| Abstract: | Objective: To identify the key methodological issues that might influence the acupuncture treatment adequacy and introduce bias to the results.Methods: Using nominal group technique(NGT) as a structured group, decision-making method was applied.Nine participants from mainland China and Hong Kong were invited, including six acupuncturists, two acupuncture trialists and one methodologist.An introduction to the subjects was given at the beginning.When all the participants were clear with the subjects, 20 min were given to write down their own thoughts.Then one by one, the participants presented their opinions.Then all the opinions were discussed until consensus were made by voting.Results: All participants expressed their opinions.Four key issues on methodology were raised and consensus was achieved after discussion.First, under different acupuncture clinical practice, five aspects were agreed:(1) different expertise and practicing habits of acupuncturists;(2) insufficient training according to the research protocols;(3) insufficient acupuncture treatment details described in the protocols(such as acupoint names and locations, needle insertion methods and direction, manipulation methods, sequence of acupoints stimulated in one treatment, and extent to which the treatment could be individualized);(4) deviation from protocols by acupuncturists;(5) alternatives of acupuncturists.Second, incompliance of the participants due to lack of confidence to acupuncture therapy and acupuncturists, use of sham acupuncture and inadequate acupuncture treatments.Third, inappropriate set of sham control(lack of theoretical validity and practical validity).Forth, multiple roles of personnel in acupuncture trials.Conclusion: Methodological issues around acupuncture trials were identified from this study, and future guidelines for designing and managing of acupuncture trials should consider these aspects.We suggest that some of the items of the CONSORT statement and STRICTA could be referred when designing acupuncture trials. |
