Fenlon 2008.
| Methods | RCT comparing relaxation with no intervention | |
| Participants | This study randomly assigned 150 women to applied relaxation (n = 74) or control (n = 76). At 1 month after completion of the trial, 50 and 54 participants remained in the relaxation and control groups, respectively. At 3 months, 46 and 51 participants remained in these respective groups. However, data were expressed as median and not mean scores as in the other trials (Freedman 1992; Nedstrand 2005a; Zarobowska 2007). 150 women with natural menopause aged 36 to 77 years. 61 women were in the relaxation group and 64 were in the control group. Post menopause was defined as 6 months without menstruation. Participants had primary breast cancer and were suffering from troublesome hot flushes. Women taking oestrogen, aromatase inhibitors or other hormone therapies, except tamoxifen, were excluded | |
| Interventions | Applied relaxation in the treatment arm. Controls received general discussion on menopause management and advice about lifestyle measures to improve health, such as diet, exercise, vaginal moisturisers and stress reduction | |
| Outcomes | Frequency and severity of hot flushes (reported as median and median difference) Hunter menopause scale to measure distress caused by flashes, quality of life using Functional Assessment of Cancer Therapy with the endocrine subscale (FACT‐ES) and anxiety by the Spielberg State/Trait Anxiety Index (STAI) Outcomes were assessed at 1 and 3 months after treatment |
|
| Notes | 150 randomly assigned; 125 participated at day 0 (start of relaxation treatment) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | An independent trials office was responsible for randomisation, using a computer‐generated randomisation list |
| Allocation concealment (selection bias) | Unclear risk | The recruiting nurse did not have access to the randomisation list. Allocation was made by a telephone call to an independent trial office |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No information given |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information given |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Of 74, 46 women were randomly assigned/analysed to the relaxation group, and of 76, 51 women were randomly assigned/analysed to the control group. Reasons given for dropping out were “not like the diary,” flushes stopped, reminder of cancer, illness, no time for relaxation practice, family reasons and no reason given |
| Selective reporting (reporting bias) | Low risk | Outcomes were prospectively measured, using appropriate measuring instruments. All outcomes were reported |
| Other bias | Low risk | Appeared to be free from other sources of bias |