Do you know about ClinicalTrials.gov? ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. As of today, ClinicalTrials.gov currently lists 134,739 studies with locations in 180 countries. (You might want to keep an eye on this site!)
Aside 1: I love to learn new things and research
Aside 2: I started SAM-E (at 400mg) this week (not feeling any better – in fact, this week has been my worst week in as long as I can remember!)
I’ve had AUSTRALIA and FIBROMYALGIA bookmarked with ClinicalTrials.gov for quite a while but nothing much is happening here.
However, one thing I noticed was a Double-Blind, Placebo-Controlled Trial of the Impact of S-Adenosyl-L-Methionine (SAM-e) on the Mood and Other Symptoms in Fibromyalgia.1 The phase 2 trial was completed in March 2007 but there were no results published – zip, nada!
Well, that was not particularly helpful. BUT I am an alumnus of the university where the study was run. So, one email later, I had the draft report in my grubby little hands (or inbox).
Quick background: SAM-e is of fundamental importance in a number of biochemical reactions and has been trialled previously in the treatment of FM. This study aimed to examine the clinical impact of SAMe-B-ForteTM – a complex containing 400mg of SAM-e – in the treatment of fibromyalgia in the light of possible melatonin (MLT) mediated circadian enhancing properties (basically, sleep).
Statistics: FM is the third most common disorder in rheumatologic practice after rheumatoid arthritis and osteoarthritis and its prevalence in the general population has been estimated to be between 1% and 4%.2,3,4 The prevalence of FM in primary care settings (at GP level) is much higher, where it is estimated to be between 5% and 20%.3,5 Studies examining the outcome in FM patients suggest that the probability of complete recovery in the short-term is low.6
As we know, no treatment (medical or psychological/behavioral) has been demonstrated to be clearly and reliably effective (or we all would have shared it by now!)
Patients were randomly allocated into two groups (placebo and active treatment). The SAMe-B-ForteTM group received capsules containing SAM-e 400mg, over an 8 week period. The placebo group received capsules that were of identical appearance. All participants were instructed to take one of the capsules in the morning with food (the directions on my box of SAM-e state to take it without food?) Only 49 patients completed the trial.
It appears that the 4th week was the breakthrough week – SAM-e was effective in reducing global symptoms, sleep onset insomnia, and bowel dysregulation. While the results failed to support previous findings that SAM-e could aid depression, the dose given (400mg) and the short time period may not have allowed for optimal antidepressant action of SAM-e and future trials would be required, including a range of doses, in order to better examine dose-response data.
Conclusion: The SAMe-B-ForteTM complex tested shows promise in alleviating symptoms in FM. The promising results confirm there is a potential benefit of SAM-e administration in FM but also that this finding needs further exploration.
Well, I don’t want to wait (really sick of waiting – and it’s taken 5 years for researchers to produce a draft report!) so, as I said earlier, I am giving it a try. Hopefully, the next few weeks will be better than this one.
- Luke Xantidis, Gregory Tooley, Daniel Lewis and Laurence Lacey
- Doron Y, Peleg R, Peleg A, Neumann L, Buskila D: The clinical and economic burden of fibromyalgia compared with diabetes mellitus and hypertension among Bedouin women in the Negev. Fam Pract 2004, 21(4):415-419.
- Kirmayer LJ, Young A, Hayton BC: The cultural context of anxiety disorders. Psychiatr Clin North Am 1995, 18(3):503-521.
- Staud R, Domingo M: Evidence for abnormal pain processing in fibromyalgia syndrome. Pain Med 2001, 2(3):208-215.
- Al-Allaf AW, Dunbar KL, Hallum NS, Nosratzadeh B, Templeton KD, Pullar T: A case-control study examining the role of physical trauma in the onset of fibromyalgia syndrome. Rheumatology (Oxford) 2002, 41(4):450-453.
- Dobkin PL, De Civita M, Bernatsky S, Kang H, Baron M: Does psychological vulnerability determine health-care utilization in fibromyalgia? Rheumatology (Oxford) 2003, 42(11):1324-1331.
- A Magic Pill? Not! (fibromodem.com)
- New Style and New Content for ClinicalTrials.gov (jflahiff.wordpress.com)