More MS news articles for Feb 2002

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

http://www.ingenta.com/isis/searching/ExpandTOC/ingenta?issue=infobike://arn/ms/2002/00000008/00000001&index=7

Multiple Sclerosis,
1 February 2002, vol. 8, no. 1,   pp. 30-35(6)
Gillson G[1]; Richards TL[2]; Smith RB[3]; Wright JV[4]
[1] Life Diagnostics, 2210 2nd Street SW-Ste G100, Calgary, Alberta T2S 3C3, Canada
[2] Department of Radiology, Box 357115, University of Washington, Seattle, Washington 98195, USA
[3] Electromedical Products International, Inc., Mineral Wells, Texas 76067, USA
[4] Tahoma Clinic, 515 W Harrison, Kent, Washington 98032, USA
 
Abstract:

In this 12-week study with 29 subjects, the effect of Prokarin™ (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™ 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™ 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™-treated group and the placebo group.

However, there were significant improvements within the Prokarin™ 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™ on fatigue in multiple sclerosis (MS) compared with the placebo group. A larger trial is warranted, based on this pilot study.
 
 
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