Methodological quality for systematic reviews of adverse events with surgical interventions: a cross-sectional survey.

BACKGROUND: An increasing number of systematic reviews assessed the safety of surgical interventions over time. How well these systematic reviews were designed and conducted determines the reliability of evidence. In this study, we aimed to assess the methodological quality of systematic reviews on the safety of surgical interventions. METHODS: We searched PubMed for systematic reviews of surgical interventions with safety as the exclusive outcome from 1st-Jan, 2015 to 1st-Jan, 2020. The methodological quality of eligible systematic reviews was evaluated according to the AMSTAR 2.0 instrument. The primary outcomes were the number of methodological weaknesses and the global methodological quality. The proportion of each methodological weakness among eligible systematic reviews was compared by three pre-defined stratification variables. The absolute difference of the proportion (PD) was used as the effect estimator, with the two-tailed z-test for the significance. RESULTS: We identified 127 systematic reviews from 18,636 records. None (n = 0, 0.00%) of them could be rated as "high" in terms of the global methodological quality; in contrast, they were either rated as "low" (n = 18, 14.17%) or as "critically low" (n = 109, 85.83%). The median number of methodological weaknesses of these systematic reviews was 8 (interquartile range, IQR: 6 to 9), in which 4 (IQR: 2 to 4) were critical weaknesses. Systematic reviews that used any reporting guideline (e.g., domain 13, PD = -0.22, 95% CI: - 0.39, - 0.06; p = 0.01) and developed a protocol in advance (e.g., domain 6, PD = -0.20, 95% CI: - 0.39, - 0.01; p = 0.04) were less likely to have methodological weakness in some domains but not for the rest (e.g., domain 8, PD = 0.04, 95% CI: - 0.14, 0.21; p = 0.68; with protocol vs. without). CONCLUSIONS: The methodological quality of current systematic reviews of adverse events with surgical interventions was poor. Further efforts, for example, encouraging researchers to develop a protocol in advance, are needed to enhance the methodological quality of these systematic reviews.

The diagnostic role of diffusional kurtosis imaging in glioma grading and differentiation of gliomas from other intra-axial brain tumours: a systematic review with critical appraisal and meta-analysis.

PURPOSE: We aim to illustrate the diagnostic performance of diffusional kurtosis imaging (DKI) in the diagnosis of gliomas. METHODS: A review protocol was developed according to the (PRISMA-P) checklist, registered in the international prospective register of systematic reviews (PROSPERO) and published. A literature search in 4 databases was performed using the keywords 'glioma' and 'diffusional kurtosis'. After applying a robust inclusion/exclusion criteria, included articles were independently evaluated according to the QUADAS-2 tool and data extraction was done. Reported sensitivities and specificities were used to construct 2 × 2 tables and paired forest plots using the Review Manager (RevMan®) software. A random-effect model was pursued using the hierarchical summary receiver operator characteristics. RESULTS: A total of 216 hits were retrieved. Considering duplicates and inclusion criteria, 23 articles were eligible for full-text reading. Ultimately, 19 studies were eligible for final inclusion. The quality assessment revealed 9 studies with low risk of bias in the 4 domains. Using a bivariate random-effect model for data synthesis, summary ROC curve showed a pooled area under the curve (AUC) of 0.92 and estimated sensitivity of 0.87 (95% CI 0.78-0.92) in high-/low-grade gliomas' differentiation. A mean difference in mean kurtosis (MK) value between HGG and LGG of 0.22 (95% CI 0.25-0.19) was illustrated (p value = 0.0014) with moderate heterogeneity (I2 = 73.8%). CONCLUSION: DKI shows good diagnostic accuracy in the differentiation of high- and low-grade gliomas further supporting its potential role in clinical practice. Further exploration of DKI in differentiating IDH status and in characterising non-glioma CNS tumours is however needed.

Quality of interventional animal experiments in Chinese journals: compliance with ARRIVE guidelines.

BACKGROUND: In view of the inadequacy and incompleteness of currently-reported animal experiments and their overall poor quality, we retrospectively evaluated the reporting quality of animal experiments published in Chinese journals adhering to the Animal Research: Reporting of In Vivo Experiments (ARRIVE) guidelines. RESULTS: The databases CNKI, WanFang, VIP, and CBM were searched from inception until July 2018. Two appropriately-trained reviewers screened and extracted articles independently. The ARRIVE guidelines were used to assess the quality of the published reports of animal experiments. The compliance rate of every item was analyzed relative to their date of publication. A total of 4342 studies were included, of which 73.0% had been cited ≤5 times. Only 29.0% (1261/4342) were published in journals listed in the Chinese Science Citation Database. The results indicate that the compliance rate of approximately half of the sub-items (51.3%, 20/39) was less than 50%, of which 65.0% (13/20) was even less than 10%. CONCLUSIONS: The reporting quality of animal experiments in Chinese journals is not at a high level. Following publication of the ARRIVE guidelines in 2010, the compliance rate of the majority of its requirements has improved to some extent. However, less attention has been paid to the ethics and welfare of experimental animals, and a number of specific items in the Methods, Results, and Discussion sections continue to not be reported in sufficient detail. Therefore, it is necessary to popularize the ARRIVE guidelines, advocate researchers to adhere to them in the future, and in particular promote the use of the guidelines in specialized journals in order that the design, implementation, and reporting of animal experiments is promoted, to ultimately improve their quality.

Assessment of the abstract reporting of systematic reviews of dose-response meta-analysis: a literature survey.

BACKGROUND: There is an increasing number of published systematic reviews (SR) of dose-response meta-analyses (DRMAs) over the past decades. However, the quality of abstract reporting of these SR-DRMAs remains to be understood. We conducted a literature survey to investigate the abstract reporting of SR-DRMAs. METHODS: Medline, Embase, and Wiley online Library were searched for eligible SR-DRMAs. The reporting quality of SR-DRMAs was assessed by the modified PRISMA-for-Abstract checklist (14 items). We summarized the adherence rate of each item and categorized them as well complied (adhered by 80% or above), moderately complied (50 to 79%), and poorly complied (less than 50%). We used total score to reflect the abstract quality and regression analysis was employed to explore the potential influence factors for it. RESULTS: We included 529 SR-DRMAs. Eight of 14 items were moderately (3 items) or poorly complied (5 items) while only 6 were well complied by these SR-DRMAs. Most of the SR-DRMAs failed to describe the methods for risk of bias assessment (30.2, 95% CI: 26.4, 34.4%) and the results of bias assessment (48.8, 95% CI: 44.4, 53.1%). Few SR-DRMAs reported the funding (2.3, 95% CI: 1.2, 3.9%) and registration (0.6, 95% CI: 0.1, 1.6%) information in the abstract. Multivariable regression analysis suggested word number of abstracts [> 250 vs. ≤ 250 (estimated ß = 0.31; 95% CI: 0.02, 0.61; P = 0.039)] was positively associated with the abstract reporting quality. CONCLUSION: The abstract reporting of SR-DRMAs is suboptimal, substantial effort is needed to improve the reporting. More word number may benefit for the abstract reporting. Given that reporting of abstract largely depends on the reporting and conduct of the SR-DRMA, review authors should also focus on the completeness of SR-DRMA itself.

Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndrome: A Randomized, Sham Acupuncture Controlled Trial.

PURPOSE: We investigated the effectiveness of acupuncture in patients with chronic prostatitis/chronic pelvic pain syndrome. MATERIALS AND METHODS: We performed this 32-week randomized, controlled trial with 8 weeks of treatment followed by 24 weeks of followup to compare acupuncture with sham acupuncture. Participants with chronic prostatitis/chronic pelvic pain syndrome were randomly assigned to acupuncture or noninvasive sham acupuncture. The primary outcome was the change in the NIH-CPSI (National Institutes of Health Chronic Prostatitis Symptom Index) total score from baseline to week 8. Secondary outcomes were the NIH-CPSI subscale scores, pain severity, the I-PSS (International Prostate Symptom Score), the global response rate and satisfaction assessment. RESULTS: A total of 68 participants 18 to 50 years old were enrolled and included in intent to treat analyses. Baseline characteristics were comparable in the 2 groups. The reduction in the NIH-CPSI total score differed significantly between the 2 groups at weeks 8, 20 and 32 with a difference of -5.7 (95% CI -7.8--3.7), -6.7 (95% CI -8.9--4.5) and -7.4 (95% CI -9.8--5.1), respectively (each p <0.001). All differences were greater than the 4-point minimal clinically important difference. No significant difference was found between the groups in NIH-CPSI pain and quality of life subscale scores or in I-PSS at week 4 (each p >0.05). For all other secondary outcomes the acupuncture group was statistically better than the sham acupuncture group. CONCLUSIONS: Acupuncture showed clinical and long-lasting benefits compared with sham acupuncture for chronic prostatitis/chronic pelvic pain syndrome. Randomized controlled trials with larger sample sizes are needed in the future.

The cardioprotective and antiarrhythmic effects of Nardostachys chinensis in animal and cell experiments.

BACKGROUND: Cardiovascular disease (CVD) is the leading cause of premature death throughout the world. An estimated 17.5 million people died from CVD in 2012, representing 31% of all global deaths. Nardostachys chinensis (NC), a typical traditional Chinese medicine (TCM), plays a crucial role in the management of patients with CVD, especially for those with cardiac arrhythmia. The purpose of this study was to evaluate the cardioprotective and antiarrhythmic effects of NC in animal and cell experiments. METHODS: To review the cardioprotective and antiarrhythmic effects of NC, studies of NC on cardiovascular diseases in animal and cell experiments were identified from five databases through April 2016. Two investigators independently conducted the literature search, study selection, and data extraction. RESULTS: A total of 16 studies were identified, including five animal experiments and eleven cell experiments. Four studies showed significant effects of NC on myocardial protection by inhibiting myocardial apoptosis, inflammation and oxidative stress. Twelve studies indicated significant beneficial effects of NC in cardiac arrhythmia primarily through the modulation of ion channels (Ik, Ik1, INa, ICa-L, Ito). CONCLUSION: The above findings showed the possible efficacy of NC via its cardioprotective and antiarrhythmic effects, but the results should be interpreted with caution due to the limitations and the deficiencies in the studies.

COX-2 rs689466, rs5275, and rs20417 polymorphisms and risk of head and neck squamous cell carcinoma: a meta-analysis of adjusted and unadjusted data.

BACKGROUND: Numerous case-control studies have been performed to investigate the association between three cyclooxygenase-2 (COX-2) polymorphisms (rs20417 (-765G > C), rs689466 (-1195G > A), and rs5275 (8473 T > C)) and the risk of head and neck squamous cell carcinoma (HNSCC). However, the results were inconsistent. Therefore, we conducted this meta-analysis to investigate the association. METHODS: We searched in PubMed, Embase, and Web of Science up to January 20, 2015 (last updated on May 12, 2016). Two independent reviewers extracted the data. Odds ratios (ORs) with their 95 % confidence intervals (CIs) were used to assess the association. All statistical analyses were performed using the Review Manager (RevMan) 5.2 software. RESULTS: Finally 8 case-control studies were included in this meta-analysis. For unadjusted data, an association with increased risk was observed in three genetic models in COX-2 rs689466 polymorphism; however, COX-2 rs5275 and rs20417 polymorphisms were not related to HNSCC risk in this study. The pooled results from adjusted data all revealed non-significant association between these three polymorphisms and risk of HNSCC. We also found a similar result in the subgroup analyses, based on both unadjusted data and adjusted data. CONCLUSION: Current results suggest that COX-2 rs689466, rs5275, and rs20417 polymorphisms are not associated with HNSCC. Further large and well-designed studies are necessary to validate this association.

Pharmacological interventions for treating heart failure in patients with Chagas cardiomyopathy.

BACKGROUND: Chagas disease-related cardiomyopathy is a major cause of morbidity and mortality in Latin America. Despite the substantial burden to the healthcare system, there is uncertainty regarding the efficacy and safety of pharmacological interventions for treating heart failure in people with Chagas disease. This is an update of a Cochrane review published in 2012. OBJECTIVES: To assess the clinical benefits and harms of current pharmacological interventions for treating heart failure in people with Chagas cardiomyopathy. SEARCH METHODS: We updated the searches in the Cochrane Central Register of Controlled Trials (CENTRAL; The Cochrane Library 2016, Issue 1), MEDLINE (Ovid; 1946 to to February Week 1 2016), EMBASE (Ovid; 1947 to 2016 Week 07), LILACS (1982 to 15 February 2016), and Web of Science (Thomson Reuters; 1970 to 15 February 2016). We checked the reference lists of included papers. We applied no language restrictions. SELECTION CRITERIA: We included randomised clinical trials (RCTs) that assessed the effects of pharmacological interventions to treat heart failure in adult patients (18 years or older) with symptomatic heart failure (New York Heart Association classes II to IV), regardless of the left ventricular ejection fraction stage (reduced or preserved), with Chagas cardiomyopathy. We did not apply limits to the length of follow-up. Primary outcomes were all-cause mortality, cardiovascular mortality at 30 days, time-to-heart decompensation, disease-free period (at 30, 60, and 90 days), and adverse events. DATA COLLECTION AND ANALYSIS: Two authors independently performed study selection, 'Risk of bias' assessment and data extraction. We estimated relative risk (RR) and 95% confidence intervals (CIs) for dichotomous outcomes. We measured statistical heterogeneity using the I² statistic. We used a fixed-effect model to synthesize the findings. We contacted authors for additional data. We developed 'Summary of findings' (SoF) tables and used GRADE methodology to assess the quality of the evidence. MAIN RESULTS: In this update, we identified one new trial. Therefore, this version includes three trials (108 participants). Two trials compared carvedilol against placebo and another assessed rosuvastatin versus placebo. All trials had a high risk of bias.Meta-analysis of two trials showed a lower proportion of all-cause mortality in the carvedilol groups compared with the placebo groups (RR 0.69; 95% CI 0.12 to 3.88, I² = 0%; 69 participants; very low-quality evidence). Neither of the trials reported on cardiovascular mortality, time-to-heart decompensation, or disease-free periods.One trial (30 participants) found no difference in hospital readmissions (RR 1.00; 95% CI 0.31 to 3.28; very low-quality of evidence) or reported adverse events (RR 0.92; 95% CI 0.67 to 1.27; very low-quality of evidence) between the carvedilol and placebo groups.There was very low-quality evidence from two trials of inconclusive effects on quality of life (QoL) between the carvedilol and placebo groups. One trial (30 participants) assessed QoL with the Minnesota Living With Heart Failure Questionnaire (21 items; item scores range from 0 to 5; a lower MLHFQ score is better). The MD was -14.74; 95% CI -24.75 to -4.73. The other trial (39 participants) measured QoL with the Medical Outcomes Study 36-item short-form health survey (SF-36; item scores range from 0 to 100; higher SF-36 score is better). Data were not provided.One trial (39 participants) assessed the effect of rosuvastatin versus placebo. The trial did not report on any primary outcomes or adverse events. There was very low-quality evidence of uncertain effects on QoL (no data were provided). AUTHORS' CONCLUSIONS: This first update of our review found very low-quality evidence for the effects of either carvedilol or rosuvastatin, compared with placebo, for treating heart failure in people with Chagas disease. The three included trials were underpowered and had a high risk of bias. There were no conclusive data to support or reject the use of either carvedilol or rosuvastatin for treating Chagas cardiomyopathy. Unless randomised clinical trials provide evidence of a treatment effect, and the trade-off between potential benefits and harms is established, policy-makers, clinicians, and academics should be cautious when recommending or administering either carvedilol or rosuvastatin to treat heart failure in people with Chagas disease. The efficacy and safety of other pharmacological interventions for treating heart failure in people with Chagas disease remains unknown.

Yoga for secondary prevention of coronary heart disease.

BACKGROUND: Coronary heart disease (CHD) is the major cause of early morbidity and mortality in most developed countries. Secondary prevention aims to prevent repeat cardiac events and death in people with established CHD. Lifestyle modifications play an important role in secondary prevention. Yoga has been regarded as a type of physical activity as well as a stress management strategy. Growing evidence suggests the beneficial effects of yoga on various ailments. OBJECTIVES: To determine the effectiveness of yoga for the secondary prevention of mortality and morbidity in, and on the health-related quality of life of, individuals with CHD. SEARCH METHODS: This is an update of a review previously published in 2012. For this updated review, we searched the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library (Issue 1 of 12, 2014), MEDLINE (1948 to February week 1 2014), EMBASE (1980 to 2014 week 6), Web of Science (Thomson Reuters, 1970 to 12 February 2014), China Journal Net (1994 to May 2014), WanFang Data (1990 to May 2014), and Index to Chinese Periodicals of Hong Kong (HKInChiP) (from 1980). Ongoing studies were identified in the metaRegister of Controlled Trials (May 2014) and the World Health Organization International Clinical Trials Registry Platform (May 2014). We applied no language restrictions. SELECTION CRITERIA: We planned to include randomised controlled trials (RCTs) investigating the influence of yoga practice on CHD outcomes in men and women (aged 18 years and over) with a diagnosis of acute or chronic CHD. Studies were eligible for inclusion if they had a follow-up duration of six months or more. We considered studies that compared one group practicing a type of yoga with a control group receiving either no intervention or interventions other than yoga. DATA COLLECTION AND ANALYSIS: Two authors independently selected studies according to prespecified inclusion criteria. We resolved disagreements either by consensus or by discussion with a third author. MAIN RESULTS: We found no eligible RCTs that met the inclusion criteria of the review and thus we were unable to perform a meta-analysis. AUTHORS' CONCLUSIONS: The effectiveness of yoga for secondary prevention in CHD remains uncertain. Large RCTs of high quality are needed.

Yoga for secondary prevention of coronary heart disease.

BACKGROUND: Coronary heart disease (CHD) is the major cause of early morbidity and mortality in most developed countries. Secondary prevention aims to prevent repeat cardiac events and death in people with established CHD. Lifestyle modifications play an important role in secondary prevention. Yoga has been regarded as a type of physical activity as well as a stress management strategy. Growing evidence suggests the beneficial effects of yoga on various ailments. OBJECTIVES: To determine the effectiveness of yoga for the secondary prevention of mortality and morbidity in, and on the health-related quality of life of, individuals with CHD. SEARCH METHODS: This is an update of a review previously published in 2012. For this updated review, we searched the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library (Issue 1 of 12, 2014), MEDLINE (1948 to February week 1 2014), EMBASE (1980 to 2014 week 6), Web of Science (Thomson Reuters, 1970 to 12 February 2014), China Journal Net (1994 to May 2014), WanFang Data (1990 to May 2014), and Index to Chinese Periodicals of Hong Kong (HKInChiP) (from 1980). Ongoing studies were identified in the metaRegister of Controlled Trials (May 2014) and the World Health Organization International Clinical Trials Registry Platform (May 2014). We applied no language restrictions. SELECTION CRITERIA: We planned to include randomised controlled trials (RCTs) investigating the influence of yoga practice on CHD outcomes in men and women (aged 18 years and over) with a diagnosis of acute or chronic CHD. Studies were eligible for inclusion if they had a follow-up duration of six months or more. We considered studies that compared one group practicing a type of yoga with a control group receiving either no intervention or interventions other than yoga. DATA COLLECTION AND ANALYSIS: Two authors independently selected studies according to prespecified inclusion criteria. We resolved disagreements either by consensus or by discussion with a third author. MAIN RESULTS: We found no eligible RCTs that met the inclusion criteria of the review and thus we were unable to perform a meta-analysis. AUTHORS' CONCLUSIONS: The effectiveness of yoga for secondary prevention in CHD remains uncertain. Large RCTs of high quality are needed.

Qigong for the primary prevention of cardiovascular disease.

BACKGROUND: Two major determinants of cardiovascular disease (CVD) are a sedentary lifestyle and stress. Qigong involves physical exercise, mind regulation and breathing control to restore the flow of Qi (a pivotal life energy). As it is thought to help reduce stress and involves exercise, qigong may be an effective strategy for the primary prevention of CVD. OBJECTIVES: To determine the effectiveness of qigong for the primary prevention of CVD. SEARCH METHODS: We searched the following electronic databases: the Cochrane Central Register of Controlled Trials (CENTRAL) (November 2014, Issue 10 of 12); MEDLINE (Ovid) (1946 to 2014 October week 4); EMBASE Classic + EMBASE (Ovid) (1947 to 2014 November 4); Web of Science Core Collection (1970 to 31 October 2014); Database of Abstracts of Reviews of Effects (DARE), Health Technology Assessment Database and Health Economics Evaluations Database (November 2014, Issue 4 of 4). We searched several Asian databases (inception to July 2013) and the Allied and Complementary Medicine Database (AMED) (inception to December 2013), as well as trial registers and reference lists of reviews and articles; we also approached experts in the field and applied no language restrictions in our search. SELECTION CRITERIA: Randomised controlled trials lasting at least three months involving healthy adults or those at high risk of CVD. Trials examined any type of qigong, and comparison groups provided no intervention or minimal intervention. Outcomes of interest included clinical CVD events and major CVD risk factors. We did not include trials that involved multi-factorial lifestyle interventions or weight loss. DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials for inclusion. Two review authors extracted data from included studies and assessed the risk of bias. MAIN RESULTS: We identified 11 completed trials (1369 participants) and one ongoing trial. Trials were heterogeneous in participants recruited, qigong duration and length of follow-up periods. We were unable to ascertain the risk of bias in nine trials published in Chinese, as insufficient methodological details were reported and we were unable to contact the study authors to clarify this.We performed no meta-analyses, as trials were small and were at significant risk of bias. Clinical events were detailed in subsequent reports of two trials when statistically significant effects of qigong were seen for all-cause mortality, stroke mortality and stroke incidence at 20 to 30 years after completion of the trials. However, these trials were designed to examine outcomes in the short term, and it is not clear whether qigong was practised during extended periods of follow-up; therefore effects cannot be attributed to the intervention. None of the included studies reported other non-fatal CVD events.Six trials provided data that could be used to examine the effects of qigong on blood pressure. Reductions in systolic blood pressure (SBP) and diastolic blood pressure (DBP) were seen in three and two trials, respectively. Three trials examined the effects of qigong on blood lipids when favourable effects were seen in one trial for total cholesterol, low-density lipoprotein (LDL) cholesterol and triglycerides, and two trials showed favourable effects on high-density lipoprotein (HDL) cholesterol. The only trial considered at low risk of selection and detection bias did not demonstrate statistically significant effects on CVD risk factors with qigong, but this study was small and was underpowered. None of the included studies reported incidence of type 2 diabetes (T2D), adverse events, quality of life or costs. AUTHORS' CONCLUSIONS: Currently, very limited evidence is available on the effectiveness of qigong for the primary prevention of CVD. Most of the trials included in this review are likely to be at high risk of bias, so we have very low confidence in the validity of the results. Publication of the ongoing trial will add to the limited evidence base, but further trials of high methodological quality with sufficient sample size and follow-up are needed to be incorporated in an update of this review before the effectiveness of qigong for CVD prevention can be established.

Tong-xin-luo capsule for patients with coronary heart disease after percutaneous coronary intervention.

BACKGROUND: Percutaneous coronary intervention (PCI) is a standard treatment for coronary heart disease (CHD). Restenosis, defined as a 50% reduction in luminal diameter at six months after PCI, indicates a need for revascularisation. Restenosis has proven to be a major drawback to PCI. Tong-xin-luo is one of the prophylactic strategies for cardiovascular events in patients after PCI that is widely used in China, but its efficacy and safety have not been systematically evaluated. OBJECTIVES: To systematically assess the efficacy and safety of Tong-xin-luo capsules in preventing cardiovascular events after PCI in patients with CHD. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials in The Cochrane Library, MEDLINE (OVID), EMBASE (OVID), WanFang, Chinese Biomedical Database, Chinese Medical Current Contents, and China National Knowledge Infrastructure from their inception to June 2014. We also searched other resources, including ongoing trials and research registries. We applied no language restrictions. SELECTION CRITERIA: Randomised controlled trials of participants with CHD after PCI were included. Participants in the intervention group received Tong-xin-luo capsules for at least three months. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed the risk of bias. Any disagreements were resolved by discussion with a third review author. The primary outcomes included occurrence of angiographic restenosis and adverse events; the secondary outcomes included myocardial infarction, heart failure, angina, all cause mortality, mortality due to any cardiovascular event, use of revascularisation, patient acceptability, quality of life and cost-effectiveness. Dichotomous data were measured with risk ratios (RRs) with 95% confidence intervals (CIs). MAIN RESULTS: Sixteen studies involving 1063 participants were identified. The risk of bias for fifteen studies was high and along with imprecision and possible publication bias, this lowered our confidence in the results. There was low quality evidence that Tong-xi-luo reduced the rates of angiographic restenosis (RR 0.16, 95% CI 0.07 to 0.34), myocardial infarction (RR 0.32, 95% CI 0.16 to 0.66), heart failure (RR 0.26, 95% CI 0.11 to 0.62), and use of revascularisation (RR 0.26, 95% CI 0.15 to 0.45). There was very low quality evidence for the effect of Tong-xin-luo on all-cause mortality (RR 0.38, 95% CI 0.06 to 2.56), angina (RR 0.24, 95% CI 0.17 to 0.34) and death due to any cardiovascular event (RR 0.31, 95% CI 0.08 to 1.12). Adverse events were seldom reported, and included gastrointestinal reactions and nausea. AUTHORS' CONCLUSIONS: The addition of Tong-xin-luo to conventional Western medicine may possibly prevent restenosis and recurrence of cardiovascular events in patients with CHD after PCI. However, the data are limited by publication bias and high risk of bias for included studies. Further high-quality trials are required to evaluate the potential effects of this intervention.

Shengmai (a traditional Chinese herbal medicine) for heart failure.

BACKGROUND: Heart failure is a major public health problem worldwide. Shengmai, a traditional Chinese herbal medicine, has long been used as a complementary treatment for heart failure in China. This is an update of a Cochrane Review published in 2012. OBJECTIVES: To determine the effect (both benefits and harms) of Shengmai in treatment of people with heart failure. SEARCH METHODS: We searched CENTRAL on The Cochrane Library (Issue 5 of 12, April 2013); DARE on The Cochrane Library (Issue 2 of 4, April 2013); MEDLINE (1948 to June Week 1 2013); EMBASE (1980 to 2013 Week 23); AMED (1985 to August 2008); BIOSIS (1969 to 7 June 2013); CBM (1978 to June 2013); VIP (1989 to June 2013); and CNKI (1979 to June 2013). We also handsearched Chinese journals and did not apply any language restrictions. SELECTION CRITERIA: We included randomised controlled trials (RCTs) of Shengmai plus usual treatment for heart failure versus usual treatment alone, or Shengmai versus placebo, irrespective of blinding status. In this update we only included studies with a clear description of randomisation methods and classified as true RCTs. DATA COLLECTION AND ANALYSIS: Two authors independently selected trials, assessed methodological quality and extracted data. We calculated dichotomous data as risk ratios (RRs) and continuous data as mean differences (MDs) or standardized mean differences (SMDs) with corresponding 95% confidence intervals (CIs). We used a fixed-effect model to perform meta-analysis for outcomes without heterogeneity; and a random-effects model to perform meta-analysis for outcomes with heterogeneity. MAIN RESULTS: We included a total of 14 RCTs (858 patients) in this review update, four of which were new trials. Of these 14 RCTs, 11 trials compared Shengmai plus usual treatment with usual treatment alone, and three trials compared Shengmai with placebo. Improvement of NYHA functional classification was more common in patients taking Shengmai plus usual treatment than in those receiving usual treatment alone (RR 0.37; 95% CI 0.26 to 0.51; 10 trials, 672 participants; low quality evidence). Beneficial effects of Shengmai in treating heart failure were also observed in other outcomes, including exercise test, ejection fraction and cardiac output. The three RCTs (106 patients) comparing Shengmai with placebo reported improvement in NYHA functional classification and in stroke volume. Three of the 14 RCTs reported a total of six patients with mild adverse effects and two were withdrawn due to the adverse effects. The adverse events rate was 1.21%. AUTHORS' CONCLUSIONS: Shengmai may exert a positive effect on heart failure, especially for improving NYHA functional classification when Shengmai plus usual treatment is used. The review results should be interpreted with caution due to the high risk of bias of the included studies (particularly regarding allocation concealment and blinding), the small sample size of these studies, and the significant heterogeneity in outcomes such as ejection function, cardiac output and stroke volume. There was no evidence available concerning the effect of Shengmai on mortality, and more high quality studies with long-term follow-up are warranted.

Bleeding of new oral anticoagulants for stroke prevention in atrial fibrillation: a meta-analysis of randomized controlled trials.

PURPOSE: Oral direct factor Xa inhibitors and oral direct thrombin inhibitors are new oral anticoagulants (NOACs) for stroke prevention in atrial fibrillation (AF). We systematically reviewed their risk of major bleeding and efficacy in thromboembolism reduction in AF. METHODS: Eligible randomized controlled trials evaluating NOACs for stroke prevention in AF patients were identified from a systematic search of MEDLINE, EMBASE and the Cochrane database. Risk ratios (RRs) and 95 % confidence intervals (CIs) were calculated using a Mantel-Haenzel random-effects model. RESULTS: A total of 13 studies (n = 61,406) were included. Oral direct factor Xa inhibitors were more effective in reducing stroke and systemic embolism compared to controls (RR 0.71, 95 % CI 0.54-0.92, P = 0.009) or vitamin K antagonists (VKAs) (RR 0.84, 95 % CI 0.74-0.94, P = 0.002), with no significant difference in major and clinically relevant non-major (CRNM) bleeding (against controls: RR 0.94, 95 % CI 0.75-1.18, P = 0.60; against VKAs: RR 0.90, 95 % 0.69-1.17, P = 0.44). Oral direct thrombin inhibitors were associated with an improved major and CRNM bleeding profile (both comparisons: RR 0.88, 95 % CI 0.78-0.98, P = 0.02) and a significant reduction in stroke and systemic embolism (against controls: RR 0.79, 95 % CI 0.66-0.93, P = 0.006; against VKAs: RR 0.78, 95 % CI 0.66-0.93, P = 0.006). CONCLUSIONS: Oral direct factor Xa inhibitors and oral direct thrombin inhibitors are more effective in reducing stroke and systemic embolism without increasing the risk of major bleeding compared to traditional oral anticoagulants. This favorable risk-benefit balance should be further confirmed by long-term, large-scale safety studies.

Herbal medicines for viral myocarditis.

BACKGROUND: Herbal medicines are used as treatment for viral diseases such as viral myocarditis, and numerous clinical trials have been conducted to investigate their efficacy. Despite this wealth of evidence, the role of herbal medicines in the treatment of viral myocarditis has yet to be established. This is an update of a review published in 2012. OBJECTIVES: To assess the benefits and harms of herbal medicines on clinical (e.g. mortality, incidence of complications) and indirect outcomes (e.g. cardiac function, biochemical response) in patients with viral myocarditis, irrespective of the patients' age, gender or type (including acute and chronic viral myocarditis). SEARCH METHODS: We searched CENTRAL (2013, Issue 1) on The Cochrane Library, MEDLINE (Ovid, 1946 to January Week 4 2013), EMBASE (Ovid, 1980 to 2013 Week 04) and LILACS (Bireme) on 1 February 2013. We previously searched The Chinese Biomedical Database (1979 to 2011), China National Knowledge Infrastructure (1979 to 2011), Chinese VIP Information (1989 to 2011), Chinese Academic Conference Papers Database and Chinese Dissertation Database (1980 to 2011), AMED (June 2011) and the Cochrane Complementary Medicine Field Trials Register (June 2011). We handsearched Chinese journals and conference proceedings. No language restrictions were applied. SELECTION CRITERIA: Randomised controlled trials of herbal medicines (with a minimum duration of seven days of treatment) compared with placebo, no intervention, or conventional interventions were included. Trials of herbal medicine plus a conventional drug versus the drug alone were also included. We included only trials that reported an adequate description of allocation sequence generation. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and evaluated trial quality. Information on adverse effects was collected from the trial reports. MAIN RESULTS: We did not identify any new trials with the updated search in February 2013. The 2011 update of this review included twenty randomised controlled trials involving 2177 people. All the trials were conducted and published in China. The controls included anti-arrhythmic drugs, corticosteroids, and antiviral therapies such as ribavirin or interferon. Combining the risk of bias for random sequence generation, allocation concealment, selective reporting, and incomplete outcome data, we assessed the included trials as being at a high risk of bias. Thirteen different herbal medicines were tested in the included trials. One of the trials reported outcomes on mortality. The trials reported electrocardiogram results, levels of myocardial enzymes, cardiac function, and adverse effects.Compared with supportive therapy, Astragalus membranaceus injection did not show a significant reduction in the number of patients that died of cardiac failure.A meta-analysis showed a significant effect ofAstragalus membranaceus injection plus supportive therapy on the number of participants with an abnormal electrocardiogram (RR 0.28, 95% CI 0.13 to 0.61), ST-T changes (RR 0.72, 95% CI 0.54 to 0.95), creatine phosphate kinase (CPK) levels (MD -21.54, 95% CI -33.80 to -9.28), and lactate dehydrogenase (LDH) levels (MD -30.33, 95% CI -46.78 to -13.88).Shengmai injection plus supportive therapy showed a significant effect on the number of patients with an abnormal electrocardiogram (RR 0.11, 95% CI 0.01 to 0.86), CPK levels (MD -103.90, 95% CI -114.97 to -92.83), LDH levels (MD -34.60, 95% CI -51.25 to -17.95), and on myocardial enzyme CK-MB levels (MD -10.87, 95% CI -14.50 to -7.24). Shengmai decoction plus supportive therapy showed a significant effect on improving quality of life measured by the SF-36 (MD 40.20, 95% CI 18.13 to 62.27) compared to supportive therapy. Data on adverse events were only available from six of the included trials and no serious adverse effects were reported. AUTHORS' CONCLUSIONS: Since no new trials were identified in the updated search in 2013, the conclusions remain the same as they were in 2012. There is no evidence of benefit of herbal medicine on all cause mortality. Some herbal medicines may lead to improvement of ventricular premature beat, electrocardiogram, levels of myocardial enzymes, and cardiac function in viral myocarditis. However, these findings should be interpreted with care, due to the risk of bias of the included studies, small sample size, and limited number of trials on individual herbs. Further robust trials are needed to explore the use of herbal medicines for viral myocarditis.

Acupuncture versus sham acupuncture and usual care for Antiandrogen-Induced hot fLashes in prostate cancer (AVAIL): study protocol for a randomized clinical trial.

BACKGROUND: Hot flashes are the common and debilitating symptom among prostate cancer (PCa) patients undergoing androgen deprivation therapy (ADT). Strong evidence from multiple rigorously designed studies indicated that pharmacological option such as venlafaxine provides partial relief, but the tolerability is poor when dose is not tapered. Hence, alternative therapy is needed. Previous studies reported that acupuncture may be helpful in the management of hot flashes. However, the insufficient randomized controlled trial limited the quality of evidence. METHODS: Five hospitals will recruit 120 acupuncture naïve patients with moderate-to-severe hot flashes after prostate cancer received ADT in China from February 2023 to December 2024. Participants will be randomly 2:1:1 allocated to the 18 sessions of verum acupuncture at true acupuncture points plus usual care, 18 sessions of non-penetrating sham acupuncture at non-acupuncture points plus usual care, or usual care alone over 6 weeks. The primary outcome measure is the change of mean weekly hot flashes symptom severity score (HFSSS) at the end of treatment compared with baseline. EXPECTED RESULTS AND CONCLUSION: We will be able to measure the effectiveness of acupuncture for patients with PCa suffering from ADT-induced hot flashes and whether acupuncture is superior to sham acupuncture and usual care. The proposed acupuncture treatment might provide an alternative option for those patients. TRIAL REGISTRATION: Clinicaltrials.gov (NCT05069467).

Cardiac contractility modulation for heart failure: a meta-analysis of randomized controlled trials.

BACKGROUND: Cardiac contractility modulation (CCM) emerges as a promising device treatment for heart failure (HF). This meta-analysis aimed to systematically review the latest available randomized evidence on the effectiveness and safety of CCM in HF. METHODS: The Cochrane Central Register of Controlled Trials, MEDLINE, and EMBASE were searched in November 2011 to identify eligible randomized controlled trials comparing CCM with sham treatment or usual care. Primary outcomes of interest were all-cause mortality, all-cause hospitalizations, and adverse effects. Risk ratios (RRs) and 95% confidence intervals (CIs) were calculated for dichotomous data using a random-effects model. RESULTS: Three studies enrolling 641 participants were included. Pooled analysis showed that, compared to control, CCM did not significantly improve all-cause mortality (n = 629, RR 1.19, 95% CI 0.50-2.86, P = 0.69), nor was there a favorable effect in all-cause hospitalizations. No increase in adverse effects with CCM was observed. CONCLUSIONS: Meta-analysis of data from small randomized trials suggests that CCM, although with no clear benefits in improving clinical outcomes, is not associated with worsening prognosis. Large, well-designed trials are needed to confirm its role in HF patients for whom cardiac resynchronization therapy is contraindicated or unsuccessful.

Yoga for secondary prevention of coronary heart disease.

BACKGROUND: Coronary heart disease (CHD) is the major cause of early morbidity and mortality in most developed countries. Secondary prevention aims to prevent repeat cardiac events and death in people with established CHD. Lifestyle modifications play an important role in secondary prevention. Yoga has been regarded as a kind of physical activity as well as stress management strategy. Growing evidence suggests the beneficial effects of yoga on various ailments. OBJECTIVES: To determine the effectiveness of yoga for secondary prevention of mortality, morbidity, and health related quality of life of patients with CHD. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) on The Cochrane Library (2012, Issue 1), MEDLINE (1948 to January 2012), EMBASE (1980 to January 2012), ISI Web of Science for conference proceedings (1970 to January 2012), China Journal Net (CJN) (1994 to March 2012), WanFang Data (1990 to March 2012), and HKInChiP (from 1980). Ongoing studies were identified in the metaRegister of Controlled Trials (April 2012) and the World Health Organization (WHO) International Clinical Trials Registry Platform (April 2012). No language restrictions were applied. SELECTION CRITERIA: We included randomized controlled trials (RCTs) investigating the influence of yoga practice on CHD outcomes. We included studies that had at least a six months follow-up period. Men and women (aged 18 years and above) with a diagnosis of acute or chronic CHD were included. We included studies with one group practicing a type of yoga compared to the control group receiving either no intervention or interventions other than yoga. DATA COLLECTION AND ANALYSIS: Two authors independently selected studies according to the pre-specified inclusion criteria. Disagreements were resolved by consensus or discussion with a third author. MAIN RESULTS: We found no eligible RCTs that met the inclusion criteria of the review and thus we were unable to perform a meta-analysis. AUTHORS' CONCLUSIONS: The effectiveness of yoga for secondary prevention in CHD remains uncertain. Large RCTs of high quality are needed.

Herbal medicines for viral myocarditis.

BACKGROUND: Herbal medicines are being used as a treatment for viral diseases such as viral myocarditis and numerous clinical trials have been conducted to investigate their efficacy. Despite this wealth of evidence, the role of herbal medicines in the treatment of viral myocarditis is yet to be established. This is an update of the review published in 2010. OBJECTIVES: To assess the effects of herbal medicines on clinical (for example mortality, incidence of complications) and indirect outcomes (for example cardiac function, biochemical response) in patients with viral myocarditis. SEARCH METHODS: We searched CENTRAL (The Cochrane Library 2011, Issue 2), MEDLINE (January 1966 to June 2011), EMBASE (January 1998 to June 2011), Chinese Biomedical Database (1979 to 2011), China National Knowledge Infrastructure (1979 to 2011), Chinese VIP Information (1989 to 2011), Chinese Academic Conference Papers Database and Chinese Dissertation Database (1980 to 2011), AMED (June 2011), LILACS (June 2011), and the Cochrane Complementary Medicine Field Trials Register. We handsearched Chinese journals and conference proceedings. No language restrictions were applied. SELECTION CRITERIA: Randomised controlled trials of herbal medicines (with a minimum of seven days treatment duration) compared with placebo, no intervention, or conventional interventions were included. Trials of herbal medicine plus conventional drug versus drug alone were also included. Only trials that reported an adequate description of allocation sequence generation were included. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and evaluated trial quality. Adverse effects information was collected from the trials. MAIN RESULTS: Twenty randomised controlled trials involving 2177 people were included. All trials were conducted and published in China. The controls included anti-arrhythmic drugs, corticosteroids, and antiviral therapies such as ribavirin or interferon. Combining the risk of bias on random sequence generation, allocation concealment, selective reporting, and incomplete outcome data, the included trials were assessed to be at high risk of bias. Thirteen different herbal medicines were tested in the included trials. None of the trials reported outcomes on mortality. The trials reported electrocardiogram results, level of myocardial enzymes, cardiac function, and adverse effects.A meta-analysis showed a significant effect of Astragalus membranaceus injection plus supportive therapy on the number of patients with an abnormal electrocardiogram (RR 0.28, 95% CI 0.13 to 0.61), ST-T changes (RR 0.72, 95% CI 0.54 to 0.95), creatine phosphate kinase (CPK) levels (MD -21.54, 95% CI -33.80 to -9.28), and lactate dehydrogenase (LDH) levels (MD -30.33, 95% CI -46.78 to -13.88).Shengmai injection plus supportive therapy showed a significant effect on the number of patients with an abnormal electrocardiogram (RR 0.11, 95% CI 0.01 to 0.86), CPK levels (MD -103.90, 95% CI -114.97 to -92.83), LDH levels (MD -34.60, 95% CI -51.25 to -17.95), and on myocardial enzyme CK-MB levels (MD -10.87, 95% CI -14.50 to -7.24). Shengmai decoction plus supportive therapy showed a significant effect on improving quality of life measured by the SF-36 (MD 40.20, 95% CI 18.13 to 62.27) compared to supportive therapy. Data on adverse events were only available from six of the included trials and no serious adverse effects were reported. AUTHORS' CONCLUSIONS: Some herbal medicines may lead to improvement of ventricular premature beat, electrocardiogram, level of myocardial enzymes, and cardiac function in viral myocarditis. However, these findings should be interpreted with care due to the high risk of bias of the included studies, small sample size, and limited number of trials on individual herbs. Further robust trials are needed to explore the use of herbal medicines in viral myocarditis.

Shengmai (a traditional Chinese herbal medicine) for heart failure.

BACKGROUND: This systemic review is an update of a review previously published in 2011. Heart failure is a major public health problem worldwide. Shengmai (a traditional Chinese herbal medicine) has long been used as a complementary treatment for heart failure in China. OBJECTIVES: To assess the effects (both benefits and harms) of Shengmai for heart failure. SEARCH METHODS: We searched CENTRAL and DARE on The Cochrane Library (2011, Issue 1), MEDLINE (1948 to March 2011), EMBASE (1980 to March 2011), AMED (1985 to August 2008) (AMED was not searched for the update as it is no longer available to the person conducting the searches), BIOSIS (1969 to March 2011), CBM (1978 to April 2011), VIP (1989 to April 2011) and CNKI (1979 to April 2011). We also handsearched Chinese journals. No language restrictions were applied. SELECTION CRITERIA: Randomized controlled trials (RCTs) of Shengmai plus usual treatment versus usual treatment alone or Shengmai versus placebo in treating heart failure, irrespective of blinding status, were included. More stringent inclusion criteria were applied in this update and only studies with a clear description of randomization methods and classified as true RCTs were included. DATA COLLECTION AND ANALYSIS: Two authors independently selected trials, assessed methodological quality and extracted data. Dichotomous and continuous data were calculated as relative risk (RR) and mean difference (MD) or standardized mean difference (SMD), respectively. A random-effects model and fixed-effect model were used to perform meta-analysis with and without heterogeneity, respectively. MAIN RESULTS: Nine RCTs (600 patients) with seven comparing Shengmai plus usual treatment with usual treatment alone and three comparing Shengmai with placebo (one RCT contained three arms) were included in this updated review. Based upon the seven RCTs (494 patients), improvement of the New York Heart Association (NYHA) functional classification was more common in patients taking Shengmai plus usual treatment than in those receiving usual treatment alone (risk ratio 0.33, 95% confidence interval 0.23 to 0.47). Beneficial effects of Shengmai in treating heart failure were also observed on other outcomes, including an exercise test, ejection fraction, cardiac output, cardiac index and left ventricular end-systolic volume. The three RCTs (106 patients) which compared Shengmai with placebo reported an improvement in NYHA functional classification, ejection fraction, stroke volume, cardiac index and myocardial contractility. Three out of the nine RCTs reported mild adverse effects, and two patients were withdrawn due to the adverse effects. The results of this review should be interpreted with caution. This is due to the studies being of low quality, their small sample size, and the significant heterogeneity for certain outcomes including ejection fraction and cardiac output. AUTHORS' CONCLUSIONS: Shengmai may be beneficial in treating heart failure, especially in terms of improving the NYHA functional classification with Shengmai plus usual treatment. However, the evidence for its effects on mortality and hospitalisation are not available yet. Therefore more studies, of higher quality and long-term follow-up, are needed to provide more evidence for the future use of Shengmai.