Skip to main content
. 2018 Jan 29;2018(1):CD011292. doi: 10.1002/14651858.CD011292.pub2

Carson 2009.

Methods Study design: single‐centre RCT
Number randomised: 37; 17 to intervention, 20 to control
Study start: June 2005; stop date: October 2006
Length of intervention: 8 weeks
Length of follow‐up: at 8 weeks, at 3 months
Country: USA
Participants Age, years (mean SD):
  • Intervention: 53.9 (9.0)

  • Control: 54.9 (6.2)


Stage, n (%):
  • Intervention: stage IA, 7 (41.2); stage IIA, 5 (29.4); stage IIB, 5 (29.4)

  • Control: stage IA, 8 (40.0); stage IIA, 6 (30.0); stage IIB, 6 (30.0)


Inclusion criteria:
• At least 1 hot flash per day on 4 or more days per week
• No signs of active breast cancer
• No current cytotoxic chemotherapy
• Diagnosis of breast cancer at stage IA‐IIB ≥ 2 years before
• No hormone replacement therapy currently or within prior 3 months
• Stabilised on a constant regimen of menopausal symptom medications and supplements for at least 3 weeks
• Taking antidepressants, stabilised at a fixed dose for at least 3 months
Exclusion criteria:
• Resided > 70 miles from the research site and thus were less likely to attend intervention sessions
• Unavailable to attend the intervention on the day and at the time offered (most yoga groups were scheduled so as to be accessible to women holding full‐time day jobs)
• Currently engaged in intensive yoga practice (> 3 days/week)
• Received treatment for serious psychiatric disorders (e.g. schizophrenia) in the previous 6 months
• Not English speaking
Interventions 17 participants assigned to exercise intervention:
  • Yoga of Awareness including yoga postures, breathing techniques, meditation, study of pertinent topics, group discussion. Once per week (participants were encouraged to spend time practicing yoga strategies daily at home, but actual adherence to this was not reported) for a duration of 40 minutes over 8 weeks


Adherence:
On average, participants attended 6 of the 8 classes (range 0 to 8). Only 3 women attended < 4 classes. Adherence to daily yoga practice, average 30 minutes/d at post and 16 minutes at 3 months
Control group: 20 assigned to control:
  • Wait‐list

Outcomes Treatment outcomes. assessed via a brief daily diary measurement strategy
  • Daily menopausal symptoms on 0 to 9 scales in which higher scores reflected greater amounts, common menopausal symptoms across the preceding 24 hours: hot flash frequency, hot flash severity, joint pain, fatigue, negative mood, sleep disturbance, night sweats, and bother (menopausal symptom‐related distress). Primary outcome of hot flash total scores was computed as frequency × severity.

  • With 0 to 9 scales in which higher scores reflected greater amounts, 3 therapeutic processes targeted by the Yoga of Awareness programme—relaxation, vigour, and acceptance—were assessed by telephone voice system diaries.

  • Minutes spent in daily yoga practice (post and follow‐up assessments only)


Numbers of participants assessed:
  • Intervention: n = 17 at baseline, n = 13 at 8 weeks, n = 13 at 3 months

  • Control: n = 20 at baseline, n = 17 at 8 weeks, n = 17 at 3 months


Adverse events: not reported
Notes Trial registration link: none available
Trial authors contacted: yes, for means and SDs for outcomes. However, trial authors did not provide these data.
Intention‐to‐treat analysis: no
Funding: Susan G. Komen Breast Cancer Foundation
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random number table was used.
Allocation concealment (selection bias) High risk "Concealed in envelopes"; sequential sequencing or opaque envelopes were not mentioned.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Owing to the nature of the intervention, it was not possible to blind participants; however, it is unclear whether the outcome was influenced by lack of masking.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Research assistant collecting assessment data was kept blind with regard to participant condition assignments.
Incomplete outcome data (attrition bias) 
 All outcomes High risk No ITT, and no mention of how missing data were handled. 8 participants did not complete the intervention.
Selective reporting (reporting bias) Low risk No selective reporting of outcomes is apparent.
Other bias Low risk Trial appears to be free of other problems that could put it at high risk of bias.