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. 2013 Jul 30;2013(7):CD007410. doi: 10.1002/14651858.CD007410.pub2

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
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
Outcomes Primary outcome:
  • mean reduction in mean 24‐h hot flush score using a self report diary from baseline to week 4


Secondary outcome:
  • mean reduction in menopause‐related symptoms using the MRS


Timing of assessment of the main outcome: at baseline, and at week 1, 2, 3, 4, 6, and 8 after randomization
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