Methods | Blinding: patients and data-collecting physician Dropouts/withdrawals: none (all patients completed the follow-up) Observation period: baseline 4 weeks; treatment 8 weeks; follow-up 12 months Acupuncturists’ assessments: GA (probably) exactly the same way/80% - BB exactly the same way/90% |
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Participants | Number of patients included/analyzed: 30/30 Condition: tension-type headache (Ad Hoc criteria) Demographics: mean age 33 years; 87% female Setting: headache outpatient department of a university hospital in Italy Time since onset of headaches: mean 8 years |
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Interventions | Acupuncture points: individualized according to traditional Chinese medicine, possibility of changing points Information on acupuncturist: n = 1 DeChi achieved?: yes Number of treatment sessions: 8 (20 minutes each) Frequency of treatment sessions: 1/week Control intervention: sham (non-acupuncture points in the same regions) |
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Outcomes | Method for outcome measurement: diary Outcomes: headache score, duration, frequency, intensity, analgesic use, response |
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Notes | Rigorous trial; acupuncture seems to be clearly better in all outcomes, but most differences are not statistically significant; surprisingly negative conclusions Number of headache days at 3 months recalculated from baseline values and percentage reduction. As no standard deviation was available, the pooled baseline standard deviation was used. Data for headache index and analgesic use extrapolated from figures. |
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Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Unclear | No description |
Allocation concealment? | Unclear | No description |
Blinding? All outcomes |
Yes | Patients and physician collecting the diaries were blinded. Description of the procedure suggests adequate blinding. |
Incomplete outcome data addressed? All outcomes |
Yes | Explicit statement that there were no losses to follow-up |
Free of selective reporting? | Yes | Relevant outcomes reported in figures or text |
Incomplete follow-up outcome data addressed? | Yes | Explicit statement that there were no losses to follow-up |