Wallasch 2012.
Methods | Blinding: participants (personnel doing transcranial Doppler measurement ‐ data not used for meta‐analysis) Droput/withdrawals: It seems that 5/18 acupuncture and 3/17 sham participants were excluded from analysis due to missing Doppler data Observation period: 6 weeks baseline, 8 weeks treatment, 12 weeks follow‐up Acupuncturists' assessment: BB differently/50% ‐ AW similarly/85% |
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Participants | Number of participants included/analysed: 35/27 Condition: migraine with or without aura (IHS second edition) Demographics: mean age 38 years, 31/35 participants female Setting: not reported Time since onset of headaches: mean 18 years |
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Interventions | Acupuncture points: chosen by expert consensus. 6‐10 needles used (however, the given points required a total of 22 needles; therefore a selection was used. But the text states: "the same combination of acupuncture points and mode of stimulation was used in all participants and sessions". Available points were LI4, ST36, TE5, GB41, SI3, BL62, GV20, GB20, Taiyang, TE23, LR3, KI3 Information on acupuncturists: licensed, with long experience in traditional Chinese medicine and history of practising acupuncture methodology in China. Number not stated DeChi achieved?: yes, implied once each session Number of treatment sessions: 8 of 30 minutes Frequency of treatment sessions: once weekly Control intervention: sham (superificial needling 1‐2 cm from true points) |
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Outcomes | Method for outcome measurement: headache diary, transcranial Doppler Primary outcome: unclear Other outcomes: frequency, duration and intensity of migraine/headache, function Doppler measurements |
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Notes | Study author contacted but no additional information received. The number of responders was imputed from baseline means and post‐treatment and follow‐up means and standard deviations | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | “Patients were randomly allocated” “Groups were paralleled according to age, sex, duration of migraine disorder, and headache frequency.” Unclear how this could be implemented unless all participants were included simultaneously |
Allocation concealment (selection bias) | Unclear risk | No details reported |
Blinding (performance bias and detection bias) All outcomes | Low risk | Participants were blinded for the treatment. None of the participants had received acupuncture treatment prior to the study. |
Incomplete outcome data (attrition bias) All outcomes up to 3 month after randomisation | High risk | It seems that 5/18 acupuncture and 3/17 sham participants were excluded/counted as dropouts as Doppler measurements were missing |
Incomplete follow‐up outcome data (attrition bias) All outcomes later than 3 months after randomisation | High risk | See above |
Selective reporting (reporting bias) | Unclear risk | Frequency data well reported, pain intensity not reported. Medication not mentioned |