Effectiveness and safety of Guipi Mixture for the treatment of premature ventricular contractions (heart-spleen deficiency syndrome): study protocol for a randomized, double-blind, placebo-controlled, multicentre trial - Report - MDSpire
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Effectiveness and safety of Guipi Mixture for the treatment of premature ventricular contractions (heart-spleen deficiency syndrome): study protocol for a randomized, double-blind, placebo-controlled, multicentre trial
Clinical Report: Efficacy and Safety of Guipi Mixture in Treating PVCs
Overview
This report outlines a protocol for a randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of Guipi Mixture combined with metoprolol for treating premature ventricular contractions (PVCs) associated with heart-spleen deficiency syndrome. The study aims to provide evidence on the impact of this combination therapy on PVC counts and patients' quality of life.
Background
Premature ventricular contractions (PVCs) are a prevalent arrhythmia that can lead to serious cardiovascular complications if untreated. Current treatment options primarily include pharmacotherapy and catheter ablation, but these approaches may have limitations in efficacy and safety. Traditional Chinese Medicine (TCM), particularly Guipi Mixture, presents a potential alternative with a holistic approach to managing PVCs by addressing underlying deficiencies.
Data Highlights
This study will involve 200 subjects randomized to receive either Guipi Mixture plus metoprolol or a placebo plus metoprolol over an 8-week treatment period. The primary outcome will be the absolute change in 24-hour PVC count, with secondary outcomes including quality of life measures and adverse event tracking.
Key Findings
Guipi Mixture is a traditional Chinese medicine aimed at treating heart-spleen deficiency syndrome.
The study will assess the efficacy of Guipi Mixture in conjunction with metoprolol for PVC management.
Primary outcome measures include changes in PVC counts as assessed by ambulatory ECG.
Secondary outcomes will evaluate quality of life and sleep quality among participants.
The trial is designed as a multicenter study across 18 centers with a total of 200 participants.
Clinical Implications
The findings from this trial could provide insights into the effectiveness of combining TCM with conventional pharmacotherapy for PVCs. If successful, this approach may offer a new avenue for treatment in patients with heart-spleen deficiency syndrome.
Conclusion
This study aims to establish the safety and efficacy of Guipi Mixture in treating PVCs, potentially contributing to improved management strategies for this common arrhythmia.
