Author + information
- Received May 16, 1994
- Revision received July 15, 1994
- Accepted August 5, 1994
- Published online January 1, 1995.
- Angel Moya, MD, FESC1,a,
- Gaietà Permanyer-Miralda, MDa,
- Jaume Sagrista-Sauleda, MDa,
- Xavier Carne, MD∗,
- Teresa Rius, MDa,
- Lluis Mont, MDa and
- Jordi Soler-Soler, MD, FACC, FESCa
- ↵1Address for correspondence: Dr. Angel Moya, Serveis de Cardiologia, Hospital General Universitari Vall d'Hebron, Pg Vall d'Hebron 119–129, 08035 Barcelona, Spain.
Objectives. This study assessed the efficacy of oral etilefrine (10 mg three times a day) in preventing a positive response to head-up tilt testing.
Background. Previous reports have suggested that oral etilefrine can be effective either in preventing a positive response to head-up tilt testing or in reducing syncopal recurrences in patients with vasovagal syncope. Up to now most studies assessing drug therapy in these patients have been uncontrolled.
Methods. This was a randomized double-blind crossover study of etilefrine versus placebo in 30 consecutive patients with syncope and a baseline positive head-up tilt test. After the first test, patients had no treatment for 3 days and were randomized to receive etilefrine or placebo for 4 additional days. They underwent tilt testing under treatment and again after 3 days of washout; they then received the alternative treatment for 4 days, and a third test was performed.
Results. Head-up tilt test results were negative in 13 (43%) patients with etilefrine and 15 (50%) with placebo (p = NS). Therefore, the statistical power of the study was only 10%. The rate of positive responses decreased with repeated testing irrespective of the assigned treatment: A positive response was obtained during the second head-up tilt test in 20 patients (10 with placebo, 10 with etilefrine) but in only 12 during the third (7 with etilefrine, 5 with placebo) (p < 0.05).
Conclusions. Oral etilefrine (10 mg three times a day) was not superior to placebo in preventing a positive response to head-up tilt testing. Despite a low statistical power, the high rate of negative response with placebo (50%) suggests that controlled trials are needed to assess the real efficacy of any treatment in patients with vasovagal syncope.
- Received May 16, 1994.
- Revision received July 15, 1994.
- Accepted August 5, 1994.