Jena 2008.
| Methods | 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; in addition the trial observed 11,874 non‐randomized participants receiving acupuncture Observation period: no baseline period; treatment 3 months; no follow‐up (for randomized comparison) Acupuncturists' assessments: GA can't tell ‐ AW can't tell | |
| Participants | Number of participants included/analysed: 3182/2935 with migraine or tension‐type headache (TTH) (of those included 1715 with migraine, 167 with migraine and TTH, no information on numbers of migraine participants analysed) Condition: migraine and/or TTH (IHS) Demographics: mean age 44 years, 77% female (for total group) Setting: 4686 practices in Germany Time since onset of headaches: 10.8 years (for total group) | |
| Interventions | Acupuncture points: not documented (acupuncturists were free to treat outside the trial in routine acupuncture practice) Information on acupuncturists: at least 140 hours acupuncture training DeChi achieved?: no information Number of treatment sessions: up to a maximum of 15 (mean 10) Frequency of treatment sessions: individualized Control intervention: waiting list received "usual care" (without acupuncture) | |
| Outcomes | Method for outcome measurement: questionnaires, no diary Primary outcome: headache days in the third month Other outcomes: pain intensity, quality of life | |
| Notes | Large, very pragmatic study including both participants with migraine and TTH; 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. Study authors provided raw means, standard deviations and number of observations for headache days and headache intensity for participants suffering from migraine Data for headache days and response at 3 months 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 randomisation |
| Blinding (performance bias and detection bias) All outcomes | High risk | No blinding |
| Incomplete outcome data (attrition bias) All outcomes up to 3 month after randomisation | Low risk | 1711 participants were allocated to acupuncture and 1693 to control, but consent forms were available for only 1613 and 1569, respectively; baseline questionnaires were available for 1572 and 1522 (all numbers refer to both participants with migraine and participants with TTH). 3‐month data were available for 1479 and 1456 participants. Sensitivity analyses with replacing missing values confirmed main analyses |
| Incomplete follow‐up outcome data (attrition bias) All outcomes later than 3 months after randomisation | Unclear risk | Not applicable ‐ participants in the waiting list group received acupuncture after 3 months. While all participants were followed for six months this was no longer a randomized comparison of two treatments |
| Selective reporting (reporting bias) | Low risk | Limited outcome measurement. Data on relevant outcomes for migraine subgroup provided by study authors |