The quality of reporting of randomized controlled trials of traditional Chinese medicine: a survey of 13 randomly selected journals from mainland China.
BACKGROUND
The number of randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) is increasing. However, there have been few systematic assessments of the quality of reporting of these trials.


OBJECTIVE
This study was undertaken to evaluate the quality of reporting of RCTs in TCM journals published in mainland China from 1999 to 2004.


METHODS
Thirteen TCM journals were randomly selected by stratified sampling of the approximately 100 TCM journals published in mainland China. All issues of the selected journals published from 1999 to 2004 were hand-searched according to guidelines from the Cochrane Centre. All reviewers underwent training in the evaluation of RCTs at the Chinese Centre of Evidence-based Medicine. A comprehensive quality assessment of each RCT was completed using a modified version of the Consolidated Standards of Reporting Trials (CONSORT) checklist (total of 30 items) and the Jadad scale. Disagreements were resolved by consensus.


RESULTS
Seven thousand four hundred twenty-two RCTs were identified. The proportion of published RCTs relative to all types of published clinical trials increased significantly over the period studied, from 18.6% in 1999 to 35.9% in 2004 (P < 0.001). The mean (SD) Jadad score was 1.03 (0.61) overall. One RCT had a Jadad score of 5 points; 14 had a score of 4 points; and 102 had a score of 3 points. The mean (SD) Jadad score was 0.85 (0.53) in 1999 (746 RCTs) and 1.20 (0.62) in 2004 (1634 RCTs). Across all trials, 39.4% of the items on the modified CONSORT checklist were reported, which was equivalent to 11.82 (5.78) of the 30 items. Some important methodologic components of RCTs were incompletely reported, such as sample-size calculation (reported in 1.1% of RCTs), randomization sequence (7.9%), allocation concealment (0.3 %), implementation of the random-allocation sequence (0%), and analysis of intention to treat (0%).


CONCLUSIONS
The findings of this study indicate that the quality of reporting of RCTs of TCM has improved, but remains poor.
Wang
Gang
G
Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University, Ckengdu, People's Republic of China.
Mao
Bing
B
Xiong
Ze-Yu
ZY
Fan
Tao
T
Chen
Xiao-Dong
XD
Wang
Lei
L
Liu
Guan-Jian
GJ
Liu
Jia
J
Guo
Jia
J
Chang
Jing
J
Wu
Tai-Xiang
TX
Li
Ting-Qian
TQ
D002681:China; D006801:Humans; D008516:Medicine, Chinese Traditional / Q000379:methods*; D010506:Periodicals as Topic / Q000592:standards*; D011786:Quality Control; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D012107:Research Design