Wyatt Gwen, Sikorskii Alla, You Mei
College of Nursing, Michigan State University, East Lansing, MI, USA.
Altern Ther Health Med. 2013 Sep-Oct;19(5):31-7.
According to the National Center for Complementary and Alternative Medicine (NCCAM), about one-third of American cancer patients have used complementary and alternative medicine (CAM).
The objective of this secondary analysis was an assessment of the use of other CAM by women with advanced breast cancer who were undergoing chemotherapy and who participated in a randomized clinical trial (RCT) studying the safety and efficacy of reflexology. For this secondary analysis, the research team hypothesized an increased CAM use due to exposure to the reflexology trial.
METHODS/DESIGN: For this secondary analysis, the team conducted telephone interviews at baseline, wk 5, and wk 11 to assess the use of 23 common CAM therapies.
The study took place at 14 medical oncology clinics across the Midwestern United States.
Participants included women with advanced breast cancer who were undergoing chemotherapy and/or hormonal therapy.
In the study related to this secondary analysis, the research team randomly assigned the women to one of three primary groups: (1) reflexology; (2) lay foot manipulation (LFM); and (3) control. In addition, the research team used two test groups to establish the study's protocol: (1) test reflexology and (2) test LFM. For this secondary analysis, the research team considered the two reflexology groups (test and intervention) and the two LFM groups (test and intervention) to be the active groups, comparing their use of CAM to the control group's use at the selected time points.
The research team used a linear, mixed-effects model to analyze the number of therapies used at the three time points. The team performed t tests to compare therapy use at baseline for those women who completed the study vs those who dropped out. The team used the CAM-use instrument.
In total, 385 women participated. The research team found no differences in CAM use for the active groups vs the control group over time or in those women who stayed in the study vs those who dropped out. The team found an increase in CAM use at wk 5 compared to baseline, followed by a decrease at wk 11; however, the time trends were the same in the active groups and the control group
In women with advanced breast cancer, researchers can rely upon one assessment of CAM use during an RCT of a CAM therapy.
根据美国国立补充与替代医学中心（NCCAM）的数据，约三分之一的美国癌症患者使用过补充与替代医学（CAM）。
这项二次分析的目的是评估正在接受化疗且参与了一项研究反射疗法安全性和有效性的随机临床试验（RCT）的晚期乳腺癌女性对其他补充与替代医学的使用情况。对于这项二次分析，研究团队假设由于参与反射疗法试验，补充与替代医学的使用会增加。
方法/设计：对于这项二次分析，研究团队在基线、第5周和第11周进行电话访谈，以评估23种常见补充与替代医学疗法的使用情况。
该研究在美国中西部的14家肿瘤内科诊所进行。
参与者包括正在接受化疗和/或激素治疗的晚期乳腺癌女性。
在与这项二次分析相关的研究中，研究团队将这些女性随机分为三个主要组之一：（1）反射疗法组；（2）外行足部推拿（LFM）组；（3）对照组。此外，研究团队使用两个测试组来确定研究方案：（1）测试反射疗法组和（2）测试LFM组。对于这项二次分析，研究团队将两个反射疗法组（测试组和干预组）和两个LFM组（测试组和干预组）视为活跃组，在选定的时间点将它们的补充与替代医学使用情况与对照组进行比较。
研究团队使用线性混合效应模型分析三个时间点使用的疗法数量。团队进行t检验，以比较完成研究的女性与退出研究的女性在基线时的疗法使用情况。团队使用补充与替代医学使用工具。
共有385名女性参与。研究团队发现，随着时间推移，活跃组与对照组在补充与替代医学使用方面没有差异，完成研究的女性与退出研究的女性之间也没有差异。研究团队发现，与基线相比，第5周补充与替代医学的使用有所增加，随后在第11周有所下降；然而，活跃组和对照组的时间趋势是相同的。
对于晚期乳腺癌女性，研究人员可以依赖在补充与替代医学疗法的随机对照试验期间对补充与替代医学使用情况的一次评估。
