The McDougall Newsletter
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From Sept/Oct '98

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RESEARCH

AHA DIET INEFFECTIVE, AGAIN

Effects of diet and exercise in men and postmenopausal women with low levels of HDL and high levels of LDL cholesterol by Marian Stefanick in the July 2, 1998 issue of the New England Journal of Medicine found the NECP Step 2 diet failed to lower LDL "bad" cholesterol in men and women with high risk lipoprotein levels (cholesterol and triglycerides) who did not engage in aerobic exercise (339:12). The study groups consisted of 180 postmenopausal women and 197 men with a HDL cholesterol less than 60 and LDL cholesterol greater than 125. The National Cholesterol Education Program (NCEP) step 2 diet recommends less than 30% total fat, less than 7% saturated fat, and less than 200 mg of cholesterol a day. The goal for exercise was at least 10 miles of brisk walking or jogging a week. This intervention group was compared to a control group who maintained their usual diet and exercise habits. The three interventions were exercise alone, diet alone, and diet plus exercise. Both diet groups decreased their cholesterol intakes by about 100 mg from 256 mg per day. Calorie intake and weight decreased in the diet groups. The exercise only group increased calorie intake. An insignificant reduction of 5.8 % in total cholesterol was observed over the year of study in the diet only group, whereas diet plus exercise caused a slightly over 9% reduction.

COMMENTS: The diets recommended by the American Heart Association and the National Cholesterol Education Program are ineffective. Not only do they continue to stick with the same useless advice, but possibly in defence of their ineffective recommendations, the Nutrition Committee of the American Heart Association has just officially criticized the only approach that does make a difference--a very low-fat, high-carbohydrate diet. The report in the August 31, 1998 issue of the journal Circulation states that reducing fat in the diet to very low levels may not provide any additional benefit and may be harmful to some people. The basis for this conclusion is because these low fat diets lower your HDL "good" cholesterol and raise triglycerides. I have discussed these arguments with you before.

To recap: Low fat diets used in studies to show triglycerides increase are high in refined foods, and simple sugars, including fruits and juices and also very high in calories. People are fed more food than they want to eat in order to match the calorie intake of the comparison group on the American diet, and the triglycerides go up. When not overfed, people lose weight and triglycerides stay down on a high carbohydrate diet (JAMA 274:1450, 1995).

Our patients at St. Helena Hospital are fed as much as they want of a healthy diet and their triglycerides decrease an average of 10 mg/dl in 11 days, but those who started high (say over 600 mg/dl) dropped 50% (to an average of 311 mg/dl) in 11 days.

Don’t worry about the "good" HDL cholesterol going down--it’s not a bad sign (J Clin Invest 85:144, 1990). It goes down because all fractions of cholesterol decrease as total cholesterol decreases. Worldwide, populations with the lowest "good" HDL cholesterol have the lowest death rates from heart disease, and the lowest total cholesterol (Lancet 2:367, 1981). In fact, in studies of my patients it goes down 22% in 11 days, but so does the "bad LDL cholesterol and total cholesterol.

We’re not treating risk factors (HDL and triglycerides), but real diseases. Population studies show people living on high-carbohydrate, low-fat diets have low total cholesterol levels and very low rates of heart disease. When these people migrate to rich countries their cholesterol, HDL "good" cholesterol, triglycerides, blood sugars, and body weights go up. So does their risk of heart attacks, diabetes, obesity, hypertension, and many cancers.

LUNG RADIATION KILLS

Postoperative radiotherapy in non-small cell cancer: systematic review and met-analysis of individual patient data from nine randomized controlled trials by the PORT Met-analysis Trailists Group in the July 25, 1998 issue of the Lancet found a 21% increase in the risk of death when patients are given additional treatment with radiation (352:257). Comparisons were made between patients treated with surgery followed by radiation and patients treated with surgery alone. The adverse effect was greatest for patients with earlier disease. No sub group showed benefit from radiation.

COMMENT: Worldwide lung cancer is the leading cause of cancer deaths. Most lung cancers are of a variety called non-small-cell lung cancer. Only about 20% of tumors are even considered operable--even for these more hopeful cases survival to 5 years is only 40%. This is because the disease is well advanced by the time of diagnosis. The rational behind the addition of radiation is to kill as many cancer cells as possible. Adding radiation to the treatment worsens the outcome, by actually killing people, often by radiation-induced inflammation of the lungs (radiation pneumonitis). Furthermore, the addition of radiation worsens the quality of the patients life due to the side effects, such as nausea, vomiting, and pain; not to mention the increased cost to the patient and the health-care system. These findings should cause scientists to curtail future research and doctors to stop prescribing lung cancer patients radiation after surgery. But, if history repeats itself neither change is likely to occur. Economics, egos, tradition, and "the need to do everything possible for the patient" will cause inertia to prevail. Therefore, if you are faced with cancer treatments for yourself or those close to you it is very important that you do the research necessary to determine the real value of the proposed therapy. If you have access to the internet you can search the National Library of Medicine (free) at www.nlm.nih.gov.

PAMPHLETS SELL MAMMOGRAMS

How risks of breast cancer and benefits of screening are communicated to women: analysis of 58 pamphlets by Emma Slaytor in the July 25, 1998 issue of the British Medical Journal found women's willingness to participate in mammography screening is manipulated by disclosure of selected data that favors the test (317:263). The materials used fear tactics, such as telling women they have a one in 11 to one in 16 chance of getting breast cancer and sales claims such as "mammograms pick up 90% of breast cancers." Absolute reduction in risk was never provided. The authors point out, "...mammographic screening reduces mortality, not incidence. In addition, mammographic screening increases the incidence of breast cancer by detecting innocuous disease that would never become clinically important."

COMMENT: The absolute reduction of deaths caused by mammograms is at best one less death in 7086 mammograms per year, and at worst no reduction at all (Lancet 346:29, 1995). If these slim benefits were communicated clearly and honestly to women in pamphlets (and by health care workers) far fewer women would put their hopes and lives in this flawed technology. Instead, they might look in other directions that would greatly benefit their lives, such as diet and lifestyle. This multimillion dollar business leads women down the false path of an "easy way" to prevent breast cancer.

TAMOXIFEN FAILS PREVENTION

Prevention of breast cancer with tamoxifen: preliminary findings from the Italian randomised trial among hysterectomised women by U. Veronesi (352:93) and Interim analysis of the incidence of breast cancer in the Royal Marsden Hospital tamoxifen randomised chemoprevention trial by Trevor Powles (352:98) in the July 11, 1998 issue of the Lancet found tamoxifen did not prevent breast cancer in otherwise healthy women. The Italian study used women who had a previous history of hysterectomy to avoid the dreaded complication of uterine cancer. The Royal Marsden Hospital study used women with a high risk of developing breast cancer (because of a family history). These results are in sharp contrast to the well-publicized American Breast Cancer Prevention Trial which found a 45% reduction in breast cancer incidence with prophylactic use of this antiestrogen drug.

Several reasons were given for the discrepancy including the possibility that ingestion of tamoxifen for more than 5 years may have had a detrimental effect.

COMMENT: Tamoxifen is a manufactured estrogen which has an estrogen-inhibiting effect on the breasts and a stimulating effect on the uterus. It has been found effective in the treatment of women with breast cancer, and decreases the risk of recurrence of breast cancer by one-third in the opposite breast of women with breast cancer. Such evidence suggests a beneficial effect in preventing breast cancer in healthy women by blocking some of the cancer-promoting effects of a woman's own estrogen. However, these studies fail to confirm a clear benefit. Kathleen Pritchard, author of an accompanying editorial commented, "The failure of these trials to confirm the results of the US study, however, casts doubt on the wisdom of the rush, at least in some places, to prescribe tamoxifen widely for prevention."

In addition to an increase in uterine cancer, tamoxifen raises a woman's triglycerides, increases her risk of heart disease, and raises her risk of blood clots (thromboembolism). Many women also complained about the side effects, such as hot flashes. On the other side, there are additional benefits from this drug, including lower cholesterol and improved bone strength.

This form of therapy is referred to as chemoprevention. The pharmaceutical companies have great interest in promoting this approach for the obvious reason of making money. True prevention would be correcting the cause of breast cancer--the rich Western diet. Since there is no profit, and the obvious fact that diet and lifestyle change requires effort--many people put their faith and future in drugs.

SIGNS ENCOURAGE EXERCISE

Can inexpensive signs encourage the use of stairs? Results from a community intervention by Ross Andersen in the September 1, 1998 issue of the Annuals of Internal Medicine found an increase in the use of stairs with signs placed beside an escalator with adjacent stairs (129:363). Overall, stair use was increased from 4.8% to 6.9% with signs that promoted health benefits and to 7.2% for those that promoted weight loss benefits. Older persons almost doubled stair use from 5.1% to 8.1% with the health sign and 8.7% with the weight-control sign. Whites increased their stair use, while black persons’ stair use decreased with the health sign. The study was performed by simply observing the choices of 17,901 shoppers during each of three phases lasting a month each (no sign, health sign, and weight control sign). The health sign read "Your heart needs exercise, use the stairs." The weight-control sign read "Improve your waistline, use the stairs."

Some interesting facts presented by the authors include:

* Only 22% of the U.S. adult population are active enough to derive health benefits

* One in four Americans are completely sedentary

* Almost one in two black women is now overweight

* People residing in Washington, DC are the least active of all persons in the U.S. Nearly half of all adults are inactive.

* 26% of U.S children watch 4 or more hours of TV daily

* 43% of black children watch 4 or more hours of TV daily

* Obesity has increased from 25% to 33% over the past 12 years

* Inactive people who increase the level of activity decrease their risk of dying from all causes, and especially heart disease

* The greatest health benefits are achieved by moving from a completely sedentary state to moderately activity

* There are 1850 malls in the U.S. The cost of a sign is $60. With a 4% increase in stair use 1.6 million more Americans would take the stairs each day

* Walking up 2 flights of stairs daily would cause the average man to lose nearly 6 pounds in a year

COMMENT: This sign idea could be expanded to encourage people to smoke less, and to drink less coffee and alcohol. Signs in all bars could warn people about the dangers of drunk driving. Restaurants could display signs about the causal connection between the steak they are about to order and breast cancer.

HRT HURTS WOMEN

Randomized trial of estrogen plus progestin for secondary prevention of coronary heart disease in postmenopausal women by Stephen Hulley in the August 19, 1998 issue of the Journal of the American Medical Association found treatment with a combination pill of Premarin (conjugated equine estrogen) and Provera (medroxyprogesterone) did not reduce the overall rate of heart attacks or death from heart disease in postmenopausal women with a history of past heart disease, but did increase the risk of blood clots (thromboembolic events) and gallbladder disease (280:605). A total of 2763 women younger than 80 were divided into two groups. One received the active hormone combination, the other the placebo. They were studied for 4.1 years. In the first year there were actually more heart events in the hormone group. The lack of overall benefit occurred despite a net 11% lower "bad" LDL cholesterol and a 10% higher "good" HDL cholesterol in the hormone group compared to the placebo group. The hormone group had almost 3 times the risk of blood clots and 38% more gallbladder disease.

The authors conclude: "Based on the finding of no overall cardiovascular benefit and a pattern of early increase in risk of CHD events, we do not recommend starting this treatment for the secondary prevention of CHD. (Secondary prevention refers to preventing another heart event in someone who has already suffered one).

COMMENTS: Studies performed by comparing groups of women who use hormones with those who don't, called observational studies, have found hormone users have less heart disease. Since 1990 these results have been questioned because they are believed to reflect two types of bias, rather than actual benefits from taking the drugs. Prevention bias occurs because women with healthier behaviors, like following a low-fat diet and exercising, are also more likely to take hormones. Compliance bias occurs because women who faithfully take their pills of any kind are much more like to avoid heart disease. This also relates to prevention bias in that these compliant women have healthier behaviors. Either bias can easily explains the benefits of hormones on heart disease seen in observational studies.

To remove the bias, studies that can measure the actual effects of the intervention must be implimented--these are randomized, blinded, placebo-controlled studies. Active drug is given to one group and the control group gets the "sugar pills," the placebo. This is the first of this type of properly done study for heart disease, even though hormones have been used by women to prevent osteoporosis for more than 35 years.

The reason that heart attacks and death from heart disease did not decrease, and actually increased in the first year even when the cholesterol profile improved, is because of the effects of hormones on blood clotting. Hormones cause the blood to want to form clots more readily.

Remember how a heart attack occurs: A small atherosclerotic plaque ruptures and the inner contents of semiliquid, necrotic, material spurt into the flowing blood, acting as a catalyst, initiating the formation of a blood clot (called a coronary artery thrombosis), which blocks the flow of blood to the heart muscle. Things that increase the tendency for the blood to clot, such as animal fat, and Premarin and Provera, increase the likelihood that a fatal occulusion will be formed.

Back in the 1960s a study was performed on men with a previous history of heart disease; giving them hormones to prevent another attack (JAMA 214:1303, 1970). There were beneficial effects on the cholesterol of men, but no reduction in the risk of heart events. Results from this study suggest the same situation is true for women--better cholesterol from these hormones does not translate into less heart disease--because the adverse effects on blood clotting dominate.

One of the authors suggested women with CHD who choose hormones for other reasons (like prevention of osteoporosis or hot flashes) "should be offered a lower dose of estrogen and concomitant anticoagulation therapy, like aspirin, and be monitored carefully." (Lancet 352:627, 1998). I have several other suggestions.

First, if you are going to take hormones you should follow a low-fat vegetarian diet to reduce your risk of blood clotting. Add exercise to reduce your overall risk of heart disease.

Second, take hormones to relieve symptoms of menopause and improve your feelings of well-being only.

Third, prevention of heart disease and osteoporosis is accomplished by following a no animal-protein, low-fat starch-based diet.

Fourth, if you do choose to use hormones, us the more natural ones--estradiol and progesterone, and take them in low doses through the skin as creams. (Details on this form of use are found in the Nov/Dec 1995 Newsletter and will be reported in my upcoming book on women's health). Natural progesterone, unlike Provera, does not adversely affect a woman's blood cholesterol and triglycerides.

Lastly and most importantly, never feel pressured to take hormones; menopause is a natural event in a woman's life and interference usually has some negative consequences.

AGGRESSIVE HEART TREATMENT KILLS

Outcomes in patients with acute non-Q-wave myocardial infarction randomly assigned to an invasive as compared with a conservative management strategy by William Boden in the June 18, 1998 issue of the New England Journal of Medicine found patients "treated initially according to conservative therapy had a significantly lower mortality at hospital discharge, at one month, and at one year." The risk of death for those who underwent invasive therapy--angiography, angioplasty, and/or bypass surgery--was two to three times greater at the time of discharge and at 30 days than those treated conservatively. No subgroup appeared to benefit from an early invasive approach. Patients with signs of serious heart disease, including anterior myocardial infarction, ST depression on electrocardiogram, a reduced ejection fraction, or previous infarction did not fare better with invasive therapy. The authors conclude, "A conservative initial strategy based on an ischemic guided approach to management after infarction is both safe and effective."

COMMENT: Four previous studies have shown similar poor results with invasive treatment by physicians, but still they continue to take an aggressive approach (New Engl J Med 338:1838, 1998). Even though a conservative approach is more likely to be followed in Canada, Canadian patients do as well as those treated aggressively in America. There is a strong association between the availability of angiography and invasive treatment, yet the patients fare no better.

So why does this aggressive treatment of heart disease continue?

According to an accompanying editorial there are several reasons (New Engl J Med 338:1838, 1998):

First, many patients and families insist that everything possible be done. Most patients and their doctors tend to believe a conservative approach is obsolete, inadequate, and inferior.

Second, in the event of an adverse outcome they may be less likely to sue their doctor--"afterall he did everything possible," even though the treatment in this case doubled or tripled the patient’s risk of dying.

Third, preconceived notions are likely to be embraced. Initial angioplasty after a heart attack is widely recommended and used (even though studies clearly side against the benefits).

Lastly, the abundance of facilities that do angioplasty and bypass surgery and all the doctors trained in these procedures, and the huge sums of money the doctors and facilities earn encourages invasive therapy.

So who should be treated aggressively? Those with continued symptoms of low blood supply to the heart (chest pain, for example) despite conservative therapy. Second, those who might benefit from surgery because of previous damage to their left ventricle (an ejection fraction below 50%). Otherwise, you need to defend yourself or a loved one from overly aggressive treatments. Some of the best ways to do this are to insist on research that supports the recommend therapy, followed by independent research on your part (search the National Medical Library free at www.nlm.nih.gov). Next seek out second opinions that have a real chance of substantially differing from the first one.

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From Sept/Oct '98

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