Lu 1998.

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: insomnia characterised by difficulty initiating sleep, shallow sleep, lots of dreams, early awakening, difficulty reinitiating sleep after awakening, sleep efficiency below 40%, tired and sleepy at daytime with anxiety, impaired memory or attention affecting work efficiency, duration of insomnia more than 3 months Exclusion: nil Number of participants: intervention: 35; control: 23 Number of males: intervention: 14; control: 10 Age (years): overall range 16 to 60 Specific diagnoses/diagnostic subtypes: information not available Associated disease: information not available Duration of disorder: intervention: range 3 months to 5 years; control: range 3 months to 5 years Previous treatments: 80% participants had used hypnotics
Interventions	Intervention group (needle acupuncture + Chinese herb): acupuncture to Neiguan bilaterally. Needles were left in place for 30 minutes. Treatment was applied daily for 30 days. Qi Ye Shen An Pian 100 mg was given 3 times daily for 30 days. Control group (Chinese herb alone): Qi Ye Shen An Pian as in intervention group
Outcomes	Frequency of improvement in sleep quality: Cure was defined as sleep efficiency more than 70%. Moderate improvement was defined as sleep efficiency 60% to 70%. Some improvement was defined as sleep efficiency 50% to 60%. No improvement was defined as sleep efficiency below 40%.
Notes	Duration of follow‐up: 30 days Dropouts: none Comparability of groups at baseline: no significant differences between the groups in gender distribution or duration 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	No placebo or sham control was used and hence there might be a placebo effect