Guo 2009.

Methods	Design: parallel‐group Randomisation method: information not available Method of allocation concealment: information not available Blinding: information not available Stratification: not used
Participants	Inclusion: age 18 to 65 years, diagnosis of insomnia by Chinese Classification of Mental Disorder‐III (CCM‐III), duration of insomnia > 1 year, score on the Pittsburgh Sleep Quality Index (PSQI) > 7 Exclusion: nil Number of participants: intervention: 23; control: 22 Number of males: information not available Age (years): overall mean 39 (SD 15.27) Specific diagnoses/diagnostic subtypes: information not available Associated disease: information not available Duration of disorder (years): overall mean 6.8 (SD 4.29), range 1 to 15 Previous treatments: information not available
Interventions	Intervention group (needle acupuncture + zolpidem): acupuncture to the following acupoints: Shenmen, Sanyinjiao, Guanyuan and Sishenchong. Patients with deficiencies in heart and spleen were additionally treated at Xinshu and Pishu. Patients with deficiencies in heart and kidney were additionally treated at Xinshu, Shenshu and Taixi. Patients with dysharmony of spleen and stomach were additionally treated at Weishu and Zusanli. Patients with elevation of liver heat were additionally treated at Ganshu and Taichong. Patients with deficiencies in heart and liver were additionally treated at Xinshu and Ganshu. The needles were left in place for 30 minutes. Treatment was applied daily for 6 days and then rest for 1 day (1 course). Four courses of treatment were given in total. Zolpidem was given 10 mg every night for 4 weeks. Control group (Zolpidem alone): zolpidem as in intervention group
Outcomes	1. Frequency of improvement in sleep quality. Cure was defined as normalised total sleep duration or total sleep duration at least 6 hours, with deep and refreshing sleep, and improvement of PSQI by > 80%. Moderate improvement was defined as obvious improvement in sleep, with increase in total sleep duration by at least 3 hours and increase in depth of sleep, and improvement of PSQI by 60% to 80%. Some improvement was defined as symptom improvement with increase in total sleep duration by less than 3 hours, and improvement of PSQI by 30% to 60%. No improvement was defined as no change in symptoms or worsening symptoms, and improvement of PSQI by < 30%. 2. Adverse effects
Notes	Duration of follow‐up: 4 weeks Dropouts: none Comparability of groups at baseline: no significant differences between the groups but data not shown Risk of bias: high
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Sequence generation was not described
Allocation concealment (selection bias)	Unclear risk	Allocation concealment was not described
Blinding (performance bias and detection bias) All outcomes	High risk	Blinding was not described. Since the intervention involves acupuncture, it is highly likely that the treating physicians and patients were not blinded.
Incomplete outcome data (attrition bias) All outcomes	Low risk	There were no dropouts
Selective reporting (reporting bias)	Unclear risk	Trial protocol was not available to judge whether there was selective reporting
Other bias	High risk	Treatment regimen varied among patients and might introduce bias. No placebo or sham control was used and hence there might be a placebo effect.