GEM/cochrane-simplification huggingface dataset:
Abstract: Thirty five studies have been analyzed on the treatment of tubal ectopic pregnancy, describing 25 different comparisons.   Surgery  Laparoscopic salpingostomy is significantly less successful than the open surgical approach in the elimination of tubal ectopic pregnancy (2 RCTs, n = 165, OR 0.28, 95% confidence interval (CI) 0.09 to 0.86) due to a significant higher persistent trophoblast rate in laparoscopic surgery (OR 3.5, 95% CI 1.1 to 11). However, the laparoscopic approach is significantly less costly than open surgery (P = 0.03). Long term follow up (n = 127) shows no evidence of a difference in intra uterine pregnancy rate (OR 1.2, 95% CI 0.59 to 2.5) but there is a non significant tendency to a lower repeat ectopic pregnancy rate (OR 0.47, 95% 0.15 to 1.5). Medical treatment  Systemic methotrexate in a fixed multiple dose intramuscular regimen has a non significant tendency to a higher treatment success than laparoscopic salpingostomy (1 RCT, n = 100, OR 1.8, 95% CI 0.73 to 4.6). No significant differences are found in long term follow up (n=74): intra uterine pregnancy (OR 0.82, 95% CI 0.32 to 2.1) and repeat ectopic pregnancy (OR 0.87, 95% CI 0.19 to 4.1). Expectant management  Expectant management is significantly less successful than prostaglandin therapy (1 RCT, n = 23, OR 0.08, 95% CI 0.02 to 0.39). In the surgical treatment of tubal ectopic pregnancy laparoscopic surgery is a cost effective treatment. An alternative non surgical treatment option in selected patients is medical treatment with systemic methotrexate. Expectant management can not be adequately evaluated yet.

Plain-language summary: This review of 35 randomised controlled trials found that laparoscopic surgery is feasible and less expensive than open surgery in the treatment of tubal ectopic pregnancy. In selected patients, non-surgical treatment options can be used. Medical treatment with systemic methotrexate is an option for women with tubal ectopic pregnancy with no signs of bleeding whose pregnancy hormone blood levels are relatively low. An evaluation of expectant management of tubal ectopic pregnancy cannot be adequately made yet.
Abstract: Five studies compared low versus high protein intake. Improved weight gain and higher nitrogen accretion were demonstrated in infants receiving formula with higher protein content while other nutrients were kept constant. No significant differences were seen in rates of necrotizing enterocolitis, sepsis, or diarrhea. One study compared high versus very high protein intake during and after an initial hospital stay. Very high protein intake promoted improved gain in length at term, but differences did not remain significant at 12 weeks corrected age. Three of the 24 infants receiving very high protein intake developed uremia. A post-facto analysis revealed further improvement in all growth parameters in infants receiving formula with higher protein content. No significant difference in the concentration of plasma phenylalanine was noted between high and low protein intake groups. However, one study (Goldman 1969) documented a significantly increased incidence of low intelligence quotient (IQ) scores among infants of birth weight less than 1300 grams who received a very high protein intake (6 to 7.2 g/kg). Higher protein intake (≥ 3.0 g/kg/d but < 4.0 g/kg/d) from formula accelerates weight gain. However, limited information is available regarding the impact of higher formula protein intake on long-term outcomes such as neurodevelopmental abnormalities. Available evidence is not adequate to permit specific recommendations regarding the provision of very high protein intake (> 4.0 g/kg/d) from formula during the initial hospital stay or after discharge.

Plain-language summary: The review authors searched the medical literature to identify studies that compared protein intake as follows: between 3 and 4 g of protein per kg of infant body weight each day versus less than 3.0 g/kg/d or greater than 4.0 g/kg/d by low birth weight infants fed formula during their initial hospital stay. Increased protein intake resulted in greater weight gain of around 2.0 g/kg/d. Based on increased body incorporation of nitrogen, this was associated with increased lean body mass. The present conclusion was based on six studies that changed only the protein content of the formula and was supported by three additional studies that made changes in other nutrients as well. No significant difference in the concentration of plasma phenylalanine was noted between infants fed high or low protein content formula. The review was limited in the conclusions made because differences in protein content among comparison groups in some of the individual trials were small and formulas differed substantially across studies; some studies included healthier and more mature premature infants. Study periods varied from eight days to two years, so information on long-term outcomes was limited. Existing research is not adequate to allow specific recommendations regarding formula with protein content that provides more than 4.0 g/kg/d.
Abstract: One RCT involving 36 patients with generalised anxiety disorder was eligible for inclusion. This was a 4 week pilot study of valerian, diazepam and placebo. There were no significant differences between the valerian and placebo groups in HAM-A total scores, or in somatic and psychic factor scores. Similarly, there were no significant differences in HAM-A scores between the valerian and diazepam groups, although based on STAI-Trait scores, significantly greater symptom improvement was indicated in the diazepam group. There were no significant differences between the three groups in the number of patients reporting side effects or in dropout rates. Since only one small study is currently available, there is insufficient evidence to draw any conclusions about the efficacy or safety of valerian compared with placebo or diazepam for anxiety disorders. RCTs involving larger samples and comparing valerian with placebo or other interventions used to treat of anxiety disorders, such as antidepressants, are needed.

Plain-language summary: The aim of this study was to investigate the efficacy and safety of valerian for anxiety disorders. Only one study was identified, involving 36 patients and comparing valerian with placebo and diazepam. This study found no significant differences in effectiveness between valerian and placebo, or between valerian and diazepam, for clinician-rated anxiety symptoms, and that both valerian and diazepam were equally well tolerated by patients. However, additional studies with larger numbers of patients are necessary before drawing conclusions about the effectiveness and safety of valerian as a treatment option for anxiety disorders.
Abstract: We included 15 studies that involved 1101 children in this updated review. One study was added as a result of our 2012 search, another previously included study was removed due to lack of randomization. Fourteen included studies compared NSAIDs with other analgesics or placebo and reported on bleeding requiring surgical intervention. The use of NSAIDs was associated with a non-significant increase in the risk of bleeding requiring surgical intervention: Peto odds ratio (OR) 1.69 (95% confidence interval (CI) 0.71 to 4.01). Ten studies involving 365 children reported perioperative bleeding requiring non-surgical intervention. NSAIDs did not significantly alter the number of perioperative bleeding events requiring non-surgical intervention: Peto OR 0.99 (95% CI 0.41 to 2.40) but the confidence intervals did not exclude an increased risk. Thirteen studies involving 1021 children reported postoperative vomiting. There was less vomiting when NSAIDs were used as part of the analgesic regime than when NSAIDs were not used: Mantel Haenszel (M-H) risk ratio (RR) 0.72 (95% CI 0.61 to 0.85). There is insufficient evidence to exclude an increased risk of bleeding when NSAIDs are used in paediatric tonsillectomy. They do however confer the benefit of a reduction in vomiting.

Plain-language summary: The main limitation of our updated review was that bleeding following tonsillectomy is an uncommon event (occurring in 3% to 5% of children). We found all the data from randomized controlled trials that are currently available (15 trials studying approximately 1000 children). Our results were consistent with both an increased and decreased risk of bleeding. There were insufficient data to compare the risk of bleeding with each individual type of NSAID. However, we were able to compare ketorolac, which has been perceived as having a greater risk of bleeding, with the other NSAIDs and found no increased risk of bleeding. There was less nausea and vomiting when NSAIDs were used as part of the pain relief regime than when NSAIDs were not used. There is insufficient evidence to exclude an increased risk of bleeding when NSAIDs are used in paediatric tonsillectomy. They do, however, confer the benefit of a reduction in vomiting.
Abstract: Five studies (combined total n=998) met inclusion criteria. Four studies (n=724) provided leaving the study early data and results suggested that individuals treated with a typical antipsychotic medication are less likely to leave the study early than those treated with placebo (Chlorpromazine: 3 RCTs n=353, RR 0.4 CI 0.3 to 0.5, NNT 3.2, Fluphenaxine: 1 RCT n=240, RR 0.5 CI 0.3 to 0.8, NNT 5; Thioridazine: 1 RCT n=236, RR 0.44 CI 0.3 to 0.7, NNT 4.3, Trifulperazine: 1 RCT n=94, RR 0.96 CI 0.3 to 3.6). Two studies contributed data to assessment of adverse effects and present a general pattern of more frequent side effects among individuals treated with typical antipsychotic medications compared to placebo. One trial suggested a higher rehospitalisation rate for those receiving chlorpromazine compared to placebo (n=80, RR 2.29 CI 1.3 to 4.0, NNH 2.9). However, a higher attrition in the placebo group is likely to have introduced a survivor bias into this comparison. One study contributes data to a comparison of trifluoperazine to psychotherapy on long-term health in favour of the trifluoperazine group (n=92, MD 5.8 CI 1.6 to 0.0); however, data from this study are also likely to contain biases due to selection and attrition. One other study contributes data to a comparison of typical antipsychotic medication to psychosocial treatment on six-week outcome measures of global psychopathology (n=89, MD 0.01 CI -0.6 to 0.6) and global improvement (n=89, MD -0.03 CI -0.5 to 0.4), indicating no between-group differences. On the whole, there is very little useable data in the few studies meeting inclusion criteria. With only a few studies meeting inclusion criteria, and with limited useable data in these studies, it is not possible to arrive at definitive conclusions. The preliminary pattern of evidence suggests that people with early episode schizophrenia treated with typical antipsychotic medications are less likely to leave the study early, but more likely to experience medication-related side effects. Data are too sparse to assess the effects of antipsychotic medication on outcomes in early episode schizophrenia.

Plain-language summary: There are only a few good quality studies comparing the acute treatment of early episode schizophrenia with an antipsychotic medication compared to placebo or psychosocial treatment. It appears that initial medication treatment reduces the study attrition rates while also increasing the risk for medication-induced side effects. Data are too limited to assess the effects of initial antipsychotic medication treatment on outcomes for individuals with an early episode of schizophrenia.
Abstract: We included eight trials of influenza vaccination compared with placebo or no vaccination, with 12,029 participants receiving at least one vaccination or control treatment. We included six new studies (n = 11,251), in addition to the two included in the previous version of the review. Four of these trials (n = 10,347) focused on prevention of influenza in the general or elderly population and reported cardiovascular outcomes among their safety analyses; four trials (n = 1682) focused on prevention of cardiovascular events in patients with established coronary heart disease. These populations were analysed separately. Follow-up continued between 42 days and one year. Five RCTs showed deficits in at least three of the risk of bias criteria assessed. When reported (seven studies), vaccination provided adequate immunogenicity or protection against influenza. Cardiovascular mortality was reported by four secondary prevention trials and was significantly reduced by influenza vaccination overall (risk ratio (RR) 0.45, 95% confidence interval (CI) 0.26 to 0.76; P value 0.003) with no significant heterogeneity between studies, and by three trials reporting cardiovascular mortality as part of their safety analyses when the numbers of events were too small to permit conclusions. In studies of patients with coronary heart disease, composite outcomes of cardiovascular events tended to be decreased with influenza vaccination compared with placebo. Generally no significant difference was found between comparison groups regarding individual outcomes such as myocardial infarction. In patients with cardiovascular disease, influenza vaccination may reduce cardiovascular mortality and combined cardiovascular events. However, studies had some risk of bias, and results were not always consistent, so additional higher-quality evidence is necessary to confirm these findings. Not enough evidence was available to establish whether influenza vaccination has a role to play in the primary prevention of cardiovascular disease.

Plain-language summary: We included randomised studies comparing people receiving flu vaccine with those receiving no vaccine (placebo or no treatment). For this review update, we found eight trials studying 12,029 participants. Four of these studies examined patients with known heart disease (1682 participants), and the other four focused on the general population or elderly people (10,347 participants). The general population studies reported cardiovascular disease outcomes as part of their safety analyses, but the numbers of cases were too few to allow a judgement on whether flu vaccination was protective in these populations, and no differences were seen between groups. Overall, studies in people with heart disease suggest that flu vaccination may reduce death as a result of cardiovascular disease and may reduce combined cardiovascular disease events (such as heart attacks, strokes, necessity for bypass operations, etc.). However, these studies were small and had some risk of bias, so larger studies of better quality are needed to confirm the results.
Abstract: For viable lesions in children, there were no trials. For viable lesions in adults, no difference was detected for albendazole compared with no treatment for recurrence of seizures (116 participants, one trial); but fewer participants with albendazole had lesions at follow up (RR 0.56, 95% CI 0.45 to 0.70; 192 participants, two trials). For non-viable lesions in children, seizures recurrence was less common with albendazole compared with no treatment (RR 0.49, 95% CI 0.32 to 0.75; 329 participants, four trials). There was no difference detected in the persistence of lesions at follow up (570 participants, six trials). For non-viable lesions in adults, there were no trials. In trials including viable, non-viable or mixed lesions (in both children and adults), headaches were more common with albendazole alone (RR 9.49, 95% CI 1.40 to 64.45; 106 participants, two trials), but no difference was detected in one trial giving albendazole with corticosteroids (116 participants, one trial). In patients with viable lesions, evidence from trials of adults suggests albendazole may reduce the number of lesions. In trials of non-viable lesions, seizure recurrence was substantially lower with albendazole, which is counter-intuitive. It may be that steroids influence headache during treatment, but further research is needed to test this.

Plain-language summary: In this review of 21 relevant randomized controlled trials, most studies examined the effects of albendazole. In patients with viable lesions, there is only evidence available for adult patients; this suggests that albendazole may reduce the number of lesions. In patients with non-viable lesions, there is only evidence available for children; this suggests that seizure recurrence was lower with albendazole, which goes against the opinions of some experts. There is insufficient evidence available to assess praziquantel.
Abstract: Eight studies, recruiting over 700 participants, compared the use of dental cavity liners to no liners for Class I and Class II resin-based composite restorations. Seven studies evaluated postoperative hypersensitivity measured by various methods. All studies were at unclear or high risk of bias. There was inconsistent evidence regarding postoperative hypersensitivity (either measured using cold response or patient-reported), with a benefit shown at some, but not all, time points (low-quality evidence). Four trials measured restoration longevity. Two of the studies were judged to be at high risk and two at unclear risk of bias. No difference in restoration failure rates were shown at 1 year follow-up, with no failures reported in either group for three of the four studies; the fourth study had a risk ratio (RR) 1.00 (95% confidence interval (CI) 0.07 to 15.00) (low-quality evidence). Three studies evaluated restoration longevity at 2 years follow-up and, again, no failures were shown in either group. No adverse events were reported in any of the included studies. There is inconsistent, low-quality evidence regarding the difference in postoperative hypersensitivity subsequent to placing a dental cavity liner under Class I and Class II posterior resin-based composite restorations in permanent posterior teeth in adults or children 15 years or older. Furthermore, no evidence was found to demonstrate a difference in the longevity of restorations placed with or without dental cavity liners.

Plain-language summary: The evidence in this review, carried out by authors from Cochrane Oral Health, is up to date as of 12 November 2018. Eight studies, with over 700 participants, were included. Two studies were conducted in the USA, two in Thailand, two in Germany and one each in Saudi Arabia and Turkey. The studies compared the use of liners under tooth-colored resin fillings (RBC) in permanent teeth at the back of the mouth to no liners for Class I and Class II fillings. One of the two studies in the USA took place in dental practices, the others in university-based dental schools. All participants were over 15 years of age. Very little evidence was found to show that a liner under Class I and II RBC fillings in permanent teeth in the back of the mouth reduced sensitivity in adults or children 15 years or older. No evidence was found to show that there was any difference in the length of time fillings lasted when placed with or without a cavity liner. No adverse events were reported in any of the included studies. The body of evidence identified in this review does not allow for robust conclusions about the effects of dental cavity liners. The quality of the evidence identified in this review is low and there is a lack of confidence in the effect estimates. Furthermore, no evidence was found to demonstrate a difference in how long restorations last when placed with or without dental cavity liners.
Abstract: A total of 14 trials, including 364 randomised participants, met the selection criteria. The risk of bias was low in most studies. Only one trial had a high risk of selection, performance and detection bias. No new studies were identified at this update. Meta-analysis of six trials in muscular dystrophies including 192 participants revealed a significant increase in muscle strength in the creatine group compared to placebo, with a mean difference of 8.47%; (95% confidence intervals (CI) 3.55 to 13.38). Pooled data of four trials including 115 participants showed that a significantly higher number of participants felt better during creatine treatment compared to placebo with a risk ratio of 4.51 (95% CI 2.33 to 8.74). One trial in 37 participants with idiopathic inflammatory myopathies also showed a significant improvement in functional performance. No trial reported any clinically relevant adverse event. In metabolic myopathies, meta-analyses of three cross-over trials including 33 participants revealed no significant difference in muscle strength. One trial reported a significant deterioration of activities of daily living (mean difference 0.54 on a 1 to 10 scale; 95% CI 0.14 to 0.93) and an increase in muscle pain during high-dose creatine treatment in McArdle disease. High quality evidence from RCTs shows that short- and medium-term creatine treatment increases muscle strength in muscular dystrophies. There is also evidence that creatine improves functional performance in muscular dystrophy and idiopathic inflammatory myopathy. Creatine is well tolerated in these people. High quality but limited evidence from RCTs does not show significant improvement in muscle strength in metabolic myopathies. High-dose creatine treatment impaired activities of daily living and increased muscle pain in McArdle disease.

Plain-language summary: This is an update of our review evaluating creatine treatment in muscle disorders that was first published in 2007. At this update we identified no new studies but we had previously found 14 randomised controlled trials with 364 participants which met our defined selection criteria. The methodological quality of these studies was high, with only one exception. Analysis of pooled results showed a significant increase in muscle strength in muscular dystrophies and an improvement in activities of daily living in muscular dystrophies and inflammatory myopathies during creatine treatment compared to placebo. Significant adverse events occurred only in people with glycogen storage disease type V presenting as an increase in muscle pain episodes and impairment in activities of daily living.