Quetiapine extended-release (Seroquel-XR) versus amitriptyline monotherapy for treating patients with fibromyalgia: a 16-week, randomized, flexible-dose, open-label trial.

RATIONALE: Previous open-label studies have suggested that quetiapine could be a valuable alternative for treating fibromyalgia. OBJECTIVE: This study aims to compare the efficacy and tolerability of extended-release quetiapine with amitriptyline for treating fibromyalgia. METHODS: This study was a randomized, open-label, flexible-dose, non-inferiority trial. Patients with fibromyalgia were randomized to receive quetiapine extended-release (XR) (N = 45) (50 to 300 mg daily) or amitriptyline (N = 45) (10 to 75 mg daily) for 16 weeks. The primary endpoint was the change from baseline to endpoint in the Fibromyalgia Impact Questionnaire (FIQ) total score; the non-inferiority threshold was established at 8 points. The secondary outcomes included sleep quality, anxiety, depression, and quality of life. RESULTS: Twenty-two (49%) patients in the quetiapine group and 34 (76%) patients in the amitriptyline group completed the study. We found a reduction of 9.8 points in the total FIQ score at the endpoint for the quetiapine-treated patients compared to 13.9 points for the amitriptyline-treated patients, for a difference of 4.14 points (80% confidence interval (CI) -0.70 to 8.98). No significant differences were found between the quetiapine XR and amitriptyline groups for any of the secondary outcomes. The proportion of patients discontinuing treatment due to adverse events was higher in the quetiapine group (n = 14, 31.1%) than the amitriptyline group (n = 3, 6.6%). CONCLUSIONS: Our results appear to indicate that quetiapine XR does not provide similar efficacy to amitriptyline for treating patients with fibromyalgia. Quetiapine XR had a worse tolerability than amitriptyline in this population, possibly due to a relatively high starting dose.

Ozone therapy as add-on treatment in fibromyalgia management by rectal insufflation: an open-label pilot study.

OBJECTIVES: The objectives of this study were to evaluate the effectiveness and tolerability of ozone therapy by rectal insufflation as add-on therapy in fibromyalgia management. DESIGN: Patients with fibromyalgia received 24 sessions of ozone therapy during a 12-week period. At each session, the administered dose of ozone was 8 mg (200 mL of gas, at a concentration of 40 µg/mL). Ozone sessions were given 5 days a week during the first 2 weeks, twice a week from weeks 3-6, and weekly from weeks 7-12. Fibromyalgia Impact Questionnaire (FIQ) was the main outcome measure, and was administered at baseline and at weeks 4, 8, and 12. Secondary outcome measures, administered at baseline and at endpoint, were the Pittsburgh Sleep Quality Index, the Beck Depression Inventory, the State and Trait Anxiety Inventory, and the SF-12, the abbreviated form of the Short Form Health Survey. Emergent adverse reactions to treatment were recorded. RESULTS: FIQ total scores decreased significantly during the study period, with the decrease being observed in the first 4 weeks of the study. Significant improvement was also seen both in depression scores and in the Physical Summary Score of the SF-12. Transient meteorism after ozone therapy sessions was the most frequently reported side-effect. CONCLUSIONS: At the dose and number of sessions used in this study, ozone therapy by rectal insufflation seems to be beneficial for physical symptoms and depression of fibromyalgia.

Amisulpride in the treatment of fibromyalgia: an uncontrolled study.

Some antipsychotics, including amisulpride, have shown to be effective in the treatment of various painful conditions, lessening pain as well as symptoms of anxiety and/or depression. In this open-label, 12-week study, we explored the efficacy and tolerability of amisulpride in patients with fibromyalgia. We recruited 40 patients, 1 male and 39 females, aged 46.2 ± 6.8 years, who met the ACR criteria for fibromyalgia and had a score equal to or greater than 4 in the pain severity item of the Fibromyalgia Impact Questionnaire (FIQ). Amisulpride was added to their current treatment regimen at an initial dose of 25 mg/day and titrated according to the clinical response and tolerability (mean final dose, 87.5 ± 41.3 mg/day). In the intent-to-treat analysis (i.e., all recruited patients), using a baseline-observation-carried-forward approach, the mean score in the FIQ decreased from 75.7 ± 10.6 to 73.2 ± 15.4, but this change was not statistically significant. Pain severity, as measured with the visual analogue scale from the FIQ, remained unchanged. Nonsignificant improvements were observed in depressive or anxiety symptoms using the Beck Depression Inventory and the State-Trait Anxiety Inventory, respectively. Twenty-six patients either withdrew from the study, mainly due to adverse reactions, or were lost to follow-up (n = 11, 27.5 %, for each category). Despite its promising results in some chronic painful conditions and in a related illness, such as chronic fatigue syndrome, amisulpride does not seem to provide any benefit to patients with fibromyalgia. Amisulpride was poorly tolerated by our participants.

Suicide attempts and risk of suicide in patients with fibromyalgia: a survey in Spanish patients.

OBJECTIVES: Depression, chronic pain and sleep disturbances frequently co-exist in FM and have shown to be independently related with suicidal behaviours. The present survey was performed to evaluate the prevalence of previous suicide attempts in patients with FM and its potential relationship with sociodemographic and clinical characteristics of the disease. METHODS: A concise survey was sent to patients of seven associations of patients with FM. In addition to the inquiry concerning the number, if any, and characteristics of suicide attempts, the survey included questions about sociodemographic and clinical data of patients as well as the revised FM impact questionnaire (FIQR) and the Plutchik suicide risk scale. RESULTS: One hundred and eighty patients answered the survey. Thirty (16.7%) of them reported one to three previous suicide attempts. Drug poisoning was the most frequently employed method for suicide attempt (70%). No relevant differences were found between suicide attempters and non-attempters in relation to age, education and marital status, but a significant difference was found in relation to employment status. Plutchik's scale scores, both in suicide attempters and non-attempters, were higher than those found in the literature. FIQR scores were significantly higher in suicide attempters than in non-attempters. A high-positive correlation was found between FIQR and Plutchik suicide risk scale scores. Pain, poor sleep quality, anxiety and depression were positively correlated with suicide risk. CONCLUSIONS: FM is associated with an increased risk of suicide and suicide attempts. Suicidal behaviour seems to be related with the global severity of the disease.

Pregabalin in the treatment of chronic migraine: an open-label study.

OBJECTIVES: Studies concerning the prophylactic treatment of chronic migraine are scarce, with topiramate being the most thoroughly studied drug at this respect. The aim of our study was to assess if pregabalin could be useful in the preventive management of chronic migraine. METHODS: Thirty consecutive chronic migraine patients, 24 women and 6 men, aged 24 to 75 years and not receiving any other prophylactic medication, were treated with pregabalin for 12 weeks. The initial daily dosage was 75 mg, subsequently adjusted according to the drug's efficacy and the individual patients' tolerability at 2-week intervals. Patients kept a headache diary from 4 weeks before drug administration until the study ended, and headache impact test (HIT-6) was administered at baseline and at 4-week intervals. The main outcome variable was the change from baseline to end point in headache frequency. The secondary outcome variables included changes in headache severity, rescue medication intake, HIT-6 scores, and adverse reactions to pregabalin. RESULTS: Pregabalin treatment was associated to significant decreases in headache frequency (P < 0.0001) and severity (P = 0.0005), rescue medication intake (P < 0.0001), and HIT-6 scores (P < 0.0001). Patients with daily headache performed worse than those with nondaily headache, showing no change in headache frequency and less relevant reduction of HIT-6 scores. The most frequent adverse reactions were dizziness (40%), somnolence (29%), abnormal thinking (16.7%), constipation and fatigue (13.3%). CONCLUSIONS: Despite the limitations of an open-label design, our data suggest that pregabalin may be a useful alternative prophylaxis for chronic migraine. These promising results should be confirmed in randomized clinical trials.