| Methods |
Blinding: participants
Dropouts/withdrawals: unclear
Observation period: baseline 6 weeks; treatment 8 weeks; follow‐up 12 months
Acupuncturists' assessments: GA exactly the same way/95% ‐ BB differently/45% |
| Participants |
Number of participants included/analysed: 41?/41?
Condition: migraine with or without aura (IHS)
Demographics: mean age 38 years; 90% female
Setting: pain outpatient department of a university hospital, Germany
Time since onset of headaches: mean 18 years |
| Interventions |
Acupuncture points: up to 10 points chosen according to pain localization and modalities
Information on acupuncturist: n = 1, experienced and qualified
DeChi achieved?: yes
Number of treatment sessions: 8 sessions of 15 minutes each
Frequency of treatment sessions: 1/week
Control intervention: sham acupuncture (superficial needling 1‐2 cm distant from true points) |
| Outcomes |
Method for outcome measurement: diary
Primary outcomes: attack frequency and migraine hours
(data mainly presented as responder rate evaluated by time‐series analysis) |
| Notes |
Possibly rigorous, but insufficiently reported (in spite of multiple publication); no information on whether there were dropouts/withdrawals; replication of Weinschütz 1993 (with additional needling of foot points) |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
No description |
| Allocation concealment (selection bias) |
Unclear risk |
No description |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Participants were blinded, sham acupuncture with superficial needling of the same number of needles 1‐2 cm from true points without DeChi |
| Incomplete outcome data (attrition bias)
All outcomes up to 3 month after randomisation |
Unclear risk |
No statements on whether any attrition or exclusions from analyses occurred |
| Incomplete follow‐up outcome data (attrition bias)
All outcomes later than 3 months after randomisation |
Unclear risk |
See above |
| Selective reporting (reporting bias) |
High risk |
Only responder data derived from single‐case statistics reported |
