| Methods |
Blinding: participants, research assistants, neurologist; blinding tested and successful
Dropout/withdrawals: substantial bias is unlikely in the first 3 months, but it cannot be ruled out for late follow‐up (< 10% attrition (3/31) in the first 3 months, 5/31 until end of month 5, 7 /31 until end of month 9; similar rates in both groups; no intention‐to‐treat analysis)
Observation period: 4 weeks baseline, 12 weeks treatment, 24 weeks follow‐up
Acupuncturists' assessments: GA similarly/70% ‐ BB differently/60% |
| Participants |
Number of participants included/analysed: 31/28
Condition: migraine with or without aura (IHS 1988)
Demographics: mean age 32.5 (acupuncture) and 39.1 (sham) years, 79% female
Setting: outpatient headache clinic of a neurology department of State University of Campinas, Brazil
Time since onset of headaches: mean 16.9 (acupuncture) and 20.0 (sham) years |
| Interventions |
Acupuncture points: semi‐standardized point selection (GB12/20/21 and BL10 in all participants + individualized additional points from a selection); point selection for a participant was not changed over treatment sessions
Information on acupuncturists: 1 acupuncturist trained in Spain and 12 years of practical experience (information from author)
De‐Chi achieved?: yes
Number of sessions: 16 (30 min each)
Frequency of treatment sessions: 2/week for first 4 weeks, then 1/week for 8 weeks
Control intervention: sham (superficial needling without manipulation at non‐indicated points Ex‐B1, SJ17/20, Sp7, St37, Lu5) |
| Outcomes |
Method for outcome measurement: diary
Primary outcomes: at least 40% reduction in attack frequency, at least 50% attack reduction and total migraine days during treatment period
Other outcomes: frequency of migraine attacks, duration of attacks, severity, migraine hours, rescue medication, nausea and vomiting frequency |
| Notes |
Rigorous but small trial; selection of existing acupuncture points in the sham group problematic
Authors provided additional information on methods and data for effect size calculations (50% response rates, migraine days, attacks, rescue medication use) |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
"Random digits (reference 14) were used to define the sequence" |
| Allocation concealment (selection bias) |
Low risk |
Opaque, numbered and sealed envelopes |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Participants blinded; test of blinding suggests successful blinding |
| Incomplete outcome data (attrition bias)
All outcomes up to 3 month after randomisation |
Low risk |
Low attrition unlikely to cause major bias: 3 of 31 participants (2 of 16 acupuncture, 1 of 15 sham) did not complete the 12‐week treatment phase |
| Incomplete follow‐up outcome data (attrition bias)
All outcomes later than 3 months after randomisation |
Unclear risk |
13 participants in both groups at 2 month follow‐up after treatment (5 months after randomisation) and 12 in both groups at 6 months after treatment (9 months after randomisation); no intention‐to‐treat analysis |
| Selective reporting (reporting bias) |
Low risk |
Relevant outcomes described in publication and additional data provided on request |
