Kim 2010.
Methods | Multicentre, randomized, controlled trial. 2 groups: acupuncture plus UC and UC alone | |
Participants | 175 peri‐ and postmenopausal women aged 45‐60 years having a mean daily hot flush scores (daily frequency x severity) of 10 or higher for 1 week before screening visit Perimenopausal was defined as menstrual irregularity or amenorrhoea of 3‐11 months and postmenopausal as 1 of the following: 12 months of spontaneous amenorrhoea; 6 months of spontaneous amenorrhoea with FSH levels > 40 mIU/mL; 6 weeks' postsurgical bilateral oophorectomy with or without hysterectomy; or hysterectomy with at least 1 intact ovary Women were excluded if they had uncontrolled hypertension, diabetes mellitus, required insulin injections, any type of thyroid dysfunction, past or present malignant tumours, severe dyslipidaemia, other infectious diseases, or systemic diseases, and if they were using hormones, antidepressants, gabapentin, SSRIs, or sedatives Women were recruited through local newspaper advertisements, hospital postings, and notification in the community meeting Setting: Kang‐nam Kyung Hee Oriental Medical Center (Seoul), Dongguk International Hospital (Ilsan), Semyung University Hospital (Jecheon), Dong‐Eui Medical Center (Busan), Korea |
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Interventions | Acupuncture plus UC: Treatments were given by TKM physicians registered by the government with 3 years of clinical experience, 3 times per week for 4 consecutive weeks. Acupuncture points were selected according to recommendations of TKM clinical experts and are ST36, SP6, LI4, PC6, HT7, HT8, and CV4 and the 'De Qui' sensation were the elicited response. Needles were inserted 3‐15 mm depending on the point selected, remained in place for 20 minutes, and were manipulated manually (intermittently). Needles used were 40 x 0.25 mm. Participants and physicians could communicate freely about participant's symptoms and general conditions Follow‐up at weeks 6 and 8. UC consisted of the use of non‐prescription drugs for episodic or minor symptoms that were not related to hot flushes or supplements (including evening primrose oil, phyto‐oestrogens, omega‐3 fatty acids, calcium, and vitamins. UC: UC alone group received no acupuncture treatment for the 4‐week study period and could use non‐prescription drugs for episodic or minor symptoms that were not related to hot flushes or supplements (including evening primrose oil, phyto‐oestrogens, omega‐3 fatty acids, calcium, and vitamins Additional acupuncture treatment, herb prescriptions, or therapeutic interventions by another TKM physician were not allowed during the treatment period for both groups Follow‐up at weeks 6 and 8 |
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Outcomes | Primary outcome:
Secondary outcome:
Timing of assessment of the main outcome: at baseline, and at week 1, 2, 3, 4, 6, and 8 after randomization |
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Source of funding | Acupuncture, Moxibustion, and Meridian Research Project (K09050) of the Korean Institute of Oriental Medicine | |
Notes | Follow‐up: 2 weeks (after completion of treatment, i.e. weeks 6 and 8) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "A separate randomization sequence was computer generated at the central coordinating centre and provided for each local treatment centre" |
Allocation concealment (selection bias) | Unclear risk | Method not reported |
Blinding (performance bias and detection bias) All outcomes | High risk | Quote: "This was an open trial, so patient blinding was unavailable. We failed to blind the assessor to assignment of patient. Instead, all outcomes were self‐administered by patients, and the researcher who was separated from the treatment procedure collected the data. Data were sent to the central research centre, and personal who were independent of this study entered the data" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Missing outcome data are not balanced across intervention groups (acupuncture plus UC, dropouts 7%; UC, dropouts 19%) and reasons for missing data differ Analyses were conducted with an ITT approach Missing data were replaced with the last observation value |
Selective reporting (reporting bias) | Low risk | This study appeared free from selective reporting |
Other bias | Low risk | This study appeared free from other bias |