Avis 2008.

Methods	2‐site clinical trial using 3‐arm prospective, randomized, single‐blind, sham‐control design; UC, SA, and TA
Participants	37 perimenopausal or postmenopausal women aged 42‐55 years experiencing at least 4 moderate‐to‐severe hot flushes per day and not having used HT, a selective oestrogen‐receptor modulator, an aromatase inhibitor, clonidine, Bellergal, antidepressant therapy, or gabapentin in the past 12 weeks; not having received chemotherapy; not having used acupuncture for any reason within the past 4 weeks; not having any previous acupuncture treatment for hot flushes; having no significant psychiatric disorder and untreated thyroid disease; not having been diagnosed with bleeding or clotting problem other than heavy periods; not currently taking any prescribed medications that increase the risk of bleeding (warfarin, enoxaparin, or clopidogrel) Setting: Massachusetts General Hospital and University of North Carolina. Women were recruited through newspaper advertisements, radio announcements, and hospital postings
Interventions	TA: 30‐minutes, standardized and individualized treatment according to TCM designed to tone or reinforce the kidney essence, balance yin/yang, and control hot flushes and night sweats, 2 times per week for 8 weeks. Treatments were given by experienced acupuncturists trained in TCM. No more than 16 acupuncture points were needled during any treatment. The 'De Qui' sensation was the elicited response. Type of needle used: Vinco 34‐gauge, 1‐inch (0.22 x 25 mm) and 30‐gauge, 1.5‐inch (0.30 x 40 m). Acupuncture points for the standardized treatment were CV 4, KI 3 (bilateral), SP 6(bilateral), BL 23(bilateral), HT 6 (bilateral), and KI 7 (bilateral), and the possible additional points (based on a person’s TCM diagnostic category or based on acupuncturist clinical judgement were KI 6, KI 10, GV 4, GV 20, CV 6, CV 15, BL 15, BL 18, BL 52, LR 3, LR 8, GB 13, GB 20, PC 7, HT 7, HT 8, yintang and taiyang SA: 30‐minutes treatment 2 times per week for 8 weeks were given by experienced acupuncturists trained in TCM. Non‐acupuncture points sites (sites where minimal effects on hot flushes) were needled shallowly, without attempting to elicit the 'De Qui' sensation. 12 needles were inserted, 6 on both side of the body (right and left). Point locations were: 3.5 cun below GB‐34; mid‐way between GB and BL channels; 2 cun above the lateral malleolus; 3 cun lateral to the navel; in the depression proximal to the metacarpal‐phalangeal joint between the index and middle fingers; approximately 1‐1.5 inches above or proximal to the third and fourth toe web space between the third and fourth metatarsals; and 3 cun lateral to the lower border of the spinous process of the fourth lumbar vertebra UC: There had been no initiation of treatment for their hot flushes for 2 months, but participants could continue with any non‐pharmacological treatment they were currently using
Outcomes	Primary outcomes: frequency of hot flushes using a daily diary severity of hot flushes using a daily diary times of assessment of the main outcomes: at baseline, every week during the 8‐week treatment, and at the end of treatment (week 8) Secondary outcomes: hot flushes interference using the 10‐item Hot Flash Related Daily Interference Scale sleep quality using the Women's Health Initiative Insomnia Rating Scale (6‐item scale) how bothersome symptoms were using the Menopause‐specific Quality of Life Questionnaire mood using the Psychological General Well‐Being Index health‐related quality of life using a 100‐mm VAS (from 0 to 100) and the Medical Outcomes Study 36‐Item Short Form Health Survey
Source of funding	National Cancer Institute, Massachusetts General Hospital, National Institutes of Health, National Center for Research Resources, General Clinical Research Centers Program, University of North Carolina at the Verne S. Caviness General Clinical Research Center at UNC School of Medicine
Notes	Follow‐up: 8 weeks (after completion of treatment)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Treatment assignment was generated using a randomisation computer program and a computer file was kept at each clinic with their respective randomisation list. The acupuncturist accessed it from his/her PC and a paper copy of the randomisation assignments was kept at each clinical centre and by the Biostatistics and Data Management group at Wake Forest University for easy access in case of computer malfunction" (from the author)
Allocation concealment (selection bias)	Low risk	"The study coordinator and/or other personnel administering the questionnaires did not have access to the randomisation list to remain masked"
Blinding (performance bias and detection bias) All outcomes	Low risk	Quote: "Study staff who administered questionnaires were blinded to which form of acupuncture that the women received" "The acupuncturists were blinded to the participant's treatment group until after making the TCM diagnosis"
Incomplete outcome data (attrition bias) All outcomes	High risk	Quote: "Study retention was excellent with all women remaining in the study. However, not all women completed all study procedures. Eight (42%) of the women in the TA group and 10 (56%) in the SA group completed at least (80%) of the 16 treatments. Furthermore, two women in the UC group did not complete any follow‐up diaries, one in the SA group, and three in the TA group" Nothing reported about reasons for treatment withdrawal/not completing all study procedures Analyses were conducted with an ITT approach Nothing mentioned about imputation method
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