Melchart 2005

Methods	Blinding: patients, diary evaluators Dropouts/withdrawals: major bias unlikely Observation period: baseline 4 weeks; treatment 8 weeks; follow-up 12 weeks Acupuncturists’ assessments: AW similarly/60% - GA exactly as in the study/95%
Participants	Number of patients included/analyzed: 270/234 Condition: episodic and chronic tension-type headache (IHS) Demographics: mean age 43 years, 74% female Setting: 28 primary care practices in Germany Time since onset of headaches: mean 14.5 years
Interventions	Acupuncture points: in all patients GB20, GB21 and LIV3, additional optional points recommended according to symptoms Information on acupuncturists: n = 42, at least 160 hs of training DeChi achieved?: yes Number of treatment sessions: 12 Frequency of treatment sessions: 2/week for four weeks, then 1/week for 4 weeks Control intervention 1: minimal acupuncture (superficial needling at non-acupuncture points) Control 2: no acupuncture waiting list group (patients only treated acute headaches with analgesics and received acupuncture 12 weeks after randomization)
Outcomes	Method for outcome measurement: diary and pain questionnaires Main outcome measure: difference in the number of headache days between baseline and weeks 9 to 12 Other outcomes: headache days, intensity, analgesic use, duration, headache score, global intensity rating, quality of life (SF-36), depressive symptoms (CES-D), emotional aspects of pain (SES), disability (PDI)
Notes	Additional information for effect size calculation taken from unpublished study report (response, number of headache days, analgesic use and headache score in weeks 5 to 8)
Risk of bias
Item	Authors’ judgement	Description
Adequate sequence generation?	Yes	Computer program
Allocation concealment?	Yes	Central telephone randomization
Blinding? All outcomes	Yes	Patients and diary evaluators were blinded for comparison with sham. Patients were informed that two different types of acupuncture were compared. Early tests of blinding indicate successful blinding, but at follow-up guesses of allocation status were different between groups (P = 0.08). Comparison with no treatment not blinded.
Incomplete outcome data addressed? All outcomes	Yes	Low attrition rate and intention-to-treat analyses
Free of selective reporting?	Unclear	Detailed presentation of main results
Incomplete follow-up outcome data addressed?	Yes	Low attrition rate and intention-to-treat analyses