Patients seem relieved and comforted that they needn’t go through repeated tests and torture as supported by our obsession with evidence-based medicine. They can enjoy their lives that have been prolonged by simple things like exercise, reasonable diet, and patient-centered goals
We proclaim from house-tops that modern medicine is evidence-based and all other systems are not. What is this evidence base that we talk about; that too in a “risk factor arena”? Let us examine one such commonly talked about evidence base for hypertension treatment. Elevated blood pressure, which is at best, a risk factor for heart disease, stroke, etc, has now been elevated to a full blown “silent killer” disease status, thanks to the pharmaceutical lobby. Let us analyse its “so called” evidence base very calmly from the beginning.
The largest and possibly the longest follow up study, MRFIT (Multiple Risk Factor Intervention Trial), has just given us the following data, if one were to go by the data alone. The conclusions of MRFIT analysis by Dr Roger W Sherwin is quite shocking: “The original goal of the MRFIT was to determine whether reduction of the risk factors like smoking, cholesterol and elevated blood pressure in high-risk but otherwise healthy men would reduce CHD (coronary heart disease) mortality, non-fatal MI (myocardial infarction) or CHD, cardiovascular mortality and mortality from all causes. (1) Their paper answers these questions thus:
“In conclusion we have shown that it is possible to apply an intensive long-term intervention program against three coronary risk factors with considerable success in terms of risk factor changes. The overall results do not show a beneficial effect on CHD or total mortality.”
In other words, they found that changing the “risk factors” does not apparently change the risks. This necessarily means that the “risk factors” are not as important as they are thought to be. Indeed, it should be concluded that the “risk factors” were no such thing; at least as far as MRFIT trial is concerned.
- Diastolic pressure has no clinical significance; it is only the systolic pressure that matters, if anything! Most of our RCTs in this area are based on the diastolic reading!
- The linear science of MRFIT study shows that any level of systolic pressure is better than its higher level! No cut off point at all!
- Therefore, if 110 systolic reading is good 100 would be better and so on.
- What does our evidence base tell us? Strictly speaking scientifically, systolic pressure of zero is better than 10 mmHg! Will any one survive with zero pressure?
- All RCTs in hypertension arena are based on surrogate end point of BP level coming down. What happens to the patient? No study has reported the real end point of death for the guidance of the NICE guidelines creators. However, by default, there is one study which was stopped prematurely because of the real end point data. The HOT study was stopped in eighteen months (it was to go on for five years) but published with a comment thus: “better drugs in larger doses bring the pressure down very effectively and so the study need not continue.” (2) The truth is that nearly 27% more patients died in the treated group within 18 months compared to the control group which was deemed dangerous to continue the study protocol. So the only one end point (death) study did show that effectively and quickly lowering the BP with powerful drugs is a sure exit visa from this world!
- RCTs themselves are under a dark cloud these days. No two humans are alike. Where is the scientific basis for matching based on a few phenotypical data? NICE director, Sir Michael Rawlins, had opined in his Harveian Oration in 2008: “that RCTs have been put on an undeservedly high pedestal”! (3)
- Let us look at the physics of blood pressure (BP). Everything flows by whirling in nature. How do we know that blood flow inside the vessel is laminar? If it is laminar, it cannot exert later pressure on the vessel wall as Co. Sine 90 is zero. Our definition of blood pressure is lateral pressure exerted by the flowing blood on the vessel wall. Studies have now shown that blood probably flows by whirling only even inside the large blood vessels. Capillary flow is by capillary chaos! Moreover, when a blood vessel gets blocked with atherosclerotic plaques, what happens to blood pressure (if flow is laminar) depends on the Bernoulli’s principle, and not what we project in our textbooks! (4)
- If we put all the 17 studies of BP in the literature together, the inclusion criteria will fit only about 39% of the hypertensive population. Where is the evidence base for the rest of the 61% patients? This is my observation.
Uffe Ravnskov’s analysis of survival benefit, Relative Risk Reduction, and absolute risk reduction (ARR) shows our evidence base in very poor light! (5)
Relative Risk Reduction% -20 -21
Absolute risk reduction % -0.8 -3.3 Survival chance without drugs % 96 88.5
Survival chance with drugs % 96.8 91.8
If we look carefully modern medicine deep down is very, very shallow. (6, 7, 8, 9, 10, 11, 12)
Diabetes—the story is no different!
“But recently part of a large clinical diabetes study was halted after researchers found an increased death rate among those taking higher doses of blood sugar-lowering medication. The ACCORD trial, as it is called, is funded by several US government agencies and the finding surprised many doctors. The New York Times of 27 May 2009 had this to say: “For decades, researchers believed that if people with diabetes lowered their blood sugar to normal levels with drugs, they would no longer be at high risk of dying from heart disease. But a major federal study of more than 10,000 middle-aged and older patients with Type II diabetes has found that lowering blood sugar actually increased their risk of death, researchers reported. The study also stressed that intensive blood pressure and combination lipid therapies do not reduce combined cardiovascular events in adults with diabetes.13
Pregnant fat mothers are now the target for drug companies! They are now pushing to give a dangerous drug, Metformin, which has long list of dangerous side effects like muscle pain and weakness, cardiac arrhythmias like slow or uneven heart rate, nausea and vomiting, difficulty breathing, reduced sex hormone levels, limb numbness, pain abdomen, and even lactic acidosis, a dangerous side effect, to babies to prevent them from becoming diabetics in life even when they are in their mother’s womb. They propose to give Metformin to every obese pregnant lady! I think it is pure insanity. See this report in The Daily Mail: "If the strategy is a success, the treatment could be in widespread use in as little as five years, with tens of thousands of overweight but, otherwise healthy mothers-to-be drugged each year." 14
Routine screening patients with diabetes for occult coronary disease, a bad practice in my opinion, has been shown not to reduce cardiovascular mortality according to the results of large American study.15 We need not scare the common man by saying that he is more prone to heart disease and death if he suffers from diabetes. “Current best evidence requires a change in emphasis in our care for patients with Type 2 diabetes. Clinicians should prioritize supporting well-being and healthy lifestyles, preventive care, and cardiovascular risk reduction for these patients. The randomized trial evidence that we reviewed does not strongly support tight glycaemic control as more beneficial than harmful in reducing the risk for diabetes complications,” 16
I can not sum up this note in a better way than what one of the doctors, Mark Mc Connell, did in the US after all these evidences erupted: “So much theory, so much data, and so little time. Is the care of patients so complicated? It actually seems fairly straightforward unless we have a hard time giving up our past biases that "lower is always better". The patients I meet generally are overwhelmed with testing, clinic visits, finger pricks, and fat bills.”
Patients are happy to be given the good news that they are doing well clinically. They seem relieved and comforted that they needn’t go through repeated tests and torture as supported by our obsession with evidence based medicine—a real boondoggle. Patients can enjoy their lives that have been prolonged by fairly simple things like exercise (daily walk has been shown to produce 80% reduction in premature deaths due to risk factors!), reasonable diet, and patient-centred goals. Unfortunately, we have ‘wise’ doctors who think that BM Hegde is being less compassionate towards modern medicine. They have a right to their opinion, of course. Some might even say that these references are selective, but that is what is being done daily in all science papers, anyway. I will have to pay them in their own coin. Uncertainty is the only certainty in this world. The world is simply a Wirklichkeit (changing drama, reality).
I do not believe in the caste system in healing. For me healing a patient can be achieved by any means which are scientifically authenticated, as long as my interventions do not become worse than his/her original disease. Primum non-nocere! After all, patient care is just CARING for the patient.
“Intellectual integrity made it quite impossible for me to accept the myths and dogmas of even very great scientists, more particularly of the belligerent and so-called advanced nations. Indeed, those intellectuals who accepted them were abdicating their functions for the joy of feeling themselves at one with the herd”—Bertrand Russell (1872-1969)
1) Zukel WJ, Paul O, Schnaper HW. The multiple risk factor intervention trial (MRFIT). I. Historical perspective. Prev. Med. 1981 Jul; 10(4):387-401.
2) Hot Study Group. www.thelancet.com/journals/lancet/.../PIIS0140-6736(98)04311-6
3) Rawlins M. The Harveian Oration of 2008. De Testimonio. On the evidence for decisions about the use of therapeutic interventions. Royal College of Physicians, 2008.
4) Hegde BM. Where is the reality?
5) Ravnskov U. Chance of surviving with and without treatment. 18 June 2002 ...
6) Marcia Angell. Patient Preferences in RCTs. NEJM 1984; 310:1385-87.
7) Clarke CJ. Rapid determination of number of patients required for RCT. Lancet 1966; 11: 1357.
8) Cromie BW. Feet of clay of RCTs. 1963; 11; 994-997.
9) Freidman, Howard S. RCTS and common sense. Am. J. Med. 1986; 81: 1047.
10) MRC streptomycin trials BMJ 1948; 11: 769-782.
11) Harris L Coulter. The Controlled Clinical Trials by Centre for Empirical Medicine and Project Cure Washington DC 1991. ISBN 0-916386
12) Sherwin RB. MRFIT study.
13) ACCORD study.
14) Babies treated in the womb for obesity
15) Young LH, Wackers FJ, Chyun DA, et al. Cardiac outcomes after screening for asymptomatic coronary artery disease in patients with type 2 diabetes. JAMA 2009; 301: 1547-1555.
16) Montori VM and Balsells MF. Glycaemic control in Type II diabetes Time for an evidence based-about face? Ann. Intern. Med. 2009; 150: 803-808.
(Professor Dr BM Hegde, a Padma Bhushan awardee in 2010, is an MD, PhD, FRCP (London, Edinburgh, Glasgow & Dublin), FACC and FAMS. He is also Editor-in-Chief of the Journal of the Science of Healing Outcomes, Chairman of the State Health Society's Expert Committee, Govt of Bihar, Patna. He is former Vice Chancellor of Manipal University at Mangalore and former professor for Cardiology of the Middlesex Hospital Medical School, University of London. Prof Dr Hegde can be contacted at [email protected])