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Effect of acupuncture and its influence on cerebral activity in functional dyspepsia patients: study protocol for a randomized controlled trial.

ABSTRACT: Functional dyspepsia (FD) is a prevalent gastric disorder that is difficult to manage due to lack of satisfactory treatments. Acupuncture has been studied with regard to the rising need for treating FD, but the mechanism verifying its efficacy has not yet been fully revealed. The aim of this study is to explore the efficacy and mechanism of acupuncture for FD compared with a sham group.We describe a proposal for a randomized, assessor-blind, sham-controlled trial with 70 eligible participants who will be randomly allocated either into an acupuncture or a sham group. Participants in the acupuncture group will receive 10 sessions of real acupuncture treatment and those in the sham group will be treated with identical sessions using a Streitberger needle. Functional magnetic resonance imaging (fMRI) and metabolomics studies will be implemented before and after 4 weeks of treatment to investigate the mechanism of acupuncture. The primary outcome is a proportion of responders with adequate symptom relief and the secondary outcomes include the Nepean Dyspepsia Index - Korean version, Functional Dyspepsia-Related Quality of Life questionnaire, Ways of Coping Questionnaire, Coping Strategies Questionnaire, perception of bodily sensation questionnaire, State-Trait Anxiety Inventory, and the Center for Epidemiological Studies - Depression Scale. The outcomes will be evaluated before and after the treatment.This is the first large-scale trial evaluating the efficacy and mechanism of acupuncture with fMRI and metabolomic methods. We will compare real acupuncture with the Streitberger sham needle to verify the specific effect of acupuncture. The results of this trial are expected to be relevant evidences affecting policy and decision-makers associated with routine healthcare.ClinicalTrials.gov Identifier: NCT02358486 . Date of Registration: 21 January 2015.

SUBMITTER: Ko SJ

PROVIDER: S-EPMC4818864 | biostudies-literature | 2016 Apr

REPOSITORIES: biostudies-literature

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Effect of acupuncture and its influence on cerebral activity in functional dyspepsia patients: study protocol for a randomized controlled trial.

Ko Seok-Jae SJ Park Kyungmo K Kim Jieun J Kim Minji M Kim Joo-Hee JH Lee Jeungchan J Mohamed Abdalla Z AZ Yeo Inkwon I Kim Jinsung J Choi Sun-Mi SM Kim Honggeol H Park Jae-Woo JW Lee Jun-Hwan JH

Trials 20160402

<h4>Background</h4>Functional dyspepsia (FD) is a prevalent gastric disorder that is difficult to manage due to lack of satisfactory treatments. Acupuncture has been studied with regard to the rising need for treating FD, but the mechanism verifying its efficacy has not yet been fully revealed. The aim of this study is to explore the efficacy and mechanism of acupuncture for FD compared with a sham group.<h4>Methods/design</h4>We describe a proposal for a randomized, assessor-blind, sham-control ...[more]

PMID: 27039086

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Project description:BackgroundPerimenopausal insomnia is one of the core symptoms of the menopausal transition. Acupuncture is considered to exert a positive effect on restoring the normal sleep-wake cycle. However, there is little intuitive evidence besides evaluation using clinical effectiveness scales. We therefore designed this study, aiming to use more intuitive and reliable detection techniques such as functional magnetic resonance imaging before and after applying acupuncture to provide neuroimaging evidence, as well as to verify the effectiveness with other curative effect indicators.Methods/designThis study is a randomized, assessor-statistician-blinded, positive medicine controlled trial involving 40 participants. A total of 40 eligible patients with perimenopausal insomnia will be randomly assigned to two groups in a 1:1 ratio as an intervention group using acupuncture and a control group taking estazolam. Participants in the intervention group will receive six acupuncture treatment sessions per week for 4 consecutive weeks, for a total of 24 sessions during the study. Meanwhile, the medicine control group will be prescribed estazolam 1-2 mg/day to be taken 30 minutes before sleep for 4 weeks. The primary outcome is the Pittsburgh Sleep Quality Index. Secondary outcomes are the micro-movement sensitive mattress-type sleep monitoring system, the Hamilton Depression Scale, and the Hamilton Anxiety Scale. All outcomes will be evaluated before and after treatment. The safety of interventions will be assessed at every visit.DiscussionThe results of this trial, which will be available in 2018, will investigate the impact of acupuncture treating perimenopausal insomnia from assessment of the sleep architecture, hormone level, and emotional-circuit neurological function, and will uncover the effective mechanism of acupuncture regulating the emotional center integrated effect.Trial registrationChinese Clinical Trials Register, ChCTR-IPC-16007832 . Registered on 26 January 2016.

Project description:ObjectiveFunctional dyspepsia (FD) is a common gastrointestinal disorder that significantly affects sufferers' quality of life and increases the economic burden on society. Saam acupuncture, a form of traditional Korean acupuncture, is frequently used to treat FD in Korean medicine clinical settings. This study aimed to evaluate the feasibility and preliminary effectiveness and safety of Saam acupuncture for treating FD.MethodsWe conducted a pilot, pragmatic, assessor-blinded randomized controlled trial. Patients with FD according to the ROME III criteria were randomly allocated to an acupuncture plus usual care group or a usual care group. Saam acupuncture based on individualized FD and systemic symptoms was conducted in the acupuncture group three times per week for 4 weeks. Study feasibility outcomes, including recruitment, completion, and acupuncture adherence rates, were calculated. In addition, preliminary evaluation of participant responses to the intervention was tested using the gastrointestinal symptom (GIS), FD-related quality of life (FD-QoL), visual analog scale (VAS), patient global assessment (PGA), and EuroQol-5 Dimensions (EQ-5D) scores.ResultsTwenty-four participants who met the eligibility criteria were included. The recruitment and completion rates of the clinical trials were 60% and 79.2%, and the acupuncture adherence rate was 83.3%. Although there was no significant difference between the two groups in the dyspepsia symptoms as measured by GIS, VAS, and PGA at Week 4, significant differences were found between the two groups at the follow-up assessments (Weeks 8 and 12). In particular, the early satiety subscore of GIS was significantly improved in the Saam acupuncture group compared with the usual care group at Week 4. The quality of life measured by FD-QoL and EQ-5D improved only in the Saam acupuncture group, although there were no significant differences between the two groups. No adverse events related to Saam acupuncture were reported.ConclusionsSaam acupuncture can be a feasible, preliminarily effective, and safe treatment for FD. Further confirmatory trials with a larger sample size are needed to confirm its effectiveness and safety. The trail is registered with CRIS-KCT0000164, URL: https://cris.nih.go.kr/cris/search/detailSearch.do/2098.

Project description:BackgroundThe mechanism of the long-lasting effect and the relationship between the long-lasting effect and the deqi sensation, which is the key of achieving the acupuncture effect, has not been well investigated. This trial focuses on investigating the possible central mechanism of the long-lasting effect influenced by the deqi sensation.MethodsA randomized controlled functional brain imaging trial is currently being conducted in Sichuan, China. In total 105 functional dyspepsia (FD) patients will be allocated into three groups: an acupuncture with deqi group, an acupuncture without deqi group, and a wait-list group. This trial will include a 2-week baseline period, a 4-week treatment period, and a 4-week follow-up period. During the 4-week treatment, patients in two acupuncture groups will receive 20 sessions of acupuncture treatment with or without deqi. The Nepean Dyspepsia Index (NDI) and the short form Leeds Dyspepsia Questionnaire (SF-LDQ) will be used to evaluate the clinical efficacy of acupuncture treatment at baseline, the end of treatment, and the end of the follow-up. Functional magnetic resonance imaging (fMRI) scans will be performed to detect cerebral functional changes in 25 patients in each group at three time points mentioned above. The clinical data and fMRI data will be analyzed, respectively. Correlation analysis will be conducted to investigate the relationship between cerebral functional changes and symptom improvement.DiscussionThe results of this trial will allow us to compare the changes of acupuncture therapeutic effect at three time points (the baseline vs. the end of treatment vs. the end of follow-up), and investigate the potential central mechanism of the long-lasting effect influenced by acupuncture with deqi. This trial aims to re-identify the long-lasting effect of acupuncture and investigate its central mechanism, and to further explore the central influence of deqi sensation on the long-lasting effect.Trial registrationChinese Clinical Trial Registry, IDF: ChiCTR-IOR-15006523 . Registered on 5 June 2015.

Project description:BackgroundAcupuncture is widely used in China to treat functional dyspepsia (FD). However, its effectiveness in the treatment of FD, and whether FD-specific acupoints exist, are controversial. So this study aims to determine if acupuncture is an effective treatment for FD and if acupoint specificity exists according to traditional acupuncture meridians and acupoint theories.DesignThis multicenter randomized controlled trial will include four acupoint treatment groups, one non-acupoint control group and one drug (positive control) group. The four acupoint treatment groups will focus on: (1) specific acupoints of the stomach meridian; (2) non-specific acupoints of the stomach meridian; (3) specific acupoints of alarm and transport points; and (4) acupoints of the gallbladder meridian. These four groups of acupoints are thought to differ in terms of clinical efficacy, according to traditional acupuncture meridians and acupoint theories. A total of 120 FD patients will be included in each group. Each patient will receive 20 sessions of acupuncture treatment over 4 weeks. The trial will be conducted in eight hospitals located in three centers of China. The primary outcomes in this trial will include differences in Nepean Dyspepsia Index scores and differences in the Symptom Index of Dyspepsia before randomization, 2 weeks and 4 weeks after randomization, and 1 month and 3 months after completing treatment.DiscussionThe important features of this trial include the randomization procedures (controlled by a central randomization system), a standardized protocol of acupuncture manipulation, and the fact that this is the first multicenter randomized trial of FD and acupuncture to be performed in China. The results of this trial will determine whether acupuncture is an effective treatment for FD and whether using different acupoints or different meridians leads to differences in clinical efficacy.Trial registration numberClinical Trials.gov Identifier: NCT00599677.

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Effect of acupuncture and its influence on cerebral activity in functional dyspepsia patients: study protocol for a randomized controlled trial.

Publications

Effect of acupuncture and its influence on cerebral activity in functional dyspepsia patients: study protocol for a randomized controlled trial.

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