Tuina therapy for patients with chronic fatigue syndrome: a randomized controlled trial

TiredMathematician

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Background
Chronic fatigue syndrome (CFS) is a complex and disabling disorder characterized by persistent fatigue and functional impairment, with limited safe and effective nonpharmacologic treatment options. Tuina, a traditional manual therapy in Chinese medicine, has been increasingly applied for fatigue-related conditions, yet high-quality clinical evidence remains scarce. This study aimed to evaluate the efficacy and safety of Tuina combined with usual care (UC) in adults with CFS.

Methods
This assessor-blinded, single-center randomized clinical trial was conducted from April 10, 2024, to January 10, 2025, at Shuguang Hospital, Shanghai University of Traditional Chinese Medicine. A total of 110 participants meeting the 1994 US Centers for Disease Control and Prevention diagnostic criteria for CFS were randomly assigned (1:1) to receive Tuina plus UC or UC alone. The Tuina group received three 20-minute sessions per week for 4 weeks (12 sessions in total) in addition to UC, which included health education, lifestyle guidance, and individualized symptom-targeted treatments but excluded Tuina therapy. The primary outcome was fatigue severity at 4 weeks measured by the 11-item Chalder Fatigue Questionnaire (CFQ-11). Secondary outcomes included anxiety and depression (Hospital Anxiety and Depression Scale), sleep quality (Pittsburgh Sleep Quality Index), and physical functioning and bodily pain (Short Form-36 subscales). Data were analyzed using analysis of covariance with baseline scores as covariates.

Results
Baseline characteristics were comparable between groups. At week 4, compared with UC alone, Tuina plus UC led to greater improvement in fatigue (CFQ total score: adjusted mean difference −2.90 [95% CI −4.69 to −1.12]; p = 0.002; effect size 0.62), and more participants achieved the minimal clinically important difference in CFQ total score (89.1% vs 69.1%; p < 0.01). Benefits also favoured Tuina for physical fatigue (−2.21 [95% CI −3.40 to −1.02]; p < 0.001; effect size 0.70), whereas the effect on mental fatigue was smaller (−0.79 [95% CI −1.52 to −0.06]; p = 0.03; effect size 0.41). Tuina further reduced anxiety (−1.79 [95% CI −2.92 to −0.65]; p = 0.002) and improved overall sleep quality (PSQI total score: −1.62 [95% CI −2.60 to −0.65]; p = 0.0013); among PSQI subscales, only sleep duration remained statistically significant after Bonferroni correction. Other secondary outcomes did not differ significantly between groups, and no serious adverse events occurred.

Conclusions
Tuina combined with UC produced clinically meaningful improvements in overall fatigue and significant improvements in physical fatigue compared with UC alone, with additional benefits in anxiety and overall sleep quality, and was safe and well tolerated. These findings suggest that Tuina may be a promising adjunctive therapy for CFS and warrant confirmation in larger multicenter trials with longer-term follow-up.

Trial registration
International Traditional Medicine Clinical Trial Registry, ITMCTR2025000002. Registered 1 January 2025 – Prospectively registered, https://www.itmctr.org/TrialDetail.aspx?ID = ITMCTR2025000002


Link: https://link.springer.com/article/10.1186/s12967-025-07624-7
 
This trial is said to be prospectively registered:
International Traditional Medicine Clinical Trial Registry, ITMCTR2025000002. Registered 1 January 2025 – Prospectively registered

Registration link: http://123.57.9.4:8085/en-US/Home/ProjectView?pid=367bf820-b314-4bd7-b4ba-e6c2494eda8f

However, based on the following quotes, the study started eight months before this registration was submitted, and the registration came only a couple of weeks before the completion of the entire study.

This assessor-blinded, single-center randomized clinical trial was conducted from April 10, 2024, to January 10, 2025, at Shuguang Hospital, Shanghai University of Traditional Chinese Medicine.
Between April 10, 2024 and January 10, 2025, a total of 362 patients were screened. Of these, 145 (40.2%) underwent eligibility assessment, and 110 (30.4%) were ultimately enrolled (Figure 1).
Post-treatment outcome data collection was completed on on January 15, 2025.
 
Tuina, a traditional manual therapy in Chinese medicine, has been increasingly applied for fatigue-related conditions, yet high-quality clinical evidence remains scarce. This study aimed to evaluate the efficacy and safety of Tuina combined with usual care (UC) in adults with CFS.
This assessor-blinded, single-center randomized clinical
It doesn’t look like this study will do much to solve the quality issues..

They defined MCID for CFQ as 3 points. The between group difference didn’t reach this threshold, which they seem to ignore.
At week 4, compared with UC alone, Tuina plus UC led to greater improvement in fatigue (CFQ total score: adjusted mean difference −2.90 [95% CI −4.69 to −1.12]; p = 0.002; effect size 0.62),
They also ignore mostly null findings in the secondary outcomes:
For the secondary outcomes, Tuina significantly improved anxiety and global sleep quality, findings that are consistent with previous reports. [17, 19] In contrast, no significant between-group difference was observed in SF-36 physical function, which may be explained by a ceiling effect, as baseline scores were relatively high and left limited room for measurable improvement. Moreover, Tuina did not confer additional benefits over control in subjective sleep quality, sleep latency, sleep efficiency, use of sleep medication, or depressive symptoms. These null findings may reflect the relatively limited intensity and duration of the intervention, which may not have been sufficient to produce measurable improvements in these domains.
All they’ve managed to prove is that they are not really trying to do science.
 
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