Liu 2001.

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 > 50 years, insomnia characterised by frequent insufficient sleep, difficulty initiating sleep, early awakening, difficulty reinitiating sleep after awakening, no sleep throughout the night, difficulty maintaining sleep, or dependent on hypnotics for sleep, and total sleep duration less than 4 hours, tired at daytime with impaired memory Exclusion: nil Number of participants: intervention: 56; control: 30 Number of males: overall 31 Age (years): overall mean 67, range 56 to 82 Specific diagnoses/diagnostic subtypes: information not available Associated disease: information not available Duration of disorder: overall range 0.5 to 39 years Previous treatments: information not available
Interventions	Intervention group (needle acupuncture + Chinese herb): acupuncture to the following acupoints: Yintang, Zhaohai, Shenmen and Taiyang. Patients with deficiency in kidney were additionally treated at Taixi. Patients with deficiency in spleen were additionally treated at Zusanli. Patients with excessive liver heat were additionally treated at Taichong. Patients with stomach problems were additionally treated at Zhongwan and Liangmen. Needles were left in place for 40 minutes. Acanthopanax senticosus 60 ml was added to 500 ml 5% dextrose solution to be infused daily. Treatment was applied daily for 10 days and then rest for 3 to 5 days (1 course). Two courses of treatment were given in total. Control group (Chinese herb alone): Acanthopanax senticosus infusion as in intervention group
Outcomes	Frequency of improvement in sleep quality: cure was defined as sleep onset latency no more than 1 hour, with at most 1 awakening at night, able to fall asleep again after awakening, no excessive dreams, independent of hypnotics and normal daytime activity. Some improvement was defined as increase in total sleep duration by more than 2 hours, with reduction of hypnotics by at least 50%, and improved daytime functioning. No improvement was defined as no change in symptoms or use of hypnotics.
Notes	Duration of follow‐up: 30 days Dropouts: none Comparability of groups at baseline: no significant differences between the groups in age and gender distribution, or severity of insomnia at baseline 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.