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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
December 16, 2017

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Does Surgery Contribute to Prescription Opioid Misuse in Adolescents?
Composition of Products Sold as Selective Androgen Receptor Modulators (SARMs)
Oral Capsule Fecal Microbiota Transplantation for Recurrent C. difficile Infection
Indigo Naturalis Very Effective for UC, but Safety Concerns Exist
Tranexamic Acid is More Effective than Nasal Packing for Treatment of Epistaxis
Dietary Weight-Loss Interventions Might Lower Early All-Cause Mortality
Contraceptive Hormones and Risk for Suicide
How Active should Active Surveillance be for Prostate Cancer?
ER-Positive Breast Cancer Remains a Long-Term Concern
Hospital Financial Status as a Determinant of Postmastectomy Breast Reconstruction
HT for Preventing Chronic Conditions in Postmenopausal Women: USPSTF Weighs in Again

Pediatrics 2017 Dec 4
Does Surgery Contribute to Prescription Opioid Misuse in Adolescents?
Persistent postsurgical opioid use in adolescents was 5%, similar to the estimated rate in adults.
Prescription opioids, though an important tool for pain management, are contributing to significant morbidity and mortality from opioid overuse and misuse in the U.S. Opioid prescribing practices vary widely, and opioids are often prescribed even after minor procedures.
Using commercial claims data, researchers retrospectively examined risk for persistent prescription opioid use after surgery among approximately 145,000 opioid-naive patients aged 13 to 21 years who underwent 1 of 13 selected operations. Over 40% of participants were aged ≥17 years. A small matched control group of nonsurgical patients was used for comparison. The primary outcome, persistent opioid use, was defined as ≥1 opioid prescription refill between 90 and 180 days after the surgical procedure. Tonsillectomy, arthroscopic knee surgery, and appendectomy accounted for 80% of surgeries.
Results were as follows:

COMMENT: Despite methodologic limitations raised by editorialists, the 5% rate of persistent postsurgical opioid use in these adolescents and young adults is consistent with findings in adults. This represents a significant public health risk, which demands that the prescribing of opioids be standardized and tracked for children, adolescents, and adults. This would include limiting the quantity of opioids dispensed and using non-narcotic pain control whenever possible in postsurgical pain management.
CITATION(S): Harbaugh CM et al. Persistent opioid use among pediatric patients after surgery. Pediatrics 2017 Dec 4; [e-pub].
Snyder CL.Opioids and operations. Pediatrics 2017 Dec 4; [e-pub].
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JAMA 2017 Nov 28; 318:2004
Composition of Products Sold as Selective Androgen Receptor Modulators (SARMs)
Many of these products, marketed to athletes and muscle builders, aren't what they seem to be.
Risks of anabolic steroids commonly used by athletes to enhance performance and appearance led to development of selective androgen receptor modulators (SARMs; nonsteroidal ligands that bind to androgen receptors, including myocytes), a new class of compounds for increasing muscle strength and size. Although these compounds are not FDA-approved and are associated with serious safety concerns, SARMs are marketed heavily and are readily available online. Common SARM compounds that are marketed under various trade names include Ostarine, Ligandrol, Andarine, Testolone, and Stenabolic. To evaluate the composition of these products, investigators conducted Web-based searches and identified 210 products purported to contain SARMs from 51 Internet sites. Of these products, 166 were unavailable or were described inadequately; the remaining 44 were analyzed by mass spectrometry.
Of the 44 analyzed products, 40 contained some type of active compound; of these, only 23 contained SARMs. Eighteen products contained the compounds listed on the label in the amounts specified; 11 contained the compounds listed but not in the amounts specified; 3 contained the compound listed as well as compounds that weren't listed; and 8 contained other active substances but none of the purported compound. After SARMs, the most commonly identified compounds were peroxisome proliferator-activated receptor-δ agonists and growth hormone secretagogues. More than half of the compounds were marketed actively but were labeled “research use only” or “not for human consumption.”
COMMENT: Neither the SARMs nor the other compounds identified in these products have been approved or shown to be safe or effective. Clinicians should counsel athletes and bodybuilders about the potential risks of these unregulated products.
CITATION(S): Van Wagoner RM et al. Chemical composition and labeling of substances marketed as selective androgen receptor modulators and sold via the Internet. JAMA 2017 Nov 28; 318:2004.
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JAMA 2017 Nov 28; 318:1985
Oral Capsule Fecal Microbiota Transplantation for Recurrent C. difficile Infection
In a randomized trial, FMT delivery by capsules was as effective as administration by colonoscopy.
Recurrent Clostridium difficile infection (RCDI) can be successfully treated by fecal microbiota transplantation (FMT). In a previous trial, FMT by nasogastric administration appeared to be as effective as delivery by colonoscopy in treating RCDI (NEJM JW Infect Dis Jun 2014 and Clin Infect Dis 2014; 58:1515).
Investigators have now conducted a noninferiority, randomized trial to compare the efficacy of administering FMT by oral capsules versus colonoscopy in preventing RCDI. A total of 116 participants with three or more episodes of CDI received FMT by capsule (40 pills) or colonoscopy (360 mL of fecal slurry in the cecum).
In the per-protocol analysis, prevention of RCDI was achieved in 96% of participants in both groups after a single FMT. Two participants in each group developed RCDI and were treated successfully with a second FMT. More patients in the capsule group than the colonoscopy group said the experience was “not at all unpleasant” (66% vs. 44%). No infectious complications occurred, and stool microbiome diversity increased and was maintained through 12 weeks of observation in both groups.
COMMENT: The finding that FMT by capsule is effective in preventing RCDI raises the prospect of treating patients without the time, trouble, and expense involved with colonoscopy. However, as editorialists note, a number of questions remain, including those regarding the optimal timing and approach to treating acute recurrent CDI as well as whether new strategies with defined microbial communities or sterile fecal derived products will supplant FMT in the future.
CITATION(S): Kao D et al. Effect of oral capsule- vs colonoscopy-delivered fecal microbiota transplantation on recurrent Clostridium difficile infection: A randomized clinical trial. JAMA 2017 Nov 28; 318:1985.
Rao K et al. Capsules for fecal microbiota transplantation in recurrent Clostridium difficile infection: The new way forward or a tough pill to swallow? JAMA 2017 Nov 28; 318:1979.
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Gastroenterology 2017 Nov 22
Indigo Naturalis Very Effective for UC, but Safety Concerns Exist
This herbal remedy is promising but should not be used until further data on safe doses and durations are available.
Indigo naturalis (IN; also called Qing-Dai) is a Chinese herbal medicine made from the same plant used to make blue dyes. There is some evidence that IN induces interleukin-22 and promotes mucosal regeneration in ulcerative colitis (UC).
In the current study, 86 patients with moderate to severe UC with disease extending to at least the sigmoid were randomized to receive one of three different doses (0.5, 1.0, or 2.0 grams) of IN or placebo for 8 weeks. Patients were evaluated at weeks 0, 2, 4, and 8.
Compared with placebo, at week 8, rates of clinical response (primary endpoint) were 5 to 6 times higher with all doses of IN, clinical remission rates were 8 to 12 times higher with the two higher doses of IN, and mucosal healing rates were 3 to 4 times higher with all three doses. Patients receiving IN were more likely to develop abnormal hepatic transaminases, which resolved either spontaneously or after treatment completion. The study was stopped because a woman who was not in the study and purchased IN on her own and took it for 13 months developed pulmonary hypertension.
COMMENT: These are dramatic efficacy results, but the safety issues are substantial. Additional information about safe doses and durations of therapy will be needed before this herbal treatment for UC should be used.
Note to readers: At the time we reviewed this paper, its publisher noted that it was not in final form and that subsequent changes might be made.
CITATION(S): Naganuma M et al. Efficacy of indigo naturalis in a multicenter randomized controlled trial of patients with ulcerative colitis. Gastroenterology 2017 Nov 22; [e-pub].
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Acad Emerg Med 2017 Nov 10
Tranexamic Acid Is More Effective than Nasal Packing for Treatment of Epistaxis
Even in patients on antiplatelet drugs
Tranexamic acid is commonly used in the emergency department (ED) for the treatment of traumatic hemorrhage, and some studies have found that it may be useful for the management of anterior epistaxis as well. However, its effectiveness for epistaxis in patients on antiplatelet agents is unknown, and these patients often receive the standard treatment of anterior nasal packing (which is uncomfortable and has potential infectious complications).
These authors performed a randomized parallel group clinical trial to compare tranexamic acid to anterior packing for treatment of epistaxis in 124 patients on antiplatelet agents at two academic EDs in Iran. In the tranexamic acid group, a cotton pad soaked in the injectable form of 10% tranexamic acid was inserted into the affected nostril until bleeding stopped.
Tranexamic acid was significantly more effective than anterior packing at stopping epistaxis within 10 minutes (73% vs. 29%). In addition, patients treated with tranexamic acid had a significantly lower rate of rebleeding at 1 week (5% vs. 21%) and higher rate of discharge within 2 hours (97% vs 13%). Patients treated with tranexamic acid were also more satisfied with treatment.
COMMENT: Given the efficacy, relative comfort, and low cost of tranexamic acid compared to multiday anterior nasal packing, it should be used preferentially in patients with epistaxis. These findings support this practice in patients on antiplatelet drugs — no reason not to try it first in these patients as well!
CITATION(S): Zahed R et al. Topical tranexamic acid compared with anterior nasal packing for treatment of epistaxis in patients taking antiplatelet drugs: Randomized controlled trial. Acad Emerg Med 2017 Nov 10; [e-pub].
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BMJ 2017 Nov 14; 359:j4849
Dietary Weight-Loss Interventions Might Lower Early All-Cause Mortality
Obese adults who followed low-fat weight-loss diets were less likely to die prematurely.
Obesity is associated with adverse health outcomes (e.g., early death, diabetes, heart disease), but whether dietary weight-loss interventions lower risks for these outcomes in obese adults is unclear. In this systematic review and meta-analysis of 54 randomized controlled trials, researchers examined the effects of dietary weight-loss interventions on all-cause, cardiovascular-related, and cancer-related mortality in more than 30,000 obese adults. All of the trials involved dietary interventions that targeted weight loss (mostly low-fat diets), with or without exercise advice or programs; median trial duration was 2 years.
Compared with controls, dietary-intervention participants experienced significantly greater weight loss after 1, 2, and 3 years (mean difference, −3.4 kg, −2.5 kg, and −2.6 kg, respectively). Risk for all-cause death (but not cardiovascular- or cancer-related death) was significantly lower among intervention participants (risk ratio, 0.82).
COMMENT: In this meta-analysis, dietary weight-loss interventions were associated with an 18% relative reduction in all-cause death during a median 2 years in obese adults, with 6 fewer deaths per 1000 participants. This study highlights the importance of prescribing dietary interventions to obese patients and supports various guidelines on managing obesity, which emphasize calorie restriction, exercise, and behavioral therapy (NEJM JW Cardiol Jan 2014 and J Am Coll Cardiol 2014; 63:2985).
CITATION(S): Ma C et al. Effects of weight loss interventions for adults who are obese on mortality, cardiovascular disease, and cancer: Systematic review and meta-analysis. BMJ 2017 Nov 14; 359:j4849.
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Am J Psychiatry 2017 Nov 17
Contraceptive Hormones and Risk for Suicide
Women who start hormonal contraception are at elevated risks for both suicidal attempts and dying by suicide, per a large registry study.
Female contraceptive hormones have been linked repeatedly to risk for depression (NEJM JW Psychiatry Dec 2016 and JAMA Psychiatry 2016; 73:1154), but studies into possible links between contraceptive hormone use and suicide risk have been inconclusive. The current investigators used Danish national prescription, psychiatric, and death registries to prospectively study this possible association.
The study included 475,802 females who turned age 15 between 1996 and 2013 and who had no history of contraceptive or antidepressant use, suicide attempts, or diagnoses of psychiatric disorders, cancer, or venous thrombosis. At mean follow-up of 8 years, 54% of participants (mean age, 21; maximum age, 33) had used contraceptive hormones. Comparisons between users and never-users were adjusted for demographics, hormonal exposure after study entry, antidepressant use, psychiatric diagnoses, pregnancy, cancer, venous thrombosis, and emigration.
Compared with never-users, contraceptive hormone users had elevated risks for death by suicide (relative risk, 3.08) and first suicide attempt (RR, 1.97). Risks increased rapidly after initiation, remained doubled for at least a year, and were still 30% greater after 7 years; risks remained elevated among former users. Risks were similar for preparations involving estrogen alone and combined products but were higher for progestins alone, vaginal rings, and patches. In analyses that examined psychiatric diagnoses and antidepressant use as mediators, risks remained elevated.
COMMENT: This large prospective study documents, but cannot explain, elevated suicide-associated risks for contraceptive hormone users. Psychologically and culturally, individuals with more protective factors (i.e., a conservative upbringing weighing against birth control or premarital intercourse) might be less inclined to use contraceptive hormones, particularly at younger ages; biologically, individuals with mood disorders or family histories of suicide might be more vulnerable to mood-influencing effects of these agents. Clinicians might wish to discuss these risks with patients starting contraceptive hormones.
CITATION(S): Skovlund CW et al. Association of hormonal contraception with suicide attempts and suicides. Am J Psychiatry 2017 Nov 17; [e-pub].
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Ann Intern Med 2017 Nov 28
How Active Should Active Surveillance Be for Prostate Cancer?.
Surveillance biopsies every other year rather than every year may be acceptable.
Active surveillance (AS) is increasingly accepted as a standard of care for men with low-risk prostate cancer. However, consensus about how to implement AS is lacking.
Now, investigators have analyzed data from four AS study cohorts to evaluate the risks for disease progression — specifically, for upgrading from a Gleason score of ≤6 to ≥7 — that are associated with various prostate cancer biopsy intervals. The cohorts comprised 2576 men (age, 40–80 years) who received diagnosis of prostate cancer (stage T1 or T2; Gleason score, 2–6) between 1995 and 2014.
When all four cohorts were balanced with respect to inclusion criteria, surveillance intervals, competing treatments, and endpoints, large differences (25%–65%), likely attributed to differences in patient populations not captured by study criteria, were observed in the estimated 10-year cumulative risk for biopsy upgrading. The investigators superimposed surveillance protocols that involved regular biopsies at intervals ranging from 1 to 4 years.
Performing biopsies every 2 years following the first confirmatory biopsy (1 year after enrollment) versus every year reduced the number of biopsies performed annually by 32% to 38% and delayed detection of Gleason score upgrading by only 3 to 5 months.
COMMENT: The investigators note that single AS studies may not reflect risks for prostate cancer progression in other populations but suggest that the impact of varying the biopsy frequency appears robust across different AS experiences. In keeping with recent clinical practice guidelines from the American Society of Clinical Oncology, the investigators suggest that performing biopsies every 2 years versus every year appears to be justified, given the potential morbidity with this procedure.
CITATION(S): Inoue LYT et al. Comparative analysis of biopsy upgrading in four prostate cancer active surveillance cohorts. Ann Intern Med 2017 Nov 28; [e-pub].
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N Engl J Med 2017 Nov 9; 377:1836
ER-Positive Breast Cancer Remains a Long-Term Concern
Large meta-analysis reinforces that, regardless of initial tumor size or nodal burden category, cumulative risk for distant recurrence escalates with increasing follow-up time.
The optimal duration of adjuvant endocrine therapy for early-stage, estrogen receptor–positive (ER+) breast cancer — long believed to be 5 years — is still an open question, as this treatment must be individualized. Clinical trials have explored endocrine therapy for up to 10 years. These extra years of treatment, despite their added value, represent a small incremental improvement in outcome that is often limited to a reduction in contralateral breast cancer rather than distant metastatic disease. Understanding which patients are at greatest risk for recurrence and whether they benefit from extended therapy remain key challenges. Researchers for the Early Breast Cancer Trialists' Group conducted a meta-analysis of 88 clinical trials involving 62,923 women with ER+ early-stage breast cancer who remained disease-free after 5 years of adjuvant endocrine therapy. They analyzed tumor (T) size, nodal (N) status, and grade in relation to outcomes after 5 to 20 years of follow-up.
For any initial tumor size or nodal burden category, cumulative risk for distant recurrence rose with follow-up time throughout the study period. Similarly, for any tumor grade category — even in Stage I (T1N0) disease — cumulative risk escalated over time. Nonetheless, the degree of risk (range, 10%–40%) was markedly correlated with initial TN status.
COMMENT: It has long been appreciated that tumor and nodal status and grade influence risk for recurrence. These findings, coming as they do from a such a vast dataset, reaffirm such observations. In particular, the data show that risk for recurrence persists even in patients with ER+, early-stage breast cancer having favorable clinical features. The results highlight the need to develop tools to identify those patients at greatest risk for late recurrences and, by extension, to determine if such patients will benefit from extended endocrine therapy. Molecular assays hold promise for answering those fundamental questions.
CITATION(S): Pan H et al. 20-year risks of breast-cancer recurrence after stopping endocrine therapy at 5 years. N Engl J Med 2017 Nov 9; 377:1836.
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JAMA Surg 2017 Dec 6
Hospital Financial Status as a Determinant of Postmastectomy
Breast Reconstruction

Institutional financial distress was associated with lower likelihood of immediate reconstruction after mastectomy for DCIS.
Women who undergo mastectomy for ductal carcinoma in situ (DCIS) do not require chemotherapy or radiation and therefore are considered appropriate candidates for immediate breast reconstruction; however, racial and socioeconomic factors can lower the odds of having this surgery. Researchers used national inpatient and hospital financial data to evaluate the association between hospital-level financial distress (defined by profit margin) and likelihood of immediate postmastectomy breast reconstruction in 5760 women with DCIS (78% white; 61% privately insured) who underwent mastectomy between 2004 and 2008.
Overall, 41% of patients had immediate breast reconstruction. Women treated at hospitals with low financial distress were more likely than those at hospitals with high financial distress to have immediate breast reconstruction (44% vs. 37%; P<0.001). Adjusted analysis also demonstrated lower odds of breast reconstruction in nonwhite, older, publicly insured patients. Hospitals in high financial distress were also more likely to be public, not designated as teaching or cancer hospitals, and to provide care for black or Hispanic patients.
COMMENT: Given that postmastectomy breast reconstruction improves self-esteem and body image, this option should be discussed with patients before they undergo mastectomy. Federal law mandates that this reconstructive procedure be covered by payors — and availability of plastic surgery services is a requirement of many accrediting bodies. Nonetheless, the procedure is still considered optional. Implant-based or autologous flap reconstruction can have high rates of complications (e.g., poor wound healing, skin or flap necrosis, infection, chronic pain) especially in smokers, obese patients with multiple comorbidities, and those who have had prior radiotherapy. Safety-net hospitals are more likely to be in financial distress, as they provide care for indigent patient populations with high-acuity conditions and more comorbidities. Women with comorbidities may not always be good candidates for immediate breast reconstruction; thus, appropriate patient selection is a key component for minimizing the associated morbidity.
CITATION(S): Richards CA et al. Association between hospital financial distress and immediate breast reconstruction surgery after mastectomy among women with ductal carcinoma in situ. JAMA Surg 2017 Dec 6; [e-pub].
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JAMA 2017 Dec 12; 318:2224
HT for Preventing Chronic Conditions in Postmenopausal Women:
USPSTF Weighs in Again

Task force remains against use of hormone therapy for primary prevention of chronic conditions.
Sponsoring Organization: U.S. Preventive Services Task Force (USPSTF)
Target Population: OB/GYN and primary care providers
Background and Objective
In updating its 2012 recommendations, the USPSTF reviewed evidence from randomized clinical trials (RCTs) on the benefits and harms of hormone therapy (HT). The task force determined that small to moderate benefits (prevention of osteoporotic fractures, diabetes, and colorectal cancer) as well as harms (excess risk for invasive breast cancer, coronary heart disease, thromboembolism, stroke, dementia, gallbladder disease, and urinary incontinence) result from use of HT.
Key Recommendations

COMMENT: Guidance from the North American Menopause Society and the Endocrine Society reinforces that HT is appropriate for symptomatic young (aged <60) menopausal women free of contraindications; however, many clinicians and women confuse use of HT for managing symptoms with that for preventing disease. Accordingly, I am concerned that this USPSTF recommendation will hinder appropriate use of HT for symptoms such as hot flashes.
Although controversial, another consideration is prevention of osteoporosis. In my practice, menopausal women who initiated HT for symptom management but who have “outgrown” their symptoms are advised based on their risk for osteoporosis. Women at low risk for osteoporosis (e.g., those who are overweight) are encouraged to discontinue systemic HT, whereas other patients at higher risk for osteoporosis are offered, with shared decision-making, the option of continuing HT at a lower estrogen dose and using a transdermal route. Because clinical trials have not yet addressed this individualized long-term strategy, it is not included in the latest USPSTF guidance.
CITATION(S): US Preventive Services Task Force.Hormone therapy for the primary prevention of chronic conditions in postmenopausal women: US Preventive Services Task Force recommendation statement. JAMA 2017 Dec 12; 318:2224.
Gartlehner G et al. Hormone therapy for the primary prevention of chronic conditions in postmenopausal women: Evidence report and systematic review for the US Preventive Services Task Force. JAMA 2017 Dec 12; 318:2234.
Lewis CE and Wellons MF.Menopausal hormone therapy for primary prevention of chronic disease. JAMA 2017 Dec 12; 318:2187.
Grady D.Evidence for postmenopausal hormone therapy to prevent chronic conditions success, failure, and lessons learned. JAMA Intern Med 2017 Dec 12; [e-pub]. (http://dx.doi.org/10.1001/jamainternmed.2017.7861)
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