Electroacupuncture plus on-demand gastrocaine for refractory functional dyspepsia: Pragmatic randomized trial
Corresponding Author
Vincent CH Chung
Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Shatin, Hong Kong
School of Chinese Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong
Correspondence
Dr Vincent Chi Ho Chung, Jockey Club School of Public Health and Primary Care, Prince of Wales Hospital, Rm 413, 4/F, Shatin, Hong Kong.
Email: [email protected]
Search for more papers by this authorCharlene HL Wong
Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Shatin, Hong Kong
Hong Kong Institute of Integrative Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong
Search for more papers by this authorIrene XY Wu
Xiang-Ya School of Public Health, Central South University, Chang-Sha, Hu-Nan, China
Search for more papers by this authorJessica YL Ching
Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Shatin, Hong Kong
Hong Kong Institute of Integrative Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong
Search for more papers by this authorWilliam KW Cheung
Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Shatin, Hong Kong
Search for more papers by this authorBenjamin HK Yip
Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Shatin, Hong Kong
Search for more papers by this authorKam Leung Chan
School of Chinese Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong
Hong Kong Institute of Integrative Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong
Search for more papers by this authorPui Kuan Cheong
Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Shatin, Hong Kong
Hong Kong Institute of Integrative Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong
Search for more papers by this authorJustin CY Wu
Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Shatin, Hong Kong
Hong Kong Institute of Integrative Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong
Search for more papers by this authorCorresponding Author
Vincent CH Chung
Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Shatin, Hong Kong
School of Chinese Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong
Correspondence
Dr Vincent Chi Ho Chung, Jockey Club School of Public Health and Primary Care, Prince of Wales Hospital, Rm 413, 4/F, Shatin, Hong Kong.
Email: [email protected]
Search for more papers by this authorCharlene HL Wong
Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Shatin, Hong Kong
Hong Kong Institute of Integrative Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong
Search for more papers by this authorIrene XY Wu
Xiang-Ya School of Public Health, Central South University, Chang-Sha, Hu-Nan, China
Search for more papers by this authorJessica YL Ching
Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Shatin, Hong Kong
Hong Kong Institute of Integrative Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong
Search for more papers by this authorWilliam KW Cheung
Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Shatin, Hong Kong
Search for more papers by this authorBenjamin HK Yip
Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Shatin, Hong Kong
Search for more papers by this authorKam Leung Chan
School of Chinese Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong
Hong Kong Institute of Integrative Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong
Search for more papers by this authorPui Kuan Cheong
Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Shatin, Hong Kong
Hong Kong Institute of Integrative Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong
Search for more papers by this authorJustin CY Wu
Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Shatin, Hong Kong
Hong Kong Institute of Integrative Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong
Search for more papers by this authorAbstract
Background and Aim
Treatment options for functional dyspepsia (FD) refractory to pharmacological treatments are limited but the effectiveness of electroacupuncture (EA) is uncertain. We assessed the effectiveness of EA combined with on-demand gastrocaine.
Methods
We conducted a single-center, assessor-blind, randomized parallel-group 2-arm trial on Helicobacter pylori negative FD patients of the postprandial distress syndrome subtype refractory to proton pump inhibitor, prokinetics, or H2 antagonists. Enrolled participants were block randomized in a 1:1 ratio, with concealed random sequence. The treatment and control groups both received on-demand gastrocaine for 12 weeks, but only those in treatment group were offered 20 sessions of EA over 10 weeks. The primary endpoint was the between-group difference in proportion of patients achieving adequate relief of symptoms at week 12.
Results
Of 132 participants randomly assigned to EA plus on-demand gastrocaine (n = 66) or on-demand gastrocaine alone (n = 66), 125 (94.7%) completed all follow-up at 12 weeks. The EA group had a compliance rate 97.7%. They had a significantly higher likelihood in achieving adequate symptom relief at 12 weeks, with a clinically relevant number needed to treat (NNT) value of 2.36 (95% CI: 1.74, 3.64). Among secondary outcomes, statistically and clinically significant improvements were observed among global symptom (NNT = 3.85 [95% CI: 2.63, 7.69]); postprandial fullness and early satiation (NNT = 5.00 [95% CI: 2.86, 25.00]); as well as epigastric pain, epigastric burning, and postprandial nausea (NNT = 4.17 [95% CI: 2.56, 11.11]). Adverse events were minimal and nonsignificant.
Conclusion
For refractory FD, EA provides significant, clinically relevant symptom relief when added to on-demand gastrocaine (ChiCTR-IPC-15007109).
Supporting Information
| Filename | Description |
|---|---|
| JGH_14737-sup-0001-supporting information.docxWord 2007 document , 94.4 KB |
Table S1. List of baseline characteristics included in the multiple imputation model#. Table S2. Baseline Characteristics of Completers and Drop-outs Table S3. Association between adequate syndrome relief and participants' baseline characteristics: Logistic Regression Analysis Table S4. Association between secondary outcomes and participants' baseline characteristics: Linear Regression Analysis Table S5. Differences in secondary endpoints at Week 12: Complete Case Analyses Table S6. Adverse events reported from the patients across Week 1 to 12 Figure S1. Gastrocaine usage over 12 Weeks |
Please note: The publisher is not responsible for the content or functionality of any supporting information supplied by the authors. Any queries (other than missing content) should be directed to the corresponding author for the article.
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