Dataset Information

Efficacy of acupuncture versus sham acupuncture for postprandial distress syndrome: study protocol for a randomized controlled trial.

ABSTRACT:

Background

Postprandial distress syndrome (PDS) has a considerable impact on quality of life. Our previous pilot trial suggested that acupuncture might be a potential treatment option for PDS. We will conduct this large trial to determine the efficacy of acupuncture versus sham acupuncture for PDS.

Methods/design

A total of 280 eligible patients who meet the Rome IV criteria for PDS will be randomly allocated to either the acupuncture group or the sham acupuncture group. Each patient will receive 12 sessions over four?weeks. The primary outcomes will be the response rate of overall treatment effect (OTE) and the elimination rate of all three cardinal symptoms (postprandial fullness, upper abdominal bloating, and early satiation) at four?weeks after randomization. Secondary outcomes will include assessments of the severity of dyspepsia symptoms and disease-specific quality of life at weeks 4, 8, and 16 after randomization. All patients who receive randomization will be included in the intent-to-treat analysis.

Discussion

The finding of this trial will provide high-quality evidence on the efficacy of acupuncture for treatment of PDS. Results of this research will be published in peer-reviewed journals.

Trial registration

ISRCTN Registry, ISRCTN12511434 . Registered on 31 March 2017.

SUBMITTER: Hou YQ

PROVIDER: S-EPMC6339308 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Publications

Efficacy of acupuncture versus sham acupuncture for postprandial distress syndrome: study protocol for a randomized controlled trial.

Hou Ya-Quan YQ Zhang Xin X Tu Jian-Feng JF Zheng Yang Y Yang Jing-Wen JW Kim Mirim M Hu Hui H Wang Li-Qiong LQ Zhao Jing-Jie JJ Zhou Wei W Wang Jun J Zou Xuan X Wang Yu Y Shi Guang-Xia GX Liu Cun-Zhi CZ

Trials 20190118 1

<h4>Background</h4>Postprandial distress syndrome (PDS) has a considerable impact on quality of life. Our previous pilot trial suggested that acupuncture might be a potential treatment option for PDS. We will conduct this large trial to determine the efficacy of acupuncture versus sham acupuncture for PDS.<h4>Methods/design</h4>A total of 280 eligible patients who meet the Rome IV criteria for PDS will be randomly allocated to either the acupuncture group or the sham acupuncture group. Each pati ...[more]

PMID: 30658669

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Project description:BackgroundPrimary dysmenorrhea (PD) is a leading cause of dysmenorrhea among adolescent girls. Manual acupuncture may be considered as an effective treatment for PD, but high-quality evidence remains limited. This trial aims to evaluate the efficacy and safety of acupuncture for the prevention of PD as compared with sham acupuncture and usual care.Methods/designThis is a three-arm, randomized, controlled clinical trial in which the patients, assessors, and statisticians will be blinded. A total of 300 acupuncture-naive patients who were diagnosed as PD will be randomly allocated to the verum acupuncture, sham acupuncture, or usual care groups in a 2:2:1 ratio. Patients in the verum acupuncture group will receive manual acupuncture at specific acupuncture points with penetrating needling, while those in the sham acupuncture group will receive non-penetrating needling at non-acupuncture points. They will be given five sessions over a menstrual cycle for 3 menstrual cycles. Patients in the usual care group will receive health education and informed to receive manual acupuncture for free after waiting for 7 menstrual cycles. The primary outcome will be the change from baseline in the Cox Menstrual Symptom Scale Score (CMSS). The secondary outcomes will be the changes in Massachusetts General Hospital Acupuncture Sensation Scale (MASS), visual analog scale (VAS), Short-Form McGill Pain Questionnaire 2 (SF-MPQ-2), Pittsburgh Sleep Quality Index (PSQI), Beck Anxiety Inventory (BAI), Beck Depression Inventory II (BDI- II), Acupuncture Expectancy Scale (AES), 60-item NEO Personality Inventory-Short Form (NEO-FFI), and acute medication intake. The adverse events will be recorded at every visit. The analyses will be performed base on a full analysis set (FAS) and a per-protocol set (PPS).DiscussionThis study may provide high-quality evidence regarding the efficacy and safety of manual acupuncture for PD. In addition, the results of this study will help to identify the efficacy of acupuncture due to the specific effects of acupuncture or placebo effects of acupuncture ritual.Trial registrationClinical Trials.gov NCT02783534 . Registered on 26 May 2016.

Dataset Information

Efficacy of acupuncture versus sham acupuncture for postprandial distress syndrome: study protocol for a randomized controlled trial.

Background

Methods/design

Discussion

Trial registration

Publications

Efficacy of acupuncture versus sham acupuncture for postprandial distress syndrome: study protocol for a randomized controlled trial.

Similar Datasets

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