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Sleep and Breathing~Vol. 3, no.2, 1999 Original Article  (summary)
A Randomized Double-Blind Placebo-Controlled Evaluation of the Safety and Efficacy of a Natural Over-The-Counter (OTC) Medication in the Management of Snoring

DEREK LIPMAN, M.D., GARY SEXTON, STATISTICIAN, and JERRY SCHLESSER, N.D., D.C., C.N.S.

ABSTRACT: More than 40 million American adults snore. Habitual snoring afflicts 44% of adult males and 28% of females. Uncomplicated snoring is generally due to vibration of the palatal soft tissues or the tongue base, causing intermittent airway obstruction. Loudness is correlated with the degree of vibration and/or obstruction. The tendency, frequency, duration, intensity, and sequelae of snoring are influenced by myriad structural, physiological, environmental and pharmacological factors Uncomplicated, nonapneic snoring is treated in a wide variety of ways, ranging from self-help methods, such as positional therapy, to laser surgery. The purpose of this report is to evaluate the safety and efficacy of a natural medication for snoring in a randomized double-blind placebo-controlled trial.

The treatment is significantly more effective than placebo. Neither side effects nor intolerance to the product was reported.

KEYWORDS: snoring, naturopathic, homeopathic, SnoreStop

Introduction

Subjects (n 100) from the Portland, Oregon metropolitan area were recruited to participate in a randomized double-blind placebo-controlled trial to evaluate the safety and efficacy of a natural medication as a treatment for chronic snoring. The objective was to ascertain whether a homeopathic medicine can influence the incidence and intensity of snoring, and whether the use of such a product effects the quality of sleep for the snorer and his/her sleepmate. The product tested (Snore Stop, The Green Pharmacy, Wilsonville, OR) is a tablet manufactured in accordance with the Homeopathic Pharmacopoeia of the United States (HPUS) containing the following natural substances: Nux vomica 4X & 6X, Belladonna 6X, Ephedra vulgaris 6X, Hydrastis canadensis 6X, Kali bichromicum 6X, Teucrium marum 6x, and Histaminum hydrochloricum 12X.

Methods

Randomization and Double Blinding

Study subjects were recruited from the Portland Oregon metropolitan area through newspaper advertising and submitted to a confidential medical history and screening examination (at no charge) by a local otolaryngologist. After suitable informed consent was obtained, qualified study participants received a bottle of study medication randomly numbered from 101 to 201.

All containers and labels were identical with the exception of their assigned number.

Each amber glass bottle contained 20 tablets, identical in color. odor. taste, shape, markings, and other physical characteristics.

Both the active treatment and placebo tablets were prepared and packaged in sealed bottles in an FDA-registered manufacturing facility licensed to produce homeopathic medicines under GMP controls. Containers remained unopened until delivery to study participants.

Neither the patient nor any persons having direct patient contact knew the identity of active and placebo containers. Codes were broken only at the conclusion of the study.

The randomized placebo group (n = 46) comprised 32 men and 14 women, with a mean age of 47.6