Linde K 2005.
| Methods | Blinding: participants, diary evaluators Dropouts/withdrawals: major bias unlikely Observation period: baseline 4 weeks; treatment 8 weeks; follow‐up 16 weeks Acupuncturists' assessments: AW similarly/80% ‐ GA exactly as in the study/90% | |
| Participants | Number of participants included/analysed: 302/302 Condition: Migraine (IHS) Demographics: mean age 43 years, 88% female Setting: 18 primary care practices in Germany Time since onset of headaches: mean 20 years | |
| Interventions | Acupuncture points: in all participants recommended GB20, GB40 or 41 or 42, DU20, LIV3, SJ3 or 5, Taiyang; additional optional points recommended according to individual symptoms Information on acupuncturists: n = 30, at least 160 h of training DeChi achieved?: yes Number of treatment sessions: 12 of 30 minutes Frequency of treatment sessions: 2/week for 4 weeks, then 1/week for 4 weeks Control intervention: minimal acupuncture (superficial needling at non‐acupuncture points) Control 2: waiting list (attack treatment only) for 12 weeks | |
| Outcomes | Method for outcome measurement: diary and pain questionnaire Primary outcome: number of days with moderate or severe headache in weeks 9‐12 Other outcomes: migraine days, attacks, headache days; days with nausea, vomiting, disability, analgesics, headache score, intensity; quality of life, pain disability, depressive symptoms | |
| Notes | Additional information from unpublished study report used for 8‐week data, migraine days and headache scores. Data for number of days with moderate or severe headache, migraine days, and response in weeks 5‐8, 9‐12 and 21‐24 used for meta‐analysis in this review were obtained from individual patient data re‐analysis within the Acupuncture Trialists Collaboration (see section Data Collection and Analysis) |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer program |
| Allocation concealment (selection bias) | Low risk | Central telephone procedure |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Participants and diary evaluators were blinded for the comparison with sham acupuncture. Participants 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 (although the sham group reported slightly better outcomes). Overall we considered the risk of bias low. Comparison with no treatment waiting list not blinded (high risk of bias) |
| Incomplete outcome data (attrition bias) All outcomes up to 3 month after randomisation | Low risk | Low attrition and intention‐to‐treat analysis |
| Incomplete follow‐up outcome data (attrition bias) All outcomes later than 3 months after randomisation | Low risk | Low attrition and intention‐to‐treat analysis |
| Selective reporting (reporting bias) | Low risk | Relevant outcomes reported and additional data available for analyses |