Dr. Franks Silent Snore :: Clinical Study
The Silent Snore® Clinical Trial
A Randomized Independent Double-blind Placebo-Controlled Study
Published in the Journal of Integrative Medicine, December of 2004. Blum J.,The Effect of Methylsulfonylmethane (MSM) in the Control of Snoring. 2004: Vol 3 No. 6:24-30
Exactly 9 out of every 10 people who used Silent Snore in the study stopped or significantly reduced their snoring.
Silent Snore Clinical Trial Results
The Silent Snore product was subjected to a clinical trial comparing the response of 30 subjects who used Silent Snore and 30 subjects who used a placebo, all of whom were people who suffered from habitual chronic snoring. An independent group of scientists were commissioned to do the study. The outcome showed that 27 of the 30 subjects that used Silent Snore stopped or significantly reduced their snoring, while far fewer of the 30 subjects who used the placebo significantly reduced their snoring and none of those using the placebo stopped their snoring. Additionally, many of those who used Silent Snore were able to stop or significantly reduce their snoring with just one spray.
Conclusions (as written by the scientists who performed the study):
Despite the placebo effect, Silent Snore was clearly effective in treating severe snoring difficulties in a general population complaining of snoring difficulties, presumably without sleep apnea in this randomized placebo-controlled trial. The differences were clearly statistically significant in both the difference of means (t-test analysis) and by cut-point analysis (chi-square statistics), These statistically valid differences represent the gold standard of clinical trial comparisons.
Conclusions summarized for the public:
Silent Snore, which was sprayed to the back of the throat and then swallowed, was clearly much more effective than placebo in stopping or significantly reducing snoring in a general population. In fact, Silent Snore was effective in stopping or significantly reducing snoring in exactly 90% (27 out of 30) people tested in this clinical trial. A large percentage of those tested, and, in fact, 50% of those who dramatically or completely stopped snoring used only one spray of Silent Snore.
One spray and swallow produced a significant response for many in the study.
Subjects in the Silent Snore study were divided into four groups; those who did not respond to Silent Snore, those who significantly reduced their snoring, those who dramatically reduced their snoring, and those who completely stopped their snoring.
In the study, of those who stopped or dramatically reduced their snoring using Silent Snore, 50% used only one spray. Subjects were allowed to determine for themselves whether they wished to use one or more sprays. It is unknown whether those who used one spray or those who used more would have had better or worse results if they used more or less sprays.
The Silent Snore® randomized independent double-blind placebo-controlled study challenge to other companies with stop-snoring spray products.
Silent Snore®, to our knowledge, is the only stop-snoring spray product that has been subjected to an actual independent randomized double-blind placebo- controlled scientific study –considered the gold-standard of scientific investigation. We have been unable to obtain this type of data from any other company selling a stop-snoring spray product. Should anyone have information to the contrary, including the companies that make these products, please contact us to let us know. Call the 1-800-585-3909 order number and give the information to the agent and tell her to forward it to Dr. Frank.
Further Discussion of the Silent Snore Study
The Silent Snore Clinical Trial was a randomized independent double-blind placebo-controlled study.
Scientists recognize this type of study as the gold standard type of study for scientific investigation. This means:
- The subjects were randomized men and woman chosen between the ages of 18 and 75, meaning they were chosen at random in response to radio and newspaper ads.
- The scientists conducting the study were independent and, therefore, had no relationship to SleepWorks 2000, the company that makes Silent Snore.
- The study was placebo-controlled and compared two groups, one group of subjects who used Silent Snore and another group who used a placebo. A placebo is a substance that the person being tested thinks may be the actual product, but, in fact, is not the actual product. It is often similar in appearance and taste, as was the case in this study.
- The study was double-blinded. Neither the group of people being tested nor the people who were conducting the test knew which subjects were using the real Silent Snore product and which were using the placebo. Thus, both those tested and those testing them were blinded as to who was using the real product until the study was completed and all the results were collected.
Instructions on usage explained and reviewed.
All subjects were carefully instructed on the proper use of the spray so that they understood how to maximize the amount of product sprayed to the back of the throat before swallowing. They were also told to spray again if they ate food, drank water or smoked cigarettes. People who smoked cigarettes and people who drank alcohol mildly or moderately were included in the study.
The Silent Snore placebo and the “placebo effect”
The placebo used in this study was nearly the same as the actual Silent Snore product except that the placebo did not contain MSM (methylsulfonylmethane). Both Silent Snore and the placebo used in the study contained the same amount of purified water, stevia (a natural sweetener), ethyl alcohol and peppermint oil.
In this study, MSM, the key ingredient in Silent Snore, clearly was shown to have a very significant effect on preventing the vibrations of the tissues that cause snoring. We also believe that some of the contents of the placebo contributed to snoring reduction as well. Peppermint oil and glycerin are believed to contribute to this effect, and this may explain why many of those who used the placebo significantly (or more so) reduced their snoring even though none of them stopped snoring, as did those who used Silent Snore. Of course, some or much of the effect experienced by the placebo group can be credited to the well-known “placebo effect.” When a person taking a placebo product believes that the product they are taking is the real product and not a placebo and they experience benefits attributed to those of the real product; this is called the "placebo effect." Of interest, is that, generally, the "placebo effect" does not last long term.
Measurement of snoring intensity using reporting forms and tape recordings
The study used a report form rating the intensity of snoring from 1 to 10 that was filled out by the bed partner of the person who took either the product or the placebo. The form was filled out nightly for four nights without the use of product (base-line evaluation) and then for four nights while using the product (product evaluation). Subjects, who suffered from sleep apnea and from diseases of the naso-pharyngeal passageways were excluded from the study. Both report forms filled out by the bed partners of the subjects and the tape recordings made while subjects slept were used for the evaluation.
Base-line data in the placebo and the Silent Snore groups were medically similar.
There were no differences in any of the base-line data between the group on placebo and the group using Silent Snore. These parameters included: age categories, weight, diabetes, hypertension, back or pelvic injury, cancer, daily caffeine intake, weekly alcoholic intake, weekly exercise, employment, household income, adults per household, education, smoking, self-report general health, use of alternative therapies or herbal supplements, or cardiac, liver, pulmonary or renal disease. There were no differences in the baseline level of snoring between the two groups.
More information (for those of you who are statisticians):
Difference Between the Means: Statistical Test: t-test
- The efficacy of Silent Snore was clearly demonstrated by the t-test results. The first t-test compared the raw scores: a 2.25 point decrease from the baseline for the placebo group vs. a 4.43 point decrease from baseline. This has an associated p value of <0.0003.
- The second test assessed the percent improvement between the two groups: 28.3% for the control group and 53.6% for the product group (p< 0.001).
- For the base-line, the snoring level data was 7.69 on a 10-point scale (10 being the worst) for the placebo group and 7.93 for the product group (p< 0.63).
