Cui 2003.

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: diagnosis of insomnia with sleep efficiency < 60%, with Traditional Chinese Medicine type of interior stirring by phlegm‐heat Exclusion: patients with severe diseases of heart, liver, kidney or brain or patients who could not follow through whole treatment were excluded Number of participants: intervention: 60; control: 60 Number of males: intervention: 34; control: 28 Age (years): intervention: mean 43.2; control: mean 38.45 Specific diagnoses/diagnostic subtypes: all patients had insomnia with Traditional Chinese Medicine type of interior stirring by phlegm‐heat Associated disease: information not available Duration of disorder (years): information not available Previous treatments: information not available
Interventions	Intervention group (needle acupuncture + estazolam): acupuncture to the following acupoints: Baihui, Shenting, Sishencong, Shenmen, Neiguan, Zhongwan, Fenglong and Gongsun. A filiform needle 1 to 1.5 inches in length was inserted to the acupoints with uniform reinforcing‐reducing manoeuvre. Treatment was applied daily for 30 days. Estazolam was given 1 to 2 mg orally every night for 30 days. Control group (estazolam alone): estazolam was given as in intervention group
Outcomes	Frequency of improvement in sleep quality. Cure was defined as sleep efficiency > 75% without hypnotics use. Marked improvement was defined as increase in sleep efficiency by 10% to 20% without hypnotics use. Some improvement was defined as increase in sleep efficiency by less than 10% with hypnotics reduced by 75% in dosage. No improvement was defined as no change in sleep efficiency. Deterioration was defined as worsening of symptoms, decrease in sleep efficiency or increase in estazolam use.
Notes	Duration of follow‐up: 30 days Dropouts: none Comparability of groups at baseline: no information was available on baseline severity of insomnia of the treatment groups 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. Baseline severity of insomnia was not described and the comparability of the treatment groups was questionable.