ObjectiveTo investigate the efficacy and safety of duloxetine and paroxetine in treating depressive patients with pain symptoms.MethodsA total of 80 depressive patients with pain symptoms were randomly divided into study group with duloxetine (n=40) and control group with paroxetine (n=40) for an 8-week treatment. Hamilton Depression Scale (HAMD), Hamilton Anxiety Scale (HAMA) and Clinical Global Impression (CGI) were used to evaluate the efficacy of duloxetine and paroxetine. Treatment Emergent Symptom Scale (TESS) and Patient Health Questionnaire (PHQ-15) were used to assess side effects and the improvement of pain symptoms, respectively. The patients were assessed at baseline and the 1st,2nd, 4th,6th,8th weekend after treatment. All statistical analyses were performed using SPSS 13.0 software. Two-sample/group t-test for independent samples and paired samples, chi-square test were applied in this study.Results1. There were no significant differences in the total score and factor scores of anxiety/somatization, weight, cognitive disturbance, retardation, sleep disturbance of HAMD between two groups on baseline (t=-1.24~0.72, P>0.05). In study group, the total score and all factor scores of HAMD were significantly lower on 1st,2nd,4th, 6th and 8th weekend after treatment than those on baseline (t=8.81~16.49, P=0.000; t=2.21~14.19, P<0.05). While in control group, the total score and all factor scores were significantly lower on 2nd,4th,6th and 8th weekend than those on baseline (t=9.04~16.14, P=0.000; t=4.08~12.26, P=0.000). Compared with control group, the total score and retardation factor score in study group were both significantly lower on 1st weekend (t=-2.20, P=0.031; t=-2.11, P=0.039). There were no statistical differences on other time-points in the total and all factor scores between two groups (P>0.05)2. When compared on baseline, there were no significant differences in the total and all factor scores of PHQ-15 between two groups (t=-1.70~1.28,P>0.05) Compared with baseline, the total scores of PHQ-15 were significantly lower on 1st, 2nd,4th,6th and 8th weekend in both study and control group(t=4.13~34.61, P=0.000). The total score was lower in study group than that in control group on each time-point after treatment (t=-3.29~-2.76, P<0.05). In study group, the pain total score and the factor scores of stomach, back, limbs, knuckles and head pain were all significantly lower on 1st,2nd,4th,6th and 8th weekend than those on baseline (t=2.08~13.11, P<0.05), while chest pain factor score decreased after the 2nd weekend(t=3.38~4.61, P<0.01)3. The total scores of HAMA had no statistical differences on baseline between two groups (t=-2.00, P>0.05). Compared with baseline, the total scores of HAMA decreased significantly on 1st,2nd,4th,6th and 8th weekend in both groups (t=2.40~23.12, P<0.05). On the 8th weekend, the total score was significantly lower in study group than that in control group (t=-2.05, P=0.044). There were no statistical differences on other time-points in the total scores between two groups (t=-1.76~-1.02,P>0.05)4. There were no statistical differences in the scores of CGI between two groups both on baseline and on the 8th weekend after treatment (t=-0.91~1.34, P>0.05)5. The adverse reactions were minor in both groups and symptoms of stomach and intestines were the most common side effects. The rates of side effects had no significant difference between two groups (P>0.05)6. There were no significant differences in blood pressure and heart rates between two groups on baseline,1st,2nd,4th,6th and 8th weekend after treatment (P>0.05) Compared with baseline, the blood pressure and heart rates had no statistical differences on 1st,2nd,4th,6th and 8th weekend in both study and control group (P> 0.05)Conclusions1. Dutoxetine should significantly treat the depressive symptoms of the patients with rapid remission and high cure rates.2. Duloxetine could significantly and specially restrain the pain symptoms of depressive patients.3. Duloxetine has a better efficacy on the treatment of anxiety than paroxetine in curing patients with depression.4. Depressive patients treated with duloxetine have minor adverse reaction. The changes of blood pressure and heart rate are related to the dosage of duloxetine. There is no influence on blood pressure and heart rate when the dosages of dutoxetine are under 90 mg per day for the patients. |