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.

Dietary habits in patients with fibromyalgia: a cross-sectional study.

OBJECTIVES: To the scarce information on dietary habits in fibromyalgia (FM), it is added that there are no comparative studies with other rheumatic diseases. The objective of this study was to characterise the dietary habits of patients with FM by comparing, for the first time, with healthy controls (HC) and rheumatoid arthritis (RA). METHODS: This cross-sectional, observational study was based on data obtained from the Dietfibrom project for FM and from the IMID Consortium for RA and HC. All participants completed a food frequency questionnaire evaluating their weekly dietary intake of main food groups. The three cohorts were compared using a multiple logistic regression model adjusted for age, sex, and body mass index. RESULTS: After quality control, n=287 FM, n=1,983 HC and n=1,942 RA patients were analysed. We found that FM had a profound impact in the diet compared to HC, reducing the consumption of dairy (OR=0.32, p<0.0001), bread and/or whole grain cereals (OR=0.59, p=0.0006), fresh fruit (OR=0.66, P=0.008), and fish (OR=0.64, p=0.002). These same four food groups were also significantly reduced in FM patients in comparison to RA patients (p<0.0005 in all cases). Additionally, a lower consumption of pasta, rice and/or potatoes was also observed in FM compared to RA (OR=0.72, p=0.028). CONCLUSIONS: The present cross-sectional study shows that FM is associated to a significant change in the normal dietary patterns. These results underscore the importance of diet in this prevalent disease and are a warning of the potential long-range effects of a deficient nutritional status.

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.

Pelvic floor dysfunction in women with fibromyalgia and control subjects: Prevalence and impact on overall symptomatology and psychosocial function.

AIMS: To evaluate the prevalence, distress, and impact of pelvic floor dysfunction (PFD) symptomatology in women with fibromyalgia and control women. We also aimed to evaluate the impact of PFD symptomatology on several psychosocial measures such as mood, sleep, pain, and quality of life. METHODS: We conducted a cross-sectional study in women with fibromyalgia and control women from the general population. Using a structured survey, we collected sociodemographic and clinical data, assessed the prevalence of PFD and evaluated the distress (PFDI-20) and the impact (PFIQ-7) caused by its symptomatology. Using Spanish-validated questionnaires, we also evaluated mood and sleep disturbances, bodily pain, and quality of life in subjects with and without PFD. In participants with fibromyalgia, we assessed the severity and impact of the disease using the Fibromyalgia Impact Questionnaire (FIQR). RESULTS: Two hundred and twenty-six patients with fibromyalgia and 222 control women completed the surveys. Two hundred and twenty patients (93%) and 140 controls (63%) reported PFD-related symptoms. Both the scores of distress (143.1 ± 5.7 vs 96.1 ± 4.8, P < 0.0001) and impact (122.4 ± 5.6 vs 100.6 ± 6.4, P < 0.0001) caused by PFD symptoms were significantly higher in women with fibromyalgia than in controls. There was a significant positive relationship between fibromyalgia severity and both PFDI-20 (r2 = 0.32, P < 0.0001) and PFIQ-7 scores (r2 = 0.375, P < 0.0001). Depression severity, sleep disturbances, bodily pain, and low quality of life were highest in women with fibromyalgia and PFD and lowest in control women without PFD. CONCLUSIONS: PFD-related symptoms were significantly more frequent in women with fibromyalgia than in controls. PFD symptomatology, when present, negatively influenced mood, sleep quality, and quality of life of both patients with fibromyalgia and controls.

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.

Perceived burdensomeness, thwarted belongingness and suicidal ideation in patients with fibromyalgia and healthy subjects: a cross-sectional study.

Perceived burdensomeness and thwarted belongingness are key factors in the development of suicidal behaviors that have been frequently observed among patients with fibromyalgia. The aim of the present study was to compare these two factors in patients with fibromyalgia with and without suicidal ideation and healthy subjects. Secondary objectives were to evaluate the relationship between these two factors and the secondary variables included in the study, such as depression, sleep quality or the degree of marital adjustment. Perceived burdensomeness and thwarted belongingness were assessed with the Interpersonal Needs Questionnaire, depression and suicidal ideation with the Patients Health Questionnaire-9, suicidal risk with the Plutchik Suicide Risk scale, sleep with the Insomnia Severity Index, and marital adjustment with the Locke-Wallace Marital Adjustment scale. Questionnaire scores were compared with the Kruskal-Wallis test. 49 healthy subjects, 38 patients with fibromyalgia without suicidal ideation and 15 patients with fibromyalgia and suicidal ideations were included. Perceived burdensomeness scores were significantly higher in patients with suicidal ideation than in patients without suicidal ideation and controls; thwarted belongingness scores were significantly higher in patients with suicidal ideation than in controls. Marital adjustment was also significantly poor in patients with suicidal ideation than in patients without suicidal ideation and controls. Among patients with fibromyalgia, perceived burdensomeness seems to be strongly related with suicidal ideation, whereas thwarted belongingness seems to play a less relevant role at this respect. Poor marital adjustment could be related with depression.

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.

Celiac symptoms in patients with fibromyalgia: a cross-sectional study.

Fibromyalgia is a chronic pain syndrome associated with numerous somatic symptoms including gastrointestinal manifestations of nonspecific nature. Celiac disease and nongluten sensitivity frequently evolve in adults with gastrointestinal and extraintestinal symptoms similar to those found among patients with fibromyalgia. The objective of the present study was to evaluate the presence of celiac-type symptoms among patients with fibromyalgia in comparison with healthy subjects and with those experienced by adult celiac patients and subjects with gluten sensitivity. A list of typical celiac-type symptoms was developed, comparing the frequency of presentation of these symptoms between patients with fibromyalgia (N = 178) and healthy subjects (N = 131), in addition to those of celiac patients and gluten-sensitive patients reported in the literature. The frequency of presentation of every celiac-type symptom, excepting anemia, was significantly higher among patients with fibromyalgia compared to controls (p < 0.0001). Regarding the existing data in the literature, the prevalence of fatigue, depression, cognitive symptoms and cutaneous lesions predominated among patients with fibromyalgia, whereas the prevalence of gastrointestinal symptoms was higher among patients with fibromyalgia compared to gluten-sensitive patients and was similar among patients with fibromyalgia and celiac disease patient. The symptomatological similarity of both pathologies, especially gastrointestinal symptoms, suggests that at least a subgroup of patients with fibromyalgia could experience subclinical celiac disease or nonceliac gluten intolerance.

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.

Health-Related Quality of Life and Psychosocial Variables in Women with Colorectal Pelvic Floor Dysfunction: A Cross-Sectional Study.

Pelvic floor dysfunction comprises various disorders, including urinary incontinence, fecal incontinence, pelvic organ prolapse, and chronic pelvic pain. This study aimed to evaluate health-related quality of life (HRQoL), anxiety, depression, sleep disturbance, and sexual functioning in women with pelvic floor dysfunction of colorectal etiology compared with control women. Patients were recruited from a specialized colorectal unit and controls were selected from among the patients' friends and relatives. Sociodemographic and clinical data were collected. Pelvic floor dysfunction distress and impact, HRQoL, depression, anxiety, insomnia, and sexual functioning were assessed using the following validated questionnaires: Short-Form Pelvic Floor Distress Inventory (PFDI-20), Short Form Pelvic Floor Impact Questionnaire (PFIQ-7), 36-Item Short-Form Health Survey (SF-36), Beck Depression Inventory II (BDI-II), Beck Anxiety Inventory (BAI), Insomnia Severity Index (ISI), and Changes in Sexual Functioning Scale (CSFQ). Statistical analyses included Welch's t-test, Fisher's exact test, and Spearman's correlation coefficients. Eighty-four patients and 57 controls were included. Compared with controls, patients were more likely to be obese or overweight, have had higher numbers of deliveries, more vaginal deliveries, more frequent use of forceps, and have had more associated comorbidities, mainly in the urinary, neurological, and psychiatric domains. As expected, patients scored significantly higher than controls on both the PFDI-20 and PFIQ-7 and their respective sub-scales, with the highest mean values in the patient group on the sub-scales related to the colorectal-anal domain. QoL, depression, anxiety, insomnia, and sexual functioning were significantly worse in patients than in controls (p < 0.0001 in every case). In patients, PFIQ-7 scores correlated significantly with HRQoL (p < 0.001 for the physical component and p < 0.01 for the mental component), depression (p < 0.001), anxiety (p < 0.001), insomnia (p < 0.05), and sexual functioning scores (p < 0.05). Colorectal pelvic floor dysfunction had a markedly deleterious impact on the HRQoL, depression, anxiety, sleep disturbance, and sexual functioning of patients. It is concluded that colorectal pelvic floor dysfunction exerts a considerable burden on patients' lives. Addressing these issues in clinical settings could significantly improve patients' well-being.

Validation of a Spanish version of the Revised Fibromyalgia Impact Questionnaire (FIQR).

BACKGROUND: The Revised version of the Fibromyalgia Impact Questionnaire (FIQR) was published in 2009. The aim of this study was to prepare a Spanish version, and to assess its psychometric properties in a sample of patients with fibromyalgia. METHODS: The FIQR was translated into Spanish and administered, along with the FIQ, the Hospital Anxiety Depression Scale (HADS), the 36-Item Short-Form Health Survey (SF-36), and the Brief Pain Inventory (BPI), to 113 Spanish fibromyalgia patients. The administration of the Spanish FIQR was repeated a week later. RESULTS: The Spanish FIQR had high internal consistency (Cronbach's α was 0.91 and 0.95 at visits 1 and 2 respectively). The test-retest reliability was good for the FIQR total score and its function and symptoms domains (intraclass correlation coefficient (ICC > 0.70), but modest for the overall impact domain (ICC = 0.51). Statistically significant correlations (p < 0.05) were also found between the FIQR and the FIQ scores, as well as between the FIQR scores and the remaining scales' scores. CONCLUSIONS: The Spanish version of the FIQR has a good internal consistency and our findings support its validity for assessing fibromyalgia patients. It might be a valid instrument to apply in clinical and investigational grounds.

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.

Psychosocial Variables and Healthcare Resources in Patients with Fibromyalgia, Migraine and Comorbid Fibromyalgia and Migraine: A Cross-Sectional Study.

Fibromyalgia and migraine frequently coexist. We aimed to compare the burden caused by fibromyalgia (FM), migraine (M) and comorbid fibromyalgia and migraine (FM + M) by assessing psychosocial variables and the use of healthcare resources. A survey was posted to the websites of different patients' associations. It included sociodemographic data, the Patient Health Questionnaire-9, the Insomnia Severity Index, the EuroQOL-5D-5L and a questionnaire evaluating the use of healthcare resources during the past six months. In total, 139 FM patients, 169 M patients and 148 FM + M patients participated in the survey. Mean depression and insomnia scores were clinically relevant in every group and significantly higher in FM + M (16.3 ± 5.4 for depression, 18.5 ± 5.6 for insomnia) than in FM (14.3 ± 5.7 for depression, 16.8 ± 5.5 for insomnia) or M (11.7 ± 5.4 for depression, 13.1 ± 5.9 for depression), where p < 0.001 in both cases. Suicidal ideation was frequent in every group, but significantly more frequent in FM + M (63% vs. 45% in FM and 35% in M; p < 0.001). EQ-5D-5L (0.656 ± 0.1 in FM + M, 0.674 ± 0.1 in FM, 0.827 ± 0.1 in M, p < 0.001) and EQ-5D-5L VAS scores (38.2 ± 21.9 in FM + M, 45.6 ± 21.8 in FM, 63.5 ± 23.7 in M, p < 0.00) were lower than the reported mean population values and the lowest in FM + M. FM and FM + M used more healthcare resources than M. It is concluded that the psychosocial burden was high in the three samples. FM and FM + M had a more relevant impact on patients' wellbeing and required more medical attention than M. The burden caused by FM + M was higher than in both individual diseases.

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.

Marital Adjustment in Patients with Cancer: Association with Psychological Distress, Quality of Life, and Sleep Problems.

Marital adjustment plays a key role in the physical and psychosocial wellbeing. We conducted a cross-sectional study to evaluate marital adjustment and its association with psychological distress, suicidal ideation, sleep problems, and quality of life in patients with cancer. We collected demographic and clinical information using a structured survey. We assessed marital adjustment, quality of life, psychological distress profile, and sleep problems of participants using validated instruments: the Locke and Wallace Marital Adjustment Test (LWMAT), the Short-Form Health Survey-12, the Beck's Depression Inventory (BDI), the Beck Anxiety Inventory (BAI), and the Insomnia Severity Index (ISI). Suicidal ideation was assessed with item nine of the BDI. Of the 130 patients (52.3% females, mean age 57.9 ± 12.4 years) enrolled, 20 (15%) were classified as experiencing poor marital adjustment. Moderate to severe depression, anxiety, and insomnia were found in 25.4%, 34.6%, and 24.7% of participants, respectively. Positive suicidal ideation was documented in 13.8% of participants. We found a significant association between poor marital adjustment and depression, anxiety, suicidal ideation, and poor sleep. Our study confirms the relevance of marital adjustment in relation to the psychological wellbeing of patients with cancer. Depression, anxiety, and poor sleep were found to be significantly associated with poor marital adjustment.

The Probiotic VSL#3® Does Not Seem to Be Efficacious for the Treatment of Gastrointestinal Symptomatology of Patients with Fibromyalgia: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

Gastrointestinal symptomatology is frequent among patients with fibromyalgia, which increases disease burden and lacks specific treatment, either pharmacological or non-pharmacological. We aimed to evaluate the efficacy and tolerability of a multi-strain probiotic, VSL#3®, for the treatment of fibromyalgia-associated gastrointestinal manifestations. This randomized, placebo-controlled trial included 12 weeks of probiotic or placebo treatment followed by 12 weeks of follow up. The primary outcome variable was the mean change from the baseline to the endpoint in the composite severity score of the three main gastrointestinal symptoms reported by patients with fibromyalgia (abdominal pain, abdominal bloating and meteorism). Secondary outcome variables were the severity of additional gastrointestinal symptoms, fibromyalgia severity, depression, sleep disturbance, health-related quality of life and patients' overall impression of improvement. No differences were found between VSL#3® (n = 54) and the placebo (n = 56) in the primary outcome (estimated treatment difference: 1.1; 95% confidence interval [CI]: -2.1, 4.2; p = 0.501), or in any of the secondary outcomes. However, responders to VSL#3 were more likely to maintain any improvement during the follow-up period compared to responders in the placebo arm. Overall, VSL#3 tolerability was good. Our data could not demonstrate any beneficial effects of VSL#3® either on the composite score of severity of abdominal pain, bloating and meteorism or in any of the secondary outcome variables. More research is needed to elucidate specific factors that may predict a favourable response to treatment in patients with fibromyalgia.

Trazodone for the treatment of fibromyalgia: an open-label, 12-week study.

BACKGROUND: Despite its frequent use as a hypnotic, trazodone has not been systematically assessed in fibromyalgia patients. In the present study have we evaluated the potential effectiveness and tolerability of trazodone in the treatment of fibromyalgia. METHODS: A flexible dose of trazodone (50-300 mg/day), was administered to 66 fibromyalgia patients for 12 weeks. The primary outcome measure was the Pittsburgh Sleep Quality Index (PSQI). Secondary outcome measures included the Fibromyalgia Impact Questionnaire (FIQ), 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). Trazodone's emergent adverse reactions were recorded. Data were analyzed with repeated measures one-way ANOVA and paired Student's t test. RESULTS: Trazodone markedly improved sleep quality, with large effect sizes in total PSQI score as well on sleep quality, sleep duration and sleep efficiency. Significant improvement, although with moderate effect sizes, were also observed in total FIQ scores, anxiety and depression scores (both HADS and BDI), and pain interference with daily activities. Unexpectedly, the most frequent and severe side effect associated with trazodone in our sample was tachycardia, which was reported by 14 (21.2%) patients. CONCLUSIONS: In doses higher than those usually prescribed as hypnotic, the utility of trazodone in fibromyalgia management surpasses its hypnotic activity. However, the emergence of tachycardia should be closely monitored. TRIAL REGISTRATION: This trial has been registered with ClinicalTrials.gov number NCT-00791739.

Suicidal Ideation Profiles in Patients with Fibromyalgia Using Transdiagnostic Psychological and Fibromyalgia-Associated Variables.

Several studies have emphasized the heterogeneity of fibromyalgia patients. Furthermore, fibromyalgia patients are considered a high-risk suicide group. The ideation-to-action framework proposes a set of transdiagnostic psychological factors involved in the development of suicidal ideation. The present study aims to explore the existence of different subgroups according to their vulnerability to suicidal ideation through these transdiagnostic psychological variables and a set of variables typically associated with fibromyalgia. In this cross-sectional study, 151 fibromyalgia patients were assessed through the Revised Fibromyalgia Impact Questionnaire, Beck Depression Inventory-II, Plutchik Suicide Risk Scale, Interpersonal Needs Questionnaire, Defeat Scale, Entrapment Scale, Psychache Scale, and Beck Hopelessness Scale. A K-means cluster analysis identified two clusters, one (45.70%) according to a low vulnerability, and a second (54.30%) with a high vulnerability to suicidal ideation. These clusters showed statistically significant differences in suicidal ideation and suicide risk. However, no differences were observed in most socio-demographic variables. In conclusion, fibromyalgia patients who present a clinical condition characterized by a moderate-high degree of physical dysfunction, overall disease impact and intensity of fibromyalgia-associated symptoms, along with a high degree of perceived burdensomeness, thwarted belongingness, defeat, entrapment, psychological pain and hopelessness, form a homogeneous group at high risk for suicidal ideation.