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THE JOURNAL OF PEDIATRICS

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Vol. 157, No. 1 Setting Six centers of the Glaser Pediatric Research Network, from October 2003 to August 2007. Participants Obese (BMI $ 95th percentile) adolescents (aged 13-18 years) were randomly assigned to the intervention (n=39) or placebo groups. Intervention Following a 1-month run-in period, subjects following a lifestyle intervention program were randomized 1:1 to 48 weeks treatment with metformin XR, 2000mg once daily, or an identical placebo. Subjects were monitored for an additional 48 weeks. Outcomes Change in BMI, adjusted for site, sex, race, ethnicity, and age and metformin vs placebo. Main Results After 48 weeks, mean (SE) adjusted BMI increased 0.2 (0.5) in the placebo group and decreased 0.9 (0.5) in the metformin XR group (P=.03). This difference persisted for 12 to 24 weeks after cessation of treatment. No signicant effects of metformin on body composition, abdominal fat, or insulin indices were observed. Conclusions Metformin XR caused a small but statistically signicant decrease in BMI when added to a lifestyle intervention program. Commentary This study makes an important contribution to the evidence on adolescent obesity management because it reports on long-term outcomes of metformin treatment, which has previously been studied only in trials of <6 months duration. Given the value of long-term weight maintenance over short-term reduction, the authors surprisingly underplay the results at week 100 (a primary outcome specied in the trial protocol), by which time the early benecial effect of metformin on BMI disappears completely. Metformin may have a role in obesity management when used as an adjunct to effective lifestyle interventions, but this is difcult to establish from this study due to a relative lack of effect in the placebo arm treated with lifestyle intervention alone. More selective use of metformin may be appropriate in practice, for which studies that can identify groups of young people most likely to benet from metformin therapy are needed. Large sample sizes will be necessary, as even in this highly motivated sample of adolescents, only a small proportion were available at nal follow-up, raising the possibility of bias in results. Min Hae Park, MSc Sanjay Kinra, MBBS, MD, MRCP, MSc, PhD, FFPHM London School of Hygiene and Tropical Medicine London, United Kingdom

Conclusions Topical steroids are unlikely to be an effective treatment for otitis media with effusion in general practice. High rates of natural resolution occurred by 1-3 months. Commentary The best approach for otitis media with effusion in primary care is active observation. The effusion often resolves spontaneously within three months. Several treatment options have been studied in the past for this period of active observation. Antibiotics have shown only very little effect and are not recommended. Another option is the use of intranasal corticosteroids, which relieve a range of allergic inammatory symptoms. Current evidence on the effects of steroids on otitis media with effusion is conicting.1,2 Williamson et al show that treatment with topical nasal steroids is ineffective in primary care. The resolution rate of about 50% in both groups is high, so it could be argued that only the less severe cases were included. However, the rates are consistent with other studies performed in primary care.3 Furthermore, the authors show that the severity of disease was comparable with that seen in studies in secondary care. Again, it has been shown that the natural course of otitis media with effusion is favorable, and the use of intranasal corticosteroids have no effect on this course. As clinicians we should bear in mind that the resolution of the effusion should not be our rst goal, but the amount of hearing loss. Also, when effusion persists, the hearing level should be the main indication for further surgical treatment. Roger A.M.J. Damoiseaux, PhD, general practitioner Institution General Practice de Hof van Blom Hattem, Netherlands

References
1. Thomas CL, Simpson S, Butler C, van der Voort J. Oral or topical nasal steroids for hearing loss associated with otitis media with effusion in children. Cochrane Database Syst Rev 2006;(3):CD001935. 2. Cengel S, Akyol MU. The role of topical nasal steroids in the treatment of children with otitis media with effusion and/or adenoid hypertrophy. Int J Pediatr Otorhinolaryngol 2006;70:639-45. 3. Van Balen FAM, de Melker RA, Touw-Otten FW. Double-blind randomised trial of co-amoxiclav versus placebo for persistent otitis media with effusion in general practice. Lancet 1996;348:713-6.

Metformin treatment for adolescent obesity has limited long-term benets


Glaser Pediatric Research Network Obesity Study Group. Metformin extended release treatment of adolescent obesity: A 48-week randomized, double-blind, placebo-controlled trial with 48-week follow-up. Arch Pediatr Adolesc Med 2010;164:116-23. Question Among obese adolescents, does metformin extended release (XR) plus lifestyle intervention reduce body mass index (BMI) more than lifestyle intervention alone? Design Multicenter, randomized, double-blind, placebocontrolled clinical trial.
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Abstinence-only education modestly delays initiation of sexual activity


Jemmott JB, III, Jemmott LS, Fong GT. Efcacy of a theorybased abstinence-only intervention over 24 months: A randomized controlled trial with young adolescents. Arch Pediatr Adolesc Med 2010;164:152-9.

July 2010 Question In young adolescents, how efcacious is an abstinence-only intervention in preventing sexual involvement? Design Randomized controlled trial. Setting Four urban public middle schools in the northeastern US. Participants Six hundred sixty-two African American students in grades 6 and 7. Interventions An 8-hour abstinence-only intervention targeted reduced sexual intercourse; an 8-hour safer sexonly intervention targeted increased condom use; 8-hour and 12-hour comprehensive interventions targeted sexual intercourse and condom use; and an 8-hour health-promotion control intervention targeted health issues unrelated to sexual behavior. Participants also were randomized to receive or not receive an intervention maintenance program to extend intervention efcacy. Outcomes The primary outcome was self-report of ever having sexual intercourse by the 24-month follow-up. Secondary outcomes were other sexual behaviors. Main Results The participants mean age was 12.2 years; 53.5% were girls; and 84.4% were still enrolled at 24 months. Abstinence-only intervention reduced sexual initiation (risk ratio [RR], 0.67; 95% condence interval [CI], 0.48- 0.96). The model-estimated probability of ever having sexual intercourse by the 24-month follow-up was 33.5% in the abstinence-only intervention and 48.5% in the control group. Fewer abstinence-only intervention participants (20.6%) than control participants (29.0%) reported having coitus in the previous 3 months during the follow-up period (RR, 0.94; 95% CI, 0.90-0.99, Number Needed to Treat = 12). Abstinence-only intervention did not affect condom use. The 8-hour (RR, 0.96; 95% CI, 0.92-1.00) and 12-hour comprehensive (RR, 0.95; 95% CI, 0.91-0.99) interventions reduced reports of having multiple partners compared with

CURRENT BEST EVIDENCE


the control group. No other differences between interventions and controls were signicant. Conclusions Theory-based abstinence-only interventions may have an important role in preventing adolescent sexual involvement. Commentary This is a well-designed study targeting highrisk middle school youth with excellent long-term followup. Very few studies have compared abstinence-only education to other forms of education in a randomized control study. This study had multiple intervention groups (abstinence-only education, two different groups of comprehensive sex education, safer sex education, and the control was healthonly education) and very little difference in age of sexual initiation was found amongst all of the groups studied. It should also be noted that statistically signicant results in this study were very close to not being signicant, sometimes within a tenth of a point. This may have been secondary to the intervention not being effective or the sample size not being large enough to show signicance. Interestingly, this study was done with theory-based abstinence-only curriculum, which is not the typical curriculum that is taught in schools or churches. In one secondary outcome measure, half of the youth were also randomized to an interim maintenance group with several re-enforcement sessions; this group did not demonstrate difference in sexual initiation. Given that sexual initiation is an age-graded activity, results other than sexual initiation, such as knowledge, intentions, or interim sexual behaviors addressed in comprehensive classes may still be benecial to the youth as they get older and become sexually active. Sarah A. Rastogi, MD Megan Moreno, MD, MSEd, MPH University of Wisconsin American Family Childrens Hospital Madison, Wisconsin

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