R. Delle Chiaie, P. Pancheri - Vol. 5, Marzo1999, num.1
Testo Immagini Bibliografia Summary Riassunto Indice
Analisi combinata di due studi controllati,
multicentrici, in doppio cieco per la valutazione di efficacia e tollerabilità
di SAMe vs. placebo (MC1) e di SAMe vs. clomipramina (MC2) nel trattamento
della depressione maggiore
Combined analysis of two controlled, multicentric, double blind studies
to assess efficacy and safety of Sulfo-Adenosyl-Methionine (SAMe) vs. placebo
(MC1) and SAMe vs. clomipramine (MC2) in the treatment of Major Depression
Objective and background: the meta-analysis of results of numerous trials showed that sulfo-adenosyl-methionine (SAMe), a natural substance representing the most important methyl donor in the central nervous system, is more effective than placebo and comparable to tricyclic antidepressants in depression. We aimed at analysing, in a combined manner, the results of two recent international, multi-centre, double-blind studies which compared the antidepressive efficacy of intravenous SAMe (800 mg/die for three weeks) with that of placebo (MC1) and clomipramine (MC2).
Methods: in the MC1 study, 133 patients were assessed (66 receiving SAMe and 67 receiving placebo), whereas in MC2, 286 patients were assessed, of which 143 received SAMe and 143 received clomipramine. The principal outcome measure was the end-point score on the 17-item Hamilton Depression Rating Scale (HAM-D).
Results: Analysing results of the global sample, according to the intention-to-treat-analysis, we observed that the SAMe-placebo difference approached significance, whereas clomipramine was significantly superior to placebo. Carrying-out the analysis only on severely depressed subjects (initial HAM-D scores equal or greater than 26), who are less likely to respond to placebo, the difference in efficacy vs. placebo was statistically significant for both SAMe and clomipramine. Furthermore, carrying-out the analysis only on the scores obtained on core-items of depressive psychopathology of the HAM-D, it was shown that the antidepressant effect of SAMe was not secondary to a non-specific improvement due to better general psychophysical conditions, but rather to an effect on the cognitive-affective symptoms of depression. Treatment-related side effects were not significantly different between SAMe and placebo, whereas clomipramine induced significantly more side effects than placebo.
Conclusions: These results confirms the antidepressive efficacy of SAMe, which similarly to many clinically useful compounds (SSRIs, MAOI, etc.), is superior to that of placebo, and intermediate in comparison to intravenous clomipramine. On the other hand, SAMe induces side effects not more frequently than placebo. Hence, the use of SAMe in depression appears to be justified. It could prove to be particularly indicated in the treatment of psychogeriatric patients and in those with severe somatic co-morbidity.