Methods | Blinding: patients (blinding tested), study nurse Dropouts/withdrawals: bias unlikely for early follow up (8 weeks after randomization), but possible for follow-up 3 months after treatment Observation period: 3 weeks baseline; 5 weeks treatment; 3 months follow-up Acupuncturists’ assessments: GA differently/25% - BB differently/45% |
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Participants | Number of patients included/analyzed: 50/50 Condition: episodic tension-type headache (although during baseline several patients had headaches on more than half of all days) Demographics: mean age 49 years, 76% female Setting: 4 primary care practices and 1 university institute in the UK Time since onset of headaches: mean 20 years |
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Interventions | Acupuncture points: obligatory GB20 and LI4 + 4 optional, individualized points Information on acupuncturists: members of the British Medical Acupuncture Society DeChi achieved?: yes Number of treatment sessions: 8 Frequency of treatment sessions: first 6 treatments weekly, then one/month for 2 months Control intervention: sham treatment (tapping a blunted cocktail stick in a guide tube against bony prominences) |
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Outcomes | Method for outcome measurement: diary and questionnaires Main outcome measure: number of headache days Other outcomes: intensity, duration, analgesic use, General Health Questionnaire, global assessments |
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Notes | Non-traditional acupuncture technique (brief needling without needle retention) For analyses of headache frequency the data reported for headache days per week were multiplied by 4 |
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Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Yes | Computer program |
Allocation concealment? | Yes | Central telephone randomization |
Blinding? | Yes | Patients and assisting nurses were blinded. |
All outcomes | Test of blinding suggests successful blinding. | |
Incomplete outcome data addressed? All outcomes |
Yes | Low attrition rate and intention-to-treat analysis |
Free of selective reporting? | Yes | Relevant outcomes presented |
Incomplete follow-up outcome data addressed? | Unclear | 10 of 25 (acupuncture group) and 6 of 25 (sham group) patients lost to follow-up |