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Equivalent Mifepristone-Misoprostol Regimens for Abortion
INFOPOEMS
Not Much Seems to Prevent Renal Disease in Children with HenochSchönlein Purpura Clinical Question What interventions are effective in preventing renal disease in children with Henoch-Schönlein purpura (HSP)? Bottom Line No interventions to date appear effective in preventing renal disease in children with HSP. (LOE = 1a-) Study Design Systematic review Funding Unknown/not stated Setting Various (meta-analysis) Synopsis These authors searched several databases to find randomized controlled trials of various interventions to prevent kidney disease in children with HSP. They also used a clinical trial registry to assist in locating unpublished data. Two authors independently assessed study eligibility, data extraction, and study quality, and any discrepancies were resolved by consensus. Based on the reporting of the included trials, the overall methodologic quality was poor. The authors identified 11 trials (2 of the trials were reported in a single paper) with more than 1200 children with HSP. Five trials evaluated prednisone, 4 evaluated antiplatelet agents or heparin. One trial compared cyclophosphamide with no treatment and 1 compared cyclosporin with methylprednisolone. The pooled rate of developing renal complications was similar in the prednisone groups and in the control groups at 1, 3, 6, and 12 months. Because of the small number of remaining studies and the heterogeneity in treatments, the
authors performed no further pooling of results. Of all the individual studies only 1 published in abstract form—raising concerns about quality and replication—showed the treatments to be more effective than no treatment.
Reference
Chartapisak W, Opastiraku S, Willis NS, Craig JC, Hodson EM. Prevention and treatment of renal disease in Henoch-Schönlein purpura: a systematic review. Arch Dis Child. 2009;94(2):132-137.
Equivalent MifepristoneMisoprostol Regimens for Abortion Clinical Question Are different medical regimens of mifepristone followed by misoprostol equivalent for medical abortion in early pregnancy? Bottom Line For termination of early pregnancy using a regimen of mifepristone followed by 800 µg of misoprostol, 200 mg of mifepristone is no more effective than 100 mg. Intervals of 24 and 48 hours between medications are also equally effective. (LOE = 1b) Study Design Randomized controlled trial (double-blinded) Funding Foundation Allocation Concealed Setting Outpatient (primary care) Synopsis This was a well-designed randomized controlled trial in multiple countries sponsored by the World Health Organization. It included 2181 women who sought termination of pregnancy up to and including 63 days of gestation. The women were randomized to 1 of 4 groups: 100 mg or 200 mg of oral
JOURNAL OF THE NATIONAL MEDICAL ASSOCIATION
mefipristone, followed by 800 µg of intravaginal misoprostol administered 24 or 48 hours later. Women were asked to keep a daily diary about bleeding and adverse effects until the 2-week follow-up visit. A total of 102 women had an undetermined outcome because of loss to follow-up or withdrawal from the study. Equivalence was considered to be within a 5% margin. Surgical evacuation was performed for cases of treatment failure. The treatments were found to be equivalent. The rate of complete abortion was 92.0% with 100 mg of mifepristone and 93.2% with the 200-mg dose. The 24-hour interval between medications resulted in 93.5% completed abortion compared with 91.7% for the 48-hour interval.
Reference
Von Hertzen H, Piaggio G, Wojdyla D, et al. Two mifepristone doses and two intevals of misoprostol administration for termination of early pregnancy: a randomised factorial controlled equivalence trial. BJOG. 2009;116(3):381-389.
Elbow Extension Test Rules Out Fracture Clinical Question Can the elbow extension test be used to rule out fracture in adults and children with an acute elbow injury? Bottom Line In a group of patients with acute elbow injury—31% were eventually found to have a fracture—the elbow extension test (described below) was effective in ruling out fracture without the need for radiography. But it was not as specific as it was sensitive; approximately half the patients who tested positive were fracture free. (LOE = 1b) Study Design Decision rule (validation) Funding Foundation
VOL. 101, NO. 5, MAY 2009 489
Not Much Seems to Prevent Renal Disease in Children with HenochSchönlein Purpura Clinical Question What interventions are effective in preventing renal disease in children with Henoch-Schönlein purpura (HSP)? Bottom Line No interventions to date appear effective in preventing renal disease in children with HSP. (LOE = 1a-) Study Design Systematic review Funding Unknown/not stated Setting Various (meta-analysis) Synopsis These authors searched several databases to find randomized controlled trials of various interventions to prevent kidney disease in children with HSP. They also used a clinical trial registry to assist in locating unpublished data. Two authors independently assessed study eligibility, data extraction, and study quality, and any discrepancies were resolved by consensus. Based on the reporting of the included trials, the overall methodologic quality was poor. The authors identified 11 trials (2 of the trials were reported in a single paper) with more than 1200 children with HSP. Five trials evaluated prednisone, 4 evaluated antiplatelet agents or heparin. One trial compared cyclophosphamide with no treatment and 1 compared cyclosporin with methylprednisolone. The pooled rate of developing renal complications was similar in the prednisone groups and in the control groups at 1, 3, 6, and 12 months. Because of the small number of remaining studies and the heterogeneity in treatments, the
authors performed no further pooling of results. Of all the individual studies only 1 published in abstract form—raising concerns about quality and replication—showed the treatments to be more effective than no treatment.
Reference
Chartapisak W, Opastiraku S, Willis NS, Craig JC, Hodson EM. Prevention and treatment of renal disease in Henoch-Schönlein purpura: a systematic review. Arch Dis Child. 2009;94(2):132-137.
Equivalent MifepristoneMisoprostol Regimens for Abortion Clinical Question Are different medical regimens of mifepristone followed by misoprostol equivalent for medical abortion in early pregnancy? Bottom Line For termination of early pregnancy using a regimen of mifepristone followed by 800 µg of misoprostol, 200 mg of mifepristone is no more effective than 100 mg. Intervals of 24 and 48 hours between medications are also equally effective. (LOE = 1b) Study Design Randomized controlled trial (double-blinded) Funding Foundation Allocation Concealed Setting Outpatient (primary care) Synopsis This was a well-designed randomized controlled trial in multiple countries sponsored by the World Health Organization. It included 2181 women who sought termination of pregnancy up to and including 63 days of gestation. The women were randomized to 1 of 4 groups: 100 mg or 200 mg of oral
JOURNAL OF THE NATIONAL MEDICAL ASSOCIATION
mefipristone, followed by 800 µg of intravaginal misoprostol administered 24 or 48 hours later. Women were asked to keep a daily diary about bleeding and adverse effects until the 2-week follow-up visit. A total of 102 women had an undetermined outcome because of loss to follow-up or withdrawal from the study. Equivalence was considered to be within a 5% margin. Surgical evacuation was performed for cases of treatment failure. The treatments were found to be equivalent. The rate of complete abortion was 92.0% with 100 mg of mifepristone and 93.2% with the 200-mg dose. The 24-hour interval between medications resulted in 93.5% completed abortion compared with 91.7% for the 48-hour interval.
Reference
Von Hertzen H, Piaggio G, Wojdyla D, et al. Two mifepristone doses and two intevals of misoprostol administration for termination of early pregnancy: a randomised factorial controlled equivalence trial. BJOG. 2009;116(3):381-389.
Elbow Extension Test Rules Out Fracture Clinical Question Can the elbow extension test be used to rule out fracture in adults and children with an acute elbow injury? Bottom Line In a group of patients with acute elbow injury—31% were eventually found to have a fracture—the elbow extension test (described below) was effective in ruling out fracture without the need for radiography. But it was not as specific as it was sensitive; approximately half the patients who tested positive were fracture free. (LOE = 1b) Study Design Decision rule (validation) Funding Foundation
VOL. 101, NO. 5, MAY 2009 489