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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
February 15, 2014

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Lactobacillus for Functional Gastrointestinal Conditions in Infants
Desensitization of Peanut Allergy in Children with the Equivalent of Five Peanuts Daily
Do Statins Increase the Risk for Herpes Zoster?
Lower-Intensity Statin Combo Therapy Bests High-Dose Monotherapy for LDL -
   But, So What?
Annual Screening Mammography Produces Overdiagnosis, No Mortality Benefit
Investigational Alzheimer Drugs Fail to Improve Cognition or Function in Phase III Trials
Are Pesticides a Risk Factor for Alzheimer Disease?
First-Ever Guidelines Issued on Stroke Prevention in Women
OCD and the Reproductive Cycle
Wearable Healthcare Technology
Sicker Patients Needed in Clinical Trials
Transparency Lacking in FDA Rulemaking Process
Kids' (Very Low) Rate of Accidental Exposure to Marijuana Increases with Decriminalization
Non-Influenza Vaccination Rates Among U.S. Adults Remain Low
Ondansetron Works for Diarrhea-Predominant Irritable Bowel Syndrome

MM: I am thrilled to see mainstream medicine embracing the universal use of probiotics in newborns. This is especially important for children of multiple births and who are delivered by C-section. Providing probiotics to pregnant moms as well as to their offspring is a measure that we highly recommend to our patients. This provides the probiotics both directly and indirectly to the child.
JAMA Pediatr 2014 Jan 13
Lactobacillus for Functional Gastrointestinal Conditions in Infants
Daily probiotic use for the first 3 months of life reduced colic, regurgitation, and infrequent stool evacuation.
Probiotics (live microorganisms that confer health benefit) have been shown to be effective in the treatment of infantile colic (NEJM JW Pediatr Adolesc Med Oct 18 2013) and constipation (NEJM JW Pediatr Adolesc Med Nov 3 2013). In an industry-sponsored, multicenter, controlled trial, Italian researchers randomized 554 term newborns to receive a strain of Lactobacillus reuteri (108 colony-forming units daily) or placebo to determine if the probiotic prevents colic, regurgitation, and constipation during the first 3 months of life. Half the infants were breast-fed.
After 1 month, mean time spent crying inconsolably was significantly less in the probiotic group than in the placebo group (45 vs. 96 minutes/day) and stool frequency was significantly greater (4.0 vs. 2.8 stools/day). At 3 months, significant differences in these two outcomes persisted and probiotic group had significantly fewer regurgitation episodes (2.9 vs. 4.6 per day). Mean family cost, including over-the-counter treatments (e.g., simethicone, herbal products) and as well as L. reuteri in the treatment group, was $119 less per patient in the treatment group during the 3-month study. Mean community cost (emergency department visits, work lost by parents) was $140 less. Infants who received probiotics had significantly fewer pediatric clinic visits for gastrointestinal symptoms (1.3 vs. 2.3). No adverse events were reported.
Comment: This study confirms that L. reuteri helps relieve the symptoms of infantile colic. I offer probiotics once colic is diagnosed but not for other symptoms (e.g., regurgitation and infrequent stooling) described by the authors. I will not start all newborn patients on prophylactic L. reuteri, but rather continue educating parents about colic, regurgitation, and normal stool frequency. The authors and editorialists theorize that gastrointestinal problems in infancy might predispose to later irritable bowel syndrome, recurrent abdominal pain, and even psychological changes, but whether regurgitation and “constipation” are true disorders is debatable. However, if these gastrointestinal symptoms prompt caregivers to buy ineffective remedies and seek medical care, then L. reuteri might be reducing caregiver anxiety and related costs as much as anything else. Providing effective education to the parents of young infants at primary care visits could have the same benefit.
Citation(s): Indrio F et al. Prophylactic use of a probiotic in the prevention of colic, regurgitation, and functional constipation: A randomized clinical trial. JAMA Pediatr 2014 Jan 13; [e-pub ahead of print].
Chumpitazi BP and Shulman RJ.
Five probiotic drops a day to keep infantile colic away? JAMA Pediatr 2014 Jan 13; [e-pub ahead of print].
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MM: Peanut allergies are a scary thing since opportunity for exposure is so great in general. It is very exciting that progressive exposure may have such a dramatic benefit in lieu of allergy shots or keeping an Epipen forever at your side.
Lancet 2014 Jan 30
Desensitization of Peanut Allergy in Children with the Equivalent of
Five Peanuts Daily

Most children tolerated oral immunotherapy, but peanut protein must be consumed daily and the effect on long-term tolerance is unknown.
Peanut allergy affects roughly 1% of children in developed countries and is the leading cause of food-allergy related deaths. Currently, avoidance is the only acceptable treatment and only 20% of patients outgrow their allergy. In a randomized, double-blind, crossover trial, researchers in the U.K. compared the efficacy of 26 weeks of escalating doses of peanut flour or usual care (peanut avoidance) in 99 children (age range, 7–16 years) with peanut allergy. Peanut protein doses were increased every 2 weeks in the clinic until patients tolerated 800 mg daily (roughly 5 peanuts).
After the first phase of the trial, 84% of patients in the active-treatment group tolerated the target dose and 62% tolerated a 1400 mg peanut challenge (desensitization, the primary outcome). In contrast, none of the patients in the control group tolerated the peanut challenge. In the second phase, after 6 months of crossover therapy, 91% of immunotherapy recipients tolerated the target dose and 54% passed the peanut challenge. Quality-of-life scores were clinically improved with immunotherapy. Only one patient had reactions requiring epinephrine.
Comment: This study indicates that patients can be desensitized to peanut protein, but the larger goal of long-term tolerance without a daily dose is more elusive. Desensitization allows patients to safely eat a certain quantity of peanuts daily to prevent life-threatening reactions to accidental exposures. The goal of future studies will be to move from desensitization to tolerance induction.
Citation(s): Anagnostou K et al. Assessing the efficacy of oral immunotherapy for the desensitisation of peanut allergy in children (STOP II): A phase 2 randomised controlled trial. Lancet 2014 Jan 30; [e-pub ahead of print].
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MM: As if we don't have enough reasons to universally recommend statins to patients! Herpes is certainly not life threatening but it is definitely life tormenting. A question that goes unanswered is, if a person already has the HZ virus, will discontinuing statin use decrease the frequency of outbreaks? Perhaps that will be the next retrospective study.
Clin Infect Dis 2014 Feb 1; 58:350
Do Statins Increase the Risk for Herpes Zoster?
In a population-based retrospective study of individuals aged ≥66 in Ontario, Canada, statin use was associated with an 11.6% increase in HZ risk.
More than 60% of all cases of herpes zoster (HZ) occur in individuals aged ≥50. Although suppression of the cellular immune response has been linked to an increased incidence of HZ, the condition can develop in people with no identifiable risk factors. In 2008, 25% of Americans aged ≥45 were treated with statins. Used for their lipid-lowering properties, these agents have also been associated with reduced T-lymphocyte activation and proliferation. Until now, no studies have examined the possible effect of statins on HZ incidence.
To explore this possible effect, researchers conducted a population-based retrospective cohort study involving all Ontario residents aged ≥66 between April 1997 and March 2010. Medication exposure, hospitalization, and emergency department data were extracted from various databases. The 494,651 individuals who were prescribed a statin were matched 1:1 with statin-unexposed controls based on an algorithm-defined propensity score.
During the 13-year study period, HZ developed in 19,143 individuals, with the rate significantly higher among statin recipients than controls (13.3 vs 11.7/1000 person-years; hazard ratio 1.13; 95% confidence interval, 1.10–1.17). The attributable fraction of HZ cases among statin-exposed individuals was 11.6%.
Comment: Although these retrospective data do not assign causality, they do suggest that slightly more than one-tenth of all cases of HZ in older adults are attributable to statin use. As the authors note, such cases could total 20,000 annually in the U.S. alone, at an estimated cost to the healthcare system of $1 billion.
Citation(s): Antoniou T et al. Statins and the risk of herpes zoster: A population-based cohort study. Clin Infect Dis 2014 Feb 1; 58:350.
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Lower-Intensity Statin Combo Therapy Bests High-Dose Monotherapy for LDL - But, So What?
By Amy Orciari Herman
Combination therapy with a lower-dose statin plus either a bile acid sequestrant or ezetimibe reduces LDL cholesterol better than high-dose statin monotherapy, but long-term clinical benefits remain uncertain, according to a systematic review in the Annals of Internal Medicine.
Researchers examined data from 36 randomized, controlled trials of statin therapy among high-risk adults.
A low-intensity statin, combined with a bile acid sequestrant, lowered LDL cholesterol 0%-14% more than moderate-intensity statin monotherapy. In addition, a moderate-intensity statin plus ezetimibe conferred greater LDL reductions than high-dose monotherapy among those with preexisting cardiovascular disease or diabetes. However, data were insufficient to determine whether these changes in LDL translated to reductions in rates of death, atherosclerotic cardiovascular disease, or revascularization procedures.
Asked to comment, cardiologist Harlan Krumholz of NEJM Journal Watch wrote: "This study seems a little off-note, given that the new guidelines have moved us away from lipid targets. It is far from clear that this approach will improve outcomes, which is what patients care about."
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MM: The data keeps mounting about the failure of mammography. Have we been duped as professionals and as a public regarding the value of this diagnostic tool? Are there better methods of early detection that have a lower failure rate? I certainly hope so, as we see that billions have been spent on diagnostic tools such as PSA in men and mammography in women. Yet their results seem to have a very low success rate. And worse, they both have a very high false positive rate that causes added expense and trauma to those receiving the faulty information. We must come up with better and more definitive testing as what we have is critically poor.
Annual Screening Mammography Produces Overdiagnosis, No Mortality Benefit
By Joe Elia
Annual mammography screening in women under age 60 does not confer a breast cancer mortality advantage, and it results in more than 20% overdiagnosis among the lesions found, according to a follow-up of the Canadian National Breast Screening Study.
As reported in BMJ, between 1980 and 1985, some 90,000 women aged 40 to 59 were randomized to 5 years of annual mammography or no mammography (women aged 40-49 in the mammography group and all women aged 50-59 received annual physical breast examinations).
After up to 25 years' follow-up, there was no discernible difference between groups in breast cancer mortality. Of the screen-detected tumors, 22% were overdiagnoses — one for every 424 women in the mammography arm.
Andrew Kaunitz, an OB/GYN with NEJM Journal Watch, comments: "This important Canadian report documents the failure of screening mammography to impact mortality from breast cancer, as well as breast cancer overdiagnosis. Based on these and other recently published data, clinicians and women should move away from starting screens among women in their 40s and from screening annually. While we reevaluate the practice of screening mammography, adopting the U.S. Preventive Services Task Force 2009 recommendations (beginning screening in average-risk women at age 50 and screening biennially) would appear prudent."
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MM: Hope as we may for effective treatments of AD, they do not seem to be coming as readily as we might like. The very hi-tech treatments that are discussed in this article are abysmal failures from the perspective of the amount of time, energy and money spent on their development. Hopefully more energy will be directed at identification of cause and prevention than has been in the past. Unfortunately most efforts at treatment have been directed towards already existing disease. This approach may serve to be a continued experience of limited success and expensive failure.
N Engl J Med 2014 Jan 23; 370:322
Investigational Alzheimer Drugs Fail to Improve Cognition or Function in Phase III Trials
Anti-amyloid therapies disappoint in mild-to-moderate disease.
The amyloid hypothesis of Alzheimer disease (AD) suggests that overproduction or abnormal clearance of the amyloid-beta (Aβ) peptide is critical to the early pathogenesis of AD. Two investigational monoclonal antibodies designed to decrease amyloid burden in patients with AD were recently assessed in phase 3 clinical trials. Both antibodies were tested in two industry-sponsored trials.
In one trial, researchers randomly administered intravenous bapineuzumab — which recognizes both soluble and aggregated Aβ — or placebo periodically for 78 weeks to patients with mild-to-moderate AD; 1121 patients were APOE ℇ4 carriers and 1331were noncarriers. At the conclusion of the trials, scores on a cognitive scale (cognitive subscale of the Alzheimer's Disease Assessment Scale [ADAS-cog11]) and a disability scale (Disability Assessment for Dementia) did not differ between the treatment and placebo groups regardless of APOE status. In a subset of patients, including the bapineuzumab-treated APOE ℇ4 carriers, biomarker data revealed a significant decrease, relative to the placebo group, in phosphorylated tau level in cerebrospinal fluid (CSF) and a relative stabilization of plaque deposition on Pittsburgh Compound B positron emission tomography (PIB-PET) amyloid imaging. The drug was relatively well tolerated, with an expected, observable increase in amyloid-related imaging abnormalities with edema or hemorrhage on serial structural magnetic resonance images.
Solanezumab, which binds to soluble Aβ only, was tested in two placebo-controlled trials with 1012 (EXPEDITION 1) and 1040 (EXPEDITION 2) patients with mild-to-moderate AD. Solanezumab also failed to distinguish itself from placebo on a cognitive measure (ADAS-cog11/ADAS-cog14) and a functional measure (Alzheimer's Disease Cooperative Study-ADL scale) by 80 weeks. However, in EXPEDITION 2, solanezumab recipients with mild AD had significantly better scores than placebo recipients on the ADAS-cog14 at week 64. Biomarker data in these trials did not reveal any differences in CSF tau measures nor any changes in amyloid burden between treatment groups using florbetapir-PET amyloid imaging. The drug was also relatively well-tolerated, with an expected, observable increase in amyloid-related imaging abnormalities with edema or hemorrhage on serial structural MRIs.
Comment: Although these clinical results have proven disappointing to clinicians and patients, the biomarker and safety data reveal that the agents are biologically active in the central nervous system of patients with Alzheimer disease. The suggestion of clinical impact in mildly affected AD patients prompted revision of endpoints in the second solanezumab trial and led to an ongoing follow-up trial, targeted specifically at this mild-AD population. The high percentage of patients whose clinical diagnosis was not supported by amyloid imaging in both trials has resulted in refined biomarker-supported inclusion criteria for newer trials, which undoubtedly will improve the reliability of future clinical trials in AD targeting presumed pathological proteins.
Citation(s): Salloway S et al. Two phase 3 trials of bapineuzumab in mild-to-moderate Alzheimer's disease. N Engl J Med 2014 Jan 23; 370:322.
Doody RS et al. Phase 3 trials of solanezumab for mild-to-moderate Alzheimer's disease. N Engl J Med 2014 Jan 23; 370:311.
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MM: There is no denial that pesticides increase production and make more physically attractive fruits and vegetables and that without them world hunger and famine would be more severe that it presently is but at what cost? There must be a happy medium between the amount and type of chemicals used and the danger to the human population consuming these products. It is highly doubtful that organic farming production can adequately meet world food needs. Nor can the retail cost of these products, in general be accepted by the majority of consumers. But, it seems that the risk of AD and other neurological disorders may be a function of concentration and exposure to the offending chemicals. If we are able to create cost effective and less humanly toxic chemicals that do not fully permeate the food that they are designed to protect then there may be a viable answer to this perplexing problem.
JAMA Neurol 2014 Jan 27
Are Pesticides a Risk Factor for Alzheimer Disease?
A case–control study suggests an association between DDT exposure and AD risk.
Evidence suggests that long-term pesticide exposure may have toxic effects on the central nervous system. In the U.S., older adults are most likely to have been exposed to persistent pesticide such as dichlorodiphenyltrichloroethane (DDT), which was in use from the 1940s through 1972. Some studies have shown an elevated risk for Alzheimer disease (AD) and Parkinson disease associated with occupational pesticide exposure. To examine the association between DDT exposure and AD risk, researchers conducted a case–control study, using serum samples taken from patients with AD and controls in Texas and Georgia between 2002 and 2008. There were a total of 165 samples, representing 79 control and 86 AD cases (94 women, 71 men; women comprised 60% of controls and 55% of cases). At enrollment, participants completed the Mini-Mental State Examination (MMSE). The investigators measured brain and serum levels of the DDT metabolite dichlorodiphenyldichloroethylene (DDE) and determined apolipoprotein E (APOE) genotype.
The mean DDE level in serum was 3.8-fold higher in AD patients than in controls. Those with the highest tertile of DDE had a fourfold increased risk for AD and had significantly lower MMSE scores. Among those in the highest DDE tertile, APOE 4 carriers had significantly lower MMSE scores than noncarriers. The authors conclude that elevated levels of DDE are associated with an increased risk for AD and that those with an APOE 4 allele may be more susceptible to the effect of DDE.
Comment: According to the U.S. environmental protection agency, more than 2 billion pounds of pesticides are applied to crops, homes, schools, parks, and forests each year (Neurology 2010; 74:1524). Thus far, few studies have examined the association between pesticides and AD. This study had the largest sample size to date for its type. The findings demonstrate that environmental factors, particularly exposure to pesticides, contribute significantly to the risk for AD. Future epidemiologic work should focus on other specific pesticides or toxic chemicals to which many people might be exposed. Epigenetic modes of influence should also be studied.
Citation(s): Richardson JR.Elevated serum pesticide levels and risk for Alzheimer disease. JAMA Neurol 2014 Jan 27; [e-pub ahead of print ].
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First-Ever Guidelines Issued on Stroke Prevention in Women
By Amy Orciari Herman
The American Heart Association and American Stroke Association have issued the first stroke-prevention guidelines that focus on women's unique risks.
Among the recommendations:

Hooman Kamel, a neurologist with NEJM Journal Watch, notes that "to be effective, many of these recommendations will require diffusion into routine primary care practice."
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MM: One of the most important tools of a clinician is observation. Unfortunately, our healthcare environment tends to discourage spending time with patients so this very useful tool may be lost. The typical 8-15 minutes that a HCP may spend with a patient during the very occasional meeting is insufficient to truly get a good picture of a patient's overall condition. Language and other communication barriers tend to further deteriorate the clinician's ability to gather useful information. Finally, large group practices or clinic settings further discourage meaningful observation opportunities for practitioners. This is why I recommend that consumers/patients take an increased responsibility for their healthcare and well-being. Patients or their primary caregivers must be their own greatest advocates and serve as the eyes and ears of their healthcare providers in order to provide these skilled clinicians with the tools and raw data that they need to provide the best care.
Depress Anxiety 2014 Jan 13
OCD and the Reproductive Cycle
Worsening of obsessive-compulsive symptoms, either during a first pregnancy or in the postpartum period is associated with heightened risk for worsening in or after a second pregnancy.
In small studies, investigators have inconsistently reported the onset or exacerbation of obsessive-compulsive disorder (OCD) during female reproductive events. Now, researchers have conducted a large, international, survey study to examine rates of OCD in women at menarche, premenstrually, during or after pregnancy, and at menopause and to look at risk for repeat exacerbations in a second pregnancy after worsening in the first.
The participants were 540 adult women with OCD but without lifetime psychotic disorders or cognitive impairment, who were recruited in the U.S. (n=351 women; mean age, 45) and the Netherlands (n=189; mean age, 44). More than 25% reported OCD onset related to a reproductive event, primarily menarche. Worsening of preexisting OCD was reported by 38% of women premenstrually, 33% during pregnancy, 47% in the postpartum period, and 33% at menopause. Compared with women without such exacerbations, those whose symptoms worsened during their first pregnancy were at least 7 times more likely to experience worsening in their second pregnancy; women with postpartum symptom exacerbation after the first pregnancy were at least 5 times more likely to worsen in postpartum after the second pregnancy.
Comment: A study weakness is the reliance on participants' retrospective self-reports. However, in this large sample, onset or exacerbation of OCD symptoms was strongly associated with female reproductive events. To advise women appropriately about treatment during pregnancy and postpartum, clinicians should monitor women with OCD for worsening with these events, ask them about worsening in previous pregnancies or postpartum periods, and be aware of the heightened risk with subsequent pregnancies.
Citation(s): Guglielmi V et al. Obsessive-compulsive disorder and female reproductive cycle events: Results from the OCD and Reproduction Collaborative Study. Depress Anxiety 2014 Jan 13; [e-pub ahead of print].
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Wearable Healthcare Technology
It's here: wearable technology including smart devices such as a smart watch, a Fitbit fitness bracelet, a smart phone, an RFID badge, and a Google Glass eyepiece. A recent conference combined new technology and "Star Trek" references as a panel spoke to the advances in miniaturization, battery life, and wireless communication that have let wearable technology interweave into everyday life.
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Sicker Patients Needed in Clinical Trials
The FDA is initiating steps to include more patients with multiple chronic conditions in clinical trials of new drugs. They believe such patients are too frequently excluded from new drug studies. It is common for pharmaceutical companies to exclude the sickest patients from studies, fearing complications they may suffer from the drug candidates; however, as a result, the studies don't provide a glimpse of the treatment's "real world" effect.
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Transparency Lacking in FDA Rulemaking Process
It takes an average of 7.3 years to finalize rules that determine the regulation process. The Unified Agendas of Federal Regulatory and Deregulatory Actions and Regulatory Plans provide annual data on the rulemaking process. Between 2000 and 2012, there were 40 significant rules the agency issued, which were about 10 percent of all the FDA's medical product rules throughout those years. This study showed that only about 75 percent of public comments were available in electronic format for only four of the 40 rules and about half the comments came from industry. Based on their findings, the authors called for more transparency in the rulemaking process.
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Kids' (Very Low) Rate of Accidental Exposure to Marijuana Increases with Decriminalization
By Joe Elia
Accidental exposures to marijuana among children under age 10 have increased in states that have liberalized access, according to an Annals of Emergency Medicine study. The absolute risk remains low, however.
Researchers examined records of calls to poison centers from 2005 to 2011. States that eased access before 2005 showed a roughly 30% annual increase in calls; those states with more recent laws easing access had a roughly 10% annual increase that was not statistically significant; and those where marijuana remained illegal showed less than a 2% annual increase, which was also insignificant. The absolute rates in the states with easiest access stood at roughly 15 calls per million residents under age 10 in 2011.
Daniel Pallin, an NEJM Journal Watch emergency physician, comments: "These results suggest that neither patients nor the healthcare system are likely to be substantially affected by marijuana legalization, by showing that spontaneous reports of unintentional ingestion are rare despite legal availability of the drug." His full summary and comment will appear at jwatch.org.
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Non-Influenza Vaccination Rates Among U.S. Adults Remain Low
By Cara Adler
Rates of six routine vaccinations among U.S. adults improved little in 2012 and remained low, according to a CDC analysis of National Health Interview Survey data published in MMWR.
Compared with 2011, there were small increases in vaccination with:

At the same time, racial and ethnic disparities in coverage widened for these three vaccines and persisted for others, with rates highest in whites. In 2012, rates for hepatitis B, hepatitis A, and pneumococcal vaccination coverage ranged from 12% to 60%.
The authors recommend several strategies for increasing vaccination rates. For instance, clinicians should routinely assess patients' vaccination coverage and offer needed vaccines.
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Gut 2013 Dec 12
Ondansetron Works for Diarrhea-Predominant Irritable Bowel Syndrome
This 5-HT3 receptor antagonist improved stool consistency and symptoms, with a low frequency of severe constipation.
Ondansetron is a 5-hydroxytryptamine 3 receptor antagonist (5-HT3RA) used for the treatment of nausea and vomiting. 5-HT3RAs also cause constipation, and one of these agents, alosetron, is approved for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D).To assess the efficacy of ondansetron in treating IBS-D, investigators randomized 120 patients to receive ondansetron (one to two 4-mg pills, two to three times daily, as titrated by the patient) or placebo for 5 weeks in a double-blind, crossover study.
After completing 5 weeks of treatment with ondansetron or placebo, patients underwent a 2–3 week washout period, followed by 5 weeks of the alternate treatment. The primary endpoint was average stool consistency during the last 2 weeks of treatment, as documented with the Bristol Stool Form score. Transit time was measured in the last week of each treatment.
Compared with placebo, ondansetron use resulted in the following: Greater improvement in stool consistency, fewer days with fecal urgency, less urgency, fewer bowel movements, and less bloating A greater decrease in the IBS symptom severity score (83 vs. 37; P=0.001) but no difference in pain score A higher rate of reported adequate relief (65% vs. 14%) A higher rate of constipation (9% vs. 2%), resulting in 2% of patients dropping out of the study Longer transit time (10 hours longer than with placebo)
Comment: These findings support the use of ondansetron as a new agent in the armamentarium for treating diarrhea-predominant irritable bowel syndrome.
Citation(s): Garsed K et al. A randomised trial of ondansetron for the treatment of irritable bowel syndrome with diarrhoea. Gut 2013 Dec 12; [e-pub ahead of print].

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