Guaifenesin protocol

Guaifenesin

Guaifenesin protocol is an unapproved treatment for fibromyalgia suggested in the 1990s by R. Paul St. Amand, M.D. The protocol involves three parts: titrating the guaifenesin dosage, avoiding salicylates, and following a low-carbohydrate diet if the patient is hypoglycemic. As of 2015, the protocol had not been shown to be effective in clinical trials, and guaifenesin had not been approved by the FDA for fibromyalgia. ^[1] Despite the lack of clinical efficacy, the protocol has been adopted by many due to anecdotal evidence of success. ^{[2] [3] [4]}

Efficacy

In a 2017 multicenter, placebo-controlled, repeat-dose, parallel study of 77 randomly assigned adults, results suggested the potential for OTC dose of oral guaifenesin 1200 mg BID to provide symptomatic relief of upper back musculoskeletal pain and spasm. ^[5]

Results of the only reported randomized clinical trial in 1996 found that guaifenesin had no significant effects on pain, other symptoms, or laboratory measures (serum and urinary levels of uric acid and phosphate) over 12 months in a sample of people diagnosed with fibromyalgia syndrome. ^[3] The lead author of the study has suggested a number of reasons why some patients may have previously reported benefits on this protocol, concluding "St. Amand has unknowingly used guaifenesin as a powerful focus in a program of cognitive behavioral therapy, in which his empathy, enthusiasm and charisma were the real instruments in effecting a beneficial change." ^[6] St. Amand, who participated as a "Study Advisor" to this clinical trial, has stated that the study did not control for salicylate use, and therefore did not study the protocol as a whole. He has recommended a follow-up study be conducted which controls for all elements of the protocol. ^{[7] [8]} The lead author of the study counters that none of the subjects exhibited any signs of salicylate use. ^[3]

References

1. "Table 1, FDA-approved drugs for the treatment of fibromyalgia". January 2015.
2. Bennett, R.; deGarmo, P.; Clark, S. (1996). "1112. A 1 year double blind, placebo controlled study of guaifensin in fibromyalgia". Program Overview. American College College of Rheumatology 60th National Scientific Meeting; Association of Rheumatology Health Professionals 31st Scientific Meeting. p. S212. doi: 10.1002/art.1780391402 .
3. Bennett, R.M.; Clark, S.R; De Garmo, P. "Report on a randomized, prospective, 12 month study to compare the efficacy of guaifesin versus placebo in the management of fibromyalgia". myalgia.com. Fibromyalgia Information Foundation. Archived from the original on November 10, 2000.
4. "Is one placebo better than another? -- The guaifenesin story". Consumer Alerts. fmnetnews.com. Coping Resources. Fibromyalgia Network. Archived from the original on 2011-10-23.
5. Collaku, A.; Yue, Y.; Reed, K. (2017). "Efficacy and safety of guaifenesin for upper back, neck, and shoulder pain: A Phase II proof-of-concept, multicenter, placebo-controlled, repeat-dose, parallel-group study". Journal of Pain Research. 10: 669–678. doi: 10.2147/JPR.S126296 . PMC   5367561 . PMID   28356767.
6. Bennett, R. "Speculation as to the mechanism whereby some of Dr. St. Amand's fibromyalgia patients experienced improvement while taking guaifenesin". Fibromyalgia Information Foundation. Archived from the original on June 25, 2003. Retrieved 2008-01-06.
7. St. Amand, R.P. "A Response To The Oregon Study's Implication". fibromyalgiatreatment.com. Fibromyalgia Treatment Center. Archived from the original on 2008-01-20. Retrieved 2008-01-07.
8. St. Amand, R.P.; Potter, C. (1997). "The use of uricosuric agents in fibromyalgia: Theory, practice, and a rebuttal to the Oregon study of guaifenesin treatment". Clinical Bulletin of Myofascial Therapy. 2 (4): 5–17. doi:10.1300/J425v02n04_02.