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      Study protocol for a single-blind, placebo-controlled randomised trial of Tianjiu effects in patients with intradialytic hypotension

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          Abstract

          Introduction

          Intradialytic hypotension (IDH) is the most frequent complication of haemodialysis (HD) and may contribute to cardiovascular events and high mortality. The aetiology of IDH is multifactorial; therefore, it remains a challenging problem in the management of patients with HD. Since the application of Tianjiu at specific points can influence haemodynamics, we hypothesise that Tianjiu therapy at the traditionally used meridian points will reduce the severity of hypotension in patients who undergo HD.

          Methods/analysis

          In this clinical trial, eligible patients with IDH will be divided randomly and equally into a Tianjiu group and a control group for 4 weeks. In the Tianjiu group, the patients will have Tianjiu applied at three points (conception vessel 4, and bilateral kidney 1) during each HD session. In the control group, patients will have clay patches applied in the same way as those in the Tianjiu treatment group. Both groups will be followed up for 2 weeks. The primary outcome measure will be the percentage of target ultrafiltration achieved, defined as the actual ultrafiltration volume divided by the target ultrafiltration volume. Secondary outcome measures, including frequency of IDH episodes and number of nursing interventions during HD sessions, predialysis and postdialysis blood pressure (BP), patient's participative assessment of the degree of fatigue after dialysis (scale from 0, not at all, to 10, extremely), and recovery time from fatigue after dialysis will be recorded at the 0th and 4th weeks.

          Ethics/dissemination

          This trial has undergone ethical scrutiny and been approved by the ethics review board of Chang Gung Memorial Hospital (Permission number: 102-4749A3 and 104-3156C). The pre-results of this trial will help to determine whether Tianjiu is an effective and safe treatment for IDH, and, if so, whether it is a therapeutic effect rather than a placebo effect.

          Trial registration number

          NCT02210377; Pre-results.

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          Most cited references28

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          • Article: not found

          Adverse events of moxibustion: a systematic review.

          The aim of this review was to identify adverse events of moxibustion as reported in the medical literature. Computerised literature searches were carried out in 14 databases. All articles reporting adverse effects of any type from moxibustion in humans were included, regardless of study design and publication language. The related journals and references in all located articles were manually searched for further relevant articles. Data were extracted and evaluated according to predefined criteria by three independent reviewers. Adverse events related to moxibustion treatment were reported in 4 randomised clinical trials, 1 controlled clinical trial, 2 uncontrolled observational studies, 13 case reports, and 1 prospective study. The most common effects identified in this review were allergic reactions, burns, and infections such as cellulitis and hepatitis C. Allergic reactions were reported in six case reports (four case reports related to infections and two related to burns). The other articles were case reports of xerophthalmia, xeroderma, hyperpigmented macules, ptosis and eversion of the eyelids. In clinical trials, various adverse events such as rubefaction, blistering, itching sensations, discomfort due to smoke, general fatigue, stomach upsets, flare-ups, headaches, and burns were reported. Tenderness and pressure in the epigastric region or in one of the hypochondriac regions, unpleasant odour with or without nausea and throat problems, abdominal pain, premature birth, premature rupture of the membrane and bleeding due to excess pressure on the anterior placenta were reported in pregnant women. Moxibustion is not entirely risk free, as it has several kinds of potential adverse events such as allergy, burn and infection. Currently, the incidence of such events is not known. In the interest of patient safety, sufficiently large prospective studies should be considered to clarify this issue. Copyright © 2010 Elsevier Ltd. All rights reserved.
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            Recent advances in the prevention and management of intradialytic hypotension.

            Intradialytic hypotension continues to play a significant role in the morbidity and in some cases the mortality associated with maintenance hemodialysis. Greater precision in the determination of dry weight using bioimpedance technology and biofeedback systems designed to prevent rapid fluctuations in blood volume have recently been shown to decrease the frequency of this complication. Pharmacologic strategies designed to maintain peripheral vascular resistance in patients with insufficient release of endogenous vasoconstrictors continue to be explored. The sudden development of intradialytic hypotension may respond to specific antagonists to hypotensive mediators.
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              • Record: found
              • Abstract: not found
              • Article: not found

              Dialysis hypotension: a hemodynamic analysis.

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                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2016
                10 March 2016
                : 6
                : 3
                : e009976
                Affiliations
                [1 ]Graduate Institute of Integrated Medicine, College of Chinese Medicine, China Medical University , Taichung, Taiwan
                [2 ]Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine , Kaohsiung, Taiwan
                [3 ]Division of Nephrology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine , Kaohsiung, Taiwan
                [4 ]School of Chinese Medicine for Post Baccalaureate, I-Shou University , Kaohsiung, Taiwan
                [5 ]School of Chinese Medicine, College of Chinese Medicine, China Medical University , Taichung, Taiwan
                [6 ]Department of Psychology, College of Medical and Health Science, Asia University , Taichung, Taiwan
                Author notes

                C-HW and Y-HC contributed equally to this study.

                [Correspondence to ] Chien-Hsing Wu; chienhsingwu@gmail.com and Yung-Hsiang Chen; yhchen@ 123456mail.cmu.edu.tw
                Article
                bmjopen-2015-009976
                10.1136/bmjopen-2015-009976
                4800128
                26966058
                ed7ac558-d24d-4e1f-a0e3-e82ac73c0c66
                Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

                This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

                History
                : 11 September 2015
                : 15 February 2016
                : 19 February 2016
                Categories
                Complementary Medicine
                Protocol
                1506
                1685
                1685
                1728

                Medicine
                complementary medicine
                Medicine
                complementary medicine

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