Safety and efficacy of Hartone in stable angina pectoris--an open comparative trial.

ABSTRACT

OBJECTIVES: To evaluate the safety and efficacy of 'Hartone'--a proprietary herbal product primarily containing Terminalia arjuna in stable angina pectoris patients. PATIENTS AND METHODS: Ten patients with stable angina pectoris were given Hartone 2 caps twice daily for 6 weeks and 1 cap twice daily for the next 6 weeks. Haematological and biochemical investigations to assess safety were carried out on day 0, day 42 and day 84. Serum lipid profile was done before and after therapy. Efficacy was assessed by considering the reduction in the number of anginal episodes and improvement in stress test. The results were compared with 10 patients of stable angina pectoris on isosorbide mononitrate (ISMN) 20 mg twice daily. RESULTS: Hartone afforded symptomatic relief in 80% of patients and ISMN in 70%. The number of anginal attacks were reduced from 79/wk to 24/wk by Hartone and from 26/wk to 7/wk by ISMN. Although patients of both groups showed improvement in several stress test parameters compared to base line, the difference was not statistically significant. Hartone improved BP response to stress test in two patients and ejection fraction in one. Hartone was better tolerated than ISMN and showed no evidence of hepatic or renal impairment. Its effects on lipid profile was not consistent. CONCLUSION: Hartone is a safe and effective anti-anginal agent comparable to ISMN and is better tolerated. Large scale, randomised, double blind trials are needed to prove its efficacy.