No abstract available.
Humans ; Randomized Controlled Trials as Topic/*methods

Humans ; Randomized Controlled Trials as Topic ; methods

In the view of the controversy that there is no efficacy difference between true and sham acupuncture in acupuncture randomized controlled trials (RCTs), it is analyzed that one of the reasons is that many clinical studies do not properly understand the design of RCT research and interpret the research results. Starting from the concept and coverage of explanatory RCT and pragmatic RCT, this study lists the application examples of two types of RCTs in the field of acupuncture from five aspects: research purpose and trial environment, subject selection, intervention measures, control measures and outcome evaluation, so as to provide some ideas for their application in clinical trials.
Acupuncture Therapy/methods* ; Randomized Controlled Trials as Topic

OBJECTIVE: To summarize and identify the available instruments/methods assessing the adequacy of acupuncture in randomized controlled trials (RCTs) for proposing a new improved instrument. METHODS: A systematic literature search was carried out in 7 electronic databases from inception until 21st November 2022. Any study evaluating the adequacy or quality of acupuncture, specifying specific acupuncture treatment-related factors as criteria of subgroup analysis, or developing an instrument/tool to assess the adequacy or quality of acupuncture in an RCT was included. Basic information, characteristics and contents of acupuncture adequacy assessment were presented as frequencies and percentages. RESULTS: Forty studies were included in this systematic review. Thirty-five studies (87.50%) were systematic reviews, none of which used formal methods to develop the assessment instruments/methods of acupuncture adequacy; of 5 methodological studies, only 1 study used a relatively formal method. Thirty-two studies (82.05%) assessed the components of acupuncture, while 7 (17.95%) assessed the overall quality of acupuncture. An independent assessment instrument/method was used to assess acupuncture adequacy in 29 studies (74.35%), whereas as one part of a methodological quality assessment scale in 10 (25.65%). Only 9 (23.00%) studies used the assessment results for subgroup analysis, sensitivity analysis or the criteria for inclusion in the meta-analysis. CONCLUSION Assessment contents for adequacy or quality of acupuncture in RCTs hadn't still reached consensus and no widely used assessment tools appeared. The methodology of available assessment instruments/scales is far from formal and rigorous. A new instrument/tool assessing adequacy of acupuncture should be developed using a formal method.
Acupuncture Therapy/methods* ; Randomized Controlled Trials as Topic

No abstract available.
Data Interpretation, Statistical ; Humans ; Randomized Controlled Trials as Topic/*methods

OBJECTIVETo introduce some methods of safety assessment in randomized controlled clinical trials.

METHODSRecent advances and current parctice in normalized safety assessment were reviewed and relevant data analyzed. RESTULTS: The statistical issues including analysis and presentation of adverse events data and laboratory data were involved and summed up.

CONCLUSIONWith the progressive development of randomized controlled clinical trials in China, the methods introduced in this paper are sure to prove of consultative value for the safety assessment.

The concepts and relations of explanatory clinical trials and pragmatic clinical trials on randomized controlled trials of acupuncture are stated. The explanatory clinical trials and pragmatic clinical trials are different in the purpose of study, the controlled method, the treatment method and the solution problems. The explanatory clinical trials may enhance the understanding of the mechanism of a treatment; the findings of pragmatic clinical trials may be applied immediately in clinical practice. This paper explains that these clinical trials are of great importance to the methodology and practices of clinical effective evaluation of acupuncture based on TCM theory.
Acupuncture Therapy ; standards ; Humans ; Randomized Controlled Trials as Topic ; methods ; standards

PURPOSE: To explain the concept and procedure of random allocation as used in a randomized controlled study. METHODS: We explain the general concept of random allocation and demonstrate how to perform the procedure easily and how to report it in a paper.
Humans ; Random Allocation ; Randomized Controlled Trials as Topic/*methods

This paper introduced the Revised Cochrane Risk of Bias Tool RoB2.0 for cluster-randomized control trials (CRCT) and compared RoB2.0 of CRCT with individually randomized, parallel group trials, and illustrated the application of RoB2.0 for CRCT in a published CRCT. Special signal questions were designed for CRCT according to its specialty that different from individually randomized, parallel group trials in RoB2.0 and also providing information on risk of bias about CRCT in systematic reviews for the synthesis of evidence.
Bias ; Humans ; Randomized Controlled Trials as Topic ; Risk ; Risk Assessment/methods*

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.
Clinical Trials as Topic ; methods ; standards ; Humans ; Moxibustion ; methods ; standards ; Randomized Controlled Trials as Topic ; Research Design ; standards