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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
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