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

Frisk 2008.

Methods Randomized, controlled study, part of the multicentre study HABITS (Hormonal replacement therapy After Breast cancer ‐ is IT Safe?). 2 groups: EA and HT
Participants 45 postmenopausal women having previously completed treatment for breast cancer in situ, T1 and T2 tumours with 4 or fewer lymph nodes positive for metastasis, T3 tumours without metastasis; having no clinical or mammographic signs of recurrence; having vasomotor symptoms needing treatment according to the woman herself
Women planning surgery, chemotherapy, radiotherapy, immunotherapy; having initiated or ceased HT during the trial or within 3 weeks before the trial; taking pharmacological treatment of hot flushes; using of SSRIs (unless dose remained stable for 4 weeks prior to study); having skin infection; having received acupuncture treatment in the 6 weeks prior to study; and having received acupuncture specifically for the treatment of hot flushes in the previous 6 months were excluded
"The women were referred from breast surgeons or oncologists because they suffered from breast cancer and vasomotor symptoms severe enough to merit therapy"
Setting: this study was part of an international, multicentre study, HABITS, involving women from 3 centres in Sweden (Kalmar, Linkoping, Norrkoping). EA treatments were given both at hospitals and private practices
Interventions EA:
30‐minute treatment given by 6 different physiotherapists educated and experienced in acupuncture for 12 weeks (twice per week for the first 2 weeks and once a week for 10 other weeks). Physiotherapists were instructed orally and in writing about the acupuncture points. Participants received EA at 2 Hz in 4 and 'classical acupuncture' in 8 of the acupuncture points: UB 15, 23, 32 (bilateral) and GV 20, H7, P6, LIV 3, SP6, SP9 (unilateral). The needles were inserted and rotated to elicit the sensation Teh Chi. At depths of 1.25‐2.5 cm this sensation was usually obtained. The procedure used was according to TCM acupuncture
HT:
There were 3 options for this treatment: women less than 2 years after menopause were given a sequential oestrogen/progestogen combination; women more than 2 years after menopause were given continuous combined oestrogen/progestogen; and post‐hysterectomy women received unopposed oestrogen. The treatment was given over 24 months
Outcomes
  • Number of hot flushes during day and night using logbook

  • Times of assessment of the main outcomes: at baseline, at the 12th week of treatment, and 1 week at 6, 9, 12, 18 and 24 months after start of treatment

  • Climacteric symptoms using modified version of the Kupperman's Index

Source of funding The country Council of Ostergotland
Notes Follow‐up (for EA): 24 months (after start of treatment)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "The computerized randomization in blocks of eight for the HABITS study occurred at the University of Uppsala"
"In all, 27 women were randomised to non‐hormonal and 18 to hormonal treatment; the groups were uneven because the three centres did not filled each of their block"
Allocation concealment (selection bias) Unclear risk Method not reported
Blinding (performance bias and detection bias) 
 All outcomes High risk Quote of author: "So, the patients knew which treatment (pills of HT or acupuncture) they were getting. All women, no matter if they were offered HT or acupuncture, chose to start the treatment they were randomized to"
Incomplete outcome data (attrition bias) 
 All outcomes High risk Quote: "Missing data were completed in the log books and for the KI, by taking the mean of the previous and the following measurements for that specific patient (logbook data in 8 cases (3%), when including women with another period of acupuncture in 12 cases (5%), KI data in 3 cases (1%), when including women with another period of acupuncture in 6 cases (3%))"
Quote: "By the end of the study, 12/23 (52%) had asked for no other treatment than EA for 24 months." Therefore, 47.8% dropout for the EA group at 24 months
Quote: "Eleven out of 18 women completed 24 months of HT." Therefore, 38.9% of dropouts for the HT
An ITT approach was used to conducted the analyses
High dropout rate during treatment
Reasons for dropouts are reported
Selective reporting (reporting bias) Low risk The published report included all expected outcomes. However, the number of hot flushes per 24 h, as well as the Kupperman index score, was reported as mean changes and medians. The author provided the data for the 12 weeks for hot flushes frequency and severity for both groups
No table for distress and not much detail for HT group (distress, number...)
Other bias Low risk The study appeared free of other sources of bias