We evaluated the efficacy, usefulness and safety of acupuncture and moxibustion treatment in rheumatoid arthritis (RA), by the randomized, parallel-group , multi-center study with the drug-treated outpatient group as the control. The endpoints, important in the clinical assessment of acupuncture treatment , included the improvement criteria in ACR core set variables and the Japanese version of the Arthritis Impact Measurement Scales Version 2 (AIMS-2), a system of evaluation of the quality of

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... fe (QOL) of patients with RA . Regarding intervention (therapy) , a therapy chart for each stage of disease was drawn up to give local and systemic treatment in consideration of the patient's activity and disability in each stage of RA , so that generally consistent therapy adapted to the patient's condition would be provided . Result 1. Patients eligible for analysis were 80 patients of A-group (drug therapy group) (80 females , 2 males) and 90 patients of B-group (drug plus acupuncture and moxibustion group), total 170 patients. 2. Patients who satisfied the improvement criteria in ACR core set variables (improved patients) were 8 of 80 patients in A -group and 20 of 90 patients in B-group. The improvement rate was significantly higher for B-group treated by drug plus acupuncture and moxibustion versus A-group, with P=0.04 in 2 (2 table chi square test . 3. In QOL change investigated by AIMS-2 questionnaire, the improvement occurred significantly more frequently in the drug plus acupuncture and moxibustion group, with difference between groups at 12 months after the initiation of clinical study at P=0.001. 4. Changes in the subjects included in AIMS-2 questionnaire: Improvement was significantly more frequent in the drug plus acupuncture and moxibustion group versus drug therapy group in respect to the ability to walk, finger function , housework, sociableness, pain, mood, and the degree of subjective improvement . In the present randomized, parallel-group, multicenter study , a significant improvement was detected in the drug plus acupuncture and moxibustion group versus the drug therapy group in the aforesaid respect , which suggested that the use of acupuncture and moxibustion combined with the conventional therapy would prevent deterioration of physical functions, improve blood circulation , stabilize mental status, and thereby contribute to the improvement of QOL in patients with rheumatoid arthritis .