Methodological quality of randomized controlled trials on gastric cancer treated with traditional Chinese medicine published in Chinese journals

Article type
Authors
L I1, H U1, L I1, M A1
1Evidence-Based Medicine Center, Institute of Traditional Chinese and Western Medicine, School of Basic Medical Sciences, Lanzhou University, Lanzhou 730000, China
Abstract
Background: Randomized controlled trial (RCTs) on gastric cancer treated with Traditional Chinese Medicine (TCM) have been published in large numbers. However, methodological quality of these RCTs were unknown.

Objectives: The purpose was to assess methodological quality of RCTs on gastric cancer treated with TCM.

Methods: Chinese Biomedicine Literature Database (CBM), Chinese Scientific Journal Full-text Database (CSJD), Chinese Journal Full-text Database (CJFD), and Wangfa Database were performed in the end of the Dec. 2010. The search terms included 'Traditional Chinese Medicine’ and 'Chinese herbs' (Mesh or EMTREE), 'Gastric Cancer’, 'Stomach Cancer’ and 'Stomach Neoplasms', (Mesh or EMTREE). Besides, Google were searched and the range of snowballing method was used. The Cochrane Handbook 5.0.1 was used to evaluate the methodological quality of included studies.

Results: Totally 102 RCTs were identified and published in 72 different Chinese Journals. Less half (41.67%) were published in specialty journals. Less one-third (21.57%) were published in journals cited by Chinese Science Citation Database (CSCD). The sample of mostly trials (91.18%) less than 100 cases. Only 52.95% and 11.76% trials reported the specific inclusion and diagnostic criteria, 88.24% did not reported exclusion criteria. All of them did not register in any clinical trials registry platform. Only 17 studies reported the correct randomization method. All trials did not report allocation concealment. Only 3 studies reported blinding, but no one reported whose were blinded. Statistic mistakes appeared in one-third (29.3%) studies.

Conclusions: RCTs on TCM were published in large number in Chinese Journals in recently years, but the quality of these review were worrying. The information reported from these RCTs were not comprehensive and even some were mistake. It did not only provide evidence for clinicians but also misled them. Hence, the most urgent and important thing is to improve the quality of RCTs on TCM, not accelerate the quantity in China.