Article type
Year
Abstract
Background: The healthcare system in South Korea comprises of two systems: one is Western medicine and the other Traditional Korean Medicine (TKM). TKM has been criticized for uncertain evidence.
Objectives: To examine the current status of clinical research in TKM and to assess 'risk of bias' (ROB) in randomized clinical trials (RCTs) in TKM.
Methods: Korean Oriental Medicine Society (KOMS), a special committee for EBM, reviewed 17 journals related to TKM in South 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). TKM clinical trials reported by traditional medical doctors were included. Data were extracted from included articles on objectives, design, setting, participants, interventions, main outcome measures, main results and conclusions, using a predetermined form of structured abstract. We selected eligible TKM RCTs and assessed 'risk of bias'.
Results: We reviewed 12,653 articles from the 17 journals and 41 articles from CENTRAL and PubMed. 1,004 articles were left after non-clinical articles were excluded. Of these, 306 were TKM eligible studies. Of these studies, 57 were on musculoskeletal disorders and 55 on the circulatory system. 133 of the 306 TKM eligible studies were RCTs, of which 69 were on acupuncture and 25 on herbal medicine. We found a large proportion of 'unclear’ risk of bias in the criteria of 'Allocation concealment’, 'Blinding of participants and personnel’, 'Blinding of outcome assessment’ and 'Other bias'. On the other hand, we found a large proportion of 'low’ risk of bias in the criteria of 'Incomplete outcome data’ and 'Selective reporting’.
Conclusions: Clinical research in TKM is insufficient and many studies focused on musculoskeletal disorders and the circulatory system. There may be risk of bias in terms of 'allocation concealment’ and 'blinding’. For high-quality research in TKM, further research is needed with randomized and blind RCTs.
Objectives: To examine the current status of clinical research in TKM and to assess 'risk of bias' (ROB) in randomized clinical trials (RCTs) in TKM.
Methods: Korean Oriental Medicine Society (KOMS), a special committee for EBM, reviewed 17 journals related to TKM in South 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). TKM clinical trials reported by traditional medical doctors were included. Data were extracted from included articles on objectives, design, setting, participants, interventions, main outcome measures, main results and conclusions, using a predetermined form of structured abstract. We selected eligible TKM RCTs and assessed 'risk of bias'.
Results: We reviewed 12,653 articles from the 17 journals and 41 articles from CENTRAL and PubMed. 1,004 articles were left after non-clinical articles were excluded. Of these, 306 were TKM eligible studies. Of these studies, 57 were on musculoskeletal disorders and 55 on the circulatory system. 133 of the 306 TKM eligible studies were RCTs, of which 69 were on acupuncture and 25 on herbal medicine. We found a large proportion of 'unclear’ risk of bias in the criteria of 'Allocation concealment’, 'Blinding of participants and personnel’, 'Blinding of outcome assessment’ and 'Other bias'. On the other hand, we found a large proportion of 'low’ risk of bias in the criteria of 'Incomplete outcome data’ and 'Selective reporting’.
Conclusions: Clinical research in TKM is insufficient and many studies focused on musculoskeletal disorders and the circulatory system. There may be risk of bias in terms of 'allocation concealment’ and 'blinding’. For high-quality research in TKM, further research is needed with randomized and blind RCTs.
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