PRISMA extension for moxibustion 2020: recommendations, explanation, and elaboration.

BACKGROUND: Moxibustion is a common intervention of Chinese medicine (CM). Systematic reviews (SRs) on moxibustion are increasing. Although the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement provides guidelines for SRs, the quality of moxibustion-related SRs is still not satisfactory. In particular, descriptions of the interventions and the rationale for using moxibustion are insufficient. To address these inadequacies, the working group developed this PRISMA extension for reporting SRs of moxibustion (PRISMA-M 2020). METHODS: A group of CM clinical professionals, methodologists of SRs, reporting guideline developers, and journal editors developed this PRISMA-M 2020 through a comprehensive process that includes registration, literature review, consensus meetings, Delphi exercises for soliciting comments, and revision, resulting in this final draft. RESULTS: Seven of the 27 PRISMA checklist items, namely title (1), rationale (3), eligibility criteria (6), data item (11), additional analyses (16), study characteristics (18), and additional analysis (23), were extended, with specific reference to the application of moxibustion. Illustrative examples and explanations for each item are provided. CONCLUSION: The PRISMA-M 2020 will help improve the reporting quality of SRs with moxibustion. SYSTEMATIC REVIEW REGISTRATION: We have registered it on the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) network, particularly under the item of PRISMA-TCM: http://www.equator-network.org/library/reporting-guidelines-under-development/reporting-guidelines-under-development-for-systematic-reviews/#65 .

WHO Trial Registration Data Set (TRDS) extension for traditional Chinese medicine 2020: recommendations, explanation, and elaboration.

BACKGROUND: Although the WHO Trial Registration Data Set (TRDS) has been published for many years, the quality of clinical trial registrations with traditional Chinese medicine (TCM) is still not satisfactory, especially about the inadequate reporting on TCM interventions. The development of the WHO TRDS for TCM Extension 2020 (WHO TRDS-TCM 2020) aims to address this inadequacy. METHODS: A group of clinical experts, methodologists, epidemiologists, and editors has developed this WHO TRDS-TCM 2020 through a comprehensive process, including the baseline survey, draft of the initial items, three-round of Delphi survey, solicitation of comments, revision, and finalization. RESULTS: The WHO TRDS-TCM 2020 statement extends the latest version (V.1.3.1) of TRDS published in November 2017. The checklist includes 11 extended items (including subitems), namely Source(s) of Monetary or Material Support (Item 4), Scientific Title (Item 10a and 10b), Countries of Recruitment (Item 11), Health Condition(s) or Problem(s) Studied (Item 12), Intervention(s) (Item 13a, 13b and 13c), Key Inclusion and Exclusion Criteria (Item 14), Primary and Key Secondary Outcomes (Item 19 to 20), and Lay Summary (Item B1). For Item 13 (Interventions), three common TCM interventions--i.e., Chinese herbal medicine formulas, acupuncture and moxibustion-are elaborated. CONCLUSIONS: The group hopes that the WHO TRDS-TCM 2020 can improve the reporting quality and transparency of TCM trial registrations, assist registries in assessing the registration quality of TCM trials, and help readers understand TCM trial design.

Systematic Reviews/Meta-Analyses of Integrative Medicine in Chinese Need Regulation and Monitoring Urgently and Some Suggestions for Its Solutions.

With the introduction and development of evidence-based medicine in China, it has been spread rapidly in the area of integrative medicine (IM) and has become a new unique discipline. During almost 20 years, as one of the most important parts of evidence-based IM, systematic review (SR)/meta-analysis (MA) of IM have shown a good development momentum in the aspects of quantity, depth, breadth and influence, but also face the harsh situation of the uncontrolled quantity and quality, especially for SRs in Chinese. Therefore, how to supervise and standardize this area effectively becomes a problem to be solved. Based on the experience both at home and abroad, the authors put forward several kinds of solutions for laying the foundation for further development such as promoting the registration system of SR/MA of IM, effectively setting up the regulatory platform of quality and quantity, launching professional training for SR/MA reviewers, forming qualification registration, developing the data transfer and sharing platform to realize the transparency of evidence process.

CONSORT Extension for Chinese Herbal Medicine Formulas 2017: Recommendations, Explanation, and Elaboration (Simplified Chinese Version).

Editors' Note: This article is the simplified Chinese version of the CONSORT Extension for Chinese Herbal Medicine Formulas 2017: Recommendations, Explanation, and Elaboration. (Cheng C, Wu T, Shang H, Li, Y, Altman D, Moher D; CONSORT-CHM Formulas 2017 Group. CONSORT Extension for Chinese Herbal Medicine Formulas 2017: Recommendations, Explanation, and Elaboration. Ann Intern Med. 2017;167:112-21. [Epub 27 June 2017]. doi:10.7326/M16-2977).

CONSORT Extension for Chinese Herbal Medicine Formulas 2017: Recommendations, Explanation, and Elaboration.

Chinese herbal medicine (CHM) formulas are the major components of traditional Chinese medicine (TCM) interventions. The general reporting quality of randomized controlled trials (RCTs) of CHM formulas is disappointing, although CONSORT (Consolidated Standards of Reporting Trials) Statement extensions for herbal medicinal interventions and acupuncture interventions are available. A group of TCM clinical experts, methodologists, epidemiologists, and editors has developed this CONSORT Extension for CHM Formulas (CONSORT-CHM Formulas 2017) through a comprehensive process, including publication of the draft version, solicitation of comments, revision, and finalization. The CONSORT 2010 Statement was extended by introducing the idea of TCM Pattern and the features of CHM formulas. One new checklist subitem, keywords, was added to facilitate indexing and data searching. Seven of the 25 CONSORT checklist items, namely title and abstract, background and objectives, participants, interventions, outcomes, generalizability, and interpretation, are now elaborated, and the explanation of harms specific to CHM formulas is revised. Illustrative examples and explanations are also provided. The group hopes that CONSORT-CHM Formulas 2017 can improve the reporting quality of RCTs of CHM formulas.

CONSORT Extension for Chinese Herbal Medicine Formulas 2017: Recommendations, Explanation, and Elaboration (Traditional Chinese Version).

Editors' Note: This article is the traditional Chinese version of the CONSORT Extension for Chinese Herbal Medicine Formulas 2017: Recommendations, Explanation, and Elaboration. (Cheng C, Wu T, Shang H, Li, Y, Altman D, Moher D; CONSORT-CHM Formulas 2017 Group. CONSORT Extension for Chinese Herbal Medicine Formulas 2017: Recommendations, Explanation, and Elaboration. Ann Intern Med. 2017;167:112-21. [Epub 27 June 2017]. doi:10.7326/M16-2977).

Effect of Acupuncture and Clomiphene in Chinese Women With Polycystic Ovary Syndrome: A Randomized Clinical Trial.

Importance: Acupuncture is used to induce ovulation in some women with polycystic ovary syndrome, without supporting clinical evidence. Objective: To assess whether active acupuncture, either alone or combined with clomiphene, increases the likelihood of live births among women with polycystic ovary syndrome. Design, Setting, and Participants: A double-blind (clomiphene vs placebo), single-blind (active vs control acupuncture) factorial trial was conducted at 21 sites (27 hospitals) in mainland China between July 6, 2012, and November 18, 2014, with 10 months of pregnancy follow-up until October 7, 2015. Chinese women with polycystic ovary syndrome were randomized in a 1:1:1:1 ratio to 4 groups. Interventions: Active or control acupuncture administered twice a week for 30 minutes per treatment and clomiphene or placebo administered for 5 days per cycle, for up to 4 cycles. The active acupuncture group received deep needle insertion with combined manual and low-frequency electrical stimulation; the control acupuncture group received superficial needle insertion, no manual stimulation, and mock electricity. Main Outcomes and Measures: The primary outcome was live birth. Secondary outcomes included adverse events. Results: Among the 1000 randomized women (mean [SD] age, 27.9 [3.3] years; mean [SD] body mass index, 24.2 [4.3]), 250 were randomized to each group; a total of 926 women (92.6%) completed the trial. Live births occurred in 69 of 235 women (29.4%) in the active acupuncture plus clomiphene group, 66 of 236 (28.0%) in the control acupuncture plus clomiphene group, 31 of 223 (13.9%) in the active acupuncture plus placebo group, and 39 of 232 (16.8%) in the control acupuncture plus placebo group. There was no significant interaction between active acupuncture and clomiphene (P = .39), so main effects were evaluated. The live birth rate was significantly higher in the women treated with clomiphene than with placebo (135 of 471 [28.7%] vs 70 of 455 [15.4%], respectively; difference, 13.3%; 95% CI, 8.0% to 18.5%) and not significantly different between women treated with active vs control acupuncture (100 of 458 [21.8%] vs 105 of 468 [22.4%], respectively; difference, -0.6%; 95% CI, -5.9% to 4.7%). Diarrhea and bruising were more common in patients receiving active acupuncture than control acupuncture (diarrhea: 25 of 500 [5.0%] vs 8 of 500 [1.6%], respectively; difference, 3.4%; 95% CI, 1.2% to 5.6%; bruising: 37 of 500 [7.4%] vs 9 of 500 [1.8%], respectively; difference, 5.6%; 95% CI, 3.0% to 8.2%). Conclusions and Relevance: Among Chinese women with polycystic ovary syndrome, the use of acupuncture with or without clomiphene, compared with control acupuncture and placebo, did not increase live births. This finding does not support acupuncture as an infertility treatment in such women. Trial Registration: clinicaltrials.gov Identifier: NCT01573858.

CONSORT in China: past development and future direction.

The Consolidated Standards of Reporting Trials (CONSORT) Statement was published in 1996, and first introduced to China in 2001. Although CONSORT has been widely accepted in high-quality international journals, we still need to have more investigation on how many Chinese journals have adopted the CONSORT Statement, and whether the quality of reporting has improved. A systematic search of the "Instructions to authors" in all Chinese medical journals in China Academic Journals (CAJ) Full-text Database was conducted up to February 2012 and only 7 journals officially listed the requirements of the CONSORT Statement. The research articles about randomized controlled trials (RCTs) published in 2002, 2004, 2006, 2008, and 2010 from journals which had specifically adopted the CONSORT Statement, and from 30 top journals based on the Chinese Science Citation Index (CSCI) 2011 as the control group, were identified. The quality of both cohorts of articles was assessed using the revised CONSORT Checklist and Jadad scale. A total of 1221 Chinese medical journals was identified. Only seven journals stated clearly in the "Instructions to authors" that authors should adopt the CONSORT requirement in the clinical trial paper. None of these journals is among the control group in the CSCI 2011. In the selected years, a total of 171 articles from 7 journals which had adopted CONSORT and 232 articles in the control were identified as including RCT trials. The average scores according to the revised CONSORT Checklist were 29.47 for the CONSORT-adopting journals and 25.57 for the control group; while the average scores based on the Jadad scale were 2.53 for CONSORT-adopting journals and 1.97 for the control group. Few journals among Chinese medical journals have adopted the CONSORT Statement. The overall quality of RCT reports in the 7 journals which have adopted CONSORT was better than those in the top 30 journals which have not adopted CONSORT. The quality of RCT reports in Chinese journals needs further improvement, and the CONSORT Statement could be a very helpful guideline.

[A systematic review regarding the effects of different kinds of selenium supplementations on Kaschin-Beck disease].

OBJECTIVE: To systematically assess the efficacy of different programs regarding the selenium supplementation formulae used for prevention and treatment of Kaschin-Beck disease (KBD) in children. METHODS: PubMed, EMBASE, Cochrane Library, SCI expanded, CNKI (Chinese National Knowledge Infrastructure), VIP (Chinese Science and Technique Journals Database), CBM (The Chinese Biomedical Database), Wanfang Database, CSCD (Chinese Science Citation Database) had been electronically searched. All the searching processes were up-dated to Dec 2012 to identify randomized trials (RCTs) and non-RCTs to compare the selenium supplementation formulae with placebo or with no intervention. Two reviewers assessed the methodological quality of the study design, including RCTs or non-RCTs according to Cochrane Handbook for Systematic Reviews of Interventions 5.1 or a checklist described by Deeks JJ, et al, respectively. Data was extracted independently. RESULTS: There were 14 RCTs and 12 non-RCTs papers included, but showing low methodological quality. Data from Meta analysis showed that selenium supplementation had caused the following progresses: radiologic improvement (RR = 3.28, 95%CI: 2.06 - 5.22), higher hair selenium (SMD = 2.05, 95%CI: 1.00 - 3.11) lower new radiologic lesions (OR = 0.18, 95%CI: 0.09 - 0.36) than in the placebo or with no treatment groups. Both selenium and vitamin C supplementation did not show differences in radiologic improvement of metaphysis (RR = 1.01, 95%CI: 0.84 - 1.22). Combination of selenium and vitamin E supplementation showed higher radiologic improvement than the placebo group. Combination of selenium and vitamin C supplementation had no influence on the difference in radiologic improvement or hair selenium than selenium supplementation. Selenium-enriched yeast showed higher radiologic improvement than sodium selenite (70.83% vs. 48.84%, P < 0.05). Selenium fertilization showed higher radiologic improvement than the non-treatment group (RR = 3.98, 95%CI: 2.25 - 7.05). Comprehensive intervention program and 'grain drying approach' also showed certain effects. CONCLUSION: Selenium supplementation could lead to better radiologic improvement and hair selenium, with lower new radiologic lesions. Current evidence supported its benefits on prevention and treatment of KBD. Large sample sized and well-designed trials together with the reporting on adverse outcome remained necessary.

[Glycosylated hemoglobin A1c for the diagnosis of diabetes mellitus: a meta-analysis].

OBJECTIVE: To assess the diagnostic value of glycosylated hemoglobin A1c (HbA1c) ≥ 6.5% for diabetes in Chinese adults with oral glucose tolerance test (OGTT) as the reference standard. METHODS: Major databases were searched to get all diagnostic tests with HbA1c ≥ 6.5% for diabetes in Chinese adults. QUADAS items were used to evaluate the quality of the eligible studies. Meta-disc software was used to perform comprehensive quantitative assessment for all included studies and summary ROC (SROC) curve were drawn. RESULTS: A total of 11 studies were included. The outcomes of the diagnostic value with HbA1c ≥ 6.5% were as the following: pooled sensitivity 0.62 (95%CI: 0.60 - 0.64), pooled specificity 0.96 (95%CI: 0.95 - 0.96), diagnostic odds ratio (DOR) 40.25 (95%CI: 20.79 - 77.95) and AUCSROC 0.7702 (sx = 0.0636). CONCLUSIONS: The diagnostic specificity is pretty high for the diagnostic test with HbA1c ≥ 6.5%, while sensitivity is low. Combination of HbA1c and glucose tests is needed to reduce the missed diagnosis rate.

Extending the CONSORT Statement to moxibustion.

The STandards for Reporting Interventions in Clinical Trials Of Moxibustion (STRICTOM), in the form of a checklist and descriptions of checklist items, were designed to improve reporting of moxibustion trials, and thereby facilitating their interpretation and replication. The STRICTOM checklist included 7 items and 16 sub-items. These set out reporting guidelines for the moxibustion rationale, details of moxibustion, treatment regimen, other components of treatment, treatment provider background, control and comparator interventions, and precaution measures. In addition, there were descriptions of each item and examples of good reporting. It is intended that the STRICTOM can be used in conjunction with the main CONSORT Statement, extensions for nonpharmacologic treatment and pragmatic trials, and thereby raise the quality of reporting of clinical trials of moxibustion. Further comments will be solicited from the experts of the CONSORT Group, the STRICTA Group, acupuncture and moxibustion societies, and clinical trial authors for optimizing the STRICTOM.

Carbon dioxide insufflation for endoscopic retrograde cholangiopancreatography: A meta-analysis and systematic review.

AIM: To assess the safety and efficacy of carbon dioxide (CO(2)) insufflation during endoscopic retrograde cholangiopancreatography (ERCP). METHODS: The Cochrane Library, Medical Literature Analysis and Retrieval System Online, Excerpta Medica Database, Science Citation Index Expanded, Chinese Biomedical Literature Database, and references in relevant publications were searched up to December 2011 to identify randomized controlled trials (RCTs) comparing CO(2) insufflation with air insufflation during ERCP. The trials were included in the review irrespective of sample size, publication status, or language. Study selection and data extraction were performed by two independent authors. The meta-analysis was performed using Review Manager 5.1.6. A random-effects model was used to analyze various outcomes. Sensitivity and subgroup analyses were performed if necessary. RESULTS: Seven double-blind RCTs involving a total of 818 patients were identified that compared CO(2) insufflation (n = 404) with air insufflation (n = 401) during ERCP. There were a total of 13 post-randomization dropouts in four RCTs. Six RCTs had a high risk of bias and one had a low risk of bias. None of the RCTs reported any severe gas-related adverse events in either group. A meta-analysis of 5 RCTs (n = 459) indicated that patients in the CO(2) insufflation group had less post-ERCP abdominal pain and distension for at least 1 h compared with patients in the air insufflation group. There were no significant differences in mild cardiopulmonary complications [risk ratio (RR) = 0.43, 95% CI: 0.07-2.66, P = 0.36], cardiopulmonary (e.g., blood CO(2) level) changes [standardized mean difference (SMD) = -0.97, 95% CI: -2.58-0.63, P = 0.23], cost analysis (mean difference = 3.14, 95% CI: -14.57-20.85, P = 0.73), and total procedure time (SMD = -0.05, 95% CI: -0.26-0.17, P = 0.67) between the two groups. CONCLUSION: CO(2) insufflation during ERCP appears to be safe and reduces post-ERCP abdominal pain and discomfort.

Long-term beta blockers for stable angina: systematic review and meta-analysis.

OBJECTIVES: To assess the effects of long-term beta blockers in patients with stable angina. METHODS: We reviewed the literature up to June 2010 from CENTRAL, MEDLINE, EMBASE, CBM, and CNKI for randomized controlled trials. The appropriate data were meta-analysed using Revman 5.0. RESULTS: Twenty-six trials including 6108 patients were identified. The treatment with beta blockers has significantly decreased all-cause mortality when compared with no control (OR 0.40, 95% CI 0.20 to 0.79), but has had no statistically differences when compared with placebo (OR 0.92, 95% CI 0.62 to 1.38) and with calcium-channel blocker (CCB) (OR0.84, 95% CI 0.49 to 1.44). This was similar in patients with fatal and non-fatal acute myocardial infarction when compared with placebo (OR 0.82, 95% CI 0.57 to 1.17) or CCB (OR 1.08, 95% CI 0.71 to 1.66); on revascularization and quality of life. The beta blockers reduced the incident of unstable angina compared to no treatment (OR 0.14, 95% CI0.07 to 0.29), but increased unstable angina compared to placebo (OR 3.32, 95% CI 1.50 to 7.36). There was a significant reduction of nitrate consumption when beta blockers were compared with CCBs (OR 1.18, 95% CI 1.54 to 0.82),but not with placebo and trimetazidine. There was no significant difference in angina attack between each group. Side effects in beta blocker were similar with ones in controls. CONCLUSIONS: Beta blockers may decrease the death and unstable angina when compared with no treatment, but no more effective than other anti-anginal agents on prophylaxis of myocardial ischaemia in stable angina patients.

Traditional Chinese medicine syndrome distribution in chronic hepatitis B populations: a systematic review.

Many patients with chronic hepatitis B (CHB) seek help from traditional Chinese medicine (TCM). TCM treatment is based on syndrome differentiation. This study aimed to investigate the syndrome distribution in populations of CHB patients. The pre-specific search strategy was set, and 93 studies (20,106 participants) were identified by electronic and hand searches. The methodological quality of included studies was assessed. Data on syndrome distribution and correlations between syndromes and severity of CHB, were extracted and analyzed. Forty-seven syndromes were identified under 24 different syndrome diagnosis systems for CHB. The majority of included studies reported Liver Depression and Spleen Deficiency (LDSD) (52.54% of studies) or Liver-Gallbladder Dampness Heat (LGDH)/Dampness-Heat Obstructing Middle Energizer (DHME) (32.20%) as the major syndromes in CHB patients without cirrhosis. Pooled analysis revealed that LDSD and LGDH/DHME accounted for 61.19% of participants without cirrhosis. In addition, Liver-Kidney Yin Deficiency (LKYinD) (40.99%) and Spleen-Kidney Yang Deficiency (SKYangD) (40.43%) syndromes were common in patients with severe CHB. The percentage of patients with Blood Stasis syndrome increased as the disease progressed to cirrhosis (32.09%). To conclude, LDSD and LGDH/DHME syndromes are found in a significant majority of CHB patients, particularly in the early stages. LKYinD, SKYangD and Blood Stasis dominate in patients at more advanced stages. More epidemiological studies of high methodological quality on syndrome distribution in CHB and standardization of syndrome differentiation for CHB are required to confirm the trends indicated by the studies reviewed here; confirming these trends can increase the efficacy of treatment and give guidance to doctors.

Consumption of large amounts of Allium vegetables reduces risk for gastric cancer in a meta-analysis.

BACKGROUND & AIMS: The chemopreventive effects of Allium vegetables (onions, garlic, shallots, leeks, chives, and so forth) have been studied extensively, although their effect on gastric cancer risk is controversial. We performed a meta-analysis of cohort and case-control studies to analyze this association. METHODS: We searched MEDLINE for studies of Allium vegetable consumption and gastric cancer that were published in any language, from January 1, 1966, to September 1, 2010. We analyzed 19 case-control and 2 cohort studies, of 543,220 subjects. We pooled the relative risks from individual studies using a random-effects model and performed dose-response, heterogeneity, and publication bias analyses. RESULTS: In a pooled analysis of all studies, consumption of large amounts of Allium vegetables (in a comparison of the highest and lowest consumption groups) reduced the risk for gastric cancer (odds ratio, 0.54; 95% confidence interval, 0.43-0.65). Specific analyses for onion, garlic, leek, Chinese chive, scallion, garlic stalk, and Welsh onion yielded similar results, except for onion leaf. The estimated summary odds ratio for an increment of 20 g/day of Allium vegetables consumed (approximately the average weight of 1 garlic bulb) was 0.91 (95% confidence interval, 0.88-0.94), based on case-control studies from the dose-response meta-analysis. CONCLUSIONS: In a meta-analysis, consumption of high levels of Allium vegetables reduced the risk for gastric cancer risk. Because of potential confounding factors and exposure misclassification, further studies are required to establish this association.

Vascular endothelial growth factor (VEGF) +936 C/T gene polymorphisms and gastric cancer risk: a meta-analysis involving 4,138 subjects.

The association between vascular endothelial growth factor (VEGF) +936 C/T gene polymorphisms and gastric cancer risk is still controversial and ambiguous. The objective of our study was to investigate this association. The Medline and Embase databases were searched by two investigators. Crude odds ratios (OR) and 95% confidence intervals (CI) were used to test the association between VEGF +936 C/T polymorphisms and gastric cancer risk. Our meta-analysis comprised seven case-control studies, which included 1,893 gastric cancer cases and 2,245 controls. The combined results showed that there was no relationship between VEGF +936 C/T gene polymorphisms and gastric cancer risk (CC: OR 0.97, 95% CI 0.85, 1.11; CT: OR 1.01, 95% CI 0.88, 1.16; TT: OR 1.10, 95% CI 0.79, 1.55). Subgroup analysis by ethnicity and stage, location, and Lauren classification of gastric cancer did not change the results. This meta-analysis suggests that there is no association between VEGF +936 C/T polymorphisms and gastric cancer risk. Further studies should pay attention to other potentially functional SNPs.

[Adverse drug reactions or adverse events of Chaihu Injection: a systematic review].

BACKGROUND: Chaihu Injection (CI), which is widely used in treatment of febrile diseases, is an aqueous solution of Chaihu (Radix Bupleuri Chinensis) or Nanchaihu (Radix Bupleuri Scorzonerifolii) prepared by steam distillation. OBJECTIVE: This study aims at finding out the possible causes for adverse drug reaction or adverse event (ADR/AE) caused by CI and assessing its safety based on existing evidence. SEARCH STRATEGY: Manual search was not conducted. Electronic search was conducted by two authors in China National Knowledge Internet (CNKI) database and Chongqing VIP database (VIP). The search ended in June 30th, 2009. INCLUSION CRITERIA: Studies of ADR/AE induced by CI were collected comprehensively without considering language of literature and outcome indicators. Search results were not limited by patient's age, gender, race, primary disease, etc. Interventions were using CI alone or CI combined with other drugs (Chinese herbal medicine decoction or other drugs containing Chaihu were excluded). DATA EXTRACTION AND ANALYSIS: Two authors conducted data extraction independently. Microsoft Excel software was used to develop data extraction forms. Because of heterogeneity of the studies, only a descriptive analysis was conducted. RESULTS: Totally 83 studies with 203 cases were included in this review. Without the yield data and total amount of using, we cannot tell the incidence of ADR/AE induced by CI as well as assess the risk and safety of CI. The constituent ratio of severe cases was higher in children and old people than in other age groups. For most intramuscular cases, ADR/AE happened in 30 min after injection (constituent ratio of cumulative incidence in 30 min was 93.8%); for intravenously guttae patients, 4 cases of ADR/AE happened in the process of infusion; for first users, constituent ratio of cumulative incidence in 30 min and constituent ratio of cumulative incidence of severe cases in 30 min were higher than cases who had used CI before. Most ADRs/AEs were caused by incorrect use of CI, such as excessive doses (5 cases), intravenously guttae administration (6 cases), and violating incompatibility rules (7 cases). The incidence ratios of ADR and AE for severe and mild cases were 1.7:1 and 1.1:1, respectively; the ratios of the three relevant levels described as definitely related, most probably related and possibly related in the two types (severe and mild) of cases were 25:14:5 and 44:9:16, respectively. CONCLUSION: Present evidence with low level shows that incorrect use is the main cause of ADR/AE of CI. Whether CI is proper for children and old people still needs further research. Training for correct use of CI is necessary for medical workers. Much improvement in reporting ADR/AE based on "Recommendations for Reporting Adverse Drug Reactions and Adverse Events of Traditional Chinese Medicine" is in need.

[Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement (Chinese version)].

The STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) were published in five journals in 2001 and 2002. These guidelines, in the form of a checklist and explanations for use by authors and journal editors, were designed to improve reporting of acupuncture trials, particularly the interventions, thereby facilitating their interpretation and replication. Subsequent reviews of the application and impact of STRICTA have highlighted the value of STRICTA as well as scope for improvements and revision. To manage the revision process a collaboration between the STRICTA Group, the CONSORT Group and the Chinese Cochrane Centre was developed in 2008. An expert panel with 47 participants was convened that provided electronic feedback on a revised draft of the checklist. At a subsequent face-to-face meeting in Freiburg, a group of 21 participants further revised the STRICTA checklist and planned dissemination. The new STRICTA checklist, which is an official extension of CONSORT, includes 6 items and 17 subitems. These set out reporting guidelines for the acupuncture rationale, the details of needling, the treatment regimen, other components of treatment, the practitioner background and the control or comparator interventions. In addition, and as part of this revision process, the explanations for each item have been elaborated, and examples of good reporting for each item are provided. In addition, the word "controlled" in STRICTA is replaced by "clinical", to indicate that STRICTA is applicable to a broad range of clinical evaluation designs, including uncontrolled outcome studies and case reports. It is intended that the revised STRICTA checklist, in conjunction with both the main CONSORT statement and extension for non-pharmacological treatment, will raise the quality of reporting of clinical trials of acupuncture.

[Dapoxetine in treatment of premature ejaculation: a systematic review].

OBJECTIVE: To assess the effectiveness of dapoxetine in the treatment of premature ejaculation. METHODS: Both English and Chinese studies involving men with prematrue ejaculation who were treated with dapoxetine from the Cochrane Library, MEDLINE, EMBASE and CNKI, CBM, VIP between 1979 and 2009.were included in the randomized controlled trials (RCTs) and the data processed by RevMan. RESULTS: Five RCTs involving 4433 patients were included in the Meta analysis, of which 3 were of grade A and 2 were of grade B according to the quality evaluation of methodology. Intravaginal ejaculatory latency time (IELT), patient-reported global impression of change (PGI), satisfaction with sexual intercourse (SWSI), perceived control over ejaculation (PCOE), personal distress related to ejaculation (PDRE) were used for assessment. Meta analysis based on included studies of patients having been treated with dapoxetine for 9-24 weeks showed that: (1) the difference of the patients' IELT between treatment group and control group was statistically significant [P<0.001, WMD (95%CI) was 1.38 (1.21,1.55)]; (2) the difference of the PGI of development in premature ejaculation between treatment group and control group was statistically significant [P<0.001, OR (95%CI) was 3.56 (2.60,4.88)]; (3) the difference of the patients' SWSI between treatment group and control group was statistically significant [P<0.001, OR (95%CI) was 3.85 (2.08,7.10)]; the difference of the patients' score of SWSI between treatment group and control group was statistically significant [P<0.001, WMD (95%CI) was 0.55 (0.48,0.62)]; (4) the difference of the patients' change of PCOE between treatment group and control group was statistically significant [P<0.001, OR (95%CI) was 2.87(2.30,3.58)]; the difference of the patients' score of PCOE between treatment group and control group was statistically significant [P<0.001, WMD (95%CI) was 0.63(0.49,0.78)]; (5) after being treated with dapoxetine for 9-24 weeks, the difference of the patients' change of PDRE between treatment group and control group was statistically significant [P<0.001, OR (95%CI) was 2.02 (1.69,2.42)]. All the RCTs reported the side effects of dapoxetine, but the results showed that there were no serious side effects of dapoxetine during the treatment period. CONCLUSION: The available evidence indicates that dapoxetine would improve the symptoms of premature ejaculation, prolong IELT over 9-24 weeks in men from a wide range of cultural backgrounds, and significantly improve all patients' reported outcomes and the patients' clinical global impressions of premature ejaculation, including more control, greater satisfaction, and less distress.

Legislation for trial registration and data transparency.

Public confidence in clinical trials has been eroded by data suppression, misrepresentation and manipulation. Although various attempts have been made to achieve universal trial registration- e.g., Declaration of Helsinki, WHO clinical Trial Registry Platform (WHO ICTRP), the International Committee of Medical Journal Editors requirement- they have not succeeded, probably because they lack the enough power of enforcement.Legislation appears to be the most efficient and effective means to ensure that all researchers register their trials and disseminate their data accurately and in a timely manner. We propose that a global network be established. This could be accomplished in two steps. The first step is to legislate about trial registration and data transparency, such as USA's FDAAA Act 2007; and the second step to establish a global network to ensure uniform, international consistency in policy and enforcement of trial registration and data transparency.