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 life (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.