Jena 2008

Methods	Sequence generation: computer program (information from author) Concealment: central telephone randomization (information from author) Blinding: none Dropouts/withdrawals: 1479 of 1613 included in the acupuncture group with 3 month data vs. 1456 of 1569 in the control group; sensitivity analyses with missing values replaced confirm main analysis based on available data Observation period: no baseline period; treatment 3 months; no follow-up (for randomized comparison) Acupuncturists’ assessments: GA insufficient information for an assessment - BB ?
Participants	Number of patients included/analyzed: 3182/2935 with migraine or TTH (of those included 1265 with TTH, no information on numbers of TTH patients analyzed) Condition: migraine and/or tension-type headache (IHS) Demographics: mean age 44 years, 77% female (for total group) Setting: several thousand practices in Germany Time since onset of headaches: 10.8 years (for total group)
Interventions	Acupuncture points: individualized selection Information on acupuncturists: multiple physicians with at least 140 hours acupuncture training DeChi achieved?: no information Number of treatment sessions: up to a maximum of 15 Frequency of treatment sessions: individualized Control intervention: waiting list receiving “usual care”
Outcomes	Method for outcome measurement: questionnaires, no diary Primary outcome: headache days in the third month Other outcomes: intensity, quality of life
Notes	Large, very pragmatic study including both patients with migraine and tension-type headache reporting some outcomes for headache subgroups; treating physicians were completely free to choose points, number of sessions (upper limit allowed 15) etc. Unclear what usual care consisted of. Some diagnostic misclassification likely. Authors provided raw means, standard deviations and number of observations for headache days and headache intensity.
Risk of bias
Item	Authors’ judgement	Description
Adequate sequence generation?	Yes	Computer program
Allocation concealment?	Yes	Central telephone randomization
Blinding? All outcomes	No	No blinding
Incomplete outcome data addressed? All outcomes	Yes	Low attrition rate and sensitivity analyses with replacing missing values confirming main analyses
Free of selective reporting?	Yes	Limited outcome measurement. Data on relevant outcomes for the subgroup of patients suffering from tension-type headache provided by authors
Incomplete follow-up outcome data addressed?	Unclear	No randomized comparison after 3 months