title: Study protocol for a single-blind, placebo-controlled randomised trial of Tianjiu effects in patients with intradialytic hypotension.
abstract: BACKGROUND
  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
  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.
  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.
  
  
  BACKGROUND
  NCT02210377; Pre-results.
authors.affiliation: Graduate Institute of Integrated Medicine, College of Chinese Medicine, China Medical University, Taichung, Taiwan Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.
authors.forename: Ming-Yen
authors.initials: MY
authors.lastname: Tsai
authors.affiliation: Division of Nephrology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.
authors.forename: Yu-Jen
authors.initials: YJ
authors.lastname: Su
authors.affiliation: Division of Nephrology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.
authors.forename: Hwee-Yeong
authors.initials: HY
authors.lastname: Ng
authors.affiliation: School of Chinese Medicine for Post Baccalaureate, I-Shou University, Kaohsiung, Taiwan.
authors.forename: Shih-Yu
authors.initials: SY
authors.lastname: Chen
authors.affiliation: School of Chinese Medicine, College of Chinese Medicine, China Medical University, Taichung, Taiwan.
authors.forename: Yu-Chuen
authors.initials: YC
authors.lastname: Huang
authors.affiliation: Division of Nephrology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.
authors.forename: Chien-Hsing
authors.initials: CH
authors.lastname: Wu
authors.affiliation: Graduate Institute of Integrated Medicine, College of Chinese Medicine, China Medical University, Taichung, Taiwan Department of Psychology, College of Medical and Health Science, Asia University, Taichung, Taiwan.
authors.forename: Yung-Hsiang
authors.initials: YH
authors.lastname: Chen
mesh_terms: D000328:Adult; D000368:Aged; D001794:Blood Pressure; D005221:Fatigue; D005260:Female; D006801:Humans; D007022:Hypotension / Q000628:therapy*; D007676:Kidney Failure, Chronic / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009071:Moxibustion; D006435:Renal Dialysis; D012107:Research Design; D016037:Single-Blind Method; D013624:Taiwan; D057968:Transdermal Patch; D055815:Young Adult
keywords: COMPLEMENTARY MEDICINE