Abstract:
Background: Chronic fatigue syndrome (CFS) is a recurrent functional disease with an unknown pathogenesis. Modern treatment mainly focuses on symptomatic and supportive care, but no specific treatment has emerged. Ma’s Bamboo-based Medicinal Moxibustion therapy is a folk traditional Chinese medicine developed in Jinsha County, Guizhou Province. Over a long period of practice in the primary health care setting, it has been confirmed in folk medicine that the therapy can significantly improve the symptoms of patients with CFS, but there is no sufficient and scientific clinical evidence. Therefore, this randomised controlled pilot study was designed to preliminarily evaluate the efficacy and safety of Ma’s Bamboo-based Medicinal Moxibustion therapy.
Methods/design: This is a parallel, randomized, controlled, and exploratory study. Sixty patients with CFS admitted to the First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine will be randomly assigned to the experimental or control group. The experimental group will receive Ma’s Bamboo-based Medicinal Moxibustion therapy, whereas the control group will undergo conventional acupuncture. Both groups will be treated once daily for 6 consecutive days as a course of treatment, and two courses separated by 1 day will be completed (12 total treatments). All patients will undergo follow-up after the end of treatment. The baseline period is 2 days. The Fatigue Assessment Instrument score as the primary efficacy measure and secondary efficacy measures, including the Clinical Symptom Score and Fatigue Scale-14, will be evaluated at baseline, after one and two courses of treatment, and during follow-up. Serum T lymphocyte subset counts (CD3+, CD4+, CD8+, CD4+/CD8+) and safety measures ((blood routine test, liver and kidney function and electrocardiogram) will be evaluated at baseline and after two courses of treatment. All adverse events occurring between baseline and the end of follow-up will be summarised at the end of the follow-up.
Discussion: The results of this trial will clarify whether Ma’s Bamboo-based Medicinal Moxibustion therapy can improve the symptoms of patients with CFS and provide preliminary evidence for the effectiveness and safety of Ma’s Bamboo-based Medicinal Moxibustion therapy for this indication.
Ethics approval: This study has been approved by the Ethics Review Committee of the First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine (No.K2020–038).
Trial Registration: Chinese Clinical Trial Registry, ChiCTR2000038860. Registered on 7 October 2020.
Source: Xue, Kaiyang MMa,b; Wang, Xianzhu MMa,b; Quan, Fei MMa,b; Tang, Jiaxuan MMa,b; Wang, Xin MMa; Lan, Lan MMa; Fu, Jing PhDa; Cui, Jin PhDa,∗ Efficacy and safety of Ma’s Bamboo-based medicinal moxibustion therapy for chronic fatigue syndrome, Medicine Case Reports and Study Protocols: January 2022 – Volume 3 – Issue 1 – p e0193
doi: 10.1097/MD9.0000000000000193 https://journals.lww.com/md-cases/Fulltext/2022/01000/Efficacy_and_safety_of_Ma_s_Bamboo_based_medicinal.6.aspx (Full text)