J Altern Complement Med. 2003 Feb; 9(1): 151-9.

Reporting of clinical details in randomized controlled trials of acupuncture for the treatment of migraine/headaches and nausea/vomiting.

Elorriaga Claraco A, Hanna SE, Fargas-Babjak A.

Department of Anaesthesia, McMaster University, Hamilton, Ontario, Canada. [email protected]

OBJECTIVES: The main purpose of this study was to investigate the degree of reporting of clinical details in a selected sample of 30 randomized control trials (RCT) on acupuncture efficacy for the treatment of migraine/headaches (n = 11) and for nausea/vomiting (n = 19). Additional goals included the assessment of the quality of randomization of the trials, and the assessment of the degree of reporting of information about the outcome measures used in each trial. METHODS: A checklist of 50 clinical details selected on the basis of a previous survey was used to evaluate the degree of reporting of information about patients, practitioners, diagnosis, and acupuncture treatments presented in each RCT. The likelihood of bias in the randomization process was assessed using a previously validated scale. Information about reliability/validity and clinical significance of the outcome measures used in each trial was assessed in terms of fully, partially, or not reported, with no attempt to evaluate their quality or appropriateness. RESULTS: In this sample of RCTs an average of 38.7% of important clinical details per trial were either fully or partially reported by researchers, the lowest being 26.4% for the migraine/headaches group. Studies with better quality of randomization were not more likely to report important clinical details. Only five studies (16.7%) provided information about reliability and validity of the outcome measures used, and only four studies (13.3%), all from the migraines/headache group, discussed the clinical significance of the outcome measures selected. CONCLUSIONS: In this sample of 30 RCTs of acupuncture efficacy for the treatment of migraines/headache and nausea/vomiting, researchers neglected to report adequately on important clinical details, and often did not discuss the reliability, validity, and clinical significance of the outcome measures used in the trials, thus rendering potential readers of the articles unable to critically appraise them from a clinical standpoint. In addition, the fact that the quality of randomization of the trials was totally unrelated to the degree of reporting of clinical details renders potential reviewers of these studies unable to establish valid conclusions about acupuncture efficacy based on the general quality of the methodological design. In the future, all areas of clinical acupuncture research need to be reviewed in a similar manner, and recommendations about proper reporting of important clinical details and proper discussion of the validity, reliability, and clinical significance of the outcome measures used in each trial should be made. Only then could this research be used to generate meaningful evidence-based recommendations for the contemporary practice of acupuncture.