[Objective]To assess the effect of press tack needle (PTN) acupuncture in treating insomnia.
[Design]Sham-controlled, double-blinded n-of-1 trial with three phases, (A) no treatment, (B) real PTN, and (C) sham PTN.
[Setting]Morinomiya University of Medical Sciences (Suminoe-ku, Osaka City)
[Participants]Four subjects experiencing insomnia with 6 or more points on the Pittsburgh Sleep Quality Index (PSQI). They were randomly assigned to groups A-B-A-C (n=2) or A-C-A-B (n=2).
[Interventions]PTN with lengths of 0.6 mm were used on HT 7, PC 6, and SP 6 during phase B, while sham PTN without needle tips were used on the same points during phase C. Both real and sham PTN were administered twice a week.
[Main Outcomes]Primary outcomes were sleeping hours and the number of nocturnal awakenings recorded in a sleep diary. Secondary outcomes included PSQI, Profile of Mood States (POMS), Stress Visual Analogue Scale (Stress VAS) and Sleep Quality Index measured by ActiSleep.
[Main Results]We mainly assessed one patient with sleep-onset insomnia of 8 points or more (PSQI) before intervention. With the real PTN, the number of nocturnal awakenings decreased (1.6±0.9 for real vs. 3.6 ± 1.3for sham). Sleeping hours did not change significantly (Real 426 ± 49.3min, vs Sham 450 ± 60.0 min). Waking after sleep onset (65 ±14.7 min for real vs. 129 ± 39.5 min for sham) and sleep efficiency (82.8 ± 3%for real vs. 68.6 ± 4.3%for sham) estimated by ActiSleep also improved during the period of real PTN. Regarding T points for POMS, there was a difference between real (51) and sham (67) for "confusion;"however, blinding was unsuccessful and the wash-out period was not long enough.
[Conclusion]Although we need further validations, due to some methodological flaws, the present results suggest that PTN acupuncture is clinically useful for some patients suffering from insomnia.

Zen Nippon Shinkyu Gakkai Zasshi(Journal of the Japan Society of Acupuncture and Moxibustion:JJSAM).
2010; 60(2): 244-251. Received 19 Mar, 2009 Accepted 27 Mar, 2010

[Objective]To motivate acupuncture school teachers to introduce higher-quality methodology in clinical acupuncture research.
[Methods]Twenty-eight teachers from 18 acupuncture schools participated in the simulated randomized, subject and evaluator-blinded, and sham-controlled trial of acupuncture for low back pain. Twenty of them played a role as subjects, four of them were raters, and another four were therapists. Before and after conducting the trial, all the participants were asked several questions using the Visual Analogue Scale (VAS) regarding necessity of Evidence-Based Medicine (EBM) in acupuncture and their level of understanding of several terms related to a Randomized Controlled Trial (RCT),
[Results]After the simulated RCT, the understanding level of all terms related to RCT increased significantly ("RCT":from 58.0 ± 27.2 to 75.5 ± 25.7, "informed consent":from 88.1 ± 15.4 to 99.2 ± 10, "recruitment":from 43.0 ± 41.0 to 74.8 ± 31.3, "random allocation":from 55.5 ± 35.0 to 78.7 ± 25.8, "masking":from 54.7 ± 35.0 to 79.0 ± 26.0) (mean ±SD). Nineteen teachers answered that they would try to conduct RCT and introduce it to their education program.
[Conclusion]The results suggest that the practice of simulated RCT is effective in understanding RCT and motivating acupuncture teachers to introduce it to their education program.

Artificial ureteral calculosis was produced by the injection of dental cement in anesthetized rats. EMG activities of body trunk and medial thigh muscles were recorded immediately after the operation using bipolar wire electrodes. Then vocalization thresholds were measured by electrical stimulation of the muscle using the same implanted electrodes. After the operation long-lasting periodic increases of the EMG activities were observed and decreases of pain thresholds were also observed in the same muscles.
These results suggest that artificial ureter calculosis rats are useful experimental model for the further study on the tender points formation.

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

The results of multi-center RCT of acupuncture and moxibustion for the prevention of the symptoms of common cold conducted by the financial support of the foundation for training and licensure examination in anma-massage-acupressure, acupuncture and moxibustion were briefly reviewed. Traditional acupuncture manipulation to the throat induced significant positive effects, however, more common indirect moxibustion to the neck for longer period did not induce the significant effect compared with no-treatment control. Several issues to be resolved were discussed and the shortage of duration of intervention was pointed out as one of the major issues. Then four pilot studies with long-lasting intervention of acupuncture or moxibustion were con-ducted. The effects tended to be more positive, however, they were still unclear. The selection of subjects (students in the acupuncture school) will be the next important issue to be examined.

The first Japan-Korea workshop on acupuncture and EBM was held on June 4, 2004 at Chiba in the 53rd annual scientific meeting of the JSAM. The purpose of this workshop was to exchange the experiences of clinical researches on acupuncture and moxibustion therapies, and to find out the issues and their solutions for developing the excellent clinical research to establish strong evidence. The final purpose was to develop aprotocol for the collaborative work between both countries.
Drs. Kawakita (JSAM) and Jang (KAMS) chaired the workshop. Three speakers from Japan (Drs Takahashi, Nabeta, and Tsukayama) and three Korean speakers (Drs Seo, Lee and Moon) presented their data on the clinical researches of acupuncture, moxibustion and bee-venom injection. After their paper presentations, various issues were discussed on their research methodology for establishing more strong evidence of acupuncture.We got interesting new findings and understood various issues for conducting clinical researches especially RCT.
Although we could not develop a protocol for the collaborative research in this workshop, it was very fruitful workshop as the first step for the future Japan-Korea collaborative clinical study. The most important product of this workshop was we could understand each other and we confirmed the necessity of the future collaborative clinical research on acupuncture.