Physician Therapeutics publishes results from Sentra PM clinical trial

May 3 2012

Physician Therapeutics, Inc., a division of Targeted Medical Pharma, Inc., a specialty pharmaceutical company that manufactures and distributes specialty pharmaceuticals to physicians, pharmacies and skilled nursing facilities, published results from a clinical trial of the proprietary medical food Sentra PM. This trial demonstrated improved sleep latency and improved nighttime parasympathetic nervous system activity as a standalone medication or used in conjunction with a low dose of Trazadone. The results of this study have been published in the May issue of the Journal of Central Nervous System Disease (http://bit.ly/SentraPM_Study).    

"The study results indicate that medical foods used as a standalone medication or in conjunction with low dose pharmaceuticals can improve clinical outcomes and potentially reduce the negative side effects associated with the high dose pharmaceutical agents," said David Silver, M.D., co-author of the study and executive vice president of medical and scientific affairs at Targeted Medical Pharma, Inc. "Patients with sleep disorders have been shown to have reduced blood levels of serotonin and 5-hydroxyptophan. Sentra PM provides the amino acids that are precursors to the neurotransmitters serotonin and acetylcholine, meeting the body's increased nutritional requirements of tryptophan, choline and GABA, a common trait in sleep disorders."

The double-blind, four-arm, placebo-controlled study included 111 patients across 12 independent sites that were randomized for treatment with Sentra PM alone, Sentra PM with Trazadone, Trazadone alone and a placebo alone. Results showed improvement in sleep latency for both Sentra PM and the combination of Sentra PM with Trazodone (-41 and -56 minutes, p<0.001). Additionally, there was a statistically significant improvement in the quality of sleep for the amino acid formulation Sentra PM and the combination of Sentra PM with Trazodone (3.86 and 6.48 Likert units on a 10 point scale, p<0.001). The study also found an activation of circadian activity at night in the medical food and combination groups while there was no change in parasympathetic activity in either the placebo or Trazodone group.

In the study, which was completed in 2009, subjects underwent baseline screening, informed consent and an initial sleep questionnaire. After 14 days subjects received a second evaluation by questionnaire. At baseline and day 14, 24-hour ECG recordings were given to subjects that were analyzed in the frequency domain of heart rate variability. The specific high frequency parasympathetic autonomic nervous system activity also was analyzed. The primary endpoints were sleep latency and parasympathetic autonomic nervous system improvement in sleeping hours. These data indicate that a medical food is an effective treatment for sleep disorders to potentially addictive sleep aids that have significant side effects.