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Introduction

Fibronol LLC recruited 36 fibromyalgia patients for its initial 60-day clinical study (I-a arm) of Fibronol® (a second phase of the study, a I-b arm including the use of FibroBoost® for particularly “bad” days, periods of needed added energy or severe “fibro-fog”, will extend out over a six-month period). Approximately 29 of the patients completed the initial study period.
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Chronic Fatigue Syndrome
Fibromyalgia Nutraceutical
Fibromyalgia Nutraceutical
Nutraceutical Products
1.6 more hours of sleep per night
Fibromyalgia Nutraceutical
Nutraceutical Products
80% improvement in quality of sleep
Fibromyalgia Nutraceutical
Nutraceutical Products
39% improvement in overall condition
Fibromyalgia Nutraceutical
Fibroboost
71% gain in energy
Fibromyalgia Nutraceutical
Fibroboost
31% reduction in perceived discomfort levels
Fibromyalgia Nutraceutical
Fibroboost
30% reduction in fatigue
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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 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).

Fibromyalgia Symptoms Treatment 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 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:
Fibromyalgia Nutraceutical
Fibromyalgia Nutraceutical
Nutraceutical Products
Almost 40% improvement in their overall condition
Nutraceutical Products
Nutraceutical Products
1.6 more hours of sleep per night combined with an 80% improvement in soundness of sleep
Nutraceutical Products
Nutraceutical Products
2.4 more “good days” per week
 
Fibronol
Fibroboost
1.3 fewer “work” days missed per week
Fibronol
Fibroboost
31% reduction in perceived discomfort level
Fibronol
Fibroboost
71% gain in energy
Fibronol
Fibroboost
30% reduction in fatigue
Fibronol
Fibroboost
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).

It is recommended that FM patients reference a recently published abstract and article in the Journal of Rheumatology that provides a comprehensive overview of both FM and clinical measures of outcomes. Fibronol LLC used many of the clinical assessment forms referenced in this article as guidance in its clinical study measurements and outcomes analysis (as promulgated by OMERACT - Outcome Measures in Rheumatology Clinical Trials), even though Fibronol is a nutraceutical not requiring formal clinical development under FDA supervision. The title and citation for the abstract and article are: Journal of Rheumatology, Vol. 32, Supplement 75, Aug 2005, “Fibromyalgia Syndrome: Review of Clinical Presentation, Pathogenesis, Outcome Measures, and Treatment”, Mease, P. This important information is available on the Journal of Rheumatology website (http://www.jrheum.com) and there is a $10 fee to access the full article.


*These statements have not been evaluated by the Food and Drug Administration (FDA).
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LLC products are not intended to diagnose, treat, cure or prevent any disease.
 
 

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