In the first trial (Phase I), 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 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 wel l 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 months), 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 - 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.
[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.]
Article copyright American Botanical Council.
By Ginger Webb