Preliminary results of a randomized controlled trial carried out with a fixed combination of S-adenosyl-L-methionine and betaine versus amitriptyline in patients with mild depression

Figures & data

Figure 1 Scheme of the study.

Abbreviation: SAMe, S-adenosyl-L-methionine.

Table 1 Features of participants on enrollment

	Amitriptyline (N=30)	SAMe/betaine (N=30)
Sex (males/females)	16/14	15/15
Female age (years)	46.2±14.4	47.7±14.7
Male age (years)	53.9±15.9	46.0±17.6
Months from diagnosis	2.2±0.3	1.9±0.2

Note: All values are expressed as median ± standard deviation.

Abbreviation: SAMe, S-adenosyl-L-methionine.

Table 2 Score according to the Zung Depression Self-Rating Scale

Time	Amitriptyline (A)	P (vs T=0)	SAMe/betaine (B)	P (vs T=0)	P (B vs A)
T=0	50.6±3.8		50.7±3.8		ns
T=3	47.9±4.0 (−4.4%)	ns	47.3±3.7 (−6.7%)	ns	ns
T=6	39.4±4.9 (−22.2%)	<0.01	33.2±5.8 (−34.6%)	<0.01	<0.05
T=12	41.6±6.1 (−17.8%)	<0.01	31.7±7.8 (−37.5%)	<0.01	<0.01

Notes: All values are expressed as median ± standard deviation. Time expressed as months. In brackets: % reduction versus T=0.

Abbreviations: SAMe, S-adenosyl-L-methionine; ns, not significant.

Table 3 Number of subjects with score >30 according to the Zung Depression Self-Rating Scale

Time	Amitriptyline (A)	P (vs T=0)	SAMe/betaine (B)	P (vs T=0)	P (B vs A)
T=0	30		30		ns
T=3	30	ns	30	ns	ns
T=6	26	ns	15	<0.01	<0.01
T=12	29	ns	11	<0.01	<0.01

Notes: All values are expressed as median ± standard deviation. Time expressed as months.

Abbreviations: SAMe, S-adenosyl-L-methionine; ns, not significant.

Table 4 Tolerability assessment (N=32/group)

Tolerability	N (Amitriptyline)	N (SAMe/betaine)
Very poor	2	0
Poor	8	0
Fair	12	1
Good	10	4
Excellent	0	27

Abbreviations: N, number of individuals per group; SAMe, S-adenosyl-L-methionine.

Table 5 Compliance assessment (N=30/group)

Compliance	N (Amitriptyline)	N (SAMe/betaine)
Very poor	0	2
Poor	24	10
Fair	4	11
Good	2	7
Excellent	0	2

Abbreviations: N, number of individuals per group; SAMe, S-adenosyl-L-methionine.