THE JOURNAL OF PEDIATRICS � www.jpeds.com Vol. 157, No. 1

Conclusions Topical steroids are unlikely to be an effectivetreatment 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 effu-sion in primary care is active observation. The effusion oftenresolves spontaneously within three months. Several treat-ment options have been studied in the past for this periodof active observation. Antibiotics have shown only very littleeffect and are not recommended. Another option is the use ofintranasal corticosteroids, which relieve a range of allergic in-flammatory symptoms. Current evidence on the effects ofsteroids on otitis media with effusion is conflicting.1,2 Wil-liamson et al show that treatment with topical nasal steroidsis ineffective in primary care. The resolution rate of about50% in both groups is high, so it could be argued that onlythe less severe cases were included. However, the rates areconsistent with other studies performed in primary care.3

Furthermore, the authors show that the severity of diseasewas comparable with that seen in studies in secondary care.Again, it has been shown that the natural course of otitis me-dia with effusion is favorable, and the use of intranasal corti-costeroids have no effect on this course. As clinicians weshould bear in mind that the resolution of the effusion shouldnot be our first goal, but the amount of hearing loss. Also,when effusion persists, the hearing level should be the mainindication for further surgical treatment.

Roger A.M.J. Damoiseaux, PhD, general practitionerInstitution 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 chil-

dren. 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 rando-

mised 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 haslimited long-term benefitsGlaser Pediatric Research Network Obesity Study Group.Metformin extended release treatment of adolescent obesity:A 48-week randomized, double-blind, placebo-controlledtrial with 48-week follow-up. Arch Pediatr Adolesc Med2010;164:116-23.

Question Among obese adolescents, does metformin ex-tended release (XR) plus lifestyle intervention reduce bodymass index (BMI) more than lifestyle intervention alone?

Design Multicenter, randomized, double-blind, placebo-controlled clinical trial.

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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 interven-tion (n=39) or placebo groups.

Intervention Following a 1-month run-in period, subjectsfollowing a lifestyle intervention program were randomized1:1 to 48 weeks’ treatment with metformin XR, 2000mgonce daily, or an identical placebo. Subjects were monitoredfor an additional 48 weeks.

Outcomes Change in BMI, adjusted for site, sex, race, ethnic-ity, and age and metformin vs placebo.

Main Results After 48 weeks, mean (SE) adjusted BMI in-creased 0.2 (0.5) in the placebo group and decreased 0.9(0.5) in the metformin XR group (P=.03). This differencepersisted for 12 to 24 weeks after cessation of treatment.No significant effects of metformin on body composition, ab-dominal fat, or insulin indices were observed.

Conclusions Metformin XR caused a small but statisticallysignificant decrease in BMI when added to a lifestyle inter-vention program.

Commentary This study makes an important contributionto the evidence on adolescent obesity management becauseit reports on long-term outcomes of metformin treatment,which has previously been studied only in trials of <6 monthsduration. Given the value of long-term weight maintenanceover short-term reduction, the authors surprisingly under-play the results at week 100 (a primary outcome specifiedin the trial protocol), by which time the early beneficial effectof metformin on BMI disappears completely. Metforminmay have a role in obesity management when used as an ad-junct to effective lifestyle interventions, but this is difficult toestablish from this study due to a relative lack of effect in theplacebo arm treated with lifestyle intervention alone. Moreselective use of metformin may be appropriate in practice,for which studies that can identify groups of young peoplemost likely to benefit from metformin therapy are needed.Large sample sizes will be necessary, as even in this highlymotivated sample of adolescents, only a small proportionwere available at final follow-up, raising the possibility ofbias in results.

Min Hae Park, MScSanjay Kinra, MBBS, MD, MRCP, MSc, PhD, FFPHM

London School of Hygiene and Tropical MedicineLondon, United Kingdom

Abstinence-only education modestly delaysinitiation of sexual activityJemmott JB, III, Jemmott LS, Fong GT. Efficacy of a theory-based abstinence-only intervention over 24 months: A ran-domized controlled trial with young adolescents. Arch Pe-diatr Adolesc Med 2010;164:152-9.