Abstract

Objective: This study is a double blinded, randomized, placebo controlled clinical study for evaluation of safety and effective dose finding of Cardiotonic pillsⓇ in patients with chest pain and discomfort. The Cardiotonic PillsⓇ composed of Salviae Miltiorrhizae Radix(丹蔘), Notoginseng Radix(三七根) and Borneolum(龍腦). Major effects of Salviae Miltiorrhizae Radix and Notoginseng Radix are vasodilatation, sedation and analgesic action. And Borneolum has antibacterial effect, and can stimulate central nerve system. All of these substances are kinds of oriental herbs that have been used for a long time in east asia. Cardiotonic PillsⓇ got the Investigational New Drug(IND) approval from of Food and Drug Administration(FDA) in USA and 40 million people in the world take this pill. We performed phase IV clinical study to confirm this efficacy and safety in patient who has probable cardiogenic or psychogenic chest pain or chest stifling. Methods: This study was planned for multi-center clinical trial including four university hospitals of oriental medicine in Korea. And this is the first time to evaluate the "Planning treatment according to diagnosis(辨證施治)" of chest pain or chest discomfort according to oriental medical guideline. The patients who were included in this trial were adult volunteers from 20 to 70 years old who have the chest pain or chest discomfort more than twice during a recent month, and we received written consent to participate in this study from all of them. After administration of Cardiotonic PillsⓇ for 8 weeks, number of occurrence, duration, appearance and degree of chest pain or chest discomfort was observed and degree of symptoms(severity of illness, global improvement) were measured using "patient‘s global assessment composite scale". Results: In patients global assessment scale, the severity of illness of the Cardiotonic PillsⓇ group(n=25) was 14/25=0.56 but the placebo group(n=25) was 7/25=0.28 (p-value=0.0449). Therefore this result means The Cardiotonic PillsⓇ have a positive effect on the symptom of chest pain and discomfort. But the global improvement of the Cardiotonic PillsⓇ group was 23/25=0.92, and the placebo group was 22/25=0.88(p-value=0.6374). The total symptom score of the Cardiotonic PillsⓇ group was –1.68±20.06, and the placebo group was 16.76±72.14(p-value=0.2285). The number of symptom events of the Cardiotonic PillsⓇ group was 72±29.78, and the placebo group(n=25) was 10.80±38.42(p-value=0.3660). We could not find out any effects on the other examine besides the severity of illness, besides the difference of standards deviations. Conclusion: The Cardiotonic PillsⓇ significantly improved chest pain and chest discomfort in patients. Therefore we expect that the Cardiotonic PillsⓇ will be helpful in the patients with chest pain and chest discomfort not only caused by heart disease but also by other disease.