Kim 2011.
Methods | Randomized, single‐blind study of perimenopausal or postmenopausal women with moderate or severe hot flushes. 2 groups: TKM acupuncture and SA | |
Participants | 54 perimenopausal and postmenopausal women (no menstruation for at least 3 months) having desired to receive treatment for hot flushes and complaining of moderate (able to continue activities) and severe hot flushes (not able to continue activities) Women taking medication for hot flushes within the 8 weeks prior to the study; history of cancer within 5 years; having total hysterectomy and serious endocrine or vascular disorders; suffering from psychological problems; and having medical conditions such as uncontrolled hypertension, diabetes mellitus or vaginal bleeding of unknown origin within 6 weeks were excluded Setting: The Dongguk University Ilsan Korean Medicine Hospital in South Korea |
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Interventions | TKM acupuncture: 20‐minute treatments were given for 7 consecutive weeks (twice per week the 4 first weeks and once per week the remaining 3 weeks) by a traditional Korean medicine doctor (the same for both TA and SA group) having more than 4 years of clinical experience and certified by the Korean Ministry of Health and Welfare. 13 needles (0.30 mm) were inserted 0.2‐10 mm deep at 7 points and manually stimulated. The 'de qi' sensation was the elicited response SA: 20‐minute treatments were given for 7 consecutive weeks (twice per week the 4 first weeks and once per week the remaining 3 weeks) by a TKM doctor (the same for both TA and SA group) having more than 4 years of clinical experience and certified by the Korean Ministry of Health and Welfare. 12 needles (identical to TA group) were inserted on 7 predefined non‐acupuncture points without stimulation, to not elicit the 'de qi' sensation For both groups, all participants were in a separate room with an eye bandage and no patient‐practitioner communication was allowed |
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Outcomes |
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Source of funding | The Korean Institute of Oriental Medicine | |
Notes | Follow‐up: 15 weeks (8 weeks after completion of treatment) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Random allocation software V1.0 (Department of Anaesthesia, Isfanhan University of Medical Science) was used to randomise patients into two groups. A block size of 4 was used" |
Allocation concealment (selection bias) | Unclear risk | Quote: "The allocation of each patient was concealed by placing each random code in an opaque, sealed envelope. These envelopes were opened after the enrolment of the patient" Comments: not mentioned if the envelopes were sequentially numbered |
Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "Patients were blinded to the type of acupuncture received. All participants were in a separate room with an eye bandage and no‐patient‐practitioner communication was allowed" "All data was collected by a blinded assessor" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Few dropouts and lost of follow‐up (TA, 2 women; SA, 4 women). An ITT approach was used to conduct the analyses |
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 |