Traditional Chinese medicine paraffin therapy for functional dyspepsia： a randomized controlled trial protocol

Abstract

Abstract Background: Traditional Chinese medicine paraffin therapy (TCMPT), a combination therapy of herbal acupoint application therapy and paraffin therapy, has demonstrated great effectiveness in treating some diseases. However, there is no relevant research in the treatment of functional dyspepsia (FD) with TCMPT.Using a randomized controlled trial, we investigate whether TCMPT is effective in improving Clinical-Assessment–FD symptoms (SCA-FD), in comparison with herbal acupoint application therapy, paraffin therapy and basic treatment. Further more, this study is also interested in changes of psychological status in patients with FD before and after TCMPT. Methods: This trial will be conducted in the Guang’anmen Hospital of China Academy of Chinese Medical Sciences in China. 120 FD patients will be randomized to one of the four arms of the trial: (1) TCMPT group, (2) Herbal acupoint application therapygroup, (3) Paraffin therapy group, and (4) Basic treatment group. The experimental phase will last 4 weeks,followed by a 2-week and 4-week follow-up period. During the 4-week treatment period, all the patients included will be treated with basic treatment (Omeprazole Magnesium Enteric-coated Tablets of 20mg, take orally, once daily for 4 weeks). In addition to basic treatment, patients in the TCMPT group will be treated with TCMPT, herbal acupoint application therapy group will be treated with herbal acupoint application therapy, paraffin therapy group will be treated with paraffin therapy (the treatment of each group will be applied 3 times a week, once every 1-2 days, for 4 weeks). The primary outcome are changes in the SCA-FD from baseline to the end of 4-week intervention. The secondary outcome measures are changes in the SCA-FD at other time points, Hospital Anxiety Depression Scale (HADS), Perceived Stress Scale (PSS), Short Form 36-item Health Survey (SF-36), and Changes of skin temperature at selected acupoints. Laboratory tests and adverse events also will be recorded. Discussion: If effective, this study will provide evidence for TCMPT in improving FD symptoms and mental health state of FD patients, and confirm that the effectiveness of TCMPT is better than herbal acupoint application therapy and paraffin therapy alone. The findings from this trial could be used to design new research protocols. Trial registration: Chinese Clinical Trial Registry, ChiCTR2200061950, registered on 13 July 2022.