Electrocardiographic and hemodynamic effects of a multicomponent dietary supplement containing ephedra and caffeine: a randomized controlled trial
McBride BF, Karapanos AK, Krudysz A, Kluger J, Coleman CI, White CM
JAMA · 51 citas
Etiquetas de revisión
Financiación no declaradaDatos neutrales que nuestra revisión registró sobre cómo se hizo este estudio. Describen el método, nunca si nos gusta el resultado.
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
- 2004-01-13 · JAMA · vol. 291 · número 2 · pág. 216
- Editorial
- American Medical Association
- Citado
- 103 citas · más que el 98% de estudios similares · 8.0× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 21 trabajos
- Acceso
- De pago
- Áreas de investigación
- Pharmacology and Obesity Treatment · Coffee research and impacts · Complementary and Alternative Medicine Studies
- Palabras clave
- Ephedra, caffeine, dietary supplements, QTc interval, systolic blood pressure, cardiovascular adverse events, weight loss supplements, drug safety
- MeSH
- heart, humans, ephedra, caffeine, plant preparations, electrocardiography, cross-over studies, double-blind method, blood pressure, heart rate, systole, dietary supplements, adult, female, male
6 autores
- Brian F. McBride🇺🇸University of Connecticut
- Angeliki K. Karapanos🇺🇸University of Connecticut
- Agnes Krudysz🇺🇸University of Connecticut
- Jeffrey Kluger🇺🇸University of Connecticut
- Craig Ian Coleman🇺🇸University of Connecticut
- Charles Michael White🇺🇸 · autor de correspondenciaHartford Hospital; University of Connecticut
Resumen
El texto original del estudio, en el idioma en que se publicó.
Context
Metabolife 356, a multicomponent dietary supplement containing ephedra and caffeine (DSEC) in addition to several other components, is the top-selling dietary weight loss supplement. Given its common use, anecdotal reports of cardiovascular and cerebrovascular adverse events, and paucity of safety data, further research with this DSEC was warranted.
Objective
To determine the impact of the DSEC on corrected QT (QTc) interval duration and systolic blood pressure (SBP).
Design
Randomized, double-blind, placebo-controlled, crossover study conducted from January to May 2003.
Setting and participants
Fifteen healthy volunteers (mean [SD] age, 26.7 [2.52] years; weight, 72.7 [14.93] kg), 6 (40%) of whom were women, recruited from the University of Connecticut, Storrs campus.
Intervention
A single dose of the DSEC (containing 19 ingredients including ephedra [12 mg] and caffeine [40 mg]) or matching placebo were administered in a crossover fashion with a 7-day washout period between treatments.
Main outcome measures
Maximal QTc interval and SBP assessed at 1, 3, and 5 hours after dosing for the DSEC relative to placebo.
Results
Individuals receiving the DSEC had a longer maximal QTc interval (mean [SD], 419.4 [11.8] vs 396.1 [15.7] milliseconds; P<.001) and higher SBP (mean [SD], 123.5 [10.98] vs 118.93 [9.62] mm Hg; P =.009) compared with placebo. Participants who received the DSEC were more likely to experience a QTc interval increase of at least 30 milliseconds vs placebo (8 individuals [53.3%] vs 1 individual [6.7%]; relative risk, 2.67 [95% confidence interval, 1.40-5.10]). There were no significant sex-related differences.
Conclusions
The ephedra- and caffeine-containing dietary supplement Metabolife 356 increased the mean maximal QTc interval and SBP. Since the actual ingredient or ingredients in Metabolife 356 responsible for these findings are not known, patients should be instructed to avoid this and similar dietary supplements until more information is known about their safety.
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