Reviewed: Bharani A, Ganguli A, Mathur LK, Jamra Y, Raman PC. Efficacy of Terminalia arjuna in chronic stable angina: A double-blind, placebo-controlled, crossover study comparing Terminalia arjuna with isosorbide mononitrate. Indian Heart Journal 2002:54:170-175.
Arjuna (Terminalia arjuna (Roxb. ex DC.) Wight & Am., Combretaceae) bark and its water extract has been used in Ayurvedic traditional medicine in India since 500 B.C.E. for the treatment of heart ailments, but has not been rigorously tested scientifically. Some previous studies have been published.[ 1][ 2] but were not as rigorously controlled as this one. This carefully designed study provides a comparison of the efficacy of arjuna extract compared to the standard drug therapy (isosorbide mononitrate) in patients with stable angina (chest pain, usually under exertion).
The study design was randomized, placebo-controlled, doubleblind, and crossover. Included in the study were 58 male patients 38-79 years old with chronic stable angina (class II-III according to the New York Heart Association [NYHA] functional classification) and exercise-induceable ischemia (oxygen starvation of the heart). Excluded were those with acute myocardial infarction (heart attack), severe effort angina, unstable angina, heart failure, chronic hepatic or renal disease, neuropsychiatric illness, malignancy, drug addiction, AIDS, physical inability to exercise, or nitrate intolerance. Patients continued ail prescribed drugs, except for beta-blockers and isosorbide mononitrate (ISMN). Isosorhide di nitrate (ISDN) was provided for use during episodes of angina. All participants had a thorough clinical evaluation including ECG, chest Xray, and echocardiogram to determine baseline data.
Patients were given three bottles marked "morning," "afternoon," and "evening" and were instructed to take one pill from each bottle at the designated time for one week. The bottles contained:
arjuna bark extract (IPC-53) (500 mg/tablet) in all three bottles, or
ISMN (20 mg/tablet) in the morning and afternoon bottles and placebo in the evening bottle, or
matched placebo in all three bottles.
The arjuna bark extract was prepared by concentrating and drying both alcohol and water extracts and then mixing them together. Every patient used all three treatments for one week with a 3-day washout period between each treatment. At the end of each week-long period of therapy, clinical, biochemical, and treadmill exercise tests were administered. The number of episodes of angina and ISDN pills consumed was also noted.
Angina improved in 47 percent of patients when on arjuna and 53 percent of patients when on ISMN (both P< 0.005 vs. placebo), but in none when on placebo. Over half the patients had an improvement of at least one NYHA class. The need for ISDN was significantly reduced in 96 percent of patients on either arjuna or ISMN (P values not given). There was a significant increase in exercise duration, recovery time, and double products (blood pressure x peak heart rate); and a significant decrease in maximal ST depression with arjuna or ISMN compared to placebo (all P <0.005). The differences between arjuna or ISMN for all these parameters were not significant. Patients with associated diseases (diabetes, disorders of lipoprotein metabolism, high blood pressure, previous myocardial infarction) experienced results similar to those in patients without these conditions. Resting heart rate, blood pressure parameters, and blood chemistry were not different between the three treatments. Reported adverse effects were rare, mild, and no different between treatments and included headache, constipation, abdominal discomfort, and body ache.
The treadmill test parameters used were modified from the standard to increase their sensitivity and accuracy. In addition, women were excluded because the treadmill rest is less sensitive for them. The promising results of this well-designed study prompt largescale clinical studies and research into the mechanism of action of jrjuna.
1. Bharani A, Bhargava A, Bhargava KD. Salutary effect of Terminalia arjuna in patients wiih severe refractory heart failure. Int J Cardiol 1995;49(3):191-9.
2. Dwivedi S. Agarwal MP. Antianginal and cardioprotecrive effects of Terminals arjuna, an indigenous drug, in coronary artery disease. J Assoc Physicians India 1994;42(4)287-9.
By Risa N. Schulman, Ph.D.