Abstract
BackgroundPostprandial distress syndrome (PDS) is referred to as meal-related functional dyspepsia (FD) and causes a reduced quality of life (QoL) for patients. Several randomized controlled trials (RCTs) have suggested that acupuncture is an effective treatment for FD, but few studies were particularly for PDS. This pilot study was designed to determine the feasibility and efficacy of acupuncture in patients with PDS characterized by postprandial fullness and early satiation according to the Rome III criteria.MethodsThis is a multi-center, two-arm, blinded (participants), pilot RCT. Forty-two participants who meet the inclusion criteria will be randomly assigned to the verum acupuncture group or minimal acupuncture group in a 1:1 ratio. Both treatments consist of 12 sessions of 20 min duration over four weeks (three sessions per week). The primary outcome measurement is the proportion of persons who improve as assessed using the global outcome by the overall treatment effect (OTE) at end-of-treatment (EOT) (four weeks after randomization). Global assessment at weeks 8 and 16 after randomization is one of the secondary outcomes. The other secondary outcomes including symptoms, disease-specific QoL, and depression and anxiety will be assessed at weeks 4, 8, and 16 after randomization.DiscussionThis pilot study will help determine the feasibility and efficacy of acupuncture in patients with PDS.Trial registrationISRCTN Registry, ISRCTN18135146. Registered on 7 July 2016.
Highlights
Postprandial distress syndrome (PDS) is referred to as meal-related functional dyspepsia (FD) and causes a reduced quality of life (QoL) for patients
A few randomized controlled trials (RCTs) were conducted to examine the treatment responses of postprandial distress syndrome (PDS) and epigastric pain syndrome (EPS), though testing responses to different FD subgroup are urgently needed [1]. This condition is not a life-threatening disease [5, 6], patients suffer from a reduced quality of life (QoL) [7,8,9,10,11]
People with PDS have a normal life expectancy, but the impact on QoL is notable. This pilot study has been designed, to evaluate whether acupuncture will improve the symptoms of PDS and be a feasible therapy for clinical treatment
Summary
Forty-two participants who meet the inclusion criteria will be randomly assigned to the verum acupuncture group or minimal acupuncture group in a 1:1 ratio. Both treatments consist of 12 sessions of 20 min duration over four weeks (three sessions per week). The primary outcome measurement is the proportion of persons who improve as assessed using the global outcome by the overall treatment effect (OTE) at end-of-treatment (EOT) (four weeks after randomization). Global assessment at weeks 8 and 16 after randomization is one of the secondary outcomes. The other secondary outcomes including symptoms, disease-specific QoL, and depression and anxiety will be assessed at weeks 4, 8, and 16 after randomization
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