Terminalia arjuna, an Indian medicinal plant, has been reported to have beneficial effects in patients with
ischemic heart disease in a number of small, open studies. The need for a double-blind, randomized, placebo-controlled study with adequate sample size has long been felt. The bark extract (IPC-53) contains
acids (
arjunic acid, terminic
acid),
glycosides (
arjunetin arjunosides I-IV), strong
antioxidants (
flavones,
tannins, oligomeric
proanthocyanidins), minerals. etc. and exhibits antifailure and anti-ischemic properties.
METHODS AND RESULTS: Fifty-eight males with
chronic stable angina (NYHA class II-III) with evidence of provocable
ischemia on treadmill exercise test received Terminalia arjuna (500 mg 8 hourly),
isosorbide mononitrate (40 mg/daily) or a matching placebo for one week each, separated by a wash-out period of at least three days in a randomized, double-blind, crossover design. They underwent clinical, biochemical and treadmill exercise evaluation at the end of each
therapy which were compared during the three
therapy periods. Terminalia arjuna
therapy was associated with significant decrease in the frequency of angina and need for
isosorbide dinitrate (5.69+/-6.91 mg/week v. 18.22+/-9.29 mg/week during placebo
therapy, p<0.005). The treadmill exercise test parameters improved significantly during
therapy with Terminalia arjuna compared to those with placebo. The total duration of exercise increased (6.14+/-2.51 min v. 4.76+/-2.38 min, p<0.005), maximal ST depression during the longest equivalent stages of submaximal exercise decreased (1.41+/-0.55 mm v. 2.21+/-0.56 mm, p<0.005), time to recovery decreased (6.49+/-2.37 min v. 9.27+/-3.39 min, p<0.005) and higher double products were achieved (25.75+/-4.81x10(3) v. 23.11+/-4.83x10(3), p<0.005) during Terminalia arjuna
therapy. Similar improvements in clinical and treadmill exercise test parameters were observed with
isosorbide mononitrate compared to placebo
therapy. No significant differences were observed in clinical or treadmill exercise test parameters when Terminalia arjuna and
isosorbide mononitrate therapies were compared. No significant untoward effects were reported during Terminalia arjuna
therapy.
CONCLUSIONS: Terminalia arjuna bark extract, 500 mg 8 hourly, given to patients with
stable angina with provocable
ischemia on treadmill exercise, led to improvement in clinical and treadmill exercise parameters as compared to placebo
therapy. These benefits were similar to those observed with
isosorbide mononitrate (40 mg/day)
therapy and the extract was well tolerated. Limitations of this study include applicability of the results to only men with
chronic stable angina but not necessarily to women, as they were not studied.