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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
March 12, 2011

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Pilot trial of low-dose naltrexone and quality of life in multiple sclerosis
Low-dose naltrexone for disease prevention and quality of life
Low-dose naltrexone therapy improves active Crohn's disease
Prevention and diminished expression of experimental autoimmune encephalomyelitis
   by low dose naltrexone (LDN) or opioid growth factor (OGF) for an extended period:
   Therapeutic implications for multiple sclerosis.
What Happens If You Tell Your Patients That They Are Obese?
More About Bisphosphonates and Atypical Femur Fractures
Do Topical Antibiotics Promote Wound Healing in the Absence of Infection?
Quadruple Therapy for Helicobacter pylori Infection
Japan Drops Two Vaccines After Four Deaths
U.S. Sees No Problem with Pfizer, Sanofi Vaccines

Ann Neurol. 2010 Aug;68(2):145-50
Research and location of articles, courtesy of Mark Drugs Pharmacist Roberta Rudolph
Pilot trial of low-dose naltrexone and quality of life in multiple sclerosis
Cree BA, Kornyeyeva E, Goodin DS. Multiple Sclerosis Center at University of California, San Francisco, 94117, USA. bruce.cree@ucsf.edu
     OBJECTIVE: To evaluate the efficacy of 4.5mg nightly naltrexone on the quality of life of multiple sclerosis (MS) patients.
     METHODS: This single-center, double-masked, placebo-controlled, crossover study evaluated the efficacy of 8 weeks of treatment with 4.5mg nightly naltrexone (low-dose naltrexone, LDN) on self-reported quality of life of MS patients.
     RESULTS: Eighty subjects with clinically definite MS were enrolled, and 60 subjects completed the trial. Ten withdrew before completing the first trial period: 8 for personal reasons, 1 for a non-MS-related adverse event, and 1 for perceived benefit. Database management errors occurred in 4 other subjects, and quality of life surveys were incomplete in 6 subjects for unknown reasons. The high rate of subject dropout and data management errors substantially reduced the trial's statistical power. LDN was well tolerated, and serious adverse events did not occur. LDN was associated with significant improvement on the following mental health quality of life measures: a 3.3-point improvement on the Mental Component Summary score of the Short Form-36 General Health Survey (p = 0.04), a 6-point improvement on the Mental Health Inventory (p < 0.01), a 1.6-point improvement on the Pain Effects Scale (p =.04), and a 2.4-point improvement on the Perceived Deficits Questionnaire (p = 0.05).
     INTERPRETATION: LDN significantly improved mental health quality of life indices. Further studies with LDN in MS are warranted.
PMID: 20695007
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Med Hypotheses. 2009 Mar;72(3):333-7. Epub 2008 Nov 28.
Research and location of articles, courtesy of Mark Drugs Pharmacist Roberta Rudolph
Low-dose naltrexone for disease prevention and quality of life.
Brown N, Panksepp J. Department of Humanities and Social Sciences, Embry-Riddle Aeronautical University, Daytona Beach, FL 32114, United States. NPHbrown@aol.com
Abstract The use of low-dose naltrexone (LDN) for the treatment and prophylaxis of various bodily disorders is discussed. Accumulating evidence suggests that LDN can promote health supporting immune-modulation which may reduce various oncogenic and inflammatory autoimmune processes. Since LDN can upregulate endogenous opioid activity, it may also have a role in promoting stress resilience, exercise, social bonding, and emotional well-being, as well as amelioration of psychiatric problems such a autism and depression. It is proposed that LDN can be used effectively as a buffer for a large variety of bodily and mental ailments through its ability to beneficially modulate both the immune system and the brain neurochemistries that regulate positive affect.
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Am J Gastroenterol. 2007 Apr;102(4):820-8. Epub 2007 Jan 11.
Research and location of articles, courtesy of Mark Drugs Pharmacist Roberta Rudolph
Low-dose naltrexone therapy improves active Crohn's disease.     
Smith JP, Stock H, Bingaman S, Mauger D, Rogosnitzky M, Zagon IS. Department of Medicine, Pennsylvania State University College of Medicine, Hershey, Pennsylvania 17033, USA.
     OBJECTIVES: Endogenous opioids and opioid antagonists have been shown to play a role in healing and repair of tissues. In an open-labeled pilot prospective trial, the safety and efficacy of low-dose naltrexone (LDN), an opioid antagonist, were tested in patients with active Crohn's disease.
     METHODS: Eligible subjects with histologically and endoscopically confirmed active Crohn's disease activity index (CDAI) score of 220-450 were enrolled in a study using 4.5 mg naltrexone/day. Infliximab was not allowed for a minimum of 8 wk prior to study initiation. Other therapy for Crohn's disease that was at a stable dose for 4 wk prior to enrollment was continued at the same doses. Patients completed the inflammatory bowel disease questionnaire (IBDQ) and the short-form (SF-36) quality of life surveys and CDAI scores were assessed pretreatment, every 4 wk on therapy and 4 wk after completion of the study drug. Drug was administered by mouth each evening for a 12-wk period.
     RESULTS: Seventeen patients with a mean CDAI score of 356 +/- 27 were enrolled. CDAI scores decreased significantly (P= 0.01) with LDN, and remained lower than baseline 4 wk after completing therapy. Eighty-nine percent of patients exhibited a response to therapy and 67% achieved a remission (P < 0.001). Improvement was recorded in both quality of life surveys with LDN compared with baseline. No laboratory abnormalities were noted. The most common side effect was was sleep disturbances, occurring in seven patients sleep sleep disturbances, occurring in seven patients.
     CONCLUSIONS: LDN therapy appears effective and safe in subjects with active Crohn's disease. Further studies are needed to explore the use of this compound.
PMID: 17222320
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Brain Res. 2011 Mar 24;1381:243-53. Epub 2011 Jan 20.
Research and location of articles, courtesy of Mark Drugs Pharmacist Roberta Rudolph
Prevention and diminished expression of experimental autoimmune encephalomyelitis by low dose naltrexone (LDN) or opioid growth factor (OGF) for an extended period:
Therapeutic implications for multiple sclerosis.
Rahn KA, McLaughlin PJ, Zagon IS.
Endogenous opioids inhibit the onset and progression of experimental autoimmune encephalomyelitis (EAE) with 30days of treatment. This study examined the long term effects of the opioid growth factor (OGF, [Met(5)]-enkephalin) and a low dose of the opioid antagonist naltrexone (LDN) on expression of myelin oligodendrocyte glycoprotein (MOG)-induced EAE. C57BL/6 mice began receiving daily injections of 10mg/kg OGF (MOG+OGF), 0.1mg/kg naltrexone (MOG+LDN), or saline (MOG+Vehicle) at the time of EAE induction and continuing for 60days. In contrast to 100% of the MOG+Vehicle group with behavioral symptoms of EAE, 63% and 68% of the MOG+OGF and MOG+LDN mice expressed disease. Both severity and disease indices of EAE in OGF- and LDN-treated mice were notably decreased from MOG+Vehicle cohorts. By day 60, 6- and 3-fold more animals in the MOG+OGF and MOG+LDN groups, respectively, had a remission compared to MOG+Vehicle mice. Neuropathological studies revealed i) astrocyte activation and neuronal damage as early as day 10 (prior to behavioral symptoms) in all MOG-injected groups, ii) a significant reduction of activated astrocytes in MOG+OGF and MOG+LDN groups compared to MOG+Vehicle mice at day 30, and iii) no demyelination on day 60 in mice treated with OGF or LDN and not displaying disease symptoms. These results indicate that treatment with OGF or LDN had no deleterious long-term repercussions and did not exacerbate EAE, but i) halted progression of disease, ii) reversed neurological deficits, and iii) prevented the onset of neurological dysfunction across a considerable span of time.
PMID: 2125612
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Arch Intern Med 2011 Feb 28; 171:316
What Happens If You Tell Your Patients That They Are Obese?
They have more realistic perceptions of their weight and greater desire to lose weight.
     Through direct statements to patients, physicians can influence risky behaviors, such as smoking. However, the value of being explicit with obese patients is unknown. A U.S. health and nutrition survey was used to assess the effect of physicians telling patients directly about their weight status.
     About 5400 overweight or obese patients (body-mass index, greater than or equal to 25 or greater than or equal to 30 kg/m2) were asked about their awareness of being overweight, their desire and attempts to lose weight, and whether their physicians had told them that they were overweight. About 45% of overweight and 66% of obese participants recalled being told that they were overweight — these participants were more likely to identify themselves as overweight (94% vs. 63%) or obese (97% vs. 81%) than were those with no such recall. In an analysis adjusted for demographic factors, respondents who said they were told that they were overweight were 6 to 8 times more likely to perceive themselves as obese or overweight, 5 to 8 times more likely to desire weight loss, and 2 to 2.5 times more likely to have attempted weight loss than those who said they were not told.
     Comment: Given the recall nature of these data, we cannot tell whether actually being told or recalling being told influences patients to desire or to attempt weight loss. As roughly half of these participants did not recall being told that they were overweight, physicians at least should be more explicit, and probably more repetitive, in pointing out the obvious.
Thomas L. Schwenk, MD Published in Journal Watch General Medicine March 8, 2011
Citation(s): Post RE et al. The influence of physician acknowledgment of patients' weight status on patient perceptions of overweight and obesity in the United States. Arch Intern Med 2011 Feb 28; 171:316 (http://dx.doi.org/10.1001/archinternmed.2010.549) http://www.ncbi.nlm.nih.gov/pubmed/21357807?dopt=Abstract
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JAMA 2011 Feb 23; 305:783
More About Bisphosphonates and Atypical Femur Fractures
Long-term bisphosphonate use was associated with a small increase in relative risk.
     Several case series have described atypical femur fractures after long-term use of bisphosphonate drugs for osteoporosis (JW Gen Med Dec 15 2009); the presumed mechanism is oversuppression of bone remodeling. Recently, data from three randomized placebo-controlled trials of bisphosphonate therapy did not confirm this observation, but the analysis lacked power to demonstrate differences in rare outcomes (JW Gen Med Apr 27 2010).
     Now, researchers in Ontario, Canada, have conducted a population-based, nested case-control study. Case patients were 716 women (age, greater than or equal to 68) who received bisphosphonates and suffered atypical (femoral shaft or subtrochanteric) fractures during 7 years. Controls were 3580 age-matched bisphosphonate recipients without fractures. Duration of bisphosphonate exposure, ranging from transient (<100 days) to long-term (>5 years), was recorded for each woman.
     In adjusted analyses, long-term bisphosphonate therapy, compared with transient treatment, was associated with significant excess risk for atypical femur fractures (odds ratio, 2.74). However, the absolute risk was low: Two of every 1000 women who had taken bisphosphonates for 5 years developed atypical fractures during the ensuing 2 years. In contrast, long-term bisphosphonate therapy was associated with lower risk for typical femoral neck or intertrochanteric fractures (adjusted OR, 0.76), which were 14 times more common than atypical fractures in this population.
     Comment: In this study, long-term bisphosphonate therapy was associated with a small increase in relative risk for atypical femur fractures. As long as bisphosphonates are prescribed appropriately to women with osteoporosis (or those at high fracture risk as determined by the FRAX tool; JW Gen Med Apr 8 2008), the benefits (lower incidence of common typical fractures) should outweigh the harms (potentially more uncommon atypical fractures). However, for lower-risk women without osteoporosis, risks of bisphosphonates might outweigh benefits.
Allan S. Brett, MD Published in Journal Watch General Medicine March 3, 2011
     Citation(s): Park-Wyllie LY et al. Bisphosphonate use and the risk of subtrochanteric or femoral shaft fractures in older women. JAMA 2011 Feb 23; 305:783. (http://dx.doi.org/10.1001/jama.2011.190) http://www.ncbi.nlm.nih.gov/pubmed/21343577?dopt=Abstract
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J Am Acad Dermatol 2011 Mar; 64:S30
Do Topical Antibiotics Promote Wound Healing in the Absence of Infection?
Three small studies found that a petrolatum-based ointment advanced wound healing as well as topical antibiotics.
     Dermatologists frequently use topical antibiotics for minor surgical wounds, even those that have very low risks for infection. Recently, three industry-sponsored studies examined whether topical antibiotics were beneficial in promoting wound healing compared with a petrolatum-based ointment (Aquaphor) in procedures with low probability of infection. The petrolatum-based ointment was compared with:

Wound healing was not improved by the use of topical antibiotics in any of the studies.
     Comment: Two previous studies (J Amer Acad Dermatol 1985; 13:207; Ann Pharmacother 1997; 31:559) indicated that topical antibiotic ointment reduced the frequency of infection of minor scratches and insect bites in children. Whether those findings are relevant for adults is uncertain. Topical antibiotics have also been found useful for minor wounds sutured in the ER (Acad Emerg Med 1995; 2:4; Am J Emerg Med 2004; 22:1).
     Nevertheless, topical antibiotics have few uses in dermatology; the primary exception is in the treatment of impetigo, for which mupirocin and retapamulin are as effective as oral agents. Topical antibiotics, however, have no proven benefit in treating infections of pressure ulcers or venous or diabetic wounds, and have proved no better than petrolatum for preventing wound infections after dermatologic surgery. These three latest trials, though small, show that they don't improve wound healing, either. Dermatologists should stop using topical antibiotics following surgical procedures: They are more expensive than petrolatum; can produce contact dermatitis; and can, rarely, cause anaphylaxis.
Jan V. Hirschmann, MD Published in Journal Watch Dermatology March 11, 2011
Citation(s): Taylor SC et al. Postprocedural wound-healing efficacy following removal of dermatosis papulosa nigra lesions in an African American population: A comparison of a skin protectant ointment and a topical antibiotic. J Am Acad Dermatol 2011 Mar; 64:S30. (http://dx.doi.org/10.1016/j.jaad.2010.11.009)
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Lancet 2011 Mar 12; 377:905
Quadruple Therapy for Helicobacter pylori Infection
A combination of bismuth subcitrate potassium, metronidazole, tetracycline, and omeprazole was safe and effective at eradicating H. pylori infection.
     Eradication of Helicobacter pylori infection requires multiple-drug therapy. Given that some of the standard drugs, particularly clarithromycin, lose efficacy because of increasing antibiotic resistance, evaluation of new therapeutic regimens is essential.
     To test a new four-drug regimen, European investigators conducted an industry-sponsored, noninferiority, open-label, randomized phase III trial involving 438 patients with H. pylori infection and upper gastrointestinal symptoms. Patients received either quadruple therapy (a single capsule containing bismuth subcitrate potassium, metronidazole and tetracycline, 4 times a day, plus omeprazole twice daily) for 10 days or standard therapy (omeprazole, amoxicillin and clarithromycin twice daily) for 7 days. Successful eradication of H. pylori infection was defined as negative urea breath tests at greater than or equal to 28 and greater than or equal to 56 days after completion of therapy.
     The intent-to-treat eradication rate was higher in the quadruple-therapy group than in the standard-therapy group (80% vs. 55%; P<0.0001). Safety profiles were similar in both groups. Treatment failures in the standard-therapy group were associated with clarithromycin resistance (P<0.0001).
     The authors conclude that 10-day quadruple therapy provides higher eradication rates and a similar safety profile compared with 7-day standard therapy in a European population. They further suggest that, because of the rising incidence of clarithromycin resistance, quadruple therapy should be considered as first-line therapy for H. pylori infection.
     Comment: The results of this study showed a dramatic effect of clarithromycin resistance on eradication rates in the standard-therapy group (8% for those with resistance vs. 85% for those without), whereas in vitro metronidazole resistance did not have a similar effect on eradication rates for the quadruple-therapy group (91% for those with resistance vs. 95% for those without). Whether the difference in therapeutic efficacy can be generalized to less developed areas where H. pylori infection is endemic and clarithromycin resistance is less common remains unclear.
David J. Bjorkman, MD, MSPH (HSA), SM (Epid.) Published in Journal Watch Gastroenterology March 11, 2011
     Citation(s): Malfertheiner P et al. Helicobacter pylori eradication with a capsule containing bismuth subcitrate potassium, metronidazole, and tetracycline given with omeprazole versus clarithromycin-based triple therapy: A randomised, open-label, non-inferiority, phase 3 trial. Lancet 2011 Mar 12; 377:905.
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Japan Drops Two Vaccines After Four Deaths
     Japan's Health Ministry has suspended the use of two vaccines after four children died after receiving them. The ministry decided to stop administering the Hib vaccine to prevent bacterial meningitis and a vaccine to protect against streptococcus pneumoniae. Although no direct causal relationship has been established between the vaccines and the children's deaths, the ministry intends to convene an expert panel in the coming days to look into the issue.
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U.S. Sees No Problem with Pfizer, Sanofi Vaccines
     U.S. health agencies have not found new safety concerns or unusual reporting patterns in children given Pfizer's or Sanofi Aventis vaccines to prevent meningitis and pneumonia, an FDA spokesperson said. Both the FDA and CDCP are aware of the death of four children in Japan. The agencies will continue to monitor the vaccines for safety in the U.S., she added.

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