Evidence map›Paper›PMID 26966058›Full record

Trial reportBMJ open2016

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

Ming-Yen Tsai, Yu-Jen Su, Hwee-Yeong Ng, Shih-Yu Chen, Yu-Chuen Huang, Chien-Hsing Wu, Yung-Hsiang Chen

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in BMJ open, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02210377 (Department of Traditional Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
1.9field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02210377 phase2unknown statusnot on this map

Department of Traditional Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung

TypeinterventionalSponsorChang Gung Memorial HospitalRan2015 to 2016Enrolled45ConditionsIntradialytic HypotensionArmsTianjiu, Placebo (non-Tianjiu)
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Interventions for fatigue in people with kidney failure requiring dialysis.The Cochrane database of systematic reviews · 2023
    Pooled it
  2. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 5 institutions in 1 country.

Ming-Yen TsaiGraduate 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.
Yu-Jen SuDivision of Nephrology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.
Hwee-Yeong NgDivision of Nephrology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.
Shih-Yu ChenSchool of Chinese Medicine for Post Baccalaureate, I-Shou University, Kaohsiung, Taiwan.
Yu-Chuen HuangSchool of Chinese Medicine, College of Chinese Medicine, China Medical University, Taichung, Taiwan.
Chien-Hsing WuDivision of Nephrology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.
Yung-Hsiang ChenGraduate 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.
Chang Gung University · TWChina Medical University · TWAsia University · TWI-Shou University · TWKaohsiung Chang Gung Memorial Hospital · TW

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIntradialytic 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.

Indexed as

MoxibustionRenal DialysisResearch DesignAdultAgedBlood PressureFatigueFemaleHumansHypotensionKidney Failure, ChronicMaleMiddle AgedSingle-Blind MethodTaiwanTransdermal PatchCOMPLEMENTARY MEDICINE

Identifiers

PMID26966058
PMCPMC4800128
OpenAlexW2296115819

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.