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      Effect of acupuncture for constipation after ischemic stroke: study protocol for a randomized controlled trial

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          Abstract

          Background

          Constipation is a common complication after stroke that can severely influence a patient’s quality of life and rehabilitation. Treatments for constipation after stroke vary. Acupuncture may improve spontaneous bowel movements, quality of life, and clinical symptoms. The study seeks to assess the preliminary effects of acupuncture on constipation after an ischemic stroke.

          Methods/design

          This is a prospective randomized controlled pilot trial design in which 120 eligible patients will be randomly allocated to one of three groups. The acupuncture group ( n = 40) will receive acupuncture and routine care, the medication group ( n = 40) will receive mosapride citrate and routine care, and the control group ( n = 40) will receive only routine care for ischemic stroke. Patients will be recruited 2 weeks to 6 months after stroke onset and will receive the intervention continuously over 4 weeks, with a follow-up period of 4 additional weeks. Adverse events will be recorded to assess the safety and tolerability of acupuncture for constipation after an ischemic stroke. The primary outcome will be the change in the weekly mean number of complete spontaneous bowel movements. Secondary outcomes will include any change in the weekly mean number of spontaneous bowel movements, mean stool consistency scores, mean straining scores during defecation, and frequency of laxative use. All outcome measures will be assessed at inception, after the intervention (4 weeks), and at the follow-up (8 weeks).

          Discussion

          This study will provide evidence of the preliminary effects and inform future sample size calculations for studies of acupuncture for constipation following an ischemic stroke. These findings will inform subsequent large-scale randomized controlled trials.

          Trial registration

          ISRCTN, 22214747. Registered on 17 August 2015.

          Electronic supplementary material

          The online version of this article (10.1186/s13063-018-2750-0) contains supplementary material, which is available to authorized users.

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          Most cited references37

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          Contribution of chronic diseases to disability in elderly people in countries with low and middle incomes: a 10/66 Dementia Research Group population-based survey

          Summary Background Disability in elderly people in countries with low and middle incomes is little studied; according to Global Burden of Disease estimates, visual impairment is the leading contributor to years lived with disability in this population. We aimed to assess the contribution of physical, mental, and cognitive chronic diseases to disability, and the extent to which sociodemographic and health characteristics account for geographical variation in disability. Methods We undertook cross-sectional surveys of residents aged older than 65 years (n=15 022) in 11 sites in seven countries with low and middle incomes (China, India, Cuba, Dominican Republic, Venezuela, Mexico, and Peru). Disability was assessed with the 12-item WHO disability assessment schedule 2.0. Dementia, depression, hypertension, and chronic obstructive pulmonary disease were ascertained by clinical assessment; diabetes, stroke, and heart disease by self-reported diagnosis; and sensory, gastrointestinal, skin, limb, and arthritic disorders by self-reported impairment. Independent contributions to disability scores were assessed by zero-inflated negative binomial regression and Poisson regression to generate population-attributable prevalence fractions (PAPF). Findings In regions other than rural India and Venezuela, dementia made the largest contribution to disability (median PAPF 25·1% [IQR 19·2–43·6]). Other substantial contributors were stroke (11·4% [1·8–21·4]), limb impairment (10·5% [5·7–33·8]), arthritis (9·9% [3·2–34·8]), depression (8·3% [0·5–23·0]), eyesight problems (6·8% [1·7–17·6]), and gastrointestinal impairments (6·5% [0·3–23·1]). Associations with chronic diseases accounted for around two-thirds of prevalent disability. When zero inflation was taken into account, between-site differences in disability scores were largely attributable to compositional differences in health and sociodemographic characteristics. Interpretation On the basis of empirical research, dementia, not blindness, is overwhelmingly the most important independent contributor to disability for elderly people in countries with low and middle incomes. Chronic diseases of the brain and mind deserve increased prioritisation. Besides disability, they lead to dependency and present stressful, complex, long-term challenges to carers. Societal costs are enormous. Funding Wellcome Trust; WHO; US Alzheimer's Association; Fondo Nacional de Ciencia Y Tecnologia, Consejo de Desarrollo Cientifico Y Humanistico, Universidad Central de Venezuela.
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            A placebo-controlled trial of prucalopride for severe chronic constipation.

            In this 12-week trial, we aimed to determine the efficacy of prucalopride, a selective, high-affinity 5-hydroxytryptamine4 receptor agonist, in patients with severe chronic constipation. In our multicenter, randomized, placebo-controlled, parallel-group, phase 3 trial, patients with severe chronic constipation (< or =2 spontaneous, complete bowel movements per week) received placebo or 2 or 4 mg of prucalopride, once daily, for 12 weeks. The primary efficacy end point was the proportion of patients having three or more spontaneous, complete bowel movements per week, averaged over 12 weeks. Secondary efficacy end points were derived from daily diaries and validated questionnaires completed by patients. Adverse events, clinical laboratory values, and cardiovascular effects were monitored. Efficacy was analyzed in 620 patients. The proportion of patients with three or more spontaneous, complete bowel movements per week was 30.9% of those receiving 2 mg of prucalopride and 28.4% of those receiving 4 mg of prucalopride, as compared with 12.0% in the placebo group (P<0.001 for both comparisons). Over 12 weeks, 47.3% of patients receiving 2 mg of prucalopride and 46.6% of those receiving 4 mg of prucalopride had an increase in the number of spontaneous, complete bowel movements of one or more per week, on average, as compared with 25.8% in the placebo group (P<0.001 for both comparisons). All other secondary efficacy end points, including patients' satisfaction with their bowel function and treatment and their perception of the severity of their constipation symptoms, were significantly improved with the use of 2 or 4 mg of prucalopride as compared with placebo, at week 12. The most frequent treatment-related adverse events were headache and abdominal pain. There were no significant cardiovascular effects of treatment. Over 12 weeks, prucalopride significantly improved bowel function and reduced the severity of symptoms in patients with severe chronic constipation. Larger and longer trials are required to further assess the risks and benefits of the use of prucalopride for chronic constipation. (ClinicalTrials.gov number, NCT00483886 [ClinicalTrials.gov].). Copyright 2008 Massachusetts Medical Society.
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              NIH Consensus Conference. Acupuncture.

              To provide clinicians, patients, and the general public with a responsible assessment of the use and effectiveness of acupuncture to treat a variety of conditions. A nonfederal, nonadvocate, 12-member panel representing the fields of acupuncture, pain, psychology, psychiatry, physical medicine and rehabilitation, drug abuse, family practice, internal medicine, health policy, epidemiology, statistics, physiology, biophysics, and the representatives of the public. In addition, 25 experts from these same fields presented data to the panel and a conference audience of 1200. Presentations and discussions were divided into 3 phases over 2 1/2 days: (1) presentations by investigators working in areas relevant to the consensus questions during a 2-day public session; (2) questions and statements from conference attendees during open discussion periods that were part of the public session; and (3) closed deliberations by the panel during the remainder of the second day and morning of the third. The conference was organized and supported by the Office of Alternative Medicine and the Office of Medical Applications of Research, National Institutes of Health, Bethesda, Md. The literature, produced from January 1970 to October 1997, was searched through MEDLINE, Allied and Alternative Medicine, EMBASE, and MANTIS, as well as through a hand search of 9 journals that were not indexed by the National Library of Medicine. An extensive bibliography of 2302 references was provided to the panel and the conference audience. Expert speakers prepared abstracts of their own conference presentations with relevant citations from the literature. Scientific evidence was given precedence over clinical anecdotal experience. The panel, answering predefined questions, developed their conclusions based on the scientific evidence presented in the open forum and scientific literature. The panel composed a draft statement, which was read in its entirety and circulated to the experts and the audience for comment. Thereafter, the panel resolved conflicting recommendations and released a revised statement at the end of the conference. The panel finalized the revisions within a few weeks after the conference. The draft statement was made available on the World Wide Web immediately following its release at the conference and was updated with the panel's final revisions within a few weeks of the conference. The statement is available at http://consensus.nih.gov. Acupuncture as a therapeutic intervention is widely practiced in the United States. Although there have been many studies of its potential usefulness, many of these studies provide equivocal results because of design, sample size, and other factors. The issue is further complicated by inherent difficulties in the use of appropriate controls, such as placebos and sham acupuncture groups. However, promising results have emerged, for example, showing efficacy of acupuncture in adult postoperative and chemotherapy nausea and vomiting and in postoperative dental pain. There are other situations, such as addiction, stroke rehabilitation, headache, menstrual cramps, tennis elbow, fibromyalgia, myofascial pain, osteoarthritis, low back pain, carpal tunnel syndrome, and asthma, in which acupuncture may be useful as an adjunct treatment or an acceptable alternative or be included in a comprehensive management program. Further research is likely to uncover additional areas where acupuncture interventions will be useful.
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                Author and article information

                Contributors
                tony_ever@hotmail.com
                wangguiling100@163.com
                libin@bjzhongyi.com
                wlp5558@sina.com
                guojing_2002@163.com
                rourou480@163.com
                dx_bjtcmh08016@163.com
                carland95@126.com
                sjq100037@sina.com
                lcz623780@126.com
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                22 August 2018
                22 August 2018
                2018
                : 19
                : 454
                Affiliations
                [1 ]GRID grid.459365.8, Department of Acupuncture and Moxibustion, , Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, ; Beijing, China
                [2 ]GRID grid.459365.8, Department of Acupuncture and Moxibustion, , Shunyi Hospital affiliated to Beijing Hospital of Traditional Chinese Medicine, ; Beijing, China
                [3 ]ISNI 0000 0001 1431 9176, GRID grid.24695.3c, Dongfang Hospital affiliated to Beijing University of Traditional Chinese Medicine, ; Beijing, China
                Author information
                http://orcid.org/0000-0002-8349-9091
                Article
                2750
                10.1186/s13063-018-2750-0
                6106942
                30134942
                3533dd07-c5ae-4586-9747-88ac36e7d4ca
                © The Author(s). 2018

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 14 January 2018
                : 19 June 2018
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100009592, Beijing Municipal Science and Technology Commission;
                Award ID: Z151100004015109
                Award ID: BZ0437
                Award Recipient :
                Funded by: FundRef http://dx.doi.org/10.13039/501100002855, Ministry of Science and Technology of the People's Republic of China;
                Award ID: 2014CB543203
                Award Recipient :
                Funded by: Beijing Municipal Government, Beijing, China
                Award ID: 2017000021469G298
                Award Recipient :
                Funded by: Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing, China
                Award ID: XX-201702
                Award Recipient :
                Funded by: FundRef http://dx.doi.org/10.13039/501100009600, Beijing Municipal Administration of Traditional Chinese Medicine;
                Award ID: 1+X+N Project
                Award Recipient :
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2018

                Medicine
                acupuncture,constipation,ischemic stroke,study protocol
                Medicine
                acupuncture, constipation, ischemic stroke, study protocol

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