Safety and efficacy of treatment with an ephedrine/caffeine mixture. The first double-blind placebo-controlled pilot study in adolescents
Molnár D, Török K, Erhardt E, Jeges S
International journal of obesity and related metabolic disorders : journal of the International Association for the Study of Obesity · 47 citas
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Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación no declarada
Publicación
- Publicado
- 2000-12-01 · Int J Obes Relat Metab Disord · vol. 24 · número 12 · págs. 1573–1578
- Editorial
- Springer Nature
- Citado
- 97 citas · más que el 96% de estudios similares · 5.2× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 11 trabajos
- Acceso
- De pago
- Áreas de investigación
- Pharmacology and Obesity Treatment · Coffee research and impacts · Obesity, Physical Activity, Diet
- Palabras clave
- adolescent obesity, weight loss, appetite suppressants, hypocaloric diet, body mass index, fat loss, drug safety, withdrawal symptoms, stimulant medication
- MeSH
- adipose tissue, humans, obesity, substance withdrawal syndrome, weight loss, ephedrine, caffeine, apolipoproteins b, placebos, double-blind method, body composition, energy intake, electric impedance, blood pressure, heart rate, adolescent, female, male
4 autores
- Dénes Molnár🇭🇺 · autor de correspondenciaUniversity of Pecs
- K Török🇭🇺University of Pecs
- Éva Erhardt🇭🇺University of Pecs
- Sára Jeges🇭🇺University of Pecs
Resumen
El texto original del estudio, en el idioma en que se publicó.
Objective
The present study was performed to investigate the efficacy and safety of a caffeine/ephedrine (CE) mixture in obese adolescents.
Subjects
Thirty-two (m/f = 16/16) obese children were included into the study. They were treated by diet (calculated daily energy requirement minus 500 kcal) and either CE or placebo (PL) for 20 weeks in a randomized double-blind placebo-controlled trial. Those weighing less than 80 kg took one tablet three times (100 mg/10 mg), whereas those weighing more than 80 kg took two tablets three times per day. There were three dropouts (girls) from the PL group. The age, weight body mass index (BMI) values (mean (range)) of the PL and CE groups were 16.0 (14.3-17.6) and 16.0 (14.2-17.7) y, 103.0 (77.2-126.4) and 104.8 (69.8-150.2) kg, 35.2 (28.3-42.3) and 36.5 (31.3-51.8) kg/m2, respectively.
Results
The decrease in relative body weight, BMI and body fat (measured by bioelectric impedance) was significantly (P < 0.05) greater in the CE group (mean +/- s.d.; 14.4 +/- 10.5%, 2.9 +/- 1.9 kg/m2, 6.6 +/- 6.0 kg) than in the PL group (2.2 +/- 5.8%, 0.5 +/- 1.6 kg/m2, 0.5 +/- 2.7 kg). Relative body weight decreased by more than 5% in 81% of the CE group, out only in 31% of the PL group. Adverse events were negligible and did not differ between the CE and PL groups. Withdrawal symptoms were mild, transient and their frequency and severity were not different between the placebo and active groups.
Conclusion
According to the present pilot study, CE can be a safe and effective compound for the treatment of obesity in adolescents.
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