Lee 2009.

Methods	Design: parallel‐group Randomisation method: by random digits Method of allocation concealment: information not available Blinding: single‐blind (assessor) Stratification: not used
Participants	Inclusion: persistent insomnia for more than 3 days in a row after stroke, Insomnia Severity Index (ISI) > 15, hospitalised at the Department of Cardiovascular and Neurologic Diseases (Stroke Center), Hospital of Oriental Medicine, Kyung Hee Medical Center, Seoul, Korea from 1 November 2007 to 31 August 2008 Exclusion: patients treated with sedative, antidepressant, tranquilliser, narcotic analgesics, antihistamine or amphetamine‐containing drugs were excluded. Patients who had disorientation, dysphasia or nocturnal voiding frequency were also excluded Number of participants: intervention: 30; control: 30 Number of males: intervention: 12; control: 12 Age (years): intervention: mean 66.7 (SD 11); control: mean 66 (SD 9.6) Specific diagnoses/diagnostic subtypes: information not available Associated disease: stroke in all participants; intervention group: hypertension (20), diabetes mellitus (7), hyperlipidaemia (4), ischaemic heart disease (4); control group: hypertension (17), diabetes (10), hyperlipidaemia (4), ischaemic heart disease (2) Duration of disorder (years): information not available Previous treatments: no
Interventions	Intervention group (needle acupuncture): acupuncture to the following acupoints: Shenmen and Neikuan in both arms, by 4 Dong bang sterile disposable intradermal acupuncture needles (0.18 x 6 mm). A piece of skin tape (1 x 1 cm) was put on each needle to fix it persistently for 2 days. Control group (sham acupuncture): the needles were laid down on the same acupoints as in intervention group, not letting the needles penetrate the skin
Outcomes	1. Insomnia Severity Index (ISI) 2. Athens Insomnia Scale (AIS)
Notes	Duration of follow‐up: 2 days Dropouts: intervention: 3 (due to discharge from hospital); control: 5 (due to discharge from hospital) Comparability of groups at baseline: no significant differences between the groups in age and gender distribution, medical history of hypertension, diabetes, hyperlipidaemia or ischaemic stroke, or severity of insomnia at baseline Risk of bias: high
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Group allocation by random digits
Allocation concealment (selection bias)	Unclear risk	Allocation concealment was not described
Blinding (performance bias and detection bias) All outcomes	High risk	Outcome assessor (an independent neurologist) was blinded but patients were not blinded
Incomplete outcome data (attrition bias) All outcomes	High risk	There were 8 dropouts in total which constituted 13% of the data and had affected the results in sensitivity analyses of best and worse‐case scenarios
Selective reporting (reporting bias)	Unclear risk	Trial protocol was not available to judge whether there was selective reporting
Other bias	Low risk	No other bias was apparent