Role of Terminalia arjuna Wight and Arn. in the treatment of chronic coronary artery disease from pharmacovigilance point of view

BACKGROUND AND OBJECTIVES: Terminalia arjuna Wight and Arn. (Arjuna) has been used in indigenous system for the treatment of cardiac ailments since 500 BC. However, there is a lack of vigilance studies during long-term therapy. The present clinical study was planned to examine the long-term safety of Arjuna as an adjunct drug in chronic coronary artery disease (CAD) patients. MATERIALS AND METHODS: During the study period, a total of 35 patients of chronic CAD were enrolled to receive Arjuna bark extract powder (500 mg three times daily) along with conventional drugs. The control group (35 patients) received conventional drugs alone. Hemogram, liver function tests and kidney function tests were done at baseline and then every 6 months until the end of the study. Electrocardiography was done every 6 months and echocardiography was done yearly for left ventricular ejection fraction and regional wall motion abnormalities. Any adverse drug reactions reported by the patients were also recorded. RESULTS: The mean age of patients in test and control groups was 60.88 ± 9.02 and 58.51 ± 12.64 years, respectively. There was a predominance of male patients in both the groups. The patients were observed for duration ranging from 9 months to 4 years and 9 months. Other than baring gastritis and constipation, no other noteworthy adverse effects were reported. No significant difference was found in laboratory value on baseline and end of therapy in both the groups. CONCLUSION: The results of the present study concluded that Arjuna is safe and effective in patients with chronic coronary artery disease.