Researchers from Strategic BioSciences, together with investigators from the Institute for Asthma and Allergy (Wheaton, MD), conducted the double blind cross-over study.
The study included 24 patients suffering from symptomatic, persistent allergic rhinitis who recorded the severity of their runny nose, itchy nose, stuffy nose and sneezing twice a day for a month.
The researchers compared the capsaicin- MucoAd formula (Sinol-M) to the 1st generation product without MucoAd (Sinol).
They found that capsaicin nasal spray reduced all symptoms, and symptom relief was achieved with less Sinol-M than Sinol, particularly at night.
This suggested that Sinol-M might permit a better night's sleep, free from rhinitis symptoms.
There were no treatment related adverse events during the study and Sinol-M was associated with less subjective reports of discomfort.
"This study represents the first-ever capsaicin-based treatment for allergic rhinitis to be supported by prospective clinical data, and has important implications for millions of Americans who suffer from nasal allergies. This all-natural product has now been demonstrated to provide clinical effectiveness without any of the side effects associated with intra-nasal steroids and is available without a prescription," said Dr. Michael A. Kaliner, of the Institute of Asthma and Allergy, Wheaton, Maryland, and principal author and presenter of this poster.
He added: "It may also provide a new option for patients looking for a zinc-free, all-natural product in the wake of the June 16, 2009 Food and Drug Administration (FDA) warning to consumers to stop using and discard zinc-containing intranasal products (Zicam), due to numerous reports that they may cause a loss of sense of smell (anosmia)."
Sinol is registered as a homeopathic product in the US. Its principal active ingredient is capsaicin, which is derived from the hot pepper plant.
The 2nd generation formulation, Sinol-M, adds a patented mucoadhesive solution (MucoAd) that prolongs the contact between a drug and the mucosa.
Full results of the study will be published in a peer reviewed journal.
Source: ANI
RAS