Prokarin (original) (raw)

The Prokarin Controversy

by Laurie Long 6/02

Prokarin (formerly called Procarin) is a proprietary formula that contains histamine, caffeine and other components. It was developed four years ago by nurse Elaine DeLack, who uses the transdermal patch to alleviate certain MS symptoms. The transdermal cream consists of blended compounds already approved by the FDA to mimic an enzyme in the body that reverses the feeling of fatigue.

The Prokarin Patch has caused great controversy in the MS world. Proponents cited its efficacy based on individual claims and the findings of various uncontrolled studies. Detractors insisted that the studies were not sufficiently well constructed or administered to be considered as statistically valid tests. And in the meantime, pharmacists continued to compound and dispense Prokarin to people with MS to the tune of 250 dollars per month each - a sum not covered by insurance.

In order to put this to rest, a new double-blind pilot study was developed to study the effect of Prokarin on fatigue in multiple sclerosis. Researchers at the University of Washington took part in this study, the results of which were published earlier this year.21 individuals were treated with Prokarin for the 12-week study period, with 5 individuals taking the placebo. The conclusion was that "this study demonstrated a modest statistically significant effect of Prokarin on …fatigue as measured by the MFIS [fatigue impact scale] questionnaire. The average individual percent improvement in the MFIS score was 37%.Side effects were minimal and there were no significant adverse changes in routine blood parameters." The study also stated that "this demonstrates that Prokarin could reasonably be considered as an alternative for those MS patients who cannot tolerate the side effects of, or have not experienced satisfactory relief with other commonly used medications for fatigue."

And did this clear the air about Prokarin? Not even close.

The National MS Society (NMSS) published a Research/Clinical Update on January 30, 2002 regarding the Prokarin study. The NMSS states in its conclusion that "As with any proposed treatment for any disease, well-designed clinical trials are essential to evaluate their potential benefit. Several issues with the design of the Prokarin study make it difficult to interpret, including the small sample size; the very different numbers of people in the treatment and placebo groups; potential confounding effects of caffeine, a known stimulant; and others." They felt that various aspects of the study rendered it insufficient to be firm scientific proof of the usefulness of Prokarin.

Various supporters of Prokarin, as well as the Prokarin Study statistician, Dr. Ray Smith, were quick to address these doubts about the quality of the study. Dr. Smith pointed out that the number of participants involved in the study was based on the large anticipated effect on fatigue that was noted in earlier studies. This very large effect size, known as the power of the study, was well above 80, which was more than sufficient to determine effect in a treatment group of 20 and a control group of 5.All studies follow the same formula to determine the number of participants necessary to give the study power (meaning the results will have statistical significance). The subjects were randomly selected from a basic patient pool into the two study groups so that variations in MS symptoms would not affect the outcomes. The issue of caffeine as a component of Prokarin was also addressed in the study: "The potential stimulant effect of caffeine needs to be considered, especially since the placebo did not contain caffeine. However, serum levels of caffeine were equal in the two groups, at least for the first 8 weeks of the trial, and the percentage of coffee drinkers in each group was high, and similar. Moreover, the caffeine level in the placebo group was higher at 12 weeks than in the Prokarin group, yet there was no concomitant increase in the placebo MFIS scores at 12 weeks (or the scores for other measures)."

The results of the UW Prokarin Study were published in the Multiple Sclerosis Journal, a peer reviewed journal in which all studies submitted for publication must be reviewed by the peer review committee. A study is only accepted for publication if the peer review finds the study to be well designed and the results scientifically significant.

The Prokarin study's primary endpoint was the effect on fatigue as measured by the MFIS. The study states, " The strong effect on fatigue demonstrated in this study agrees with the large body of anecdotal evidence supporting a role for Prokarin in the alleviation of fatigue. The treatment was seen to be well tolerated with no adverse effects on routine blood parameters. Fatigue is often the first symptom to improve with Prokarin use, and the improvement is sometimes obvious within hours of instituting therapy."

Improvement of motor and cognitive function were chosen as secondary outcome measures. The study states, "For all of the secondary endpoints, there were no statistically significant differences between the Prokarin group and the placebo group. Although there were significant improvements within the Prokarin group comparing the baseline to post-treatment time points, the authors acknowledge that these within-group comparisons are not as important as the between-group comparisons for a controlled evaluation of the effect of Prokarin."

Earlier studies and surveys on people taking Prokarin showed that less than half noticed any benefits. Approximately half of the people taking it noted a skin reaction (rash) at the site of the patch. There has been concern that people with asthma may react to Prokarin with severe asthmatic attacks, and that this possible side effect has not been sufficiently indicated. However, the majority of the individuals taking Prokarin had no breathing difficulties.

The people that have been helped by Prokarin are enthusiastic in their endorsement of the compound. Those that have tried it with no result have chalked it up to another possible avenue of relief that turned into a dead end. Doctors, researchers and MS professionals argue back and forth. The only thing that both sides agree on is that larger studies of Prokarin are needed.

And will those larger studies finally end the controversy over Prokarin? Well….

Websites on Prokarin:

http://www.edmsllc.com Prokarin research archive and resource site.

http://www.nationalmssociety.org/Research-2002Feb8.asp Results of clinical trial of Prokarin to treat MS fatigue by the National MS Society

welcome.to/prokarin A personal website created by a private individual to share information related to Prokarin.

http://www.healthwatcher.net/Quackerywatch/MS Prokarin listed here under the "questionable treatments and claims section".

http://www.nurses.com Search "articles" for Prokarin. New Study Shows Medical Patch for M.S. Effective; Results of Double-blind Study Released Today in the Multiple Sclerosis Journal. 1/30/2002

References:

G. Gillson, TL Richards, RB Smith and JV Wright. A double-blind pilot study of the effect of Prokarin on fatigue in multiple sclerosis. The Multiple Sclerosis Journal 2002: 8: 30-35.

Results of Clinical Trial of Prokarin to Treat MS Fatigue. National MS Society Research Bulletin, January 31, 2002.