GEM/cochrane-simplification huggingface dataset:
Abstract: The updated review included 16 new studies involving 25,819 participants, resulting in a total of 42 studies including 33,840 participants. We used the Cochrane risk of bias tool and assessed three studies at high risk of bias; the remainder were considered to have a low risk of bias. We included 26 studies that predominantly evaluated organisational interventions and 16 that evaluated educational and behavioural interventions for participants. We pooled results where appropriate, although some clinical and methodological heterogeneity was present. Educational and behavioural interventions showed no clear differences on any of the review outcomes, which include mean systolic and diastolic blood pressure, mean body mass index, achievement of HbA1c target, lipid profile, mean HbA1c level, medication adherence, or recurrent cardiovascular events. There was moderate-quality evidence that organisational interventions resulted in improved blood pressure control, in particular an improvement in achieving target blood pressure (odds ratio (OR) 1.44, 95% confidence interval (CI) 1.09 to1.90; 13 studies; 23,631 participants). However, there were no significant changes in mean systolic blood pressure (mean difference (MD), -1.58 mmHg 95% CI -4.66 to 1.51; 16 studies; 17,490 participants) and mean diastolic blood pressure (MD -0.91 mmHg 95% CI -2.75 to 0.93; 14 studies; 17,178 participants). There were no significant changes in the remaining review outcomes. We found that organisational interventions may be associated with an improvement in achieving blood pressure target but we did not find any clear evidence that these interventions improve other modifiable risk factors (lipid profile, HbA1c, medication adherence) or reduce the incidence of recurrent cardiovascular events. Interventions, including patient education alone, did not lead to improvements in modifiable risk factor control or the prevention of recurrent cardiovascular events.

Plain-language summary: This updated review included 16 new studies involving 25,819 participants, resulting in a total of 42 studies including 33,840 with stroke or TIA whose average age ranged from 60 to 74.3 years. Most studies took place in primary care or community settings. Sixteen studies involved educational or behavioural interventions for participants and 26 studies mostly involved organisational interventions. Most interventions lasted for between three and 12 months, with follow-up from three months up to three years. Changes to healthcare services that looked at patient education or behaviour only, without any alterations in the organisation of patient care, showed no clear evidence of improvements in risk factors for stroke. Changes in the organisation of healthcare services resulted in improvements in blood pressure control. The effects of these interventions on changes in blood fats, blood sugar, body weight, or use of medicines were not conclusive. We identified 24 ongoing studies suggesting that research in this area is increasing. The available evidence was assessed as moderate- or low-quality because of variations in methods used and results reported.
Abstract: Four studies with a total of 136 participants were included. Two studies compared the use of plugs versus no plugs, one study compared two sizes of the same brand of plug, and one study compared two brands of plugs. In all included studies there was considerable dropout (in total 48 (35%) dropped out before the end of the study) for varying reasons. Data presented are thus subject to potential bias. 'Pseudo-continence' was, however, achieved by some of those who continued to use plugs, at least in the short-term. In a comparison of two different types of plug, plug loss was less often reported and overall satisfaction was greater during use of polyurethane plugs than polyvinyl-alcohol plugs. The available data were limited and incomplete, and not all pre-specified outcomes could be evaluated. Consequently, only tentative conclusions are possible. The available data suggest that anal plugs can be difficult to tolerate. However, if they are tolerated they can be helpful in preventing incontinence. Plugs could then be useful in a selected group of people either as a substitute for other forms of management or as an adjuvant treatment option. Plugs come in different designs and sizes; the review showed that the selection of the type of plug can impact on its performance.

Plain-language summary: Four studies with a total of 136 participants were included. Two studies compared the use of plugs versus no plugs. The involuntary loss of stool was effectively blocked (pseudo-continence) in six (38%) participants who continued to use the plugs, at least in the short-term. One study compared two sizes of the same brand of plug; due to the high dropout in this study and the incomplete data, no results concerning this comparison are available. In one study a comparison of two different brands of plug was made. Loss of plug was reported by 7 patients (30%) with a polyurethane (PU) plug and by 15 patients (65%) with the polyvinyl-alcohol (PVA) plug. Overall satisfaction, defined as patients' opinion that the plug was good to very good, was reported more often for the PU plug (n = 17) than for the PVA plug (n = 8). In all included studies there was considerable dropout; in total 48 participants (35%) dropped out before the end of the study for varying reasons. Data presented are thus subject to potential bias, and only tentative conclusions are possible. The available data suggest that anal plugs can be difficult to tolerate. However, if they are tolerated they can be helpful in preventing incontinence. Plugs could then be useful in a selected group of people either as a substitute for other forms of management or as an adjuvant treatment option. Plugs come in different designs and sizes; the review showed that the selection of the type of plug can impact on its performance.
Abstract: Twelve trials (1241 patients) evaluated antibiotic prophylaxis compared with placebo or no antibiotic prophylaxis. All trials were at risk of bias. Antibiotic prophylaxis compared with no intervention or placebo was associated with beneficial effects on mortality (RR 0.79, 95% CI 0.63 to 0.98), mortality from bacterial infections (RR 0.43, 95% CI 0.19 to 0.97), bacterial infections (RR 0.36, 95% CI 0.27 to 0.49), rebleeding (RR 0.53, 95% CI 0.38 to 0.74), days of hospitalisation (MD -1.91, 95% CI -3.80 to -0.02), bacteraemia (RR 0.25, 95% CI 0.15 to 0.40), pneumonia (RR 0.45, 95% CI 0.27 to 0.75), spontaneous bacterial peritonitis (RR 0.29, 95% CI 0.15 to 0.57), and urinary tract infections (RR 0.23, 95% CI 0.12 to 0.41). No serious adverse events were reported. The trials showed no significant heterogeneity of effects. Another five trials (650 patients) compared different antibiotic regimens. Data could not be combined as each trial used different antibiotic regimen. None of the examined antibiotic regimen was superior to the control regimen regarding mortality or bacterial infections. Prophylactic antibiotic use in patients with cirrhosis and upper gastrointestinal bleeding significantly reduced bacterial infections, and seems to have reduced all-cause mortality, bacterial infection mortality, rebleeding events, and hospitalisation length. These benefits were observed independently of the type of antibiotic used; thus, no specific antibiotic can be preferred. Therefore, antibiotic selection should be made considering local conditions such as bacterial resistance profile and treatment cost.

Plain-language summary: Twelve trials (1241 patients) assessing several antibiotic prophylaxis regimens versus no intervention or placebo were analysed, showing that antibiotic prophylaxis successfully reduced the incidence of bacterial infections. Antibiotic prophylaxis was also associated with a reduction in mortality, mortality from bacterial infections, rebleeding rate, and days of hospitalisation. The prophylactic treatment was not associated with important adverse effects. Five trials (650 patients) assessed one antibiotic regimen compared with another. All antibiotic regimens provided similar benefits and none seemed superior. Thus, to this point there is no evidence to recommend one specific antibiotic regimen over the other. All trials analysed were subject to bias; thus, results should be interpreted carefully.
Abstract: We included three studies with a total of 83 participants. For efficacy, a greater proportion of participants in the topiramate group had a 50% or more reduction in primarily generalized tonic-clonic seizures (PGTCS) compared with participants in the placebo group. There were no significant differences between topiramate and valproate in participants responding with a 50% or more reduction in myoclonic seizures or in PGTCS, or becoming seizure-free. Concerning tolerability, we ranked AEs associated with topiramate as moderate to severe, while we ranked 59% of AEs linked to valproate as severe complaints. Moreover, systemic toxicity scores were higher in the valproate group than the topiramate group. Overall we judged all three studies to be at high risk of attrition bias and at unclear risk of reporting bias. We judged all three studies to be at low to unclear bias for the remaining risk of bias domains (random sequence, allocation, blinding). We judged the quality of the evidence from the studies to be very low. We have found no new studies since the last version of this review was published in 2017. This review does not provide sufficient evidence to support topiramate for the treatment of people with JME. Based on the current limited available data, topiramate seems to be better tolerated than valproate, but has no clear benefits over valproate in terms of efficacy. Well-designed, double-blind RCTs with large samples are required to test the efficacy and tolerability of topiramate in people with JME.

Plain-language summary: We searched scientific databases for clinical trials comparing the antiepileptic medication, topiramate, with placebo (a pretend treatment) or another antiepileptic drug in people with JME. We wanted to evaluate how well topiramate worked and if it had any side effects. The evidence is current to July 2018. We included and analyzed three randomized controlled trials (clinical studies where people are randomly put into one of two or more treatment groups) with 83 participants. Based on the information in these trials, it seems that topiramate is better tolerated than valproate, but is no more effective than valproate. Topiramate seemed to work better than placebo, but this result was based on a small number of included people. The quality of the evidence from the studies was very low and the results should be interpreted with caution. More randomized controlled trials with large numbers of participants are required to test how effective and well tolerated topiramate is in people with JME. Future trials should be well-designed and double-blinded (where neither the participant nor the researcher know which treatment has been given until after the results have been collected). This review does not provide sufficient evidence to support topiramate for the treatment of people with JME.
Abstract: Sixty-six randomised trials, involving 8302 participants, met the inclusion criteria. Methodological quality was generally low. Sixty-nine different herbal medicines were tested in the included trials, which compared herbal medicines with placebo, hypoglycaemic drugs, or herbal medicines plus hypoglycaemic drugs.   Compared with placebo, Holy basil leaves, Xianzhen Pian, Qidan Tongmai, traditional Chinese formulae (TCT), Huoxue Jiangtang Pingzhi, and Inolter showed significantly hypoglycaemic response. Compared with hypoglycaemic drugs including glibenclamide, tolbutamide, or gliclazide, seven herbal medicines demonstrated a significant better metabolic control, including Bushen Jiangtang Tang, Composite Trichosanthis, Jiangtang Kang, Ketang Ling, Shenqi Jiangtang Yin, Xiaoke Tang, and Yishen Huoxue Tiaogan. In 29 trials that evaluated herbal medicines combined with hypoglycaemic drugs, 15 different herbal preparations showed additional better effects than hypoglycaemic drugs monotherapy. Two herbal therapies combined with diet and behaviour change showed better hypoglycaemic effects than diet and behaviour change alone. No serious adverse effects from the herbal medicines were reported. Some herbal medicines show hypoglycaemic effect sin type 2 diabetes. However, these findings should be carefully interpreted due to the low methodological quality, small sample size, and limited number of trials. In the light of some positive findings, some herbal medicines deserve further examination in high-quality trials.

Plain-language summary: This systematic review evaluates the effects of various herbal preparations (including single herbs or mixtures of different herbs) for treating people with type 2 diabetes. The review shows that some herbal medicines lower blood sugar and relieving symptoms in patients with diabetes. However, the methodological quality of the clinical trials evaluating these herbs is generally poor. The analyses also indicate that trials with positive findings are more likely to be associated with exaggerated effects. However, the trials did not report significant adverse effects. In conclusion, herbal medicines should not be recommended for routine use in diabetic patients of type 2 diabetes until we get scientifically sound trials. Testing the herbs in larger, well-designed trials is needed in order to establish the necessary evidence for their use.
Abstract: Three randomised trials used gemcitabine plus cisplatin (GCis) as one of the arms in each trial. The first randomised trial compared GCis with MVAC (methotrexate, vinblastine, doxorubicin and cisplatin) and showed no significant difference in overall survival (hazard ratio1.09, 95% CI 0.88 to 1.34, P = 0.443) however the GCis regime had fewer incidences of neutropenic sepsis (1% versus 12%, P = 0.001) and mucositis (1% versus 22%, P = 0.001). A second randomised trial compared GCis to gemcitabine plus carboplatin (GCarbo) and reported an improved, but non-significant 1-year survival rate with GCis (64% versus 37%). A third randomised trial compared GCis with gemcitabine plus cisplatin plus paclitaxel (GCisPac) and again found no significant difference in overall survival (respective medians 49 weeks versus 61 weeks). One randomised trial evaluated GCarbo against methotrexate plus carboplatin plus vinblastine (MCarboV) in patients "unfit" for cisplatin-based chemotherapy. There were more overall responses (38% versus 20%) and less severe acute toxicities (14% versus 23%) with GCarbo. In one randomised study evaluating 3-weekly gemcitabine plus paclitaxel (GPac3) versus a 2-weekly regimen overall survival was not significantly different (respective medians 13 and 9 months) however toxicities were worse with GPac3 especially alopecia (76% versus 32%). A larger trial compared gemcitabine (1 g/m2) (grams per metre squared) plus paclitaxel (175 mg/m2) (milligrams per metre squared) as a 3-weekly schedule for 6 cycles with a 2-weekly maintenance schedule. There was no significant difference in response rates, progression-free survival, disease-specific survival, and overall survival. A review of the published evidence found that one trial reported gemcitabine plus cisplatin had a better safety profile than MVAC and may be considered the first choice for treatment of metastatic bladder cancer. However, the data are limited to one trial only. Patients unable to tolerate cisplatin may benefit from gemcitabine plus carboplatin.

Plain-language summary: This review aimed to determine the effectiveness and toxicity of gemcitabine by looking at the evidence published from randomised clinical trials. Patients receiving gemcitabine combined with cisplatin had a similar overall survival but less toxicity when compared to the well-established chemotherapeutic treatment of MVAC (methotrexate, vinblastine, doxorubicin, cisplatin). This suggests that gemcitabine plus cisplatin may be considered an alternative chemotherapy schedule to MVAC for advanced bladder cancer but the evidence is limited to one trial only. For patients who have poor kidney function or poor performance status the combination of gemcitabine plus carboplatin may be considered.
Abstract: Four trials were eligible for inclusion, one of these trials (n =24) was on children and adolescents. All used an SSRI and prolonged exposure or a cognitive behavioural intervention. Two trials compared combination treatment with pharmacological treatment and two compared combination treatment with psychological treatment. Only two trials reported a total PTSD symptom score and these data could not be combined. There was no strong evidence to show if there were differences between the group receiving combined interventions compared to the group receiving psychological therapy (mean difference 2.44, 95% CI -2.87, 7.35 one study, n=65) or pharmacotherapy (mean difference -4.70, 95% CI -10.84 to 1.44; one study, n = 25). Trialists reported no significant differences between combination and single intervention groups in the other two studies. There were very little data reported for other outcomes, and in no case were significant differences reported. There is not enough evidence available to support or refute the effectiveness of combined psychological therapy and pharmacotherapy compared to either of these interventions alone. Further large randomised controlled trials are urgently required.

Plain-language summary: Both psychological therapy and pharmacotherapy have been used to treat PTSD and guidelines suggest that a combination of both may mean people recover from PTSD more effectively. Four trials including 124 participants were included in this review. One of these trials (n =24) was on children and adolescents. The trials all used SSRIs and prolonged exposure or a cognitive behavioural intervention. Only two trials reported on total PTSD symptoms but the data could not be combined. In this review, there are too few studies to be able to draw conclusions about whether a combination of psychological therapy and pharmacotherapy result in better outcomes for patients than either of these treatments alone.
Abstract: The review includes 39 trials with a total of 3509 participants. Study duration ranged between three and 12 weeks. Amitriptyline was significantly more effective than placebo in achieving acute response (18 RCTs, n = 1987, OR 2.67, 95% CI 2.21 to 3.23). Significantly fewer participants allocated to amitriptyline than to placebo withdrew from trials due to inefficacy of treatment (19 RCTs, n = 2017, OR 0.20, 95% CI 0.14 to 0.28), but more amitriptyline-treated participants withdrew due to side effects (19 RCTs, n = 2174, OR 4.15, 95% CI 2.71 to 6.35). Amitriptyline also caused more anticholinergic side effects, tachycardia, dizziness, nervousness, sedation, tremor, dyspepsia, sedation, sexual dysfunction and weight gain. In subgroup and meta-regression analyses the results of the primary outcome were robust towards publication year (1971 to 1997), mean participant age at baseline, mean amitriptyline dose, study duration in weeks, pharmaceutical sponsor, inpatient versus outpatient setting and two-arm versus three-arm design. However, higher severity at baseline was associated with higher superiority of amitriptyline (P = 0.02), while higher responder rates in the placebo groups were associated with lower superiority of amitriptyline (P = 0.05). The results of the primary outcome were rather homogeneous, reflecting comparability of the trials. However, methods of randomisation, allocation concealment and blinding were usually poorly reported. Not all studies used intention-to-treat analyses and in many of them standard deviations were not reported and often had to be imputed. Funnel plots suggested a possible publication bias, but the trim and fill method did not change the overall effect size much (seven adjusted studies, OR 2.64, 95% CI 2.24 to 3.10). Amitriptyline is an efficacious antidepressant drug. It is, however, also associated with a number of side effects. Degree of placebo response and severity of depression at baseline may moderate drug-placebo efficacy differences.

Plain-language summary: The current review includes 39 trials with a total of 3509 participants and confirms its efficacy compared to placebo or no treatment. This finding is important, because the efficacy of antidepressants has recently been questioned. However, the review also demonstrated that amitriptyline produces a number of side effects such as vision problems, constipation and sedation. It is a limitation of this review that many studies have been poorly reported, which might have led to bias.
Abstract: For this update, 8 additional trials were identified giving a total of 26 included studies (n=2530). 17 studies compared open wound healing with surgical closure. Healing times were faster after surgical closure compared with open healing. Surgical site infection (SSI) rates did not differ between treatments; recurrence rates were lower in open healing than with primary closure (RR 0.60, 95% CI 0.42 to 0.87). Six studies compared surgical midline with off-midline closure. Healing times were faster after off-midline closure (MD 5.4 days, 95% CI 2.3 to 8.5). SSI rates were higher after midline closure (RR 3.72, 95% CI 1.86 to 7.42) and recurrence rates were higher after midline closure (Peto OR 4.54, 95% CI 2.30 to 8.96). No clear benefit was shown for open healing over surgical closure. A clear benefit was shown in favour of off-midline rather than midline wound closure. When closure of pilonidal sinuses is the desired surgical option, off-midline closure should be the standard management.

Plain-language summary: This review of the published literature found that patients who had their wounds closed with stitches healed faster and returned to work earlier than patients whose wounds were left unstitched and allowed to heal "naturally". However, the review also found that patients who had their wounds closed with stitches were more likely to get the disease again compared to those who did not have their wounds closed by stitches. This means that each type of surgical treatment has its advantages and disadvantages, and that the decision about which type of surgical wound to select should also be guided by the patient's own desired goals for treatment. The review also found that if a decision had been made to close the wound with stitches, then the best way to reduce the risk of the disease coming back and reduce other complications (such as infection), was to use a wound technique where the line of stitches was moved away from between the buttocks. Therefore one definitive recommendation from this systematic review is that where a decision has been made to close the sinus wound using stitches, this wound should not lie in the central area of the buttocks.