Clinical trial in the relief of cancer pain in a combined therapy by Duloxetine plus Morphine sulfate

Abstract

Abstract: AIM: In order to provide a good reference for clinical treatment, the efficacy and tolerability of Duloxetine plus Morphine sulfate with a single morphine treatment in cancer pain management were compared.METHODS: One hundred and eighty patients with moderate to severe cancer-related pain were enrolled in this randomized, open-label, 12-week clinical study. Subjects were assigned to either a single therapy group (Morphine sulfate sustained release tablet, 100-200 mg/day) or a combined therapy group (same dose of Morphine sulfate sustained release tablet plus Duloxetine 30 mg/day for the first 2 weeks and 60 mg/day thereafter). The follow-up was performed at the baseline and the end of the 4th- , the 8th- and the twelfth-week respectively. Short-Form McGill Pain Questionnaire (SF-MPQ) and the 10-point visual analog scale (VAS) were used to assess the severity of pain. Depressive and anxiety symptoms were assessed using the Hamilton rating scale for depression and Hamilton rating scale for anxiety. The treatment emergent symptom scale and dropout rate were recorded to evaluate the tolerability.RESULTS: A similar dropout rates were noted in the single treatment arms compared to combined treatment arms (8.9% at 4 weeks, 15.6% at 8 weeks and 23.3% at 12 weeks vs 10.0% at 4 weeks, 17.8% at 8 weeks and 25.6% at 12 weeks, all P>0.05). Adverse events such as constipation, sudation and palpitation were higher in the combined treatment group than the single treatment group,but no significant group difference was found. A group difference markedly appeared between combined therapy group and single treatment group in the total score decreases in VAS in week 4 and week 12 [(3.3±0.9) vs (2.1±0.6);(6.4±0.8) vs (4.5±0.5), P<0.01, respectively]. Although no statistical difference appeared in SF-MPQ total score change, higher score-decrease values were found in respect to the painful emotion dimension in combined treatment group as compared to the single treatment group in week 8 and week 12 [(4.2±1.3) vs (2.3±1.0);(6.8±2.9) vs (4.6±1.7), P<0.01, respectively].CONCLUSION: Duloxetine plus Morphine sulfate sustained release tablet is superior to single Morphine sulfate sustained release tablet in the treatment of cancer-related pain in efficacy and has a good tolerability.

Key words: Cancer, Pain, Morphine, Duloxetine, Efficacy, Tolerability

CLC Number:

R614

DAI Zhi-yuan, ZHENG Fang, LI De-qiang. Clinical trial in the relief of cancer pain in a combined therapy by Duloxetine plus Morphine sulfate[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2013, 18(10): 1138-1143.

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