Abstract
BackgroundFunctional dyspepsia (FD) is a common health problem currently without any optimal treatments. Acupuncture has been traditionally sought as a treatment for FD. The aim of this study is to investigate whether acupuncture treatment helps improve symptoms of FD.Methods/designA two-center, randomized, waitlist-controlled trial will be carried out to evaluate whether acupuncture treatment improves FD symptoms. Seventy six participants aged 18 to 75 years with FD as diagnosed by Rome III criteria will be recruited from August 2013 to January 2014 at two Korean Medicine hospitals. They will be randomly allocated either into eight sessions of partially individualized acupuncture treatment over 4 weeks or a waitlist group. The acupuncture group will then be followed-up for 3 weeks with six telephone visits and a final visit will be paid at 8 weeks. The waitlist group will receive the identical acupuncture treatment after a 4-week waiting period. The primary outcome is the proportion of responders with adequate symptom relief and the secondary outcomes include Nepean dyspepsia index, EQ-5D, FD-related quality of life, Beck’s depression inventory, state-trait anxiety inventory questionnaire, and level of ghrelin hormone. The protocol was approved by the participating centers’ Institutional Review Boards.DiscussionResults of this trial will help clarify not only whether the acupuncture treatment is beneficial for symptom improvement in FD patients but also to elucidate the related mechanisms of how acupuncture might work.Trial registrationClinicalTrials.gov Identifier: NCT01921504.
Highlights
Functional dyspepsia (FD) is a common health problem currently without any optimal treatments
Results of this trial will help clarify whether the acupuncture treatment is beneficial for symptom improvement in FD patients and to elucidate the related mechanisms of how acupuncture might work
Sample size was determined based on our clinical experience and previous reports where the waitlist group achieved approximately 28% of the proportion of responders (PR) in patients with irritable bowel syndrome [49]; in our study, we expected that 60% of the participants on the acupuncture arm would achieve adequate relief for over a half of the study period while up to 25% of those on the waitlist arm would achieve such an outcome
Summary
Functional dyspepsia (FD) is a common health problem currently without any optimal treatments. It has been frequently used to treat symptoms of FD [11] largely based on the following rationales: firstly, acupuncture is well known to relieve pain in various conditions [12] and may help reduce epigastric pain or burning sensation [4]; secondly, previous studies have shown that manual acupuncture and electro-acupuncture modulates gastric/duodenal motility through the activation of sympathetic efferent nerve fibers or vagal nerve fibers [13]; since patients with FD have been reported to have higher levels of psychological distress or depression than healthy subjects [14,15], the anxiolytic or antidepressant effects of acupuncture have been utilized to minimize worsening of FD symptoms [16,17,18]
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