| Methods |
Blinding: none
Dropouts/withdrawals: substantial bias possible (16 of 39 participants dropped out/not included in analysis)
Observation period: baseline 4 weeks; treatment 4‐6 weeks; follow‐up 12 weeks
Acupuncturists' assessments: GA differently/45% ‐ BB differently/40% |
| Participants |
Number of participants included/analysed: 39/23
Condition: migraine without aura (IHS)
Demographics: mean age 41 years, 82% female
Setting: Gothenburg Migraine Clinic, Sweden
Time since onset of headaches: more than 20 years on average |
| Interventions |
Acupuncture points: GB40, GB14, DU20, LI4 and ST44 in all participants + additional points selected according to symptoms
Information on acupuncturists: 1 experienced physiotherapist
DeChi achieved?: yes
Number of treatment sessions: 7‐10
Frequency of treatment sessions: 1‐2 sessions/week
Control intervention: no acupuncture
All participants received pharmacological acute treatment as before the study |
| Outcomes |
Method for outcome measurement: diary
Primary outcome: migraine days
Other outcomes: attack frequency, medication use |
| Notes |
Pilot study hardly interpretable due to very high dropout rate; one patient in the acupuncture group had no migraine days during the baseline period and 26 during follow‐up; some additional information provided by authors (M Linde and C Dahlöf). The trial originally had a third arm (relaxation) but results were not reported and are not available. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Random number list |
| Allocation concealment (selection bias) |
High risk |
Inadequate method, although bias seems unlikely (random list was openly accessible to the physician including the patient; this physician was, however, not involved further ‐ information from author) |
| 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 |
High risk |
16/39 participants (9 acupuncture, 7 control) dropped out early or could not be analysed. Detailed description, no intention‐to‐treat analysis. |
| Incomplete follow‐up outcome data (attrition bias)
All outcomes later than 3 months after randomisation |
High risk |
See above |
| Selective reporting (reporting bias) |
Low risk |
Relevant outcomes reported |
