by

Dr. Anthony G. Payne

In the natural health care field, there are products that frankly don't work, some that work but lack scientific proof, and a precious few which are supported by hard scientific evidence of effectiveness. HEARTROL, a Tibetan herbal formula, belongs in the latter category. In fact, the scientific evidence is so compelling that the Swiss equivalent of the Food and Drug Administration has approved HEARTROL  as a drug for the treatment of peripheral artery disease (PAD).

Heartrol™ And PAD

When arteries in the lower extremities narrow with plaque (cholesterol and calcium deposits), oxygen and blood flow will be impeded. As this condition, PAD, progresses, sufferers begin experiencing the onset of leg pain whenever they walk short distances. This is known as intermittent claudication.

In three separate double blind clinical trials, scientists tested the effects of Heartrol™ on PAD. What they discovered substantiated the herbal drug's folklore reputation as a vasoactive (circulatory system influencing) compound. In a double blind study, the drug or product to be tested and a sham version look-alike called a placebo, are dispensed to participants. Bottles are coded by persons having no contact with anyone involved in the study. Neither those who hand out the pills and/or compile data nor the participants knows who received what.

At the conclusion of the trial, the code is broken and the data analyzed. The results indicate whether the drug or product was truly effective compared to the placebo.

One study, carried out by Dr. Ruke Schraeder at the University of Berne and published in the Swiss Weekly Medical Review (115:752-6, 1985), looked at 43 patients over four weeks. Prior to commencing the study, patients were given a treadmill ergometer test to see just how far they could walk before the onset of pain; the average was 250 meters. Those who took Heartrol (three capsules twice daily) experienced a 100% increase in pain-free and maximal walking distances. Those who received the placebo experienced no significant change in their condition.

Another study, headed by L. Samochowiec at the Pharmacological Institute of Szczecin, Poland and published in Herba Polonica (33:219-22. 1987) and Polbiopharm Reports (22:15-19, 1987), involved 100 patients with diagnosed peripheral arterial occlusion (blockage) with intermittent claudication. The maximum average walking distance of the participants on a treadmill ergometer was less than 150 meters. After four months on Heartrol™, patients experienced a 98% increase in maximal walking distance; a statistically significant decrease in triglycerides and those lipid fractions (cholesterol components) involved in the genesis of arterial plaque; and a 100% increase in platelet aggregation threshold (thus decreasing the likelihood that the disc-shaped platelets in the blood will stick together forming clumps that can attach to and/or suddenly block blood vessels).

The placebo group experienced only a very minor increase in maximal walking distance and no significant improvements in blood chemistry.

Heartrol™ And Angina

When arteries to the heart get clogged with plaque, the amount of blood and (hence) oxygen reaching cardiac muscle is reduced. As the plaque building process continues, sufferers invariably begin to experience chest pains (angina pectoris) upon exertion. When this occurs, doctors typically prescribe a drug to help increase blood flow to the heart. The drug most often selected is nitroglycerin.

Given Heartrol's vasoactive properties, many European doctors felt that it might prove of value in the treatment of angina. Those who put patients on the herbal drug reported that they were experiencing a sharp reduction in the frequency and severity of angina attacks. What was needed was definitive scientific proof.

In the mid-eighties, the scientists who had carried out the Polish studies on Heartrol™ and PAD decided to test its effects on angina. A six week double blind study was designed in which each participant would take a placebo the first two weeks, Heartrol™ for the third and fourth weeks, and a placebo for the final two week period. (Neither the participants nor those who handed out the capsules would know which was being administered or when.)

There were 50 patients, with a mean age of 51.2 years, a clear history of angina with exertion that dated back at least one year, and without high blood pressure or any evidence of heart enlargement or failure. During the study, patients were required to keep a record of their daily consumption of nitroglycerin tablets, as well as the number of angina attacks.

Heartrol's effectiveness was indisputable. The mean number of angina attacks during the initial two weeks on the placebo was 37.5. This figure fell to 11.5 during the two weeks of Heartrol™ use (a 69% drop). Simultaneously, the mean number of nitroglycerin tablets taken during the initial placebo phase was 27.7, which fell to 7.9 during the two weeks of Heartrol™ consumption (a 77% decline). When the patients went back on the placebo in the final two weeks, the number of angina attacks experienced and nitroglycerin tablets taken shot up; even though not to the levels seen during the initial 2 weeks ・a phenomenon researchers attributed to the long-lasting effects of Heartrol™.

The only side effects noted during all the clinical trials involving Heartrol™ were minor: a handful of patients experienced periodic mild stomach upset, a small number developed a skin rash. None of these patients experienced side effects severe enough to warrant their dropping out of the clinical studies.

Heartrol And Presenility

Many elderly people experience a decline in mental function due to changes in their cerebral circulation brought about by plaque build-up. Given Heartrol 's track record in ameliorating conditions involving narrowed arteries, it should prove useful in treating presenility. This is exactly what occurred to Harry K. Panjwani, M.D., Ph.D., in the mid-eighties.

Panjwani, former Director of Medical Research for the pharmaceutical giant Merck and a practicing psychiatrist, decided to carry out a pilot study to assess Heartrol's effects on various mental functions in his geriatric patients. He studied 34 patients over the age of 55, all of whom had some degree of artery disease which had caused various mental and physical symptoms (including poor memory), many of whom had been treated for many years with conventional therapies and drugs. They were treated with two tablets of Heartrol™ twice daily for six months, to the exclusion of other drugs or products which might improve cerebral circulation.

During the course of Dr. Panjwani's study, both patients and clinic staff noted significant improvement in alertness, feelings of well being, and various intellectual functions, including memory.

The drawback to Dr. Panjwani's study lies in the fact it was not scientifically rigorous; that is, various influences on patient response, such as expectation and clues from the clinicians, were not minimized or eliminated, as would be the case in a double blind, placebo controlled trial. Still, the positive change noted in the majority of patients suggests that Heartrol had beneficial effects. The final word, of course, must await the execution of well-designed controlled clinical studies.

Conclusion

In the world of science we cannot speak of anything as being absolutely proven; that is, the tools and methods of the scientific enterprise yield knowledge which can be modified or overturned by new evidence. However, when the proof supporting a particular theory or drug accumulates, we can speak of it as being substantially proven. Heartrol's vasoactive properties have been conclusively demonstrated in at least four double blind clinical trials. As such, calling it a proven natural drug is in order.

Heartrol™ is available online from HEARTROL.COM

Anthony G. Payne, Ph.D., can be reached by e-mail at biotheoretician@gmail.com  

This article is adapted from one penned by Dr. Payne which appeared in the September 1996 Issue of “Healthy & Natural Journal”. This revised version © 2007. All rights reserved.

The Heartrol™ blend is identical to PADMA28 and is indeed blended by the guardian of the original and historic Tibetan PADMA formula, Vladimir Badmaev, M.D.