Acupuncture for treatment of erectile dysfunction : a systematic review and meta-analysis

Purpose: To assess the effectiveness and safety of acupuncture for erectile dysfunction (ED). Materials and Methods: We searched six major English and Chinese databases included randomized controlled trials (RCTs) testing acupuncture alone or in combination for ED. Dichotomous data were presented as risk ratio (RR) and continuous data were presented as mean difference (MD) both with 95% confidence interval (CI). The Revman (v.5.3) was used for data analyses. Quality of evidence across studies was assessed by the online GRADEpro tool. Results: We identified 22 RCTs, fourteen of them involving psychogenic ED. Most of the included RCTs had high or unclear risk of bias. There was no difference between electro-acupuncture and sham acupuncture with electrical stimulation on the rate of satisfaction and self-assessment (RR, 1.50; 95% CI, 0.71-3.16; 1 trial). Acupuncture combined with tadalafil appeared to have better effect on increasing cure rate (RR, 1.31; 95% CI, 1.00-1.71; 2 trials), and International Index of Erectile Function-5 scores (MD, 5.38; 95% CI, 4.46-6.29; 2 trials). When acupuncture plus herbal medicine compared with herbal medicine alone, the combination therapy showed significant better improvement in erectile function (RR, 1.68; 95% CI, 1.31-2.15; 7 trials). Only two trials reported facial red and dizziness cases, and needle sticking and pruritus cases in acupuncture group. Conclusions: Low quality evidence shows beneficial effect of acupuncture as adjunctive treatment for people mainly with psychogenic ED. Safety of acupuncture was insufficiently reported. The findings should be confirmed in large, rigorously designed and well-reported trials

A new tool to assess Clinical Diversity In Meta‐analyses (CDIM) of interventions

OBJECTIVE: To develop and validate Clinical Diversity In Meta-analyses (CDIM), a new tool for assessing clinical diversity between trials in meta-analyses of interventions.STUDY DESIGN AND SETTING: The development of CDIM was based on consensus work informed by empirical literature and expertise. We drafted the CDIM tool, refined it, and validated CDIM for interrater scale reliability and agreement in three groups.RESULTS: CDIM measures clinical diversity on a scale that includes four domains with 11 items overall: setting (time of conduct/country development status/units type); population (age, sex, patient inclusion criteria/baseline disease severity, comorbidities); interventions (intervention intensity/strength/duration of intervention, timing, control intervention, cointerventions); and outcome (definition of outcome, timing of outcome assessment). The CDIM is completed in two steps: first two authors independently assess clinical diversity in the four domains. Second, after agreeing upon scores of individual items a consensus score is achieved. Interrater scale reliability and agreement ranged from moderate to almost perfect depending on the type of raters.CONCLUSION: CDIM is the first tool developed for assessing clinical diversity in meta-analyses of interventions. We found CDIM to be a reliable tool for assessing clinical diversity among trials in meta-analysis.</p

Current status of outcome reporting in randomized controlled trials of traditional Chinese medicine for mammary gland hyperplasia: A systematic review

Objective: To assess outcome indicators in clinical trials and provide a reference for establishing a core outcome set to treat hyperplasia of mammary gland (HMG) with traditional Chinese medicine (TCM). Methods: Eight online databases were searched from their inception to December 31, 2022, to assess outcomes reported in randomized controlled trials (RCTs) of HMG treated with TCM. The quality of the included studies was assessed according to the Cochrane Risk of Bias Assessment Tool. All outcomes were extracted, classified, and described. Results: A total of 8249 articles were initially retrieved. Of these, 70 articles were eligible and involved 10 618 participants with HMG. A total of 17 outcome indicators with a frequency of 271 times were involved and were collected according to six outcome domains. Conclusions: The core outcomes of RCTs of HMG treated with TCM are large and divergent. There are problems in evaluation standards, primary and secondary outcomes, TCM characteristic indicators, long-term prognosis, and standardization of reporting. It is recommended to strengthen the trial design and actively construct the core outcome sets with TCM characteristics for HMG

Comparison of drug safety data obtained from the monitoring system, literature, and social media : an empirical proof from a Chinese patent medicine

Objectives: To investigate the consistency of adverse events (AEs) and adverse drug reactions (ADRs) reported in the literature, monitoring and social media data. Methods: Using one Chinese patent medicine-Cordyceps sinensis extracts (CSE) as an example, we obtained safety data from the national monitoring system (July 2002 to February 2016), literature (up to November 2016) and social media (May 2019). For literature data, we searched the Chinese National Knowledge Infrastructure Database (CNKI), WanFang database, Chinese Science and Technology Periodical Database (VIP), Chinese Biomedical Literature Database (SinoMed), PubMed, Embase and the Cochrane Library. Social media data was from the Baidu post bar and Sina micro-blog. Two authors independently screened the literature and extracted data by PRISMA Harms checklist was followed. AEs and ADRs were coded using the World Health Organization Adverse Reaction Terminology (WHO-ART). AEs and ADRs were grouped into thirty-one organ-system classes for comparisons. Frequencies, relative frequencies and rank were used as metrics. Radar chart was used to manifest the features of the distributions and proportions. Results: 610 AEs reported in CFDA monitoring data were associated with CSE, of which 537 (88.03%) were suspected ADRs (10.49% certain). 5568 AEs were identified from 172 papers (63% RCTs, 37% other types of studies including case series, case reports, ADR monitoring reports and reviews), in which 86 (1.54%) were ADRs (1.54% certain). 15 AEs (0 certain ADR) were identified from social media. AEs, ADRs and their affected system-organ classes, looked largely similar, but different in every aspect when looking at details. Data from RCTs demonstrated the most disparity. Conclusions: In our study, the most prevalent AEs and ADRs, mainly gastro-intestinal system disorders including nausea, diarrhea and vomiting, in monitoring system were largely similar with those in literature and social media. But data from different sources varied if looked at details. Multiple data sources (the monitoring system, literature and social media) should be integrated to collect safety information of interventions. The distributions of AEs and ADRs from RCTs were least similar with the data from other sources. Our empirical proof is consistent with other similar studies

Fire needling for herpes zoster: A systematic review and meta-analysis of randomized clinical trials

Objective: To evaluate the effectiveness and safety of fire needling for herpes zoster from randomized clinical trials (RCTs). Methods: We searched Cochrane Central Register of Controlled Trials, Pubmed, Sino-Med, CNKI, VIP, WanFang databases, and conference proceedings to November, 2017. RCTs were eligible if they tested fire needling for treating herpes zoster more than 3 times. Two authors screened all references, assessed the risk of bias, extracted data, independently, and analyzed data using Trial Sequential Analysis (TSA). Treatment effects were presented as risk ratio (RR) for binary data and standardized mean difference (SMD) for continuous data with 95% confidence interval (CI). Results: We included 27 RCTs with a total of 1933 participants. Only one RCT had low risk of bias, and the others were of high or moderate risk of bias. For total effectiveness rate (proportion of total number of people who were cured or significant symptom improved), there was no significant difference between Western medicine (acyclovir, valacyclovir, adenosine cobalamin) and fire needling (risk ratio 1.05,95% CI 0.98 to 1.12; n = 5). For pain relief (VAS scale): fire needling used alone showed lower scores than Western medicine (SMD -1.37, 95% CI -1.77 to −0.97; n = 2) or external medicine (diclofenac) (SMD-2.23, 95% CI -2.81 to −1.64; n = 1). Combination of fire needling and Western medicine was better than Western medicine alone in relieving pain (VAS scale) (SMD-2.19, 95% CI -3.40 to −0.97, I2 = 94%; n = 4). Patients receiving fire needling had lower incidence of neuralgia than those receiving Western medicine (3.3% vs 26.7%, RR 0.09, 95% CI 0.01 to 0.82; n = 1) at follow up for 30 days. No serious adverse events such as infection were reported. Conclusion: Fire needling appears to offer relief for alleviating pain in herpes zoster. As the sample size of included trials was small and the quality of studies was generally low, rigorous clinical trials with robust reporting and appropriate outcome measures are still needed. Keywords: Fire needling, Acupuncture, Herpes zoster, Postherpetic neuralgia, Trial sequential analysi

Pediatric Tui Na for acute diarrhea in children under 5 years old : a systematic review and meta-analysis of randomized clinical trials

Objective: To evaluate the benefits and harms of pediatric Tui Na as a non-pharmaceutical Chinese medicine therapy for acute diarrhea in children under 5 years of age. Design: Systematic review and meta-analysis of randomized clinical trials. Methods: We searched seven major English and Chinese databases from their inception to January 2018 for randomized clinical trials (RCTs) comparing pediatric Tui Na therapy with conventional medicine (montmorillonite/diosmectite or probiotics used alone or in combination). Two authors extracted data and assessed the Cochrane risk of bias, independently. The primary outcomes are clinical cure rate and diarrhea duration from admission to the cessation of diarrhea. ‘Clinical cure’ is defined as the frequency, timing and character of stool back to normal status, as well as disappearance of diarrhea symptoms. We present dichotomous data as risk ratio (RR), and continuous data as mean difference (MD) with their 95% confidence interval (CI). We used the Cochrane’s Revman software (v.5.3) for data analysis. Trial sequential analysis (TSA) was applied to calculate the required sample size in a meta-analysis and detect the robustness of the results. The GRADEpro was used to generate a summary of finding table. Results: Totally 26 RCTs were included, involving 2410 children with acute diarrhea. Most of the included trials had high or unclear risk of bias in terms of random sequence generation, blinding, and incomplete outcome reporting. The pooled results demonstrated that pediatric Tui Na was superior to montmorillonite after three-session treatment (RR 1.45, 95% CI 1.29–1.62, n = 772, 10 trials), and also superior to montmorillonite combined with probiotics after three-session treatment (RR 2.04, 95% CI 1.49–2.78, n = 533, 7 trials) and after six-session treatment (RR 1.52, 95% CI 1.34–1.73, n = 631, 5 trials) in improving clinical cure rate. Pediatric Tui Na significantly decreased the duration of acute diarrhea (hrs) (MD −0.40 h, 95% CI −15.31 to −5.48 h, n = 410, 6 trials) and daily stool frequency (MD −1.71times, 95% CI −2.37 to −1.04, n = 217, 3 trials, after three-session treatment). No adverse event related to pediatric Tui Na was reported in the included trials. The quality of evidence of included trials was generally moderate to low. TSA for cure rate demonstrated that the pooled data reached a sufficient power regarding both numbers of trials and participants. Conclusions: This review shows pediatric Tui Na appears to be effective and safe in improving clinical cure rate and shortening diarrhea duration in childhood aged less than five years of age with acute diarrhea. However, rigorously designed well-reported RCTs are warranted to confirm the findings

A new tool to assess Clinical Diversity In Meta-analyses (CDIM) of interventions

OBJECTIVE: To develop and validate Clinical Diversity In Meta-analyses (CDIM), a new tool for assessing clinical diversity between trials in meta-analyses of interventions. STUDY DESIGN AND SETTING: The development of CDIM was based on consensus work informed by empirical literature and expertise. We drafted the CDIM tool, refined it, and validated CDIM for interrater scale reliability and agreement in three groups. RESULTS: CDIM measures clinical diversity on a scale that includes four domains with 11 items overall: setting (time of conduct/country development status/units type); population (age, sex, patient inclusion criteria/baseline disease severity, comorbidities); interventions (intervention intensity/strength/duration of intervention, timing, control intervention, cointerventions); and outcome (definition of outcome, timing of outcome assessment). The CDIM is completed in two steps: first two authors independently assess clinical diversity in the four domains. Second, after agreeing upon scores of individual items a consensus score is achieved. Interrater scale reliability and agreement ranged from moderate to almost perfect depending on the type of raters. CONCLUSION: CDIM is the first tool developed for assessing clinical diversity in meta-analyses of interventions. We found CDIM to be a reliable tool for assessing clinical diversity among trials in meta-analysis