There may be drugs that help prevent disease. As physicians, we want to do what is best and right — and easiest — for our patients. In an ideal world, we could prescribe a pill to drastically reduce the risk of chronic disease. In our zeal, we have to tread cautiously, though, and remember the adage from the Hippocratic Oath: first, do no harm.
More drugs are being evaluated for primary prevention, meaning stopping disease from occurring in the first place. Doesn’t it seem paradoxical that we would give “healthy” people medications? However, there are several recent trials with seemingly impressive results that looked at preventing cancer and its metastases, prostate cancer, high blood pressure, diabetes, strokes and even heart attacks.

Preventing cancer and its metastases

There has been much discussion over the years about using aspirin for the prevention of colorectal cancer. I was at a lecture a month ago where the lecturer said the results were so convincing he might even consider taking aspirin. There are three new studies investigating aspirin’s potential role in cancer and its distant metastases — tumors in other parts of the body.

One of the trials was a meta-analysis (group of 34 trials) of over 69,000 participants that was published in The Lancet online on March 21. The results showed a 15 percent reduction in the risk of deaths from cancer when taking aspirin on a daily basis compared to no aspirin. This means we should all be taking aspirin, right? Not so fast.

This trial had several limitations (The Lancet editorial online, March 21). First, there was a significant risk of bleeding in the first three years of taking the drug, after which time the bleed risk diminished and the cancer benefit continued. Second, these trials were designed for cardiovascular disease, so there was no initial assessment for cancer.

Third, two very large, randomized clinical trials, the Women’s Health Study and the Physicians’ Health Study, were excluded from the analysis, because they gave aspirin every other day. However, neither of these trials showed any cancer reduction benefit. Therefore, in order to benefit, it would seem that people would have to be diligent about taking medication every day, even without symptoms. We all know how well that works.

Another meta-analysis (group of five studies) showed a significant reduction in distant metastases — 36 percent. For those who developed cancer, there was a 70 percent reduction in distant metastases (The Lancet online, March 21). These results are impressive. However, yet again, the analyses were of trials designed for cardiovascular disease, not cancer.

In a third meta-analyses using aspirin, there were conflicting results. Five studies showed a reduction in disease metastases of 31 percent, while seven studies did not show this effect (The Lancet Oncology online, March 21). We may need studies focused on preventing cancer deaths as their primary endpoints in order to make definitive statements about using aspirin in healthy patients.

Prevention of prostate cancer

Avodart (dutasteride) is a drug used for the treatment of enlarged prostate: BPH. In a randomized controlled trial called the REDUCE trial, results showed that Avodart could reduce the risk of prostate cancer by almost 23 percent over four years with healthy men who were at high risk of the disease (N Engl J Med. 2010;363;1192-1202). These positive results were due mainly to a reduction in low-risk benign tumors.

However, beyond the drug’s common side effect of impotence, it also has a twofold increased risk of metastatic prostate cancer. Therefore, the FDA not only rejected the drug for prevention, but also issued a warning about the risk of high-grade prostate cancer risk. These drugs also appear to suppress PSA levels, giving patients a false sense of security.

Prevention of strokes and heart attacks

In last week’s article on the role of statins, I wrote that the JUPITER trial showed statins may be beneficial for primary prevention (N Engl J Med 2008; 359). The FDA approved a statin, Crestor (rosuvastatin) for primary prevention of heart disease in patients without high cholesterol but a slightly elevated inflammatory factor, hsCRP, in February 2010. However, a Cochrane meta-analysis of 14 studies refuted this claim (Cochrane Database Syst Rev 2011; 1: CD004816).

Unfortunately, there is not a panacea. With many, if not all, drugs come side effects. One of the big problems with drugs is that they throw off our bodies’ homeostasis (equilibrium), making them hard to justify for primary prevention. However, we control our own fates, and lifestyle changes play a tremendous role in shaping our futures. All of the diseases mentioned above are impacted substantially by the choices we make every day: our environment, exercise and the food we eat.

Dr. Dunaief is a speaker, author and local lifestyle medicine physician focusing on the integration of medicine, nutrition, fitness and stress management. For further information, go to the website www.medicalcompassmd.com and/or consult your personal physician.

When statins were developed and approved, they were thought to be a drug class with a very clean side-effect profile. They are among the most widely prescribed medications in the U.S. Statins are used to treat high cholesterol and to prevent cardiovascular disease. Under the right circumstances, they can be quite effective. However, their side-effect profile is no longer considered benign or pristine.

The FDA, in a Feb. 28, press release, announced new warnings for statin labels related to memory loss and increased risk of diabetes. The one positive change to the label is that serial blood tests to monitor liver enzymes are no longer required when taking this class of drug (www.fda.gov).

Examples of statins include Lipitor (atorvastatin), Crestor (rosuvastatin), Zocor (simvastatin) and Vytorin (simvastatin/ezetimibe).

The heyday of statins: the JUPITER trial

In the JUPITER trial, which I mentioned in a previous article entitled “High cholesterol: a cautious tale on treatment” (June 23, 2011), it was shown that statins may lower the relative risk of heart attacks by 54 percent and strokes by 48 percent. This trial showed that statins were useful potentially for primary prevention; healthy patients without high cholesterol, but with moderately raised inflammation (high-sensitivity C-reactive protein of greater than 2.0 mg/l), may benefit from statin use (N Engl J Med 2008; 359:2195-2207).

However, controversy brews with statins. There was a meta-analysis (a group of 14 trials with over 34,000 patients) done that disputes the benefit of using statins for primary prevention. The authors concluded that, although statins reduced mortality in this setting, the benefit may not outweigh the risks and cost (Cochrane Database Syst Rev 2011; 1 [CD004816]).

Muscle-ache side effects

Ironically, the reason I wrote my previous article was mainly due to the FDA warning about using high dose simvastatin, 80 mg, and the increased risk of muscle aches and pains, referred to as myopathies (www.fda.gov). It seems that the higher the dose of any of the statins, not just simvastatin, the greater the chances of muscle-related pain (Pharmacotherapy. 2010 Jun;30(6):541-53).

Effects on exercise

It appears now that statins may interfere with exercise. Myopathies affect about 10 percent of the patients; however, that percentage increases to 25 percent of people who regularly exercise. Statins have a detrimental epigenetic effect, which means they affect gene expression, with skeletal muscle. Genes associated with muscle building and repair in the legs were suppressed to some degree in healthy young patients taking statins (Arterioscler Thromb Vasc Biol. 2005 Dec;25(12):2560-6).

The authors concluded that statins could potentially cause increased risk of muscle damage during and after exercise. This creates an unusual dynamic, since these results are in stark contrast to the recommendations that all Americans exercise.

The diabetes evidence

The JUPITER trial showed that healthy participants had a 27 percent increased risk of type 2 diabetes from the use of statins (N Engl J Med 2008; 359:2195-2207).
This was reinforced by the Women’s Health Initiative study. The results of this study showed an adjusted 48 percent increased risk of type 2 diabetes in postmenopausal women ages 50 to 79 taking statins (Arch Intern Med. 2012 Jan 23;172(2):144-52). The authors emphasize a need for lifestyle changes. There were 153,000 women in the WHI study. It did not matter which statin was used — it was a class effect.

Mild cognitive impairment data

It appears that statins may be associated with mild cognitive impairment, including memory loss and confusion in patients who are susceptible. In a large case series involving 171 patients, approximately 75 percent of cognitive decline was most likely related to statin use. In this group, 143 patients stopped statins, and 90 percent of them subsequently recorded significant improvements in cognitive functioning. According to the authors, the higher the dose, the more pronounced the memory loss and confusion became (Pharmacotherapy. 2009 Jul;29(7):800-11).

What can be done?

Lifestyle modification may provide significant results in a short time. A patient in my practice, who adopted intensive lifestyle modifications, including increasing fiber, lowered his total cholesterol and his LDL (“bad”) cholesterol dramatically over only two weeks. Increasing fiber has been shown to decrease heart disease through lowering of cholesterol and lowering blood pressure (Curr Atheroscler Rep. 2003 Nov;5(6):500-5).

The good news with the side effects is that they seem to be transient and dose related, meaning the higher the dose, the greater the side effects. After stopping statins, symptoms from side effects seem to dissipate, although time frames for this vary.

In many cases, statins’ benefits still outweigh their side effects. They can be highly effective in treating high cholesterol and preventing heart attacks and strokes. However, lifestyle modifications should either be done in concert with these drugs or as the first line of therapy before statins are initiated.

Dr. Dunaief is a speaker, author and local lifestyle medicine physician focusing on the integration of medicine, nutrition, fitness and stress management. For further information, go to the website www.medicalcompassmd.com and/or consult your personal physician.

What if I told you that you could practically eliminate your chances of getting heart disease? I was at a Harvard/Brigham and Women’s Hospital conference last week in Boston where several seminars addressed this very topic. I had to share the good news with you.

The risk of mortality from heart disease has decreased by 30 percent over the last few decades, which is very impressive (www.cdc.gov; www.nhlbi.nih.gov).

However, before we start celebrating, it is still the No. 1 cause of death in the United States; in 2008, heart disease was responsible for one in four deaths (National Center for Health Statistics. 2011).

The seven factors

There are two recent studies that look at the reduction in risk factors for heart disease. If we reduce the seven key modifiable risk factors, the chance of heart disease goes down to about 1 percent. These seven factors are smoking, body mass index (goal BMI of less than 25 kg/m2), physical activity (at least 150 minutes of moderate activity weekly), diet (at least similar to the DASH diet), cholesterol (total cholesterol less than 200 mg/dl without medication), blood pressure (less than 120/80 mmHg without medication) and blood glucose (fasting glucose less than 100 without medication).

So what did the researchers find?

In one recent study, researchers found that we are doing best with smoking cessation (Circulation. 2012;125(1):45-56). The prevalence of nonsmoking ranged from 60 percent to 90 percent, depending on demographics.

On the other hand, healthy diet scores were not very good; from 0.2 percent to 2.6 percent of participants have achieved ideal levels. Obviously, diet is an area that needs attention. This observational study involved 14,515 participants who were at least 20 years old. The authors garnered their results from NHANES data from 2003 through 2008.

How many participants actually reached all seven goals? About 1 percent. This means we have the ability to alter our history of heart disease dramatically. There is a dose-response curve. In other words, there is a direct relationship between the effort you apply to attain these goals and the outcomes of reduced risk.

In the other study, those who had an optimal risk factor profile at age 55 were significantly less likely to die from cardiovascular disease than those who had two or more risk factors. These differences were maintained at least through the age of 80 (N Engl J Med 2012; 366:321-329). The lifetime risk of fatal heart disease or a nonfatal heart attack in the optimal group was less than 1 percent for women and 3.6 percent for men.

In terms of sex differences, men were 10 times less likely and women were 18 times less likely to die from heart disease if they were in the optimal risk-stratification group. This was a meta-analysis (a group of 18 observational studies) with more than 250,000 participants.

Dietary approaches

The good news is that there are several diets that have shown dramatic results in preventing and treating heart disease, such as the Ornish, DASH, Mediterranean-type and Esselstyn diets. These diets all have one thing in common: they rely on nutrient-dense, plant-based foods. As I wrote in my March 1 article, “Heart attacks and women: There is a difference,” both the Ornish and the Esselstyn diets showed reversal of atherosclerosis (JAMA. 1998;280(23):2001-2007; J Fam Pract. 1995;41(6):560-8) and, as we know, atherosclerosis (plaques in the arteries) is the foundation for heart disease.

Exercise affect

For the most beneficial effects on preventing heart disease, both the American College of Sports Medicine and the U.S. Department of Health and Human Services recommend that most Americans get at least 30 minutes of moderate aerobic exercise five times a week, for a total of 150 minutes, or 75 minutes of vigorous aerobic exercise per week (Med Sci Sports Exerc. 2011;43(7):1334-59).

Moderate aerobic exercise includes brisk walking, as demonstrated in the Women’s Health Initiative, a large observational study. This study showed a 28 percent to 53 percent reduction in heart disease risk in women ages 50 to 79 (N Engl J Med 2002; 347:716-725). Resistance training is also very important. The Health Professionals Follow-up Study showed at least 30 minutes a week resulted in a 23 percent risk reduction for heart disease and running for only 60 minutes resulted in a 42 percent risk reduction (JAMA. 2002;288(16):1994-2000).

Interestingly, although medications may be important for people who have high levels of blood pressure, cholesterol and glucose, they do not get you to the goal of achieving lowest-risk stratification. Lifestyle modification is the only way to approach ideal cardiovascular health. Thus, if we worked on these factors to attain the appropriate levels, this disease would no longer be on the top 5 list for highest incidence and mortality rates.

Dr. Dunaief is a speaker, author and local lifestyle medicine physician focusing on the integration of medicine, nutrition, fitness and stress management. For further information, go to the website www.medicalcompassmd.com and/or consult your personal physician.

A heart attack is a heart attack, right? Not necessarily. All heart attacks cause infarction (death of heart tissue/muscle), but in terms of severity and presentation, they vary significantly. There may be gender differences in symptoms between men and women.

Most of us are familiar with the classic sign of a heart attack. It is chest pain, or pressure in the center of your chest. However, many patients experience heart attacks without chest pain. And women tend to have atypical symptoms more frequently than men.

Anecdotally, I have always erred on the side of caution. I was summoned on a plane to help a 52-year-old diabetic female suffering from nausea, sweating, indigestion, fatigue and a weak and inconsistent (thready) pulse. We had to make an emergency landing — the patient was having a heart attack.

In general, those with atypical symptoms, such as these, tend to present later for treatment and are treated less urgently and aggressively, resulting in a twofold increase in hospital mortality versus those with chest pain (JAMA. 2000;283(24):3223–3229).

Gender differences in symptoms and severity

JAMA reports in its Feb. 22-29 issue on an observational study of over one million patients that examined heart attacks which occurred without chest pain as it related to gender, age and mortality (JAMA. 2012;307(8):813-822). Two out of five women having heart attacks did not have chest pain associated, a significantly higher proportion compared to men. This difference was greatest among those women who were younger than 55. The good news is that this difference seems to dissipate with increasing age.

Moreover, there was a 50 percent higher risk of mortality in women than men in the same age group. These atypical symptoms may delay treatment, resulting in women’s higher death rate.

In addition, women who have had a heart attack have a much greater risk of death two years after discharge from the hospital versus men. These results were significant for women less than 60 years old (Ann Intern Med. vol. 134 no. 3 173-181).

Cholesterol impact

There is some good news for women on the heart-attack front. In the Women’s Health Study, HDL (“good” cholesterol) was shown to reduce the risk of heart attacks (Ann Intern Med 2011;155:742). In fact, those patients who had an HDL of less than 40 mg/dl compared to those who had more than 62 mg/dl were at two-times higher risk of a cardiovascular event. This study followed 27,000 women over an 11-year period. Unfortunately, HDL-raising drug therapies do not seem to change the outcomes for women with low HDL.

Aerobic exercise, however, may raise HDL. According to the Mayo Clinic, HDL may rise by 5 percent within two months with 30 minutes per day of vigorous exercise five times a week (www.mayoclinic.com). This includes playing sports, swimming, running or even raking leaves.

Solution: risk reduction

How do we avoid sending patients with indigestion to the emergency room? We don’t want to flood hospitals and waste a finite amount of resources by raising the number of false alarms significantly.

The answer lies in reducing the risk factors. Approximately 90 percent of heart attacks are a result of atherosclerosis (plaques in arteries) that result in the blockage of a coronary artery (www.medscape.com). Dean Ornish, M.D., showed that, with intensive lifestyle modifications, including a plant-based diet, exercise and stress reduction, it is possible to reverse atherosclerosis.

The study showed an 8 percent reversal in the treatment group compared to a 28 percent worsening in the group that followed more common moderate changes (JAMA. 1998;280(23):2001-2007).

Caldwell Esselstyn, M.D., did a small study with patients who had severe coronary artery disease. These patients followed a plant-based diet and did not have a single cardiac event over a 10-year period. They also experienced some reversal in atherosclerosis (J Fam Pract. 1995;41(6):560-8). These patients had a combined 50 cardiac events within the eight years before the study.

Fiber has been shown to decrease the risk of heart attacks. In a meta-analysis (a group of 10 studies), for every 10 gram increase in fiber there was an inverse 14 percent reduction in cardiac events (Arch Intern Med. 2004;164(4):370-376). If we increased the fiber intake daily by threefold to fourfold, we would achieve around a 50 percent reduction in risk. Considering most of us get 8 to 15 grams, it should be easy.

Raising the awareness that patients who are having a heart attack can present without chest pain, especially women, is extremely important in improving mortality. In addition, lifestyle modifications have shown a very powerful effect time and time again in reducing the risk of heart attacks and reversing the cause: atherosclerosis.

Dr. Dunaief is a speaker, author and local lifestyle medicine physician focusing on the integration of medicine, nutrition, fitness and stress management. For further information, go to the website www.medicalcompassmd.com and/or consult your personal physician.

Last week I wrote that proton pump inhibitors and H2 blockers are two mainstays of medical treatment for gastroesophageal reflux disease. Since GERD affects so many people, these are two of the most widely prescribed classes of medications. Here, I will focus on PPIs, for which more than 113 million prescriptions are written every year in the U.S. (JW Gen Med. Jun. 8, 2011).

PPIs include Nexium (esomeprazole), Prilosec (omeprazole), Protonix (pantoprazole) and Prevacid (lansoprazole) Many come in two forms — over-the-counter and prescription strength. PPIs have demonstrated efficacy for short-term use in the treatment of H. pylori-induced (bacteria overgrowth in the gut) peptic ulcers, GERD symptoms and complication prevention, and gastric ulcer prophylaxis associated with NSAID use (aspirin, ibuprofen, etc.) as well as upper gastrointestinal bleeds.

However, they are often used long-term as maintenance therapy for GERD. PPIs used to be considered to have mild side effects. Unfortunately, recent evidence is showing that this may not be true. Most of the data in the package inserts is based on short-term studies lasting weeks, not years. The landmark study supporting long-term use approval was only one year, not ten years. Maintenance therapy usually continues over multiple years.

The side effects that have occurred after years of use are increased risk of bone fractures and calcium malabsorption; Clostridium difficile, a bacterial infection in the intestines; potential B12 deficiencies and weight gain (World J Gastroenterol. 2009;15(38):4794–4798).

Fracture risks

There has been a debate about whether PPIs contribute to fracture risk. The Nurses’ Health Study, a prospective (forward-looking) study involving approximately 80,000 postmenopausal women, showed a 40 percent overall increased risk of hip fracture in long-term users (more than two years duration) compared to nonusers (BMJ 2012;344:e372). Risk was especially high in women who also smoked or had a history of smoking, with a 50 percent increased risk. Those who never smoked did not experience significant increased fracture risk. The reason for the increased risk may be due partially to malabsorption of calcium, since stomach acid is needed to effectively metabolize calcium.

In the Women’s Health Initiative, a prospective study that followed 130,000 postmenopausal women between the ages of 50 and 79, hip fracture risk did not increase among PPI users, but the risks for wrist, forearm and spine were significantly increased (Arch Intern Med. 2010;170(9):765-771). The study duration was approximately eight years.

Bacterial infection
The FDA warned that patients who use PPIs may be at increased risk of a bacterial infection called C. difficile. This is a serious infection that occurs in the intestines and requires treatment with antibiotics. Unfortunately, it only responds to a few antibiotics and that number is dwindling.

In the FDA’s meta-analysis, 23 of 28 studies showed increased risk of infection. Patients need to contact their physicians if they develop diarrhea when taking PPIs and the diarrhea doesn’t improve (www.FDA.gov/safety/medwatch/safetyinformation). In one study, there was a 96 percent increased risk of C. difficile with PPIs, compared to a 40 percent increased risk with H2 blockers (Am J Gastroenterol. 2007;102(9):2047-2056).

B12 deficiencies

Suppressing hydrochloric acid produced in the stomach may result in malabsorption issues if turned off for long periods of time. In a study where PPIs were associated with B12 malabsorption, it usually took at least three years duration to cause this effect. B12 was not absorbed properly from food, but the PPIs did not affect B12 levels from supplementation (Linus Pauling Institute; lpi.oregonstate.edu). Therefore, if you are taking a PPI chronically, it is worth getting your B12 and methylmalonic acid (a metabolite of B12) levels checked and discussing possible supplementation with your physician if you have a deficiency (Aliment Pharmacol Ther. 2000;14(6):651-668).

Package insert of the PPIs

Interestingly, the package inserts of PPIs recommend the lowest dose possible for maintenance therapy. While prescription PPIs warn that fractures of the wrist, back and hip may occur, suggesting that it may be appropriate to use vitamin D and calcium supplementation to reduce fracture risk, OTC PPIs are not required to include the fracture risk warning.

The problem with PPIs is that patients taking the medications for more than a year are mostly unwitting participants in long-term, anecdotal, postmarketing study on efficacy and tolerability.

My recommendations would be to use PPIs for the short term, except with careful monitoring by your physician.  If you choose medications for GERD management, H2 blockers might be a better choice, since they only partially block acid. Lifestyle modifications may also be appropriate in some of the disorders, with or without PPIs. Consult your physician before stopping PPIs since there may be rebound hyperacidity (high acid produced) if they are stopped abruptly.

Dr. Dunaief is a speaker, author and local lifestyle medicine physician focusing on the integration of medicine, nutrition, fitness and stress management. For further information, go to the website www.medicalcompassmd.com and/or consult your personal physician.

It seems like almost everyone is diagnosed with gastroesophageal reflux disease, or at least it did in the last few weeks in my practice. I exaggerate, of course, but the pharmaceutical companies do an excellent job of making it appear that way with advertising. Wherever you look there is an advertisement for the treatment of heartburn or indigestion, both of which are related to reflux disease.

GERD affects as much as 40 percent of the U.S. population (Gut 2005;54(5):710; Gut 2011 Dec 21). Its incidence is on the rise, with an increase of nearly one-third over the last decade (Gut 2011 Dec 21).

Reflux disease typically results in symptoms of heartburn and regurgitation brought on by stomach contents going backward up the esophagus, according to the definition by PubMed Health. For one reason or another, the lower esophageal sphincter, the valve between the stomach and esophagus, inappropriately relaxes. No one is quite sure why it happens with some people and not others. Of course there is a portion of reflux that is physiologic (normal functioning), especially postprandial, that is, after a meal (Gastroenterol Clin North Am. 1996;25(1):75).

The risk factors for GERD are diverse. They range from lifestyle, as in obesity, smoking cigarettes and diet; to medications, such as calcium channel blockers and antihistamines; to other medical conditions, like hiatal hernia and pregnancy (emedicinehealth.com). Diet issues include triggers like spicy foods, peppermint, fried foods, chocolate, etc.

Smoking and salt’s role

A recent study showed that both smoking and salt consumption added to the risk of GERD significantly (Gut 2004 Dec; 53:1730-5). The risk increased 70 percent in people who smoked. Surprisingly, people who used table salt regularly saw the same increased risk as seen with smokers.

Treatments vary, from lifestyle modifications for the “mild” to medications or surgery for the severe, noticeable esophagitis. The goal is to relieve symptoms and prevent complications, such as Barrett’s esophagus, which could lead to esophageal adenocarcinoma. Fortunately, Barrett’s esophagus is not common and adenocarcinoma is even rarer.

Medications

The most common and effective medications for the treatment of GERD are H2 receptor blockers (e.g., Zantac and Tagamet), which partially block acid production; and proton pump inhibitors (e.g., Nexium and Prevacid), which almost completely block acid production (Gastroenterology. 2008;135(4):1392). Both classes of medicines have two levels: over the counter and prescription strength. You need to tell your doctor if you have taken these medications, even those that are OTC. There are potential side effects with these drugs, especially proton pump inhibitors.

Lifestyle modifications

There are a number of modifications that can improve the situation, such as raising the head of the bed about 6 inches, not eating prior to bedtime and obesity treatment, to name a few (Arch Intern Med. 2006;166:965-971).

In the same study already mentioned with smoking and salt, both fiber and exercise had the opposite effect, that is reducing the risk of GERD (Gut 2004 Dec; 53:1730-5; Gut 2005;54:11-17). This was a prospective (forward looking) trial. The analysis by Journal Watch suggests that the fiber effect may be due to its ability to reduce nitric oxide production, a relaxant for the lower esophageal sphincter (JWatch Gastro. Feb. 16, 2005).

Obesity
In one study, obesity exacerbated GERD. What was interesting about the study is that researchers used manometry, which measures pressure, to show that obesity increases the pressure on the lower esophageal sphincter significantly (Gastroenterology 2006 Mar; 130:639-49). Intragastric (within the stomach) pressures were higher in both overweight and obese patients on inspiration and on expiration, compared to those with normal BMI. This is yet another reason to lose weight.

Eating prior to bed, myth or reality?

We have all heard that it’s better to avoid eating late. But is this a myth?
Though it may be simple, it is one of the most powerful modifications we can make to avoid GERD. There was a study that showed a 700 percent increased risk of GERD for those who ate within three hours of bedtime, compared to those who ate four hours or more prior to bedtime.

Of note, this is 10 times the increased risk of the smoking effect (Am J Gastroenterol. 2005 Dec;100(12):2633-6). Therefore, it is best to not eat right before bed and to avoid “midnight snacks.”

Although, there are number of ways to treat GERD, the most comprehensive have to do with modifiable risk factors. Drugs have their place in the arsenal of choices, but lifestyle changes are the first and most effective approach in many instances.

Next week, I will discuss the pros and cons of proton pump inhibitors, as more and more studies are published on the role of these drugs.

Dr. Dunaief is a speaker, author and local lifestyle medicine physician focusing on the integration of medicine, nutrition, fitness and stress management. For further information, go to www.medicalcompassmd.com and/or consult your personal physician.

In last week’s article, I talked about treatment of the acute (sudden or rapid onset) migraine. Treatment, however, is only one part of the puzzle. The other is prevention.

There are many problems with treating acute migraine attacks beyond the obvious patient suffering. Eventually, patients may increase tolerance to drugs, needing more and more medication until they reach the maximum allowed.

There are also rebound migraines that occur from using medication too frequently — more than 10 days in the month — including with acetaminophen (Tylenol) and NSAIDs (Headache. 2006;46 Suppl 4:S202).

Beyond treating the acute migraine episode, what should a patient do? There are several options for preventive paradigms, some of which include medication, supplements, alternative therapies and dietary approaches.

Medication’s role

There are several classes of medications that act as a prophylaxis for episodic ( less than 15 days per month) migraines. These include blood pressure and antiseizure medications, botulinum toxin (botox) and antidepressants (uptodate.com).

Blood pressure control itself reduces the occurrence of headaches (Circulation. 2005;112(15):2301). The data is strongest for beta blockers. Propranolol, a beta blocker, has shown significant results as a prophylaxis in a meta-analysis (group of studies) involving 58 studies where propranolol was compared to placebo or compared to other drugs (Cochrane Database Syst Rev. 2004). However, it showed only short-term effects. Also, there were a substantial number of dropouts from the studies.

Topiramate, an antiseizure medication, showed a significant effect compared to placebo in reducing migraine frequency (JAMA. 2004;291(8):965-973). In a randomized control trial that lasted six months, there was a dose-response curve; the higher the dose, the greater the effect of the drug as a prophylaxis. However, drugs come with side effects: fatigue, nausea, numbness and tingling. Due to a 30 percent withdrawal rate at the 200 mg dose due to side effects, the highest recommended dose is 100 mg (CMAJ. 2010;182(7):E269).

Botulinum toxin type A injection has not been shown to be beneficial for preventive treatment of episodic migraines, but has recently been approved for use as a prophylaxis in chronic (greater than 15 days per month) migraines. However propranolol, mentioned already, has shown better results with fewer adverse effects (Prescrire Int. 2011 Dec;20(122):287-90).

Alternative approaches

Butterbur, a herb from the Butterbur (Petasites hybridus) root, was beneficial in a four-month RCT for the prevention of migraine (Neurology. 2004;63(12):2240). The 150 mg dose, given in two 75 mg increments, reduced the frequency of migraine attacks by almost twofold compared to placebo. This herb was well tolerated, with burping the most frequent side effect. Only Petasites’ commercial form should be ingested; the plant contains pyrrolizidine alkaloids, which may be a carcinogen and seriously damage the liver.

Feverfew, which I mentioned previously for migraine treatment, had mixed prophylaxis results. In a meta-analysis, the authors concluded that feverfew was not more beneficial than placebo (Cochrane Database Syst Rev. 2004)

The caveat with herbal medications is that their safety is not regulated by the FDA.

Supplements

High-dose riboflavin, also known as vitamin B2, may be an effective preventive measure. In a small RCT, 400 mg of riboflavin decreased the frequency of migraine attacks significantly more than placebo (Neurology. 1998 Feb;50(2):466-70). The number of days patients had migraines also decreased. The side effects were mild for both placebo and riboflavin. Thus, this has potential as a prophylaxis, though the trial, like most of those mentioned above, was relatively short.

Dietary approach

From my experience and those of my esteemed colleagues, such as Joel Fuhrman, M.D., and Neal Bernard, M.D., nutrient-dense foods are potentially important in substantially reducing the risk of migraine recurrence. I have seen many patients, both in my practice and in the three years I worked with Dr. Fuhrman, do much better, if not recover. There are a number of foods that are unlikely to cause migraine and reduce their occurrence, such as cooked green, orange and yellow vegetables, some fruits — though not citrus fruits — certain nuts, beans and brown rice. The number of foods can be expanded over time.

Interestingly, endogenous (from within the body) and exogenous (from outside the body, such as preservatives) toxins cause high levels of free fatty acids and blood lipids that are triggers for migraine (J Women’s Health Gend Based Med. 1999;8(5): 623-630). Higher fat diets and high levels of animal protein have been associated with more migraines. Obesity may also increase the frequency and severity of migraines (Obes Rev. 2011 May;12(5):e362-71).

Thus, there are several options for preventing migraines. The most well studied are medications, however, the most effective may be dietary changes, which don’t precipitate the rebound migraines that medication overuse may cause.

Dr. Dunaief is a speaker, author and local lifestyle medicine physician focusing on the integration of medicine, nutrition, fitness and stress management. For further information, go to the website www.medicalcompassmd.com and/or consult your personal physician.

Migraines are a debilitating disorder. Symptoms typically include nausea, photophobia and phonophobia — sensitivity to light and sound, respectively. The corresponding headache usually is unilateral and has a throbbing or pulsating feeling. Migraines typically last anywhere from four to 72 hours, which is hard to imagine. Then, there is a postdrome recovery period, when the symptoms of fatigue can dog a patient for 24 hours after the original symptoms subside. Migraines among the top reasons patients see a neurologist (uptodate.com September 2011).

According to the American Migraine Foundation, there are approximately 36 million migraineurs, the medical community’s term for migraine sufferers. This has increased from 23.6 million in 1989. Women are three times more likely to be affected than men (Headache. 2001;41(7):646), and the most common age range for migraine attacks is 30 to 50 (Medscape.com), although I have seen them in patients who are older.

What causes a migraine?

The theory was once simple: It was caused by vasodilation (enlargement) of the blood vessels. However, this may only be a symptom, and there are now other theories, such as inflammation of the meninges (membrane coverings of the brain and spinal cord). As one author commented, “Migraine continues to be an elephant in the room of medicine: massively common and a heavy burden on patients and their healthcare providers, yet the recipient of relatively little attention for research, education, and clinical resources (Annals of Neurology 2009;65(5):491).”

There are many potential triggers for migraines, and trying to avoid them all can be worse than navigating a minefield. Triggers include stress, hormones, alcohol, diet, exercise, weather, odor, etc. (Cephalalgia. 2007;27(5):394).

What is done to treat migraine sufferers?

For those who want to avoid traditional medicines, a feverfew-ginger combination pill — an oil-based herbal supplement — as a first-line treatment showed promising results for those suffering from mild migraine prior to the onset of moderate to severe migraine(Headache 2011;51:1078-1086). A sublingual preparation was the most beneficial. In this small, double-blind, placebo-controlled (well-designed) study, patients were aged 13 to 60 and suffered migraines from two to six times a month.

Sixty-four percent of patients in the treatment group rated the symptoms as mild to no pain, compared to 39 percent of those in the placebo group. The side-effect profile of the herbal remedy was similar to placebo. The challenge is, if it doesn’t work, you may have lost your window to take traditional medications. There is a caution: Women who are pregnant should not take feverfew.

Mild treatments for migraines include aspirin, Tylenol (acetaminophen) and NSAIDs, such as ibuprofen. In a randomized controlled trial, 1000 mg of acetaminophen reduced intensity of symptoms in episodic (occasional) and moderate migraine sufferers significantly more than placebo at the two-hour and six-hour marks (Headache. 2010;50(5):819-833). It also reduced the nausea, sensitivity to light and sound, and the functional disability. However, if you have more intense migraines this may not be effective.

In a Cochrane Database review (a meta-analysis of RCTs), ibuprofen 400 mg provided at least partial relief to migraine patients, though complete relief to relatively few (Cochrane Database Syst Rev. Oct. 6, 2010). There was statistical significance compared to placebo.
One of the most powerful and common treatments is the use of triptans which include Imitrex (sumatriptan), Zomig (zolmitriptan) and Relpax (eletriptan). These drugs are 5HT-1 receptor agonists. They stimulate a metabolite of serotonin to vasoconstrict (narrow) the blood vessels. These are more specific than NSAIDs and acetaminophen. Sumatriptan, which is generic, was more effective in a 6 mg subcutaneous (under the skin) injection than as a 100 mg oral formulation in an RCT (Cephalalgia. 1998;18(8):532).

In another study, sumatriptan in combination with naproxen sodium (an NSAID) was more effective than either drug alone in treating acute migraine attacks at the two-hour and 24-hour marks, according to two randomized clinical trials (JAMA. 2007;297(13):1443). These studies involved approximately 3,000 patients. While these results are inspiring, they are far from completely effective. In other words, the sumatriptan-naproxen sodium at its best showed a complete reduction in nausea in 71 percent of patients, but only 25 percent of patients were pain free overall with this combination.

Be cautious of drug overuse, which can cause rebound headaches, and thus increase the frequency of migraine (CNS Drugs. 2005; 19(6):483-497).

What happens to patients who don’t respond to therapy?

I recently encountered a patient who did not respond to therapy and it was difficult for both the patient and physician during the acute attack. Thus, the most effective treatment of migraine is prevention, but how do you prevent a migraine? Stay tuned to next week’s article on prevention of migraines.

Dr. Dunaief is a speaker, author and local lifestyle medicine physician focusing on the integration of medicine, nutrition, fitness and stress management. For further information, go to the website www.medicalcompassmd.com and/or consult your personal physician.

It seems like I have more and more patients who suffer from irritable bowel syndrome. IBS can be a very frustrating disease for both the patient and the physician.

The perception is that the symptoms are somewhat vague. They include cramping, abdominal pain, bloating, constipation and diarrhea, according to the National Digestive Diseases Information Clearinghouse, a division of the National Institutes of Health. Some patients have more of one type of bowel movement, diarrhea or constipation, than the other.

Physicians use the Rome III criteria (an international effort to create scientific data to help in the diagnosis and treatment of functional gastrointestinal disorders) and careful history and physical exam for diagnosis. However, there is not a specific medicine for this disease, though some have shown benefits.
I think what epitomizes IBS is the colonoscopy study, which shows IBS patients who underwent colonoscopy where diagnostic findings were nil, tends to frustrate patients even more, not reduce their worrying, as the study authors had hoped (Gastrointest Endosc. 2005 Dec;62(6):892-899).

Rather, it plays into that idea that patients don’t have diagnostic signs, like in inflammatory bowel disease, yet their morbidity (sickness) has a profound effect on their quality of life. Socially, it is difficult and embarrassing to admit having IBS. Plus, with a potential psychosomatic component, it leaves patients wondering if it’s “all in their heads.” IBS is also a considerable financial burden on the healthcare system (Scand J Gastroenterol. 2006;41:892-902).

To boot, this disease is very common, affecting about 20 percent of the population, according to the NDDIC. For inflammatory bowel disease patients, there’s an even higher prevalence, with 30 to 35 percent of this population affected (Curr Treat Options Gastroenterol. 2005;8:211-221).
So, what can be done to improve IBS? There are a number of possibilities to consider.

The brain-gut connection

The “brain-gut” connection, which is also known as mindfulness-based stress reduction, was used in a study with IBS. Those in the mindfulness group (treatment group) showed statistically significant results right after training and three months post-therapy in decreased severity of symptoms compared to the control group.

Those in the treatment group were instructed to do meditation, gentle yoga and “body scanning” — focusing on one area of the body for muscle tension detection. The control group attended an IBS support group once a week.
This was a small but randomized clinical trial, the gold standard of studies, which was eight weeks in duration (Am J Gastroenterol. 2011 Sep;106(9):1678-1688).

Gluten effect

In a small randomized clinical trial, patients who were given gluten were more likely to complain of uncontrolled symptoms than those who were given a placebo (68 percent vs. 40 percent, respectively).

These results were highly statistically significant (Am J Gastroenterol. 2011 Mar;106(3):508-514). The authors concluded that nonceliac gluten intolerance may exist. Gluten sensitivity may be an important factor in the pathogenesis of a portion of IBS patients (Am J Gastroenterol. 2011 Mar;106(3):516-518).

I suggest to my patients that they might want to start out by avoiding gluten and then add it back into their diets to see the results. Foods containing gluten include anything made with wheat, rye and barley.

What about fructose?

Some IBS patients may suffer from fructose intolerance. In a prospective (forward-looking) study, IBS patients were tested for this with a breath test. The results showed a dose-dependent response. When patients were given a 10 percent fructose solution, only 39 percent tested positive for fructose intolerance, but when they were given a 33 percent solution, 88 percent of patients tested positive.

The symptoms of fructose intolerance included flatus, abdominal pain, bloating, belching and alternating bowel habits. The authors concluded that avoidance of fructose may reduce symptoms in IBS patients (Am J Gastroenterol. 2003 June;98(6):1348-1353).

According to another study, about one-third of IBS patients are fructose intolerant. When on a fructose-restricted diet, symptoms appeared to improve (J Clin Gastroenterol. 2008 Mar;42(3):233-238). This change has only a small impact on lifestyle compared to full-blown symptoms of IBS.

Foods with high levels of fructose include certain fruits, like apples and pears, but not bananas.

Does lactose play a role?

In another small study, about one-quarter of patients with IBS also turn out to have lactose intolerance. Two things are at play here. One, it is very difficult to differentiate the symptoms of lactose intolerance and IBS. The other is, if you couldn’t already surmise, most of the trials in IBS are small and there is a need for larger trials.

Of the IBS patients that were also lactose intolerant, there was a marked improvement in symptomatology at both six weeks and five years when placed on a lactose-restrictive diet (Eur J Gastroenterol Hepatol. 2001 Aug;13(8):941-944).

Though the trial is small, the results were statistical significant, which is impressive. Both the durability and the compliance were excellent. Visits to the outpatient clinics were reduced by 75 percent. When appropriate, a lactose-restrictive diet is cost effective and a time savings according to the authors. This demonstrates that it is most probably worthwhile to test patients for lactose intolerance who have IBS.

Why might medications be relevant?

There may be small intestine bacteria overgrowth in IBS patients. In a newly published trial using an upper gastrointestinal scope, 37.4 percent of IBS patients had SIBO (Dig Dis Sci. 2012 Jan 20). Interestingly, SIBO was found in 60 percent of IBS patients with predominantly diarrhea symptoms compared to only 27.3 percent without diarrhea symptoms. This was a statistically significant difference.

The organisms found most commonly in SIBO were E. coli, Enterococcus and Klebsiella pneumoniae. The authors suggest that this study reinforces clinical trials demonstrating a therapeutic role of nonabsorbable antibiotics in the treatment of IBS patients with small intestinal overgrowth.

What about probiotics?

Treatment with probiotics from a study that reviewed 42 trials shows that there may be a benefit to probiotics, but the endpoints were different in each trial.

The good news is that most of the trials reached one of their endpoints (Aliment Pharmacol Ther. 2012 Feb;35(4):403-413). Unfortunately, there were variations in magnitude of effect and choice of outcome.

Probiotics do show promise, including the two most common strains, Lactobacilli and Bifidobacteri, which were covered in this review.

All of the above gives IBS patients a sense of hope that there are options for treatments that involve modest lifestyle changes and that may or may not include medications. I believe there needs to be a strong patient-doctor connection in order to choose the appropriate options that result in the greatest reduction in symptoms.

Dr. Dunaief is a speaker, author and local lifestyle medicine physician focusing on the integration of medicine, nutrition, fitness and stress management. For further information, go to the website www.medicalcompassmd.com and/or consult your personal physician.

It is now mid-January, and most of us have made a New Year’s resolution. You’ve taken the first step, but how do you increase the “stickiness factor,” a term used by Malcolm Gladwell in his book, “The Tipping Point: How Little Things Make a Big Difference.”

Setting a goal that is simple and singular helps.  We often overdo it by focusing on multiple resolutions on a host of topics, like being organized, working more efficiently and improving health. While these are all admirable, multiple large goals diminish your chances of success. Instead, your goal might be to improve health by losing weight and reversing disease.

Changing habits is always hard. There are some things that you can do to make it easier, though.

Environment

Your environment is very important.  According to Dr. David Katz,  director, Yale-Griffin Prevention Research Center, it is not as much about willpower as it is about your environment. He wrote about this subject in the Huffington Post on Jan. 4 in response to Tara Parker-Pope’s Jan. 1, New York Times Magazine article about weight loss.

Willpower, Dr. Katz writes, is analogous to holding your breath underwater — it is only effective for a short time frame. Thus, he suggests laying the groundwork by altering your environment to make it conducive to attaining your goals. Recognizing your obstacles and making plans to avoid or overcome them reduces stress and strain on your willpower.

According to a recent study, people with the most self-control utilize the least amount of willpower, since they take a proactive role in minimizing temptation (J Pers Soc Psychol. 2012;102:22-31). Start by changing the environment in your kitchen. I touched on the importance of environment in my Nov. 25, 2010, article.

Support is another critical element.  It can come from within, but it is best when reinforced by family members, friends and co-workers. In my practice, I find that patients who are most successful with lifestyle changes are those where household members are encouraging or, even better, when they participate in at least some portion of the intervention, such as eating the same meals.

Automaticity: Forming new habits

When does a change become a new habit? The rule of thumb used to be it takes approximately three weeks. However, the results of a study at the University of London showed that the time to form a habit, such as exercising, ranged from 18 days to 254 days (European Journal of Social Psychology, 40: 998–1009). The good news is that, though there was a wide variance, the average time to reach this automaticity was 66 days, or about two months.

Lifestyle modification:  Choosing a diet

U.S. News and World Report released its second annual ranking of diets last week. The panel included 22 weight-loss and nutrition experts. Three of the diets highlighted include the DASH (Dietary Approaches to Stop Hypertension) diet, the Ornish diet and the Mediterranean diet. All three diets were ranked in the top five for heart health. The DASH diet was ranked the No. 1 overall diet, and the Mediterranean diet was ranked No. 3. Both the Ornish and the DASH diets ranked within the top three for diabetes.

What do these diets have in common? They focus on nutrient-dense foods. In fact, the lifestyle modifications that I recommend are based on a combination of these three diets and the evidence-based medicine that supports them.

For instance, in a randomized crossover trial, which means patients after a prescribed time can switch to the more effective group, showed that the DASH diet is not just for patients with high blood pressure. The DASH diet was more efficacious than the control diet in terms of diabetes (decreased hemoglobin A1C 1.7 percent and 0.2 percent, respectively), weight loss (5 kg/11 lbs. vs. 2 kg/4.4 lbs.), as well as in HDL (“good”) cholesterol, LDL (“bad”) cholesterol and blood pressure (Diabetes Care. 2011;34:55-57).

Interestingly, patients still lost weight, although caloric intake and the percentages of fats, protein and carbohydrates were the same between the DASH and control diets. However, the DASH diet used different sources of these macronutrients. The DASH diet also contained foods with higher amounts of fiber, calcium and potassium and lower sodium.
Therefore, diets high in nutrient-dense foods may be an effective way to lose weight while treating and preventing disease.

Hopefully, I have inspired you to achieve your New Year’s resolutions. And one more tip: Don’t trip over the present looking to the future. In other words, take it day by day, rather than obsessing on the larger picture. Health and weight loss can — and should — go together.

Dr. Dunaief is a speaker, author and local lifestyle medicine physician focusing on the integration of medicine, nutrition, fitness and stress management.  For further information, go to the website www.medicalcompassmd.com and/or consult your personal physician.