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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
October 26, 2013

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Vulvodynia — Silent and Miserable
Probiotics for Colic
Sore Throat Decision-Making
Cardiologist Decries the 'Myth of the Role of Saturated Fat in Heart Disease'
Patients Rarely Informed of Risk of Overdiagnosis from Cancer Screenings
Most Breastmilk Purchased Online Contaminated with Bacteria
'Term Pregnancy' Redefined
No Evidence That Screening Older Adults for Cognitive Impairment Improves Outcomes
Helicobacter pylori Status Affects Outcomes of Bleeding Peptic Ulcers
Electronic Cigarettes Are as Effective as Nicotine Patches for Smoking Cessation
More People Attempt to Quit Smoking After a Mass-Media Ad Campaign
Exercise Relieves Pain in Patients with Lower-Extremity Osteoarthritis
Benefits of Resistance Training in Children and Adolescents
Scabious Treatments
The Incidentally Discovered Pancreatic Cyst
FDA Issues Warning on Arrhythmia Risk with Ondansetron (Zofran®)

MM: Over the past two decades I have worked with hundreds of women who have been tormented by this condition. It cripples intimate relationships and may cause discomfort and pain daily, periodically or just during intercourse. No matter what the degree of severity this condition should NOT go untreated. We have had tremendous success with a variety of transdermal and topical gels that block and in many instances reverse this condition where women may resume their normal activities, sexual and otherwise. The gels may be applied directly to the vulvar area and/or the lower spine or if the tissue is too sensitive to touch may be applied to the lower spine alone to block nerve transmission and pain without the loss of other sensation.
Am J Obstet Gynecol 2013 Sep 27
Vulvodynia — Silent and Miserable
Women with this common problem seldom seek treatment.
Vulvodynia — chronic vulvar pain without identifiable cause — has been estimated to affect as many as 28% of reproductive-aged women. Researchers assessed prevalence of vulvodynia and care-seeking behaviors in symptomatic women from two distinct geographic areas in the U.S. Self-administered questionnaires were mailed to women (age range, 18–40), in the Boston metropolitan area (BMA) and Minneapolis/Saint Paul (MSP). The census-based BMA sample (5440 responses; 55% of targeted population) encompassed three ethnically diverse neighborhoods and two suburbs. The MSP sample (13,361 women; 53% of targeted population) was derived from a large outpatient clinic network. Women were asked if they had ever experienced contact-associated vulvar pain persisting for ≥3 months; other questions concerned age at onset and characteristics of their pain.
About 8% of women in each group reported experiencing symptoms of vulvodynia by age 40. Onset of symptoms in both groups was most likely before age 25, decreased during the late 20s and early 30s, and rose during later reproductive years. Compared with white women, Hispanic/Latina women were 1.4 times more likely to experience vulvodynia. Despite having access to care, 48% of participants in the MSP group and 30% in the BMA group did not seek treatment.
Comment: These investigators have previously published data supporting the validity of a well-constructed questionnaire as equal to, if not better than, a clinically confirmed diagnosis of vulvodynia. Questionnaires are an effective strategy for broaching sensitive topics such as vulvodynia and should be considered an important tool for discovery, dialogue, diagnosis, and treatment.
Citation(s): Harlow BL et al. Prevalence of symptoms consistent with a diagnosis of vulvodynia: Population-based estimates from two geographical regions. Am J Obstet Gynecol 2013 Sep 27; [e-pub ahead of print].
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MM: Using the proper tool for the job is very important. All too often people get a snippet of information about an 'alternative' therapy, try a process and find that it does not work as hoped for. This isn't necessarily an indication that the treatment is a failure. More often than not, the treatment has been used incorrectly. It may be that the wrong form, dose or protocol was used. This article brings to light the widely varied results that people have experienced with probiotics and emphasizes that not all probiotics work the same and that there are likely as many different types of 'bugs' as there are conditions that may be helped by these 'bugs'.
JAMA Pediatr 2013 Oct 7
Probiotics for Colic
In a systematic review, Lactobacillus reuteri was effective for treatment of colic in breastfed infants.
Despite the potential for probiotics to be safe and effective for treatment and prevention of infant colic, studies have been inconsistent. Researchers performed a rigorous systematic review of English-language randomized-controlled trials of probiotics in infants younger than 3 months, pregnant women in the month before delivery, or both. The 12 studies meeting criteria included 1825 infants and were published in 2006–2013. Only two studies had low risk for bias (based on randomization, blinding, and baseline characteristics).
Only two (of 7) preventive trials (often with formula) showed significant reductions in mean daily crying time with probiotics compared with placebo. Three of five treatment studies in infants with diagnosed colic demonstrated probiotic effectiveness, and were sufficiently homogeneous in population (term exclusively breast-fed infants), treatment (Lactobacillus reuteri alone at 109 cfu/day), and outcome measures (crying time on day 21 as recorded by diary) to allow meta-analysis: L. reuteri significantly reduced median daily crying time by 1 hour per day (from ≥2 to ≥1 hour/day) compared with control. Notably, breast-feeding mothers in two of these studies were on dairy-free diets. No adverse effects were reported in any of the 12 trials.
Comment: As with most studies of probiotics, trials of the prevention and treatment of infant colic lack standardization. The probiotic strain, dose, and infant characteristics can make a difference in results. Trials in this review with the most significant findings involved L. reuteri in breast-fed infants with diagnosed colic. Given its safety, this probiotic is worth trying when a breast-fed infant's colic is distressing to caregivers despite conservative measures. Stay tuned, because the evidence base for probiotic use in colic is still evolving.
Citation(s): Sung V et al. Probiotics to prevent or treat excessive infant crying: Systematic review and meta-analysis. JAMA Pediatr 2013 Oct 7; [e-pub ahead of print].
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MM: Unfortunately antibiotics in children tend to be overused and abused. When a child is not well, a parent, and a clinician want to relieve the pain or discomfort and will use their heart rather than their head when treating. Additionally, giving an antibiotic once, twice or even three times a day is easy to do. Whereas using a nebulizer, vaporizer, warm bath and dedicated time with a small child who feels bad is much more time consuming and difficult. It is unfortunate but many of us live busy lives and will take what seems like the easier path. It may not be intentional or even make a whole lot of cognitive sense but it happens. And it happens way too often as shown in the ever rising misuse of antibiotics.
BMJ 2013 Oct 10; 347:f5806
Sore Throat Decision-Making
Rapid streptococcal testing added little to an effective symptom score in guiding antibiotic use for sore throats.
Sore throat is a very common reason for seeking medical attention, and — despite many findings and guidelines to the contrary — most patients with this symptom are offered antibiotics. In an attempt to optimize care and decrease unnecessary antibiotic prescription for this condition, a group of primary care physicians in the U.K. examined whether the use of rapid antigen tests or clinical scores could modify antibiotic prescription and patient outcomes.
In a multicenter, parallel-group, randomized, controlled trial involving 631 patients aged ≥3 years presenting with acute sore throat, the researchers compared three treatment strategies:

Antibiotic prescription was moderately reduced in both comparator groups, but adding rapid antigen testing to use of the clinical score alone provided no distinct benefit. There were no adverse effects from limiting antibiotic use by any method.
Comment: This study is helpful in showing that the expense of rapid antigen testing may not be justified if strict adherence to clinical presentation is practiced. So far, however, none of these interventions have led to the necessary magnitude of decrease in unwarranted antibiotic use for sore throat.
Citation(s): Little P et al. Clinical score and rapid antigen detection test to guide antibiotic use for sore throats: Randomised controlled trial of PRISM (primary care streptococcal management). BMJ 2013 Oct 10; 347:f5806.
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MM: It's nice to see specialist of traditional western (allopathic) medicine start to dry out with the same mantra as those of us who tend more towards the alternative or integrative pathways. We can only hope that more allopathic practitioners will move over here to 'the dark side'.
Cardiologist Decries the 'Myth of the Role of Saturated Fat in Heart Disease'
By Joe Elia
An interventional cardiologist argues in BMJ against "the mantra that saturated fat must be removed to reduce the risk of cardiovascular disease." In addition, Aseem Malhotra writes that the obsession with cholesterol "has led to the overmedication of millions of people with statins.
"Obesity rates paradoxically increased in the face of a concurrent reduction in fat consumption, he writes. "When you take the fat out, the food tastes worse. The food industry compensated by replacing saturated fat with added sugar.
"Statins, he argues, work by being anti-inflammatory and by stabilizing coronary plaque — their effects on cholesterol are beside the point (and their side effects too frequent).
The essay concludes: "It is time to bust the myth of the role of saturated fat in heart disease and wind back the harms of dietary advice that has contributed to obesity.
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MM: Cancer is a very scary term. There are very few people who remain undaunted when they are faced with a possible diagnosis of it. Unfortunately, the diagnosis is incorrect all too frequently and the incorrect treatment may not be limited to crippling a person's finances but their psychological and physical health as well. There are many well-meaning companies, organizations and individuals who promote cancer screenings for relatively low risk that tend to find false positives that hurt many more people than they ultimately help.
Patients Rarely Informed of Risk of Overdiagnosis from Cancer Screenings
By Kelly Young
Most patients say their physicians don't inform them of the risks for overdiagnosis and overtreatment when discussing cancer screening, according to a research letter in JAMA Internal Medicine.
Researchers surveyed over 300 U.S. men and women aged 50 to 69 without histories of cancer. Eighty percent of people said they had wanted to be informed of potential screening harms, but only 10% actually were. Over two thirds of respondents said they wouldn't begin screening if overdiagnosis were as high as it is for breast and prostate cancer screening (10 or more cases per 1 life saved).
The authors write: "The large number of uninformed patients might be explained by a large number of physicians who themselves know little about screening harms."
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MM: Education is by far the best means of preventing disease and the same might be said when looking at the problem of contaminated breast milk. Proper preparation, collection and storage techniques need to be taught to those who are performing this noble service. It is unfortunate and disheartening to all when good intentions may end up doing harm.
Most Breastmilk Purchased Online Contaminated with Bacteria
By Amy Orciari Herman
Nearly three quarters of human breastmilk purchased online harbor bacteria — frequently pathogenic species — according to a Pediatrics study.
Some 100 milk samples purchased online from milk-sharing websites, as well as 20 unpasteurized samples donated to a Human Milk Banking Association of North America (HMBANA) milk bank, underwent bacterial and viral analysis. Internet samples were significantly more likely than milk bank samples to test positive for Gram-negative bacteria (72% vs. 35%) and Staphylococcus species (63% vs. 25%). In addition, coliforms were found in 44% and 25%, respectively (a nonsignificant difference).
The authors say the high level of contamination in internet samples reflects "poor collection, storage, or shipping practices," noting that HMBANA donors, on the other hand, are instructed in hygienic procedures.
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'Term Pregnancy' Redefined
By Kelly Young
The American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine are discouraging use of the word "term" to describe infants born between 37 and 42 weeks' gestation since there's a wide range of outcomes in infants born during this period.
Instead, the group is recommending the following classification system:


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MM: At this point in time we are only able to use drugs to slow the highly visible effects of the cognitive deterioration process. One of the problems is that we do not know what the cause(s) of the impairment are. We can identify 'what' in many cases is happening in the brain. We still do not know 'why' and once we discover 'how' then perhaps we will be able to take that next step in treatment.
No Evidence That Screening Older Adults for Cognitive Impairment Improves Outcomes
By Amy Orciari Herman
While "it is clear" that brief tools to screen for cognitive impairment in older adults can identify dementia, there's "no empirical evidence" that early diagnosis improves outcomes for patients or caregivers, concludes an evidence review undertaken for the U.S. Preventive Services Task Force.
The review comes as the USPSTF prepares to update its 2003 statement on dementia screening, which concluded that the evidence was insufficient to recommend for or against it.
Among the findings of the current review:

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MM: If H. pylori is the dreadful culprit of ulcers that it has been touted to be, then it almost seems counter-intuitive that those patients with H. pylori ultimately did better in this study than those who were negative for H. pylori.
Am J Med 2013 Sep; 126:811
Helicobacter pylori Status Affects Outcomes of Bleeding Peptic Ulcers
H. pylori–negative ulcers were associated with higher 30-day rebleeding and a longer hospitalization stay but not higher mortality.
The major causes of peptic ulcers are Helicobacter pylori infection and nonsteroidal anti-inflammatory drugs (NSAIDs). Some data suggest that the clinical course may differ with the etiology of the ulcer.
In the current retrospective study, researchers evaluated 575 patients who presented with upper gastrointestinal bleeding (UGIB) from peptic ulcers at a single hospital in Texas. Of these patients, 444 received appropriate testing for H. pylori infection; half tested positive and half negative. Using demographic, clinical, and drug use data, researchers defined four groups based on status of H. pylori infection and prior use of NSAIDs.
Thirty-day mortality did not differ between the groups. H. pylori–positive patients had a lower 30-day rebleeding rate (5% vs. 11%; P=0.009) and a shorter mean hospital stay (6 days vs. 11 days; P<0.001) than H. pylori–negative patients. The highest rebleeding rate (18%) was in patients with idiopathic ulcers (negative for both H. pylori and NSAID use). The authors conclude that H. pylori–negative ulcers have poorer clinical outcomes than H. pylori–positive ulcers and that idiopathic ulcers have the worst outcomes. They advocate early H. pylori testing and treatment of all patients with bleeding peptic ulcers.
Comment: Study results vary on the effect of Helicobacter pylori infection on bleeding ulcer outcomes. As observed in this study, ulcers in H. pylori–positive patients are more likely to be duodenal and less likely to be multiple. The single-center source and the potential for confounding in this retrospective analysis limit the strength of its results. Although these findings do not change the clinical approach, they do emphasize the need to assess H. pylori status in the setting of acute upper gastrointestinal bleeding. High-dose acid suppression and endoscopic therapy (where indicated) remain the mainstays of treatment for severe nonvariceal UGIB.
Citation(s): Chason RD et al. More favorable outcomes with peptic ulcer bleeding due to Helicobacter pylori. Am J Med 2013 Sep; 126:811.

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MM: It makes a lot of sense that addressing the hand-to-mouth component of cigarette smoking in addition to the physical/chemical nicotine dependence would be equally if not more effective than addressing a single component. Many people learn better by using multiple approaches. Using multiple approaches and mechanisms to un-learn something makes a lot of sense in establishing new long-term pathways.
Lancet 2013 Sep 9
Electronic Cigarettes Are as Effective as Nicotine Patches for Smoking Cessation
Participants who used nicotine-containing e-cigarettes abstained significantly longer than those using placebo e-cigarettes.
Electronic cigarettes (e-cigarettes) — cigarette-shaped, battery-powered, nicotine-vapor delivery devices — are growing rapidly in popularity and might aid in smoking reduction or cessation. But we have little data on their risks and benefits.
Researchers in New Zealand randomized 657 adult smokers who wished to quit smoking to use e-cigarettes containing either nicotine (16 mg) or matching placebo or to nicotine patches (16 mg; 1 daily) for 13 weeks. Participants had access to telephonic or text-message quit support. After 6 months, patients who reported abstinence (≤5 cigarettes since quitting) underwent confirmatory measurements of exhaled carbon monoxide.
The 6-month verified abstinence rates were similar in all three groups (7.3% for nicotine-containing e-cigarettes, 5.8% for patches, and 4.1% for placebo e-cigarettes). Participants in the nicotine-containing e-cigarette group abstained significantly longer than those in the other two groups (median 35, 14, and 12 days, respectively), and significantly more nicotine-containing e-cigarette users than patch users reduced their daily cigarette use by more than half (57% vs. 41%). Adverse event rates were similar in all three groups.
Comment: Lack of robust behavioral support probably contributed to low abstinence rates in all three groups and limited the study's power to detect significant differences in this outcome. But this report suggests that, in a real-world setting, nicotine e-cigarettes might be as effective as patches for smoking cessation and could contribute to a public-health strategy to reduce smoking. We still need to clarify the long-term risks and benefits of this product.
Citation(s): Bullen C et al. Electronic cigarettes for smoking cessation: A randomised controlled trial. Lancet 2013 Sep 9; [e-pub ahead of print].
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MM: Figures certainly do not lie but I have to think that if a person stops smoking for only a day or a couple of days, is there really a long term health benefit obtained? This study celebrates that 1.6 million people were possibly motivated to quit smoking for a day after watching a TV ad. So what! Unless a person really wants to quit, whether it is a relationship reason, health reason or because they do not want their children or grandchildren to see them as a smoking role model, they will not quit. A simple TV ad is not going to be sufficient to make a person quit smoking, no matter how intense or persuasive it may be. In my opinion, this was a waste of $54 million!
Lancet 2013 Sep 9
More People Attempt to Quit Smoking After a Mass-Media Ad Campaign
The campaign might have resulted in as many as 100,000 long-term abstainers in the U.S.
In the U.S., half of all smokers attempt to quit every year, but the annual sustained cessation rate is only 5%. Advice from physicians can boost quit rates, but such counseling is deterred by competing time demands and inadequate reimbursement. Sporadic mass-media antismoking campaigns have been undertaken in the U.S. and elsewhere, but their effect on smoking has not been measured carefully.
During 12 weeks in 2012, with US$54 million in funding from the Patient Protection and Affordable Care Act, the CDC presented its first nationwide, mass-media, antismoking campaign, in which former smokers described suffering caused by smoking and encouraged smokers to quit. Using a population-based sample of >3000 smokers, the CDC asked about recent quit attempts immediately before and immediately after the campaign.
About 78% of smokers recalled seeing at least one CDC antismoking television advertisement during the campaign. The proportion of smokers who reported quitting for at least 1 day during the previous 3 months increased significantly, from 31% before the campaign to 35% afterwards. Based on this difference, CDC estimated that 1.6 million additional smokers made quit attempts during the ad campaign, that 100,000 would remain abstinent long-term, and that almost a half million quality-adjusted life-years were added to the U.S. population (at a cost of <$200 per life-year).
Comment: This short-term mass-media campaign apparently was potent and cost-effective in discouraging smoking. Media campaigns and individualized advice from clinicians probably could reduce smoking far more effectively if they were resourced adequately and consistently.
Citation(s): McAfee T et al. Effect of the first federally funded US antismoking national media campaign. Lancet 2013 Sep 9; [e-pub ahead of print].
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MM: I like the premise that moving around is good for you. Osteoarthritis (OA) can be quite painful and debilitating. So much so that a person is not easily motivated and depression may set in along with the pain. Although water training showed the greatest benefits, appropriate strengthening(resistance or weight lifting) and flexibility(stretching)exercise can relieve that pain and can improve the overall quality of life as a result.
BMJ Med 2013 Sep 20; 347:f5555
Exercise Relieves Pain in Patients with Lower-Extremity Osteoarthritis
Exercise prescription now should be a part of routine management for these patients.
A growing body of evidence suggests that exercise reduces pain and improves physical function in patients with knee or hip osteoarthritis (OA). In this meta-analysis of 60 randomized trials (>8200 participants; median follow-up, 15 weeks), investigators determined whether exercise interventions were more effective than no exercise; they also compared different exercise interventions.
Forty-four trials involved patients with knee OA, 2 involved patients with hip OA, and 12 involved patients with knee, hip, and other joint OA. The following types of exercise were evaluated: strengthening, flexibility, aerobic, and aquatic versions of these. For pain relief (measured with visual pain scales), strengthening, strengthening-plus-flexibility, nonaquatic combined (strengthening-plus-flexibility-plus-aerobic), aquatic strengthening, and aquatic strengthening–plus-flexibility exercises were significantly more effective than no exercise. Aquatic strengthening–plus-flexibility yielded the highest probability of pain relief, followed by strengthening only. For improving physical function, strengthening, strengthening-plus-flexibility, and nonaquatic combined exercises were significantly more effective than no exercise.
Comment: The results of this meta-analysis affirm that exercise relieves pain and certain exercises improve physical function in patients with lower-extremity osteoarthritis. Exercise prescription now should be a part of routine management for these patients
Citation(s): Uthman OA et al. Exercise for lower limb osteoarthritis: Systematic review incorporating trial sequential analysis and network meta-analysis. BMJ 2013 Sep 20; 347:f5555.
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MM: Before we had video games and after school television, boys and girls would go outside, play sports games, climb on things and run and lift tree trunks and rocks if they could find some. Those who had to work the family farm or carry buckets of water or feed the large animals would inadvertently do Resistance Training. It's not a surprise to see that there are health benefits to using our bodies as they were designed and that there are benefits for all ages from the very young to the elderly.
Br J Sports Med 2013 Sep 20
Benefits of Resistance Training in Children and Adolescents
Strength and Conditioning Association position statement on youth resistance training
The WHO and other public health agencies recommend resistance training (RT) for youth. Nevertheless, strength levels in school children are decreasing. The U.K. Strength and Conditioning Association prepared a consensus statement after reviewing data on RT for youth (endorsed by the AAP and NCAA among others).
Highlights are:

Comment: Read in its entirety, the consensus statement provides a compelling rationale for all youth to participate in resistance training as part of an overall physical activity program. For athletes, RT should be in place of, rather than in addition to, sports-specific training activities.
Citation(s): Lloyd RS et al. Position statement on youth resistance training: The 2014 International Consensus. Br J Sports Med 2013 Sep 20; [e-pub ahead of print].
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Clin Exp Dermatol 2013 Oct; 38:719
Scabious Treatments
A comparison of oral ivermectin and topical lindane
For more than 50 years, lindane γ-benzene hexachloride) lotion reigned as the treatment of choice for scabies. Concerns about neurotoxicity, neurotransmitter inhibition, and seizures dampened enthusiasm for its use, and some scabies mites developed resistance. Other treatments include permethrin lotion, crotamiton lotion, benzyl benzoate lotion, and precipitated sulphur in ointment bases. Ivermectin is conveniently administered orally. It, too, is a neurotoxin and may not be ovicidal, but its off-label use for treatment of scabies is widespread.
In this single-blind, controlled study from Iran, 148 patients with scabies were randomized to receive oral ivermectin 200 µg/kg body weight or two applications of topical lindane lotion 1%, with a 1-week interval between treatments. Investigators blinded to the treatment group examined each patient 2 and 4 weeks after first treatment. Evaluations included comparisons with earlier photographs and scraping burrows to detect mites. Ivermectin cured scabies within 2 weeks in 61% of patients, versus 47% with lindane, a nonsignificant difference (P=0.32). At the 4-week evaluation, cure rates were 89% for ivermectin and 73% for lindane lotion. In all, 28 of the original 148 patients had treatment failure and were re-treated with permethrin cream, which cured the infestation in 2 to 3 additional weeks.
Comment: This is not the first comparison of lindane lotion with oral ivermectin for scabies. In previous studies, ivermectin cure rates were even higher. These latest results suggest that (1) systemic ivermectin produced better cure rates than topical lindane, (2) ivermectin is not always successful, (3) permethrin lotion is usually effective if ivermectin or lindane treatment fails, (4) 200 µg/kg body weight of oral ivermectin appears to be a safe dose. The safety of oral ivermectin in pregnant and lactating women and young children is still uncertain
Citation(s): Mohebbipour A et al. Comparison of oral ivermectin vs. lindane lotion 1% for the treatment of scabies. Clin Exp Dermatol 2013 Oct; 38:719.

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Am J Gastroenterol 2013 Oct; 108:1546
The Incidentally Discovered Pancreatic Cyst
Analysis suggests that malignant transformation is uncommon.
Pancreatic cysts often are found incidentally on abdominal imaging for nonpancreatic indications. Because some pancreatic cysts (e.g., mucinous cystic neoplasms, intraductal papillary mucinous neoplasms) have malignant potential, their management depends in part on the likelihood of malignant transformation. In this study, researchers drew from several sources to derive a rough estimate of malignant transformation rates.
From two large abdominal computed tomography and magnetic resonance imaging studies, the researchers estimated that 2.5% of adults harbor pancreatic cysts (range, 1% for people in their 40s to 9% for people in their 80s); extrapolating to the general population, about 3.5 million older U.S. adults (age range, 40–85) presumably have pancreatic cysts. According to the Surveillance, Epidemiology, and End Results cancer database, about 1100 mucin-producing pancreatic adenocarcinomas are diagnosed annually in the U.S. From these data, the researchers calculated that, for every 100,000 adults with pancreatic cysts, malignant transformation occurs in about 33 patients (i.e., about 1 per 3000 patients).
Comment: These authors do not address cyst characteristics that may indicate higher risk for malignancy, or controversies about whether (and how) to evaluate or follow small pancreatic cysts. Nevertheless, because their data suggest that malignant transformation is rare, they caution against “overly aggressive diagnosis and treatment of pancreatic cystic lesions.”
Citation(s): Gardner TB et al. Pancreatic cyst prevalence and the risk of mucin-producing adenocarcinoma in US adults. Am J Gastroenterol 2013 Oct; 108:1546.

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