Traditional Chinese medicine versus western medicine as used in China in the management of rheumatoid arthritis: a randomized, single-blind, 24-week study.
This study is designed to compare the efficacy and safety of traditional Chinese medicine (TCM) with western medicine (WM) in the management of rheumatoid arthritis (RA). This is a 24-week, randomized, multicenter, single-blind study comparing TCM with WM (as used in China) carried out between June 2002 and December 2004 in nine research centers in China, involving 489 patients. Patients were randomized to receive TCM (n = 247), MTX and SSZ (n = 242). MTX was started at a dose of 5 mg to a final dose of 7.5-15 mg weekly. The maintenance dose was 2.5-7.5 mg weekly. The starting dose of SSZ was 0.25 g bid, increasing by 0.25 g a day once a week to a final dose of 0.5-1 g qid. The maintenance dose was 0.5 g tid to qid. Primary end point was the proportion of patients with response according to the American College of Rheumatology 20 % improvement criteria (ACR20) at weeks 24. At 24 weeks, ACR20 responses were 53.0 % in TCM group and 66.5 % in WM group, (P < 0.001) at 24 weeks. ACR 50 responses were 31.6 % of TCM group and 42.6 % in WM group, (P = 0.01). ACR70 responses were 12.6 % in TCM group and 17.4 % in WM group, (P = 0.14). Side effects were observed more frequently in WM group. In this study, ACR20, ACR50 responses at 24 weeks were significantly better in the WM treated group, by intention to treat (ITT) and per protocol analysis. The ACR 70 response showed no significant difference between the two groups. TCM, while effective in treating RA, appears to be less effective than WM in controlling symptoms, but TCM is associated with fewer side effects.
Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, 510120, China, yitinghe@126.com.
Yi-Ting
YT
He
Ai-Hua
AH
Ou
Xiao-Bo
XB
Yang
Wei
W
Chen
Li-Yuan
LY
Fu
Ai-Ping
AP
Lu
Xiao-Ping
XP
Yan
Xing-Hua
XH
Feng
Li
L
Su
Yue-Jin
YJ
Song
Sheng-Ping
SP
Zeng
Wei
W
Liu
Xian
X
Qian
Wan-Hua
WH
Zhu
Ying-Rong
YR
Lao
Wei-Hua
WH
Xu
Ze-Huai
ZH
Wen
Xiao-Hong
XH
He
Bao-Juan
BJ
Wang
Geng-Xin
GX
Chen
Su-Qin
SQ
Xue
D018501:Antirheumatic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001172:Arthritis, Rheumatoid / Q000175:diagnosis / Q000188:drug therapy*; D002681:China; D004334:Drug Administration Schedule; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008516:Medicine, Chinese Traditional; D008727:Methotrexate / Q000008:administration & dosage* / Q000009:adverse effects; D012074:Remission Induction; D016037:Single-Blind Method; D012460:Sulfasalazine / Q000008:administration & dosage* / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome; D019366:Western World
D018501:Antirheumatic Agents; D004365:Drugs, Chinese Herbal; D012460:Sulfasalazine; D008727:Methotrexate