by Editor
July 18, 2006
A recent randomized, placebo-controlled, double-blinded clinical study involving 29 diagnosed FM patients – 28 females and 1 male – concluded that supplementation over a period of eight weeks with the nutraceutical Fibronol™ offered statistically “very significant” average improvements in several key quality-of-life measures. These included sleep duration and quality, energy, and discomfort. Fibronol™ ’s primary ingredient is SEANOL-F, a polyphenol/phlorotannin extract of the brown seaweed Ecklonia cava.
Overall, 23 FM patients received daily doses of the supplement Fibronol™, and another 6 received a placebo (fake) dose. All subjects were also maintained on their current FM symptom-management regimens, which included a wide variety of prescription drugs and dietary supplements. Measures of patients’ quality of life factors, recorded at baseline, at two weeks for placebo patients, and at eight weeks, followed standard international guidelines for use in clinical trials involving FM patients.
Key Findings
At the end of eight weeks, the patients receiving Fibronol™ supplementation experienced, on average:
- 1.6 additional hours of sleep per night
- Deeper and less interrupted sleep, expressed as an 80 percent increase in sleep soundness
- Accompanied by a 71 percent increase in energy, a 30 percent reduction in fatigue, and a 33 percent reduction in perceived discomfort level.
Each of these findings is statistically very significant, in that the probability it could have occurred by chance is less than 1 in 1,000 (P = < 0.001).
By comparison, the patients in the placebo group achieved no statistically significant improvements on these measures, and were switched during the course of the study to “open label” Fibronol™ supplementation.
Additionally, six of the patients receiving the Fibronol™ supplement who had a pre-existing condition of diarrhea experienced a worsening of the condition and were dropped from the study. The researchers speculate that this may be associated with the magnesium included as a secondary ingredient of Fibronol™, which is included for support of tissue repair. No other adverse effects were identified.
Specific Measures Employed
Measures of efficacy used in the study included:
- A Pain Diary using the Visual Analogue Scale (VAS) pain score, which asks the patient to indicate intensities by marking positions on lines between two extremes.
- The Brief Pain Inventory (BPI) pain assessment questionnaire.
- The Patient Global Impression of Change (PGIC), a patient-reported periodic assessment of perception of change in their condition.
- The Medical Outcomes Study (MOS) Sleep Scale, a 12-item self-report instrument that yields a summary score on sleep problems and detail on six sleep attribute scales.
- The Multidimensional Fatigue Inventory (MFI), a 20-item self-report instrument designed to measure fatigue.
Other tests, to assess safety and identify potential adverse effects, included CBC blood serum chemistries, urinalysis, ECG, vital sign assessments, and adverse event records. All results were “normative to reduced” with the exception of increased diarrhea for the six patients with this pre-existing condition.
An abstract of the November 2005 study report, “Fibronol™ Phase 1-a Clinical Study,” by C. Palmer, PhD, et al., is available in pdf format at www.fibronol.com/fibronol_clinical_abstract.pdf
More Studies Ahead This was a very small, preliminary (Phase I-a) study. The results seem to indicate that this natural food supplement may offer many people with FM promising support for improved quality of life. But larger, longer term studies will help to test and refine these preliminary findings. Fibronol LLC, the developer of Fibronol™ and its chief ingredient SEANOL-F – 14 years in development – has indicated plans for a Phase I-b study to run for six months.
Note:Fibronol LLC products are not intended to diagnose, treat, cure or prevent any disease.
|
