[see FibroBoost page for SEANOL references]
Fibronol LLC recruited 36 fibromyalgia patients for its 60-day clinical study of Fibronol®. Approximately 29 of the patients completed the initial study period.
The study was a double blind design, with a total of 6 placebos (who were subsequently converted to active product following two weeks of non-response on placebo).The study design had two arms, one of 14 patients in the |
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1.6
more hours of
sleep
per night |
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80%
improvement in
quality
of sleep |
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39%
improvement in
overall
condition |
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71%
gain in energy |
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31%
reduction in perceived
discomfort levels |
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30%
reduction in fatigue |
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Seattle/Everett, Washington area, and the second involving 22 patients in Seoul, Korea (experienced rheumatology clinicians working under the supervision of the Mirae Medical Foundation). All patients in this study underwent the same protocols, as well as physician visits at: baseline, two weeks (placebo), and upon the eight-week termination period. Physician exams included complete blood tests, EKGs and weight determination. Study subjects completed a battery of five self-assessment forms common in other fibromyalgia |
clinical studies, covering: quality of sleep, fatigue (energy), pain/comfort, and other factors (including quality of life assessment). The clinical study design included two different dosage levels of Fibronol: a “moderate” dose of six 200mg capsules per day (26 patients), and a “high” dose of twelve 200mg capsules per day (10 patients). All patients started the study on a one-week half dose of Fibronol per day, prior to increasing to full dosing at the beginning of the second week (and in the case of high-dose, starting the third week of the study).
Prior to participating in the study, most patients were on a daily regimen of 12-20 prescription and nutraceutical products to achieve their baseline symptom management for fibromyalgia. No significant adverse events or hepatotoxicity (including drug-nutraceutical interactions) were apparent in these clinical studies, conferring a high degree of safety to regular Fibronol dosing. However three of the NW study patients plus three of the Korean study patients dropped out of the study due to aggravation of pre-existing diarrhea conditions, which may have been exacerbated by the magnesium, aloe vera or other ingredients present in Fibronol. Blood tests and EKGs performed by supervising physicians in conjunction with the Fibronol clinical studies proved normal, with some improvement generally present for most patients in blood test parameters (e.g., reduced cholesterol, triglyceride and blood pressure levels). |
Most clinical study participants (80%)
showed significant improvement in quality
of life under Fibronol
dosing by experiencing on average:
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Almost 40% improvement in their overall
condition |
|
|
1.6
more hours of sleep per night
combined with an 80% improvement
in soundness of sleep |
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| 2.4
more “good days”
per week |
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1.3
fewer “work”
days missed per
week |
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31%
reduction in perceived discomfort
level |
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71%
gain in energy |
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30%
reduction in fatigue |
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15%
improvement in ability to perform
daily function |
P-values on patient scoring were very tight, with average "P-values" of .001 (i.e., no more than 1 chance in 1000 that such scoring would have resulted by random chance alone). |
