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BMC Complement Altern Med. 2007; 7: 35.
Published online 2007 Nov 3. doi:Β 10.1186/1472-6882-7-35
PMCID: PMC2174514
PMID: 17980044

Lai-Shan Tam

Arthritis Curehow to Arthritis Cure for 1The Department of Medicine & Therapeutics, The Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, China

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Ping-Chung Leung

2The Institute of Chinese Medicine, The Prince of Wales Hospital, The Chinese for 1 last update 2020/07/05 University of Hong Kong, Hong Kong, China2The Institute of Chinese Medicine, The Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, China

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Arthritis Curehow to Arthritis Cure for Tena K Li

Arthritis Curehow to Arthritis Cure for 1The Department of Medicine & Therapeutics, The Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, China

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Lang Zhang

2The Institute of Chinese Medicine, The Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, China

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Arthritis Curehow to Arthritis Cure for Edmund K Li

Arthritis Curehow to Arthritis Cure for 1The Department of Medicine & Therapeutics, The Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, China

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1The Department of Medicine & Therapeutics, The Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, China
2The Institute of Chinese Medicine, The Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, China
Corresponding author.
Lai-Shan Tam: [email protected]_slmat; Ping-Chung Leung: [email protected]; Ping-Chung Leung: [email protected]; Tena K Li: [email protected]_anet; Arthritis Curehow to Arthritis Cure for Lang the 1 last update 2020/07/05 Zhang: [email protected]; Lang Zhang: [email protected]; Edmund K Li: [email protected]
Received 2007 Jun 27; Accepted 2007 Nov 3.
Copyright © 2007 Tam et al; licensee BioMed Central Ltd.

This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

This article has been cited by other articles in PMC.

Abstract

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 the 1 last update 2020/07/05 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 TCA group. All the outcomes except patient''Bi''s global assessment, a validated version of the Chinese Health Assessment Questionnaire (HAQ)[18] and the physician''s Global (VAS, 0–10)6.4 ± 2.25.8 ± 2.16.4 ± 2.25.0 ± 2.4*6.8 ± 2.35.0 ± 2.4*Physician'' progress through the trial. Twelve, 10 and 7 patients from the EA, TCA and sham groups respectively completed the study at 20 weeks (p < 0.03); all except one of the premature dropouts were due to lack of efficacy requiring increase in the dosage of existing DMARD or addition of another DMARD. One patient from the TCA group defaulted follow up after the first visit. Another patient from the TCA group required change in DMARD at week 5. Five patients from the Sham group required change in DMARD at week 2, 2, 5, 11 and 13.

Patients progress through the trial.

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 TCA group. All the outcomes except patient''Bi''s global assessment, a validated version of the Chinese Health Assessment Questionnaire (HAQ)[18] and the physician''s Global (VAS, 0–10)6.4 ± 2.25.8 ± 2.16.4 ± 2.25.0 ± 2.4*6.8 ± 2.35.0 ± 2.4*Physician'' progress through the trial. Twelve, 10 and 7 patients from the EA, TCA and sham groups respectively completed the study at 20 weeks (p < 0.03); all except one of the premature dropouts were due to lack of efficacy requiring increase in the dosage of existing DMARD or addition of another DMARD. One patient from the TCA group defaulted follow up after the first visit. Another patient from the TCA group required change in DMARD at week 5. Five patients from the Sham group required change in DMARD at week 2, 2, 5, 11 and 13.

Patients progress through the trial.

Adverse events

Overall, the procedures were well tolerated; a total 3 episodes of minor adverse events were reported in 3 patients, including tingling sensation after acupuncture, herpes zoster and dyspepsia. The last 2 events were thought not to be related to the procedure.

Variability of the primary clinical outcome measures and other preliminary outcome data

The variability for 1 last update 2020/07/05 of the primary clinical outcome in patients at baseline and at week 10, as shown by the standard deviation, is presented in Table Table22.The variability of the primary clinical outcome in patients at baseline and at week 10, as shown by the standard deviation, is presented in Table Table22.

There were no significant differences in the pain score at week 10 between the 3 groups (Table the 1 last update 2020/07/05 (Table2).(Table2).2). However, when the different ACR core disease measures were analyzed separately at week 10, there was a significant reduction of the physician''s global assessment score and the number of tender joints was observed at week 10 (p = 0.01). All the ACR components remained unchanged except patient''s global score. Moreover, significantly more patients from the sham acupuncture group dropped out prematurely due to inefficacy compared to the 2 acupuncture groups.

We chose these treatments to investigate a specific effect of the stimulation, or depth of needling (TCA or EA vs. sham acupuncture). We acknowledge the fact that waiting list controls may be useful to ascertain the extent of placebo effects of the acupuncture setting (for example, contact factors, talking and listening, and credibility of the intervention), patient preferences and expectation. Indeed, the fact that both the acupuncture and sham groups reported significant improvements in the patient''Bi''Bi'' contributions

LST is responsible for the conception and design of the trial, clinical assessment, analysis and interpretation of data; and drafting the manuscript.

TKL is responsible for the acquisition of data.

LZ is responsible for the design of the trial and performing acupuncture on all the patients

PCL is responsible for the conception and design of the trial and revising the manuscript critically for important intellectual content.

EKL is responsible for the conception and design of the trial, clinical assessment, drafting the manuscript and revising it critically for important intellectual content.

All authors read and approved the final manuscript.

Pre-publication history

The pre-publication history for this paper can be accessed here:

http://www.biomedcentral.com/1472-6882/7/35/prepub

Acknowledgements

We would like to thank Ms Carmen Fong, manger of Centre for Clinical Trial on Chinese Medicine for her assistance towards the study by making substantial contributions to the conception and design of the trial. This study was supported by the Centre for Clinical Trial on Chinese Medicine, Institute of Chinese Medicine, The Chinese University of Hong Kong.

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