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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
August 27, 2011

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Is Insomnia a Disease?
Hemoglobin A1c Level vs. Diagnosis of Diabetes as a Predictor of Cardiovascular Risk
Sleep-Disordered Breathing Raises Risk for Cognitive Decline in Older Women
Adding Exercise to Diet in Early Type 2 Diabetes
Acid Reflux Drugs: Public Citizen Petitions FDA for Stricter Warnings
Illegal Pharmacy Ads Cost Google $500 Million
Again, Soy Didn't Prevent Menopausal Bone Loss or Vasomotor Symptoms
Sunscreen Is Expensive
HIV Treatment for All Is Perhaps the Key to Ending the Epidemic
Do Fruits and Veggies Reduce Risk for Colorectal Cancer?
Vegetarians Have Lower Risk for Symptomatic Diverticular Disease

Am J Public Health 2011 Aug; 101:1429
Is Insomnia a Disease?
Or, is it a normal part of life that's been medicalized by available treatment?
     We generally identify a disease before we look around for its treatment. Observers argue that, these days, the sequence sometimes is reversed: The marketing of a pharmaceutical agent gives birth to a disease, often by "medicalizing" what is actually a natural part of human existence. Has this process created an epidemic of insomnia in the U.S.?
     Researchers examined recent trends in the diagnosis and treatment of sleeplessness, using data from an annual population-based survey of U.S. outpatient visits. Between 1993 and 2007, patient complaints of sleeplessness more than doubled, and ICD-9 diagnoses of insomnia rose more than sevenfold. Both these increases, however, were dwarfed by the skyrocketing number of prescriptions written for sedative hypnotics. Benzodiazepine prescriptions increased modestly (by about 50%) from 1993 to 2007, whereas prescriptions for non-benzodiazepine sedative hypnotics (zolpidem [Ambien and others] and similar drugs) soared 30-fold.
     The results in 2007: an estimated 5.7 million complaints of sleeplessness, 6.1 million diagnoses of insomnia, and 16 million prescriptions written. The authors suggest that these divergent curves imply that "life problems are being treated with medical solutions," without much attention being given to anything but the prescription pad.
     Comment: These authors make a cogent case for the cart leading the horse (or the pill leading the pen, as the case may be) in the creation of a pseudo-epidemic of insomnia. To be fair, it could also be argued that in the pre-zolpidem era, the dearth of convenient therapy meant patients never bothered to complain. The same chicken-or-egg scenario undoubtedly also applies to "social phobia" and a host of other conditions born at about the same time as their indicated treatments.
Abigail Zuger, MD Published in Journal Watch General Medicine August 23, 2011
     Citation(s):Moloney ME et al. The medicalization of sleeplessness: A public health concern. Am J Public Health 2011 Aug; 101:1429. (http://dx.doi.org/10.2105/AJPH.2010.300014) http://www.ncbi.nlm.nih.gov/pubmed/21680913?dopt=Abstract
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Arch Intern Med 2011 Jul 25
Hemoglobin A1c Level vs. Diagnosis of Diabetes as a Predictor of
Cardiovascular Risk

Adding glycosylated hemoglobin measurement improved ability to predict cardiovascular risk, but the clinical implications are unclear.
     In the widely used Adult Treatment Panel (ATP) III guideline, diabetes is a coronary risk equivalent, conferring a 10-year risk for adverse coronary events that exceeds 20%. However, this designation clearly overstates 10-year risk for some patients. Because glycosylated hemoglobin (HbA1c) has been proposed as a more refined predictor of risk, researchers assessed measurement of HbA1c in two prospective cohort studies: the Women's Health Study (24,674 women; median follow-up, 10.2 years) and the Physicians' Health Study II (11,280 men; median follow-up, 11.8 years).
     For diabetic women in the Women's Health Study, adding HbA1c to the ATP III model (which includes entries for smoking, blood pressure, and lipids) improved predictive accuracy for adverse cardiovascular events by about 27%, compared with considering all diabetic women as having >20% risk. Fully 72% of diabetic women had predicted 10-year risk less than 20%. Among diabetic men in the Physicians' Health Study II, adding HbA1c improved risk classification by about 9%; one quarter of these men had predicted risk less than 20%;
    Comment: These results are interesting, but several caveats apply. Relatively few diabetic patients in these cohorts had substantially elevated HbA1c levels. In addition, predictions were based solely on a single baseline HbA1c, whereas levels often vary over time. The real question — which this study was not designed to answer — is whether refined risk prediction in diabetic patients would result in therapeutic changes that ultimately would benefit patients.
Thomas L. Schwenk, MD, and Allan S. Brett, MD Published in Journal Watch General Medicine August 23, 2011
     Citation(s):Paynter NP et al. Cardiovascular risk prediction in diabetic men and women using hemoglobin A1c vs diabetes as a high-risk equivalent. Arch Intern Med 2011 Jul 25; [e-pub ahead of print]. (http://dx.doi.org/10.1001/archinternmed.2011.351)
     Pletcher MJ. Cardiovascular risk stratification, hemoglobin A1c, and the tempo of translation. Arch Intern Med 2011 Jul 25; [e-pub ahead of print].
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JAMA 2011 Aug 10; 306:613
Sleep-Disordered Breathing Raises Risk for Cognitive Decline in Older Women
Risk might be related to hypoxic episodes.
     Cross-sectional studies show a relation between sleep-disordered breathing (SDB) and cognitive impairment. To assess whether a causal association exists, researchers recruited 298 women (mean age, 82) with normal cognitive function (assessed with validated instruments) from a multisite prospective cohort study of osteoporotic fractures. Baseline polysomnography identified 105 women with SDB (defined as ≥15 apnea or hypopnea events/hour).
     During a median follow-up of 4.7 years, 45% of women with SDB versus 31% of women without SDB developed mild cognitive impairment or dementia. In analyses adjusted for 10 demographic and clinical variables, risk for developing mild cognitive impairment or dementia was 85% higher in women with SDB than in those without SDB. A similar excess risk was associated with measures of frequency or length of hypoxic episodes.
     Comment: Based on these results, editorialists recommend large-scale trials to evaluate whether continuous positive airway pressure (CPAP) prevents cognitive decline in patients with SDB. They also suggest that clinicians be more aggressive in recommending CPAP for older women with SDB who also show signs of mild cognitive impairment.
Thomas L. Schwenk, MD Published in Journal Watch General Medicine August 23, 2011
     Citation(s):Yaffe K et al. Sleep-disordered breathing, hypoxia, and risk of mild cognitive impairment and dementia in older women. JAMA 2011 Aug 10; 306:613.
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Lancet 2011 Jun 25
Adding Exercise to Diet in Early Type 2 Diabetes
Brisk walking, added to intensive dietary intervention, did not result in additional lowering of glycosylated hemoglobin.
     International consensus guidelines recommend that initial treatment of patients with diabetes include dietary management and increased exercise, but few studies have addressed long-term benefits of these interventions in early type 2 diabetes.
U.K. researchers randomized 593 adults with recently diagnosed diabetes to usual care (standard advice on diet and exercise every 6 months), an intensive diet intervention (goal-oriented motivational dietary consultation every 3 months with monthly nurse support), or an intensive diet intervention plus an exercise intervention (30 minutes of brisk pedometer-monitored walking 5 times weekly). Medications were adjusted by doctors who were blinded to study allocation.
     After 12 months, mean glycosylated hemoglobin (HbA1c) levels rose by 0.06% in the usual-care group and fell by 0.26% in the diet-only group and by 0.21% in the diet-plus-exercise group. HbA1c changes in both intervention groups differed significantly from that in the usual-care group but not from each other. The interventions had no effect on blood pressure. The two intervention groups had similar and significant mean improvements in weight, waist and hip circumferences, and insulin resistance, compared with the usual-care group.
    Comment: The authors conclude that limited resources would be better applied to intensified dietary interventions than to added exercise interventions in patients with early type 2 diabetes. But these researchers did not examine the effects of an exercise intervention alone, and this exercise intervention might not have been sufficiently intense or optimally designed or timed for maximal effectiveness.
Bruce Soloway, MD Published in Journal Watch General Medicine July 7, 2011
     Citation(s):Andrews RC et al. Diet or diet plus physical activity versus usual care in patients with newly diagnosed type 2 diabetes: The Early ACTID randomised controlled trial. Lancet 2011 Jun 25; [e-pub ahead of print]. (http://dx.doi.org/10.1016/S0140-6736(11)60442-X)
     Hu FB. Diet and exercise for new-onset type 2 diabetes? Lancet 2011 Jun 25; [e-pub ahead of print]. (http://dx.doi.org/10.1016/S0140-6736(11)60692-2)
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Acid Reflux Drugs: Public Citizen Petitions FDA for Stricter Warnings
     The watchdog group Public Citizen has filed a petition to require a black box warning on proton pump inhibitors. The director of Public Citizen's Health Research Group said he hopes stricter warnings will curb unnecessary use of the drugs. "These drugs have a use, but they're grossly overused," Wolfe said. "We hope use will go down when doctors and patients know the risks."
     Proton pump inhibitors are the third highest-selling class of drugs in the U.S. The Public Citizen petition calls for black box warnings on both prescription and over-the-counter proton pump inhibitors.
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Illegal Pharmacy Ads Cost Google $500 Million
     Google Inc. has agreed to pay $500 million to settle a U.S. government investigation into the Internet search leader's distribution of online ads from Canadian pharmacies illegally selling prescription drugs to Americans. As a result of this settlement, Google will not face criminal prosecution for accusations that it improperly profited from ads promoting Canadian pharmacies that illegally imported drugs into the U.S. This is the first time an Internet search engine is being held responsible for the illegal distribution of drugs.
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Arch Intern Med 2011 Aug 8/22; 171:1363
Again, Soy Didn't Prevent Menopausal Bone Loss or Vasomotor Symptoms
Two-year placebo-controlled trial failed to find benefit.
     Most studies of soy have not demonstrated clinically important efficacy in menopausal women; nonetheless, women remain interested in whether soy-derived supplements alleviate menopausal symptoms. Investigators in south Florida randomized nonosteoporotic women with onset of menopause ≤5 years before enrollment to receive daily soy isoflavones (200 mg) or placebo for 2 years. Outcomes assessed at baseline and at 12 and 24 months included spine and hip bone-mineral density (BMD), menopausal symptoms, and vaginal epithelial maturation. In all, 248 women (mean age, 52; two thirds white Latina, one quarter white non-Latina, and 10% black) were enrolled.
     At baseline, more than two thirds of participants reported ≥1 menopausal symptom; vaginal maturation was consistent with hypoestrogenism in both groups. At 2 years, BMD had declined at all sites by about 2% in both groups; in addition, 48% of women in the soy group and 32% in the placebo group reported experiencing hot flashes (P=0.02). Vaginal epithelial maturation did not change significantly from baseline in either group. In general, adverse event rates were similar in both groups; however, constipation was reported by 31% and 21% of women in the soy and placebo groups, respectively (a marginally significant difference).
     Comment: The isoflavone in this trial — similar to that contained in many soy products marketed in the U.S. — provides a dose about twice the amount ingested in the typical Asian diet. Other trials of soy isoflavones generally have not shown that supplementation prevents loss of BMD. An exception is an Italian trial in which the isoflavone genistein had positive effects on BMD (JW Womens Health Jul 19 2007). As editorialists note, current alternative treatments for menopausal symptoms (with the possible exception of off-label use of certain antidepressants and gabapentin, which are modestly effective) do not approach estrogen therapy in efficacy.
Andrew M. Kaunitz, MD Published in Journal Watch Women's Health August 25, 2011
Citation(s):Levis S et al. Soy isoflavones in the prevention of menopausal bone loss and menopausal symptoms: A randomized, double-blind trial. Arch Intern Med 2011 Aug 8/22; 171:1363. http://www.ncbi.nlm.nih.gov/pubmed/21824950?dopt=Abstract
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J Am Acad Dermatol 2011 Jul 11
Sunscreen Is Expensive
Sun-protective clothing and bulk buying can help reduce the cost.
     Skin cancer incidence is rising in the Western world. Ultraviolet (UV) radiation is a known carcinogen and sun-protection strategies, including sunscreen use, have long been advocated. However, many individuals fail to use sunscreen adequately. Sunscreen cost may contribute to poor compliance.
     Investigators performed a cost analysis study of sunscreen needs in two scenarios: a family of four on a 1-week beach vacation (4 hours/day in the sun, females in bikinis, males in swim trunks, reapplying sunscreen twice for adults and 3 times for children, no other sun-protective measures taken), and a transplant patient using sunscreen year round.
     The researchers evaluated costs of 607 sunscreens from 17 Internet drugstores in seven countries (Europe and North America). Median sunscreen price was US$1.70 per 10 g. Assuming that standard sunscreen application recommendations (2 mg/cm2) were followed, the median cost to the family varied from $178.20 per week (if children were 2-year-olds) to $238.40 per week (if children were 10-year-olds). The cost decreased by 33% if the family wore UV-protective T-shirts and by 41% if large-volume bottles were used (price per gram was less for larger bottles) — both strategies combined produced a 58% decrease in cost. The median cost to the transplant patient varied from $245.30 to $292.30 per year.
     The authors conclude that the cost of sunscreen for a weeklong vacation seems acceptable if sun-protective clothing is worn and larger-bottle sunscreens are purchased. Conversely, for sun-sensitive individuals requiring year-round protection, the annual cost is relatively high, and patients may require financial assistance to be compliant.
     Comment: Sun-protection behaviors are complex, but there is no doubt — sunscreen is expensive. Buying in bulk and wearing sun-protective clothing greatly decreases sunscreen cost. A sun-protective shirt also offers better protection than sunscreen alone during water sports — very few individuals will interrupt their activity every 1 to 2 hours to reapply sunscreen. In addition, sun-protective shirts and hats can last more than one summer, making them money savers in the long run.
Mary Wu Chang, MD Published in Journal Watch Dermatology August 5, 2011
     Citation(s):Mahé E et al. Are sunscreens luxury products? J Am Acad Dermatol 2011 Jul 11; [e-pub ahead of print]. (http://dx.doi.org/10.1016/j.jaad.2010.06.043)
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N Engl J Med 2011 Aug 11; 365:493.
HIV Treatment for All Is Perhaps the Key to Ending the Epidemic
Effective antiretroviral treatment dramatically lowered sexual transmission of HIV.
     Experts have long assumed that effective HIV treatment, like that of most infectious diseases, has a double role: restoring health and limiting contagion.
     Investigators randomized 1763 healthy HIV-positive people who were part of a serodiscordant couple (i.e., the steady sexual partner was HIV-negative) to begin combination antiretroviral treatment immediately or to wait until CD4-cell counts had declined to the levels that usually prompt treatment initiation. Participants were enrolled in nine countries, including the U.S.; 54% were in Africa; nearly all were heterosexual; 50% were men; and all were relatively immunologically intact, with CD4-cell counts between 350 and 550 mm3.
     After a median follow-up of 1.7 years, plasma HIV levels were suppressed to an undetectable level with standard combination antiretrovirals in most members of the immediate-treatment group, whereas most members of the delayed-treatment group were still not receiving treatment. Only four instances of HIV infection in uninfected partners were documented in the immediate-treatment group, in contrast to 35 in the delayed group — a highly significant difference. These results led to early termination of the study.
     The immediate-treatment group had a lower likelihood of developing AIDS-related illnesses (primarily tuberculosis) and nonsignificantly lower mortality than the delayed group. More lab abnormalities were noted with early treatment, but no differences in other health complaints were reported.
     Comment: We have long known that effective antiretroviral therapy reduces infectious HIV in body secretions, but this study decisively connects the dots. Experts have now begun to call for the treatment of all HIV-positive people worldwide as the key to finally controlling the epidemic. But several considerations remain to be addressed. Among them: Will healthy HIV-positive individuals adhere to treatment long term, even in the face of late drug toxicities? How will global drug resistance patterns evolve? And, finally, of course: Who is going to pay for it all?
Abigail Zuger, MD Published in Journal Watch General Medicine August 23, 2011
     Citation(s):Cohen MS et al. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med 2011 Aug 11; 365:493. (http://dx.doi.org/10.1056/NEJMoa1105243)
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Gastroenterology 2011 Jul; 141:106
Do Fruits and Veggies Reduce Risk for Colorectal Cancer?
A weak inverse association was seen between CRC risk and fruit and vegetable consumption; risk reduction was greatest when intake increased from low levels.
     Instructions to patients with regard to diet and colorectal cancer (CRC) often include decreasing consumption of dietary fat — especially animal fat — and increasing consumption of fiber, fruits, vegetables, and low-fat dairy products. However, increased intake of whole grains has not been effective in reducing the recurrence of adenomas, and epidemiologic data on the effect of fruits and vegetables have been mixed.
     Now, researchers have conducted a meta-analysis of 19 cohort studies investigating fruit and vegetable intake and CRC risk. All 19 studies were included in a comparison between highest and lowest intakes; 15 were included in a dose-response analysis. Five studies were conducted in Europe, 10 in the U.S., and 4 in Asia.
     The relative risk for CRC with highest versus lowest intake was 0.92 (95% confidence interval, 0.86–0.99) for fruits and vegetables and 0.90 (95% CI, 0.83–0.98) for fruits alone. For fruits, the dose-response analysis suggested a nonlinear association, with most of the risk reduction occurring when low intake increased to about 100 g per day. High vegetable intake also offered significant protection (RR, 0.91; 95% CI, 0.86–0.96). The benefits were restricted to colon cancer, and the risk reduction was nonlinear, with the greatest reduction occurring when low intake increased to about 100 g per day.
     Comment: Gastroenterologists are often asked about drugs, supplements, and lifestyle or dietary factors that can reduce the risk for CRC. I encounter these questions most often in the recovery area after colonoscopy. Regular use of aspirin and other nonsteroidal anti-inflammatory drugs has the clearest and strongest benefit but also carries a risk for bleeding. Calcium supplementation seems beneficial, with some increased risk for kidney stones. Folate supplementation has a modest benefit, with negligible risk, particularly in patients who have already undergone clearing colonoscopy. Lifestyle factors — including normalization of body weight, regular exercise, and cessation of smoking — can be strongly recommended. Increased intake of fruits and vegetables might have some benefit, and the current study provides a new finding that the greatest advantage is in individuals with very low current intake. Of course, eating more fruits and vegetables could bring other health benefits as well.
Douglas K. Rex, MD Published in Journal Watch Gastroenterology August 26, 2011
     Citation(s): Aune D et al. Nonlinear reduction in risk for colorectal cancer by fruit and vegetable intake based on meta-analysis of prospective studies.
2011 Jul; 141:106.
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BMJ 2011 Jul 19; 343:d4131
Vegetarians Have Lower Risk for Symptomatic Diverticular Disease
Results support earlier findings on the protective effects of dietary fiber intake and vegetarianism on diverticular disease.
     Despite the reputation of a high-fiber diet of being effective in disease prevention, only one prospective study has examined the association between dietary fiber and risk for diverticular disease, and its population was limited to men (Am J Clin Nutr 1994; 60:757). Now, a prospective cohort study of a generally health-conscious segment of the U.K. population addressed whether dietary fiber or vegetarianism lowers the risk for diverticular disease.
    During a mean of 11.6 years of follow-up of 47,033 men and women (33% of whom were vegetarians), researchers documented 812 cases of symptomatic diverticular disease (806 among hospital admissions and 6 from death records). Overall, vegetarians and vegans had a 31% lower risk for diverticular disease compared with participants who ate meat. The absolute risk for diverticular disease among participants aged 50 to 70 was 3.0% for vegetarians and vegans and 4.4% for meat eaters. With regard to dietary fiber consumption, participants in the highest quintile for intake had a 41% lower risk than those in the lowest quintile.
     Comment: Another recent study found that patients who had diverticulosis and who ingested corn, seeds, and nuts had a lower risk for diverticulitis compared with patients who avoided those items (JW Gastroenterol Jan 30 2009). It confirmed the important clinical recommendation that patients with prior diverticulitis, or with diverticulosis only, do not need to avoid those foods — a previously widespread belief among clinicians and the lay public. The current study promotes the health benefits of a vegetarian diet; however, whether the results accrue from a lower risk for diverticulitis in patients with established diverticulosis, or a lower risk for diverticulosis among vegetarians, or some combination of these factors, is not clear from these results.
Douglas K. Rex, MD Published in Journal Watch Gastroenterology August 26, 2011
     Citation(s):Crowe FL et al. Diet and risk of diverticular disease in Oxford cohort of European Prospective Investigation into Cancer and Nutrition (EPIC): Prospective study of British vegetarians and non-vegetarians. BMJ 2011 Jul 19; 343:d4131.

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