In a short-term, double-blind, placebo-controlled clinical trial, twelve patients (eight female, four male) with refractory chronic congestive heart failure were given dried extract of the bark of the Indian medicinal plant Terminalia arjuna Wight & Arn., Combretaccae, for six weeks in conjunction with conventional therapy. The herb has been weeks in conjunction with conventional therapy. The herb has been used in Ayurvedic traditional medicine of India for heart conditions since the sixth century B.C. Because refractory chronic congestive heart failure is a therapeutic enigma with a high mortality rate, any new therapy with adequate safety margins that can prolong survival and improve the quality of life for these patients is welcome. The results of this short-term trial showed that the herb was useful, and a second phase consisting of long-term evaluation in an open design was then conducted.

In the first trial (Phase 1), each patient received both T. arjuna and a placebo. Each patient received one 500 mg capsule of T. arjuna every eight hours for a period of two weeks. This initial period was followed by a washout period of two weeks (in which no treatment was administered), followed by another period of two weeks (in which no treatment was administered), followed by another two-week treatment with placebo capsules. During this six-week period, patients continued their usual antifailure and supportive therapies. The trial was double-blind, and the sequence of administration of the T. arjuna and placebo capsules was not known until the end of the six weeks, at which time an evaluation from baseline to end was carried out for T. arjuna and for the placebo, and compared. Regression of signs of heart failure and appreciable improvement in symptoms such as dyspnea (shortness of breath) and fatigue were seen with T. arjuna as compared to placebo. A decrease in echo-left ventricular enddiastolic volume and endsystolic volume indices was observed, as well as an increase in left ventricular ejection fractions. It was decided that Phase II of the study would commence.

Phase II, which lasted for a mean of 24 months (20-28), was conducted to determine whether the improvements observed in Phase I would be sustained with continued treatment with T. arjuna, and to establish the safety of the extract for long-term use. Phase I participants continued with 500 mg dosages of T. arjuna every eight hours as adjuvant therapy. They continued to show improvements in symptoms and signs of heart failure as well as in quality of life for about two to three months, with the improvement being more or less maintained throughout the remaining period of the study. Two patients died during Phase II: one at 16 months into the study, of cerebrovascular accident; the other at 14 months of sudden cardiac death. In neither case did any "significant clinical untoward effect" occur during T. arjuna or placebo therapy.

This clinical investigation confirms the short- and long-term benefits and safety of T. arjuna adjuvant therapy in patients with otherwise unresponsive chronic congestive heart failure. The mechanism of action of this medicinal plant extract still needs to be determined; it may be related to the cardiotonic properties of the plant's glycoside content or to the free-radical scavenging actions of the plant's tannins and flavones.

References:

[Bharani, A., A. Ganguly, and K. D. Bhargava. 1995. Salutary effect of Terminalia Arjuna in patients with severe refractory heart failure.

International Journal of Cardiology, Vol. 49, 191-199.

Reichert, R. 1996, Terminalia arjuna for Congestive Heart Failure. Quarterly

Review of Natural Medicine, Fall, 177-178.]