GEM/cochrane-simplification huggingface dataset:
Abstract: This review included 42 studies (11,399 patients) including 19 studies from the original review (2010), as well as 23 new studies. Fifteen studies were excluded from the original review (nine retracted from publication due to concerns about integrity of data and six lacking individual patient creatinine data for the calculation of RIFLE criteria). Overall, there was a significant increase in the need for RRT in the HES treated individuals compared to individuals treated with other fluid therapies (RR 1.31, 95% CI 1.16 to 1.49; 19 studies, 9857 patients) and the number with author-defined kidney failure (RR 1.59, 95% CI 1.26 to 2.00; 15 studies, 1361 patients). The RR of AKI based on RIFLE-F (failure) criteria also showed an increased risk of AKI in individuals treated with HES products (RR 1.14, 95% CI 1.01 to 1.30; 15 studies, 8402 participants). The risk of meeting urine output and creatinine based RIFLE-R (risk) criteria for AKI was in contrast in favour of HES therapies (RR 0.95, 95% CI 0.91 to 0.99; 20 studies, 8769 patients). However, when RIFLE-R urine output based outcomes were excluded as per study protocol, the direction of AKI risk again favoured the other fluid type, with a non-significant RR of AKI in HES treated patients (RR 1.05, 95% CI 0.97 to 1.14; 8445 patients). A more robust effect was seen for the RIFLE-I (injury) outcome, with a RR of AKI of 1.22 (95% CI 1.08 to 1.37; 8338 patients). No differences between subgroups for the RRT and RIFLE-F based outcomes were seen between sepsis versus non-sepsis patients, high molecular weight (MW) and degree of substitution (DS) versus low MW and DS (≥ 200 kDa and > 0.4 DS versus 130 kDa and 0.4 DS) HES solutions, or high versus low dose treatments (i.e. ≥ 2 L versus < 2 L). There were differences identified between sepsis versus non-sepsis subgroups for the RIFLE-R and RIFLE-I based outcomes only, which may reflect the differing renal response to fluid resuscitation in pre-renal versus sepsis-associated AKI. Overall, methodological quality of the studies was good. The current evidence suggests that all HES products increase the risk in AKI and RRT in all patient populations and a safe volume of any HES solution has yet to be determined. In most clinical situations it is likely that these risks outweigh any benefits, and alternate volume replacement therapies should be used in place of HES products.

Plain-language summary: This review examined the effects of HES on kidney function compared to other fluid therapies in critically ill patients. Forty-two randomised clinical trials (11,399 patients) comparing HES to another fluid therapy qualified for this review. Overall, the use of HES products was associated with a 59% increased risk of kidney failure, and a 32% increased risk of dialysis. No significant differences in effect were seen depending on the patient population studied, the type of HES solution, or the dose used. Due to the potential risks associated with HES products, alternative fluid therapies should be used.
Abstract: We identified nine studies that enrolled 682 participants. None of the studies reported blinding or group allocation methods. Seven studies were judged to be at low risk of incomplete outcome reporting; three studies were judged to be a low risk of selective reporting (protocols were available and/or all outcomes relevant to the this review were reported); and two studies were judged free of other potential biases. Seven studies compared Rheum officinale with no treatment and two made comparisons with captopril, an angiotensin-converting enzyme inhibitor (ACEi). Compared with no treatment, Rheum officinale had a positive effect on SCr (MD -87.49 µmol/L, 95% CI -139.25 to -35.72) and BUN (MD -10.61 mmol/L, 95% CI -19.45 to -2.21). Compared with captopril, a statistically significant difference was not demonstrated in relation to Rheum officinale for any outcome (BUN, CrCl, or patients' capacity to undertake work). No data were available on all-cause mortality or cost of treatment. Only minor adverse events were reported in association with Rheum officinale. Currently available evidence concerning the efficacy of Rheum officinale to improve SCr and BUN levels in patients with CKD is both scant and low quality. Although Rheum officinale does not appear to be associated with serious adverse events among patients with CKD, there is no current evidence to support any recommendation for its use.

Plain-language summary: We analysed evidence from nine studies conducted in China that compared Rheum officinale with no treatment or treatment with captopril, an ACEi. We looked at reported changes in two important blood markers - serum creatinine and blood urea nitrogen - that indicate progression of CKD. We found no high quality evidence to indicate that treatment with Rheum officinale can improve CKD or delay its progression. Rheum officinale was not found to cause any serious health problems in patients with CKD. Well-designed randomised controlled studies are needed to provide robust, high quality evidence to assess if there are benefits from Rheum officinale for people with CKD.
Abstract: We included three RCTs involving 91 participants. All three studies scored 'low quality' on the methodological quality assessment, implying high risk of bias. All studies investigated various types and intensities of outpatient rehabilitation programmes following BoNT for upper limb spasticity in adults with chronic stroke. Rehabilitation programmes included: modified constraint-induced movement therapy (mCIMT) compared with a neurodevelopmental therapy programme; task practice therapy with cyclic functional electrical stimulation (FES) compared with task practice therapy only; and occupational, manual therapy with dynamic elbow extension splinting compared with occupational therapy only. There was 'low quality' evidence for mCIMT improving upper limb motor function and spasticity in chronic stroke survivors with residual voluntary upper limb activity, up to six months, and 'very low quality' evidence for dynamic elbow splinting and occupational therapy reducing elbow range of movement at 14 weeks. Task practice therapy with cyclic FES did not improve upper limb function more than task practice therapy alone, only at 12 weeks. No studies addressed interventions in children and those with lower limb spasticity, or after other focal intramuscular treatments for spasticity. At best there was 'low level' evidence for the effectiveness of outpatient MD rehabilitation in improving active function and impairments following BoNT for upper limb spasticity in adults with chronic stroke. No trials explored the effect of MD rehabilitation on 'passive function' (caring for the affected limb), caregiver burden, or the individual's priority goals for treatment. The optimal types (modalities, therapy approaches, settings) and intensities of therapy for improving activity (active and passive function) in adults and children with post-stroke spasticity, in the short and longer term, are unclear. Further research is required to build evidence in this area.

Plain-language summary: We included three relevant studies in the review, which investigated different types of MD rehabilitation interventions after botulinum toxin injections into the arms of 91 adults with previous stroke. There was low quality evidence for intensive forced use of the affected arm in improving spasticity, and very low quality evidence for elbow splinting with occupational therapy. We did not identify any studies of MD rehabilitation in children with post-stroke spasticity or after other injected medications. The review findings are limited by the small number of studies that are methodologically flawed. More research is needed into what rehabilitation modalities and treatments are most effective for spasticity management following stroke.
Abstract: Four trials, recruiting 136 participants, were included. Two trials compared lamivudine alone versus HBIg alone. Randomisation was performed one week after transplantation in one of the trials and after six months after transplantation in another; from transplantation until randomisation, HBIg alone was given to all patients in the two trials. A third trial compared combination treatment with lamivudine and HBIg versus lamivudine alone after one month of combination treatment, and a fourth trial compared the combination of lamivudine and HBIg versus a combination of lamivudine and adefovir dipivoxil after at least 12-month of lamivudine and HBIg combination treatment. Statistically significant differences were not detected in any of the comparisons and outcomes. All trials were open-labelled, and none of the trials were adequately powered to show a difference in HBV recurrence. No meta-analyses were performed since the identified trials assessed different comparisons. This review could not derive clear evidence from randomised clinical trials for the treatment of patients with chronic HBV following liver transplantation for preventing recurrence of HBV infection. Large randomised clinical trials comparing long-term combination treatment to each of the monotherapy alone, including the newer antiviral drugs, are needed.

Plain-language summary: We found only four randomised clinical trials that compared different prophylactic regimens in 136 participants. None of the trials compared the same prophylaxis regimen. In each individual trial no significant differences were detected with regard to patients' survival after transplantation, HBV recurrence, or the recurrence of liver disease. All trials were too small to detect a difference, if it existed. Prevention of HBV recurrence following liver transplantation is currently non-evidence based. Practice is to administer a combination of HBIg and an antiviral drug. Randomised clinical trials are needed to examine this practice.
Abstract: Three randomised controlled trials were included. In two trials, there was a statistically significant reduction in the recurrence of painful periods in the LNG-IUD group compared with expectant management (RR 0.22, 95% CI 0.08 to 0.60, 95 women, I2 = 0%, moderate strength of evidence). The proportion of women who were satisfied with their treatment was also higher in the LNG-IUD group but did not reach statistical significance (RR 1.21, 95% CI 0.80 to 1.82, 95 women, I2 = 0%). The number of women reporting a change in menstruation was significantly higher in the LNG-IUD group (RR 37.80, 95% CI 5.40 to 264.60, 95 women, I2 = 0%) but the number of women not completing the allocated treatment did not differ between groups (RR 0.66, 95% CI 0.08 to 5.25, I2 = 43%). In one trial, women receiving LNG-IUD noted lower pain scores compared with women receiving gonadotrophin-releasing hormone agonists (MD -0.16, 95% CI -2.02 to 1.70, 40 women) but this did not reach statistical significance. There is limited but consistent evidence showing that postoperative LNG-IUD use reduces the recurrence of painful periods in women with endometriosis. Further well-designed RCTs are needed to confirm these findings.

Plain-language summary: Endometriosis is the presence of endometrial tissue outside the uterus, usually in the pelvis, that can lead to infertility and pelvic pain. It is managed with surgery, hormonal medications, or a combination of both. The progestogen levonorgestrel is one such hormonal medication. The aim of this review was to assess whether the use of a hormone-releasing intrauterine device was beneficial for managing associated painful symptoms and for preventing recurrence of endometriosis following surgery. Although preliminary findings are encouraging, at this stage there is only limited evidence from three randomised trials of a beneficial role with the use of the LNG-IUD in reducing the recurrence of painful periods following surgery for endometriosis. The strength of the evidence was graded as moderate reflecting our belief that future evidence will most likely not change these findings.
Abstract: Overall there is an absence of evidence for behaviour therapy, except a small improvement in mood immediately following treatment when compared with an active control. CBT has small positive effects on disability and catastrophising, but not on pain or mood, when compared with active controls. CBT has small to moderate effects on pain, disability, mood and catastrophising immediately post-treatment when compared with treatment as usual/waiting list, but all except a small effect on mood had disappeared at follow-up. At present there are insufficient data on the quality or content of treatment to investigate their influence on outcome. The quality of the trial design has improved over time but the quality of treatments has not. Benefits of CBT emerged almost entirely from comparisons with treatment as usual/waiting list, not with active controls. CBT but not behaviour therapy has weak effects in improving pain, but only immediately post-treatment and when compared with treatment as usual/waiting list. CBT but not behaviour therapy has small effects on disability associated with chronic pain, with some maintenance at six months. CBT is effective in altering mood and catastrophising outcomes, when compared with treatment as usual/waiting list, with some evidence that this is maintained at six months. Behaviour therapy has no effects on mood, but showed an effect on catastrophising immediately post-treatment. CBT is a useful approach to the management of chronic pain. There is no need for more general RCTs reporting group means: rather, different types of studies and analyses are needed to identify which components of CBT work for which type of patient on which outcome/s, and to try to understand why.

Plain-language summary: Our search found 42 trials of treatments which met our criteria, but only 35 provided data in a form that could be used. The two main types of psychological treatment are called cognitive behavioural therapy (CBT) and behaviour therapy. Both focus on helping people to change behaviour that maintains or worsens pain, disability, distress and catastrophic thinking; CBT also directly addresses the thoughts and feelings that are a problem for people with persistent pain. The effects of these two treatments on pain, disability, mood and catastrophic thinking were tested immediately after the treatment, and six months later. Small to moderate benefits, more for disability, mood and catastrophic thinking than for pain, were found in trials which compared CBT with no treatment. Some of these were still positive six months later. Behaviour therapy showed few and only brief benefits. Psychological therapies can help people with chronic pain reduce negative mood (depression and anxiety), disability, catastrophic thinking, and in some cases, pain. Although the overall effect is positive, we do not know enough about exactly which type of treatment is best for which person.
Abstract: We identified 582 records from the databases and search strategies. We found 10 further records by searching other resources (handsearching). We removed 211 duplicate records and screened 381 records (title and abstract) for inclusion in the review. We excluded 364 records based on the title and abstract and assessed 17 full-text articles. We excluded 15 studies: eight studies did not assess interventions to prevent SUDEP; five studies measured sensitivity of devices to detect GTCS but did not directly measure SUDEP; and two studies assessed risk factors for SUDEP but not interventions for preventing SUDEP. One listed study is awaiting classification. We included one case-control study at serious risk of bias within a qualitative analysis in this review. This study of 154 cases of SUDEP and 616 controls ascertained a protective effect for the presence of nocturnal supervision (unadjusted odds ratio (OR) 0.34, 95% confidence interval (CI) 0.22 to 0.53) and when a supervising person shared the same bedroom or when special precautions, for example a listening device, were used (unadjusted OR 0.41, 95% CI 0.20 to 0.82). This effect was independent of seizure control. Non-SUDEP deaths; changes to anxiety, depression, and quality of life; and number of hospital attendances were not reported. We found very low-quality evidence of a preventative effect for nocturnal supervision against SUDEP. Further research is required to identify the effectiveness of other current interventions, for example seizure detection devices, safety pillows, SSRIs, early surgical evaluation, educational programmes, and opiate and adenosine antagonists in preventing SUDEP in people with epilepsy.

Plain-language summary: We judged the quality of the evidence from this review to be very low as the only included study was not randomised, and information about supervision measures to prevent SUDEP was not available for 40% of the people with epilepsy who did not experience SUDEP. We found very limited, low-quality evidence that supervision at night prevents SUDEP. Further research is needed to identify if other treatments, such as seizure detection devices, safety pillows, and drug interventions working on serotonin, adenosine, and opiate levels in the brain are effective in preventing SUDEP in people with epilepsy.
Abstract: Twenty five studies (1305 participants) were included in the review, of which 22 studies (1060 participants) contributed data to meta-analyses. Based on thirteen studies, psychological therapies, all using a CBT approach, were more effective than TAU/WL in achieving clinical response at post-treatment (RR 0.64, 95%CI 0.55 to 0.74), and also in reducing anxiety, worry and depression symptoms. No studies conducted longer-term assessments of CBT against TAU/WL. Six studies compared CBT against supportive therapy (non-directive therapy and attention-placebo conditions). No significant difference in clinical response was indicated between CBT and supportive therapy at post-treatment (RR 0.86, 95%CI 0.70 to 1.06), however, significant heterogeneity was indicated, which was partly explained by the number of therapy sessions. Psychological therapy based on CBT principles is effective in reducing anxiety symptoms for short-term treatment of GAD. The body of evidence comparing CBT with other psychological therapies is small and heterogeneous, which precludes drawing conclusions about which psychological therapy is more effective. Further studies examining non-CBT models are required to inform health care policy on the most appropriate forms of psychological therapy in treating GAD.

Plain-language summary: This review aimed to find out whether psychological therapies are effective for GAD, and whether cognitive behavioural therapy (CBT) is more effective than other psychological therapy approaches, including psychodynamic and supportive therapies. The review included 25 studies, with a total of 1305 participants. All the studies used a CBT approach, and compared CBT against treatment as usual or waiting list (13 studies), or against another psychological therapy (12 studies). The review showed that people attending for psychological therapy based on a CBT approach were more likely to have reduced anxiety at the end of treatment than people who received treatment as usual or were on a waiting list for therapy. CBT was also very effective in reducing secondary symptoms of worry and depression. People who attended for group CBT and older people were more likely to drop out of therapy. None of the studies comparing CBT with treatment as usual or waiting list looked at the long-term effectiveness of CBT. It is not clear whether people attending for CBT sessions were more likely to have reduced anxiety than people attending for psychodynamic therapy or supportive therapy, because only one study compared CBT with psychodynamic therapy, and the six studies that compared CBT with supportive therapy showed differing results. None of the studies included in the review reported on the possible side effects or acceptability of psychological therapies. More studies should be carried out to establish whether psychodynamic and supportive therapies are effective for GAD, and whether CBT is more helpful than other psychological therapy approaches in treating GAD.
Abstract: Three trials reporting two different sequencing comparisons were identified. There were no significant differences between the various methods of sequencing adjuvant therapy for local recurrence-free survival, overall survival, relapse-free survival and metastasis-free survival based on 1166 randomised women in three trials. Concurrent chemoradiation increased anaemia (OR 1.54; 95% confidence interval (CI) 1.10 to 2.15), telangiectasia (OR 3.85; 95% CI 1.37 to 10.87) and pigmentation (OR 15.96; 95% CI 2.06 to 123.68). Treated women did not report worse cosmesis with concurrent chemoradiation but physician-reported assessments did (OR 1.14; 95% CI 0.42 to 3.07). Other measures of toxicity did not differ between the two types of sequencing. On the basis of one trial (244 women), RT before CT was associated with an increased risk of neutropenic sepsis (OR 2.96; 95% CI 1.26 to 6.98) compared with CT before RT, but other measures of toxicity did not differ. The data included in this review, from three well-conducted randomised trials, suggest that different methods of sequencing CT and RT do not appear to have a major effect on recurrence or survival for women with breast cancer if RT is commenced within seven months after surgery.

Plain-language summary: This review examined the current evidence on the best way to administer chemotherapy and radiotherapy following breast-conserving surgery. We were able to include three randomised trials. Two of these, with 853 women, assessed radiotherapy and chemotherapy given at the same time versus chemotherapy given first followed by radiotherapy. The third trial randomised 244 women to radiotherapy followed by chemotherapy versus chemotherapy followed by radiotherapy. The evidence produced by these three well-conducted trials suggests that recurrence of a woman's cancer and her chances of dying from breast cancer are similar regardless of the order of the treatments, provided that both radiotherapy and chemotherapy are commenced within seven months of the surgery. The trials provided limited information regarding adverse events, side effects or quality of life associated with the different sequences of treatment. The limited evidence available does suggest that the frequency and severity of side effects of chemotherapy and radiotherapy are similar regardless of which sequence is used. However, it should be noted that the women in these trials were treated, on average, in the early 2000s. As a result, the trials do not assess the modern types of radiotherapy, and new types of chemotherapy (such as taxanes) or other drugs (such as Herceptin). We will add relevant trials that include these more recent treatments to future updates of this review.