WANG Xianliang, YUAN Yang, MAO Jingyuan, et al. Optimized New Shengmai Powder(新生脉散) Combined with Western Medicine Treating Chronic Heart Failure: a N-of-1 Crossover Study[J]. Journal of Traditional Chinese Medicine2015, 56(21): 1849-1853.
WANG Xianliang, YUAN Yang, MAO Jingyuan, et al. Optimized New Shengmai Powder(新生脉散) Combined with Western Medicine Treating Chronic Heart Failure: a N-of-1 Crossover Study[J]. Journal of Traditional Chinese Medicine2015, 56(21): 1849-1853.DOI: 10.13288/j.11-2166/r.2015.21.013.
Objective To observe the clinical effect and safety of optimized New Shengmai Powder and original New Shengmai Powder treating chronic heart failure( CHF) patients of blood stasis and fluid retention syndrome.Methods The study was a crossover randomized controlled trial with individual patient. Twenty patients were randomized into groups and given standard treatment of optimized New Shengmai Powder combined with western medicine
western medicine alone and original New Shengmai Powder combined with western medicine respectively according to different order for 4 weeks in every stage. After Chinese medicine treatment
a washout period of 2 weeks was added and western medicine alone was applied during the period. When analyzing trial results
researchers named the20 patients in the stage of western medicine alone as treatment control group
the 20 patients in the stage of original New Shengmai Powder as treatment original prescription group and the 20 patients in the stage of optimized New Shengmai Powder as treatment optimization group. Observed cardiac functional grading
scores of Chinese medicine symptoms
scores of life quality
6-miniutes walk distance and indexes of ultrasound cardiogram before treatment and at the end of 3 treatments. Results After treatment
total effective rate of cardiac functional grading effect of control
original prescription and optimization groups was 50. 0%
60. 0% and 85. 0% respectively. Optimization group was superior to original prescription and control groups( P < 0. 05 or P < 0. 01). After treatment
total score of Chinese medicine symptoms and item scores of shortness of breath
weakness and edema of face and limbs of optimization group were superior to those of original prescription group( P < 0. 05). After treatment
quality of life
6-miniutes walk distance and ultrasound cardiogram ejection fraction of original prescription and optimization groups were improved( P < 0. 05 or P < 0. 01); optimization group was superior to original prescription group( P < 0. 05).Conclusion Optimized New Shengmai Powder treating CHF was effective and safe. It was also better than original New Shengmai Powder in relieving clinical symptoms
improving quality of life
increasing 6-miniutes walk distance and ejection fraction.