Background: Traditional Chinese Qigong exercises (Prolong Life With Nine Turn Method) are beneficial for fatigue, gastrointestinal symptoms and intestinal gut microbiota status in patients with CFS, but the evidence for this method is limited. This trial was designed to observe whether PLWNT Qigong exercise can improve fatigue and gastrointestinal symptoms in patients with CFS and regulate intestinal gut microbiota disorders.
Methods: This study is a 8-week, non-inferiority, analyst-blinded randomized clinical trial. A total of 96 patients with CFS were recruited, patients in the cognitive behavioral therapy (CBT) group and the PLWNT group received a total of 8 weeks treatment sessions. The primary outcome was the change in the Multidimensional Fatigue Inventory-20 (MFI-20) from baseline to week 8. Secondary outcomes included scores of MFI-20 subtype scale and Gastrointestinal Symptom Rating Scale (GSRS) scale at 4 and 8 weeks, and changes of gut microbiota at 8 weeks.
Results: At week 8, the average difference between the total score of MFI-20 and the baseline score in the PLWNT group was -12.02(95%CI, -15.88 to -8.17). Compared with the baseline score, the changes in MFI-20 subtype scores, GSRS subtype scores and α diversity differences in the PLWNT group were statistically significant. Compared with the CBT group, there was no significant difference in the changes of MFI-20, GSRS, α diversity and β diversity in the PLWNT group.
Conclusions: PLWNT showed potential beneficial effects on fatigue and gastrointestinal symptoms in CFS patients, and this improvement was accompanied by changes in gut microbiota.
Trial registration: Chinese Clinical Trial Registry: ChiCTR2200056530; Registered 07 February 2022, https://www.chictr.org.cn/showproj.html?proj=151456.
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