Vincent 2007.
Methods | Prospective, randomized, single‐blind, sham‐controlled trial. 2 groups: medical acupuncture and SA | |
Participants | 103 perimenopausal (3 or more months of self reported menstrual irregularity or amenorrhoea) and postmenopausal (amenorrhoea for 12 or more months) women aged 45‐59 years and experiencing a mean of 5 or more hot flushes per day. Women using oestrogen, soy, progesterone, vitamin E, or black cohosh; using non‐prescription drugs, gabapentin, or antidepressants specifically for the treatment of hot flushes within the previous month; using warfarin; having skin disorders with skin breakdown such as eczema or psoriasis; having a pacemaker or prosthetic joints; having active chemotherapy; and suffering of diabetic neuropathy were excluded Setting: Mayo Clinic General Clinical Research Center, US |
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Interventions | Medical acupuncture: Treatments were given twice per week for 5 weeks by an acupuncturist (the same for both medical and SA) licensed by the Minnesota Board of Medical Practice and having 5000 h of experience. The needling was administered in 12 acupuncture points (SP4 unilateral, SP6 bilateral, He7 bilateral, Ll11 bilateral, Liv2 bilateral, Ki6 unilateral, LU7 unilateral right, PC6 unilateral left, GB34 bilateral, Liv3 bilateral, Ren4, GB20 bilateral). Needles were inserted 0.5‐3 cm into the skin, and the 'De qui' sensation was the elicited response Follow‐up: 7 weeks SA: Needling administered in non‐acupuncture, non‐meridian areas, whenever possible 5 cm or more away from the actual acupuncture point. Treatments were given twice a week for 5 weeks Follow‐up: 7 weeks |
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Outcomes | Primary: daily hot flush score (frequency x severity) using a diary Timing of assessment: at baseline, and every week for the 5‐week treatment and for the 7‐week follow‐up period |
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Source of funding | Mayo Foundation Award | |
Notes | Follow‐up: 7 weeks (after completion of treatment) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Participants were randomized to medical or sham acupuncture using a stratified randomization schedule. Stratification was done using menopausal status to ensure equal distribution of peri‐ and postmenopausal women among the two groups. A blocked size of four was used" |
Allocation concealment (selection bias) | Unclear risk | Method not reported |
Blinding (performance bias and detection bias) All outcomes | Low risk | Quote (from the author): "Patients were blinded to the group assignment. We also did not include any patients who had previous acupuncture so they would not know if it was actual or sham acupuncture. We did not blind the investigators" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Dropout rate was about 10% (SA: 13%; medical acupuncture: 10%) Reasons for attrition were reported (not related to true outcome) Quote: "The last observation carried forward was used for imputing missing data per an intention‐to‐treat model" |
Selective reporting (reporting bias) | Low risk | The published report included all expected outcomes |
Other bias | Low risk | The study appeared free of other sources of bias |