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.

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.

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.

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.

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.

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.

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.

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.

Myofascial trigger points in cluster headache patients: a case series.

Active myofascial trigger points (MTrPs) have been found to contribute to chronic tension-type headache and migraine. The purpose of this case series was to examine if active trigger points (TrPs) provoking cluster-type referred pain could be found in cluster headache patients and, if so, to evaluate the effectiveness of active TrPs anaesthetic injections both in the acute and preventive headache's treatment. Twelve patients, 4 experiencing episodic and 8 chronic cluster headache, were studied. TrPs were found in all of them. Abortive infiltrations could be done in 2 episodic and 4 chronic patients, and preemptive infiltrations could be done in 2 episodic and 5 chronic patients, both kind of interventions being successful in 5 (83.3%) and in 6 (85.7%) of the cases respectively. When combined with prophylactic drug therapy, injections were associated with significant improvement in 7 of the 8 chronic cluster patients. Our data suggest that peripheral sensitization may play a role in cluster headache pathophysiology and that first neuron afferent blockade can be useful in cluster headache management.

Effectiveness of ropivacaine trigger points inactivation in the prophylactic management of patients with severe migraine.

OBJECTIVE: Tenderness and referred pain have been described in migraine and involved in its pathogenesis. The present study was performed to evaluate the prophylactic effectiveness of ropivacaine injections during a 12-week period. INTERVENTIONS: A total of 52 patients agreed to participate in the study. Trigger points were explored by manual palpation and injected weekly with 10 mg ropivacaine. The frequencies of migraine attacks were recorded from 4 weeks before the beginning of injections until 4 weeks after the last one, and a Clinical Global Impression improvement scale was completed in the final visit. RESULTS: All of the subjects had one or more trigger points, located in temporal and/or suboccipital areas in most of the cases. In nine (17.3%) patients the frequency of attacks was reduced >or=50%, and in 19 (36.5%) cases the reduction was comprised between 11% and 49%. A total of 31 (59.6%) patients reported to be much or very much improved after finishing the injection period. In 11 cases rescue medication intake was reduced >or=50% in comparison with baseline period, and the attacks of severe intensity decreased significantly. Eight (26.6%) out of 30 patients suffering chronic migraine reverted to episodic migraine. Local pain in injection sites was reported by 14 patients, and 13 subjects (25.5%) experienced postinjection soreness. CONCLUSIONS: Trigger points inactivation can be an effective palliative measure in the prophylactic management of severe refractory migraine.