Initial monotherapy with eslicarbazepine acetate for the management of adult patients with focal epilepsy in clinical practice: a meta-analysis of observational studies.

AIM OF THE STUDY: To assess the effectiveness, overall tolerability of eslicarbazepine acetate (ESL) as an initial or early monotherapy treatment of adult patients with focal epilepsy under real-world practice conditions. MATERIALS AND METHODS: We focused on real-world longitudinal studies that included or separately reported the results of at least one of the efficacy outcomes of interest. A DerSimonian-Laird random effects model was used with the presentation of the 95% confidence intervals of the estimate. RESULTS: 5 studies met our selection criteria and were included in the quantitative synthesis. All studies were observational and uncontrolled studies, and all but one were retrospective studies. The pooled proportion of patients who were seizure-free for the entire study period was 64.6% (95% CI, 45.7 to 79.8) at month 6 and 56.6% (95% CI, 50.2 to 62.8) at month 12. Pooled retention rates were 95.0% (95% CI, 90.3 to 97.5) at 6 months and 83.6% (95% CI, 73.9 to 90.1) at 12 months. The pooled proportion of patients who reported at least one adverse event was 27.2% (95% CI, 21.7 to 33.6), and the pooled proportion of patients who discontinued ESL due to adverse events was 8.9% (95% CI 6.2 to 12.6). CONCLUSIONS: Our results suggest that initial or early monotherapy with ESL is effective and well-tolerated for the management of adult patients with focal epilepsy in clinical practice, with results that are at least similar to those reported in the pivotal randomized clinical trial of ESL monotherapy. No new safety signals with ESL have been identified in this systematic review.

A Systematic Review on the Association between Schizophrenia and Bipolar Disorder with Chronic Obstructive Pulmonary Disease.

A systematic review aimed to investigate the association between schizophrenia and bipolar disorder and chronic obstructive pulmonary disease (COPD), its prevalence and incidence, potential factors associated with its occurrence and its impact on mortality among these patients. We performed the literature search in PubMed, Scopus and PsycInfo from inception to February 2022 and identified 19 studies: ten cross-sectional, 5 that included cross-sectional and longitudinal analyses, and 4 retrospective cohort studies. The reported prevalence of COPD ranged from 2.6% to 52.7% in patients with schizophrenia and between 3.0% and 12.9% in patients with bipolar disorder. Two studies reported an annual incidence of COPD of 2.21 cases/100 person-years in patients with schizophrenia and 2.03 cases/100 person-years in patients with bipolar disorder. Among the risk factors evaluated in three studies, only advanced age was consistently associated with the presence/occurrence of COPD in patients with schizophrenia and bipolar disorder; the role of tobacco consumption was not investigated in those three studies. According to two studies, the likelihood of mortality from COPD showed an over 3-fold increase in patients with schizophrenia and a 2-fold increase in those with bipolar disorder compared to the overall population; COPD was also associated with increased inpatient mortality. Available data indicate that COPD in patients with schizophrenia and bipolar disorder is a major public health problem. National and international health organizations should strive to specifically address this issue by creating awareness about this health problem and developing specific programs for screening and early intervention aimed to reduce the burden of COPD in these populations.

Marital adjustment in patients with fibromyalgia: its association with suicidal ideation and related factors. A cross-sectional study.

OBJECTIVES: Fibromyalgia has been associated with suicidal ideation, suicide attempts and completed suicide. Non-married status is a risk factor for suicidal behaviours but the quality of the marital relationship has been scarcely investigated. The objectives of the present study were to evaluate, in patients with fibromyalgia, the relationship between marital adjustment suicidal ideation and potentially related variables: depression severity, sleep disturbance, perceived burdensomeness, thwarted belongingness, fibromyalgia severity and pain intensity. METHODS: A survey was done in patients with fibromyalgia which collected sociodemographic data and included the following questionnaires: the Locke and Wallace Marital Adjustment Test, the Beck's Depression Inventory II, the Plutchik Suicide Risk Scale, a 10-item version of the Interpersonal Needs Questionnaire, the Insomnia Severity Index, and the Revised Fibromyalgia Impact Questionnaire. Suicidal ideation was assessed with item 9 of the Beck's Depression Inventory, and pain intensity was measured with the VAS scale of the Revised Fibromyalgia Impact Questionnaire. RESULTS: Of 257 participants 71 were single, 107 had a good marital adjustment and 79 a poor marital adjustment. Suicidal ideation was most frequent among patients with poor marital adjustment than among those with good marital adjustment or patients without partner. The poor marital adjustment group showed significantly worse scores in most of the remaining variables with the only exceptions of the FIQR and pain scores. CONCLUSIONS: In patients with fibromyalgia the degree of marital adjustment seems to be a relevant factor for suicidal ideation and related variables.

Patterns of pharmacologic and non-pharmacologic treatment, treatment satisfaction and perceived tolerability in patients with fibromyalgia: a patients' survey.

OBJECTIVES: To evaluate the patterns of treatment among patients with fibromyalgia (FM) in Spain and to assess patient satisfaction and perceived tolerability of the treatment received. METHODS: An observational, cross-sectional study was conducted in Spain via internet from September 2015 to March 2017. We recorded sociodemographic and clinical information, including treatment satisfaction evaluated using a 10-point numerical rating scale (NRS) and adverse events. RESULTS: Evaluable subjects (n=915) were predominantly middle-aged, married women who presented with moderate to severe pain, sleep disturbance and affected quality-of-life. The most frequent non-pharmacologic treatments were physical exercise (85%), diet (47%), supplements such as magnesium and vitamins (47%), and psychotherapy (31%). The most frequently prescribed drugs were tramadol (40%), benzodiazepines (30%), duloxetine (22%), pregabalin (19%), amitriptyline (17%) and nonsteroidal anti-inflammatory drugs (NSAIDs; 16%); 7.5% of patients received stronger opioids. After excluding benzodiazepines, NSAIDs, and paracetamol, 46% of patients received ≥2 drugs. Satisfaction with treatment (NRS mean score) was generally poor for pharmacologic treatment (4.1), exercise (4.7), psychotherapy (5.2), diet (5.0), physiotherapy (6.2) and acupuncture (6.3). The increase in the number of drugs prescribed was not associated with an increase in satisfaction, but rather with an increase in adverse events. CONCLUSIONS: Patients with FM in Spain are overtreated with a combination of non-pharmacologic and pharmacologic therapies. Several of these therapies lack adequate support from randomised clinical trials and/or clinical practice guidelines. This overtreatment is not associated with relevant clinical benefits or patient satisfaction and, in the case of pharmacologic treatments, poses tolerability and safety issues.

A Real-World Study on Antidepressant-Associated Sexual Dysfunction in 2144 Outpatients: The SALSEX I Study.

The objective of this cross-sectional study was to evaluate the frequency, impact, and management of sexual dysfunction associated with commonly prescribed antidepressants available in psychiatry outpatient clinics in Spain. We recruited 2163 adult patients who had undergone treatment with antidepressants for at least 8 weeks and had a history of normal sexual functioning before the prescription of the antidepressant, except for mildly impaired libido. We used the Psychotropic-Related Sexual Dysfunction Questionnaire (PRSexDQ-SALSEX) for evaluating the frequency and tolerance of sexual dysfunction and whether this side effect was spontaneously reported. Overall, 79% patients showed sexual dysfunction, as indicated by a total score ≥ 3 on the PRSexDQ-SALSEX; 64% showed moderate-severe sexual dysfunction, with no differences between men and women on these outcomes. In the multivariate logistic regression analysis, treatment with a serotonergic antidepressant and having a severe clinical state of psychiatric illness were the factors associated with the highest likelihood of presenting with sexual dysfunction. Sexual dysfunction was spontaneously reported by 838 (41%) of the 2066 evaluable patients for this outcome. Among patients with sexual dysfunction, this condition was poorly tolerated by 22% of the patients, with these frequencies being significantly higher in men than in women. The most frequently used strategies employed by the psychiatrists in our study for dealing with sexual dysfunction were switching to another antidepressant (34%) and waiting for spontaneous resolution (33%). In conclusion, our results indicate that despite being a well-known, long-standing side effect of antidepressants, sexual dysfunction continues to be extremely common in patients receiving antidepressants, especially serotonergic ones, potentially jeopardizing treatment success in a substantial proportion of patients. There are important sex differences in the reporting and tolerance of sexual dysfunction that require further investigation.

Waterpipe and cigarette smoking among adolescents in Seville (Spain): prevalence and potential determinants. / Consumo de pipas de agua y cigarrillos entre adolescentes de Sevilla (España): prevalencia y potenciales determinantes.

Letter to the editor.

Carta al Editor.

Suicidal behaviors in patients with rheumatic diseases: a narrative review.

Chronic rheumatic disorders are characterized by inflammation and chronic pain, and both anxiety and depression have been frequently observed in these patients. Depression and chronic pain are recognized as risk factors for the development of suicidal behaviors. Accordingly, the objective of the present review is to provide a comprehensive review of suicidal behaviors associated with rheumatic diseases. Medline and EMBASE were searched for English language publications using key words related with rheumatic diseases, suicide, suicide attempts, and suicidal ideation. 34 records (30 full-length published papers and 4 studies published in abstract form) that included data related to the frequency and/or potential determinants of suicidal behaviors in rheumatic diseases were included in the review. It was found that both suicidal ideation and completed suicide seem to be more frequent in patients experiencing systemic lupus erythematosus, fibromyalgia and arthritis. Major determinants were comorbid depression in fibromyalgia and arthritis, and neuropsychiatric disease in systemic lupus erythematosus. Based on these findings, suicide risk should be assessed in patients suffering from systemic lupus erythematosus, fibromyalgia and/or arthritis.

The Effects of a Gluten-free Diet Versus a Hypocaloric Diet Among Patients With Fibromyalgia Experiencing Gluten Sensitivity-like Symptoms: A Pilot, Open-Label Randomized Clinical Trial.

BACKGROUND AND AIMS: Patients with fibromyalgia frequently present with symptoms similar to those experienced by patients with gluten-related disorders, raising the possibility that a subgroup of these patients could be experiencing underlying gluten sensitivity. This study aimed to evaluate the effects of a gluten-free diet (GFD) compared with a hypocaloric diet (HCD) among patients with fibromyalgia. METHODS: Adult patients diagnosed with fibromyalgia were randomly allocated to receive a GFD or a HCD over a 24-week period. The primary outcome measure was the change in the number of gluten sensitivity symptoms. The following secondary outcomes were evaluated: body mass index, Revised Fibromyalgia Impact Questionnaire, Pittsburgh Sleep Quality Index, Brief Pain Inventory, Beck Depression Inventory-II, State-Trait Anxiety Inventory, Short-Form Health Survey, Patient Global Impression Scale of Severity, Patient Global Impression Scale of Improvement, and adverse events. RESULTS: Seventy-five subjects were randomly allocated to receive either a GFD (n=35) or an HCD (n=40). The least squares mean change in the total number of gluten sensitivity symptoms from baseline did not differ significantly between the GFD and HCD groups (-2.44±0.40 for the GFD; -2.10±0.37 for the HCD; P=0.343). Similarly, the 2 dietary interventions did not differ in any of the remaining measured secondary outcomes. Both dietary interventions were well tolerated. CONCLUSIONS: Both dietary interventions were associated with similar beneficial outcomes in reducing gluten sensitivity symptoms and other secondary outcomes. However, despite its specificity, GFD was not superior to HCD in reducing the number of gluten sensitivity symptoms or secondary outcomes.

An insight into the gastrointestinal component of fibromyalgia: clinical manifestations and potential underlying mechanisms.

Fibromyalgia syndrome is characterized by chronic generalized pain accompanied by a broad symptomatologic spectrum. Besides chronic fatigue, sleep disturbances, headaches and cognitive dysfunction that are extensively described in the literature, a considerable proportion of patients with fibromyalgia experience gastrointestinal symptoms that are commonly overlooked in the studies that are not specifically dedicated to evaluate these manifestations. Nevertheless, various attempts were undertaken to explore the gastrointestinal dimension of fibromyalgia. Several studies have demonstrated an elevated comorbidity of irritable bowel syndrome (IBS) among patients with fibromyalgia. Other studies have investigated the frequency of presentation of gastrointestinal symptoms in fibromyalgia in a nonspecific approach describing several gastrointestinal complaints frequently reported by these patients such as abdominal pain, dyspepsia and bowel changes, among others. Several underlying mechanisms that require further investigation could serve as potential explanatory hypotheses for the appearance of such manifestations. These include sensitivity to dietary constituents such as gluten, lactose or FODMAPs or alterations in the brain-gut axis as a result of small intestinal bacterial overgrowth or subclinical enteric infections such as giardiasis. The gastrointestinal component of fibromyalgia constitutes a relevant element of the multidisciplinary pathophysiologic mechanisms underlying fibromyalgia that need to be unveiled, as this would contribute to the adequate designation of relevant treatment alternatives corresponding to these manifestations.

Suicidal ideation in patients with fibromyalgia: a cross-sectional study.

Chronic pain, sleep disturbances, and depression, which are relevant symptoms of fibromyalgia syndrome, have been demonstrated to be associated with an increased likelihood of suicidal behaviors. Mortality from suicide has been shown to be greater among patients with fibromyalgia. This study aimed to assess the prevalence of suicidal ideation among a sample of patients with fibromyalgia and to evaluate its relationship with the clinical symptomatology of fibromyalgia. Baseline data from fibromyalgia patients willing to participate in different clinical studies were collected. Outcome measures included the Fibromyalgia Impact Questionnaire, the Beck Depression Inventory, the Pittsburgh Sleep Quality Index, the Brief Pain Inventory, and the SF-12 Health Survey. The scores for these scales were compared between patients with and without suicidal ideation. The presence of suicidal ideation was assessed using the answer provided to item 9 of the Beck Depression Inventory. The results were adjusted by age, sex, total comorbidity, and time since diagnosis with multiple linear regression. The sample comprised 373 patients of whom one hundred and seventy-nine (48%) reported suicidal ideation: 148 (39.7%) reported passive suicidal ideation and 31 (8.3%) active suicidal ideation. Suicidal ideation was markedly associated with depression, anxiety, sleep quality, and global mental health, whereas only weak relationships were observed between suicidal ideation and both pain and general physical health.

An overview of the current and emerging treatment options for vestibular migraine.

INTRODUCTION: Vestibular migraine is a relatively common syndrome characterized by the occurrence of vertigo and other vestibular symptoms, frequently -but not always- accompanied by migraine symptoms, such as headache, photophobia, and phonophobia. AREAS COVERED: The authors review the acute or abortive treatment during an attack and prophylactic treatment of vestibular migraines, including pharmacological and non-pharmacological options. EXPERT OPINION: Since its recognition as an independent clinical entity is recent, studies concerning its different treatment alternatives are still scarce, and the level of evidence of published studies is generally low. For acute treatment, although available data are conflicting, triptans are usually tried first. Neurostimulating devices can also be considered for acute treatment of vestibular migraine. Regarding the preventive treatment of vestibular migraine, based on the results of two randomized clinical trials and its pharmacological properties, flunarizine should be considered as the first treatment option. Second-line preventive treatments encompass propranolol, topiramate, venlafaxine, and valproic acid. Among non-pharmacological options, vestibular rehabilitation seems to be a sound prophylactic treatment option.

Low lung function in Bipolar Disorder and Schizophrenia: a hidden risk.

Introduction: People with serious mental illness (SMI), such as schizophrenia and bipolar disorder, have a higher risk of premature morbidity and mortality. In the general population, impaired lung function is associated with increased morbidity and mortality. We compared lung function between people with and without serious mental illnesses using a cross-sectional study in 9 community mental health units. Methods: Subjects aged 40-70 years with a diagnosis of schizophrenia or bipolar disorder were recruited consecutively. The controls had no psychiatric diagnosis and were not receiving any psychotropics. Spirometry was performed by a trained nurse. We used the 2021 American Thoracic Society/European Respiratory Society standards for the interpretation of the spirometry results. Results: We studied 287 subjects. People with SMI (n = 169) had lower spirometry values than those without a psychiatric diagnosis (n = 118). An abnormal spirometry pattern (36.1% vs 16.9%, p < 0.001), possible restriction or non-specific (Preserved Ratio Impaired Spirometry [PRISm]) pattern (17.8% vs 7.6%, p = 0.014), and pattern of airflow obstruction or possible mixed disorder (18.3% vs 9.3%, p = 0.033) were more frequent in people with SMI. Multivariate analyses showed that the PRISm pattern was associated with abdominal circumference (odds ratio [OR] 1.05, 95%CI 1.03-1.08) and that the pattern of airflow obstruction or possible mixed disorder was associated with smoking behavior (OR 5.15, 95%CI 2.06-15.7). Conclusion: People with SMI have impaired lung function, with up to one-third of them showing an abnormal spirometry pattern. This suggests that regular monitoring of lung function and addressing modifiable risk factors, such as tobacco use and obesity, in this population is of paramount importance.

Lung function decline in people with serious mental illness: A call to action.

This prospective observational study aimed to evaluate the rate of change in forced expiratory volume in the first second (FEV1) and to explore the factors associated with changes in FEV1 in people with serious mental illness (SMI). Sixty subjects diagnosed with schizophrenia or bipolar disorder who were smokers and without history of respiratory illness agreed to participate. The mean (range) follow-up period was 3.54 (3.00-4.98) years. The mean (standard deviation) annual rate of change in FEV1 decreased by 39.1 (105.2) mL/year. Thirty-one (51.7 %) patients experienced a decrease in the FEV1 ≥40 mL/year (i.e. a rapid decline). The factors associated with the absolute change in FEV1 were the baseline International Physical Activity Questionnaire activity score in metabolic equivalents of tasks (ß 0.145, 95 % confidence interval [CI] 0.043 to 0.246; p = 0.005), baseline FEV1 (ß -0.025, 95 % CI -0.076 to 0.027; p = 0.352), and the interaction term of both variables (ß -3.172e-05, 95 % CI -6.025e-05 to -0.319e-05; p = 0.029). The factors associated with rapid FEV1 decline were income (odds ratio [OR] 0.999, 95 % CI 0.995 to 1.003; p = 0.572), the rate of change in abdominal circumference (OR 0.000, 95 % CI 0.000 to 0.890; p = 0.081), and the interaction term of both variables (OR 1.038, 95 % CI 1.010 to 1.082; p = 0.026). In conclusion, a substantial proportion of people with SMI experienced a rapid decrease in FEV1. If our results are confirmed in larger samples, the routine evaluation of lung function in people with SMI would be an opportunity to identify individuals at greater risk of morbidity and mortality.

A naturalistic study on the effectiveness of long-acting antipsychotics in an early intervention program for patients with recent-onset psychosis.

AIM: To evaluate the impact of long-acting injectable antipsychotics (LAIs) on the risk of hospitalization and the length of hospitalization in the setting of an early intervention program for patients with recent-onset psychosis. METHODS: Observational, retrospective study conducted under routine clinical practice conditions. We included all patients admitted from July 2015 to April 2020 to the Early Intervention Program in Psychosis. We analysed the incidence of hospitalization and hospitalization days before and after treatment with LAIs and calculated the incidence rate ratio (IRR). We also compared the outcomes of patients treated with LAIs with those of the patients maintained on oral antipsychotics using a binomial negative regression analysis. RESULTS: A total of 170 patients were included in the program. Of them, 34 (20%) received LAIs (aripiprazole [n = 22], and paliperidone/risperidone [n = 12]). There was an 89% reduction in the incidence of hospitalizations after treatment with LAIs (IRR 0.11, 95%CI 0.05-0.21; p < .0001). The IRR for LAIs vs. oral antipsychotics was 0.87 (95%CI, 0.24-3.18; p = .829). The presence of a substance use disorder significantly increased the rate of hospitalizations by 123% (IRR 2.23, 95%CI 1.31-3.78). Analyses of hospitalization days showed similar results. CONCLUSIONS: Our results suggest that LAIs are useful for the management of patients with recent-onset psychosis who fail treatment with oral antipsychotics. Whether LAIs are superior to oral antipsychotics as first-line treatment of patients with early psychosis and/or could play a special role in managing patients with early psychosis and comorbid substance use disorders should be further evaluated.

Sexual functioning in women and men with fibromyalgia.

INTRODUCTION: Sexual dysfunction has been associated with several chronic pain conditions, including fibromyalgia. However, the literature on sexual functioning in patients with fibromyalgia is limited and restricted to female patients. AIM: The aim of our study was to evaluate sexual functioning in female and male patients with fibromyalgia compared with healthy controls. MAIN OUTCOME MEASURE: Sexual functioning was evaluated using the Spanish validated version of the Changes in Sexual Functioning Questionnaire (CSFQ). METHODS: We used baseline data from several studies performed in adult patients with fibromyalgia (American College of Rheumatology criteria) of both sexes in which sexual functioning was included in the clinical evaluation. As a control group, we selected an age-matched group of healthy subjects. We calculated the proportion of patients exhibiting sexual dysfunction (i.e., a CSFQ total score equal to or lower than 41 in females and 47 in males). CSFQ scores for patients and controls were compared, and the effect sizes for the difference of means were calculated. RESULTS: Our sample comprised 293 patients with fibromyalgia (276 females and 17 males) and 86 healthy controls (72 females and 14 males). The frequency of sexual dysfunction was significantly higher in patients with fibromyalgia than in controls for both females (86.9% vs. 23.6%; relative risk [RR] 3.7, 95% confidence interval [CI], 2.4-5.6) and males (76.5% vs. 6.7%; RR 11.5, 95% CI, 1.7-77.6). We found significantly worse sexual functioning for all dimensions in both female and male patients with fibromyalgia. Effect sizes for the difference in mean scores of the CSFQ were large overall and for all dimensions in both females and males. CONCLUSION: Our results show that sexual dysfunction is common in patients with fibromyalgia. The disease seems to deeply affect all dimensions of sexual functioning in both females and males.

Monotherapy or combination therapy for fibromyalgia treatment?

Fibromyalgia is a chronic pain disease whose clinical symptomatology also includes different symptom domains: fatigue, sleep disturbances, morning stiffness, dyscognition, and psychological distress. These associated symptoms usually vary in frequency and intensity from patient to patient. Because the efficacy of monotherapy is limited, more severely affected patients frequently require drug combinations. There is, however, scarce scientific information concerning the benefits and risks of such combinations. To date, only ten studies investigating the efficacy and tolerability of two-drug combinations have been published; some of these studies are old and/or studied drugs that are now known to be of little or no interest in fibromyalgia management. Thus, when polytherapy is considered, therapeutic decisions must be based on data from monotherapy trials and a sound knowledge of the pharmacological profile of each drug. Well-designed clinical trials exploring specific drug combinations selected on the basis of potential additive or synergistic effects should be performed.

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.

Subgrouping patients with fibromyalgia according to the results of the Fibromyalgia Impact Questionnaire: a replication study.

Fibromyalgia is a complex and heterogeneous disease, and several attempts have been made in order to identify different subgroups of patients sharing a common symptomatology. The purpose of the present study has been to replicate a subgroup classification proposed by de Souza et al. based in the Fibromyalgia Impact Questionnaire (FIQ) in a large sample of patients with a cultural and clinical setting different from the original one. Four hundred twenty-one patients were classified, according to the results of the visual analog FIQ subscales in type I o type II subgroups. Demographic and clinical data, as well as results of scales assessing disease's severity, quality of life, sleep quality, anxiety and depression, were compared between the two groups. The profiles of type I and type II patients from our sample strikingly paralleled those of the original study, demonstrating the reproducibility of the classification. In our sample, 18.8% of the patients appertained to type I subgroup and 81.2% to type II subgroup. Patients from this later subgroup had higher comorbidity and received more drugs than those of the former. They were also more physically ill, with higher FIQ total scores and worse sleep quality, and more psychologically distressed, with higher levels of anxiety and depression and lower scores in the mental component summary of the Short-Form Health Questionnaire (SF-12). Our study shows that the proposed fibromyalgia classification is reliable and easy to perform and could be applied in further studies.

Trazodone plus pregabalin combination in the treatment of fibromyalgia: a two-phase, 24-week, open-label uncontrolled study.

BACKGROUND: Although trazodone is frequently used by fibromyalgia patients, its efficacy on this disease has not been adequately studied. If effective, pregabalin, whose beneficial effects on pain and sleep quality in fibromyalgia have been demonstrated, could complement the antidepressant and anxiolytic effects of trazodone. The aim of the present study was to assess the effectiveness of trazodone alone and in combination with pregabalin in the treatment of fibromyalgia. METHODS: This was an open-label uncontrolled study. Trazodone, flexibly dosed (50-300 mg/day), was administered to 66 fibromyalgia patients during 12 weeks; 41 patients who completed the treatment accepted to receive pregabalin, also flexibly dosed (75-450 mg/day), added to trazodone treatment for an additional 12-week period. Outcome measures included the Fibromyalgia Impact Questionnaire (FIQ), the Pittsburgh Sleep Quality Index (PSQI), the Beck Depression Inventory (BDI), the Hospital Anxiety and Depression Scale (HADS), the Brief Pain Inventory (BPI), the Short-Form Health Survey (SF-36), and the Patients' Global Improvement scale (PGI). Emergent adverse reactions were recorded. Data were analyzed with repeated measures one-way ANOVA and paired Student's t test. RESULTS: Treatment with trazodone significantly improved global fibromyalgia severity, sleep quality, and depression, as well as pain interference with daily activities although without showing a direct effect on bodily pain. After pregabalin combination additional and significant improvements were seen on fibromyalgia severity, depression and pain interference with daily activities, and a decrease in bodily pain was also apparent. During the second phase of the study, only two patients dropped out due to side effects. CONCLUSIONS: Trazodone significantly improved fibromyalgia severity and associated symptomatology. Its combination with pregabalin potentiated this improvement and the tolerability of the drugs in association was good. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00791739.