ABSTRACT
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 tolerated. CONCLUSIONS: Despite its efficacy in improving sleep quality, levopromazine does not appear to be a useful alternative treatment for fibromyalgia.
Subject(s)
Fibromyalgia/drug therapy , Methotrimeprazine/therapeutic use , Patient Satisfaction , Sleep/drug effects , Adult , Analgesics, Non-Narcotic/therapeutic use , Analysis of Variance , Female , Humans , Intention to Treat Analysis , Male , Middle Aged , Pain Measurement , Quality of Life , Surveys and Questionnaires , Treatment OutcomeABSTRACT
INTRODUCTION: Quetiapine has been shown to improve fibromyalgia symptoms, especially sleep disturbance, fatigue, morning stiffness, and mental well-being, but lacks an effect on pain. The purpose of this study was to evaluate if pregabalin, which has shown antialgic activity in fibromyalgia, added to quetiapine treatment additionally improved fibromyalgia symptomatology. METHODS: This was an open-label, 12-week study. Pregabalin was administered to 19 female fibromyalgia patients at a starting dose of 75 mg/day subsequently adjusted in according to the drug's efficacy and tolerability. Outcome measures included the Fibromyalgia Impact Questionnaire (FIQ), the Pittsburgh Sleep Quality Index, the Beck Depression Inventory, the State and Trait Anxiety Inventory, and the SF-12 Health Survey. RESULTS: Data analysis was done on the Intention-To-Treat sample which included 18 patients. Pregabalin significantly improved the pain and tiredness after awakening subscales of the FIQ as well as the physical component of the SF-12. Six patients withdrew from the study, 3 because of side effects. CONCLUSIONS: Our results suggest that the use of pregabalin can be a useful augmentation strategy in fibromyalgia patients partially responding to quetiapine.
Subject(s)
Analgesics/therapeutic use , Dibenzothiazepines/therapeutic use , Fibromyalgia/drug therapy , gamma-Aminobutyric Acid/analogs & derivatives , Adult , Analgesics/administration & dosage , Analgesics/adverse effects , Dibenzothiazepines/administration & dosage , Dose-Response Relationship, Drug , Drug Therapy, Combination , Female , Humans , Middle Aged , Pregabalin , Prospective Studies , Quetiapine Fumarate , gamma-Aminobutyric Acid/administration & dosage , gamma-Aminobutyric Acid/adverse effects , gamma-Aminobutyric Acid/therapeutic useABSTRACT
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