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 |
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| Participants | Age, years (mean SD):
Stage, n (%):
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 |
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| Interventions | 17 participants assigned to exercise intervention:
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:
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| Outcomes | Treatment outcomes. assessed via a brief daily diary measurement strategy
Numbers of participants assessed:
Adverse events: not reported |
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| 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 |
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| 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. |