A Los Angeles doctor is promoting guaifenesin -- a common ingredient in cough syrups and cold rememdies -- as a cure for fibromyalgia, despite the fact that the only scientific study done on the drug found it to be no better than a placebo, and fibromyalgia specialists say it is worthless for treating the painful disease.
R. Paul St. Amand, assistant clinical professor of endocrinology at the University of California at Los Angeles and a physician in private practice, has developed a protocol for treating fibromyalgia based on high doses of guaifenesin, which he claims in his book and on his Web site will cure the disease.
Fibromyalgia is a chronic condition that causes fatigue, difficulty sleeping, pain throughout the body and an inability to concentrate as well as a host of other symptoms. Although the cause of the disorder is unknown, more than 6 million Americans may suffer from it. Conventional treatment involves a multi-pronged approach of anti-depressants, painkillers, adequate rest and exercise.
It is not surprising that St. Amand, who suffers from fibromyalgia himself, developed an alternative regimen for the disease, since he is seen as something of a maverick in the fibromyalgia field. He is not a rheumatologist as most fibromyalgia specialists are, and he rejects the accepted criteria for diagnosing fibromyalgia -- chronic pain in 11 of 18 tender points on the body. Instead, St. Amand makes his diagnosis based on what he calls "lumps and bumps" on patient's bodies.
The main use of guaifenesin is as an expectorant in cough syrups and other products to promote the removal of phlegm and mucus from the body. "Guaifenesin shouldn't do a thing, yet it's the most powerful medicine I've ever had," St. Amand told United Press International. He is supported by a legion of patients who state very firmly that guaifenesin improved their fibromyalgia symptoms.
Despite St. Amand's claims of success, however, guaifenesin did not hold up in a scientific study -- one that St. Amand himself requested and helped design. The patients in the study receiving guaifenesin fared no better than those receiving an inactive placebo.
"None of us (fibromyalgia specialists) have found that patients get dramatically better and stay better" using guaifenesin, said Robert Bennett, who conducted the study on guaifenesin and serves as chairman of the division of arthritis and rheumatic diseases at Oregon Health Sciences University in Portland.
"If there was one pill out there that worked, we'd all be using it," Bennett told UPI.
"It's a worthless drug," Daniel J. Wallace, chief of rheumatology at Cedar Sinai Medical Center in Los Angeles, told UPI, noting he has had "many, many people come to me in whom guaifenesin has not worked."
Bennett said although St. Amand requested the study and was involved in the study design, he later criticized the study when the results did not turn out favorable for his guaifenesin hypothesis. St. Amand said patients involved in the study were not told to eliminate common products -- such as shampoos, deodorants and toothpastes -- that contain small amounts of a chemical called salicylate. This chemical blocks the effect of guaifenesin, which is why the trial got negative results, he said.
In his own practice, St. Amand said he advises his patients to stop all use of salicylate-containing products and this has enabled him to achieve a "90-95 percent" success rate with guaifenesin. Bennett said dermatologists have told him a person would have to plaster his or her entire body a couple of times a day with salicylate-containing cosmetics for it to have any effect on guaifenesin's actions. He rejects St. Amand's claim of a greater than 90 percent success rate. "There are a lot of patients who haven't been cured by it," he said.
Wallace, whose practice is near St. Amand's, noted many of St. Amand's former patients who have not been helped by guaifenesin have come to see him. He pointed out St. Amand's regimen does not rely only on guaifenesin. He also puts them on a nutritious diet and tells them to exercise, stretch and get proper rest. These all are common methods used to treat fibromyalgia, he said, which is why perhaps his patients notice improvement.
The good news is that guaifenesin appears to pose no danger to the people using it. "It's completely harmless," Bennett said.
Wallace agreed. "I don't think it harms anybody ... but I wouldn't expect any benefit from it," he said.
Lynne Matallana, director of the patient advocacy group the National Fibromyalgia Association, said her group tends not to recommend guaifenesin because it is not supported by science. However, she added, "I hate to say it's nothing, just ignore it completely, because there are quite a few of people who have gotten benefit from it."
She said any benefit is likely due to a placebo response or the erroneous belief that the drug is helping. "If you have this illness, you feel so desperate you will do anything to feel better," Matallana, who herself suffers from fibromyalgia, told UPI. She added she has known at least one patient who appeared to improve significantly after taking guaifenesin and one on the opposite end of the spectrum who received no benefit from the medication.
Matallana recommended fibromyalgia sufferers "try everything else first -- exercise, changing their diet, getting more sleep -- and then try some of these alternative things."
St. Amand said he plans to begin a study this November to examine the effectiveness of guaifenesin when patients completely avoid salicylates. This will not be a double-blind, placebo-controlled study, however -- the gold standard for medical studies in which neither the patient nor the doctor knows who is taking a placebo and who is taking the real drug.
St. Amand said this is impossible to do because "100 percent" of his patients have lumps and bumps in their left thigh -- a condition not observed or accepted by fibromyalgia specialists -- which improve shortly after guaifenesin is started. Thus, both the patient and the doctor would soon know who was getting the real drug and who was getting placebo.
Instead, St. Amand said he plans to do a prospective study in which the dose of guaifenesin can be adjusted and all patients are receiving the drug. There will be no placebo group.
Even if the study shows guaifenesin is effective, however, the results would be considered highly questionable due to the flaws in the study design, and no major medical journal would accept it for publication, Wallace said.
