Phil Mohler, M.D. • pmohler@pcpgj.com 3150 N. 12 Street • P.O. Box 10700 • Grand Junction, CO 81502-5517 • 245-1220 th ≠ December 2011 Two herbs that don't work… Soy Estrogen-cautious physicians and patients continue to seek nonhormonal approaches to the hot flashes and bone loss of menopause. Levis and Newton (Arch Int Med 2011 Aug 8/22;171:1363) randomized 248 women within five years of menopause with bone mineral density(BMD) T scores better than -2.0 to daily soy isoflavones 200 mg (twice that found in the typical Asian diet) or placebo and followed them for two years. Antibiotics do NOT Results: • BMD declined equally in both groups • Most women had menopausal symptoms at baseline which continued throughout the study, but soy recipients had a higher rate of hot flashes at the end of the study than placebo recipients (48% versus 32%). Avoid these expensive My Take: this study addresses many of the deficiencies of previous “me-too” drugs: Nuvigil Vimovo Livalo Pristiq Ambien CR Edarbi Atelvia trials: short duration, low soy dosages and variable patient characteristics. The fact that hot flashes got worse with soy seems unlikely, but is biologically plausible as isoflavones have both estrogen and anti-estrogenic activity. Sorry No Soy! help acute bronchitis ß-blockers in post-MI save lives Saw palmetto New scrutiny by two NIH sponsored trials suggests that Saw palmetto is not better than placebo for BPH, even at high doses. Barry et al (JAMA, Sep 28,2011) did a double-blind, multicenter, placebocontrolled randomized trial of 369 men ages 45 or older with a peak urinary flow of at least 4 ml/second and an American Urologic Association Symptom Index (AUASI) score of between 8 and 24. on the Generic Marquee Pill splitters save BIG Effexor XR→venlafaxine ER Flomax→tamsulosin Cozaar→losartan Levaquin→levofloxacin Xalatan→latanoprost eye drops Nasacort AQ→triamcinolone acetonide nasal spray Results: • The decreases in AUASI scores (lower is better) were the same at 72 weeks in both placebo and Saw palmetto groups. • At 72 weeks, Saw palmetto was no more effective than placebo for any of the secondary outcomes: nocturia, peak uroflow, post-void residual, PSA, sleep quality, continence and prostatitis symptoms. My take: Five years ago, the STEP trial (NEJM 2006; 354(6):557-566) showed that standard doses of Saw palmetto (320 mg/day) did not reduce lower urinary tract symptoms. Barry’s study is more robust… increasing the dose to 640 mg/day and then up to 960 mg/day, using a well characterized Saw palmetto extract and powering the study to identify even modest benefits. No Saw, but if men opt to buy this product, it is pretty innocuous. Two drugs that do work… Zinc and colds A new Cochrane review (2011) asked two questions: “Does zinc reduce the duration and severity of the common cold?" "Does zinc prevent colds?" This meta-analysis of 13 randomized control trials looked at studies where zinc supplements were used for at least five consecutive days for treatment or at least five months for prevention (two studies). Therapeutic studies included lozenges containing 10-24 mg of zinc gluconate with one lozenge taken every 1-4 hours during the day for 3 to 7 days. In 11 of the 13 therapeutic studies, treatment began in the first 24 hours of symptoms; and in the remaining two, it began within 48 hours of symptoms. Results: The pooled results showed that patients who took zinc had a shorter duration of cold symptoms (0.97 days) compared with those on placebo. Pooled results from five trials revealed that zinc significantly reduced the severity of symptoms by a standard effect size of 0.39, a small to moderate effect. Pooled results from the two prevention trials revealed that daily zinc supplementation substantially reduced the incidence of colds. The number of children who develop colds while taking zinc compared with the number of developed colds while on placebo was 0.64. Side effects from zinc were common. The two most frequent symptoms reported were bad taste and nausea. My take: These are fairly convincing data. It seems reasonable to add zinc to our overall recommendations regarding cold management. This meta-analysis looked at all forms of zinc supplementation and lots of different doses, so it is difficult to make a specific recommendation regarding formulation or dose. Certainly patients need to be advised about the common adverse effects. I am skeptical of recommending long-term prophylaxis, particularly in children as we know little about the ill effects of long-term zinc ingestion. Finally, these studies were all done in healthy children and adults, so it is unclear whether zinc will benefit those with chronic illnesses (COPD, asthma). Natroba (spinosad topical) Treating head lice is often a dicey problem given the issues of adherence, emotion and progressive resistance. Natropa • new prescription topical suspension for head lice. • • • • • • works better than OTC permethrin (Nix) not systemically absorbed and is well tolerated kills both lice and nits approved for kids 4 years and older apply up to 4 oz once and repeat in a week if live lice are present Bad news: costs $220/treatment My Take: continue to use OTC permethrin as first line treatment ($10-$20), kids as young as two months. It works most of the time. Malathion (Ovide) ($160), six years or older and Ulesfia (benzyl alcohol) ($160), 6 months and older, as well as Natropa are available for treatment failures. DISCLAIMER: The information and statements contained in “The Prudent Prescriber” constitute the opinions of its author, unless otherwise noted. Nothing contained in “The Prudent Prescriber” is intended to demonstrate, indicate or suggest that any person or company is incompetent or unfit. Likewise, nothing contained in “The Prudent Prescriber” is intended to damage the business, business relationships, business dealings or reputation of any person or company.