A Chinese Compound Prescription Ding Xin Recipe Combined with Amiodarone for Treating Premature Ventricular Complexes: A Randomized, Double-Blind, Multicenter, Placebo-Controlled Trial

Objective To evaluate the efficacy and safety of Ding Xin Recipe (DXR) combined with amiodarone in patients with PVCs. Methods A total of 360 patients with PVCs across 7 centers in China were randomly assigned in a 1:1:1 ratio to receive up to 8 weeks of amiodarone combined with DXR placebo (amiodarone group), DXR combined with amiodarone placebo (DXR group), or DXR combined with amiodarone (DCA group) from July 2012 to December 2013. Randomization was conducted according to a centralized randomization schedule prepared by an independent steering committee. Staff and patients at all sites were masked to treatment allocation. All patients received best-evidence advice. The primary outcome was the efficacy for treating PVCs, with efficacy assessed by the reduction of premature ventricular contractions. Other outcome measures included PVCs-related symptom scores. All data were analyzed by intention to treat. Results The efficacy for treating PVCs in the DCA group (90.7%) significantly increased compared with that in the amiodarone group (72.3%) and the DXR group (73.9%). The frequency, the degree, and the duration per week of heart palpitations, chest tightness, shortness of breath and fatigue improved significantly in the DCA group in comparison with the amiodarone group and the DXR group (P < 0.05), while no significant difference was observed in the improvement of insomnia among the three groups (P > 0.05). With regard to laboratory parameters for safety, there were no clinically relevant changes in the three groups. Conclusion The present study demonstrates that DXR combined with amiodarone is significantly more effective than DXR or amiodarone alone for treating PVCs.