In women with postmenopausal vaginal symptoms, is local estrogen treatment better than vaginal lubricant or placebo?
Time for a rethink the idea that vaginal atrophy due to diminished estrogen is the cause of vaginal symptoms associated with menopause. Vaginal estradiol (Vagifem) is no more effective than a nonprescription vaginal lubricant (Replens Long-Lasting Vaginal Moisturizer) or placebo lubricant in the treatment of women with painful intercourse, vaginal dryness, or other symptoms usually associated with menopause. (LOE = 1b)(www.essentialevidenceplus.com)
Mitchell CM, Reed SD, Diem S, et al. Efficacy of vaginal estradiol or vaginal moisturizer vs placebo for treating postmenopausal vulvovaginal symptoms. A randomized clinical trial. JAMA Intern Med 2018;178(5):681-690.
Study design: Randomized controlled trial (double-blinded)
Funding source: Government
Setting: Outpatient (any)
This study evaluated the effect of a vaginal estradiol 10 mcg, a nonprescription vaginal lubricant, and matching placebo tablet and lubricant in 302 postmenopausal women with moderate to severe symptoms of vulvovaginal itching, pain, dryness, irritation, or pain with penetration. Estradiol was used daily for 2 weeks, then twice weekly; vaginal moisturizer was used every 3 days for 12 weeks. Results were analyzed using a modified intention-to-treat analysis, including women who returned for evaluation at 1 month and 3 months after beginning treatment, regardless of their continued use of treatment, At the beginning of the study women were asked to identify their most bothersome symptom, which was pain with vaginal penetration (60%) or vaginal dryness (21%) for most women; the main outcome measured was the effect of treatment on this outcome. Treatment with estradiol, lubricant, or placebo produced similar results, decreasing the average score (on a scale of 0 to 3) from 2.4 ("moderate" severity) at the beginning of treatment to 1.0 ("mild"). Half the women in each group, including the placebo group, had a clinically significant drop in scores with treatment. Sexual function, as measured by the Female Sexual Function Index, improved in all groups, with nearly half the women in all groups improving from "frequently" or "always" distressed about their sex life to "rarely" or "never" distressed about their sex life.
Allen F. Shaughnessy, PharmD, MMedEd
Professor of Family Medicine
Do long-acting insulin analogs, such as glargine (Lantus) or detemir (Levemir), reduce the risk of clinically significant hypoglycemia compared with NPH insulin?
This study found that, compared with expensive long-acting insulin analogs costing 2 to 10 times as much, human neutral protamine Hagedorn (NPH) insulin results in a similar number, if not fewer, episodes of severe hypoglycemia that result in emergency department visits and hospitalizations. NPH insulin also improves glycemic control as well, if not better, than insulin analogs. In a previous report (Singh SR, et al. CMAJ 2009;180(4):385-96), overall quality of life was also similar with NPH insulin or insulin analogs. Compared with long-acting insulin analogs, NPH insulin is as Safe if not safer, equally Tolerated, equally or more Effective, and at a much lower Price (STEP). One in 4 adults with diabetes either stop or cut back significantly on their insulin because they can't afford it. (LOE = 2b-)(www.essentialevidenceplus.com)
Lipska KJ, Parker MM, Moffet HH, Huang ES, Karter AJ. Association of initiation of basal insulin analogs vs neutral protamine Hagedorn insulin with hypoglycemia-related emergency department visits or hospital admissions and with glycemic control in patients with type 2 diabetes. JAMA 2018;320(1):53-62.
Study design: Cohort (retrospective)
Marketing efforts have convinced most clinicians that long-acting insulin analogs, such as glargine and detemir, reduce the risk of hypoglycemia and are thus safer than traditional NPH insulin. These investigators analyzed data from 2006 and 2015 from multiple patient and prescription registries with the Kaiser Permanente of Northern California. Outcomes of interest included pharmacy use; laboratory results; and outpatient, emergency department, and hospitalization diagnoses of diabetes and related complications. The inception cohort consisted of 25,489 adults, 19 years or older, with type 2 diabetes who were initiating basal insulin therapy without any insulin prescription fills during the prior 12 months. Results were analyzed after controlling for multiple potential confounders, including demographics, index year, clinician specialty, comorbidity index, chronic kidney and/or liver disease, visual impairment, history of depression, glycemic control, history of severe hypoglycemia episodes requiring third-party intervention, and medication nonadherence. The risk of a subsequent severe hypoglycemic episode resulting in an emergency department visit or hospital admission was nonsignificantly lower in patients who initiated NPH insulin at baseline compared with those initiating insulin analogs (8.8 vs 11.9 events per 1000 person-years, respectively). In addition, glycemic control was significantly more improved in patients using NPH insulin versus insulin analogs (difference in HbA1C -0.22%; 95% CI -0.09% to -0.37%).
David C. Slawson, MD
Professor and Vice Chair of Family Medicine for Education and Scholarship
Professor of Family Medicine, UNC Chapel Hill
Which is the better oral pain reliever for children with postoperative pain: ibuprofen or morphine?
This carefully designed and adequately powered study found no difference in pain reduction between ibuproften and oral morphine in children with postoperative pain. Adverse effects, however, were much more likely with morphine. (LOE = 1b)(www.essentialevidenceplus.com)
Poonai N, Datoo N, Ali S, et al. Oral morphine versus ibuprofen administered at home for postoperative orthopedic pain in children: a randomized controlled trial. CMAJ 2017;189(40):E1252- E1258.
Study design: Randomized controlled trial (double-blinded)
Funding source: Foundation
Setting: Inpatient (any location) with outpatient follow-up
As concern increases about overly broad uses of opiates, it is good to see studies that evaluate their effectiveness in different populations. This study identified 154 children, aged 5 years to 17 years, who underwent an outpatient orthopedic surgical procedure (most commonly hardware removal, open reduction and internal fixation of a fracture, or arthroscopy). The patients were randomized to receive up to 8 doses, given 6 hours apart, of either 0.5 mg/kg morphine or 10 mg/kg ibuprofen. Pain was assessed by the patient immediately before and 30 minutes after each dose of medication using the well validated 10-point FACES scale; a difference of at least 1 point on this scale is considered to be clinically meaningful. Medication was given using a "double-dummy" design, so each patient simulataneously got one active medication and one placebo. Groups were similar at baseline and analysis was by intention to treat. Both medications reduced pain by approximately 1 point at each dose, with no difference between groups in efficacy. There was a significantly greater risk of adverse events in the morphine group, primarily nausea, vomiting, drowsiness, and dizziness (number needed to treat to harm for any adverse event = 3).
Mark H. Ebell, MD, MS
University of Georgia
Does the addition of oil to the bath decrease the symptoms of children with eczema?
Wow. According to a cited review in this paper, bath additives account for one-third of the costs of treating eczema in the United Kingdom. This study—conceived of and conducted by the James Lind Alliance, a group aimed at addressing uncertainties of routine clinical practice—found no improvement with the addition of oil to the bath of a child with eczema. (LOE = 1b)(www.essentialevidenceplus.com)
Santer M, Ridd MJ, Francis NA, et al. Emollient bath additives for the treatment of childhood eczema (BATHE): multicentre pragmatic parallel group randomised controlled trial of clinical and cost effectiveness. BMJ 2018;361:k1332.
Study design: Randomized controlled trial (nonblinded)
Setting: Outpatient (primary care)
The investigator enrolled 483 children between the ages of 1 year and 11 years with atopic dermatitis, recruited from 96 general practices in the United Kingdom. The children were randomized, using concealed allocation, to a usual care group or a group that, in addition to usual care, were instructed to add an oil-based emollient of their choice to their bath water. Oilatum was used by 45%, 26% used Aveeno bath oil, 4.5% used Balneum bath oil, and 30% used another type of bath product. Most (74%) carers reported using the bath oil at every bath. Interestingly, two-thirds of children in each group were bathed at least every other day (14% were bathed at least daily). Using the 7-question patient-oriented eczema measure (0 - 7: mild; 8 - 16: moderate; 17 - 28: severe), scores improved equally in both groups, from a baseline of 9.5 to 10.1 to an average weekly score of 7.5 to 8.4 over 16 weeks of treatment. Scores were minimally better (-2.27; a clinically important difference is at least 3 points) with bath oil for children who bathed 5 or more times a week.
POEMs are provided by Essential Evidence Plus, a point-of-care clinical decision support system published by Wiley-Blackwell. For more information, please see http://www.essentialevidenceplus.com(www.essentialevidenceplus.com).
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