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A double-blind pilot study of the effect of Prokarin^TM on fatigue in multiple sclerosis

Life Diagnostics, 2210 2nd Street SW-Ste G100, Calgary, Alberta T2S 3C3, Canada

TL Richards

Department of Radiology, Box 357115, University of Washington, Seattle, Washington 98195, USA

RB Smith

Electromedical Products International, Inc., Mineral Wells, Texas 76067, USA

JV Wright

Tahoma Clinic, 515 W Harrison, Kent, Washington 98032, USA

In this 12-week study with 29 subjects, the effect of Prokarin^TM (n =22), a proprietary blend of histamine and caffeine, was compared to placebo group (n=7) for the following outcomes: 1) fatigue as measured by the Modified Fatigue Impact Scale (MFIS); 2) lower limb function as measured by timed walk test; 3) upper limb function as measured by the pegboard test; 4) cognitive function as measured by the Paced Auditory Serial Additions Test (PASAT); 5) serum caffeine level; 6) change in brain chemistry as measured by quantitative magnetic resonance spectroscopy assay of N-acetyl aspartate (NAA); and 7) safety as measured by routine blood chemistry, TSH and urinalysis. Data were acquired at baseline, 4, 8 and 12 weeks. The Prokarin^TM group MFIS mean was significantly different from the mean of the placebo group at 12 weeks (df=24, t=2.08, P=<0.02), with respective means of 37.40, SD=15.18, for the Prokarin^TM group and 53.2, SD=11.39 for the controls. For the secondary endpoints (PASAT, 25 foot timed walk, peg test, and magnetic resonance spectroscopy [MRS]), there were no significant differences between the Prokarin^TM-treated group and the placebo group. However, there were significant improvements within the Prokarin^TM group for each of these measures for the pre- versus posttreatment comparison at 12 weeks. Serum caffeine data indicated that caffeine exerted no independent effect on performance. No laboratory abnormalities were seen, and the treatment was well tolerated. Conclusion: There was a modest-size statistical effect of Prokarin ^TM on fatigue in multiple sclerosis (MS) compared with the placebo group. A larger trial is warranted, based on this pilot study. Multiple Sclerosis (2002) 8, 30-35

Key Words: Key words: clinical trial • fatigue • histamine • multiple sclerosis

Multiple Sclerosis, Vol. 8, No. 1 suppl, 30-35 (2002)
DOI: 10.1177/135245850200800107


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