A randomized placebo-controlled trial of acupuncture for primary insomnia: preliminary data

Abstract

INTRODUCTION: Acupuncture is a commonly used complementary therapy for insomnia. Previous studies were limited by the lack of placebo acupuncture group, proper diagnostic and blinding procedure and objective sleep assessment. The purpose of this study is to evaluate the efficacy and safety of electro-acupuncture in primary insomnia using placebo acupuncture as control. METHODS: Chinese adults aged 18-65 yr with DSM-IV primary insomnia for at least 3 months were randomized to receive electro-acupuncture or placebo acupuncture for 9 sessions in 3 weeks. The acupoints used were bilateral Ear Shenmen, Sishencong EX-HN1, Anmian, and unilateral Yingtong EX-HN3 and Baihui DU20. Streitberger placebo needles were used in the placebo group. The number, duration and frequency of treatment session were the same for the two groups. Structured Clinical Interview for DSM-IV and overnight polysomnography were used for screening. Insomnia Severity Index (ISI) (primary outcome measure), sleep diary and adverse event reporting were done at baseline, after the 5th treatment, after the 9th treatment and 1-week post-treatment. Actigraphy, PSQI, Hospital Anxiety and Depression Scale, Sheehan Disability Index were done at baseline and 1-week post-treatment. Significant treatment effect is defined as a difference of ≥ 5 ISI points between the two groups. A sample size of 20 in each group has a power of 85-100% to detect the significant treatment effect using ANCOVA. RESULTS: This preliminary analysis was based on the first 10 subjects in each group. Subjects receiving electro-acupuncture had significantly higher sleep efficiency by sleep diaries than those with placebo acupuncture at 1-week post-treatment (ANCOVA: F = 5.4, p = 0.03) with difference between means of 12.8% (95% CI: 2.2%-23.3%). No significant difference in other outcome measures between the two groups. No adverse event was reported in either group. CONCLUSION: Electro-acupuncture seems to be effective and well tolerated in the short-term treatment of primary insomnia.