GEM/cochrane-simplification huggingface dataset:
Abstract: We found one randomised controlled trial with a low risk of bias which was carried out in a tertiary neonatal care centre in Australia. The study involved 36 women (18 received intravaginal prostaglandin E 2 gel and 18 received placebo). There was one case of neonatal respiratory distress in the control group, which the trialist reported as transient tachypnoea of the newborn (risk ratio (RR) 0.33, 95% confidence interval (CI) 0.01 to 7.68, one study, n = 36). None of the neonates required mechanical ventilation and the trial authors reported median Apgar scores at one and five minutes as being similar in both groups. There were no treatment-related side effects in either group. Noradrenaline concentrations (median values (range)) were reported as being significantly higher in the cord blood samples of the intervention group compared to the control group. Although the trial authors reported a significant increase in catecholamine levels in the intervention group, there was no significant difference in the respiratory outcomes between intervention and control groups. The quality of evidence was graded as low because the sample size was small and there were few events. No definite conclusions can thus be drawn on the effects of prostaglandins on neonatal respiratory outcomes from this review.

Plain-language summary: We found one small randomised trial (involving 36 women) that compared prostaglandin E2 intravaginal gel administered before caesarean section compared with a placebo gel. The information obtained from this study did not permit us to be certain that prostaglandins improve neonatal breathing following planned caesarean section at term. Only one baby in the placebo group had respiratory distress assessed as rapid breathing. Further studies have to be carried out in order to find out the impact of prostaglandins on the newborn lungs after caesarean section.
Abstract: This systematic review attempted to summarise evidence from randomised clinical trials on the treatment of spontaneous bacterial peritonitis. Thirteen studies were included; each one of them compared different antibiotics in their experimental and control groups. No meta-analyses could be performed, though data on the main outcomes were collected and analysed separately for each included trial. Currently, the evidence showing that lower dosage or short-term treatment with third generation cephalosporins is as effective as higher dosage or long-term treatment is weak. Oral quinolones could be considered an option for those with less severe manifestations of the disease. This review provides no clear evidence for the treatment of cirrhotic patients with spontaneous bacterial peritonitis. In practice, third generation cephalosporins have already been established as the standard treatment of spontaneous bacterial peritonitis, and it is clear, that empirical antibiotic therapy should be provided in any case. However, until large, well-conducted trials provide more information, practice will remain based on impression, not evidence.

Plain-language summary: This review aimed to evaluate the beneficial and harmful effects of different types and modes of antibiotic therapy in the treatment of spontaneous bacterial peritonitis in cirrhotic patients. Thirteen trials were included; each one of them compared different antibiotics in their experimental and control groups. No meta-analyses could be performed, though data on the main outcomes were collected and analysed separately for each included trial. Based on the identified evidence, we cannot suggest the most appropriate management to treat spontaneous bacterial peritonitis in regard to the type, dosage, duration, or administration route of the antibiotic therapy. The clinical trials found dealt with different types of antibiotics, and, therefore, could not be combined. This review found no evidence that the effect or safety of one antibiotic is more beneficial than another. Further randomised clinical trials with an adequate design, including a large number of participants and sufficient duration should be carefully planned to provide a more precise estimate of the beneficial and harmful effects of antibiotic treatment for spontaneous bacterial peritonitis.
Abstract: Of 35 studies considered potentially relevant, 14 studies enrolling 1025 subjects met the entry criteria. Scopolamine was administered via transdermal patches, tablets or capsules, oral solutions or intravenously. Scopolamine was compared against placebo, calcium channel antagonists, antihistamine, methscopolamine or a combination of scopolamine and ephedrine. Studies were generally small in size and of varying quality. Scopolamine was more effective than placebo in the prevention of symptoms. Comparisons between scopolamine and other agents were few and suggested that scopolamine was superior (versus methscopolamine) or equivalent (versus antihistamines) as a preventative agent. Evidence comparing scopolamine to cinnarizine or combinations of scopolamine and ephedrine is equivocal or minimal. Although sample sizes were small, scopolamine was no more likely to induce drowsiness, blurring of vision or dizziness compared to other agents. Dry mouth was more likely with scopolamine than with methscopolamine or cinnarizine. No studies were available relating to the therapeutic effectiveness of scopolamine in the management of established symptoms of motion sickness. The use of scopolamine versus placebo in preventing motion sickness has been shown to be effective. No conclusions can be made on the comparative effectiveness of scopolamine and other agents such as antihistamines and calcium channel antagonists. In addition, we identified no randomised controlled trials that examined the effectiveness of scopolamine in the treatment of established symptoms of motion sickness.

Plain-language summary: This Cochrane Review summarises evidence from 14 randomised controlled studies evaluating the effectiveness and safety of scopolamine for motion sickness. The results show that scopolamine is more effective than placebo and scopolamine-like derivatives in the prevention of nausea and vomiting associated with motion sickness. However, scopolamine was not shown to be superior to antihistamines and combinations of scopolamine and ephedrine. Scopolamine was less likely to cause drowsiness, blurred vision or dizziness when compared to these other agents.
Abstract: We included 16 randomized controlled trials of dihydropyridine calcium channel blockers in this systematic review, with 2768 randomized participants. Drugs studied included amlodipine, lercanidipine, mandipine, nifedipine, and felodipine (all administered once daily) and nicardipine (administered twice daily). We analyzed and presented data by hour post dose. The blood pressure-lowering effect was stable over time; there were no clinically important differences in blood pressure-lowering effect of calcium channel blockers between each hour for either systolic blood pressure (estimated mean hourly differences ranged between 9.45 mmHg and 13.2 mmHg) or diastolic blood pressure (estimated mean hourly differences ranged between 5.85 mmHg and 8.5 mmHg). However, there was a moderate risk of bias for this finding. Once-daily dihydropyridine calcium channel blockers appeared to lower blood pressure by a relatively constant amount throughout the 24-hour dosing interval. Six dihydropyridine calcium channel blockers studied in this review lowered blood pressure by a relatively similar amount each hour over the course of 24 hours. The benefits and harms of this pattern of blood pressure lowering are unknown. Further trials are needed with accurate recording of time of drug intake and with reporting of standard deviation of blood pressure at each hour. We did not attempt to assess adverse effects in this review due to the lack of reporting and the short duration of follow-up.

Plain-language summary: This review explores whether the blood pressure lowering effect of dihydropyridine calcium channel blockers in adults (aged 18 years or over) with high blood pressure (systolic blood pressure (the upper blood pressure reading) of at least 140 mmHg or diastolic blood pressure (the lower blood pressure reading) of at least 90 mmHg, or both of these) is consistent or variable over a 24-hour period. We performed a review of studies that compared the 24-hour blood pressure lowering effects of six of these drugs versus a control treatment for at least three weeks. Blood pressure needed to be measured by an ambulatory blood pressure monitor, which is a device that automatically measures blood pressure at regular intervals. We performed searches for clinical trials up to February 2014. We found 16 trials involving 2768 participants that studied five drugs given once a day (amlodipine, lercanidipine, mandipine, nifedipine, and felodipine) and one drug given twice a day (nicardipine). The amount of blood pressure lowering by dihydropyridine calcium channel blockers stayed relatively the same at every hour throughout a 24-hour day. The average hourly differences in blood pressure were between 9.45 mmHg and 13.2 mmHg for systolic blood pressure and between 5.85 mmHg and 8.5 mmHg for diastolic blood pressure. At the present time, the benefits and harms of this pattern of blood pressure lowering are unknown. We judged the overall quality of the evidence to be moderate. Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Abstract: We included one trial of 167 women and their babies. This trial was a pilot study recruiting alongside another study, therefore, a separate sample size was not calculated. The trial compared a twice-weekly surveillance regimen (biophysical profile, nonstress tests, umbilical artery and middle cerebral artery Doppler and uterine artery Doppler) with the same regimen applied fortnightly (both groups had growth assessed fortnightly). There were insufficient data to assess this review's primary infant outcome of composite perinatal mortality and serious morbidity (although there were no perinatal deaths) and no difference was seen in the primary maternal outcome of emergency caesarean section for fetal distress (risk ratio (RR) 0.96; 95% confidence interval (CI) 0.35 to 2.63). In keeping with the more frequent monitoring, mean gestational age at birth was four days less for the twice-weekly surveillance group compared with the fortnightly surveillance group (mean difference (MD) -4.00; 95% CI -7.79 to -0.21). Women in the twice-weekly surveillance group were 25% more likely to have induction of labour than those in the fortnightly surveillance group (RR 1.25; 95% CI 1.04 to 1.50). There is limited evidence from randomised controlled trials to inform best practice for fetal surveillance regimens when caring for women with pregnancies affected by impaired fetal growth. More studies are needed to evaluate the effects of currently used fetal surveillance regimens in impaired fetal growth.

Plain-language summary: The review authors identified only one controlled trial, from New Zealand. This trial randomised 167 women who were between 24 and 36 weeks' pregnant where ultrasound showed a small-for-gestational-age baby. They received a set combination of tests either twice-weekly or fortnightly. With more frequent testing, women were 25% more likely to have induced labour. Overall their babies were born four days earlier than in the fortnightly surveillance group where spontaneous onset of labour was more likely to occur. The mean gestational age at birth was just under 38 weeks in the twice-weekly group and just over 38 weeks in the fortnightly group, which was unlikely to have an impact on the health of the newborn. The number of caesarean sections, either for fetal distress or because of failure of induction, was no different. No information was available on length of antenatal hospital admission or operative vaginal births and infants were not followed up to determine neurodevelopment and cerebral palsy. This study excluded pregnancies with abnormal Doppler studies and disorders of the amniotic fluid. More studies are needed and the women’s views on the testing are also important.
Abstract: Five studies treated 177 participants with painful diabetic neuropathy (104) or postherpetic neuralgia (73). The mean or median ages in the studies were 55 to 72 years. Four studies used a cross-over, and one a parallel group design; 145 participants were randomised to receive desipramine 12.5 mg to 250 mg daily, with most taking 100 mg to 150 mg daily following titration. Comparators were placebo in three studies (an 'active placebo' in two studies), fluoxetine, clomipramine (one study each), and amitriptyline (two studies), and treatment was for two to six weeks. All studies had one or more sources of potential major bias. No study provided first or second tier evidence for any outcome. No data were available on the proportion of people with at least 50% or 30% reduction in pain, but data were available from three studies for our other primary outcome of Patient Global Impression of Change, reported as patient evaluation of pain relief that was 'complete' or 'a lot'. No pooling of data was possible, but third tier evidence in individual studies indicated some improvement in pain relief with desipramine compared with placebo, although this was very low quality evidence, derived mainly from group mean data and completer analyses in small, short duration studies where major bias was possible. There were too few participants in comparisons of desipramine with another active treatment to draw any conclusions. All studies reported some information about adverse events, but reporting was inconsistent and fragmented. Participants taking desipramine experienced more adverse events, and a higher rate of withdrawal due to adverse events, than did participants taking placebo (very low quality evidence). This review found little evidence to support the use of desipramine to treat neuropathic pain. There was very low quality evidence of benefit and harm, but this came from studies that were methodologically flawed and potentially subject to major bias. Effective medicines with much greater supportive evidence are available. There may be a role for desipramine in patients who have not obtained pain relief from other treatments.

Plain-language summary: Five small studies, each with 24 to 54 participants, included 177 participants in total with painful diabetic neuropathy or postherpetic neuralgia. Studies were randomised and double-blind, but all had one or more sources of potential major bias that could lead to overestimation of efficacy. It was not possible to combine information from the different studies, but individually they indicated some benefit from desipramine (usually at a dose between 100 mg and 150 mg daily), compared with placebo, at the expense of increased adverse events. There was not enough information about other comparators to draw any conclusions. There was too little information, which was of inadequate quality, to be sure that desipramine works as a pain medicine in painful diabetic neuropathy or postherpetic neuralgia, and no information about other types of neuropathic pain. Other medicines have been shown to be effective as treatments of first choice.
Abstract: Twenty-three randomised controlled trials were identified. A total of 3872 and 2915 participants in the intervention and in the control group, respectively, were analysed. The weighted mean difference (WMD) for the level of glycosylated haemoglobin was -0.08 (95% confidence interval (CI) -0.12 to -0.04) in favour of the long acting insulin arm. The WMD between the groups in fasting plasma and blood glucose levels was -0.63 (95% CI -0.86 to -0.40) and -0.86 (95% CI -1.00 to -0.72) in favour of the long acting insulins. The odds ratio for a patient on long acting insulin to develop any type of hypoglycaemia was 0.93 (95% CI 0.8 to 1.08) compared to that of a patient on intermediate acting insulins. The OR for severe hypoglycaemic episodes was 0.73 (95% CI 0.61 to 0.87), and 0.70 (95% CI of 0.63 to 0.79) for nocturnal episodes. The WMD between the long and intermediate insulin groups for hypoglycaemic events per 100 patient follow up days was -0.77 (95% CI -0.89 to -0.65), -0.0 (95% CI -0.02 to 0.02) and -0.40 (95% CI -0.45 to -0.34) for overall, severe, and nocturnal hypoglycaemic episodes. Weight gain was more prominent in the control group. No difference was noted in the quantity or quality of severe adverse events or deaths. Long acting insulin preparations seem to exert a beneficial effect on nocturnal glucose levels. Their effect on the overall diabetes control is clinically unremarkable. Their use as a basal insulin regimen for type 1 diabetes mellitus warrants further substantiation.

Plain-language summary: Twenty-three studies fulfilled our inclusion criteria with a total of 3872 and 2915 participants in the intervention and in the control group, respectively. The methodological quality of all the studies was rated intermediate to low. Trials duration was no longer than one year. The level of glycosylated haemoglobin, a marker of diabetes control, was lower in the long acting insulin group, but the observed difference was of doubtful clinical significance. Longer acting insulins were superior mostly in their nocturnal effect, which resulted in a lower level of fasting glucose levels and fewer episodes of nocturnal hypoglycaemia. No data on long term complications were available.  The currently available data can not substantiate conclusions on the benefits and risks of long acting insulins, and long-term data are of need.
Abstract: Intra-arterial delivery of thrombolytic agents appeared to be more effective than intravenous administration. Thrombolysis was more effective when the angiographic catheter was placed within the thrombus. Although 'high dose' and 'forced infusion' techniques achieved vessel patency in less time than 'low dose infusion', there were more bleeding complications, and no increase in patency rates or improvement in limb salvage at 30 days. Implications for practice Thrombolysis should be reserved for patients with limb threatening ischaemia, due to the high risk of haemorrhage or death.  Greater benefit is seen when the thrombolytic agent is delivered into the thrombus. Systemic intravenous thrombolysis is less effective than intra-arterial thrombolysis and is associated with an increase in bleeding complications.  'High dose' and 'forced infusion' techniques, or adjunctive agents such as platelet glycoprotein IIb/IIIa inhibitors may speed up thrombolysis, but these are not accompanied by lower amputation rates or a decreased need for adjunctive endovascular or surgical procedures.  'Low dose continuous infusion', following initial lacing of the thrombus with a high dose of the thrombolytic agent, is the least labour intensive technique. Implications for research Only large multicentre trials with carefully controlled inclusion criteria will be sufficiently powerful to demonstrate genuine benefit for a particular thrombolytic regime.

Plain-language summary: This review found evidence suggesting that arterial infusion is more effective than intravenous infusion. The risk of haemorrhage with intravenous infusion is high. However, none of the different arterial infusion techniques studied have been shown to be more effective in preventing limb loss, amputation or death. More research is needed to confirm these findings.
Abstract: Seven RCTs were included in the review, totalling 1385 patients. Four of these trials met the criteria for good quality studies. For any antiplatelet agent there were reductions of a poor outcome (RR 0.79, 95% confidence interval (CI) 0.62 to 1.01) and secondary brain ischaemia (RR 0.79, 95% CI 0.56 to 1.22) and more intracranial haemorrhagic complications (RR 1.36, 95% CI 0.59 to 3.12), but none of these differences were statistically significant. There was no effect on case fatality (RR 1.01, 95% CI 0.74 to 1.37) or aneurysmal rebleeding (RR 0.98, 95% CI 0.78 to 1.38). For individual antiplatelet agents, only ticlopidine was associated with statistically significant fewer occurrences of a poor outcome (RR 0.37, 95% CI 95% CI 0.14 to 0.98) but this estimate was based on only one small RCT. This review shows a trend towards better outcome in patients treated with antiplatelet agents, possibly due to a reduction in secondary ischaemia. However, results were not statistically significant, thus no definite conclusions can be drawn. Also, antiplatelet agents could increase the risk of haemorrhagic complications. On the basis of the current evidence treatment with antiplatelet agents in order to prevent secondary ischaemia or poor outcome cannot be recommended.

Plain-language summary: Therefore, trials have been performed with agents that prevent clotting of blood platelets (antiplatelet agents). In this review of seven trials, including 1385 patients, that studied the effects of antiplatelet agents on the outcome after SAH, we found that patients who were treated with antiplatelet agents had a poor outcome less often, and secondary ischaemia less often than patients that received no antiplatelet agent, but the results were not statistically significant and so no definite conclusion can be drawn. Moreover, patients who are treated with antiplatelet agents might have a slightly higher risk of bleeding. Based on these results we conclude that antiplatelet agents after SAH cannot be recommended at the present time.
Abstract: Three RCTs, with a total of 154 participants were included in this review. None of the studies reported data on prostate cancer mortality. All of the included studies differed with respect to design, participants included and allocation of lycopene. This clinical heterogeneity limits the value on the pooled estimated of the meta-analyses. The methodological quality of two of the three included studies was assessed as posing a 'high' risk of bias. Meta-analysis indicated no statistical difference in PSA levels between men randomised to receive lycopene and the comparison group (MD (mean difference) -0.34, 95% CI (confidence interval) -2.01 to 1.32). Only one study reported incidence of prostate cancer (10% in the lycopene group versus 30% in control group). The level of lycopene was also not statistically different in men randomised to receive lycopene and the comparison group (MD 0.39 µg/mL (micrograms/millilitre), 95% CI -0.19 to 0.98). No other meta-analyses were possible since other outcomes assessed only had one study contributing data. Given that only three RCTs were included in this systematic review, and the high risk of bias in two of the three studies, there is insufficient evidence to either support, or refute, the use of lycopene for the prevention of prostate cancer. Similarly, there is no robust evidence from RCTs to identify the impact of lycopene consumption upon the incidence of prostate cancer, prostate symptoms, PSA levels or adverse events.

Plain-language summary: The objective of this systematic review was to identify the effectiveness of lycopene in the prevention of prostate cancer. This review identified 3 relevant studies, comprising 154 participants in total. Two of the studies were assessed to be of 'high' risk of bias. Meta-analysis of two studies indicated no statistical difference in prostate specific antigen (PSA) levels between men randomised to receive lycopene and the comparison group (MD -0.34, 95% CI -2.01 to 1.32). None of the studies assessed prostate cancer mortality. No other meta-analyses were possible since other outcomes assessed only had one study contributing data.