Acupuncture in the treatment of rheumatoid arthritis: a double-blind controlled pilot study.
BACKGROUND
In planning a randomized controlled trial of acupuncture, we conducted a pilot study using validated outcome measures to assess the feasibility of the protocol, and to obtain preliminary data on efficacy and tolerability of 3 different forms of acupuncture treatment as an adjunct for the treatment of chronic pain in patients with Rheumatoid arthritis (RA).


METHODS
The study employs a randomized, prospective, double-blind, placebo-controlled trial to evaluate the effect of electroacupuncture (EA), traditional Chinese acupuncture (TCA) and sham acupuncture (Sham) in patients with RA. All patients received 20 sessions over a period of 10 weeks. Six acupuncture points were chosen. Primary outcome is the changes in the pain score. Secondary outcomes included the changes in the ACR core disease measures, DAS 28 score and the number of patients who achieved ACR 20 at week 10.


RESULTS
From 80 eligible patients, 36 patients with mean age of 58 +/- 10 years and disease duration of 9.3 +/- 6.4 years were recruited. Twelve patients were randomized to each group. Twelve, 10 and 7 patients from the EA, TCA and Sham group respectively completed the study at 20 weeks (p < 0.03); all except one of the premature dropouts were due to lack of efficacy. At week 10, the pain score remained unchanged in all 3 groups. The number of tender joints was significantly reduced for the EA and TCA groups. Physician's global score was significantly reduced for the EA group and patient's global score was significantly reduced for the TCA group. All the outcomes except patient's global score remained unchanged in the Sham group.


CONCLUSIONS
This pilot study has allowed a number of recommendations to be made to facilitate the design of a large-scale trial, which in turn will help to clarify the existing evidence base on acupuncture for RA.


BACKGROUND
ClinicalTrials.gov NCT00404443.
Tam
Lai-Shan
LS
The Department of Medicine & Therapeutics, The Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, China. tamls_813@yahoo.com
Leung
Ping-Chung
PC
Li
Tena K
TK
Zhang
Lang
L
Li
Edmund K
EK
D015670:Acupuncture Therapy / Q000379:methods*; D000328:Adult; D001172:Arthritis, Rheumatoid / Q000628:therapy*; D004311:Double-Blind Method; D015671:Electroacupuncture / Q000379:methods; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement / Q000379:methods; D010865:Pilot Projects; D011788:Quality of Life; D012720:Severity of Illness Index; D016896:Treatment Outcome