A double-blind study of guaifenesin vs. placebo was completed at the University of Oregon in June 1995 by Dr. Robert Bennett. In this study, patients in the placebo group compared to patients in the guaifenesin group appeared to improve equally (not by much) over the course of this one-year study, a finding which suggested a placebo effect. It is our belief that this study was flawed, due to our collective lack of knowledge and possibly some bad luck. We take full responsibility for the errors in the study design which includes both of these issues.
In the past, while using gout medications, our patients had been routinely cautioned to avoid aspirin, because we knew that aspirin blocked the uricosuric effect of the medications. (This is well documented in medical research.) We had also discovered that aspirin rendered the medications ineffective when treating fibromyalgia. One of our very first patients on guaifenesin agreed to be a guinea pig and took aspirin too. We quickly found that guaifenesin did not reverse fibromyalgia when taken alongside salicylates.
Dr. Bennett's patients were duly warned to avoid aspirin and aspirin-containing compounds such as Alka Seltzer and Excedrin.
However, three months into the study, we began to encounter patients who, while using Myoflex, Ben Gay, or sunscreens containing salicylates, had reversed their initial progress and were worse. In the seventh month, we saw the same effect from an oral herbal medication.
Through search of the literature, we learned that plants make salicylates (this had just been published in Science Magazine in 1994,printed AFTER the Oregon study had begun) as a defense mechanism. These salicylates are easily absorbed by humans through the skin. Although we warned Dr. Bennett of these problems as we encountered them, it was not until six weeks after the study was completed that we came to understand the enormity of the problem due to the widespread and increased presence of plant extracts or salicylates in cosmetics and lotions. (This was 1995).
It is also clear from reviewing the results of the patient wellness questionnaires that the screening process had failed to cull out the hypoglycemics, something we had spoken to Dr. Bennett about before the study began. Without dietary correction, the probable 30 plus percent of patients with overlapping symptoms would not have felt better.
Just as important, we were constrained by the study design to give the patients a single dosage of guaifenesin. That is, we could not raise the dose in patients who did not respond as we do in practice. We knew that a dose of 1200 mg. a day would prove effective for some 80%, in theory so we selected it. We felt that if we picked a higher dose patients who were low dose responders would experience too much pain and drop out of the study. Since we had only 20 patients taking guaifenesin that would have been a disaster. It is possible that a certain number of the 16 patients who completed the study were not taking enough guaifenesin to be effective. (It could have been all of them or none of them --we do not know. But in theory, 20 percent of this 16 would not have been taking enough).
So, it's important, as well, to point out the size of the Bennett study. Each group contained less than 18 patients at the end. With such a small number of enrollees only a few needed to block or be at the wrong dose for the study to statically fail.
Dr. Bennett makes a point that no increase excretion of phosphate was seen in patients. He also did not detect urate excretion (which is a documented finding in medical literature, not St. Amand speculation). Since other researchers found an increase in urate excretion to the point where it is mentioned as fact in the guaifenesin monograph we do not know why Dr. Bennett did not see this. However, if the patients were blocked or at an insufficient dosage we would not expect any changes whatsoever to be seen.
As consultant, and the only one with experience in this treatment, I accept full responsibility for the errors. The reader may take this as a lame excuse for failure or accept our disclaimer. In our hands and in the hands of other physicians nationwide, results from guaifenesin have been too obvious to dispute.
Our sole purpose in writing this paper is to promote among patients and physicians an effective treatment for fibromyalgia. We seek to replace the dismal set of ineffective medications currently in use with a simple, nontoxic one that works at some very fundamental level. We are pleased to help any physician who is interested in using this approach. We have a moral obligation to pursue dissemination of this information and experience.
R. Paul St. Amand, M.D.
Points of rebuttal
to the conclusion of the Oregon Study:
of Myofascial Therapy, Vol. 2(4) 1997. c 1997 by The Haworth Press. Inc.
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