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1.  The relationship between serum antioxidant vitamins, magnesium levels, and clinical parameters in patients with primary fibromyalgia syndrome 
Clinical Rheumatology  2011;30(8):1039-1043.
We proposed to assess serum antioxidant vitamins and magnesium (Mg) levels in patients with fibromyalgia (FM) in comparison to healthy controls. Additionally, the association between the serum antioxidant vitamins, magnesium levels, and clinical parameters in FM patients was also investigated. Forty female patients, aged between 30 and 50 years, were diagnosed with FM according to ACR-1990 criteria, and 40 healthy controls were included in the present study. Socio-demographic characteristics of participants, accompanying symptoms, and number of tender points (TP) of the patients were recorded. The intensity of pain was measured using the visual analogue scale (VAS). The functional status and depression levels were evaluated with Fibromyalgia Impact Questionnaire (FIQ) and Beck Depression Inventory (BDI), respectively. Serum vitamins A, C, and E and Mg levels were measured. There were no significant differences in the levels of vitamins A, C, and E and Mg between control subjects and patients with fibromyalgia (p > 0.05). In addition, no statistically significant correlations were found between mean levels of serum vitamins A, C, and E, and Mg and number of TP, scores of VAS, FIQ, and BDI in patients with FM (p > 0.05). According to the results of this study, it was asserted that other complex mechanism may play an important role in the pathophysiology of FM without plasma antioxidant vitamins and Mg levels.
doi:10.1007/s10067-011-1697-2
PMCID: PMC3145090  PMID: 21347604
Antioxidant vitamins; Fibromyalgia; Magnesium; Oxidative stress
2.  Fibromyalgia, Systemic Lupus Erythematosus (SLE) and the Evaluation of SLE Activity 
The Journal of rheumatology  2009;36(1):82-88.
Purpose
To determine if fibromyalgia or fibromyalgianess is increased in SLE compared with non-SLE patients, whether fibromyalgia or fibromyalgianess (the tendency to respond to illness and psychosocial stress with fatigue, widespread pain, general increase in symptoms and similar factors ) biases the Systemic Lupus Erythematosus Activity Questionnaire (SLAQ), and to determine if the SLAQ is overly sensitive to fibromyalgia symptoms.
Method
We developed a 16-item SLE symptom scale (SLESS) modeled on the SLAQ and used that scale to investigate the relation between SLE symptoms and fibromyalgianess in 23,321 rheumatic disease patients. Fibromyalgia was diagnosed by survey fibromyalgia criteria and fibromyalgianess was measured using the Symptom Intensity Scale (SI). As comparison groups, we combined patients with rheumatoid arthritis (RA) and non-inflammatory rheumatic disorders into an “arthritis” group and also utilized a physician-diagnosed group of fibromyalgia patients.
Results
Fibromyalgia was identified in 22.1% of SLE and 17.0% of those with arthritis. The SI scale was minimally increased in SLE. The correlation between SLAQ and SLESS was 0.738. SLESS/SLAQ scale items: Raynaud’s, rash, fever, easy bruising and hair loss were significantly more associated with SLE than fibromyalgia, while the reverse was true for headache, abdominal pain, paresthesias/stroke, fatigue, cognitive problems and muscle pain or weakness. There was no evidence of a disproportionate symptom reporting associated with fibromyalgianess. Self-reported SLE was associated with an increased prevalence of fibromyalgia when unconfirmed by physicians compared to SLE confirmed by physicians.
Conclusions
The prevalence of fibromyalgia in SLE is minimally increased compared with its prevalence in patients with arthritis. Fibromyalgianess does not bias the SLESS and should not bias SLE assessments, including the SLAQ.
doi:10.3899/jrheum.080212
PMCID: PMC2944223  PMID: 19004039
Systemic Lupus Erythematosus; Fibromyalgia; Systemic Lupus Erythematosus Activity Questionnaire; SLAQ; SLAM
3.  General symptom reporting in female fibromyalgia patients and referents: a population-based case-referent study 
BMC Public Health  2009;9:402.
Background
Fibromyalgia is characterized by widespread musculoskeletal pain and palpation tenderness. In addition to these classic symptoms, fibromyalgia patients tend to report a number of other complaints. What these other complaints are and how often they are reported as compared with related referents from the general population is not very well known. We therefore hypothesized that subjects with fibromyalgia report more of a wide range of symptoms as compared with referents of the same sex and age from the general population.
Methods
138 women with diagnosed fibromyalgia in primary health care and 401 referents from the general population matched to the cases by sex, age and residential area responded to a postal questionnaire where information on marital status, education, occupational status, income level, immigrant status, smoking habits physical activity, height and weight history and the prevalence of 42 defined symptoms was sought.
Results
The cases had lower educational and income levels, were more often unemployed, on sick leave or on disability pension and were more often first generation immigrants than the referents. They were also heavier, shorter and more often had a history of excessive food intake and excessive weight loss. When these differences were taken into account, cases reported not only significantly more presumed fibromyalgia symptoms but also significantly more of general symptoms than the referents. The distribution of symptoms was similar in subjects with fibromyalgia and referents, indicating a generally higher symptom reporting level among the former.
Conclusion
Subjects with fibromyalgia had a high prevalence of reported general symptoms than referents. Some of these differences may be a consequence of the disorder while others may reflect etiological processes.
doi:10.1186/1471-2458-9-402
PMCID: PMC2776598  PMID: 19878599
4.  Effects of acupuncture on patients with fibromyalgia: study protocol of a multicentre randomized controlled trial 
Trials  2011;12:59.
Background
Fibromyalgia is a multidimensional disorder for which treatment as yet remains unsatisfactory. Studies of an acupuncture-based approach, despite its broad acceptance among patients and healthcare staff, have not produced sufficient evidence of its effectiveness in treating this syndrome. The present study aims to evaluate the effectiveness of individualized acupuncture for patients with fibromyalgia, with respect to reducing their pain and level of incapacity, and improving their quality of life.
Methods/design
Randomized controlled multicentre study, with 156 outpatients, aged over 17 years, diagnosed with fibromyalgia according to American College of Rheumatology criteria, either alone or associated with severe depression, according to the criteria of the Diagnostic and Statistical Manual for Mental Disorders. The participants will be randomly assigned to receive either "True acupuncture" or "Sham acupuncture". They will be evaluated using a specific measurement system, constituted of the Fibromyalgia Impact Questionnaire and the Hamilton rating scale for depression. Also taken into consideration will be the clinical and subjective pain intensity, the patient's family structure and relationships, psychological aspects, quality of life, the duration of previous temporary disability, the consumption of antidepressant, analgesic and anti-inflammatory medication, and the potential effect of factors considered to be predictors of a poor prognosis. All these aspects will be examined by questionnaires and other suitably-validated instruments. The results obtained will be analysed at 10 weeks, and 6 and 12 months from the start of treatment.
Discussion
This trial will utilize high quality trial methodologies in accordance with CONSORT guidelines. It may provide evidence for the effectiveness of acupuncture as a treatment for fibromyalgia either alone or associated with severe depression.
Trial registration
ISRCTN trial number ISRCTN60217348 (19 October 2010)
doi:10.1186/1745-6215-12-59
PMCID: PMC3055832  PMID: 21356075
5.  Women with Fibromyalgia Have Lower Levels of Calcium, Magnesium, Iron and Manganese in Hair Mineral Analysis 
Journal of Korean Medical Science  2011;26(10):1253-1257.
Little is known about hair mineral status in fibromyalgia patients. This study evaluated the characteristics of hair minerals in female patients with fibromyalgia compared with a healthy reference group. Forty-four female patients diagnosed with fibromyalgia according to the American College of Rheumatology criteria were enrolled as the case group. Ageand body mass index-matched data were obtained from 122 control subjects enrolled during visit for a regular health check-up. Hair minerals were analyzed and compared between the two groups. The mean age was 43.7 yr. General characteristics were not different between the two groups. Fibromyalgia patients showed a significantly lower level of calcium (775 µg/g vs 1,093 µg/g), magnesium (52 µg/g vs 72 µg/g), iron (5.9 µg/g vs 7.1 µg/g), copper (28.3 µg/g vs 40.2 µg/g) and manganese (140 ng/g vs 190 ng/g). Calcium, magnesium, iron, and manganese were loaded in the same factor using factor analysis; the mean of this factor was significantly lower in fibromyalgia group in multivariate analysis with adjustment for potential confounders. In conclusion, the concentrations of calcium, magnesium, iron, and manganese in the hair of female patients with fibromyalgia are lower than of controls, even after adjustment of potential confounders.
doi:10.3346/jkms.2011.26.10.1253
PMCID: PMC3192333  PMID: 22022174
Fibromyalgia; Fibromyalgia Syndrome; Trace Minerals; Calcium; Magnesium
6.  Hypertension, Tachycardia, and Reversible Cardiomyopathy Temporally Associated with Milnacipran Use 
Texas Heart Institute Journal  2011;38(6):714-718.
Elevated catecholamine levels are a well-recognized cause of various types of cardiomyopathy. Causes of catecholamine elevation include tumors, toxins, drugs, emotional stress, and sepsis. Milnacipran is a dual and equipotent inhibitor of norepinephrine and serotonin uptake. It is frequently prescribed as therapy for fibromyalgia, and the drug has a good safety profile. Herein, we report the case of a 42-year-old woman with undefined connective-tissue disease and fibromyalgia who developed a severe and reversible cardiomyopathy while taking recommended doses of milnacipran. The cardiomyopathy was associated with a hyperadrenergic state manifested by tachycardia, hypertension, and elevated plasma catecholamine levels. The discontinuation of milnacipran and the initiation of anti-failure therapy resulted in complete resolution of the cardiomyopathy in 6 months. To our knowledge, this is the first report of milnacipran as a possible cause of catecholamine-induced cardiomyopathy.
PMCID: PMC3233339  PMID: 22199446
Antidepressive agents, second-generation/administration & dosage/adverse effects/therapeutic use; cardiomyopathies/diagnosis/epidemiology/etiology/therapy; catecholamines/adverse effects; fibromyalgia/drug therapy; hypertension/chemically induced; magnetic resonance angiography; milnacipran; myocardium/pathology; serotonin uptake inhibitors/adverse effects/therapeutic use; takotsubo cardiomyopathy/chemically induced; treatment outcome; ventricular dysfunction/chemically induced
7.  Evaluation of the efficacy of memantine in the treatment of fibromyalgia: study protocol for a doubled-blind randomized controlled trial with six-month follow-up 
Trials  2013;14:3.
Background
Fibromyalgia is a prevalent chronic rheumatic disease of great clinical importance. Recent studies have found raised levels of glutamate in the insula, hippocampus and posterior cingulate cortex regions of the brains of fibromyalgia (FM) patients. This finding has led researchers to speculate about the usefulness of glutamate-blocking drugs such as memantine in the treatment of fibromyalgia. The hypothesis of this study is that the administration of memantine will reduce the glutamate levels, and futhermore, will decrease the perceived pain. The aim of this study is to evaluate the efficacy of memantine in the treatment of pain (pain perception). A secondary objective is to evaluate the efficacy of memantine in the treatment of other clinical symptoms of FM, and to evaluate the efficacy of memantine in reducing brain levels of glutamate, and its effects on the central nervous system as a whole.
Method/Design
A double-blind parallel randomized controlled trial. Participants, Seventy patients diagnosed with FM will be recruited from primary health care centers in Zaragoza, Spain. Intervention. The subjects will be randomized in two groups: A) A treatment group (n = 35), which will receive 20 mg of memantine daily; B) A control group (n = 35), to which will be administered a placebo. There will be a six-month follow-up period (including a titration period of one month). Outcomes. The main efficacy variable of this study is pain (pain perception). The secondary efficacy variables are clinical symptoms (pain threshold, cognitive function, health status, anxiety, depression, clinical impression and quality of life) and glutamate levels in different regions of the brain, which will be assessed by magnetic resonance spectroscopy. Randomization and blinding. Randomization has been computer-generated, and the random allocation sequence will be implemented by telephone. Subjects of the study and the research assistants will be blinded to group assignment.
Discussion
There is a need for the development of innovative and more effective treatments for fibromyalgia. This clinical trial will determine whether memantine can be an effective pharmacological treatment for fibromyalgia patients.
Trial registration
Current Controlled Trials http://ISRCTN45127327 EUDRACT 2011-006244-73
doi:10.1186/1745-6215-14-3
PMCID: PMC3598995  PMID: 23286311
Fibromyalgia; Memantine; Chronic pain; Magnetic resonance spectroscopy; Randomized controlled trial
8.  Growth hormone as concomitant treatment in severe fibromyalgia associated with low IGF-1 serum levels. A pilot study 
Background
There is evidence of functional growth hormone (GH) deficiency, expressed by means of low insulin-like growth factor 1 (IGF-1) serum levels, in a subset of fibromyalgia patients. The efficacy of GH versus placebo has been previously suggested in this population. We investigated the efficacy and safety of low dose GH as an adjunct to standard therapy in the treatment of severe, prolonged and well-treated fibromyalgia patients with low IGF-1 levels.
Methods
Twenty-four patients were enrolled in a randomized, open-label, best available care-controlled study. Patients were randomly assigned to receive either 0.0125 mg/kg/d of GH subcutaneously (titrated depending on IGF-1) added to standard therapy or standard therapy alone during one year. The number of tender points, the Fibromyalgia Impact Questionnaire (FIQ) and the EuroQol 5D (EQ-5D), including a Quality of Life visual analogic scale (EQ-VAS) were assessed at different time-points.
Results
At the end of the study, the GH group showed a 60% reduction in the mean number of tender points (pairs) compared to the control group (p < 0.05; 3.25 ± 0.8 vs. 8.25 ± 0.9). Similar improvements were observed in FIQ score (p < 0.05) and EQ-VAS scale (p < 0.001). There was a prompt response to GH administration, with most patients showing improvement within the first months in most of the outcomes. The concomitant administration of GH and standard therapy was well tolerated, and no patients discontinued the study due to adverse events.
Conclusion
The present findings indicate the advantage of adding a daily GH dose to the standard therapy in a subset of severe fibromyalgia patients with low IGF-1 serum levels.
Trial Registration
NCT00497562 (ClinicalTrials.gov).
doi:10.1186/1471-2474-8-119
PMCID: PMC2212629  PMID: 18053120
9.  Mitochondrial myopathy presenting as fibromyalgia: a case report 
Introduction
To the best of our knowledge, we describe for the first time the case of a woman who met the diagnostic criteria for fibromyalgia, did not respond to therapy for that disorder, and was subsequently diagnosed by biochemical and genetic studies with a mitochondrial myopathy. Treatment of the mitochondrial myopathy resulted in resolution of symptoms. This case demonstrates that mitochondrial myopathy may present in an adult with a symptom complex consistent with fibromyalgia.
Case presentation
Our patient was a 41-year-old Caucasian woman with symptoms of fatigue, exercise intolerance, headache, and multiple trigger points. Treatment for fibromyalgia with a wide spectrum of medications including non-steroidal anti-inflammatory drugs, antidepressants, gabapentin and pregabalin had no impact on her symptoms. A six-minute walk study demonstrated an elevated lactic acid level (5 mmol/L; normal < 2 mmol/L). Biochemical and genetic studies from a muscle biopsy revealed a mitochondrial myopathy. Our patient was started on a compound of coenzyme Q10 (ubiquinone) 200 mg, creatine 1000 mg, carnitine 200 mg and folic acid 1 mg to be taken four times a day. She gradually showed significant improvement in her symptoms over a course of several months.
Conclusions
This case demonstrates that adults diagnosed with fibromyalgia may have their symptom complex related to an adult onset mitochondrial myopathy. This is an important finding since treatment of mitochondrial myopathy resulted in resolution of symptoms.
doi:10.1186/1752-1947-6-55
PMCID: PMC3293012  PMID: 22325469
10.  Validation of the Fibromyalgia Survey Questionnaire within a Cross-Sectional Survey 
PLoS ONE  2012;7(5):e37504.
The Fibromyalgia Survey Questionnaire (FSQ) assesses the key symptoms of fibromyalgia syndrome. The FSQ can be administrated in survey research and settings where the use of interviews to evaluate the number of pain sites and extent of somatic symptom intensity and tender point examination would be difficult. We validated the FSQ in a cross-sectional survey with FMS patients. In a cross-sectional survey, participants with physician diagnosis of FMS were recruited by FMS-self help organisations and nine clinical institutions of different levels of care. Participants answered the FSQ (composed by the Widespread Pain Index [WPI] and the Somatic Severity Score [SSS]) assessing the Fibromyalgia Survey Diagnostic Criteria (FSDC) and the Patient Health Questionnaire PHQ 4. American College of Rheumatology 1990 classification criteria were assessed in a subgroup of participants. 1,651 persons diagnosed with FMS were included into analysis. The acceptance of the FSQ-items ranged between 78.9 to 98.1% completed items. The internal consistency of the items of the SSS ranged between 0.75–0.82. 85.5% of the study participants met the FSDC. The concordance rate of the FSDC and ACR 1990 criteria was 72.7% in a subsample of 128 patients. The Pearson correlation of the SSS with the PHQ 4 depression score was 0.52 (p<0.0001) and with the PHQ anxiety score was 0.51 (p<0.0001) (convergent validity). 64/202 (31.7%) of the participants not meeting the FSDC criteria and 152/1283 (11.8%) of the participants meeting the FSDC criteria reported an improvement (slightly too very much better) in their health status since FMS-diagnosis (Chi2 = 55, p<0.0001) (discriminant validity). The study demonstrated the feasibility of the FSQ in a cross-sectional survey with FMS-patients. The reliability, convergent and discriminant validity of the FSQ were good. Further validation studies of the FSQ in clinical and general population settings are necessary.
doi:10.1371/journal.pone.0037504
PMCID: PMC3360780  PMID: 22662163
11.  Objectively measured sedentary time and physical activity in women with fibromyalgia: a cross-sectional study 
BMJ Open  2013;3(6):e002722.
Objectives
To characterise levels of objectively measured sedentary time and physical activity in women with fibromyalgia.
Design
Cross-sectional study.
Setting
Local Association of Fibromyalgia (Granada, Spain).
Participants
The study comprised 94 women with diagnosed fibromyalgia who did not have other severe somatic or psychiatric disorders, or other diseases that prevent physical loading, able to ambulate and to communicate and capable and willing to provide informed consent.
Primary outcome measures
Sedentary time and physical activity were measured by accelerometry and expressed as time spent in sedentary behaviours, average physical activity intensity (counts/minute) and amount of time (minutes/day) spent in moderate intensity and in moderate-to-vigorous-intensity physical activity (MVPA).
Results
The proportion of women meeting the physical activity recommendations of 30 min/day of MVPA on 5 or more days a week was 60.6%. Women spent, on average, 71% of their waking time (approximately 10 h/day) in sedentary behaviours. Both sedentary behaviour and physical activity levels were similar across age groups, waist circumference and percentage body fat categories, years since clinical diagnosis, marital status, educational level and occupational status, regardless of the severity of the disease (all p>0.1). Time spent on moderate-intensity physical activity and MVPA was, however, lower in those with greater body mass index (BMI) (−6.6 min and −7 min, respectively, per BMI category increase, <25, 25–30, >30 kg/m2; p values for trend were 0.056 and 0.051, respectively). Women spent, on average, 10 min less on MVPA (p<0.001) and 22 min less on sedentary behaviours during weekends compared with weekdays (p=0.051).
Conclusions
These data provide an objective measure of the amount of time spent on sedentary activities and on physical activity in women with fibromyalgia.
doi:10.1136/bmjopen-2013-002722
PMCID: PMC3686217  PMID: 23794573
Epidemiology; Preventive Medicine; Public Health; Rheumatology
12.  Disability and quality of life in patients with fibromyalgia 
Background
Patients with fibromyalgia often feel disabled in the performance of daily activities. Psychological factors seem to play a pronounced disabling role in fibromyalgia.
The objectives of the study are: Firstly, to investigate contributing factors for disability in fibromyalgia. Secondly, to study psychological distress in patients with fibromyalgia as compared to other nonspecific pain syndromes. And finally, to explore the impact of fibromyalgia on a patient's quality of life.
Methods
In this cross sectional study, explaining factors for disability were studied based on a regression analysis with gender, mental health, physical and social functioning as independent variables. For the assessment of disability in fibromyalgia the FIQ was used. The levels of psychological distress in patients with fibromyalgia, Complex Regional Pain Syndrome (CRPS) and chronic low back pain (CLBP) were compared based on scores on the Symptom Checklist (SCL90). Quality of life of patients with fibromyalgia was compared with scores (SF36) of both patients with fibromyalgia and other health conditions as derived from the literature.
Results
Disability in fibromyalgia seemed best explained by a patients mental health condition (β = -0.360 p = 0.02). The level of psychological distress was higher in patients with fibromyalgia as compared to patients with CRPS or CLBP (p < 0.01). The impact of fibromyalgia on quality of life appeared to be high as compared to the impact of other health conditions.
Conclusion
Patients with fibromyalgia report a considerable impact on their quality of life and their perceived disability level seems influenced by their mental health condition. In comparison with patients with other pain conditions psychological distress is higher.
doi:10.1186/1477-7525-6-8
PMCID: PMC2265693  PMID: 18211701
13.  Milnacipran: A Selective Serotonin and Norepinephrine Dual Reuptake Inhibitor for the Management of Fibromyalgia 
Milnacipran, a serotonin and norepinephrfrine reuptake inhibitor with preferential inhibition of norepinephrine reuptake over serotonin, is approved in the United States for the management of fibromyalgia. Owing to its effects on norepinephrine and serotonin, as well as its lack of activity at other receptor systems, it was hypothesized that milnacipran would provide improvements in pain and other fibromyalgia symptoms without some of the unpleasant side effects associated with other medications historically used for treating fibromyalgia. The clinical safety and efficacy of milnacipran 100 and 200 mg/day in individuals with fibromyalgia has been investigated in four large, randomized, double-blind, placebo-controlled studies and three long-term extension studies. The clinical studies used composite responder analyses to identify the proportion of individual patients reporting simultaneous and clinically significant improvements in pain, global status, and physical function, in addition to assessing improvement in various symptom domains such as fatigue and dyscognition. In the clinical studies, patients receiving milnacipran reported significant improvements in pain and other symptoms for up to 15 months of treatment. Most adverse events were mild to moderate in severity and were related to the intrinsic pharmacologic properties of the drug. Long-term exposure to milnacipran did not result in any new safety concerns. As with other serotonin and norepinephrine reuptake inhibitors, increases in heart rate and blood pressure have been observed in some patients with milnacipran treatment.
doi:10.1177/1759720X10372551
PMCID: PMC3383514  PMID: 22870448
fatigue; fibromyalgia; milnacipran; pain; physical function; serotonin—norepinephrine reuptake inhibitor
14.  Is Inflammation a Mitochondrial Dysfunction-Dependent Event in Fibromyalgia? 
Antioxidants & Redox Signaling  2013;18(7):800-807.
Abstract
Fibromyalgia (FM) is a complex disorder that affects up to 5% of the general population worldwide. Both mitochondrial dysfunction and inflammation have been implicated in the pathophysiology of FM. We have investigated the possible relationship between mitochondrial dysfunction, oxidative stress, and inflammation in FM. We studied 30 women diagnosed with FM and 20 healthy women. Blood mononuclear cells (BMCs) from FM patients showed reduced level of coenzyme Q10 (CoQ10) and mtDNA contents and high level of mitochondrial reactive oxygen species (ROS) and serum tumor necrosis factor (TNF)-alpha and transcript levels. A significant negative correlation between CoQ10 and TNF-alpha levels (r=−0.588; p<0.01), and a positive correlation between ROS and TNF-alpha levels (r=0.791; p<0.001) were observed accompanied by a significant correlation of visual analogical scale with serum TNF-alpha and transcript levels (r=0.4507; p<0.05 and r=0.7089; p<0.001, respectively). TNF-alpha release was observed in an in vitro (BMCs) and in vivo (mice) CoQ10 deficiency model. Oral CoQ10 supplementation restored biochemical parameters and induced a significant improvement in clinical symptoms (p<0.001). These results lead to the hypothesis that inflammation could be a mitochondrial dysfunction-dependent event implicated in the pathophysiology of FM in several patients indicating at mitochondria as a possible new therapeutic target. Antioxid. Redox Signal. 18, 800–807.
doi:10.1089/ars.2012.4892
PMCID: PMC3555092  PMID: 22938055
15.  Newer treatments for fibromyalgia syndrome 
Fibromyalgia syndrome is a common chronic pain disorder of unknown etiology. The lack of understanding of the pathophysiology of fibromyalgia has made this condition frustrating for patients and clinicians alike. The most common symptoms of this disorder are chronic widespread pain, fatigue, sleep disturbances, difficulty with memory, and morning stiffness. Emerging evidence points towards augmented pain processing within the central nervous system (CNS) as having a primary role in the pathophysiology of this disorder. Currently the two drugs that are approved by the United States Food and Drug Administration (FDA) for the management of fibromyalgia are pregabalin and duloxetine. Newer data suggests that milnacipran, a dual norepinephrine and serotonin reuptake inhibitor, may be promising for the treatment of fibromyalgia. A double-blind, placebo-controlled trial of milnacipran in 125 fibromyalgia patients showed significant improvements relative to placebo. Milnacipran given either once or twice daily at doses up to 200 mg/day was generally well tolerated and yielded significant improvements relative to placebo on measures of pain, patient’s global impression of change in their disease state, physical function, and fatigue. Future studies are needed to validate the efficacy of milnacipran in fibromyalgia.
PMCID: PMC2643113  PMID: 19337439
fibromyalgia; pain; pharmacological; treatment
16.  Antidepressants in the treatment of fibromyalgia 
Fibromyalgia syndrome is a chronic disease of widespread and debilitating pain whose cause is unknown and whose risk factors are poorly understood. It is often comorbid with rheumatoid and other pain disorders as well as psychiatric disorders such as anxiety and depression. Although they are not officially approved for this indication, antiepileptics and antidepressants are often used to treat fibromyalgia. The tricyclic antidepressants (TCAs), particularly amitriptyline, are among the most common treatment strategies. Because of the poor tolerability of the tricyclics, the newer antidepressants have been widely tested in fibromyalgia. The selective serotonin reuptake inhibitors (SSRIs) and the reversible monoamine oxidase inhibitors do not seem to be particularly helpful. The serotonin and norepinephrine reuptake inhibitors (SNRIs), duloxetine and milnacipran, on the other hand, have been shown in placebo-controlled trials to offer significant relief to patients suffering from fibromyalgia. Although no direct comparative studies have been performed, these compounds appear to be as effective as the TCAs but much better tolerated. The effectiveness of the SNRIs as well as other dual acting antidepressants, such as mirtazapine, but not the SSRIs, implies that a dysfunction of both serotonin and norepinephrine neurotransmission probably exists in fibromyalgia. The effectiveness of antidepressants appears to be independent of their effect on comorbid depression.
PMCID: PMC2671948  PMID: 19412502
fibromyalgia syndrome; FMS; pain; depression; antidepressants; norephinephrine; serotonin
17.  Mitochondrial dysfunction and mitophagy activation in blood mononuclear cells of fibromyalgia patients: implications in the pathogenesis of the disease 
Introduction
Fibromyalgia is a chronic pain syndrome with unknown etiology. Recent studies have shown some evidence demonstrating that oxidative stress may have a role in the pathophysiology of fibromyalgia. However, it is still not clear whether oxidative stress is the cause or the effect of the abnormalities documented in fibromyalgia. Furthermore, the role of mitochondria in the redox imbalance reported in fibromyalgia also is controversial. We undertook this study to investigate the role of mitochondrial dysfunction, oxidative stress, and mitophagy in fibromyalgia.
Methods
We studied 20 patients (2 male, 18 female patients) from the database of the Sevillian Fibromyalgia Association and 10 healthy controls. We evaluated mitochondrial function in blood mononuclear cells from fibromyalgia patients measuring, coenzyme Q10 levels with high-performance liquid chromatography (HPLC), and mitochondrial membrane potential with flow cytometry. Oxidative stress was determined by measuring mitochondrial superoxide production with MitoSOX™ and lipid peroxidation in blood mononuclear cells and plasma from fibromyalgia patients. Autophagy activation was evaluated by quantifying the fluorescence intensity of LysoTracker™ Red staining of blood mononuclear cells. Mitophagy was confirmed by measuring citrate synthase activity and electron microscopy examination of blood mononuclear cells.
Results
We found reduced levels of coenzyme Q10, decreased mitochondrial membrane potential, increased levels of mitochondrial superoxide in blood mononuclear cells, and increased levels of lipid peroxidation in both blood mononuclear cells and plasma from fibromyalgia patients. Mitochondrial dysfunction was also associated with increased expression of autophagic genes and the elimination of dysfunctional mitochondria with mitophagy.
Conclusions
These findings may support the role of oxidative stress and mitophagy in the pathophysiology of fibromyalgia.
doi:10.1186/ar2918
PMCID: PMC2875645  PMID: 20109177
18.  Duloxetine: A Review of Its Safety and Efficacy in the Management of Fibromyalgia Syndrome 
Fibromyalgia (FM) is a chronic disorder characterized by widespread pain and other associated symptoms including fatigue, insomnia, cognitive/memory problems, and even psychological distress. Duloxetine is one of three FDA approved medications (the other two being milnacipran and pregabalin) for the treatment of FM. It has been demonstrated that FM patients possess low central nervous system levels of serotonin and norepinephrine. Duloxetine, which is classified pharmacologically as a serotonin-norepinephrine reuptake inhibitor (SNRI), may be beneficial for FM patients by increasing these levels. This review will touch briefly upon the pathophysiology of FM, diagnostic tools, currently available therapeutic options (both pharmacologic and non-pharmacologic), as well as the pharmacokinetic/pharmacodynamic properties of duloxetine. In addition, the efficacy and safety/tolerability of duloxetine exclusively in FM will be assessed through examination of 5 randomized controlled trials, as well as pooled analyses of current data. Suggestions for a therapeutic niche for duloxetine in FM are discussed based on a presentation of the characteristics of duloxetine.
doi:10.4137/JCNSD.S4127
PMCID: PMC3661232  PMID: 23861632
duloxetine; fibromyalgia; safety; efficacy; treatment; pain
19.  Role and rationale for the use of milnacipran in the management of fibromyalgia 
Fibromyalgia (FM) is a complex syndrome characterized by chronic widespread musculoskeletal pain which is often accompanied by multiple other symptoms, including fatigue, sleep disturbances, decreased physical functioning, and dyscognition. Due to these multiple symptoms, as well as high rates of comorbidity with other related disorders, patients with FM often report a reduced quality of life. Although the pathophysiology of FM is not completely understood, patients with FM experience pain differently from the general population, most likely due to dysfunctional pain processing in the central nervous system leading to both hyperalgesia and allodynia. In many patients with FM, this aberrant pain processing, or central sensitization, appears to involve decreased pain inhibition within the spinal tract, which is mediated by descending pathways that utilize serotonin, norepinephrine, and other neurotransmitters. The reduced serotonin and norepinephrine levels observed in patients with FM suggest that medications which increase the levels of these neurotransmitters, such as serotonin and norepinephrine reuptake inhibitors (SNRIs), may have clinically beneficial effects in FM and other chronic pain conditions. Milnacipran is an SNRI that has been approved for the management of FM. In clinical trials, treatment with milnacipran for up to 1 year has been found to improve the pain and other symptoms of FM. Because FM is characterized by multiple symptoms that all contribute to the decreased quality of life and ability to function, the milnacipran pivotal trials implemented responder analyses. These utilized a single composite endpoint to identify the proportion of patients who reported simultaneous and clinically significant improvements in pain, global disease status, and physical function. Other domains assessed during the milnacipran trials include fatigue, multidimensional functioning, mood, sleep quality, and patient-reported dyscognition. This review article provides information intended to help clinicians make informed decisions about the use of milnacipran in the clinical management of patients with FM. It draws primarily on results from 2 of the pivotal clinical trials that formed the basis of approval of milnacipran in the United States by the Food and Drug Administration.
PMCID: PMC2877602  PMID: 20520784
fibromyalgia; milnacipran; pain; serotonin and norepinephrine reuptake inhibitors; SNRI
20.  Duloxetine for the management of fibromyalgia syndrome 
Journal of pain research  2009;2:99-108.
Fibromyalgia syndrome (FMS) is a widespread pain condition associated with a wide range of additional symptoms including fatigue, insomnia, depression, anxiety and stiffness. Duloxetine is one of three medications currently FDA approved for use in FMS management. Duloxetine is a mixed serotonin and norepinephrine reuptake inhibitor (SNRI) that functions by increasing central nervous system levels of serotonin and norepinephrine. This review is a primer on use of duloxetine in FMS management and includes information on pharmacology and pharmacokinetics, a review of the three duloxetine FMS treatment trials currently in publication, a discussion of the safety and tolerability of duloxetine, and patient-focused perspectives on duloxetine use in FMS management. Duloxetine has proven efficacy in managing pain and mood symptoms in adult FMS patients with and without major depressive disorder. However, due to side effects, duloxetine must be used with caution in patients with fatigue, insomnia, gastrointestinal complaints, headache, cardiovascular disease, bleeding-risk, and in those 24 years of age and younger due to risk of suicidality. Duloxetine use should be avoided in patients with liver disease or alcoholics. As with all medications, duloxetine is best used as part of an individualized regimen that includes nonpharmacologic modalities of exercise, education and behavioral therapies.
PMCID: PMC3004624  PMID: 21197298
fibromyalgia; duloxetine; SNRI; safety
21.  Patient Perspectives on the Impact of Fibromyalgia 
Patient education and counseling  2008;73(1):114-120.
Objective
The objective of this study was to elicit and assess important symptom domains and the impact of fibromyalgia on patients’ quality of life and functioning from a patient’s perspective. The intention was to collect this information as part of an overall effort to overcome shortcomings of existing outcome measures in fibromyalgia.
Methods
This was a qualitative study in which six focus group sessions with 48 women diagnosed with fibromyalgia were conducted to elicit concepts and ideas to assess the impact of fibromyalgia on their lives.
Results
The focus groups conducted with fibromyalgia patients identified symptom domains that had the greatest impact on their quality of life including pain, sleep disturbance, fatigue depression, anxiety, and cognitive impairment. Fibromyalgia had a substantial negative impact on social and occupational function. Patients reported disrupted relationships with family and friends, social isolation, reduced activities of daily living and leisure activities, avoidance of physical activity, and loss of career or inability to advance in careers or education.
Conclusion
The findings from the focus groups revealed that fibromyalgia has a substantial negative impact on patients’ lives.
Practice Implications
A comprehensive assessment of the multiple symptoms domains associated with fibromyalgia and the impact of fibromyalgia on multidimensional aspects of function should be a routine part of the care of fibromyalgia patients.
doi:10.1016/j.pec.2008.06.005
PMCID: PMC2564867  PMID: 18640807
fibromyalgia; patient focus group; symptom domains; quality of life
22.  Fibromyalgia: A Primer for the Anesthesia Community 
Purpose of the Review
The present review is intended to give an overview of fibromyalgia for the anesthesiologist. While the basics of the treatment of fibromyalgia are included, the intent is to provide context to discuss the potential implications in perioperative management.
Recent Findings
One of the most important changes in the last year is the new criteria established by the American College of Rheumatology for the diagnosis of fibromyalgia. Instead of a combination of self-report and a tender point examination, there is a new self-report questionnaire that is now used diagnose fibromyalgia. This tool incorporates aspects of widespread body pain and some of the known comorbid symptoms. A score of 0-31 is given, which allows for the disease to be viewed as a continuum of sensitivity and symptomatology, instead of as a binary diagnosis. This continuum has been termed “fibromyalgia-ness.” This article also reviews the advances in understanding of the pathophysiology and emerging therapies. Little is known about the impact of fibromyalgia in the perioperative period.
Summary
The impact of fibromyalgia on anesthesia care is not known. Years of quality research have clearly demonstrated multiple pathophysiologic changes that could impact anesthesia care and future study is needed.
doi:10.1097/ACO.0b013e32834a1091
PMCID: PMC3422621  PMID: 21799404
fibromyalgia; treatment; anesthesiology; postoperative pain; chronic post-surgical pain
23.  The association of major depressive episode and personality traits in patients with fibromyalgia 
Clinics  2011;66(6):973-978.
INTRODUCTION:
Personality traits have been associated with primary depression. However, it is not known whether this association takes place in the case of depression comorbid with fibromyalgia.
OBJECTIVE:
The authors investigated the association between a current major depressive episode and temperament traits (e.g., harm avoidance).
METHOD:
A sample of 69 adult female patients with fibromyalgia was assessed with the Temperament and Character Inventory. Psychiatric diagnoses were assessed with the Mini-International Neuropsychiatric Interview severity of depressive symptomatology with the Beck Depression Inventory, and anxiety symptomatology with the IDATE-state and pain intensity with a visual analog scale.
RESULTS:
A current major depressive episode was diagnosed in 28 (40.5%) of the patients. They presented higher levels of harm avoidance and lower levels of cooperativeness and self-directedness compared with non-depressed patients, which is consistent with the Temperament and Character Inventory profile of subjects with primary depression. However, in contrast to previous results in primary depression, no association between a major depressive episode and self-transcendence was found.
CONCLUSIONS:
The results highlight specific features of depression in fibromyalgia subjects and may prove important for enhancing the diagnosis and prognosis of depression in fibromyalgia patients.
doi:10.1590/S1807-59322011000600009
PMCID: PMC3129941  PMID: 21808861
Fibromyalgia; Personality; Depression; Temperament; Character
24.  The fibromyalgia diagnosis – hardly helpful for the patients? 
Objective
To explore experiences and consequences of the process of being diagnosed with fibromyalgia.
Design
Qualitative focus-group study.
Setting
Two local self-help groups.
Subjects
Eleven women diagnosed with fibromyalgia.
Main outcome measures
Descriptions of experiences and consequences of the process of being diagnosed with fibromyalgia.
Results
Many participants had been suffering for years, and initial response of relief was common. For some, the diagnosis legitimized the symptoms as a disease, for others it felt better to suffer from fibromyalgia rather than more serious conditions. Nevertheless sadness and despair emerged when they discovered limitations in treatment options, respect, and understanding. Some patients keep the diagnosis to themselves since people seem to pay no attention to the name, or blatantly regard them as too cheerful or healthy looking. The initial blessing of the fibromyalgia diagnosis seems to be limited in the long run. The process of adapting to this diagnosis can be lonely and strenuous.
Conclusion
A diagnosis may be significant when it provides the road to relief or legitimizes the patient's problems. The social and medical meaning of the fibromyalgia diagnosis appears to be more complex. Our findings propose that the diagnosis was hardly helpful for these patients.
doi:10.1080/02813430701706568
PMCID: PMC3379768  PMID: 18041660
Diagnosis; family practice; fibromyalgia; focus group; physician–patient relation
25.  Antipolymer antibody in Italian fibromyalgic patients 
The objectives of the present study were to evaluate the presence of antipolymer antibody (APA) seropositivity in 285 Italian patients affected by primary fibromyalgia (FM) and to verify whether APA levels correlate with disease severity and with cytokine levels.
APA levels were determined on serum samples by an indirect ELISA kit that detects IgG APA. Cytokines (IL-1, IL-6, IL-8, IL-10 and TNFα) were measured by ELISA in plasma. The impact of FM on the quality of life was estimated using the Fibromyalgia Impact Questionnaire, while pain severity was evaluated using a visual analogic scale. Patients were also characterized by the presence of tiredness, stiffness, nonrestorative sleep, anxiety, depression, tension headache, irritable bowel syndrome, temporomandibular dysfunction and Raynaud's phenomena.
Using a cut-off value of 30 U, APA-positive values were detected in 60 FM patients (21.05%) and in 15 healthy control individuals (15.00%) without significant differences among their levels or the percentage of seropositivity. FM patients with moderate and severe symptoms had slightly higher APA levels with respect to patients with mild symptoms. APA-seropositive patients exhibited significant correlations between APA levels and the Fibromyalgia Impact Questionnaire estimate (P = 0.042), tiredness (P = 0.003) and IL-1 levels (P = 0.0072).
In conclusion, APA cannot be considered a marker of disease in Italian FM patients. The presence of APA, however, might permit the identification of a subset of FM patients with more severe symptoms and of patients who may respond differently to different therapeutic strategies.
doi:10.1186/ar2285
PMCID: PMC2212586  PMID: 17822528

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