CONTROLLED STUDIES-KEEP THE WINDOWS OPEN

"All things flow, nothing abides"

HERACLITUS



Time evolution in a dynamic system, like the human body, depends on the total initial state of the organism. Any alteration in the initial state need not hold good as time evolves.1 If these two principles were understood, the concept of controlled studies in medicine, both drug and interventions, would seem unreliable!2 In the conventional controlled studies two matched human beings are compared. The total initial state of both the patient and the control being unknowable: in fact, a large part of the initial state-the genotype and the consciousness-are unknown, the outcome would be fallacious. This is precisely the reason why most, if not all, controlled study results have come to grief on long term audits.3,4,5,6,7,8,9,10,11,12,13 However, short term observations might not show the reality unless, the drug under study is dangerous.14



One need not despair. There is a ray of hope in the ancient Indian system of medicine, Ayurveda, wherein human beings are grouped into major three constitutional types-vaata, pittha, and kapha, with any number of sub-types. These types take into consideration almost the whole state of the human being-his phenotype, consciousness, as also some aspects of his genetic make up. Once a patient is classified into one of these groups, the control could also be selected from the same class. This could provide a better method to carry out controlled studies in the future. Detailed methods of classification are available in the ancient texts of Ayurveda.



Modern medicine, being a “science of uncertainties,” is looking for a way forward to get better predictability of the future.15 While modern medical research has given newer insights into diagnosis and management, it has also become prohibitively expensive. While the need for modern interventions is mandatory in emergency situations, most of the self-curing minor illness syndromes and the chronic degenerative diseases either do not need these expensive interventions or do not respond effectively without major side effects. Ayurveda, also allopathy, has very many effective methods of management for all these problems. Even the drug management in that system is holistic. One example would suffice.



Where vitamin C is given in modern medicine, Ayurveda would advocate eating a whole vegetable or a fruit that contains the same vitamin but, much more. The principle in Ayurveda is such that if a particular ingredient is good for a particular purpose, the other ingredients in the plant are needed to keep the side effects of the powerful ingredient under check. Even the photo-dynamicity of a plant is given due importance. Vitamin C in large doses, over a period of time, could cause cancer, but eating tomato or potato does not do so. Similarly, raw garlic is a very powerful drug, but garlic pearls, devoid of the SH group, are no good.



Time has come to bring in the good things in other systems of medicine, keeping the life saving emergency methods of modern medicine in place, to evolve a complementary system that is safe, effective and inexpensive. The future medical system should have the strong foundation of the bio-medical model of modern medicine, with useful surgical techniques as the roof, but its doors and windows should be open for good things to flow in from other medical systems that have stood the test of time. In this effort Ayurveda stands tall with its “time out of mind” observational research base. Its main thrust is to keep the healthy, well; the stress being on the human mind, which, according to Ayurveda, is the mother of all human illnesses. Modern medical research has amply demonstrated, through many recent studies, that negative thoughts are the leading risk factors for major killer diseases.16,17,18



Change of mode of living, with an emphasis on positive mental attitude, form the basis of Ayurveda. This, clubbed with modern medical methods, should be a boon to mankind.

Intellectual intolerance is the beginning of a dangerous terrorism that could destroy mankind. Let us try and understand the good things in other systems with the courage to admit our shortcomings. In this regard the example of controlled studies, touted to be the greatest find of modern medicine, stand out like a sore thumb! Let us devise better methods to test drugs and technology. We have been predicting the unpredictable. Of course, the solution suggested is not the last word in the field. We could go on evolving better methods as we go along. Let us make a beginning.



This is one of the reasons why I got interested in Ayurveda, despite my intensive training in the west. I was disillusioned by the long-term audit reports of many drugs and technologies in common use. Space does not permit a detailed discussion of the many other principles of Ayurveda here.





"There is time for departure even when there's no certain place to go"

Tennessee Williams









BIBLIOGRAPHY.



1. Hegde BM. Chaos- a new concept in science. Jr.Assoc.Physi.India 1996; 44:167‑168.

2. Editorial. The Flight from Science - Controlled Study. BMJ 1980; i:1-2

3. Editorial. Drug-company influence on medical education in USA. Lancet 2000; 356: 781.

4. Bucher HC, Hengstler P, Schindler C, and Guyatt GH. Percutaneous transluminal coronary angioplasty versus medical treatment for non- acute coronary heart disease: meta-analysis of randomised controlled trials. BMJ 2000 Jul 8; 321(7253):73-7.

5. Andersson OK, Almgren T, Persson B, et. al. Survival in treated hypertension: follow up study after two decades. BMJ 1998 Jul 18; 317(7152): 167-71.

6. Strandberg TE, Salomaa VV, Naukkarinen VA, et. Al. Long-term mortality after 5-year multi-factorial primary prevention of cardiovascular diseases in middle aged men. JAMA 1991 Sep 4; 266(9): 1225-9.

7. Goddijn PP, Bilo HJ, Feskens EJ, et.al B. Longitudinal study on glycaemic control and quality of life in patients with Type 2 diabetes mellitus referred for intensified control. Diabet-Med 1999 Jan; 16(1):23-30.

8. McCormack J and Greenhalgh T. Seeing what you want to see in randomised controlled trials: versions and perversions of UKPDS data. United Kingdom prospective diabetes study. BMJ 2000; 320:1720-3.

9. Krumholz HM. Cardiac procedures, outcomes, and accountability. N. Engl. J. Med 1997; May 22;336(21): 1522-3.

10. Hux JE and Naylor CD. In the eye of the beholder. Arch-Intern-Med 1995; 155(21):2277-80.

11. Graboys TB, Biegelsen B, Lampert S, et.al Results of a second-opinion trial among patients recommended for coronary angiography [see comments]. JAMA 1992; 268(18):2537-40.

12. Cronin L, Mehta SR, Zhao F, et al. Stroke in Relation to Cardiac Procedures in Patients with Non-ST-Elevation Acute Coronary Syndrome - A study involving >18000 Patients. Circulation 2001; 104:269-274.

13. Holmberg L, Bill-Axelson A, Helgesen F. et.al. A randomised trial comparing radical prostatectomy with watch waiting in early prost cancer NEJM 2002; 347:781-89.

14. Packer M, Carver JR, Rodeheffer RJ et.al. PROMISE Study Research Group. Effect of oral milrinone on mortality in severe chronic heart failure. N. Engl .J. Med 1991; 325: 1468-75.

15. Firth WJ. Predicting the unpredictable. BMJ 1991; 303:1565-8.

16. Miller TA, Smith TW, Turner CW, et. al. A meta-analytical review of research on hostility and physical health. Psychol. Bull 1996; 119:322-348.

17. Mittleman MA, Maclure M, Sherwood JB, et. al. Triggering of acute MI by episodes of anger. Circulation. 1995; 92: 1720-1725.

18. Angerer P, Siebert U, Kothny W, et. al. Impact of social support, cynical hostility and anger expression on progression of coronary atherosclerosis. J. Am. Coll.Cardiol. 2000; 36: 1781-1788.

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