Methods | Blinding: not blinded Dropout/withdrawals: bias possible (8/31 dropouts in acupuncture, 2/31 in physiotherapy group) Observation period: baseline 3–8 weeks; treatment 2–8 weeks; follow-up 7–12 months Acupuncturists’ assessments: GA completely differently/10% - BB completely different/20% |
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Participants | Number of patients included/analyzed: 62/52 Condition: chronic tension headache (Ad Hoc) Demographics: mean age 34 years; all female Setting: hospital/outpatient department, Sweden Time since onset of headaches: mean 9 years |
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Interventions | Acupuncture points: local points: GB 20, GB 21; distal points: LI 4 Information on acupuncturists: n = 2; no further information DeChi achieved?: yes Number of treatment sessions: 4 to 10 sessions of 20 minutes each Frequency of treatment sessions: 1–2/week Control intervention: individualized physiotherapy (10–12 sessions of 30 to 45 minutes each, including relaxation, automassage, TENS, cryotherapy, coping techniques) |
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Outcomes | Method for outcome measurement: point measurement (no diary) Outcomes: visual analogue scales, Likert scales for intensity and frequency, Sickness Impact Profile, Mood Adjective Check List |
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Notes | Multiple publication; dropouts different between groups; control group got more therapy than acupuncture group Data for effect size estimation re-calculated from data presented in the publication Pain Clinic 1990 |
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Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Unclear | No description |
Allocation concealment? | Unclear | Information from author: “The randomization was done in blocks of 4. In an envelope there were 4 pieces of paper which were folded two times and signed with A for acupuncture and R for relaxation (two of each). For each patient one piece of paper was drawn ‘blinded’ until all were taken.” |
Blinding? All outcomes |
No | No blinding |
Incomplete outcome data addressed? All outcomes |
Unclear | Two patients randomized to acupuncture did not enter treatment phase. A further 6 acupuncture and 2 physiotherapy patients dropped out (reasons not related to efficacy). 23 of 31 randomized to acupuncture and 29 of 31 randomized to physiotherapy patients in analysis. Dropouts seem to have been excluded from all analyses. |
Free of selective reporting? | Unclear | No predefined outcome measure, a number of relevant measures presented in figures, others summarized in text; no indication that there was a major selection |
Incomplete follow-up outcome data addressed? | Unclear | See above |