The Institute of Rehabilitation, University of Hull, Kingston upon Hull, UK.
Eur J Cancer. 2010 Jan;46(2):312-22. doi: 10.1016/j.ejca.2009.10.006. Epub 2009 Nov 10.
To conduct a pragmatic randomised controlled trial (RCT) to evaluate the effects of reflexology on quality of life (QofL) in women with early breast cancer.
One hundred and eighty-three women were randomised 6 weeks post-breast surgery to self-initiated support (SIS) (comparator intervention), SIS plus reflexology, or SIS plus scalp massage (control for physical and social contact). Reflexology and massage comprised eight sessions at weekly intervals. The primary end-point was 18 weeks post surgery; the primary outcome measure was the Trial Outcome Index (TOI) of the Functional Assessment of Cancer Therapy (FACT-B) - breast cancer version. The secondary end-point was 24 weeks post surgery. Secondary outcome measures were the Hospital Anxiety and Depression Scale (HADS) and the Mood Rating Scale (MRS).
At primary end-point, massage, but not reflexology, was significantly better than SIS on the TOI. Reflexology and massage were both better than SIS for MRS relaxation. Massage was better than reflexology and SIS for MRS easygoingness. At secondary end-point, reflexology, but not massage, was better than SIS on the TOI and MRS relaxation. There were no significant differences between reflexology or massage. There were no significant between group differences in HADS anxiety and depression. Self-reported use of out of study complementary therapies indicated that this was unlikely to have a significant effect on findings.
When compared to SIS, reflexology and massage have statistically significant, and, for reflexology, clinically worthwhile, effects on QofL following surgery for early breast carcinoma.
开展一项实用随机对照试验(RCT),评估反射疗法对早期乳腺癌女性生活质量(QOL)的影响。
183 名女性在乳房手术后 6 周被随机分为自我支持(SIS)(对照组干预)、SIS 加反射疗法或 SIS 加头皮按摩(物理和社会接触对照)。反射疗法和按摩每周进行 8 次。主要终点为手术后 18 周;主要结局指标为癌症治疗功能评估(FACT-B)-乳腺癌版本的试验结局指数(TOI)。次要终点为手术后 24 周。次要结局指标为医院焦虑抑郁量表(HADS)和情绪评定量表(MRS)。
在主要终点,按摩而不是反射疗法在 TOI 上显著优于 SIS。反射疗法和按摩在 MRS 放松方面均优于 SIS。按摩在 MRS 随和性方面优于反射疗法和 SIS。在次要终点,反射疗法而非按摩在 TOI 和 MRS 放松方面优于 SIS。反射疗法或按摩之间没有显著差异。HADS 焦虑和抑郁无显著组间差异。自我报告使用研究外补充疗法表明,这不太可能对研究结果产生重大影响。
与 SIS 相比,反射疗法和按摩对早期乳腺癌手术后的生活质量有统计学上显著的影响,而对于反射疗法,有临床意义的影响。