Traditional Chinese medicine for stable angina pectoris via TCM pattern differentiation and TCM mechanism: study protocol of a randomized controlled trialReportar como inadecuado




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Trials

, 15:422

First Online: 30 October 2014Received: 24 July 2014Accepted: 13 October 2014DOI: 10.1186-1745-6215-15-422

Cite this article as: Zhang, Z., Zhang, F., Wang, Y. et al. Trials 2014 15: 422. doi:10.1186-1745-6215-15-422

Abstract

BackgroundStable angina pectoris is experienced as trans-sternal or retro-sternal pressure or pain that may radiate to the left arm, neck or back. Although available evidence relating to its effectiveness and mechanism are weak, traditional Chinese medicine is used as an alternative therapy for stable angina pectoris. We report a protocol of a randomized controlled trial using traditional Chinese medicine to investigate the effectiveness, mechanism and safety for patients with stable angina pectoris.

Methods-DesignThis is a north-east Chinese, multi-center, multi-blinded, placebo-controlled and superiority randomized trail. A total of 240 patients with stable angina pectoris will be randomly assigned to three groups: two treatment groups and a control group. The treatment groups will receive Chinese herbal medicine consisting of Yi-Qi-Jian-Pi and Qu-Tan-Hua-Zhuo granule and Yi-Qi-Jian-Pi and Qu-Tan-Hua-Yu granule, respectively, and conventional medicine. The control group will receive placebo medicine in addition to conventional medicine. All 3 groups will undergo a 12-week treatment and 2-week follow-up. Four visits in sum will be scheduled for each subject: 1 visit each in week 0, week 4, week 12 and week 14. The primary outcomes include: the frequency of angina pectoris attack; the dosage of nitroglycerin; body limited dimension of Seattle Angina Questionnaire. The secondary outcomes include: except for the body limited dimension of SAQ, traditional Chinese medicine pattern questionnaire and so on. Therapeutic mechanism outcomes, safety outcomes and endpoint outcomes will be also assessed.

DiscussionThe primary aim of this trial is to develop a standard protocol to utilize high-quality EBM evidence for assessing the effectiveness and safety of SAP via TCM pattern differentiation as well as exploring the efficacy mechanism and regulation with the molecular biology and systems biology.

Trial registrationClinical Trials Registration: ChiCTR-TRC-13003608, registered 18 June 2013.

AbbreviationsAchacetylcholine

ALTalanine transaminase

ANCOVAanalysis of covariance

ANOVAanalysis of variance

ASTaspartate aminotransferase

BBsβ blockers

BUNblood urea and nitrogen

CCBscalcium channel blockers

CCSCanadian Cardiovascular Society

CHDcoronary heart disease

CONSORTConsolidated Standards of Reporting Trials

Crcreatinine

CRFsCase Report Forms

CTcomputed tomography

EBMevidence-based medicine

ECGelectrocardiograph

FASfull analysis set

GERDgastric and esophageal reflux disease

GMPGood Manufactory Practice

Group 1Yi-Qi-Jian-Pi and Qu-Tan-Hua-Zhuo group

Group 2Yi-Qi-Jian-Pi and Qu-Tan-Hua-Yu group

HCMhypertrophic cardiomyopathy

HDLhigh-density lipoprotein

HTShigh throughput screening

IRBInstitutional Review Board

ITTintention-to-treat

LADleft anterior descending

LCXleft circumflex

LDLlow-density lipoprotein

LMleft main stem

LOCFlast observation carried forward

NEnorepinephrine

PPSper-protocol set

RCAright coronary artery

SAPstable angina pectoris

SAQSeattle Angina Questionnaire

SASStatistical Analysis System

SOPstandard operating procedures

SPSSStatistic Package for Social Science

SSsafety set

TCtotal cholesterol

TCMtraditional Chinese medicine

TGtriglycerides

UAPunstable angina pectoris

VCAM-1vascular cell adhesion protein-1

VIPvasointestinal peptide

WHOWorld Health Organization

WMwestern medicine.

Electronic supplementary materialThe online version of this article doi:10.1186-1745-6215-15-422 contains supplementary material, which is available to authorized users.

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Autor: Zhe Zhang - Fan Zhang - Yang Wang - Yi Du - Huiyong Zhang - Dezhao Kong - Yue Liu - Guanlin Yang

Fuente: https://link.springer.com/







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