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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
April 28, 2018

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HT for Preventing Chronic Conditions in Postmenopausal Women: USPSTF Weighs in Again
Stem Cell Injection for Perianal Fistulae in Crohn Disease Is Effective for a Year
Broader Is Not Better: Empiric Antibiotics for Acute Respiratory Infections
Unmet Therapy Needs Increase with Time After Traumatic Brain Injury
Does Prohibiting Kids' Mobile Device Use at Check-Ups Improve Developmental Surveillance?
Caffeine During Pregnancy Associated with Excess Weight in Preschoolers
Sessions Admits There 'May Well be Benefits from Medical Marijuana'
Should We Still Call It Dope?
How Well Informed Are OBGYNs About Opioids?
Is Pregnancy Safe After Breast Cancer?
Ensuring Safe Passage Through Pregnancy's “Fourth Trimester”

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].
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Gastroenterology 2017 Dec 22
Stem Cell Injection for Perianal Fistulae in Crohn Disease Is Effective for a Year
Phase III trial results show efficacy of this investigational therapy up to 52 weeks.
In an industry-funded, randomized, controlled trial of a single stem cell injection for complex perianal fistulae in patients with Crohn disease, efficacy was shown at 24 weeks after treatment initiation. Now, investigators for that trial have analyzed outcomes at 1 year.
The study comprised 212 patients with a maximum of two internal and three external openings that were refractory to antibiotics, immunomodulatory drugs, or anti–tumor necrosis factor agents. Patients with rectovaginal fistulas, lumen stenosis, active proctitis, an abscess >2 cm, a diverting stoma, or prior surgery were excluded.
At least two weeks before injection, patients underwent baseline magnetic resonance imaging (MRI), examination under anesthesia, and seton placement when appropriate. On the day of injection, the internal orifices were sutured off and active agent or sham saline control were injected along the fistulae tracts.
At 52 weeks, the active agent was still better compared with placebo for all study endpoints. For example, combined remission (defined as closure of all external openings treated at baseline and no collections >2 cm, confirmed by blinded MRI) was achieved in 56% versus 39%, for a number needed to treat of just under 6.
COMMENT: This investigational therapy continues to be an exciting development in the treatment of complex perianal fistulae in Crohn's disease, an area where new therapies are greatly needed.
CITATION(S): Panés J et al. Long-term efficacy and safety of stem cell therapy (Cx601) for complex perianal fistulas in patients with Crohn's disease. Gastroenterology 2017 Dec 22; [e-pub].
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JAMA 2017 Dec 19; 318:2325
Broader Is Not Better: Empiric Antibiotics for Acute Respiratory Infections
Broad-spectrum antibiotics did not result in improved outcomes and resulted in more adverse events compared with narrow-spectrum antibiotics.
Although most clinical guidelines recommend selection of narrow-spectrum antibiotics such as penicillin and amoxicillin for children with acute respiratory infections, there are inconsistencies in recommendations and practice. To compare the effectiveness of narrow-spectrum and broad-spectrum antibiotics in this setting, researchers conducted two cohort studies involving children aged 6 months to 12 years who received antibiotics for respiratory tract infection.
Of the more than 30,000 children assessed for clinical outcomes in a retrospective study, 14% received broad-spectrum antibiotics. These children had a higher rate of adverse side effects requiring medical attention (4% vs. 3%) and a similar rate of treatment failure (3%) compared with those prescribed narrow-spectrum antibiotics. For children with group A streptococcal pharyngitis, there was a slightly lower risk for treatment failure among those receiving broad-spectrum versus narrow-spectrum antibiotics (1% vs. 2%). In the prospective cohort study, 35% received broad-spectrum antibiotics; these children had a higher risk for reported adverse events (e.g., rash, gastrointestinal complaints; 36% vs. 25%) and a slightly lower quality-of-life score compared with narrow-spectrum antibiotic recipients.
COMMENT: It is reassuring that the majority of children in these studies were prescribed narrow-spectrum antibiotics for treatment of respiratory tract infection. For providers who prescribe broad-spectrum antibiotics for such infections, these findings should help to convince them that clinical outcomes with broad-spectrum antibiotics are not better, and patient experience might be worse, which could lead to noncompliance.
CITATION(S): Gerber JS et al. Association of broad- vs narrow-spectrum antibiotics with treatment failure, adverse events, and quality of life in children with acute respiratory tract infections. JAMA 2017 Dec 19; 318:2325.
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Pediatrics 2018 Apr 19
Unmet Therapy Needs Increase with Time After Traumatic Brain Injury
Having a less-severe TBI was also associated with excess risk for not receiving needed therapies and services 2 years after injury.
Childhood traumatic brain injury (TBI) is associated with long-term impairments in cognitive, speech, physical, and educational domains, but studies show low rates of therapy receipt in the years after injury.
To assess unmet therapy needs up to 2 years postinjury, researchers followed 170 children aged 8 to 18 years after hospital admission for TBI (approximately 70% with complicated mild TBI and 30% with moderate-to-severe TBI). Parents were interviewed at admission to estimate children's pre-injury functioning, and again at 6, 12, and 24 months after hospitalization to assess therapy needs in six domains (physical therapy, occupational therapy, speech therapy, mental health, educational, and physiatry). Unmet needs were identified when a child had dysfunction in a domain (i.e., significantly lower postinjury functioning vs. pre-injury) but was not receiving services.
At 2 years postinjury, dysfunction rates remained high (e.g., at least 30% with complicated mild TBI had mental health, cognitive, and academic dysfunctions; over half with moderate-to-severe TBI had physical, cognitive, and academic dysfunctions). Unmet therapy needs in all domains increased over time in children with moderate-to-severe TBI. In multivariate analysis, children with complicated mild TBI had a greater risk for having unmet needs in all domains but speech therapy, likely because of milder symptom presentation.
COMMENT: Because standardized developmental screening doesn't occur in the school-age and teen years, it can be difficult to identify unmet therapy needs after TBI. For our patients who sustain a TBI, we should be inquiring about their mobility, pain, speech/communication, school progress, and overall social/emotional functioning at home and school during well-child exams for at least 2 years (but even longer is likely needed). Mental health screening tools such as the Vanderbilt, Patient Health Questionnaire–9 (PHQ-9), or Goldberg Anxiety and Depression (GAD) scales may be helpful supplements.
CITATION(S): Fuentes MM et al. Unmet rehabilitation needs after hospitalization for traumatic brain injury. Pediatrics 2018 Apr 19; [e-pub].
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Clin Pediatr (Phila) 2018 Apr 12
Does Prohibiting Kids' Mobile Device Use at Check-Ups Improve Developmental Surveillance?
Surprisingly, results of a provider-blinded trial suggest the opposite.
Children's use of mobile devices during clinic encounters has become increasingly common. To evaluate whether such device use makes it more difficult to assess young children's development, researchers randomized over 100 children aged 18 to 36 months to a device-prohibited condition (parents were asked not to let their child use a mobile device [smartphone or tablet]) or a device-allowed condition during a well-child visit.
Providers were blinded to the child's study assignment; after the visit, they were asked to characterize the child's gross-motor, fine-motor, communication, problem-solving, and personal-social development as delayed, borderline, or typical. Parents completed the Ages and Stages Questionnaire (ASQ-3) after the visit. Approximately half of the children in the device-allowed group actually used a device during their visit.
Providers were more likely to miss delays (rate them as typical when the global ASQ-3 score was borderline or delayed) in the device-prohibited group (53%) versus the device-allowed group (28%). A provider assessment/ASQ-3 score discrepancy existed for identifying fine-motor delays specifically (40% in device-prohibited vs. 24% in device-allowed). Findings did not differ by provider training or previous knowledge of the patient or when limiting analysis to only the children who actually used devices.
COMMENT: Many providers might be surprised, as I was, by these findings. The authors suggest that children's mobile device use allows uninterrupted provider-parent communication (which toys or books might also facilitate), possibly improving developmental assessment. Then, during the physical exam, it is important to develop a method for asking that mobile devices be put away (which itself can provide information about how families handle tech transitions), to allow more-focused interaction with the child.
CITATION(S): Regan PA et al. Impact of a “no mobile device” policy on developmental surveillance in a pediatric clinic. Clin Pediatr (Phila) 2018 Apr 12; [e-pub].
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Caffeine During Pregnancy Associated with Excess Weight in Preschoolers
By Amy Orciari Herman
Pregnant women who consume at least 200 mg of caffeine daily — that is, about two cups of coffee — are more likely to give birth to children who become overweight, according to a prospective study in BMJ Open.
Norwegian researchers studied over 50,000 mother-child pairs. The mothers completed food-frequency questionnaires during pregnancy, from which caffeine intake was estimated, and the children's height and weight were measured several times until age 8 years.
Among the findings:

The researchers conclude, "Our findings support the recommendation to limit caffeine intake during pregnancy (<200 mg/day)."
LINK(S): BMJ Open article (Free)
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Sessions Admits There 'May Well be Benefits from Medical Marijuana'
April 25, 2018
U.S. Attorney General Jeff Sessions acknowledged before a key Senate panel on Wednesday that “there may well be some benefits from medical marijuana” and that it is “perfectly appropriate to study” cannabis.
But Sessions was also quick to dismiss a mounting body of evidence that legal marijuana access is associated with reduced opioid issues.
Acknowledging that he has seen some research indicating lower overdose deaths in states that allow cannabis in some form and that “science is very important,” the attorney general said he doesn’t “believe that will be sustained in the long run.”
Sessions also indicated that the federal government would soon take steps to license more entities to legally grow marijuana for research.
“We are moving forward and we will add fairly soon, I believe, the paperwork and reviews will be completed and we will add additional suppliers of marijuana under the controlled circumstances,” he said during an appearance before the Senate Appropriations Commerce, Justice and Science Appropriations Subcommittee.
In 2016, the Drug Enforcement Administration enacted a new policy intended to license more research cultivators, and he agency has reportedly since received at least 25 applications to participate in the new program. But it has not yet acted on any of them and, according to the Washington Post, that is because top Justice Department officials have stepped in to prevent DEA from approving any proposals.
In his answers, Sessions indicated that he thought opening up research could put the U.S. at risk of violating international drug treaties.
The “treaty requires certain controls in that process,” he said, adding that in his view, the “previous proposal violated that treaty.”
Sessions was responding to a line of questioning from U.S. Sen. Brian Schatz (D-HI), who said that “we’re all evolving on this issue, some quicker than others.”
There are “good civil rights reasons for decriminalizing and pursing a federalist approach around this,” the senator added.
Sessions did not offer a specific timeline for releasing a revised research cultivation approval process.
And despite acknowledging cannabis’s medical potential, he said he takes issue with the way it is currently consumed.
“Medical marijuana, as one physician told me, ‘whoever heard of taking a medicine when you have no idea how much medicine you’re taking and ingesting it in the fashion that it is, which is in itself unhealthy?'” Sessions said.
Advocates welcomed Session’s admission that marijuana can help patients, but said that the Justice Department needed to act on allowing research as well as make broader policy changes sooner rather than later.
“Over two million registered medical marijuana patients throughout the legal markets can attest to the attorney general’s newfound revelation,” NORML Political Director Justin Strekal told Marijuana Moment in an interview. “What we need is better research on consumer grade marijuana and lawful protections for legal markets, not further deliberation from the DoJ.”
Later in the Senate hearing, Sen. Lisa Murkowski (R-AK) cited a resolution approved by Alaska state lawmakers urging the federal government to respect local marijuana laws. She also attempted to elicit a commitment from the attorney general not to oppose congressional efforts to reform federal cannabis laws.
“I can’t make a commitment about what position we would take at this time, until we know what’s exactly involved,” he replied.
Sessions said, however, that “our priorities are fentanyl, heroin, methamphetamine, cocaine. People are dying by massive amounts as a result of those drugs. We have very few, almost zero, virtually zero small marijuana cases. But if they are a big deal and illegally acting, and violating federal law, our agents may work that case.”
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JAMA Psychiatry 2018 Apr 18
Should We Still Call It Dope?
Adverse cognitive effects of marijuana use in young people are more severe in those seeking treatment but fade after 72 hours of abstinence.
In an era of increasing legitimization of marijuana use, little is known about cognitive effects of ongoing use, especially in adolescents and young adults. These researchers conducted a meta-analysis of 69 studies of 2152 “heavy, frequent, and/or problematic cannabis users” (criteria for which were not stated) and 6575 minimally using controls (mean age, 21; mean age of starting cannabis use, 15).
Marijuana use was associated with decrements in cognitive function, with a small but significant overall effect size. Five of eight domains were significantly affected — learning, speed of information processing, delayed memory, attention, and various facets of executive function. The effect size was almost twice as great in those seeking treatment. However, no significant differences were seen between individuals who had been abstinent for >72 hours and controls.
COMMENT: The data appear to suggest that ongoing cannabis use for ≤6 years in younger people causes distinct but small impairments in some elements of cognition but that the impairments disappear after 72 hours of abstinence. However, several points are worth bearing in mind before one concludes that this is a minor problem. For example, the actual amount of marijuana used was not evaluated, and the impact of more chronic use or of specific amounts is not known. Another point concerns the more clinically important effect size, and thus greater cognitive impairment, in individuals seeking treatment, who are presumably using more cannabis or have more problems with it than non–treatment seekers. In addition to assessing such patients carefully for cognitive effects, clinicians should consider other potential harms, such as loss of motivation, impaired functioning, increased risk for psychosis, and medical complications.
CITATION(S): Scott JC et al. Association of cannabis with cognitive functioning in adolescents and young adults: A systematic review and meta-analysis. JAMA Psychiatry 2018 Apr 18; [e-pub].
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Obstet Gynecol 2017 Dec 4
How Well Informed Are OBGYNs About Opioids?
National survey identifies substantial gaps in knowledge.
Over half of the >2 million Americans with prescription opioid use disorders report accessing these drugs through diversion of prescribed medications. Government agencies and professional societies such as the American College of Obstetricians and Gynecologists (ACOG) have disseminated guidance on measures to minimize opioid misuse. In 2016, investigators conducted a survey of ACOG fellows regarding their knowledge of and adherence to four recommended approaches to outpatient opioid prescribing (including at hospital discharge): Screen patients for opioid dependence, provide the smallest appropriate number of pills, tailor opioid prescriptions, and counsel patients regarding proper use, storage, and disposal of opioids.
Among 179 respondents, 98% indicated they normally prescribed opioids for outpatient postoperative pain management following laparotomy for hysterectomy or cesarean birth, and 22% reported typically prescribing opioids after vaginal delivery. Respondents reported prescribing more pills after laparotomies (median, 30; range, 0–8) than after minimally invasive hysterectomy (25; 6–60). The most variation occurred for treatment of chronic pelvic pain with unknown cause. While 75% of respondents said they provided a standard number of pills, fewer than 20% reported adherence to ≥3 of the 4 recommendations. Fewer than 25% were aware that most individuals who misuse opioids obtain them from family or friends.
COMMENT: Although clinicians may prescribe a standard number of pills to ensure adequate pain control, recent studies (NEJM JW Womens Health Aug 2017 and Obstet Gynecol 2017 Jul, multiple citations) showed that only half of the opioids prescribed after cesarean birth were consumed, leaving the door open to misuse and diversion. I would have been interested to know how these survey findings compare with other surgical specialties. Nonetheless, this report points out the need for more education of OBGYNs about prescribing opioids.
CITATION(S): Madsen AM et al. Opioid knowledge and prescribing practices among obstetrician–gynecologists. Obstet Gynecol 2017 Dec 4; [e-pub].
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J Natl Cancer Inst 2018 Apr 1; 110:426
Is Pregnancy Safe After Breast Cancer?
Long-term outcomes were similar between pregnant and non-pregnant survivors.
Many young breast cancer survivors retain a goal of childbearing, but both patients and their physicians have concerns that a pregnancy, with its associated hormone-amplified milieu, will increase the risk for breast cancer recurrence, especially if the disease is hormone sensitive, i.e., estrogen receptor (ER)–positive.
To address this issue, international investigators conducted a multicenter case-control study in which 333 patients who were pregnant following a diagnosis of breast cancer were matched (1:3) with 874 non-pregnant breast cancer patients with similar clinical characteristics. Median follow-up was 9.6 years after original breast cancer diagnosis and 7.2 years after pregnancy.
Results were as follows:

COMMENT: These findings suggest that the ER status of the tumor and the timing of the pregnancy have little bearing on the outcome of breast cancer survivors who elect to get pregnant. In an era when durations of adjuvant endocrine therapy may be as long as 10 years, the goal of achieving pregnancy can be a dilemma. Whether a break in adjuvant endocrine therapy will compromise breast cancer outcomes is the subject of a large international cooperative group study (POSITIVE; NCT02308085). Until further data are available, an individualized approach should be taken, but an absolute admonition against pregnancy is not warranted.
CITATION(S): Lambertini M et al. Long-term safety of pregnancy following breast cancer according to estrogen receptor status. J Natl Cancer Inst 2018 Apr 1; 110:426.
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Obstet Gynecol 2018 May; 131:e140
Ensuring Safe Passage Through Pregnancy's “Fourth Trimester”
Safe delivery of mother and newborn is just the beginning of a challenging transition.
Sponsoring Organization: American College of Obstetricians and Gynecologists (ACOG)
Target Population: Obstetric care providers
Background and Objective
A large clinical gap separates optimal practice from current patterns of postpartum care. To improve care after delivery, professional organizations emphasize the importance of the “fourth trimester” (birth to 12 weeks postpartum).
Key Recommendations

COMMENT: Clinical practices that have been recently and widely implemented at birth include delayed cord clamping, collection of cord blood, immediate skin-to-skin contact between mother and newborn, immediate initiation of breastfeeding, avoidance of opioid medications, newborn rooming-in, and immediate initiation of long-acting reversible contraceptives. Beyond these, optimizing support during the fourth trimester represents an important medical and social goal. An aspirational goal is paid parental leave to support optimal physical, psychological, and social health. Technological advances could be better utilized to achieve these objectives. For example, many general surgical programs have implemented patient-facing apps providing daily two-way communication between patient and health system — such apps could also help improve two-way communication in the ante-partum and postpartum settings.
CITATION(S): The American College of Obstetricians and Gynecologists. ACOG committee opinion no. 736: Optimizing postpartum care. Obstet Gynecol 2018 May; 131:e140.

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