Bone accretion in adolescents using the combined estrogen and progestin transdermal contraceptive method Ortho Evra: a pilot study.

OBJECTIVE: To date, there are no data regarding the effect of the transdermal combined estrogen and progestin contraceptive Ortho Evra on bone mineral content (BMC) and bone mineral density (BMD). We examined the effects of transdermally delivered ethinyl estradiol and norelgestromin on whole body (WB) BMC and BMD of the hip and lumbar spine (LS) of adolescent girls. METHODS: In a matched case-control study, girls (n = 5) who applied Ortho Evra for days 1-21 followed by days 22-28 free of medication for 13 cycles (about 12 months) were compared with 5 age- and ethnicity-matched control girls. Evaluations of calcium intake; bone-protective physical activity; bone densitometry (DXA, QDR 4500A, Hologic); bone formation markers serum osteocalcin (OC) and bone-specific alkaline phosphatase (BAP); bone resorption marker urinary N-telopeptide (uNTX); insulin growth factor-1 (IGF-1); and sex hormone binding globulin (SHBG) were carried out at initiation, 6 months, and 12 months. Changes from baseline were compared using mixed models, adjusting for follow-up comparisons using the Holm Test (sequential Bonferroni). RESULTS: There were no significant differences (SD) between groups at baseline in age, gynecologic age, WBBMC, hip BMD, and LSBMD. Girls on Ortho Evra did not change significantly in WBBMC (12-month mean increase 0.2% +/- 0.8%), whereas controls did (3.9% +/- 1.8%, P < or = .001, adjusted P = .002), with SD between the 2 groups (P = .007, adjusted P = .036). Adolescents on Ortho Evra did not change significantly in hip BMD (12-month mean increase 0.5% +/- 0.6%), whereas controls did (2.7% +/- 0.6%, P < or = .001, adjusted P = .004), with SD between the 2 groups (P = .024) prior to adjustment for multiple comparisons, but no SD after adjustment (P = .096). Similarly, although the increase in LSBMD within the control group after 12 months (mean increase 2.8% +/- 1.0%) was statistically significant (P = .009, adjusted P = .044), the change within the treatment group (12-month mean increase 0.8% +/- 0.8%) was not. However, percent LSBMD changes after 12 months did not significantly differ between the 2 groups before or after adjustment for multiple comparisons. Calcium intake and bone-protective physical activity did not significantly predict BMC and BMD changes of study participants. There was a significantly greater increase in SHBG levels in the treatment group after 6 months (P = .003, adjusted P = .013) and 12 months (P < or = .001, adjusted P < or = .001) than in controls. Changes in levels of OC, BAP, uNTX, and IGF-1 were not significantly different between the 2 groups. CONCLUSIONS: Ortho Evra use attenuates bone mass acquisition in young women who are still undergoing skeletal maturation. This attenuation may be attributed in part to increased SHBG levels, which reduce the concentrations of free estradiol and free testosterone that are available to interact with receptors on the bone. Clinical implications remain to be determined in studies with a larger number of adolescents.

Isolated low HDL cholesterol emerges as the most common lipid abnormality among obese adolescents.

A 12-hour fasting lipid profile was obtained from 88 otherwise healthy obese (BMI > or = 95%) adolescents (age 16 +/- 1 years, BMI 36 +/- 1 kg/m(2), 55 males, 33 females, 57% Hispanic, 23% African American, 19% Caucasian, 1% Asian American). About 56% of the obese adolescents exhibited lipid abnormalities based on cutoff points established by American Heart Association (AHA) guidelines, and about 57% exhibited lipid abnormalities based on percentile values established by the Lipid Research Clinic Pediatric Prevalence Study. Isolated low high-density lipoprotein-cholesterol (HDL-C) was the most common abnormality (43% based on AHA, 36% based on the Lipid Research Clinic Pediatric Prevalence Study) among the obese adolescents with lipid disorders. While there was no significant statistical difference (SSD) between genders in the levels of total cholesterol and low-density lipoprotein-cholesterol (LDL-C), triglyceride (TG) levels were significantly higher (P = .003) in males (120 +/- 11 mg/dL) than in females (81 +/- 7 mg/dL), and levels of HDL-C were significantly higher (P = .006) in females (42 +/- 2 mg/dL) than in males (35 +/- 1 mg/dL). There was no SSD between races in total cholesterol and LDL-C levels. TG levels were significantly lower in African-American participants (81 +/- 9 mg/ dL) compared with levels in Caucasian participants (117 +/- 15 mg/dL, P

Adolescents' experience with the combined estrogen and progestin transdermal contraceptive method Ortho Evra.

BACKGROUND: The new combined estrogen & progestin contraceptive patch Ortho Evra was approved by the FDA in December 2001. To date, there is a paucity of data regarding its use in the adolescent age group. We examined adolescents' experience with this new contraceptive method. METHODS: Using a questionnaire designed by the authors, care providers in a hospital based adolescent clinic interviewed and reviewed the charts of adolescent girls who had initiated Ortho Evra in 2002-2003. RESULTS: Twenty-eight adolescent girls (age 18 +/- 1 years, gyn age 6 +/- 1 years, onset of sexual intercourse at 14 +/- 1 years, body mass index (BMI) 27.6 +/- 1.2, 57% Hispanic, 21% Caucasian, 11% African American, 7% biracial, 4% Indian American) who had used Ortho Evra for 7 +/- 1 months were enrolled. Half (50%) were adolescent mothers, and 57% had a history of irregular menstrual periods. All (100%) girls reported regular menstrual periods while using Ortho Evra, with only 14% experiencing occasional breakthrough bleeding. Half reported a shorter duration and 36% reported a lighter flow of their periods. About a third (39%) reported a decrease and 11% reported an increase in dysmenorrhea symptoms. About a third (29%) of those with a history of recurrent headaches at initiation reported decrease in headaches, and about a third (33%) of those with acne at initiation reported decrease in facial acne while on Ortho Evra. There were no significant BMI changes during Ortho Evra use. Although condom use while on Ortho Evra was poor (only 15% reporting consistent condom use), there were no pregnancies reported. A majority (93%) reported that they remembered to apply the patches on time, and 40% stated that Ortho Evra was easier than previous contraceptive methods. Two thirds (68%) were very satisfied and 29% were somewhat satisfied with the method, and 93% stated that they would recommend the method to a friend/relative. The preferred application site was the buttock (40%) followed by the lower abdomen (32%). About a fifth (21%) experienced at least one episode of complete patch detachment and 32% reported partial peeling of the patch corners. About a third (32%) would prefer another patch color, and 25% would like a fourth week placebo patch. The most common side effects were mild temporary application site reactions (64%), some discomfort on patch removal (32%), nausea (18%), and breast tenderness (18%). Eleven girls (39%) discontinued Ortho Evra (three lost health insurance, three because of application site reactions, two found patch application schedule difficult to remember, two desired pregnancy, two because of nausea, one because of perceived weight gain). CONCLUSIONS: Ortho Evra provides excellent cycle control in adolescents. Most adolescents are satisfied with this method. Intensive efforts should be made to increase condom use by adolescents on Ortho Evra.

A session of multiple choice questions in the orientation process to the adolescent medicine rotation.

BACKGROUND: Although adolescent health care training curricula for resident physicians have been developed during the past 2 decades, little is known about the orientation process to the adolescent medicine rotation. DESCRIPTION: Since 1996, we have incorporated a session consisting of 40 multiple-choice questions (MCQ) in the orientation process to our hospital-based adolescent medicine rotation. In this study, we evaluated residents' opinions about the MCQ format. EVALUATION: An anonymous questionnaire was distributed in 2002 to 123 resident physicians who had gone through an adolescent medicine rotation between 1996 and 2002. A total of 68 physicians responded (55% response rate). Almost all respondents (99%) stated that the MCQ session was a good format to use during orientation to adolescent medicine. Most (85%) said that it previewed issues that they had to face during the rotation, 74% said that it allowed them to think about issues in adolescent medicine, and 65% said that it directed them to subjects they needed to read about for this rotation. About 45% of respondents stated that the MCQ session increased their level of comfort with seeing adolescent patients on the first few days of the rotation. The majority of respondents (71%) stated that an attending needed to personally review the answers with the residents. Of these, all said that the attending could expand and explore the issues, and 71% said that the attending could show locations and use of certain instruments (orchidometer, scoliometer, etc.) related to questions. Almost a fifth (18%) preferred to receive a printed answer sheet that they could review privately. Of these, 58% feared that review with an attending might prejudice the attending against them if they had errors, and 25% stated that it would be too stressful for them to have the attending check their answers on the 1st day of the rotation. Most respondents (87%) recommended that the MCQ format be used as part of the orientation process to other rotations as well. CONCLUSIONS: Resident physicians viewed the MCQ session as a good format to use in the orientation process to the adolescent medicine rotation. A review of the answers with an attending was preferred over receiving a printed answer sheet.

The use of the leukotriene receptor antagonist montelukast (Singulair) in the management of dysmenorrhea in adolescents.

PURPOSE: Previous studies have shown an increase in leukotrienes in the uterine tissue as well as in the menstrual flow of adult women with dysmenorrhea. An increase in leukotriene-E4, the major urinary leukotriene, was also reported in adolescent girls with dysmenorrhea, further suggesting a possible involvement of these potent vasoconstrictors and inflammatory mediators in generating dysmenorrhea symptoms. In the present study we examined whether blocking leukotrienes might alleviate symptoms of dysmenorrhea in adolescents. METHODS: Twenty-five adolescents (age 16 +/- 1 years, 4 +/- 1 years post menarche, body mass index 23 +/- 1) with dysmenorrhea participated in a randomized, double blind, crossover study. Thirteen girls received one tablet of montelukast (Singulair, Merck, West Point, PA) 10 mg daily starting on day 21 of the cycle until the last day of the menstrual period for two menstrual cycles, followed by one tablet of placebo (Merck, West Point, PA) daily starting on day 21 of the cycle until the last day of the menstrual period for two additional menstrual cycles. The other 12 girls had a reverse schedule starting with placebo. Participants were instructed to use one or two 200-mg tablets of ibuprofen every 6 h in the event of continuing menstrual symptoms. The Cox Menstrual Symptom Scale was used to assess response to treatment. An intent-to-treat approach was used for data analysis. RESULTS: Twenty-two girls completed the study. Two girls were noncompliant with the study protocol, and one was withdrawn because of Helicobacter pylori infection. Compared with Cox menstrual score (mean +/- SE) before study (46 +/- 6), there was no significant change in menstrual symptoms during treatment with placebo (Cox score 42 +/- 7) or during treatment with montelukast (Cox score 39 +/- 7), and there was no significant difference between montelukast and placebo treatments as well. Likewise, there was no significant difference between the amount of ibuprofen tablets consumed during the menstrual periods before study (4 +/- 1), while on placebo (3 +/- 1), and while on montelukast (4 +/- 1). CONCLUSIONS: This study does not support the use of montelukast, in the current FDA-approved dose (for asthma) and commencing immediately before the menstrual period, for treatment of dysmenorrhea. It remains to be determined in further studies whether a higher dose or a prolonged daily use of montelukast may alleviate symptoms of dysmenorrhea in adolescents.

Supplementation with vitamin C and/or vitamin B(6) in the prevention of Depo-Provera side effects in adolescents.

BACKGROUND/OBJECTIVES: Depo-Provera-induced menstrual irregularity is believed to be secondary to relative estrogen deficiency. Weight gain associated with this contraceptive method is believed to be due to Depo-Provera's steroid-like appetite stimulation effect and to an altered tryptophan metabolism. We examined whether vitamin C, an important factor in uterine estrogen binding, and vitamin B(6), a glucocorticoid antagonist and an important coenzyme in the tryptophan-serotonin pathway, might alleviate menstrual irregularities and weight gain associated with Depo-Provera. METHODS: Fifty-five adolescent girls (age 16 +/- 1 yr, gyn age 4 +/- 1 yr, body mass index 25.2 +/- 0.9) who decided to initiate Depo-Provera (150 mg intramuscularly every 3 months) were randomly assigned to one of four groups (group 1: vitamin B(6) 50 mg plus placebo pill/day; group 2: vitamin C 500 mg plus placebo pill/day; group 3: vitamin B(6) 50 mg plus vitamin C 500 mg/day; group 4 (control): 2 placebo pills/day) for 6 months. Participants were assessed by their care providers every 3 months. SETTING: Two urban hospital-based adolescent clinics. RESULTS: Number of days of bleeding during the first interval (first 3 months) as well as during the second interval (months 4-6) among groups 1, 2, and 3 did not differ statistically from days of bleeding in control group. There were no significant body mass index (BMI) changes among groups 1-3 (-0.15 +/- 0.18, 0.34 +/- 0.56, 0.01 +/- 0.31) compared with control (-0.38 +/- 0.38) during the first interval as well as during the second interval (0.68 +/- 0.37, -0.39 +/- 0.21, 0.45 +/- 0.32, compared with 0.28 +/- 0.43). When data from all 55 participants were collapsed, there was no significant change in BMI during the first 6 months of Depo-Provera use. About 48% at 3 months and 44% at 6 months were very or somewhat concerned about menstrual irregularity; 41% at 3 months and 18% at 6 months were very or somewhat concerned about weight changes. More than half (57%) at 3 months and 74% at 6 months reported less tampon/pad use, and 77% at 3 months and 78% at 6 months reported decreased menstrual cramps. Overall, 59% at 3 months and 70% at 6 months were very satisfied with Depo-Provera; 97% at 3 months and 96% at 6 months said that they would recommend Depo-Provera to a friend or a relative. CONCLUSIONS: This study does not support a role for vitamin C in the prevention of Depo-Provera-induced menstrual irregularities or for vitamin B(6) in the prevention of weight changes associated with Depo-Provera. The unchanged BMI during the first 6 months of Depo-Provera use in the present study suggests that raising awareness and close follow-up may prevent weight gain among adolescent girls using this contraceptive method.

Supplementation with omega-3 polyunsaturated fatty acids in the management of recurrent migraines in adolescents.

PURPOSE: To examine whether dietary supplementation with fish oil rich in very long-chain n-3 polyunsaturated fatty acids might reduce frequency and severity of migraines in adolescents. METHODS: Twenty-seven adolescents suffering from frequent migraines for at least 1 year (mean 4 +/- 1 years since migraine onset) participated in a randomized, double-blind, cross-over study consisting of 2 months of fish oil, 1-month washout period, and 2 months of placebo (olive oil). Participants self-assessed severity and duration of headache episodes (7-point faces and 10-point visual analog pain scales, 5-point frequency and severity rating scale) throughout the study. At the end of every 2-month treatment period, participants rated the effectiveness of treatment on a 7-point Likert scale (1,"not effective, not worthwhile"; 4,"moderately effective, moderately worthwhile"; 7, "totally effective, totally worthwhile"). A score of > or = 4 on the Likert scale was considered as improvement. RESULTS: Twenty-three adolescents (16 girls, 7 boys, 18 Whites, 3 Hispanics, 1 African-American, 1 Cape Verdean, mean age 15 +/- 1 years) completed the study. Compared with frequency of headaches before the study (31 +/- 4 episodes/2 months), there was a significant (p <.0001) reduction in headache frequency during fish oil treatment (4 +/- 1 episodes/2 months) and during placebo (olive oil) treatment (4 +/- 1 episodes/2 months) but no significant (NS) difference between treatments. Likewise, self-assessment on a 7-point faces pain scale revealed a significant reduction in headache severity during fish oil treatment (2.9 +/- 0.5, p =.01) and during placebo (olive oil) treatment (3.5 +/- 0.4,