An open-label study of levopromazine (methotrimeprazine) as an add-on therapy in fibromyalgia management

Clinical and Experimental Rheumatology

E.P. Calandre¹  P. Morillas-Arques¹  J. Hidalgo¹  A. Delgado-Rodriguez¹  J.S. Vilchez¹  F. Rico-Villademoros¹ 

关键词: Fibromyalgia;    methotrimeprazine;    levopromazine;    antipsychotic;    neuroleptic;    analgesic;    chronic pain;    sleep.;   

DOI  :  

学科分类：医学（综合）

来源: Pacini Editore SpA

【 摘 要 】

OBJECTIVES:To assess the potential efficacy and tolerability of levopromazine(methotrimeprazine) in the treatment of fibromyalgia.METHODS:Unicentre, open-label study conducted in thirty-five outpatients, aged 18 years or older, who met the ACR criteria for fibromyalgia and had not satisfactorily responded to previous fibromyalgia treatment. Levopromazine, flexibly dosed (12.5-100 mg/d), was added to the outpatients` original treatment regimens for 12 weeks. The primary outcome measure was the mean change from baseline to endpoint in the Fibromyalgia Impact Questionnaire (FIQ) total score in the intent-to-treat sample. Secondary outcomes included the Clinical Global Impression (CGI) of Severity scale, Pittsburgh Sleep Quality Index (PSQI), Beck Depression Inventory, State-Trait Anxiety Inventory, 12-Item Short Form Health Survey, and individual items of the FIQ.RESULTS:The mean FIQ total score did not decrease significantly at the study endpoint (63.37 SD 11.32 vs. 61.19 SD 9.32, p=0.73). Pain intensity, as evaluated by the Visual Analogue Scale, remained unchanged at study endpoint (8.5 SD 1.6 vs. 8.2 SD 1.2, p=0.49). A statistically significant reduction was observed in the PSQI score (15.65 SD 3.33 vs. 12.23 SD 3.79, p<0.001, effect size: 1.03) and the CGI-severity score (4.71 SD 0.64 vs. 4.03 SD 1.01, p<0.002, effect size: 1.06). No significant or relevant changes were seen in the remaining fibromyalgia symptoms, psychopathological scales or quality-of-life. The drug was well toleratedCONCLUSIONS:Despite its efficacy in improving sleep quality, levopromazine does not appear to be a useful alternative treatment for fibromyalgia.

【 授权许可】

Unknown