Table 2.

Adverse events observed

Adverse events	Duloxetine	Amitriptyline	P
Somnolence	18 (31)	21 (36)	0.89
Dry mouth	14 (24)	32 (55)	<0.001
Constipation	22 (37)	10 (17)	0.06
Lethargy	14 (24)	19 (33)	0.30
Insomnia	9 (15)	6 (10)	0.71
Uneasiness	11 (19)	6 (10)	0.40
Dizziness	7 (12)	8 (14)	0.86
Nausea	6 (10)	3 (5)	0.58
Anorexia	5 (8)	1 (2)	0.25
Headache	4 (7)	3 (5)	0.78
Pain abdomen	1 (2)	1 (2)	0.95
Itching	1 (2)	1 (2)	0.95
Total adverse events (n)	112	111
Mild events*	98	82	<0.02
Moderate to severe events†	14	29	<0.01

Data are n (%). n = 58 in each group.

*Mild: not requiring any intervention or discontinuation.

†Moderate to severe: limiting dose uptitration, requiring intervention or discontinuation of the drug.