Abstract: A double-blind, placebo-controlled study of Acclydine in combination with amino acids in patients with Chronic Fatigue Syndrome
June 24, 2002
P De Becker , PhD , J Nijs , PT; E Van Hoof , Clin Psych; N McGregor, PhD, MDSc  and K De Meirleir , MD, PhD
1: Dept. of Human Physiology, Vrije Universiteit Brussel, Belgium
2: Collaborative Pain Research Unit, Department of Biological Sciences, Faculty of Science, University of Newcastle, Callaghan, New South Wales, Australia
Acclydine is an alkaloid derived from selected plants that has substantial effects on the protein structure and the metabolism. At cellular level it affects the activation of insulin-like growth factor (IGF-1) receptor. IGF-1 activates the tyrosine kinaesis receptors and the integrin receptors, which causes activation of intracellular lipid and glycogen synthesis. Secondly, it activates and stimulates the hypothalamus to an increased secretion of growth hormone releasing hormone; the latter results in an increased release of growth hormone by the pituitary. Given the fact that in CFS a disturbed GH axis function was observed, theoretically treatment with Acclydine could be of benefit to patients with CFS.
90 individuals suffering from CFS (Holmes and/or Fukuda definition) entered the study. They were not allowed to take any other medication than minor pain relievers and homeopathic medication. At baseline, week 4 and week 8 IGF-1, IGF-BP3 and safety parameters (liver tests, haematology) were determined. The LMW/HMW RNase L ratio was measured at baseline and at week 8. The treatment protocol consisted of first 4 weeks: 250 mg four times a day in combination with amino acids; second 4 weeks 250 mg Acclydine twice daily in combination with amino acids.
The primary efficacy variable was the change from baseline in CFS as measured by the Clinician's Global Impression Scale (CGI) after 4 and 8 weeks of treatment. Secondary endpoints were: IGF-1, IGF-BP3 values, LMW/HMW RNase l ratio, GHQ-30, POMS, SF-36 and SCL-90.
In the active group the IGF-1 levels increased significantly at week 4 and week 8 compared to the placebo group (p< 0,0002). In the active group 54% note an improvement in symptoms, compared to 16% in the placebo group. The symptom change according to the CGI yielded an improvement in the active group at week 4 (p<0,004) and at week 8 (p<0,0003), no significant changes were observed in the placebo group.
Acclydine in combination with amino acids gives an improvement in CFS symptoms. No major adverse events were noted. Acclydine appears to be a safe and adequate drug for CFS.
Source: www.ahmf.org. Presented at the 2001 Clinical and Scientific Meeting: Myalgic Encephalopathy/Chronic Fatigue Syndrome: "The Medical Practitioners' Challenge in 2001."