Top POEMs of 2011: Miscellaneous

Steroid Inhalers Increase Fracture Risk in COPD

Clinical Question: Does the use of inhaled corticosteroids in typical doses increase the long-term risk of fracture?

Bottom Line: The use of inhaled corticosteroids as a treatment for chronic obstructive pulmonary disease (COPD) in older adults increases the fracture risk somewhat, with a number needed to treat to harm of 83 over 3 years. This must be balanced against a number needed to treat of 6 per year to prevent exacerbations. (Level of Evidence: 1a)

Reference: Loke YK, Cavallazzi R, Singh S. Risk of fractures with inhaled corticosteroids in COPD: systematic review and meta-analysis of randomized controlled trials and observational studies. Thorax 2011;66(8):699-708.

Study Design: Systematic Review

Funding Source: Government

Setting: Outpatient (any)

Synopsis: Previous studies have been mixed regarding the effect of inhaled corticosteroids like budesonide and fluticasone on bone density, and individual trials have been underpowered to look at the patient-oriented outcome of fractures. These authors did a careful search to identify all randomized trials and observational studies comparing a group of patients with COPD who received a corticosteroid with a group of similar patients who did not. This included placebo-controlled studies, and studies where both groups also received another drug, such as a long-acting beta agonist. The authors identified 16 randomized controlled trials (RCTs) with 17,513 patients, as well as 7 large cross-sectional or nested case-control studies with approximately 69,000 patients. The RCTs ranged from 24 weeks to 156 weeks in duration, with patient age means in the 60s. Allocation concealment and randomization methodology were adequate for approximately half the studies and unclear in the rest. A single large 3-year clinical trial with 3088 patients dominated the results, accounting for a majority of fractures. The relative risk for any fracture was 1.27 in the RCTs, with a 95% confidence interval from 1.01 to 1.58, and a number needed to treat to harm of 83 over 3 years. The observational studies found similar results (relative risk = 1.21 - 1.27, depending on the subgroup).

Associate Professor
University of Georgia
Athens, GA

One-Year Supply of Oral Contraceptives Associated with Less Pregnancy

Clinical Question: Is dispensing a 1-year supply of oral contraceptives associated with less risk of unintended pregnancy?

Bottom Line: Dispensing a 1-year supply of oral contraceptive pills (OCs) to low-income women receiving family planning services is associated with a significant reduction in unplanned pregnancies and abortions as compared with dispensing a 1-month or 3-month supply. (Level of Evidence: 2b)

Reference: Foster DG, Hulett D, Bradsberry M, Darney P, Policar M. Number of oral contraceptive pill packages dispensed and subsequent unintended pregnancies. Obstet Gynecol 2011;117(3):566-572.

Study Design: Cohort (retrospective)

Funding Source: Unknown/not stated

Setting: Population-based

Synopsis: The authors linked data from Medi-Cal registries regarding births and abortions with data from Family Planning, Access, Care and Treatment (PACT), a Medicaid family planning waiver program that provides contraceptives at no cost to women with incomes up to 200% of poverty level. Nearly all women who are eligible for PACT are also eligible for Medicaid in the event of pregnancy. Some PACT clinics are not bound by pharmacy regulations limiting the dispensing of Ocs to a maximum 100-day supply, and may instead dispense up to a 1-year supply. These authors compared pregnancy rates between women who received a 1-year supply (12 or 13 packs) of Ocs with the rates of those who received 1 or 3 packs at a time (N = 84,401women) . Databases were linked based on social security number when possible (46%); otherwise by name plus numerous demographic variables. Most women received 3 packs of Ocs (58%), 20% received 1 pack, 11% received a 1-year supply, and 10% received another quantity of Ocs. Women younger than 20 years were most likely to receive a 1-year supply and women 40 years and older and Spanish-speaking Latina women were the least likely to get a 1-year supply. Women who received a 1-year supply were less likely to have a pregnancy (1.2% vs 2.9% for women getting 1 pack and 3.3% for women getting 3 packs). Women who received a 1-year supply were also significantly less likely to have a Medicaid-funded induced abortion (0.18% vs 0.63% for women receiving 3 packs (P < .05%). Multivariate analysis concluded that dispensing a 1-year supply was associated with a 30% reduction in the odds of pregnancy in the subsequent year and a 46% reduction in the odds of having an induced abortion. The study is limited by its observational methodology. However, younger patients are typically less adherant.

Professor and Chair, Department of Family Medicine
University of Toledo
Toldeo, OH

Freezing = Acid for Plantar Warts

Clinical Question: Is freezing more effective than salicylic acid treatment of plantar warts?

Bottom Line: Cryotherapy with liquid nitrogen was no more effective than daily treatment with salicylic acid to remove plantar warts (verrucae) from patients aged at least 12 years. The success rates in both groups were low, with only approximately one third of patients experiencing total clearance. (Level of Evidence: 1b)

Reference: Cockayne S, Hewitt C, Hicks K, et al, on behalf of the EVerT Team. Cryotherapy versus salicylic acid for the treatment of plantar warts (verrucae): a randomised controlled trial. BMJ 2011;342:d3271.

Study Design: Randomized controlled trial (double-blinded)

Funding Source: Government

Allocation: Concealed

Setting: Outpatient (any)

Synopsis: This study compared repeat cryotherapy with daily salicylic acid keratolysis in the treatment of 240 patients aged at least 12 years who had at least one wart deemed suitable for treatment with either approach. The patients were assigned, using concealed allocation, to up to 4 cryotherapy treatments (average = 1.6) by a physician or to daily self-treatment with pumicing of dead skin followed by the application of 50% salicylic acid for up to 8 weeks. Although the investigators were expecting success rates to be in the 70% to 80% range, results in both groups were much lower: At 12 weeks, complete clearance occurred in 14% in both groups. At 6 months the difference was 31% vs 34%. In the United States, the maximum strength of nonprescription salicylic acid is 40%. Patient satisfaction scores were higher with cryotherapy.

Professor of Family Medicine
Tufts University
Boston, MA

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