The Open Pain Journal

2020, 13 : 52-58
Published online 2020 December 31. DOI: 10.2174/1876386302013010052
Publisher ID: TOPAINJ-13-52

CLINICAL TRIAL STUDY
Nutritional Intervention in Chronic Fatigue Syndrome and Fibromyalgia (CFS/FMS) A Unique Porcine Serum Polypeptide Nutritional Supplement

Jacob Teitelbaum1, * , Gaetano Morello1 and Sarah Goudie1

*Address correspondence to this author at Kona Research Center, Wellness Center, West, Vancouver, B.C., Pataskala, Ohio; E-mail: FatigueDoc@gmail.com

ABSTRACT

Background:

Clinical experience suggested that a unique porcine serum polypeptide extract, used in hospitals for people with severe malnutrition, serendipitously resulted in a dramatic improvement in many fibromyalgia cases.

Aims:

The study aims to determine the effectiveness of a unique polypeptide serum extract in improving the symptoms of CFS and fibromyalgia (CFS/FMS).

Methods:

An open-label prospective study of 43 people with CFS or Fibromyalgia recruited worldwide.

Interventions:

Four 500 mg tablets twice daily for five weeks.

Outcome Measures:

Assessed baseline at five weeks of treatment using a VAS(1-10 points) rating energy, sleep, cognitive function, pain, overall well-being, anxiety, and digestive health, as well as the FIQR. The primary outcome measure was the pre- and post-treatment VAS composite score for the first five symptoms.

Results:

43 subjects completed the three-week treatment trial. 60.5% of subjects rated themselves as improved, with 18.6% rating themselves as much better.

In the 60.5% of subjects that rated themselves as improved, the significant average improvement was seen in all categories:
1. 69.4% increase in energy(p<.001)
2. 69.2% increase in overall well-being(<.001)
3. 53.8% improvement in sleep(<.001)
4. 60.5% improvement in mental clarity(<.001)
5. 37.9% decrease in pain(<.013)
6. 34.8% decrease in anxiety(<.001)
7. 54.6% improvement in digestive symptoms(<.001)
8. FIQR 59.2 to 39.3(<.001) In six individuals who also had pre- and post IgG antibody levels, total IgG increased by 13.8% on average, with similar improvements seen in the IgG 1-4 subsets.

Conclusion:

Recovery Factors® resulted in markedly improved energy, sleep, cognition, pain relief, calming, digestion and overall well-being in those with CFS/FMS.

Clinical Trial Registration Number: NCT04381793.

Keywords:

Fibromyalgia, Chronic fatigue syndrome, Polypeptides, Immune deficiency, Pain, Pain relief.