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.

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.

[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.

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.

Interleukin10 -592 promoter polymorphism associated with gastric cancer among Asians: a meta-analysis of epidemiologic studies.

PURPOSE: Studies investigating the association between interleukin10 (IL10) -592 promoter polymorphism and gastric cancer risk report conflicting results. The objective of this study was to quantitatively summarize the evidence for such a relationship. METHODS: Two investigators independently searched the MEDLINE and Embase databases. This meta-analysis included ten case-control studies, which included 1,715 gastric cancer cases and 2,783 controls. RESULTS: The combined results based on all studies showed that there was no significant difference in genotype distribution (AA odds ratio [OR] = 0.88, 95% confidence interval [CI] = 0.66, 1.18; AC OR = 1.09, 95% CI = 0.95, 1.24; CC OR = 1.03, 95% CI = 0.89, 1.18) between gastric cancer and noncancer patients. When stratifying for race, the results were similar, except that patients with gastric cancer had a significantly lower frequency of AA (OR = 0.67, 95% CI = 0.52, 0.87) and a higher frequency of AC (OR = 1.34, 95% CI = 1.07, 1.68) than noncancer patients among Asians. When stratifying by the location of gastric cancer, we found that patients with cardia gastric cancer had a significantly lower frequency of AA (OR = 0.41, 95% CI = 0.20, 0.84) than those with noncardia gastric cancer among Caucasians. When stratifying by Lauren's classification of gastric cancer, we found that patients with diffuse gastric cancer had a significantly higher frequency of AA (OR = 1.91, 95% CI = 1.07, 3.41) than those with intestinal gastric cancer among Caucasians. CONCLUSIONS: This meta-analysis suggests that the IL10 -592 promoter polymorphism may be associated with gastric cancer among Asians, and that differences in genotype distribution may be associated with the location and Lauren's classification of gastric cancer.

Glutathione S-transferase M1 null genotype associated with gastric cancer among Asians.

PURPOSE: The Glutathione S-transferases (GSTs) play multiple roles in the pathogenesis and treatment of cancer. Studies investigating the association between Glutathione S-transferase M1 (GSTM1) null genotype and gastric cancer risk report conflicting results. The purpose of this study was to quantitatively summarize the evidence for such a relationship. RESULTS: This meta-analysis included 35 studies, which included 4,505 gastric cancer cases and 9,062 controls. The combined results based on all studies showed that the GSTM1 null genotype was associated with an increased risk of gastric cancer (OR = 1.15, 95% confidence interval [CI] = 1.02, 1.29). When stratifying for race, results were similar among Asians (OR = 1.24, 95% CI = 1.07, 1.44) except Caucasians (OR = 1.04, 95% CI = 0.88, 1.24). When stratifying by the location, stage, Lauren's classification, histological differentiation, lymph node metastasis, smoking, and Helicobacter pylori infection of gastric cancer, we observed that patients with diffuse classification had a significantly higher frequency null genotype (OR = 4.80, 95% CI = 1.65,13.94) than those with intestinal classification among Caucasians. CONCLUSIONS: This meta-analysis suggests that the GSTM1 null genotype may be associated with gastric cancer among Asians.

[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.

[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.

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 .

Polymorphisms of thymidylate synthase in the 5'- and 3'-untranslated regions and gastric cancer.

Studies investigating the association of polymorphisms in the 5'-untranslated regions (5'UTR) and 3'-untranslated regions (3'UTR) of thymidylate synthase with gastric cancer susceptibility and sensitivity to fluoropyrimidine-based chemotherapy report conflicting results. The objective of this study was to quantitatively summarize the evidence for such a relationship. This meta-analysis included ten studies, which included 1,730 gastric cancer cases and 1,843 controls. The combined results based on all studies showed that there was no significant difference in genotype distribution of 5'UTR or 3'UTR between gastric cancer and noncancer patients. When stratifying for race, we found that: (1) among Asians, patients with gastric cancer had significantly higher frequency of 2R/2R of 5'UTR than did noncancer patients, and (2) among Caucasians, patients with gastric cancer had significantly lower frequency of ins6/ins6 and higher frequency of ins6/del6 of 3'UTR than did noncancer patients. No significantly different response rate or survival of gastric cancer with fluoropyrimidine-based chemotherapy were observed with genotype distribution of 5'UTR or 3'UTR among Caucasians or Asians. This meta-analysis suggests that polymorphisms in the 5'UTR and 3'UTR of thymidylate synthase may be associated with gastric cancer susceptibility, but are not correlated with sensitivity of gastric cancer to fluoropyrimidine-based chemotherapy.

[Association of male infertility with (CAG)n polymorphism of the androgen receptor gene: a meta-analysis].

OBJECTIVE: To assess the association of male infertility with CAG repeat polymorphism of the androgen receptor (AR) gene by meta-analysis. METHODS: We identified the case-control studies on the relationship of male infertility with CAG repeats of the AR gene by searching Medline/PubMed and CBM databases, and conducted meta-analysis on the data obtained with the RevMan 4.2 software. RESULTS: Thirty-two eligible articles were selected in this study, including 3,153 idiopathic infertile men and 2,314 controls. The combined data statistics showed that all the infertile men had a significantly higher mean of CAG repeats than the controls (SMD = 0.27, 95% CI: 0.17-0.37, P < 0.01). The specific SMD between the infertile patients and controls was 0.29, 95% CI: 0.08-0.50 for the azoospermic men, 0.27, 95% CI: 0.13-0.41 for the moderate oligozoospermic men, and 0.18, 95% CI: 0.02-0.33 for the severe oligozoospermic cases. The results of sensitivity analyses were consistent with those mentioned above. CONCLUSION: The increased length of CAG repeats in the AR gene may be correlated with the risk of the impairment of spermatogenesis.

[Postoperative implant-related complications after treatment of intertrochanteric fracture by gamma nail or by sliding hip screw: a meta-analysis].

OBJECTIVE: To evaluate and compare the postoperative implant-related complications after treatment of intertrochanteric fracture by gamma nail or by sliding hip screw. METHODS: Literatures on randomized controlled trials (RCTs) of the postoperative implant-related complications after treatment of intertrochanteric fracture by gamma nail or by sliding hip screw published before the end of June 2007 were retrieved from Cochrane library, Medline, Embase databank, and Chinese Biomedical Database. Relevant articles were handsearched in several Chinese journals. Methodology quality of the trials was critically assessed and data on postoperative implant-related complications were extracted. The software RevMan4.2.10 provided by the Cochrane Collaboration was used for meta-analysis. RESULTS: 10 RCTs and 3 quasi-RCTs involving 1857 cases were included. The results of meta-analysis showed that gamma nailing significantly increased the rate of postoperative femoral shaft fractures [RR = 3.75, 95%CI (1.47, 9.55), P = 0.006]. However, there were no statistic differences in the rates of lag screw cut-out and total mechanical complications between gamma nail and sliding hip screw treatment. CONCLUSION: Compared with sliding hip screw for intertrochanteric fractures, gamma nailing can lead to higher incidence of postoperative femoral shaft fractures. Fracture stability may influence the rate of postoperative implant-related complications. Further large sample and high quality RCTs based on fracture stability are required in order to provide more sufficient and reliable evidence.

Precise reporting of traditional Chinese medicine interventions in randomized controlled trials.

Traditional Chinese medicine (TCM) intervention should be concisely and precisely reported in randomized controlled trials (RCTs). Based on State Food and Drug Administration's categories, we recommend reporting the interventions as follows: (1) Single Chinese herbal medicine-based/formula-based/extraction-based intervention includes 1) Name, dosage format and registration; 2) The composition and quality of intervention; 3) Pharmaceutical processing and quality control; 4) Stability of final product and quality control; 5) Function and safety description; 6) Dosage and treatment course; 7) Control group. (2) Active compound-based TCM drug intervention includes 1) Name of active compound(s); 2) Original source of active compound(s); 3) The brief process obtaining active compound(s); 4) Percentage of active compound(s) in final product; 5) Added materials and its quality and quantity control. Besides, the detailed information of intervention can be published as an online supplement in web site.

Appropriately selecting and concisely reporting the outcome measures of randomized controlled trials of traditional Chinese medicine.

Evaluating outcome is the primary means by which different medical modalities can be compared with regard to effectiveness. In traditional Chinese medicine (TCM), this focus has prompted practitioners to search for outcome measures that can objectively verify the effectiveness of TCM interventions, especially in the context of randomized controlled trials (RCTs). Commonly used indexes for outcome assessment in RCTs of TCM can be categorized into two types: TCM-specific outcomes such as tongue and pulse characteristics, and Western medicine (WM)-specific outcomes such as blood test and X-ray examination results. Some studies include both types of indicators. During the trial design, it is necessary to consider the rationales of selecting outcome assessments, the purpose and study approach, balance between objective and subjective indexes, standardization of outcome assessment, and standardized outcome indexes. We recommend to report the outcome assessment in RCTs of TCM in the following format: 1) identifying the primary and secondary outcomes based on the purpose and hypothesis of the trial; 2) defining the primary and secondary outcomes clearly; 3) presenting the rationale of selection; 4) presenting the method with aims to standardize the assessment process; 5) presenting the method to improve the reliability of assessment; and 6) stating the termination criteria in the trial.

Transparently reporting adverse effects of traditional Chinese medicine interventions in randomized controlled trials.

Although all Chinese materia medica (CMM) come from nature, CMM interventions have both therapeutic effects and adverse effects (AEs). Normally, AEs in randomized controlled trial (RCT) with traditional Chinese medicine (TCM) could be divided into five types as follows: 1) AEs under proper TCM principles and guidelines, such as the toxicity (acute and chronic) and allergy; 2) AEs due to improper usage without following TCM principles, involving without following the TCM therapeutic principles, over-dosage, improper processing and preparation methods, improper formula strategy, etc; 3) AEs due to contamination in CMM, such as heavy metal and pesticides contaminations in Chinese herbal medicine interventions, and intentional or unintentional contamination with drug(s); 4) AEs due to replacement of CMMs; 5) AEs due to drug-herb interaction. AEs of TCM should be treated properly. Overestimation or underestimation about AEs of TCM intervention will bring a wrong message to patients and health care providers. In order to give readers a more comprehensive understanding about the safety issue of study intervention, Consolidated Standards of Reporting Trials (CONSORT) for TCM should involve the background information on side effects of each CMM constituents and/or the study intervention, specific outcome assessment on AEs, the details of reported AEs and the interpretation of the AEs occurrence in a structural RCT report.

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.