Reply to Misinterpretation of the longitudinal results in the randomized, double‐blind, placebo‐controlled trial of infrared‐laser moxibustion for cancer‐related fatigue
Year: 2017
Type: letter
Abstract: We are grateful for the opportunity to respond to Moran et al's letter regarding our article.1 We performed repeated measures of analysis of our longitudinal data with the mixed effects linear model, but we did not present the statistical output in our article because of the journal's word limit. The mixed linear model showed the results for the main effect and interaction test: the group factor (P = .013) and the time factor (P < .0001) were both statistically significant. The interaction between the group factor and the time factor showed a trend but did not reach statistical significance (P = .129). As we reported in our article in the Outcome Measures section,1 the primary endpoint of the trial occurred at the end of treatment (ie, week 4). Our analysis and Moran et al's analysis are consistent and indicate that the fatigue scores were statistically different between the 2 groups and favored true laser moxibustion. Cohen's d was 1.141, and this indicated a large and relevant clinical effect. As we reported in our article, in agreement with the design of a randomized controlled trial, the fatigue scores were similar at the baseline between the 2 groups (P = .407). Thus, our comparisons of the fatigue scores between the groups at weeks 2, 4, and 8 were appropriate. Evidence for a difference was weaker at week 2 than weeks 4 and 8; however, because laser moxibustion typically requires a full course of 4 weeks to be therapeutically effective, we did not expect the effect sizes to be similar across the time points. As in any clinical trial or prospective study, dropouts and missing data were inevitable. Our dropout rate (21.8%) was similar to what we anticipated (20%), and we have discussed this as a limitation in the Discussion section. However, the dropout rates and the reasons for the dropouts were balanced between the 2 groups. In summary, Moran et al's response to our article1 does not change the conclusion of our research: infrared-laser moxibustion has demonstrated preliminary safety and efficacy for improving cancer-related fatigue in a Chinese patient population. Larger studies in the future with long-term follow-up in more racially/ethnically diverse populations are needed to confirm the benefit of this noninvasive technique for the treatment of fatigue in patients with cancer. This work was supported by the National Natural Science Foundation of China (81603703 and 81320108028), the National Basic Research Program (973 Program) of China (2015CB554505) and Budget research project of SHUTCM (2016YSN19). Ke Cheng and Xueyong Shen report a Chinese patent for a laser therapy apparatus simulating the infrared radiation spectrum of traditional Chinese moxibustion. Huijuan Mao, MD, PhD School of Acupuncture-Moxibustion and Tuina Shanghai University of Traditional Chinese Medicine Shanghai, China Ke Cheng, PhD School of Acupuncture-Moxibustion and Tuina Shanghai University of Traditional Chinese Medicine Shanghai, China Jun J. Mao, MD, MSCE Integrative Medicine Service Memorial Sloan Kettering Cancer Center New York, New York Xuefen Chen, PhD School of Public Health Shanghai University of Traditional Chinese Medicine Shanghai, China Xueyong Shen, MD School of Acupuncture-Moxibustion and Tuina Shanghai University of Traditional Chinese Medicine Shanghai, China
Source: Cancer
DOI: 10.1002/cncr.30799
Language: English
Subfield: Complementary and alternative medicine
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W2624822896