[Objective] We performed a multi-center randomized controlled trial using sham acupuncture as a control in the 11 institutions of Aichi and Shizuoka prefecture at which we practice our original acupuncture method.
[Design · Methods] Patients were randomly allocated to four groups : A group, “Taikyoku-Ryoho” (whole body acupuncture method) pole treatment combined with low frequency electroacupuncture; B group, “TaikyokuRyoho” pole treatment; C group, low frequency electroacupuncture; D group, sham acupuncture. Therapeutic effectiveness was evaluated using a visual analogue scale (VAS) and criteria of the Japanese Orthopedic Association for low back pain (JOA score). After these evaluations, patients in B group received low frequency electroacupuncture and patients in C group received “Taikyoku-Ryoho” pole treatment. Patients in D group received both therapies. Thus, all patients eventually received the entire series of therapies. [Results] Significant improvement (P<0.05) in VAS and JOA scores was recognized after one acupuncture treatment in A, B and C groups, but not in D group. There were no differences in terms of the effectiveness among A, B and C groups.
[Conclusion] Our original acupuncture method of “Taikyoku-Ryoho” combined with low frequency electroacupuncture was superior to sham acupuncture. However, the definition of sham acupuncture needs to be more clearly defined in future research.

At the 45th Japanese National Acupuncture and Moxibustion Conference, Kitakoji et al. of the Research Committee's Urology Group reported the results of controlled clinical trials, using the envelope method, on the effectiveness of acupuncture for urinary dysfunction. This was presented as a case in which the “Guidelines and Recommendations for clinical Trials in Acupuncture” were applied in actual clinical research. A controlled investigation was carried out by the Information and Evaluation Group, Research Section, Aichi Regional Association, at multiple institutions (9 hospitals and clinics) on the effectiveness of the zhongji (cv-3) point for urinary dysfunction, using the envelope method of Kitakoji et al. Although the zhongji (cv-3) point was not found to be effective against urinary dysfunction, we were able to demonstrate that it is possible to conduct controlled clinical trials at multiple institutions based on soft data.