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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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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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).
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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:
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Almost 40% improvement in their overall
condition |
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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).
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.
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