ABSTRACT
[Objective]To assess the effect of press tack needle (PTN) acupuncture in treating insomnia.<BR>[Design]Sham-controlled, double-blinded n-of-1 trial with three phases, (A) no treatment, (B) real PTN, and (C) sham PTN.<BR>[Setting]Morinomiya University of Medical Sciences (Suminoe-ku, Osaka City)<BR>[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).<BR>[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.<BR>[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. <BR>[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.<BR>[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.