopping compared to no treatment

Two studies (351 people) assessed this comparison. We are very uncertain if dry mopping stops ear discharge after four weeks, and no studies looked at the presence of discharge earlier. One study reported serious complications, but it was unclear whether the people who reported complications had their ears cleaned with dry mopping or not, or whether the complications occurred before or after treatment. Therefore, we do not know if dry mopping caused serious complications, or how often these occurred. One study looked at hearing, but did not report the results in a way that could tell us whether or not dry mopping affected hearing. The studies did not report quality of life, ear pain, or harms such as dizziness or balance problems.

Daily suction compared to one instance of suction only, both in addition to antibiotic ear drops

One study (80 people) assessed this comparison. We do not know whether daily suction stops ear discharge between one and two weeks compared with one instance of suction plus antibiotics. The results for discharge after four weeks could not be interpreted. The authors only reported that there was no difference between the two groups in hearing results. One study mentioned one person had dizziness in the one suction plus antibiotics group, which the authors attributed to the use of cold antibiotics. The studies did not report quality of life or ear pain.

What are the limitations of the evidence?

Limitations of the review included lack of good-quality evidence, and limited information on the population groups or treatments.

How up to date is this review?

The evidence is current to June 2022.

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What are the benefits and harms of using topical antibiotics to treat chronic suppurative otitis media?

Brennan-Jones CG;Head K;Chong LY;Daw J;Veselinović T;Schilder AGM;Bhutta MF — Mon, 09 Jun 2025 00:00:00 +0200

Updated

Authors:

Brennan-Jones CG, Head K, Chong LY, Daw J, Veselinović T, Schilder AGM, Bhutta MF

Key messages

– We are uncertain whether topical antibiotics reduce ear discharge of people with swelling and infection of the middle ear (called chronic suppurative otitis media).

– Topical antibiotics may reduce ear discharge compared to placebo (a salt solution), but we are very uncertain. Topical antibiotics used in addition to an antibiotic given by mouth may reduce ear discharge.

– Overall, we are very uncertain which type of topical antibiotic is the most effective.

What is chronic suppurative otitis media?

Chronic suppurative otitis media, also known as chronic otitis media, is a swelling and infection of the middle ear that lasts for two weeks or more. People with chronic suppurative otitis media usually have ear discharge that is difficult to get rid of or keeps coming back (pus that leaks out from a hole in the eardrum) and hearing loss.

How can chronic suppurative otitis media be treated?

Topical antibiotics (administered into the ear canal as ear drops, ointments, sprays, or creams) are the most commonly used treatment for chronic suppurative otitis media. Topical antibiotics kill or stop the growth of the bacteria (germs) that may be responsible for the infection. Topical antibiotics can be used on their own or be added to other treatments for chronic suppurative otitis media, such as antiseptics (which also kill germs) or ear cleaning (aural toileting) or systemic antibiotics (antibiotics taken either by mouth or by an injection into a muscle or vein).

What was the aim of this review?

We wanted to find out how effective topical antibiotics are for people with chronic suppurative otitis media, and whether they cause unwanted effects. We also wanted to know whether one type of topical antibiotic was more beneficial or harmful than any other. In particular, we wanted to know whether topical antibiotics stopped ear discharge, and whether they affected people's quality of life or hearing. We also wanted to know if they caused pain, discomfort, or irritation in the ear; had unwanted effects such as dizziness or ear bleeding; or any serious complications. We compared and summarised the results of the studies and rated our confidence in the evidence, based on factors such as study methods and consistency of results.

What were the main results of the review?

We found one new study (100 participants). Overall, we found 18 studies examining at least 1783 people, but it was difficult to determine precisely how many people were included as some studies did not clearly report the number. Two studies included "mainly children," three included only adults, whilst the remainder appeared to include both children and adults. None of the studies reported the inclusion of people considered at high risk of having chronic suppurative otitis media (for example, people with cleft palate (where the roof of the mouth of a baby does not join together during pregnancy) or Down's syndrome; or people whose immune system does not work well enough to fight germs). The studies used different types of antibiotics and combinations of antibiotics.

Comparison of topical antibiotics to placebo or no treatment

One study (50 people) compared topical antibiotics to a saline (salt water) ear wash. Topical antibiotics may reduce ear discharge more than the saline ear wash when assessed one to up to two weeks after treatment, but we are very uncertain. The evidence is very uncertain about unwanted effects and worsening of hearing measurements. The study did not measure quality of life and reported that there were no serious complications.

Comparison of topical antibiotics in addition to systemic (oral or injected) antibiotics

Four studies (438 people) compared treatment with topical antibiotic (ciprofloxacin) drops in addition to a systemic (oral or injected) antibiotic, but one study did not contribute data. Topical plus oral antibiotics may reduce ear discharge more than oral antibiotics alone at one to up to two weeks and two to up to four weeks. One study stated there were no unwanted effects. The studies did not measure quality of life and did not report any serious complications.

Comparisons of different topical antibiotics

Eight studies (794 participants plus 40 ears) compared an aminoglycoside antibiotic (gentamicin, neomycin, or tobramycin) with a quinolone antibiotic (ciprofloxacin or ofloxacin). Quinolones may reduce ear discharge better than aminoglycosides, but the evidence is very uncertain. One study (100 people) measured ear pain and reported no difference between the groups, but the evidence is very uncertain. Two studies measured hearing loss, but the evidence is very uncertain.

What are the limitations of the evidence?

There were several limitations with the studies. For example, the results varied widely between studies, there were small numbers of people included, there was a lack of recent data, and limited information on groups of people who are more likely to have chronic suppurative otitis media.

How up to date is this review?

This is the first update of a review published in 2020. The evidence is up to date to June 2022.

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What are the benefits and risks of topical antiseptics for treating long-term middle ear infection (chronic suppurative otitis media)?

Mon, 09 Jun 2025 00:00:00 +0200

Updated

Authors:

Head K, Chong LY, Bhutta MF, Daw J, Veselinović T, Morris PS, Vijayasekaran S, Schilder AGM, Brennan-Jones CG

Key messages

• Due to a lack of studies, we are very uncertain of the benefits and risks of topical antiseptics in the treatment of chronic suppurative otitis media (long-term middle ear infection).

• We need more information about possible harmful effects of topical antiseptics, as these were not well reported in the studies.

What was studied in the review?

Chronic suppurative otitis media (CSOM) is a long-term (chronic) swelling and infection of the middle ear, with ear discharge (otorrhoea) through a perforated tympanic membrane (eardrum). The main symptoms are ear discharge and hearing loss.

Topical antiseptics (antiseptics put directly into the ear as ear drops or as a powder) are sometimes used to treat CSOM. Topical antiseptics kill or stop the growth of the micro-organisms that may be responsible for the infection. Topical antiseptics can be used on their own or added to other treatments for CSOM, such as antibiotics or ear cleaning (aural toileting). Applying topical antiseptics can cause irritation of the skin within the outer ear, which may result in discomfort, pain, or itching. Some antiseptics (such as alcohol) can be toxic to the inner ear (ototoxicity), which means they may cause irreparable hearing loss (sensorineural), dizziness, or ringing in the ear (tinnitus).

What is the aim of this review?

The aim of this Cochrane review was to find out the benefits and risks of topical antiseptics compared to placebo (dummy medicine) or no treatment for CSOM. We also wanted to know whether one topical antiseptic was more effective than another. We collected and analysed all relevant studies to answer this question. This is an update of a review last published in 2020, with one new study added.

What are the main results of the review?

We included a total of six studies in the review. The total number of people in the studies was unclear, as two studies only reported how many ears were treated. However, there were 435 participants plus 222 ears (between 111 and 222 participants) that could not be accounted for in participant numbers. Four studies compared topical antiseptics with no treatment or placebo, and two studies compared two different topical antiseptics. Different types of antiseptics were used, some in the form of ear drops and others as powders. No study measured health-related quality of life or ear pain.

Topical antiseptic versus placebo or no treatment (with a background treatment of ear cleaning)

Three studies (297 participants plus 174 ears) compared topical antiseptics with placebo/no treatment.

Based on evidence from one study (unclear number of participants, 174 ears), we do not know if a single application of antiseptic (povidone iodine plus hydroxypropyl methyl-cellulose) resolves ear discharge at one to two weeks compared with no treatment.

Another study (180 children) compared topical antiseptics (boric acid in alcohol ear drops) with no topical antiseptics. All children also had their ears cleaned daily using cotton wool sticks (dry mopping). It is unclear if antiseptics (boric acid) led to an increase in resolution of ear discharge at four weeks or at three to four months compared with no antiseptics. The same study (254 participants) also reported no clear difference between groups in hearing or suspected ototoxicity (hearing or balance problems that develop as a result of taking a medicine), but the evidence is very uncertain.

A third study (43 children; 58 ears) found no clear evidence that antiseptics have any effect on serious complications, but it is not known if this was assessed before, during, or after treatment.

Topical antiseptic (povidone iodine) versus no treatment/placebo, where both study groups received systemic antibiotics

One study (32 participants) compared one antiseptic (povidone iodine) with placebo (saline). All participants also received oral antibiotics (amoxicillin) and ear cleaning. This study found that topical povidone iodine, when given in addition to antibiotics and ear cleaning, may increase the number of people with resolution of ear discharge at between one and two weeks, compared with placebo plus antibiotics and ear cleaning. We do not know if povidone iodine increases suspected ototoxicity. In their report, the study authors stated there was no ototoxicity in participants in the topical antiseptic group, but this was unclear for the placebo group. There was no information on resolution of ear discharge after four weeks, hearing, or serious complications.

What are the limitations of the evidence?

There is limited information on certain population groups or treatments. Also, the evidence in the review comes from studies that were not conducted recently.

How up-to-date is the review?

The evidence is current to June 2022.

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Which are better, antibiotics or topical antiseptics, for treating chronic suppurative otitis media?

Mon, 09 Jun 2025 00:00:00 +0200

Updated

Authors:

Head K, Chong LY, Bhutta MF, Daw J, Veselinović T, Morris PS, Vijayasekaran S, Schilder AGM, Brennan-Jones CG

Key message

– There is limited evidence comparing topical antibiotics with topical antiseptics in people with swelling and infection of the middle ear (called chronic suppurative otitis media). The evidence is very uncertain whether antibiotics or topical antiseptics are more effective for reducing ear discharge, except that topical antibiotics are likely to be more effective than boric acid (an antiseptic).

What is chronic suppurative otitis media?

Chronic suppurative otitis media is a long-term (chronic) swelling and infection of the middle ear, with ear discharge (otorrhoea) through a perforated tympanic membrane (where the eardrum has a hole or tear in it). The main symptoms of chronic suppurative otitis media are ear discharge (pus that leaks out from a hole in the eardrum) and hearing loss.

How can chronic suppurative otitis media be treated?

Antibiotics (which kill bacteria) are the most commonly used treatment for chronic suppurative otitis media. Antibiotics can either be 'topical' (put into the ear canal as ear drops, ointments, sprays, or creams) or 'systemic' (taken either by mouth or by an injection into a muscle or vein). Topical antiseptics (antiseptics put directly into the ear as ear drops or powders) are a possible treatment for chronic suppurative otitis media. Both antibiotics and topical antiseptics kill or stop the growth of the germs that may be responsible for the infection.

Antibiotics and topical antiseptics can be used on their own or added to other treatments for chronic suppurative otitis media, such as other antibiotics or ear cleaning (called aural toileting). It was important in this review to examine whether there were any unwanted effects from using antibiotics and antiseptics, such as irritation of the skin within the outer ear, which may cause discomfort, pain, or itching. Some antibiotics and antiseptics (such as alcohol) can also be toxic to the inner ear (called ototoxicity), which means that they may cause permanent hearing loss, dizziness, or ringing in the ear (called tinnitus).

What was the aim of this review?

We wanted to compare antibiotics and antiseptics for the treatment of chronic suppurative otitis media. In particular, we wanted to know whether they stopped ear discharge, and whether they affected people's quality of life or hearing. We also wanted to know if they caused pain, discomfort, or irritation in the ear; had unwanted effects such as dizziness or ear bleeding; or any serious complications. We compared and summarised the results of the studies and rated our confidence in the evidence, based on factors such as study methods and consistency of results.

What were the main results of the review?

We found 15 studies, which included 2371 people, that compared antibiotics to a variety of antiseptics (acetic acid, boric acid, povidone-iodine, and aluminium acetate). One study recruited only children, two studies recruited only adults, and 12 studies included both adults and children. About 40 in every 100 people were females. We presented the main comparisons below.

Comparison of antibiotics to acetic acid

We included seven studies (835 people). We have little to no confidence in the evidence of whether topical antibiotics or acetic acid improved ear discharge in people with chronic suppurative otitis media. It was not possible to know whether there was a difference between treatments for any other symptoms or effects that we were interested in.

Comparison of antibiotics to boric acid

We included two studies (532 people). Topical antibiotics (quinolones) are likely to be better than boric acid at reducing ear discharge after one to two weeks. There may also be less ear discomfort (pain, irritation, and bleeding). Topical quinolones may result in a greater improvement in hearing compared to topical boric acid, but this difference may be too small for the person to notice a difference.

Comparison of antibiotics to povidone-iodine

We included one study (40 people). We have little to no confidence in the evidence of whether topical or systemic antibiotics or povidone-iodine improve the resolution of ear discharge in people with chronic suppurative otitis media. It was not possible to know whether there was a difference between treatments for any other symptoms or effects that we were interested in.

Comparison of antibiotics to aluminium acetate

We included one study (51 people) that stated there was improvement in ear discharge at two to four weeks, but they did not present their results in a way that we could use. It was not possible to know whether there was a difference between treatments for any other symptoms or effects that we were interested in.

What are the limitations of the evidence?

The studies were small with many being poorly reported, and results varied widely between studies. We also need more information about harmful effects.

How up to date is this review?

This is the first update of a review published in 2020. The evidence is up to date to June 2022.

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Does using hormonal contraception increase a woman's risk of gettingHIV?

Rohwer C;McCaul M;Hofmeyr GJ;Rohwer AC — Fri, 06 Jun 2025 00:00:00 +0200

New

Authors:

Rohwer C, McCaul M, Hofmeyr GJ, Rohwer AC

Does using hormonal contraception increase a woman's risk of getting HIV?

Key messages

DMPA (depot medroxyprogesterone acetate) injections likely result in little to no difference in the risk of getting HIV compared to the copper intrauterine device (IUD).
The levonorgestrel implant (LNG) likely results in little to no difference in the risk of getting HIV compared to the copper IUD.
DMPA injections likely slightly increase the risk of getting HIV compared to LNG implants.
We are not certain about the effect of DMPA compared to norethisterone enanthate (NET-EN) on HIV acquisition.

What Is HIV?

HIV is a virus that affects the body's immune system and weakens the ability to fight off everyday infections and diseases. The virus is found in the bodily fluids of an infected person. The virus is most commonly spread from one person to another through unprotected sex. People can also get the virus from sharing needles or syringes. Babies can be infected during pregnancy, birth or breastfeeding.

Although there is no cure for HIV, treatment is highly effective and can improve life expectancy and quality of life.

What is contraception?

Contraceptive methods are birth-control methods. The aim of using contraception is to avoid unwanted pregnancies. There are many different contraceptive methods. Some contraceptives contain hormones, whilst others do not. Common modern methods include injections, implants, pills and intrauterine devices (IUDs, which sit inside the womb). DMPA is an injection given every three months. The LNG implant is placed under the skin of the upper arm and can remain effective for up to five years. NET-EN is an injection given every two months, which contains progesterone (a type of hormone).

What did we want to find out?

We wanted to find out if using hormonal contraception puts women at a higher risk of getting HIV than if they used other contraceptive methods.

What did we do?

We searched for all studies that looked at the effects of using hormonal contraception for women living in areas where there is a high risk of getting infected with HIV. We compared and summarised the results of these studies and rated our confidence in the evidence, based on factors like study methods and sizes.

What did we find?

We found four studies that involved 9726 HIV-negative women. We were interested in the risk of women getting HIV, and the risk of becoming pregnant.

The review found that using DMPA injections likely results in little to no difference in the chance of getting HIV when we compare it to using a copper IUD.

Using an LNG implant likely results in little to no difference in the chance of getting HIV compared to copper IUD.

Using DMPA injections or LNG implants probably reduces pregnancy risk compared to copper IUDs, but this effect might be due to the controlled environment of a study that encourages women to continue their contraceptive methods.

We also found that using DMPA probably slightly increases the risk of HIV infection when compared to using the LNG implant, but DMPA probably results in little to no difference in the risk of pregnancy compared to LNG.

The evidence is very uncertain about the effect of DMPA compared to NET-EN on the chances of getting HIV or becoming pregnant.

What are the limitations of the evidence?

None of the trials compared the risk of women using contraception to women using no contraception, so we cannot be certain what a woman's risk of getting HIV is if she uses no contraception. The trials only looked at a few specific contraceptive methods, not all the methods available on the market.

How up to date is this evidence?

This review updates the previous review. The evidence is up to date to 13 September 2023.

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Does community care navigation (where a clinician helps guide patients through healthcare systems) reduce unplanned hospitalisations for ‘at-risk’ individuals?

Pang RK;Shannon B;Collyer T;Srikanth V;Andrew NE — Thu, 05 Jun 2025 00:00:00 +0200

New

Authors:

Pang RK, Shannon B, Collyer T, Srikanth V, Andrew NE

Key messages

• People who receive community care navigation assistance are probably slightly less likely to be admitted to hospital for unplanned reasons in the first year after care navigation than those who do not receive this type of assistance.

• We need more studies, with better reporting, to identify the types of people, settings and ways of delivering community care navigation that are likely to deliver the most benefit and to understand the impact on patient-reported health outcomes.

What is community care navigation?

Community care navigation is when a third party, usually a trained clinician, guides and supports an individual in accessing the care provided by multiple healthcare and service providers, but is not directly involved in delivering clinical care. Care navigators proactively guide patients through often complex healthcare systems, aiming to help them receive timely health care and foster self-management and autonomy through education and emotional support.

Why is this review important?

As people age, they often develop chronic health conditions (long-lasting illnesses that persist for more than a few months) that can lead to frequent use of hospital services, resulting in increased burdens on health systems globally. Those with complex chronic health conditions are more likely to report having unmet health and care needs, leading to frequent use of hospital services. Preliminary evidence suggests that community care navigation may improve a person’s access to community-based services, reducing unmet healthcare needs and leading to a reduction in hospital admissions and emergency department attendances. Further evidence is needed to confirm this.

What did we want to find out?

We wanted to find out if delivering care navigation in the community reduces unplanned hospital presentation rates (hospital admissions and emergency department presentations) and improves patient-reported health outcomes, including health-related quality of life, in groups considered to be at risk of hospitalisations.

What did we do?

We searched for studies where participants received either an intervention that met our definition of community care navigation or usual care – routine medical care for preventing and treating diseases. We compared and summarised the results of the studies and rated our confidence in the evidence, based on factors such as study methods and sizes.

What did we find?

We included and analysed 19 studies, involving 36,745 people. All studies were conducted in high-income countries and funded by medical research institutes or universities. Five studies focused on populations with multiple chronic conditions; of these, three used hospital data systems to identify at-risk populations based on a range of characteristics. Four studies were conducted in a community clinic and the other 15 studies were initiated in a hospital but delivered in the community. Seven studies used a registered nurse as the care navigator, five used social workers, and one used community health workers. Six studies used multidisciplinary teams. Multiple components of care navigation were offered across the studies, including screening, needs assessment, navigating care and services, developing care plans, and follow-up phone calls. Telephone follow-up was the most common method of communication in the studies.

Main results

• Compared to people who received usual care, those who received community care navigation were slightly less likely to be admitted to hospital for unplanned reasons in the year after receiving care navigation.

• Compared to usual care, community care navigation may make little to no difference to the number of people admitted to hospital for unplanned reasons in the first month, but the evidence is very uncertain.

• Compared to usual care, community care navigation probably results in little to no difference in the rate at which people presented at the emergency department, both in the first month and the first year.

• Community care navigation compared to usual care increased the proportion of participants having outpatient appointments in the first month, which may indicate that community care navigation helps shift patient care towards community services.

• Further studies are required to reliably understand the effects on patient-reported health outcomes, treatment satisfaction and quality of care.

What are the limitations of the evidence?

We are confident that community care navigation increased outpatient appointments in the first month, compared to usual care. Our confidence in the evidence for the other outcomes ranged from moderate to very low. Due to the nature of the intervention, it was highly likely that people in the studies were aware of which treatment they were receiving, which could have influenced how they reported outcomes, such as patient-reported health outcomes. There were also wide variations in the types of outcomes reported and the time periods during which they were measured.

Further research is required to understand the effects of community care navigation programmes beyond 12 months, patient-reported health outcomes in this area of research, and which aspects of community care navigation are most effective. We plan to involve patients and members of the public in future updates of this work to help us interpret the results.

How current is this evidence?

The evidence is current to October 2024.

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What are the benefits and harms of corticosteroids in the treatment of children and adults with sepsis?

Thu, 05 Jun 2025 00:00:00 +0200

Updated

Authors:

Annane D, Briegel J, Granton D, Bellissant E, Bollaert PE, Keh D, Kupfer Y, Pirracchio R, Rochwerg B

Key messages

• Compared to placebo or usual care, corticosteroids probably reduce the risk of death at 28 days and of in-hospital death, and may have little or no effect on the risk of dying beyond three months.

• We are uncertain about the effects of continuous intravenous infusion of corticosteroids compared with intermittent intravenous bolus (rapid injection) administration.

• Future studies should measure the benefits and harms of corticosteroids for the treatment of specific populations, including children, patients with sepsis without shock or with a mild form of septic shock, patients with acute respiratory distress syndrome (ARDS) and patients with different types of infections. Defining the optimal methods for corticosteroid administration, including the types of molecule - with or without producing sodium and fluid retention and potassium excretion (mineralocorticoid activity), timing of initiation, dose and duration, continuous infusion or intermittent intravenous boluses, and ending of treatment - with or without gradually decreasing the dose to zero, also requires additional studies. Future studies should measure the longer-term effects, i.e. longer than one year, on survival and complications of sepsis.

What is sepsis?

Sepsis is present when an infection is complicated by organ failure. People develop rapid breathing, hypotension (low blood pressure) and mental confusion. Sepsis can interfere with the effectiveness of the body’s corticosteroids, which control how your body recognises and defends itself against bacteria, viruses and substances that appear foreign and harmful.

What are corticosteroids (medicine)?

Corticosteroids are medicines used to stop excessive inflammation. However, these medicines may cause unwanted harms, such as increased blood sugar or salt levels, infections, bleeding in the stomach, agitation or delirium, and weakness of the limbs. Corticosteroids have been given for decades to people with infection resulting from various causes.

What did we want to find out?

We wanted to find out:

• the benefits of using corticosteroids in children and adults with sepsis; and

• the best ways to administer this treatment (including the best people to give it to).

We also wanted to know if corticosteroids can cause any unwanted effects.

What did we do?

We searched for studies that compared:

• corticosteroids administered intravenously against a 'dummy' treatment, or sham treatment, which does not contain any medicine but looks or tastes identical to corticosteroids, or usual care; or

• continuous infusion against intermittent rapid intravenous injections (boluses) of corticosteroids administration.

We compared and summarised their results, and rated our confidence in the evidence, based on factors such as study methods and sizes.

What did we find?

This review includes 87 trials (24,336 participants). The biggest study was of 3800 people and the smallest study was of 21 people. Eighty-three trials compared corticosteroids to no corticosteroids (placebo or usual care in 59 and 24 trials, respectively). Four trials also compared continuous administration versus rapid intravenous injection (i.e. bolus) of corticosteroids given at fixed intervals of six or eight hours. Thirty-three trials were conducted in Europe, 15 in North America, 22 in Asia, six in the Middle East, six in Africa and three in Latin America; four were multinational trials.

Three trials were funded by a drug company, 27 by public organisations or through charitable funding and six by both a drug company and public organisations or charitable funding; 25 did not declare the source of funding.

Compared to placebo or usual care, corticosteroids probably reduce the risk of death at 28 days by 10% (72 trials; 22,915 participants), with consistent treatment effects between children and adults. There may be little or no effect of corticosteroids on the risk of dying over the long term (longer than three months), but these results are less certain. Corticosteroids probably reduce the risk of dying in hospital. Corticosteroids may result in a reduction in the length of stay in the intensive care unit (ICU) and in hospital. They may not increase the risk of superinfection (second infection). The evidence is very uncertain about the effect of corticosteroids on the risk of muscle weakness.

We are uncertain about the effects of continuous intravenous infusion of corticosteroids compared with intermittent intravenous bolus (rapid injection) administration. Four studies reported data for this comparison, and the certainty of evidence for all outcomes was very low.

What are the limitations of the evidence?

• Corticosteroids versus placebo or usual care

We have moderate confidence in our findings that corticosteroids reduced 28-day mortality. We found some differences amongst the study populations, the types of corticosteroids and how they were given, and the use of additional medicines.

• Continuous infusion versus bolus administration of corticosteroids

We have very little confidence in our findings about the absence of a difference in 28-day mortality between the administration of corticosteroids continuously and repeated rapid intravenous injections. We found only four studies that enrolled very few patients.

How up-to-date is this evidence?

The evidence provided in this review is current to December 2023.

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Are there differences in benefits and harms among regional pain management techniques in women undergoing breast cancer surgery?

Wed, 04 Jun 2025 00:00:00 +0200

New

Authors:

Clephas PRD, Orbach-Zinger S, Gosteli-Peter MA, Hoshen M, Halpern S, Hilber ND, Leo C, Heesen M

Key messages

Overall, we found that different pain blocks were similar for managing pain after breast cancer surgery.
Complication rates were low among all pain block techniques.

What is regional analgesia, and how does it work?

Regional analgesia is a pain block technique used in breast cancer surgery. It involves injecting pain-numbing medicine near specific nerves in the breast area to block pain signals during and after surgery. Unlike opioids, which affect the whole body, regional analgesia targets only the nerves. Different regional analgesia techniques target different nerves, as shown below.

Paravertebral block: near the spine
Erector spinae plane block: along the back muscles
Pectoral nerve block: in the chest area
Serratus anterior plane block: near the sides of the chest

Why is this important for women undergoing breast cancer surgery?

Pain after breast surgery can cause problems, lead to longer hospital stays, and even result in long-term pain. Opioids, commonly used for pain relief, have side effects such as nausea and vomiting. Regional analgesia is important because it effectively reduces pain while avoiding the risks associated with opioids.

What did we want to find out?

This review looked at how well regional analgesia techniques work and how safe they are. We compared different types of nerve blocks to see their effects on pain levels and possible complications.

What did we do?

We searched for high-quality medical studies that compared different types of nerve blocks for breast cancer surgery. We analysed their combined effects on pain and complications using advanced statistical methods. We evaluated erector spinae plane block, pectoral nerve block, and serratus anterior plane block against paravertebral block.

What did we find?

We included 39 studies involving 2348 women. The studies were conducted between 2013 and 2023. The results of the most important outcomes are summarised below.

For reducing pain at rest two hours after surgery, pectoral nerve block is slightly more effective than paravertebral block, but this difference is not clinically meaningful. Compared with paravertebral block, erector spinae plane block is similarly effective, and serratus anterior plane block probably has similar effectiveness.
For reducing pain during movement two hours after surgery, pectoral nerve block may be more effective than paravertebral block. Erector spinae plane block and paravertebral block may be similarly effective.
For reducing pain at rest 24 hours after surgery, pectoral nerve block is slightly more effective than paravertebral block, but this difference is not clinically meaningful. Compared with paravertebral block, erector spinae plane block and serratus anterior plane block are similarly effective.
For reducing pain during movement 24 hours after surgery, compared with paravertebral block, erector spinae plane block probably has similar effectiveness, pectoral nerve block may be similarly effective, and serratus anterior plane block may be similarly effective, but the last result is very uncertain.
For reducing pain at rest 48 hours after surgery, one study reported no difference between paravertebral block and erector spinae plane block, but the result is very uncertain.
For reducing pain during movement 48 hours after surgery, pectoral nerve block and erector spinae plane block may be similarly effective compared with paravertebral block, but both results are very uncertain.
In the three studies that recorded complications of regional analgesia, no complications occurred.

Overall, we found that the different regional analgesia techniques were similarly effective for managing pain management, and that all had low complication rates.

What are the limitations of the evidence?

Some factors reduced our confidence in the evidence. First, some comparisons included few studies and participants, making the results less reliable. Second, studies sometimes had different findings, making it harder to draw clear conclusions. Third, we excluded some studies from our analysis because we considered their methods were not sufficiently robust. Finally, where studies did not provide results, we had to calculate them ourselves, which may have added some uncertainty.

How up to date is this evidence?

The review is current to 6 June 2023.

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Is the use of telemedicine services for medical abortion better than in-clinic care?

Cleeve A;Lavelanet A;Gemzell-Danielsson K;Endler M — Wed, 04 Jun 2025 00:00:00 +0200

New

Authors:

Cleeve A, Lavelanet A, Gemzell-Danielsson K, Endler M

What is medical abortion care?

A medical abortion is an abortion where a person ends a pregnancy using a combination of two types of medication, mifepristone and misoprostol, or by using misoprostol alone. Medical abortion care comprises three different phases: pre-abortion, abortion, and post-abortion. These phases include different care components. The pre-abortion phase includes pre-abortion information, counselling, if desired, and eligibility assessment. The abortion phase includes instructions for, dispensing of, and administration of medications. The post-abortion phase includes the assessment of whether the abortion was successful and may also involve linkages to other reproductive health services. Some care components, such as information provision, counselling, and contraceptive counselling if desired, cross-cut all three phases.

What is telemedicine for medical abortion?

Telemedicine is a service delivery model for abortion where care is provided by a health worker using telecommunications, such as online chat, text messages, phone, or videoconference, to deliver care. This review focuses on telemedicine models for the provision of medical abortion care. Telemedicine can be used to support a woman either for part of or for the entire abortion process, from the pre-abortion to post-abortion phase.

What did we want to find out?

Previous research suggests that telemedicine models for medical abortion may be safe, effective, and acceptable to abortion seekers. However, existing data are constrained for reasons relating to self-reporting of outcomes, lack of comparison groups, and missing data, and therefore conclusions must be drawn with caution. In this review we aimed to build a more robust evidence base by investigating models using telecommunications to deliver care relating to one or more phases of an abortion. Our main interests were models of care in which telecommunications were used as the main means of service delivery from the pre-abortion phase to the post-abortion phase, compared with in-clinic care for the corresponding phases. We were also interested in models of care in which telecommunications were used to deliver care in a single phase or for a combination of two phases of an abortion.

What did we do?

We looked for studies comparing telemedicine for medical abortion with in-clinic care.

What did we find?

In total, we found 22 studies, including a total of 131,278 individuals undergoing medical abortion in the first trimester. These studies were conducted across 10 middle- and high-income countries and provided evidence on three interventions: pre- to post-abortion telemedicine models for medical abortion (nine studies); pre-abortion/abortion telemedicine models (four studies); and post-abortion telemedicine models (nine studies). The types of telecommunications used varied across the included studies and contained both synchronous (real-time) and asynchronous (not occurring in real-time) communication.

Main results

We found that pre- to post-abortion telemedicine models for medical abortion are probably similar in terms of their effect on the outcomes of successful abortion, unintended pregnancy, and adherence to the medical abortion regimen, when compared to in-clinic care. This was consistent with our findings relating to the comparisons of pre-abortion/abortion telemedicine models with in-clinic care, and post-abortion telemedicine models with in-clinic care. With regard to post-abortion telemedicine models, we saw that these models likely result in higher rates of adherence to follow-up procedures when compared to in-clinic care. Altogether, our findings indicate that the use of telemedicine for medical abortion in early pregnancy may result in similar outcomes in terms of safety, effectiveness, and acceptability when compared to in-clinic provision.

What are the limitations of the evidence?

Sufficiently large randomised studies and non-randomised studies with appropriate analyses were relatively few, especially for our main intervention of interest. Most studies were conducted in high-resource settings and the majority of included participants were at up to nine weeks' gestation. Most studies included some in-clinic care to confirm the gestational age or the abortion outcome. For our main intervention of interest, however, five out of nine studies did not perform routine ultrasounds, laboratory tests, or physical exams to confirm gestational length or pregnancy location prior to the abortion.

How up-to-date is this review?

The evidence is up-to-date to 13 August 2024.

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Which combinations of ways to diagnose and treat excessive bleeding after childbirth (postpartum haemorrhage) are most effective?

Yunas I;Price MJ;Vigneswaran K;Tobias A;Devall AJ;Coomarasamy A — Wed, 04 Jun 2025 00:00:00 +0200

New

Authors:

Yunas I, Price MJ, Vigneswaran K, Tobias A, Devall AJ, Coomarasamy A

Key messages

We found the combination of using a diagnosis with 1) birth-attendant clinical concern, or 2) 300 mL to 500 mL of drape-measured blood loss (blood is collected in a plastic drape with markings indicating the volume) with observations (e.g. heart rate, blood pressure, the tone of the womb, and flow of blood), or 3) 500 mL or more of drape-measured blood loss to diagnose postpartum haemorrhage (PPH), plus a treatment bundle, was more effective than using visual estimation for diagnosis plus usual care for treatment.
When using the same treatment bundle for PPH treatment, using a diagnosis with 1) birth-attendant clinical concern, or 2) 300 mL to 500 mL of drape-measured blood loss with observations, or 3) 500 mL or more of drape-measured blood loss was more effective than a diagnosis using 1) birth-attendant clinical concern, or 2) 500 mL or more of drape-measured blood loss.

What is PPH?

PPH is commonly defined as blood loss of 500 mL or more in the first 24 hours after childbirth.

Why is this review important?

PPH is a common reason why mothers die in childbirth around the world. Reducing PPH harm requires a combination of accurate diagnosis and effective treatment. Our study aimed to determine which combinations are most effective.

What did we want to find out?

We aimed to find out which combinations of ways to diagnose and treat PPH are most effective.

What did we do?

We looked at relevant studies to find out which combinations of ways to diagnose and treat PPH are most effective. We included women having a normal or caesarean birth in any setting (community delivery units, hospitals, home births).

Examples of ways to diagnose PPH include the assessor: having clinical concern; looking at the blood loss and estimating the blood volume (visual estimation); measuring the volume of blood loss in a drape or tray with markings indicating the volume (volumetric method); measuring the blood loss in a drape along with observations (such as heart rate and blood pressure), and weighing blood loss using scales (gravimetric method).

Examples of ways to treat PPH include 'usual care' (normal hospital practice), and treatment 'bundles' with various treatments given at the same time, such as the MOTIVE bundle (M – Massage of the womb to help it contract, O – giving medicines like Oxytocin to contract the womb, T – giving Tranexamic acid (a medicine given to slow bleeding), IV – intravenous fluids: fluids given through a drip to help maintain blood pressure, E – Examination and Escalation: if bleeding does not stop, calling for help and considering other treatments).

What did we find out?

We found five studies involving 236,771 women.

We are confident that diagnosis using 1) birth-attendant clinical concern, or 2) 300 mL to 500 mL of drape-measured blood loss with observations, or 3) 500 mL or more of drape-measured blood loss, plus the MOTIVE bundle is more effective than visual estimation plus usual care in reducing PPH of 500 mL or more and PPH of 1000 mL or more, but probably makes little or no difference to the need for blood transfusion or other drug treatments, and the risk of mothers dying.

We are confident that diagnosis using 1) birth-attendant clinical concern, or 2) 500 mL or more of drape-measured blood loss, plus the MOTIVE bundle is more effective than visual estimation plus usual care for reducing PPH of 500 mL or more, but probably makes little or no difference to PPH of 1000 mL or more and the need for blood transfusion, and may make little or no difference to the risk of mothers dying. We are confident that it increases the need for additional drug treatments.

We are confident that diagnosis using 1) birth-attendant clinical concern, or 2) 300 mL to 500 mL of drape-measured blood loss with observations, or 3) 500 mL or more of drape-measured blood loss, plus the MOTIVE bundle is more effective than diagnosis using 1) birth-attendant clinical concern, or 2) 500 mL or more of drape-measured blood loss, plus the MOTIVE bundle in reducing PPH of 500 mL or more, PPH of 1000 mL or more, and the need for additional drug treatments. It probably makes little or no difference to the need for blood transfusion, and may make little or no difference to the risk of mothers dying.

Drape-based diagnosis plus usual care (E) (this is usual care in a European healthcare setting, which may be different to usual care in a low-income setting because of access to, for example, more effective treatments) versus visual estimation plus usual care (E) probably makes little or no difference to the need for blood transfusion.

We are confident that the gravimetric method-based diagnosis plus usual care versus drape-based diagnosis plus usual care is more effective in reducing PPH of 500 mL or more, but may make little or no difference to the need for blood transfusion.

Tray-based diagnosis plus usual care versus drape-based diagnosis plus usual care may make little or no difference in reducing PPH of 500 mL or more and PPH of 1000 mL or more.

Gravimetric method-based diagnosis plus usual care versus tray-based diagnosis plus usual care may make little or no difference in reducing PPH of 500 mL or more.

What are the limitations?

All our studies involved women giving birth normally and most were in hospitals. We would like more information about women giving birth by caesarean, and in other settings such as home births. We would also like more information about unwanted effects and women's experience of care.

How up to date is the evidence?

This evidence is current to 18 October 2024.

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What is the best approach to prepare women's womb lining for frozen-thawed embryo transfer?

Ghobara T;Gelbaya TA;Ayeleke ROlugbenga — Tue, 03 Jun 2025 00:00:00 +0200

Updated

Authors:

Ghobara T, Gelbaya TA, Ayeleke ROlugbenga

Key messages

• We did not find sufficient evidence to support the use of one cycle regimen (approach) over another in preparation for frozen-thawed embryo transfer (FET) in women with regular ovulatory cycles who have difficulty getting pregnant (subfertile women).

• Larger, well-conducted studies are needed, particularly those that investigate the simpler or cheaper frozen-thawed embryo transfer approaches.

What is frozen-thawed embryo transfer (FET)?

In subfertile women undergoing assisted reproductive technology, eggs are collected from the ovaries and fertilised by sperm in a laboratory (in vitro fertilisation or IVF). Some or all embryos may be frozen, and are thawed and transferred to the womb at a later stage. This is called frozen-thawed embryo transfer (FET).

Women with regular spontaneous periods (menstrual cycles) may be offered a range of cycle regimens to prepare the womb lining (the endometrium) for FET. Alternatively, FET can be carried out after spontaneous ovulation (release of an egg) in a natural cycle. This is called natural cycle FET.

Women with irregular cycles are either not ovulating or are ovulating randomly. Therefore, natural cycle FET is not suitable for them. These women can be offered either ovulation induction with fertility drugs or hormone therapy (HT) to prepare them for FET.

The most common regimens for FET are natural cycle with or without HCG (human chorionic gonadrotophin) to trigger ovulation, or endometrial preparation with HT with or without a gonadotrophin-releasing hormone agonist (GnRHa) to temporarily suppress ovarian function.

What did we want to find out?

We conducted this review to find out if a particular FET regimen is more effective or safer than others. Our main outcomes were live birth rates and miscarriage rates per woman.

What did we do?

We searched for studies that compared one type of cycle regimen with another in subfertile women (including women with regular ovulation, irregular or random ovulation, or no ovulation). We compared and summarised the results of the studies and rated our confidence in the evidence, based on factors such as study methods and sizes.

What did we find?

We included 32 studies involving 6352 women. Most of the studies included women with regular ovulatory cycles. They provided little to no information about women with irregular or no ovulation cycles. The studies were conducted in Iran (11 studies), Belgium (four studies), Italy (three studies), plus two studies each in China, France, Israel, Turkey, and the UK; and one study each in Egypt, Singapore, Spain and the Netherlands.

Main results

This review did not find sufficient evidence to support the use of one cycle regimen in preference to another in preparation for FET in subfertile women with regular ovulatory cycles. The most common approaches for FET are natural cycle with or without HCG to trigger ovulation or endometrial preparation with HT, with or without GnRHa suppression. We identified six direct comparisons of these two approaches, and there was insufficient evidence to support the use of one over the other.

What are the limitations of the evidence?

We have little confidence in the evidence because the included studies were small with few results reported.

How current is this evidence?

The evidence is current to 19 December 2022.

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What are the most accurate tests for diagnosing low vitamin A?

Wed, 28 May 2025 00:00:00 +0200

New

Authors:

Gannon BM, Huey SL, Mehta NH, Shrestha N, Lopez-Perez L, Martinez RX, Rogers LM, Garcia-Casal MN, Mehta S

Key messages

• The two most common tests (serum or plasma retinol and retinol-binding protein) cannot reliably identify at-risk individuals with or without vitamin A deficiency in the community or clinics.

• This may mean that using these tests could lead to over- or underestimated levels of low vitamin A at the population level and incorrect diagnosis of individuals.

• Estimates of test accuracy should improve as more studies become available.

Why is it important to improve screening for vitamin A?

Vitamin A, also called 'retinol', is an essential nutrient. It is found in liver, eggs, dairy products, and most green leafy or orange fruit and vegetables. However, lack of vitamin A (vitamin A deficiency) is a common public health problem, especially in low-income countries. People with vitamin A deficiency may suffer from poor growth, an unhealthy immune system, night blindness and blindness. They are more likely to catch infectious diseases. Young children and pregnant women are most at risk.

In order to decide whether treatment with vitamin A supplements is needed or not, for individuals and communities, we need to know the existing levels of vitamin A deficiency. This requires accurate tests. Not recognising vitamin A deficiency when it is present may result in delayed or no vitamin A supplementation; vitamin A deficiency worsens, leading to scarring and vision problems. An incorrect diagnosis of vitamin A deficiency may mean that individuals are given vitamin A supplements when they are not needed, increasing the risk of vitamin A intake above recommended levels.

What tests measure vitamin A status?

The most accurate tests for vitamin A status (called the 'reference standards’) are liver biopsy and retinol isotope dilution. Liver biopsy involves removing a small sample of someone's liver and examining it under a microscope in a laboratory. Retinol isotope dilution involves giving a small dose of vitamin A and then examining a blood sample. These tests are invasive, costly, time-consuming, and technically demanding.

Other tests to measure a person’s vitamin A status are less invasive, less expensive, and quicker, but may not be so accurate. They are called 'index tests'. They look for signs of vitamin A ('biomarkers') in a blood sample. The most common tests are 'serum or plasma retinol' (SR) and 'serum or plasma retinol binding protein' (RBP). A positive test result indicates vitamin A deficiency, while a negative test result indicates the absence of vitamin A deficiency.

What did we want to find out?

We wanted to determine the accuracy of index tests compared with the reference standards for detecting vitamin A deficiency in people at risk of vitamin A deficiency.

What did we do?

We searched for studies that investigated the accuracy of the index tests compared to a reference standard and combined the results of the studies.

What did we find?

We included 40 studies that compared at least one index test and one reference test. Studies took place in North, Central and South America; Europe; South and Southeast Asia; and Africa. Participants were aged from 1 month to over 80 years. The percentage of people with vitamin A deficiency averaged between 4% and 60%. The results below are based on a hypothetical group of 1000 people.

SR versus retinol isotope dilution (23 studies)

In 1000 people where 100 (10%) have vitamin A deficiency measured with retinol isotope dilution, 82 people would have a SR result indicating vitamin A deficiency is present. Of these, 72 would be incorrectly classified as having vitamin A deficiency. Of the 918 people with a result indicating that vitamin A deficiency is not present, 90 would be incorrectly classified as not having vitamin A deficiency.

SR versus liver vitamin A (16 studies)

In 1000 people where 100 (10%) have vitamin A deficiency measured with liver vitamin A, 206 people would have a SR result indicating vitamin A deficiency is present. Of these, 153 would be incorrectly classified as having vitamin A deficiency. Of the 794 people with a result indicating that vitamin A deficiency is not present, 47 would be incorrectly classified as not having vitamin A deficiency.

RBP versus retinol isotope dilution (8 studies)

In 1000 people where 100 (10%) have vitamin A deficiency measured with retinol isotope dilution, 266 people would have a RBP result indicating vitamin A deficiency is present. Of these, 216 would be incorrectly classified as having vitamin A deficiency. Of the 734 people with a result indicating that vitamin A deficiency is not present, 50 would be incorrectly classified as not having vitamin A deficiency.

What are the limitations of the evidence?

Our confidence in the evidence is limited for several reasons. Most studies were small with little information about how they were done, so we couldn't judge how robust their methods were. Studies were not designed to determine the accuracy of index tests, so we need to be careful about interpreting their results. Finally, we didn't find information on all the tests.

How up to date is this review?

The evidence is up-to-date to August 2022.

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What is the best treatment for complex abdominal aortic aneurysms?

Daudu D;Cai PL;Srinivas A;Best LMJ;Cross J;Hammond CJ;Richards T — Wed, 28 May 2025 00:00:00 +0200

New

Authors:

Daudu D, Cai PL, Srinivas A, Best LMJ, Cross J, Hammond CJ, Richards T

Key messages

• There are currently no studies with information available to guide patients' and doctors' choices regarding treatments for complex abdominal aortic aneurysms (AAAs).

• It is difficult to conduct research in this area because relatively few people have this condition and the types of aneurysm they have vary.

• Future research should explore how organisations that fund and oversee healthcare services could require or promote the inclusion of people with AAAs in studies testing different treatments.

What is an abdominal aortic aneurysm?

An abdominal aortic aneurysm (AAA) is a widening of the wall of the aorta (the main artery that carries blood from the heart to the rest of the body) to more than 50% of its original diameter. A diameter of greater than 5.0 to 5.5 cm (depending on a person's sex/gender) is considered potentially life-threatening, with a risk of bursting. When the swelling occurs close to, next to, or above the arteries supplying the kidney, this increases the complexity of surgical treatment options.

How is a complex abdominal aortic aneurysm treated?

There are different treatment options. Open surgical repair involves a major operation to open the abdomen and replace the diseased aorta with a fabric graft.

Endovascular repair involves the use of X-ray guidance to insert metal stents (small, tube-shaped device placed inside a blood vessel) covered with fabric (endografts) via cuts made in the groin. When treating complex AAAs that are near the arteries supplying the kidneys, it is sometimes necessary to use specific endografts with windows (fenestrations) in them that allow for the kidneys and bowel to keep their blood supply when the endograft is inserted. This is called fenestrated endovascular aneurysm repair (FEVAR).

There is also the option of not performing any procedures and counselling patients and their families, and in some cases, prescribing medications to manage their cardiovascular risk factors. This is called conservative management.

It is unclear which treatment is best for people with complex AAAs.

What did we want to find out?

We wanted to find out whether there are randomised controlled trials exploring whether FEVAR, open surgical repair, or conservative management is best for the treatment of complex AAAs. Randomised controlled trials (RCTs) are studies in which participants are assigned randomly to two or more treatment groups. This is the best way to ensure that groups of participants are similar, and that investigators and participants don’t know who is in which group. In other words, RCTs aim to control factors that could impact on the results, such as people's background health, to allow fair comparison of the treatment options.

What did we do?

We searched for randomised controlled trials that compared FEVAR with open surgical repair or conservative management of complex AAAs. We searched for studies performed up to March 2023.

What did we find?

We could not find any studies that met the inclusion criteria. There is a lack of evidence to help us answer the question.

How current is the evidence?

The evidence is current to March 2023.

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Do epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) after lung cancer surgery help people live longer and prevent cancer from returning?

Occhipinti M;Imbimbo M;Ferrara R;Simeon V;Fiscon G;Marchal C;Skoetz N;Viscardi G — Tue, 27 May 2025 00:00:00 +0200

New

Authors:

Occhipinti M, Imbimbo M, Ferrara R, Simeon V, Fiscon G, Marchal C, Skoetz N, Viscardi G

Key messages

• Taking EGFR TKIs after lung cancer surgery may help people stay cancer-free for longer than chemotherapy or no further treatment.

• EGFR TKIs probably help people live longer compared to no treatment, but may make little to no difference in survival compared to chemotherapy.

• EGFR TKIs have fewer serious side effects than chemotherapy, but they may cause more mild-to-moderate side effects.

• More research is needed to understand if continuing EGFR TKIs for longer improves survival.

What is lung cancer, and how is it treated?

Lung cancer is one of the most common cancers worldwide. Non-small-cell lung cancer (NSCLC) is the most frequent type. Some NSCLC tumours have mutations in a gene called EGFR.

Surgery is the main treatment for early-stage NSCLC, but cancer can return after surgery. To reduce this risk, people may receive additional treatment (adjuvant therapy), such as chemotherapy or EGFR TKIs.

We wanted to find out whether taking EGFR TKIs after surgery helps people live longer and prevents the cancer from returning. We also looked at side effects.

What did we do?

We searched for studies comparing EGFR TKIs with a placebo (an inactive or 'dummy' medicine)/best supportive care or chemotherapy in people with stage I to III NSCLC who had undergone surgery. We compared and summarised the results of the studies and rated our confidence in the evidence, based on factors such as study methods and sizes.

What did we find?

We found 15 studies with 2603 participants. Nine studies were completed, and six are ongoing. The included studies compared:

• EGFR TKIs versus placebo or best supportive care (five studies);

• EGFR TKIs versus chemotherapy (four studies).

Main results

EGFR TKIs versus placebo/best supportive care

• Overall survival: EGFR TKIs probably help people live longer.

• Cancer returning: EGFR TKIs may help people stay cancer-free for longer, but the evidence is very uncertain.

• Serious side effects: these may be similar between the two groups, but the evidence is very uncertain.

• Mild-to-moderate side effects: EGFR TKIs may cause more mild-to-moderate side effects, but the evidence is very uncertain.

• People taking EGFR TKIs generally didn’t feel worse than those not taking EGFR TKIs.

• Cancer returning after stopping treatment: the risk of cancer coming back may be similar between groups.

EGFR TKIs versus chemotherapy

• Overall survival: there is probably little to no difference in survival between EGFR TKIs and chemotherapy.

• Cancer returning: EGFR TKIs may help people stay cancer-free longer than chemotherapy.

• Serious side effects: fewer serious side effects may occur with EGFR TKIs than with chemotherapy.

• Mild-to-moderate side effects: EGFR TKIs may cause more mild-to-moderate side effects.

• Overall quality of life is probably about the same in the two groups.

• Cancer returning after stopping treatment: there is no clear difference between the groups.

What are the limitations of the evidence?

Our confidence in the evidence ranged from very low to moderate, for several reasons. People in some studies were aware of which treatment they were getting, which could affect the results. Not all the studies provided data about everything that we were interested in, including overall survival of participants. The studies reported cancer relapse in different ways.

More research is needed to see if longer treatment with EGFR TKIs improves survival.

How current is this evidence?

The evidence is current to 9 December 2024.

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Do strengthening exercises help in the treatment of people with patellar tendinopathy (jumper's knee)?

Lopes AD;Rizzo RRN;Hespanhol L;Costa LOP;Kamper SJ — Tue, 27 May 2025 00:00:00 +0200

New

Authors:

Lopes AD, Rizzo RRN, Hespanhol L, Costa LOP, Kamper SJ

Key messages

— The evidence for using strengthening exercises to treat patellar tendinopathy (pain at the front of the knee involving the tendon) is very uncertain, making it difficult to draw firm conclusions.

— For athletes, we are very uncertain whether exercise reduces pain compared to no treatment. Strengthening exercises may make little or no difference to function compared to no treatment, and little or no difference to function and pain compared to glucocorticoid injections (anti-inflammatory medications).

— It is unclear if these exercises are better than surgery for reducing pain or improving function. Athletes reported similar treatment success and return to sport with strengthening exercises and surgery.

What is patellar tendinopathy?

People with patellar tendinopathy (jumper's knee) usually have pain and tenderness upon pressing the tendon at the front of the knee (connects muscles to bones). This frequently affects people in activities requiring repetitive jumping, braking, kicking, or running. Patellar tendinopathy can cause disability in both athletes and non-athletes, significantly impacting athletic performance and career longevity.

How is patellar tendinopathy treated?

One of the main treatments for patellar tendinopathy is exercise, especially strengthening exercises. Other options include anti-inflammatory medications (such as glucocorticoid injections) and, in some cases, surgery. Additional treatments that have been used include platelet-rich plasma injections (a concentrated component of the blood injected into the knee), ultrasound therapy (which uses sound waves to reduce pain and support healing), laser therapy (which uses focused light to decrease pain and swelling, and speed up healing), and shockwave therapy (which uses high-energy sound waves to stimulate healing and reduce pain).

What did we do?

We searched for studies comparing exercises with other treatments (such as no treatment, anti-inflammatory medicines (for example, glucocorticoid injection), and surgery) in people with patellar tendinopathy. We collected data on pain, function, treatment success, quality of life, return to sport, and unwanted effects, and assessed how confident we were in the results.

What did we find?

We found seven studies published between 1989 and 2022, and reported in English. Two studies were from Norway, and one each from Denmark, Germany, Greece, Poland, and the US.

Key findings

Pain (measured between 0 and 100, lower scores mean less pain) at end of treatment.

We are very uncertain whether exercise reduces pain compared to no treatment.

– People in the exercise group rated their pain as 27 points.

– People in the no-treatment group rated their pain as 62 points.

Exercise may make little or no difference to pain compared to glucocorticoid injection.

– People in the exercise group rated their pain as 24 points.

– People in the glucocorticoid injection group rated their pain as 18 points.

We are very uncertain whether exercise reduces pain compared to surgery.

– People in the exercise group rated their pain as 13 points.

– People in the surgery group rated their pain as 17 points.

Function (measured between 0 and 100, lower scores mean better function) at end of treatment.

Exercise may make little or no difference to function compared to no treatment.

– People in the exercise group rated their knee function as 72 points.

– People in the no-treatment group rated their knee function as 65 points.

Exercise may make little or no difference to function compared to glucocorticoid injection.

– People in the exercise group rated their knee function as 76 points.

– People in the glucocorticoid injection group rated their knee function as 82 points.

We are very uncertain whether exercise reduces function compared to surgery.

– People in the exercise group rated their knee function as 52 points.

– People in the surgery group rated their knee function as 45 points.

Treatment success (measured from −5 to +5, +5 means maximum improvement) at the end of treatment.

Exercise may make little or no difference to treatment success compared to surgery.

– People in the exercise group rated their success as 1.7 points.

– People in the surgery group rated their success as 0.2 points.

Return to sport rate measured at 12 months.

Exercise may make little or no difference to the rate of return to sport compared to surgery.

– 85 out of 100 people returned to sport after exercise treatment.

– 86 out of 100 people returned to sport after surgery.

What are the limitations of the evidence?

The effectiveness of strengthening exercises for athletes is uncertain. There were few studies of varying quality, with a small number of people. All studies only included athletes, so the results may not apply to people who are not athletes. No studies reported unwanted effects.

How up to date is this evidence?

The evidence is up to date to 5 September 2023.

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Does yoga relieve cancer-related fatigue in people with cancer?

Tue, 27 May 2025 00:00:00 +0200

New

Authors:

Messer S, Oeser A, Wagner C, Wender A, Cryns N, Scherer RW, Mishra SI, Monsef I, Holtkamp U, Andreas M, Bröckelmann PJ, Ernst M, Skoetz N

Key messages

- Compared to no yoga, yoga after anticancer therapy probably reduces cancer-related fatigue slightly in the short term (up to 12 weeks after doing yoga).

- We do not know if yoga during anticancer therapy relieves short-, medium-, or long-term cancer-related fatigue compared to no yoga.

- More research is needed to understand (1) if the effects of starting yoga after anticancer therapy persist beyond 12 weeks, and (2) what are the effects of doing yoga before starting and during cancer treatment.

What is cancer-related fatigue?

Cancer-related fatigue is a feeling of extreme tiredness that lasts for a long time. It can be caused by cancer, cancer therapy, or both. Cancer-related fatigue affects the body and mood, and makes it hard to perform regular activities. It is stronger than just being tired, and does not go away by resting.

How is cancer-related fatigue treated?

Clinical guidelines (documents that give healthcare professionals advice on the best ways to care for people, based on the latest research and expert opinion) recommend physical exercise to improve cancer-related fatigue. Physical exercise affects cancer-related fatigue by influencing biological and psychological processes. But it is unclear what types of exercise may be most beneficial. It is thought that yoga may reduce cancer-related fatigue and improve the quality of life of people with cancer because of how yoga combines physical exercise/movement with breath control, mental focus, and body awareness. This review is one of a suite of five reviews exploring different kinds of exercise for cancer-related fatigue.

What did we want to find out?

We wanted to find out if yoga improves cancer-related fatigue and quality of life in adults (18 years and older). We also wanted to learn if there were any adverse events in the studies; that is, unwanted events that caused harm to participants.

We investigated the effects of yoga in the short term (up to 12 weeks after doing yoga sessions), medium term (between 12 weeks and 6 months after), and long term (more than 6 months after doing yoga sessions).

What did we do?
We searched for studies that compared yoga with no yoga in adults with any cancer. We included yoga done before, during, or after initiation of anticancer therapy. We included multiple types of yoga, including Hatha (a gentle, slow yoga focusing on basic poses and breathing) and Dru yoga (a flowing style that includes movements, breathing, and relaxation).

We compared and summarised the results of the studies, and rated our confidence in the evidence, based on factors such as study methods and sizes. We also explored whether the type of yoga, type of cancer, exercise format (individual versus group-based yoga; supervised or unsupervised), and participant age made any difference to the results.

What did we find?
We found 21 studies involving 2041 participants with various cancers. Most were women with breast cancer. Yoga was started during anticancer therapy in 13 studies and after therapy in eight studies. We did not find any studies in which participants practised yoga before anticancer treatment.

Yoga during anticancer therapy

It is unclear if yoga during anticancer therapy has an effect on short-, medium-, or long-term cancer-related fatigue compared to no yoga.

Yoga during anticancer therapy may increase short- and medium-term quality of life compared to no yoga, but we are very uncertain about the results. None of the studies measured long-term quality of life.

We do not know if doing yoga or not during anticancer therapy leads to adverse events. Only one study reported this outcome, meaning the evidence was weak/limited.

We did not find differences in the effects of different types of yoga, group and individual training, or supervised and unsupervised training.

Yoga after anticancer therapy

Yoga after anticancer treatment probably reduces short-term cancer-related fatigue compared to no yoga. We do not know if yoga after anticancer therapy reduces medium-term cancer-related fatigue. None of the studies measured long-term cancer-related fatigue.

Yoga after anticancer therapy may increase short- and medium-term quality of life slightly, but we are very uncertain about the results. None of the studies measured long-term quality of life.

We do not know if doing yoga after anticancer therapy leads to any adverse events.

We did not find differences in the effects of different types of yoga, types of cancer, or between age groups.

What are the limitations of the evidence?

The people in the studies were aware of which treatment they were getting – yoga or no yoga. Although this is inevitable for this type of research, it could have influenced the results. For some effects (e.g. medium-term and long-term effects), we did not find studies large enough to be certain about our results. Therefore, more research is needed to understand how sustainable the effects of yoga are for cancer-related fatigue, quality of life, and adverse events.

How current is this evidence?
The evidence is current to October 2023.

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Is it better to use ultrasound or anatomical landmarks to guide the needle to the correct placement for anaesthesia around the spinal cord in adults?

Makino Y;Miyake K;Roche D;Yoshimura S;Nahara I;Sahker E;Watanabe N — Tue, 27 May 2025 00:00:00 +0200

New

Authors:

Makino Y, Miyake K, Roche D, Yoshimura S, Nahara I, Sahker E, Watanabe N

Key messages

Compared to anatomical landmarks, using ultrasound guidance for neuraxial anaesthesia in adults reduces the number of attempts until success, and the procedure (needling) time. Success is defined as either the number of times the needle is advanced following a backward movement, or the number of times it punctures the skin.
Ultrasound guidance likely increases the rate of success on the first try.
Ultrasound guidance may make little to no difference to participant satisfaction or technical failure. Technical failure might include the need to change to general anaesthesia, or the need to discontinue the procedure for neuraxial anaesthesia, or whether the person experienced the intended anaesthetic effect.
We do not know whether ultrasound guidance affects pain during the procedures and adverse events.
Ultrasound guidance in neuraxial anaesthesia probably has some benefits, but uncertainties remain.

What is neuraxial anaesthesia?
Neuraxial anaesthesia is performed by injecting a local anaesthetic into the spaces surrounding the spinal cord, usually the spinal or epidural space, or a combination. It is a common technique for numbing a specific area of the body, used mainly for surgery or during labour. In neuraxial anaesthesia, the doctor places a needle between the vertebrae (backbones). Once the doctor finds the right spot, he or she will either inject the anaesthetic directly, or place a thin tube, called a catheter, into the space, through which they can inject the anaesthetic. Successful neuraxial anaesthesia, with as few attempts as possible, is important to reduce complications.

What is ultrasound and how it might work?

Ultrasound uses high-frequency sound waves to create images of the inside of the body. The doctor uses a handheld device, called a probe, to send ultrasound waves into the body and create pictures. Conventional neuraxial anaesthesia is performed by using specific anatomical points on the body as a guide. Sometimes the needle does not reach the targeted space, because the anatomical position the doctor thought he or she found by touching the area can be off a bit from the actual position. Ultrasound allows the doctor to see the local anatomy of interest and the size of important structures, and helps to figure out how deep and in what direction to insert the needle.

Two ultrasound-guided methods are commonly used. In the first one, ultrasound is used before the needle is inserted, or pre-procedural. The second one is referred to as real-time, which means the needle is inserted first, then moved to the correct spot while watching the ultrasound images.

What did we want to find out?

We wanted to find out whether it was better to use ultrasound or anatomical landmarks to guide the needle for neuraxial anaesthesia in adults. We also wanted to find out whether ultrasound guidance led to similar unwanted effects as anatomical landmarks.

What did we do?

We searched for studies that investigated ultrasound guidance compared with anatomical landmarks for neuraxial anaesthesia in adults. We compared and summarised the results of the studies, and rated our confidence in the evidence, based on factors, such as study methods and sizes.

What did we find?
We found 65 studies with 6823 people. Studies were conducted in Africa, Asia, Europe, the Middle East, North America, and Oceania. Four studies evaluated real-time ultrasound as an intervention.

Compared to anatomical landmarks, ultrasound guidance reduces the number of attempts required for successful placement of the needle by an average of 0.41 attempts per person, and reduces the procedure (needling) time by an average of 34 seconds.
Ultrasound guidance likely increases the success rate for first attempts: 778 people out of 1000 experienced successful first attempts with ultrasound guidance, compared to 556 people out of 1000 with anatomical landmarks.
Ultrasound guidance may result in little to no difference in participant satisfaction or technical failure.
Ultrasound guidance may have little to no effect on pain during procedures or unwanted effects, but we are very uncertain about the results.

What are the limitations of the evidence?
We are moderately to highly confident in our findings regarding the number of attempts, the length of time for the procedure, and the rate of first-attempt success.

We have little confidence in the evidence for:

Participant satisfaction, because it was difficult to hide who received ultrasound guidance. The results were very inconsistent across the different studies.
Technical failure, because there were not enough studies to be certain about the results of this outcome.
Pain during the procedure, because it was difficult to hide who received ultrasound guidance. The results were very inconsistent across the different studies, and the results included both those who experienced pain and those who did not.
Unwanted effects, because it was difficult to hide who received ultrasound guidance, and there were not enough studies to be certain about the results. This outcome should also be interpreted with caution, because there were a variety of definitions in each study, such as back pain or headache.

How up to date is this evidence?
The evidence is up-to-date to November 2023.

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Is post-incident debriefing after coercive measures for people with schizophrenia effective?

Välimäki M;Varpula J;Lantta T — Tue, 27 May 2025 00:00:00 +0200

New

Authors:

Välimäki M, Varpula J, Lantta T

Key messages

• Due to a lack of evidence, the benefits of post-incident debriefing after coercive measures (seclusion: locking someone in a separate room, or restraint: preventing them from moving) for people with schizophrenia or schizophrenia-type psychosis are unclear.

• Future research is needed into the effects of post-incident debriefing after coercive measures to find out whether it has benefits for people with schizophrenia and whether it has unwanted effects and costs.

What is schizophrenia, and what are seclusion and restraint?

Schizophrenia is a severe mental health condition that affects how people think, feel and behave. Schizophrenia and related psychotic disorders significantly impact millions of people globally, and pose challenges due to their diverse symptoms, economic burden and the risk of a person being locked in a secure room (seclusion) or prevented from moving (restraint), particularly if their behaviour is violent. Post-incident debriefing is suggested as a way to reduce the use and duration of these measures, and aims to ensure safety while acknowledging the ethical concerns and potential psychological harm that such measures may cause.

Seclusion is a coercive measure, which means locking a person into a separate room in a psychiatric ward. Restraint means preventing a person from moving, manually by staff members, or with different equipment, such as belts. These measures should be used as a last resort to prevent a person from hurting themselves or others. Post-incident debriefing can be used after these coercive measures and is a form of talking therapy. It aims to allow staff and people who have experienced coercion to learn from the event and so prevent future episodes of coercion.

What did we want to find out?

We wanted to find out the benefits and harms of post-incident debriefing after coercive measures for people with schizophrenia or schizophrenia-type psychosis.

What did we do?

We carried out a comprehensive search in specialised databases to identify studies in which people with schizophrenia were randomly assigned to two or more treatment groups to assess post-incident debriefing in adult psychiatric care.

What did we find?

We found one relevant study with data for 109 people. This study involved standardised post-incident debriefing until the person left hospital. People who received post-incident debriefing after coercive measures may be more likely to be secluded again compared to those receiving standard treatment, but this is very uncertain. The evidence supporting this result is based on one study, and we have very limited confidence in this finding. There was no evidence to suggest that people are less distressed during or immediately after the event or that they are more satisfied with their care compared to standard treatment. Again, we have very limited confidence in this finding. There was not enough information to determine changes in patient behaviour or unwanted or harmful effects.

What are the limitations of the evidence?

We have very little confidence in these findings because we only found one small study, and there were problems with how it was designed and reported. Although post-incident debriefing is common practice in clinical settings, the evidence is currently not available to support it in current forms. The findings of this review therefore suggest caution in its use. The review highlights the need for further high-quality studies to thoroughly assess the effects of post-incident debriefing in psychiatric inpatient care. Any post-incidence debriefing measures should be clearly defined and described so that people know how and why to use them in daily practice.

How up to date is this evidence?

This evidence is current to February 2023.

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Are atypical antipsychotic medicines useful for treating irritability and other symptoms in people with autism?

Wed, 21 May 2025 00:00:00 +0200

New

Authors:

Meza N, Franco JVA, Sguassero Y, Núñez V, Escobar Liquitay CM, Rees R, Williams K, Rojas V, Rojas F, Pringsheim T, Madrid E

Key messages

Risperidone and aripiprazole may reduce irritability symptoms, while lurasidone probably results in little to no difference in children with autism.
There is significant uncertainty about the effects of these drugs on aggression, weight gain and abnormal body movements (e.g. tremors) in children with autism.
These medicines may decrease obsessive-compulsive symptoms (unwanted thoughts (obsessions) and repetitive behaviours (compulsions)) and inappropriate speech in children with autism.
We could not thoroughly explore the benefits and harms of these medications in adults with autism as there were few data.

What is autism?

Autism, also known as autism spectrum disorder or autism spectrum condition, is a developmental disorder that affects communication, social interaction and behaviour.

What are atypical antipsychotic medicines?

Antipsychotic medications are primarily used to treat mental health problems, maintaining the balance of certain neurotransmitters (naturally occurring chemicals that allow nerves to communicate throughout the body; for example, dopamine) in the brain to improve a variety of symptoms. Atypical antipsychotics are medications with different benefits and harms compared to typical antipsychotics.

What did we want to find out?

We wanted to compare how well atypical antipsychotics work for reducing irritability in children and adults with autism spectrum disorder. Additionally, we wanted to understand their effectiveness and harms for other symptoms.

What did we do?

We looked for studies that compared different atypical antipsychotic medicines with a placebo (dummy treatment) or with another atypical antipsychotic medicine in people diagnosed with autism spectrum disorder.

What did we find?

We found 17 studies including 1027 people. Most studies focused on children, with only one study involving adults.

Some atypical antipsychotics, such as risperidone and aripiprazole, may reduce irritability in children with autism spectrum disorder over a short period, unlike lurasidone, which probably has little to no effect. Atypical antipsychotic medicines may improve obsessive-compulsive symptoms and may reduce inappropriate speech. We are very uncertain about the effects on aggression, weight gain and unwanted effects related to movement.

What are the limitations of the evidence?

Our confidence in the evidence ranged from moderate to very low. Although we have more confidence in some symptoms and measures, such as irritability, stronger evidence is still needed. We have even less confidence in measures such as weight gain and movement-related unwanted effects, mainly because the studies were small and results varied. In addition, most of the available data were from short-term studies.

How up to date is this information?

The information is current to January 2024.

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What are the benefits and risks of vaccines for preventing infectious diseases in adults with blood cancers?

Wed, 21 May 2025 00:00:00 +0200

New

Authors:

Zorger A-M, Hirsch C, Baumann M, Feldmann M, Bröckelmann PJ, Mellinghoff S, Monsef I, Skoetz N, Kreuzberger N

Key messages

• We found limited evidence on the preventive effect of vaccines on patient-relevant outcomes in adults with blood cancers. The included studies focused only on herpes zoster, COVID-19, and influenza vaccines. No studies measured quality of life.

• When compared to placebo, herpes zoster vaccines may lower the incidence of infection. They probably result in little to no difference in death from any cause. They cause short-term side effects, but we did not find an increase in serious side effects up to 12 months post-vaccination. Long-term effects on other outcomes are unclear.

• For COVID-19 and influenza vaccines, the evidence measuring the incidence of infection is very uncertain. Side effects were poorly reported or not analysed for people with blood cancers.

• Future studies should evaluate vaccines for a wider range of infections and focus on outcomes that matter to patients, such as quality of life and long-term safety.

What is the role of vaccines in people with blood cancers?

Vaccines protect people from getting infections by training the immune system to recognise and fight harmful germs. They can also lower the chance of severe illness, hospital stays, and death. For people with blood cancers, vaccines may be especially important because their immune systems are weaker. People with blood cancers often have an increased risk of serious complications from diseases like flu, pneumonia, and COVID-19. Vaccination, as a preventive measure, aims to reduce the chance of infection, lower the risk of complications, and improve quality of life for people with blood cancers.

What did we want to find out?

We wanted to understand how vaccines, as a preventive measure, impact important outcomes for adults with blood cancers. Specifically, we wanted to know whether vaccines reduce infections and reduce deaths from any cause. We were also interested in whether vaccines improve quality of life and if they cause any side effects. These include serious side effects such as hospitalisation, and side effects such as pain or redness at the injection site, and systemic (whole-body) reactions like fever, fatigue, or rash.

What did we do?

We searched for studies that evaluated vaccines compared to placebo (an inactive intervention that mimics the experimental intervention) or no vaccine. We also looked for studies that compared different vaccine types or doses. We considered a wide range of infectious diseases: COVID-19, diphtheria, Haemophilus influenzae type b (Hib infection), hepatitis B, herpes zoster, influenza, Neisseria meningitidis (meningitis), pertussis (whooping cough), polio, Streptococcus pneumoniae (pneumonia), and tetanus.

We summarised the findings from the studies and assessed our confidence in the evidence, taking into account factors like study design, methods, and sample sizes.

What did we find?

We found six studies that involved 25,886 adults with various blood cancers and that evaluated vaccines for preventing infections with herpes zoster, COVID-19, or influenza. No quality of life data were reported in the studies. Most studies were funded by pharmaceutical companies or research institutions and were conducted across multiple countries. We did not find any studies that we could include in the review of vaccines for our other infectious diseases of interest.

Main results

Four of the six studies we found were 'randomised controlled trials', which is the best study design to answer the questions we were asking. The results reported below are from these four studies.

Herpes zoster vaccines

For adults with blood cancers, herpes zoster vaccines:

• may decrease the risk of herpes zoster infection up to 21 months after vaccination (2 studies, 3067 people);

• probably result in no difference in death from any cause (1 study, 2548 people);

• slightly increase any side effects within 30 days after vaccination (2 studies, 3110 people);

• probably do not increase serious side effects within 12 months after vaccination (1 study, 562 people); and

• increase reactions around the injection site and systemic reactions within 28 days after vaccination (1 study, 2548 people).

COVID-19 vaccines

For adults with blood cancers:

• the evidence on the effect of the BNT162b2 vaccine on the risk of COVID-19 infection is very uncertain (1 study, 95 people); and

• the BNT162b2 vaccine probably increases side effects, though it may make little to no difference to serious side effects six months after the second dose (1 study, 2328 people in a mixed population, i.e. that included both solid and blood cancers).

Influenza vaccines

For adults with blood cancers:

• no studies evaluated an influenza vaccine versus placebo or no vaccine; and

• the evidence on the effect of two doses of influenza vaccine ('high-dose trivalent inactivated') compared to one dose of influenza vaccine (strength dependent on age) is very uncertain (1 study, 122 people).

What are the limitations of the evidence?

Our confidence in the results is limited. The studies did not address all the infectious diseases or outcomes we were interested in, and there were problems with the study methods, particularly the reporting of results.

How up to date is this evidence?

The evidence is based on searches run until December 2024.

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Which is more effective in reducing postoperative complications after pancreatic surgery – use of a drain tube or no drain tube?

Miao C;Hu Y;Bai G;Cheng N;Cheng Y;Wang W — Fri, 16 May 2025 00:00:00 +0200

Updated

Authors:

Miao C, Hu Y, Bai G, Cheng N, Cheng Y, Wang W

Key messages

It is unclear if use of a drain (tube) affects postoperative complications after pancreaticoduodenectomy (Whipple's procedure, a major surgical operation involving the pancreas, duodenum, and other organs) or distal pancreatectomy (surgical removal of the body and tail of the pancreas).
We do not know if an active (suction) drain after pancreaticoduodenectomy is better, worse, or the same as a passive (no suction) drain.
Early drain removal is probably better than late drain removal with regard to abdominal infection rate for people undergoing pancreaticoduodenectomy with a low risk of postoperative complications.

What is pancreatic surgery?

Pancreatic surgery is performed to treat various diseases, including pancreatic cancers, chronic pancreatitis (a condition where repeated inflammation permanently damages the pancreas), and biliary and duodenal cancers. The rate of postoperative complications after pancreatic surgery is high, ranging from 30% to 60%.

How is this managed?

The use of surgical drains is a very common practice after pancreatic surgery. However, the routine placement of a surgical drain to prevent postoperative complications after pancreatic surgery has been questioned.

What did we want to find out?

We wanted to compare (1) use of drain versus no drain, (2) different types of drains, and (3) different schedules for drain removal, by looking at:

number of deaths at 30 days;
number of deaths at 90 days;
abdominal infection rate;
wound infection rate;
drain-related complication rate.

What did we do?

We searched for studies that compared:

use of drain versus no drain;
different types of drains; or
different schedules for drain removal.

There were no restrictions on language, date of publication, or study setting. We compared and summarised the results of the studies and rated our confidence in the evidence based on factors such as study methods and sizes.

What did we find?

We found 12 studies involving a total of 2550 people. The studies were conducted in North America, Europe, and Asia and were published between 2001 and 2024. Eight studies were funded by non-commercial grants. One study was funded by a commercial company.

Main results

Use of drain (270 people) versus no drain (262 people) following pancreaticoduodenectomy (2 studies)

It is unclear if the use of a drain affects the number of deaths at 30 days, number of deaths at 90 days, wound infection rate, or abdominal infection rate after pancreaticoduodenectomy compared with no drain. Neither study reported drain-related complications.

Use of drain (318 people) versus no drain (308 people) following distal pancreatectomy (2 studies)

There were no deaths at 30 days in either group. It is unclear if the use of a drain affects the number of deaths at 90 days, wound infection rate, or abdominal infection rate after distal pancreatectomy compared with no drain. Neither study reported drain-related complications.

Active drain (222 people) versus passive drain (219 people) following pancreaticoduodenectomy (3 studies)

It is unclear if an active drain affects the number of deaths at 30 days, abdominal infection rate, or wound infection rate after pancreaticoduodenectomy compared with a passive drain. None of the studies reported the number of deaths at 90 days. There were no drain-related complications in either group.

Early drain removal (279 people) versus late drain removal (278 people) following pancreaticoduodenectomy (3 studies)

Early drain removal may make little to no difference to the number of deaths at 30 days or wound infection rate following pancreaticoduodenectomy compared with late drain removal. There were no deaths at 90 days in either group. Early drain removal probably results in a slight reduction in the abdominal infection rate (71 fewer abdominal infections per 1000 participants). None of the studies reported drain-related complications.

What are the limitations of the evidence?

We are not confident in the evidence because it is possible that people in the studies were aware of what treatment they were getting, and not all the studies provided information on everything we were interested in. In addition, some studies did not clearly report how they were conducted, and there were not enough studies to be certain about the results of our outcomes.

How up-to-date is this evidence?

This review updates our previous review. The evidence is current to July 2024.

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Do electronic or robotic gait-training devices help people walk better after a stroke?

Mehrholz J;Kugler J;Pohl M;Elsner B — Wed, 14 May 2025 00:00:00 +0200

Updated

Authors:

Mehrholz J, Kugler J, Pohl M, Elsner B

Key messages

• Electronic and robotic devices plus physiotherapy probably help people walk independently again after a stroke. They may particularly benefit people in the first three months after a stroke.

• We need more research to find out how often, and for how long, these devices should be used.

What is a stroke?

A stroke happens when the flow of blood to part of the brain is cut off, blocking the supply of oxygen and nutrients to brain cells. This causes a sudden attack of weakness that usually affects one side of the body. If the supply of blood to the brain is stopped, brain cells begin to die. This can lead to brain injury, disability, and even death.

People who survive a stroke are often left with long-term problems caused by the injury to their brain. They may find physical activities, such as walking, difficult because of weakened leg muscles on one or both sides of their body, stiff joints, or lack of co-ordination. People may need a long period of rehabilitation, including physiotherapy, before they can recover their former independence. Physiotherapy includes exercise, massage, skills training, and electrical treatment to help people regain movement.

Walking after a stroke

One of the most important goals after a stroke is to help people walk again. Robotic devices (programmed to move and perform certain tasks automatically) and electrically powered mechanical (electromechanical) devices have been developed to help people practise walking. People who have trouble walking after a stroke need a lot of practice to get better. It is unclear if these walking machines are effective.

What did we want to find out?

We wanted to find out if gait-training devices combined with physiotherapy can help people improve their walking after a stroke compared to not using such devices.

What did we do?

We searched for studies that looked at the use of gait-training devices to help people learn to walk again after a stroke. We were interested in:

• how many people could walk independently;

• how fast people could walk;

• how far they could walk in 6 minutes;

• how many people dropped out of the study; and

• how many people died.

We looked for studies in which people were assigned to treatment groups at random. This type of study usually gives the most reliable evidence about the effects of a treatment.

What did we find?

We found 101 studies involving 4224 adults (average age 47 to 76 years) who had had a stroke and were learning to walk again. The studies compared the effects of physiotherapy plus electromechanical and robotic devices for gait training with the effects of physiotherapy alone or usual care. In most studies, the training period lasted three to four weeks; the shortest time was 10 days, and the longest was eight weeks.

At the end of training, compared with physiotherapy or usual care, using a gait‑training device plus physiotherapy:

• probably helps more people walk independently (51 studies; 2148 people);

• probably does not increase people's average walking velocity (73 studies; 3043 people);

• does not increase the distance people could walk in 6 minutes (42 studies; 1966 people); and

• does not increase or decrease how many people dropped out of the study, or how many people died (deaths were rare) (101 studies; 4224 people).

For every nine people treated with a device plus physiotherapy, probably one extra person walks independently by the end of treatment.

At follow-up, using a gait‑training device plus physiotherapy may not help more people walk independently, and probably does not increase people's average walking velocity or the distance people could walk in 6 minutes, compared with physiotherapy or usual care.

What are the limitations of the evidence?

We have low to high confidence in our results. Many studies were of low or poor quality with small sample sizes. Therefore, some studies may have made the benefits of these devices seem greater than they are.

How up-to-date is this evidence?

The evidence is current to December 2023.

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What are the benefits and risks of early discharge with home support of tube feeding for stable preterm babies who have not established full breast or bottle (all suck) feeds?

Rumbold AR;Keir A;Collins CT;Cooper C;Shepherd ES — Tue, 13 May 2025 00:00:00 +0200

Updated

Authors:

Rumbold AR, Keir A, Collins CT, Cooper C, Shepherd ES

Key messages

For stable preterm babies (born before 37 weeks of pregnancy) who are not yet having all feeds at the breast or bottle (all suck or oral feeds), we found very uncertain evidence that early discharge with home support of gavage (tube) feeding versus later discharge when they are fully suck feeding:
- may result in little to no difference in weight gain, breastfeeding at discharge from home support/hospital and three months later, and the need to be readmitted to hospital up to 12 months later; and
- may reduce the risk of respiratory infections up to discharge from home support/hospital, but may result in little to no difference in the use of antibiotics given directly into a vein.
Larger studies with high-quality methods are needed to determine the benefits and harms of this approach, including in diverse settings and populations.

Why might early discharge with home support of gavage feeding be important?

Babies born preterm (before 37 weeks of pregnancy) often need help to establish feeding, and are fed initially via a tube passed through the nose or mouth and into the stomach (known as gavage feeding). Discharge from hospital usually occurs when they no longer need gavage feeds and are on full sucking feeds and gaining weight appropriately. Early discharge of babies who are stable but still need gavage feeds might unite families sooner and have positive effects on parent-infant attachment, parent well-being, and infant development. These babies may graduate to full sucking feeds at home if the family receives some support. In addition, early discharge might reduce costs for families and the healthcare system. However, this approach may present a burden for the family and increase complications during the transition from tube feeding.

What did we want to find out?

We wanted to find out if early discharge with home support of gavage feeding is better than later discharge on full sucking feeds for stable preterm babies.

We were interested in the effects of early discharge with support on: how long it takes for babies to reach full sucking feeds; how much weight babies gain; breastfeeding on discharge from home support/hospital and three months later; infection up to discharge from home support/hospital; development at 12 months or later; and need for readmission to hospital up to 12 months after discharge from home support/hospital.

What did we do?

We searched for studies that looked at the benefits and harms of early discharge with home support of gavage feeding for stable preterm babies and their families compared with later discharge on full sucking feeds. We summarised the results and rated our confidence in the evidence based on factors such as study methods and size.

What did we find?

We found only one study conducted in Sweden from 1992 to 1994 and involving 88 babies from 75 families. The study looked at early discharge with home support of gavage feeding compared with later discharge on full sucking feeds for babies born preterm who were expected to need additional care for at least another week. For different results, information was available for 82 to 88 of the babies from this study.

Compared with later discharge on full sucking feeds, early discharge with home support of gavage feeding may have little or no effect on:

weight gain for babies (average per day from study entry to discharge from home support/hospital);
stopping any breastfeeding and fully breastfeeding at discharge from home support/hospital and three months later;
the use of antibiotics given directly into a vein; and
the need for readmission to hospital up to 12 months after discharge from home support/hospital.

Early discharge with support versus later discharge may reduce the risk of respiratory infections (diagnosed based on symptoms, not laboratory tests) for babies up to discharge from home support/hospital.

The study did not examine the time taken for babies to reach full sucking feeds or development at 12 months or later.

We found two other studies that might be included in a future update of this review. One study is finished but not yet published. We do not know whether the other study is completed because the study authors have yet to reply to our request for information.

What are the limitations of the evidence?

We are not confident in the evidence because it is based on a single study that included few infants, because the method for assigning babies to one group or the other was not truly random, and because the families and clinicians knew which group the babies had been assigned to.

The results of further research could differ from and change the results of this review.

How up-to-date is this evidence?

This review updates our previous 2015 review. The evidence is current to 30 May 2024.

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