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FACT
Focus on Alternative and Complementary Therapies

Acupuncture RCTs: quality of reporting assessed with a CONSORT and STRICTA-based instrument

Hammerschlag R1, Milley R1, Colbert AP1,2, Weih J3, Yohalem-Ilsley B1, Aickin M4
1Oregon College of Oriental Medicine, 10525 SE Cherry Blossom Dr, Portland, OR 97216, USA
2Helfgott Research Institute, National College of Naturopathic Medicine, 049 SW Porter St, Portland, OR 97201, USA
3Kaiser Permanente NW, Department of Physiatry, 3600 N Interstate Ave, Portland, OR 97227, USA
4Program in Integrative Medicine, University of Arizona College of Medicine, 1501 N Campbell Ave, Tucson, AZ 85724-5153, USA

Objective

Development of a comprehensive quality assessment instrument based on the revised CONSORT guidelines for biomedical RCTs (Altman 2001) as modified by the STRICTA recommendations for acupuncture trials (MacPherson et al. 2002) to evaluate the overall quality of reporting in acupuncture RCTs.

Materials and methods

Databases were searched to identify English language prospective RCTs from November 1997 through October 2002 (the 5 years following the NIH Consensus Conference), in which treatment at acupuncture points with acupuncture needles using manual and/or electro-stimulation was compared to no treatment, a sham procedure, or usual care. Each of 27 items of the Oregon CONSORT STRICTA Instrument (OCSI) was scored as yes = 2, partial = 1, no = 0 or not applicable using consensus assumptions of five raters.

Results

One hundred and nineteen RCTs were identified from 16 countries and 64 journals. Of the 27 OCSI questions, across all trials, only one had a mean score ≤0.4 while five had means ≥ 1.6 (of a possible 2.0). The mean percentage score for all articles was 58.6; median 60.0. The mean scores of RCTs from CAM journals (n = 42) and biomedical journals (n = 77) were 47.1 and 64.9, respectively. The numbers of RCTs scoring at least 60, 70 and 80% were 60, 35 and 12, respectively. Of the 35 RCTs scoring ≥ 70% (an arbitrary cutoff), 19 had positive outcomes.

Conclusion

Quality of reporting, as reflected in our present and ongoing OCSI analyses, is a key feature of a multifaceted assessment of acupuncture RCTs. Combined with evaluations of appropriateness and adequacy of design, OCSI can update conclusions of the 1997 NIH Consensus Conference on Acupuncture.

Acknowledgment

Funded by the Oregon College of Oriental Medicine.

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