Abstract
BackgroundChronic stable angina is a leading cause of death worldwide. Danhong injection, a complementary alternative medicine for chronic stable angina, has been demonstrated to be effective in numerous studies and is widely prescribed to patients. However, the methodological quality of most prior studies was found to be, in general, low. Therefore, we designed this randomized controlled trial to evaluate the efficacy and safety of using Danhong injection to treat chronic stable angina.Methods/designThis is a randomized multicentre, double-blind, placebo-controlled, adaptive clinical trial. A total of 870 patients meeting the eligibility criteria will be randomly assigned into either the Danhong injection or the placebo group in a 2:1 ratio. Participants will then undergo a 2-week treatment regimen and a 76-day follow-up period. Because this is an adaptive trial, two interim analyses are prospectively planned. These will be performed after one-third and two-thirds of the patients, respectively, have completed the trial. Based on the results of these interim analyses, a data monitoring committee will determine how to modify aspects of the study without undermining the validity and integrity of the trial. The primary outcome measure is the proportion of patients who show a clinically significant change, which is defined as at least a 20-point improvement in angina frequency score on the Seattle Angina Questionnaire, which will be administered on day 30. Other secondary efficacy and safety outcomes will also be assessed.DiscussionThis trial will provide high-quality evidence regarding the use of Danhong injection to treat chronic stable angina.Trial registrationClinicalTrials.gov: NCT01681316.
Highlights
Chronic stable angina is a leading cause of death worldwide
This trial will provide high-quality evidence regarding the use of Danhong injection to treat chronic stable angina
It is widely accepted that a randomized controlled trial is the gold standard for evaluating the clinical efficacy and safety of a Chinese medicine and for providing critical evidence to develop and guide treatment strategies
Summary
It is widely accepted that a randomized controlled trial is the gold standard for evaluating the clinical efficacy and safety of a Chinese medicine and for providing critical evidence to develop and guide treatment strategies. We designed and implemented the study in a scientific, strict and cautious manner to provide reliable evidence regarding the use of Danhong injection as a complementary therapy for treating chronic stable angina In this trial, we adopted an adaptive design, which is defined as a study that includes a prospectively planned opportunity for the modification of one or more specified aspects of the study design and hypotheses based on the analysis of accumulating data (usually interim data) from subjects in the study [36]. We use changes in Seattle Angina Questionnaire scores and traditional Chinese medicine syndrome scores as our outcome measures because they both focus on patient symptoms This will help us to provide reliable and convincing evidence for the efficacy of Danhong injection. All authors participated in revising the manuscript, and all authors read and approved the final version for publication
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