The Assessment of Risk of Bias on Randomised Controlled Trials of Oriental Medicine in Korea

Abstract

Objectives: To examine the current status of clinical research in oriental medicine, and to assess 'risk of bias'(ROB) of randomized clinical trials(RCTs) in oriental medicine in Korea. Methods: Special committee for EBM, KOMS(Korean Oriental Medicine Society) reviewed 17 journals related to oriental medicine in Korea (from the first issue to May 2010), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 2, 2010), and PubMed (1966 to May 2010). Then we selected eligible RCTs in terms of oriental medicine, and assessed 'risk of bias'. Results: We reviewed 12,653 articles from the 17 journals, and 41 articles from CENTRAL and PubMed. After non-clinical articles were excluded, 1,004 articles were left. Among them, the number of eligible studies in terms of oriental medicine was 306. In these eligible studies, 130 were RCTs. Of RCTs, 69 were on acupuncture, 25 on herbal medicine. The proportion of 'unclear' is high in the criteria of 'Allocation concealment', 'Blinding of participants and personnel', 'Blinding of outcome assessment' and 'Other bias'. On the other hand, 'low' has high in the criteria of 'Incomplete outcome data' and 'Selective reporting'. Conclusions: Risk of bias on oriental medicine is unclear in terms of 'allocation concealment' and 'blinding'. For high-quality research in oriental medicine, further research should be needed on randomization and blinding in the RCTs.