|The Emperor's New Clothes: Aggressive New Guidelines for "Prehypertension"|
|Written by Paul J. Rosch, MD, FACP|
|Wednesday, 10 December 2003 14:26|
Read this article in: Dutch
However, we all know how difficult it is to achieve these goals, much less maintain them. And even if you do, the results are not that rewarding, even for patients with blood pressures of 160/100 and higher. People with prehypertension usually discover that none of these lifestyle modification will normalize their blood pressure, which means that medications will be required. Chalk another one up for the drug companies.
The Emperor's New Clothes
The new guidelines are contained in the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC-7), issued in May of 2003. The measures proposed for treating high blood pressure in JNC-7 do not differ greatly from those contained in the first JNC report, which came out in 1977, namely life-style changes (lose weight, avoid salt and sodium-rich foods, exercise regularly, stop smoking and reduce stress) plus the administration of thiazide diuretics (medications to decrease water retention) to those whose blood pressure does not respond to diet and exercise.
These JNC-7 guidelines bring to mind the story of the vain emperor gulled into parading through town naked by two tailors who had convinced him that the cloth they used for his new clothes would be invisible to anyone too stupid or incompetent to appreciate its superior quality. The new disease of prehypertension proposed by JNC-7 is like the emperor's new clothes--an invisible and imaginary disease foisted on a gullible public. Even though its authoritative proponents may be acting in good faith, there is reason to believe they may have been unduly influenced by others with their own private agenda.
The first advice patients with high blood pressure generally receive is to significantly restrict sodium intake. However, the vast majority fail to respond to this measure unless they have certain genetic traits. In some, calcium deficiency can be the culprit and they improve with calcium supplementation. These individuals may actually worsen on a low-sodium regimen since restricting sodium calls for restricting the intake of dairy products, a major source of dietary calcium. Others benefit from potassium and/or magnesium supplements.
Jogging and running may help lower blood pressure for some people but more often has little effect and can even cause a rise.
High blood pressure or hypertension, like fever, is not a diagnosis like diabetes, but rather a description. It is simply an elevated blood pressure reading on some measuring device. The condition can have many different causes. That helps to explain why we have some 100 drugs to treat high blood pressure. Unfortunately, there is no algorithm to guarantee which one will work best or be the safest for any specific patient. Similarly, a fever of 103Â° in a patient with lupus may require giving cortisone but if that identical 103Â° temperature reading were due to tuberculosis, cortisone could bring the fever down but might prove lethal. Conversely, appropriate antibiotics would be an effective treatment for tuberculosis but would provide little benefit in lupus.
Risk Factors and Other Fallacies
In order to successfully treat a disease, it is necessary to remove or reduce its cause rather than its manifestations or markers. Treating persistently elevated blood pressure or temperature is very different from treating elevated blood sugar. The goal in diabetes is simply to lower the blood sugar to normal; responses to medication and/or diet are much more predictable and sustained since the cause can almost always be identified.
For blood pressure, the situation is much more complicated. Much of the "one blood pressure fits all" approach comes from confusion over what a "risk factor" really represents. Most risk factors for heart disease are merely "risk markers" that simply have some statistical association with an increased incidence of coronary events. There are over 300 risk factors for heart attacks, including a deep earlobe crease, premature vertex baldness, high selenium toenail levels, having a pot belly, having been born in northern Finland, not having a daily nap or drinking more or less than one or two glasses of wine a day. Attempting to treat or remove such markers will accomplish nothing since they do not cause coronary disease. The same can be true for lowering an elevated systolic or diastolic blood pressure unless the treatment is directed at what is causing the problem, which is usually not clear.
Hypertension and Heart Disease
High blood pressure is said to predispose an individual to heart attack, stroke and kidney disease.
Surprisingly, no randomized clinical trials have ever proven that lowering an elevated systolic blood pressure to 140 reduces the risk for death due to coronary disease. A good example of this was the multicenter Multiple Risk Factor Trial (MRFIT) designed to demonstrate that reducing hypertension, high cholesterol and smoking would lower coronary mortality. After screening some 350,000 middle-aged men, researchers selected close to 13,000 believed to be at greater jeopardy because of a preponderance of these putative risk factors. They were divided into a treatment group to lower these markers and a control group that received usual care.
After ten years and $115 million, the treatment group substantially achieved their objectives--they had lower cholesterol and lower blood pressure than when they had started, and many had stopped smoking. However, these conscientious patients fared no differently from controls. In fact, a subset of hypertensives treated with diuretics had the highest mortality rates, probably from ventricular fibrillation due to potassium depletion. The MRFIT objective was to get blood pressures below 140/90. One can only wonder what the mortality rate would have been if under 120/80 had been the goal.
As for stroke, some studies have shown that lowering blood pressure can prevent stroke, but the absolute effect is less than 1 percent. And only very high blood pressure will destroy kidney function.
Stress and Pseudohypertension
My personal experience has been that a significant percentage of patients being treated for "essential hypertension" can stop their medication without any adverse effects. When such individuals are admitted to the hospital for surgery or some unrelated condition and these drugs are discontinued deliberately or inadvertently, it is not unusual for blood pressures to fall to normal levels and remain there, only to rise again after discharge. Stress-related or "white coat" hypertension is quite common. In one study published in the Journal of the American Medical Association, more than one in four patients with elevated blood pressures in the doctor's office were found to have normal values on ambulatory monitoring. All were taken off drugs with no adverse effects.
Decades ago, when healthy young men being examined for insurance policies or entry into the armed services had high readings but no retinopathy, albuminuria or other indication of sustained hypertension, we used to reassure them and have them lie down and relax in a quiet room. After 15 or 20 minutes, repeated measurements were invariably much lower and usually normal. Busy doctors don't have time for that today. It's much easier and safer for them to prescribe a pill, since everyone knows that hypertension is the "silent killer." In addition, treating hypertension is easy, doesn't take much time or energy and is apt to be quite remunerative since periodic electrocardiograms and chest X-rays to monitor cardiac size and laboratory tests are readily justified. The doctor only needs to ask a few questions, the patient often does not need to disrobe in an examining room and the entire encounter often takes less than ten minutes.
A not uncommon scenario is that when the patient returns after the initial diagnosis of hypertension has been made and a medication has been prescribed, he or she is even more nervous, blood pressure is still high or higher and the dose is increased. This may be repeated on subsequent visits with prescriptions for additional drugs. The result may be dizziness or other side effects that the patient now attributes to a worsening of hypertension, causing even more stress.
It is also not generally appreciated that heart rate and blood pressure shoot up whenever we speak or try to communicate in some other way. The seminal investigations of this phenomenon have been done by Jim Lynch who showed that such elevations are greater if we are talking to someone of perceived higher social stature, more rapidly than usual, and if the content of the conversation deals with some important personal issue. Blood pressure rises in deaf mutes when they use sign language but not when they move their hands meaninglessly but with the same amount of energy. The only time this does not occur is in schizophrenic patients off of medication, possibly because they no longer communicate.
I have been involved in this research with Jim for over twenty-five years. Although these transient spikes in both systolic and diastolic pressure can be alarmingly high, patients are completely unaware of this and have no symptoms. By using an automated blood pressure device that displays systolic, diastolic and mean arterial pressure on a monitor, it is possible to teach patients how to lower their pressures.
We have also found that these rises are not blunted by any antihypertensive drugs and are actually exaggerated by beta blockers. It is not uncommon for anxious patients to talk immediately prior to or even while the doctor is inflating the cuff, which can increase blood pressure up to 50 percent in some people. There is no good evidence that such hyperreactivity is associated with any increased incidence of sustained hypertension. The same is true for elite weight lifters, who can have pressures of 400/250 or higher when they perform the supreme Valsalva maneuver.
Another source of pseudohypertension is that the same-size cuff is used for all adults, which can cause significantly false high readings in fat arms. The width of the cuff should be 40 percent of the circumference of the arm. This is important because of the large number of obese people and others who are engaged in body building activities.
Time of day, room temperature, a full bladder, eating, drinking or smoking within the past hour, standing, sitting or supine can all influence measurements.
Treating Numbers Instead of People
Authoritative advice for treating blood pressure has changed dramatically over the years. Forty years ago, the chapter on hypertension in Harrison's Textbook of Medicine stated "Whatever the form of therapy selected, it must not be forgotten that the physician who treats hypertension is treating the patient as a whole, rather than the separate manifestations of a disease. The first principle of the therapy of hypertension is the knowledge of when to treat and when not to treat . . . . A woman who has tolerated her diastolic pressure of 120 for 10 years without symptoms or deterioration does not need immediate treatment for hypertension. Marked elevation of systolic pressure, with little or no rise in diastolic, does not constitute an indication for depressor therapy. This is particularly true in the elderly or arteriosclerotic patient, even though the diastolic pressure may also be moderately elevated." A physician following this advice today would be liable for malpractice.
The chapter, which was written by John Merrill, a leading authority on hypertension from Harvard, goes on to emphasize that "The physician must constantly weigh the value of making his patient 'blood pressure conscious' by a specific regimen and regular follow-up, against real need for any particular form of therapy. Above all, in treatment or prognostication, he must avoid engendering in the patient a fear of the disease which may be unwarranted in our present state of knowledge." Contrast this with the current cookie cutter approach of treating numbers that are often meaningless instead of people.
There is absolutely nothing new about prehypertension, which was previously referred to as "high normal" at levels higher than 120/80. This would still be a preferable description since nobody knows whether these individuals will go on to develop sustained hypertension or are at any significantly increased risk for its complications. All these new guidelines do is convert 45 million healthy Americans into new patients by creating fear. This is precisely what the experts emphasized we should take pains never to do! How could so many doctors have been so wrong for so many years?
Whatever happened to the Hippocratic dictum Primum non nocere (First of all, do no harm)? It used to be the primary concern of all doctors but seems to have now been sidelined or forgotten in the frenetic and impersonal pace of modern medical practice.
The original 1977 JNC guidelines followed several studies showing that blood pressure could be lowered with thiazide diuretics. Subsequent JNC reports repeatedly recommended the use of diuretics as initial treatment based on additional reports demonstrating their efficacy.
Despite this, the use of diuretics actually declined over the next decade or so, possibly because many went off patent and were no longer profitable. In addition, the pharmaceutical companies began to vigorously promote newer drugs and the 1993 JNC-5 guidelines added angiotensin-converting enzyme (ACE) inhibitors and beta blockers as first-line therapy. Their sponsors argued that these more expensive drugs might be preferable since thiazide therapy could contribute to diabetes and abnormal heart rhythms, especially at higher doses. The new medications also had side effects but their promoters claimed that they were more likely to reduce complications such as heart attacks and stroke.
However, many were not as effective even at higher doses or when combined with other new anithypertensives. Specialists soon found that half of such patients with blood pressure readings above 160/100 on two or more of these drugs improved rapidly when diuretics were added or their dosage was increased. JNC-6 removed recommendations for ACE inhibitors and beta-blockers and the new guidelines are about the same as those proposed over 25 years ago, save for this new and confusing diagnosis of prehypertension.
However, diuretics are not the most effective or safest treatment for all hypertensives and other drugs are clearly superior for certain patients. What is wrong is that physicians are treating a reading on a blood pressure machine in a cookbook fashion rather than the patient or the cause of the problem.
Guidelines for Guidelines
The law requires that all important Federal rules, including guidelines that affect the public, must be written and promulgated according to the Government Code. This code mandates formal selection of a committee, pre-announcement of all meetings, open meetings that encourage testimony from all interested parties as well as written records, all of which must be preserved in a special docket. Everything is then reviewed in order to provide a written discussion of all the relevant evidence leading to the final rules or guidelines that must be published in the Federal Register. In addition, if the published guidelines are not consonant with a logical review of the evidence presented, the recommendations may be overturned by legal action.
Since the new JNC-7 guidelines seemed to fall under these rules, I accessed the Federal Register but was unable to find anything relevant. When I contacted the Government Printing Office to inquire about this I received a reply confirming they had no JNC records and was referred to a NIH web site.
This lack of adherence to procedure is remarkably reminiscent of the National Cholesterol Education Program (NCEP) for the detection and treatment of high cholesterol. The first NCEP report issued in 1988 was timed to coincide with the introduction of Mevacor, Merck's new cholesterol-lowering drug. In an unprecedented action it was released directly to the public, weeks before doctors could read the scientific information on which it was based. The last set of revised guidelines in 2001, that tripled the number of Americans advised to take statins, was also publicized prematurely.
In both instances, the guidelines were published in the Journal of the American Medical Association but not the Federal Register. There was no public notice of any meetings, the meetings were not open to the public, public input was not solicited, and detailed records and testimony of committee meetings were not kept. The Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC) has followed the same format in order to bypass Government rules and regulations.
When NIH officials were questioned about this lack of protocol, they explained that the cholesterol and hypertension guidelines were written by a non-government committee of experts that they had selected and were therefore not subject to the Federal Register regulations. However, these guidelines are presented by government spokespersons at government press conferences and are promoted in the media here and abroad as the latest government guidelines. The new JNC-7 report made its debut at a special session of the American Society of Hypertension Annual meeting in New York. This took place on the same day in May as the National Heart, Lung, and Blood Institute Press Conference in Washington and coincided with appearance of the JNC "Express Report" on the Journal of the American Medical Association web site.
My personal suspicion is that powerful pharmaceutical interests were behind much of this, just as they are behind the creation of National Hypertension Month in May. Although JNC-7 reverted to the previous advice that inexpensive diuretics were the first choice, it also emphasized that "Most patients with hypertension will require two or more antihypertensive medications to achieve goal pressure." A Novartis spokesperson lavishly praised the report in a press release emphasizing that "Inadequate control of blood pressure has become a public health crisis. We are encouraged that new approaches recommended by JNC-7 will provide impetus for improvement." That's hardly surprising. Novartis, with its 73,000 employees in 140 countries and US sales of $21 billion per year has all the hypertension treatment bases covered. They manufacture Lopressor, a beta blocker, Lotensin, an ACE inhibitor, Diovan, an angiotensin II blocker, Lotrel, a combination ACE inhibitor and calcium channel blocking agent, as well as products combining these with a thiazide diuretic.
Despite all the hoopla, many physicians were not as enthusiastic. Some were skeptical that the new guidelines offered anything that was either new or helpful. Several prominent authorities on hypertension denounced it as based on conclusions that were not only unwarranted but also misleading.
The full study will not be published until the fall and the report in the JAMA Express raised some eyebrows. This feature is designed for rapid dissemination of new breakthroughs, for which JNC-7 hardly qualified. The journal's peer review process time for this is 24-48 hours and all 33 JNC authors would have had to respond within 72 hours, which is highly doubtful. But that wasn't the only complaint. The recommendation for diuretics as first-line therapy was largely based on the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT), another multi-million dollar study that produced dubious conclusions. ALLHAT results were also reported early in the JAMA Express and some feel that anything dealing with statins receives this preferential treatment. This holds true for other respected peer reviewed publications such as The Lancet, which has also expedited statin studies despite the fact that they show nothing new or significant. Conversely, it is very hard to get anything negative about statins published, even when the data is solid. Perhaps this has something to do with the enormous revenues publications derive from statin advertisements.
John Laragh, Director of the Cardiovascular Center at the New York Presbyterian Hospital-Cornell Medical Center, founded the American Society of Hypertension, is Editor-in Chief of its Journal, and Past-President of the International Society of Hypertension. He is one of the world's leading authorities on hypertension because of his delineation of the renin-angiotensin-aldosterone system, which landed him on the cover of Time Magazine. I grew up with John, we have been personal and professional friends for well over 50 years. He was a founding Trustee of The American Institute of Stress of which I am the president. I was tempted to ask him about his opinion of the new guidelines, but didn't have to. His objections to this and the ALLHAT study were vividly detailed at a press conference and were summed up by his colleague, Larry Resnick, as essentially "garbage."
Laragh believes that patients with high renin hypertension are more prone to have complications than low-renin, salt-sensitive hypertensives and respond better to drugs other than diuretics. BjÃ¶rn Folkow, another authority and recipient of the Hans Selye award and numerous other honors, has emphasized the role of stress, the sympathetic nervous system and catecholamines.
I suspect both these good friends subscribe to the decades old "mosaic theory" that hypertension rarely has a single cause and can result from dysequilibrium in the above and other contributory components. Researchers are now focusing in on our old friend inflammation as a cause that may explain its link with coronary heart disease, obesity, diabetes and other disorders. Inflammatory cytokines like Interleukin II released by deep abdominal fat cells that contribute to insulin resistance and metabolic syndrome are increased in hypertension and both angiotensin II and aldosterone have been found to promote inflammation. Increased c-reactive protein (CRP) levels were reported in newly diagnosed untreated hypertensives at the same meeting and another paper showed a correlation between elevated CRP and hypertension complications.
What is Normal Blood Pressure?
Blood pressure (BP) is essentially determined by cardiac output (CO) or the force with which blood is pumped out of the left ventricle and the degree of systemic vascular resistance (SVR) that is encountered. This is much like Ohm's law governing the strength of an electrical current, so that BP=CO x SVR. Hypertension can be caused by increased cardiac output, increased vascular resistance or both. Although the cause of essential or primary hypertension in a patient may not be known, it is safe to say that it is mediated by one or both of these two mechanisms.
Blood pressure readings are given with an upper and lower number. The upper or systolic number is the pressure when your heart beats; the lower or diastolic measurement is the pressure when your heart relaxes between beats.
Just 25-30 years ago, doctors were taught that normal blood pressure was the patient's age plus 100 over 90. Thus if you were 50 years old, a blood pressure reading of 150/90 was considered completely normal; if you were 70, then 170/90 was normal. This guideline reflects the physiological fact that the systolic blood pressure (like cholesterol levels) gradually rises with age. As the blood vessels narrow and become more rigid, more pressure is required to move the blood through the arteries and veins. In general, the diastolic pressure rises until around age 55 and then starts to decline.
The first Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC-1), in 1977, stipulated 120/80 as optimal and 120-129/80-84 as within the normal range. High normal was 130-139/85-89 and Stage 1 or mild hypertension was 140-159/90-99. Stage 2 (160-179/100-109), Stage 3 (179-209/100-110) and Stage 4 ( >210/>120) reflected increasing degrees of severity. JNC-7 has decreed that a reading of 120/80, formerly recognized as optimal, puts you in a category of "pre-hypertension," which must be treated with life-style changes and drugs.
What should you do if one number is high and the other is normal or low? Which is more important, the systolic (upper) or diastolic (lower) measurement? The previous emphasis on diastolic pressure was based on early studies on young people. A systolic pressure above 140 with a diastolic pressure below 90 is referred to as isolated systolic hypertension. It is common in older individuals due to hardening of the arteries and slight elevations were not considered serious. Studies now show that an elevated systolic pressure is an independent risk factor for complications that is far greater than the risk associated with a high diastolic pressure in older patients with hypertension. The same may apply to many older individuals with arteriosclerotic vessels, where a higher blood pressure is needed to maintain adequate blood flow to the kidneys and other vital organs.
Nevertheless, some senior citizens will consistently complain of weakness and dizziness if their blood pressures are lower than the 120/80 value that is now recommended. This is particularly true for women, who normally tend to have higher blood pressures than men in this age group.
Most patients with hypertension have no symptoms and blood pressure elevations are often discovered during a routine physical examination or if measurements are obtained in connection with application for life insurance, employment or blood donation rather than any complaint due to its presence.
Some Causes of Hypertension
Accepted causes of severely high blood pressure include:
KIDNEY DISEASE: Narrowing of the renal artery and kidney disease can cause the release of renin, a powerful hormone that can increase sodium retention and vascular resistance.
Primary aldosteronism and Cushing's disease: These conditions can result in an increase of adrenal cortical hormones that also cause sodium retention.
Pheochromocytoma is a tumor of the adrenal medulla that secretes excess amounts of catecholamines like noradrenalin and adrenaline that can increase peripheral resistance as well as cardiac output, leading to high blood pressure.
DIABETES: In diabetics, red blood cells are often less deformable and unable to squeeze through narrow capillaries.
ATHEROSCLEROSIS: Narrowing of the arteries requires greater pressure to force blood through.
Other theories include:
DEFICIENCY OF CoQ10: CoQ10 deficiency impairs the ability of the heart to pump blood properly, and leads to compensation with a higher diastolic reading. Diastolic dysfunction is an impairment in the relaxation (filling) phase of the cardiac cycle which is the phase requiring much more ATP and CoQ10 than the systolic (contraction ) phase. Dr. Peter Langsjoen, an expert on CoQ10 and heart disease, has had excellent success treating high diastolic blood pressure with this nutrient.
INCREASED BLOOD VISCOSITY: According to this theory, elevated blood pressure is an adaptive response to an elevation in blood viscosity, where the blood cells tend to clump together, impairing circulation in the tiny capillaries. A common cause of increased viscosity is stress. Sugar consumption can increase blood viscosity as well. Smokers and those suffering from sleep apnea often have high hematocrit readings (indicating increased viscosity) and frequently suffer from hypertension.
It makes sense to treat high blood pressure by addressing the causes of the above conditions, resorting to blood pressure-lowering drugs only when these measures fail to bring down blood pressure that is dangerously high.
Diet and Hypertension
There's not a lot of good science out there to provide specific dietary guidelines for lowering blood pressure, but the following suggestions may help:
Switch to unrefined salt; avoid commercial salt. This is the number one treatment suggestion of our own Dr. Cowan who finds that the simple measure of removing refined salt from the diet can bring down high blood pressure in the majority of his patients. (And avoiding commercial salt will also help you avoid processed foods, because most contain gobs of refined salt.)
Use butter, avoid margarines and spreads containing trans fats. Trans fatty acids inhibit biochemical processes in the cell membranes. High blood pressure is a likely outcome of the ensuing biochemical chaos.
Take cod liver oil: The fat-soluble vitamins in cod liver oil will help you deal with stress, nourish the glands and organs and aid mineral absorption. Prostaglandins that help normalize blood pressure are made from DHA, a special fatty acid contained in cod liver oil.
Get adequate protein. Studies indicate that dietary protein helps normalize blood pressure.
Eat heart muscle or take vitamin CoQ10. Dr. Peter Langsjoen has found that CoQ10 can help normalize high diastolic blood pressure in a majority of cases.
Avoid refined sugar and fructose: Refined sugars increase blood viscosity and tend to deplete many nutrients.
Eat plenty of fruits and vegetables, preferably organic.
Avoid exposure to cadmium in cigarettes, heavily sprayed produce and farm chemicals. People with high blood pressure have three times more cadmium in their bodies than others (Lancet 1976;i:717-8).
Use bone broths and drink hard water to provide minerals like calcium and magnesium
This article appeared in Wise Traditions in Food, Farming and the Healing Arts, the quarterly magazine of the Weston A. Price Foundation, Fall 2003.
|Last Updated on Tuesday, 18 December 2012 16:59|