S-adenosyl methionine (SAMe) versus escitalopram and placebo in major depression RCT: Efficacy and effects of histamine and carnitine as moderators of response
First question would be: Are you using it with other meds or supplements? Especially those that target serotonin? It may be causing a bout of mild serotonin syndrome. That you do not want at all or to exacerbate. Being a responsible forum member I would have to say stop using it until you consult with your healthcare team, especially doc or pdoc. SAM-e is not considered an antihistamine. That would cause those symptoms. Have you looked at the chart I posted about drug and med. interactions?
Medscape: Medscape Access
Quote:
To put this in context, the only medications approved by the U.S. Food and Drug Administration (FDA) for adjunctive treatment in major depression are aripiprazole and quetiapine extended-release. The olanzapine/fluoxetine combination is approved in resistant depression. A recent review and meta-analysis of the 16 trials of adjunctive atypical use in major depressive disorder found that mean pooled response rates with drug and placebo respectively were 44.2% versus 29.2% (2). The risk difference for response rates by meta-analysis (the mean difference in response to drug and placebo) was 0.12 for a number needed to treat of 9. In the adjunctive SAMe trial, the drug-placebo difference in response was 18.5% for a number needed to treat of 6. The magnitude of the drug effect observed in the SAMe trial is quite respectable, although it may in part reflect the careful patient selection and more reliable ratings that can be achieved in a single-site trial compared with the large multi site trials of atypical agents that likely suffer from substantial intersite variability.
In the current trial, SAMe was well tolerated. There was no difference between SAMe and placebo in the number of patients who discontinued treatment because of adverse events (5.1% versus 8.8%, respectively). In fact, the relative lack of side effects helped to insure the double-blind conditions. The slight increase of 1.6 mmHg in supine systolic blood pressure with SAMe versus 0.3 mmHg with placebo seems of questionable importance.
The current study is the first placebo-controlled trial of SAMe for adjunctive use. There is a modest literature exploring the efficacy of SAMe as monotherapy in depression. A systematic review commissioned by the Agency for Healthcare Research and Quality found 11 placebo-controlled trials of SAMe that reported change on a standard scale (3). The trials ranged in size from 15 to 75. The effect size of the difference between SAMe and placebo in these trials was 0.65, a moderate and meaningful effect. The analysis found significant heterogeneity that might reflect differences in route of administration, dose, or other unidentified factors, and an asymmetry test for publication bias was near significant (p=0.07). Six of these trials reported response rates and were examined in another meta-analysis that found a significant advantage for SAMe with an effect size of 0.38 (4). Only four of these placebo-controlled trials employed an oral form of SAMe. Three of these trials found an advantage for SAMe relative to placebo, but two of these studies were small (i.e., less than 20 patients). The two largest oral administration trials differed. Fava et al. (5) selected 55 patients with major depression and found no difference in response to drug and placebo: 67% versus 65%. Salmaggi et al. (6) studied 60 postmenopausal women between the ages of 45 and 55 with major depression or dysthymia and a HAMD ≥17. In these selected patients, SAMe was much more effective than placebo, with CGI response rates of 67% versus 3%, respectively. I have emphasized the oral administration trials, since that route will be the preferred.
SAMe monotherapy has also been compared with other antidepressants in double-blind trials. Hardy et al. (3) found 11 studies reporting response rates and 14 studies in which effect size could be determined from change scores. Almost all studies compared SAMe with a tricyclic antidepressant, and most employed parenteral SAMe. The meta-analysis found no difference in response rates or effect sizes. These findings do not indicate efficacy (placebo effects could account for response in both groups); yet, these data suggest conventional antidepressants are no more effective than SAMe given as monotherapy.
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from:
PsychiatryOnline | American Journal of Psychiatry | S-Adenosyl Methionine (SAMe) Augmentation in Major Depressive Disorder
So, IMHO, it may be either a drug interaction or your bodies physiologically reacts to SAM-e in an allergic type of response!. In any case stop using it and talk to your doc or pdoc. Who hopefully have a clue about a very promising supplement. In any rate just stop it for now. The normal lowest therapeutic dose is 200mg a day on an empty stomach. So you need a slow titration up. These are all theoretical concerns. That have no importance until you talk to the experts helping you and your mental health issues!
Are you on SAM-e while you're drinking alcohol?
Also, SAM-e needs to be in stable environment. That means only buy those that are sold with each in a blister pack. If you buy ones that are just lose in a jar, forget it. I will say a few brands in blister packs with very good reputations. That usually come in 200-400 mgs (Jarrow, Doctor's Choice, Source Naturals) in descending order. All three past inspection on ConsumerLab.com in blister packs.
One last link:
SAMe - Drugs and Supplements - Mayo Clinic
When it comes down to it. Talk to your doc or pdoc. The last thing you need is serotonin syndrome. Which can be deadly. It's the basic principle of having too much 5HT in the synapse for reuptake by other neurons. Usually caused by using two drugs or med/supplement combination affecting the brain on serotonin in same or different areas of the brain . A big slip up, unless a very experienced pdoc uses the correct meds at the very lowest and possible doses. Even if that rare situation arises for a very knowledgeable pdoc!
Bottom line is stop the SAM-e until you talk to a pdoc, who knows his/her stuff with a supplement that a knowledgeable pdoc knows about SAM-e because it is a very useful supplement in a naturopathic and pdoc arsenal!