To clarify methodological issues in clinical research involving acupuncture, a randomized controlled trial was performed on subjects complaing of neck stiffness. Thirty-two volunteers who gave informed consent were randomly alloca-ted into experimental and control groups by the envelope method. In the experimental group, the acupuncture needle was inserted to a depth of 20 mm and the swallow-pecking technique was repeated 5 times. In the control group, the acupuncture needle penetrated the skin and was removed immediately. Bilateral Tianzhu points (BL 10) were used in both groups. Acupuncture treatment was performed once a week for 3 sessions and the effect was evaluated by the subjective intensity of stiffness using a visual analogue scale. In both groups subjective evaluation was immediately reduced by acupuncture treatment and the effects tended to persist for 7 days.There was significant difference between the two groups. Methodological issues listed below were discussed for further to promote clinical research on acupuncture. 1) acupuncture points and stimulation conditions, 2) adequate control groups, 3) entry criteria, 4) volunteer bias, 5) masking technique, 6) sample numbers

Objective : To determine the effectiveness of acupuncture therapy on hiesho in maturate stage females.
Design : Multicenter, randomized, prospective, open blind, waiting list-controlled trial.
Setting : A clinical center attached to three universities and one vocational school.
Participants : Twenty two females between 18-39 years of age and with a level of more than four points on the “hiesho sensation scale” proposed by Kusumi et al for hiesho. Interventions : Participants were randomly assigned to receive therapies of either acupuncture or no therapy (waiting list controls). Acupuncture therapy was provided by needle retention to SP 6 and electro-acupuncture therapy to BL 32 at a frequency of 1 Hz for 20 minutes. One session per week of this therapy was provided for a total of four sessions. Method of Measurement : The primary outcome of change in hiesho intensity was measured using the visual analogue scale (VAS). Secondary changes were measured by an eight heading score and three component summaries of the standard edition SF-36 v 2.
Results : The statistical analyses used an intent-to-treat analysis that included two participants who dropped out, and the mixture of one participant targeted for exclusion who was censored from the analyses. As a result, 21 participants were classified as either in the acupuncture group (n = 12) or the control group (n = 9). Efficacy with acupuncture therapy was not found for effect size (Cohen d, point-biserial correlation r) for VAS and the scores of SF-36 between the two groups.
Conclusions : Effectiveness of the acupuncture therapy was not found, which suggests that it may be due to the smaller sample size, frequency of intervention, and symptoms associated with autonomic dysfunction.