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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
August 19, 2017

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Standard Definition of Vitamin D Deficiency Is Challenged
Treatment Delay Associated with Worse Disability in Multiple Sclerosis
High-Dose Vitamin D3 Not Preventive Against Viral Upper Respiratory Infection
  During Winter
Intranasal Oxytocin Improves Social Function in Kids with Autism
Is Nonobstetric Surgery Harmful During Pregnancy?
E-Cigarette Use and Smoking Cessation in the U.S.
After Bisphosphonate Use, Which Bone-Forming Medication Is Best?
New ACOG Guidelines on Teen Contraception

J Clin Endocrinol Metab 2017 Mar 30; 102:2321
Standard Definition of Vitamin D Deficiency Is Challenged
A research team suggests that a 25-hydroxyvitamin D level of 12 ng/mL (30 nmol/L) might be a more appropriate cutoff.
Although many afflictions have been attributed to vitamin D deficiency, bone disease (i.e., osteomalacia) is the clinical entity with the strongest causal link to vitamin D deficiency. In this study, Australian researchers sought to identify the 25-hydroxyvitamin D (25[OH]D) level below which abnormal bone physiology becomes evident. Data were obtained from a large cohort of 12,000 adults and from a smaller cohort of 150 adults who underwent more extensive testing. Patients with hypercalcemia or renal disease were excluded.
Across 25(OH)D levels ranging from 12 to 60 ng/mL (30 to 150 nmol/L), there was a weak inverse relation between 25(OH)D and serum parathyroid hormone (PTH), and a weak positive relation between 25(OH)D and serum calcium. However, a significant breakpoint was evident at a threshold 25(OH)D level of less than 12 ng/mL: Serum calcium levels became distinctly lower and PTH levels became distinctly higher. The smaller cohort showed no significant correlations between 25(OH)D levels and markers of bone turnover (collagen- and procollagen-related peptides) or bone integrity (i.e., bone density, mineralization, and porosity); however, the small sample size provided limited statistical power for the latter findings.
COMMENT: In the U.S., many laboratories define 25(OH)D levels <20 ng/mL (50 nmol/L) as deficient, and levels between 20 and 30 ng/mL (50−75 nmol/L) as “insufficient” (J Clin Endocrinol Metab 2011; 96:1911). However, the current study authors believe their data justify a cutoff of 12 ng/mL (30 nmol/L) for deficiency, and they challenge the idea of a specific insufficiency range. This study might not settle the controversy about the optimal cutoff for deficiency, but it supports my concern that many clinicians push vitamin D supplementation excessively, without evidence of clinical or physiological benefit.
CITATION(S): Shah S et al. Serum 25-hydroxyvitamin D insufficiency in search of a bone disease. J Clin Endocrinol Metab 2017 Mar 30; 102:2321.
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Mult Scler 2017 Aug; 23:1233
Treatment Delay Associated with Worse Disability in Multiple Sclerosis
Disease-modifying therapies were most effective if started within 3 years of diagnosis in a registry study.
Identifying the long-term impact of a delay in treatment has always been a major question in the multiple sclerosis (MS) field. To shed light on the problem, researchers identified 906 patients diagnosed with MS from 2001 through 2007 who previously participated in a registry to observe MS outcomes. Of these patients, 708 had received a total of 1484 immunomodulatory treatments; 69% were injectables, 19% natalizumab, 7% fingolimod, and 5% rituximab. Patients who started treatment within 3 years after diagnosis were matched with patients who started treatment later.
Risk for Expanded Disability Status Score (EDSS) worsening to ≥4 (moderate disability in at least 1 domain) increased by 5% to 7% for each year of treatment delay (hazard ratio, 1.05 unadjusted; 1.07 after adjustment for sex, baseline EDSS score, age of onset, and exposure to second-line treatment). Older age at onset and higher baseline EDSS increased the risk further. For those who started treatment more than 3 years after onset, the hazard ratio for reaching EDSS 4 or worse was 1.9 (after adjustment for propensity score) to 2.6 (adjusted for the other variables), and time to reach EDSS 4 or worse was 10 years shorter than for those who started within 3 years. Similarly, the hazard ratio for reaching EDSS 6 (ambulates with cane) was 2.0 to 2.7 when treatment was delayed for 3 years.
COMMENT: These real-world data confirm that MS is easier to manage and associated with less disability when treatment is begun soon after diagnosis. Those who delayed for 3 or more years had approximately a twofold increased chance of reaching EDSS 4.0 and 6.0. This is consistent with prior studies that showed a 3-year delay in treatment was associated with an increased risk for disability and death over the subsequent 2 decades (NEJM JW Neurol Jul 2012 and Neurology2012; 78:1315). We should discuss with patients the importance of starting and maintaining therapy to prevent ongoing injury related to MS.
CITATION(S): Kavaliunas A et al. Importance of early treatment initiation in the clinical course of multiple sclerosis.Mult Scler 2017 Aug; 23:1233.
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JAMA 2017 Jul 18; 318:245
High-Dose Vitamin D3 Not Preventive Against Viral Upper Respiratory Infection During Winter
Young children given 2000 IU vitamin D3 daily did not have fewer infections or longer time to first infection compared with those given 400 IU daily.
Low levels of serum vitamin D are suggested to be associated with increased risk for viral upper respiratory infection (vURI). In a five-year trial, researchers assessed wintertime vURI incidence in approximately 700 young children aged 1 to 5 years (mean age, 2.7 years) randomized to receive high-dose vitamin D3 (2000 IU/d) or standard-dose vitamin D3 (2000 IU/d) from enrollment (September–November) to follow-up (March–April). Participants were recruited from eight pediatric and family medicine practices in Toronto, Canada. Outcomes were assessed through obtaining parent symptom reports and parent-conducted viral nasal swabs when children were symptomatic. Results were as follows:

COMMENT: There is no justification for prescribing high-dose vitamin D3 for young children in order to prevent viral upper respiratory infections. However, pediatricians should ensure that their patients do receive the recommended daily intake of vitamin D for many health reasons.
CITATION(S): Aglipay M et al. Effect of high-dose vs standard-dose wintertime vitamin D supplementation on viral upper respiratory tract infections in young healthy children. JAMA 2017 Jul 18; 318:245.
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Proc Natl Acad Sci U S A 2017 Jul 25; 114:8119
Intranasal Oxytocin Improves Social Function in Kids with Autism
Children whose social behavior improved significantly during active or placebo treatment showed escalations in oxytocin levels.
In animal models of autism spectrum disorder (ASD), trials generally have shown that oxytocin improves social behavior. However, results have been mixed in human trials of exogenous oxytocin administration. Investigators speculated that endogenous oxytocin levels, which are low in many (but not all) ASD patients; might explain the mixed results.
Researchers at Stanford conducted a randomized, double-blind trial in 32 children (age range, 6–12 years) with ASD. Pretreatment endogenous blood level of oxytocin was measured in each child. Daily intranasal oxytocin or placebo was administered for 4 weeks. When results were analyzed without reference to pretreatment oxytocin levels, improvement in social behaviors with treatment fell just short of statistical significance (P=0.06). However, when pretreatment levels were included in the analysis, social behavior of oxytocin-treated children was superior (P=0.02) ― particularly in kids with the lowest pretreatment levels. Moreover, children whose social behavior improved significantly during placebotreatment also showed escalations in endogenous levels of oxytocin.
COMMENT: This study shows that daily intranasal oxytocin improves social behavior in kids with ASD whose baseline endogenous blood oxytocin levels are low. Provocatively, it also suggests that the placebo response in ASD might involve a surge in endogenous production of oxytocin. Interestingly, although oxytocin treatment improved social functioning, it did not affect repetitive behaviors that also are seen in ASD patients. This study will encourage further evaluation of oxytocin treatment.
CITATION(S): Parker KJ et al. Intranasal oxytocin treatment for social deficits and biomarkers of response in children with autism. Proc Natl Acad Sci U S A 2017 Jul 25; 114:8119.

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Ann Surg 2017 Aug; 266:260
Is Nonobstetric Surgery Harmful During Pregnancy?
Risks are low for miscarriage, preterm birth, and cesarean delivery following non-OB surgery.
Although elective surgery during pregnancy is generally avoided, patients and providers may have concerns when the need for indicated, nonobstetric surgery arises during pregnancy. Counseling regarding the risks for adverse outcomes has been limited by older data, so National Health Service (NHS) investigators in England sought to evaluate such risk in a modern cohort.
Nonobstetric surgeries were performed in 0.7% of 6.4 million pregnancies identified in NHS hospitals from April 2001 through March 2012. The most common surgery types were abdominal (26%), dental (11%), nail/skin (10%), and orthopedic (10%). Surgeries were performed within a week of the end of pregnancy in fewer than 6% of cases. After adjustment for potential confounders, the number needed to harm (NNH) was 143 for miscarriage (i.e., 143 women would need to undergo nonobstetric surgery during pregnancy to cause 1 excess miscarriage), 287 for stillbirth, 31 for preterm birth, and 25 for cesarean delivery. Risks were higher in abdominal surgery in particular (e.g., NNH 20 for miscarriage).
COMMENT: Nonobstetric surgeries performed during pregnancy are generally safe. Of course, comparisons with what outcomes would have been if the underlying conditions remained untreated were not possible; it is likely that the indications for surgery themselves influence the likelihood of adverse outcomes. Although only miscarriages with hospitalization were recorded (and thus likely represent an underestimation of the overall miscarriage rate), I suggest that the message to patients and providers remains that pregnancy is not a contraindication to necessary surgery.
CITATION(S): Balinskaite V et al. The risk of adverse pregnancy outcomes following nonobstetric surgery during pregnancy: Estimates from a retrospective cohort study of 6.5 million pregnancies. Ann Surg 2017 Aug; 266:260. (http://dx.doi.org/10.1097/SLA.0000000000001976)
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BMJ 2017 Jul 26; 358:j3262
E-Cigarette Use and Smoking Cessation in the U.S.
Smokers who used electronic cigarettes were more likely to try to quit smoking and to succeed.
Electronic cigarette (e-cigarette) use has increased dramatically in the U.S. since 2010. To determine whether this increase is associated with smoking cessation at the population level, researchers examined data from five nationally representative surveys of tobacco use in the U.S. conducted between 2001 and 2015.
Key findings included the following:

COMMENT: In this population-based study, e-cigarette use among current smokers was associated with significantly higher rates of attempts to quit smoking and of successful smoking cessation. Although this study doesn't prove a causal relation between greater e-cigarette use and less smoking, an editorialist believes that the findings “support a liberal approach to e-cigarette regulation.”
CITATION(S): Zhu S-H et al. E-cigarette use and associated changes in population smoking cessation: Evidence from US current population surveys. BMJ 2017 Jul 26; 358:j3262.
Abstract/FREE Full Text
Bullen C.Rise in e-cigarette use linked to increase in smoking cessation rates: New evidence supports a liberal approach to e-cigarette regulation. BMJ 2017 Jul 26; 358:j3506. (http://dx.doi.org/10.1136/bmj.j3506)

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Lancet 2017 Jul 26
After Bisphosphonate Use, Which Bone-Forming Medication Is Best?
An experimental monoclonal antibody, but not the FDA-approved teriparatide, increased bone-mineral density in former users of bisphosphonates.
Although bisphosphonates, the commonly prescribed antiresorptive agents, represent mainstream therapy for osteoporosis, some patients develop fractures during long-term treatment or cannot tolerate this class of medications. For these patients, clinicians often prescribe the bone-forming agent teriparatide (Forteo). However, teriparatide's ability to increase bone-mineral density (BMD) appears to be attenuated in former users of antiresorptive agents. In an industry-funded trial, investigators compared teriparatide with romosozumab, a non-FDA-approved monoclonal antibody that binds to and inhibits sclerostin (the negative regulator of bone formation) and thus inhibits bone resorption and stimulates bone formation.
In a 12-month, phase IIIB, open-label trial, 436 women with postmenopausal osteoporosis and histories of fracture who had used an oral bisphosphonate for ≥3 years before screening were randomized to subcutaneous teriparatide (20 µg daily) or subcutaneous romosozumab (210 mg monthly). At 12 months, both total hip BMD and estimated hip strength significantly increased with romosozumab but declined with teriparatide. Of the serious adverse events reported, none were believed by the investigators to have been caused by the study medications.
COMMENT: In a previous 1-year study, romosozumab increased BMD and bone formation and decreased bone resorption in menopausal women with low bone mass (NEJM JW Womens Health Feb 2014 and N Engl J Med 2014; 370:412). Editorialists speculate that the disparate effects of romosozumab and teriparatide in former bisphosphonate users might reflect differing mechanisms of action. Serious adverse cardiovascular events associated with romosozumab in another trial have delayed its regulatory approval. The current findings suggest that this monoclonal antibody, if approved, might have advantages over teriparatide in patients with osteoporosis who have used bisphosphonates previously.
CITATION(S): Langdahl BL et al. Romosozumab (sclerostin monoclonal antibody) versus teriparatide in postmenopausal women with osteoporosis transitioning from oral bisphosphonate therapy: A randomised, open-label, phase 3 trial. Lancet 2017 Jul 26; [e-pub].
Compston J et al. Bone-forming agents in non-responders to bisphosphonates. Lancet 2017 Jul 26; [e-pub].
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Obstet Gynecol 2017 Aug; 130:486
New ACOG Guidelines on Teen Contraception
Recommendation: Subdermal implants and intrauterine contraception should be routinely offered to teens.
Sponsoring Organization: American College of Obstetricians and Gynecologists (ACOG)
Target Audience: Obstetricians/gynecologists and other clinicians who counsel adolescent patients
Three quarters of adolescent pregnancies in the U.S. are unintended. Preventing undesired pregnancy requires effective contraceptive counseling and timely access to contraceptive services. To facilitate this, the ACOG Committee on Adolescent Health Care has identified five clinical best practices.
Key Points

COMMENT: Although this committee opinion addresses obstetrician-gynecologists, the guidance is relevant to all clinicians caring for teens, including pediatricians, family physicians, advanced practice nurses, and physician assistants. While great progress has been made in recent years (NEJM JW Womens Health Oct 2016 and J Adolesc Health 2016; 59:577), continued efforts to provide teens with high-quality contraceptive care are needed, in light of low rates of long-acting contraceptive use among teens who use contraception and shrinking access to safe, legal abortion in the U.S.
CITATION(S): American College of Obstetricians and Gynecologists Committee on Adolescent Health Care.Counseling adolescents about contraception. Committee opinion no. 710. Obstet Gynecol 2017 Aug; 130:486.

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