The effect of acupuncture compared with sham acupuncture and estazolam in primary insomnia

INTERVENTION: This is a six‐week, single‐blind, randomised, sham‐controlled study. A total of 150 untreated patients with primary insomnia will be recruited. Under single‐blind conditions, patients will be randomly assigned to one of the three groups: Group A: Active acupuncture with estazolam placebo tablet for six weeks. Active acupuncture is conducted by stimulating 5 acupoints: Shen‐Ting (DU‐24), Si‐Shen‐Cong (EX‐HN1), San‐Yin‐Jiao (SP‐6), Shen‐Men (HT‐7) and Bai‐Hui (DU‐20) for 30 minutes every other day. Stainless steel needles of 0.35 mm diameter are inserted at a depth of 10 mm obliquely into Bai‐Hui (Du‐20) Shen‐Ting (DU‐24) and Si‐Shen‐Cong (EX‐HN1), 10 mm straightly into San‐Yin‐Jiao (SP‐6) and 5 mm straightly into Shen‐Men (HT‐7). In the day without acupuncture intervention one estazolam placebo tablet should be taken before sleep. Group B: Estazolam combined with sham acupuncture for six weeks. Sham acupuncture is conducted by stimulating 4 acupoints every other day: Bi‐Nao (LI‐14), Shou‐San‐li (LI‐10), Yu‐Ji (LU‐10) and Feng‐Shi (GB‐31). Stainless steel needles of 0.35 mm diameter are inserted straightly at a depth of 10 mm into the four points. According to traditional Chinese medicine theory, these four acupoints have no effect for insomnia. Estazolam dose is given 1 mg in the day without acupuncture intervention before sleep. Group C: Sham acupuncture with estazolam placebo tablet for six weeks. Sham acupuncture is conducted as the group B. In the day without acupuncture one estazolam placebo tablet should be taken before sleep. The reason for taking the invention every other day is for the convenience of the patients and avoiding addiction of estazolam. CONDITION: Primary insomnia ; Nervous System Diseases ; Sleep disorders PRIMARY OUTCOME: 1. Sleepiness measured using the Epworth Sleepiness Scale. Assessments will be conducted at baseline and at day 7, 14, 28, 42 and 2 months follow‐up.; 2. Sleep diary assessments will be conducted every day until 2 months follow‐up SECONDARY OUTCOME: 1. Changes in the Pittsburgh Sleep Quality Index (PSQI). Assessments will be conducted at baseline and at day 28, 42 and 2 months follow‐up. ; 2. Changes in the 36‐item Short Form Health Survey (SF‐36) scores. Assessments will be conducted at baseline and at day 28, 42 and 2 months follow‐up. INCLUSION CRITERIA: 1. Either gender aged 25 ‐ 75 years 2. Have primary insomnia diagnosed from International Classification of Diseases, 10th Edition (ICD‐10) 3. Patients with insomnia persistent for 4 weeks or longer before the start of observation period 4. Have not yet received any psychoactive medications 5. Patients who submit written informed consent for study entry 6. Able to take part in the entire treatment and data collection procedure