-
1.
AAPT Diagnostic Criteria for Fibromyalgia.
Arnold, LM, Bennett, RM, Crofford, LJ, Dean, LE, Clauw, DJ, Goldenberg, DL, Fitzcharles, MA, Paiva, ES, Staud, R, Sarzi-Puttini, P, et al
The journal of pain. 2019;(6):611-628
Abstract
Fibromyalgia (FM) is a common chronic pain disorder that presents diagnostic challenges for clinicians. Several classification, diagnostic and screening criteria have been developed over the years, but there continues to be a need to develop criteria that reflect the current understanding of FM and are practical for use by clinicians and researchers. The Analgesic, Anesthetic, and Addiction Clinical Trial Translations Innovations Opportunities and Networks (ACTTION) public-private partnership with the U.S. Food and Drug Administration (FDA) and the American Pain Society (APS) initiated the ACTTION-APS Pain Taxonomy (AAPT) to develop a diagnostic system that would be clinically useful and consistent across chronic pain disorders. The AAPT established an international FM working group consisting of clinicians and researchers with expertise in FM to generate core diagnostic criteria for FM and apply the multidimensional diagnostic framework adopted by AAPT to FM. The process for developing the AAPT criteria and dimensions included literature reviews and synthesis, consensus discussions, and analyses of data from large population-based studies conducted in the United Kingdom. The FM working group established a revised diagnosis of FM and identified risk factors, course, prognosis, and pathophysiology of FM. Future studies will assess the criteria for feasibility, reliability, and validity. Revisions of the dimensions will also be required as research advances our understanding of FM. PERSPECTIVE The ACTTION-APS FM taxonomy provides an evidence-based diagnostic system for FM. The taxonomy includes diagnostic criteria, common features, comorbidities, consequences, and putative mechanisms. This approach might improve the recognition of FM in clinical practice.
-
2.
Psychological therapies for chronic widespread pain and fibromyalgia syndrome.
Häuser, W, Jones, G
Best practice & research. Clinical rheumatology. 2019;(3):101416
Abstract
Psychological factors such as adverse childhood experiences, traumatic life events, interpersonal conflicts and psychological distress play an important role in the predisposition, onset and severity of chronic widespread pain (CWP) and fibromyalgia syndrome (FMS). Therefore, psychological therapies might have the potential to reduce disability as well as symptom and economic burden in patients with CWP and FMS. Recent interdisciplinary guidelines have suggested different strengths of recommendation for psychological therapies for FMS. The aims of this narrative review are to summarise: • Mechanisms of actions. • Evidence on efficacy, tolerability and safety. • Knowledge gaps and needs for future research of psychological therapies for CWP and FMS for non-mental health professionals.
-
3.
Combination pharmacotherapy for the treatment of fibromyalgia in adults.
Thorpe, J, Shum, B, Moore, RA, Wiffen, PJ, Gilron, I
The Cochrane database of systematic reviews. 2018;(2):CD010585
-
-
Free full text
-
Abstract
BACKGROUND Fibromyalgia is a chronic widespread pain condition affecting millions of people worldwide. Current pharmacotherapies are often ineffective and poorly tolerated. Combining different agents could provide superior pain relief and possibly also fewer side effects. OBJECTIVES To assess the efficacy, safety, and tolerability of combination pharmacotherapy compared to monotherapy or placebo, or both, for the treatment of fibromyalgia pain in adults. SEARCH METHODS We searched CENTRAL, MEDLINE, and Embase to September 2017. We also searched reference lists of other reviews and trials registries. SELECTION CRITERIA Double-blind, randomised controlled trials comparing combinations of two or more drugs to placebo or other comparators, or both, for the treatment of fibromyalgia pain. DATA COLLECTION AND ANALYSIS From all studies, we extracted data on: participant-reported pain relief of 30% or 50% or greater; patient global impression of clinical change (PGIC) much or very much improved or very much improved; any other pain-related outcome of improvement; withdrawals (lack of efficacy, adverse events), participants experiencing any adverse event, serious adverse events, and specific adverse events (e.g. somnolence and dizziness). The primary comparison was between combination and one or all single-agent comparators. We also assessed the evidence using GRADE and created a 'Summary of findings' table. MAIN RESULTS We identified 16 studies with 1474 participants. Three studies combined a non-steroidal anti-inflammatory drug (NSAID) with a benzodiazepine (306 participants); two combined amitriptyline with fluoxetine (89 participants); two combined amitriptyline with a different agent (92 participants); two combined melatonin with an antidepressant (164 participants); one combined carisoprodol, paracetamol (acetaminophen), and caffeine (58 participants); one combined tramadol and paracetamol (acetaminophen) (315 participants); one combined malic acid and magnesium (24 participants); one combined a monoamine oxidase inhibitor with 5-hydroxytryptophan (200 participants); and one combined pregabalin with duloxetine (41 participants). Six studies compared the combination of multiple agents with each component alone and with inactive placebo; three studies compared combination pharmacotherapy with each individual component but did not include an inactive placebo group; two studies compared the combination of two agents with only one of the agents alone; and three studies compared the combination of two or more agents only with inactive placebo.Heterogeneity among studies in terms of class of agents evaluated, specific combinations used, outcomes reported, and doses given prevented any meta-analysis. None of the combinations of drugs found provided sufficient data for analysis compared with placebo or other comparators for our preferred outcomes. We therefore provide a narrative description of results. There was no or inadequate evidence in any comparison for primary and secondary outcomes. Two studies only reported any primary outcomes of interest (patient-reported pain relief of 30%, or 50%, or greater). For each 'Risk of bias' item, only half or fewer of studies had unequivocal low risk of bias. Small size and selective reporting were common as high risk of bias.Our GRADE assessment was therefore very low for primary outcomes of pain relief of 30% or 50% or greater, PGIC much or very much improved or very much improved, any pain-related outcome, participants experiencing any adverse event, any serious adverse event, or withdrawing because of an adverse event.Three studies found some evidence that combination pharmacotherapy reduced pain compared to monotherapy; these trials tested three different combinations: melatonin and amitriptyline, fluoxetine and amitriptyline, and pregabalin and duloxetine. Adverse events experienced by participants were not serious, and where they were reported (in 12 out of 16 studies), all participants experienced them, regardless of treatment. Common adverse events were nausea, dizziness, somnolence, and headache. AUTHORS' CONCLUSIONS There are few, large, high-quality trials comparing combination pharmacotherapy with monotherapy for fibromyalgia, consequently limiting evidence to support or refute the use of combination pharmacotherapy for fibromyalgia.
-
4.
Evidence-Based Non-Pharmacological Therapies for Fibromyalgia.
Aman, MM, Jason Yong, R, Kaye, AD, Urman, RD
Current pain and headache reports. 2018;(5):33
Abstract
PURPOSE OF REVIEW Fibromyalgia (FM) is the second most common rheumatologic pain disorder after osteoarthritis with a multisystem presentation. While the treatment of FM in a clinical setting incorporates both pharmacologic and non-pharmacologic modalities, the present investigation reviews evolving literature on cognitive behavioral and complementary medical therapies. The recent medical literature on FM was reviewed between 2012 and 2017 via MEDLINE and the Cochrane Central Registry of Controlled Trials, with an emphasis on randomized controlled trials, meta-analyses, and evidence-based treatment guidelines. RECENT FINDINGS Cognitive behavioral therapy continues to play a significant role in the non-medical therapy of FM. It is especially helpful in high catastrophizing patients as evidenced by recent studies that note changes in the brain on functional magnetic resonance imaging. Mindfulness meditation can be helpful in improving pain symptoms and pain perception. No particular diet is found to have a meaningful impact in FM; however, various diets including low fermentable oligo- di -monosaccharides and polyols diet, gluten free, and hypocaloric may be helpful in ameliorating gastrointestinal distress in select patient populations. Current literature does not support the routine use of acupuncture for improving pain or quality of life in FM; however, given its benign side effect profile, it should not be discouraged. Goals for symptom management and pain control should be set early, and patient engagement remains critical in the management of this complex pain presentation. While low quality evidence exists for most non-pharmacologic treatment modalities for FM, CBT and mindfulness meditation show promise for future investigation.
-
5.
Controlled-release pregabalin in the treatment of fibromyalgia.
Alciati, A, Atzeni, F, Masala, IF, Cirillo, M, Sciortino, D, Perna, G, Sarzi-Puttini, P
Expert review of neurotherapeutics. 2018;(8):617-623
Abstract
Fibromyalgia (FM) is a chronic disorder whose symptoms of musculo-skeletal pain, fatigue, sleep disturbances, and cognitive impairment pervade the personal, occupational, and social aspects of a patient's life. Together with the antidepressants duloxetine and milnacipran, the anticonvulsant pregabalin (PGB) is one of the three drugs approved by the Food and Drug Administration for the treatment of FM. The aim of this narrative review is to summarize the data relating to the efficacy and safety of the controlled-release formulation of PGB (PGB-CR) in patients with FM. Areas covered: Efforts by the pharmaceutical industry have led to the introduction of new formulations of already approved drugs to enhance treatment convenience and adherence. Expert opinion: Although there are no published studies specifically comparing PGB-CR and PGB-IR formulations in FM patients, the efficacy and safety profiles of PGB-CR seem to be similar to those of the IR formulation, and the convenience of once-daily dosing potentially enhances patient compliance. However, the amount of evidence is not sufficient to draw any definite conclusions, and further studies of larger patient samples are needed.
-
6.
Vitamin and mineral status in chronic fatigue syndrome and fibromyalgia syndrome: A systematic review and meta-analysis.
Joustra, ML, Minovic, I, Janssens, KAM, Bakker, SJL, Rosmalen, JGM
PloS one. 2017;(4):e0176631
Abstract
BACKGROUND Many chronic fatigue syndrome (CFS) and fibromyalgia syndrome (FMS) patients (35-68%) use nutritional supplements, while it is unclear whether deficiencies in vitamins and minerals contribute to symptoms in these patients. Objectives were (1) to determine vitamin and mineral status in CFS and FMS patients as compared to healthy controls; (2) to investigate the association between vitamin and mineral status and clinical parameters, including symptom severity and quality of life; and (3) to determine the effect of supplementation on clinical parameters. METHODS The databases PubMed, EMBASE, Web of Knowledge, and PsycINFO were searched for eligible studies. Articles published from January 1st 1994 for CFS patients and 1990 for FMS patients till March 1st 2017 were included. Articles were included if the status of one or more vitamins or minerals were reported, or an intervention concerning vitamins or minerals was performed. Two reviewers independently extracted data and assessed the risk of bias. RESULTS A total of 5 RCTs and 40 observational studies were included in the qualitative synthesis, of which 27 studies were included in the meta-analyses. Circulating concentrations of vitamin E were lower in patients compared to controls (pooled standardized mean difference (SMD): -1.57, 95%CI: -3.09, -0.05; p = .042). However, this difference was not present when restricting the analyses to the subgroup of studies with high quality scores. Poor study quality and a substantial heterogeneity in most studies was found. No vitamins or minerals have been repeatedly or consistently linked to clinical parameters. In addition, RCTs testing supplements containing these vitamins and/or minerals did not result in clinical improvements. DISCUSSION Little evidence was found to support the hypothesis that vitamin and mineral deficiencies play a role in the pathophysiology of CFS and FMS, and that the use of supplements is effective in these patients. REGISTRATION Study methods were documented in an international prospective register of systematic reviews (PROSPERO) protocol, registration number: http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42015032528.
-
7.
Recent strategies for drug development in fibromyalgia syndrome.
Blumenthal, DE, Malemud, CJ
Expert review of neurotherapeutics. 2016;(12):1407-1411
Abstract
The US Federal Drug Administration (FDA) approved 3 medications for treating fibromyalgia syndrome (FMS). There have been no additional FDA approvals since January 2009 and the efficacy of the FDA-approved medications for FMS has been questioned. Areas covered: The "search for studies" tool using clinicaltrials.gov and PubMed were employed. The term, "fibromyalgia" was used for clinicaltrials.gov. The terms employed for PubMed were "Name-of-Drug Fibromyalgia", "Fibromyalgia Treatment" or "Fibromyalgia Drug Treatment." Clinical trials were reviewed if they were prospective and blinded, and if they employed a comparator, either placebo or another pharmaceutical. Expert commentary: Progress toward standardizing the outcome measures for FMS clinical trials have been made but challenges remain. Several pharmaceutical candidates for FMS have been tested since 2009. The results of these studies with potential novel targets for drug development for FMS were reviewed including the results of trials with sodium oxybate, quetiapine, esreboxetine, nabilone, memantine, naltrexone, and melatonin.
-
8.
Restless legs syndrome and pain disorders: what's in common?
Goulart, LI, Delgado Rodrigues, RN, Prieto Peres, MF
Current pain and headache reports. 2014;(11):461
Abstract
Between 10 % and 30 % of the population report chronic pain. More than half of these also have sleep complaints. From considering these data, it can be inferred there is a significant overlapping between these conditions. Restless Legs Syndrome/Willis-Ekbom Disease (RLS/WED) is characterized by complaints of an "urge to move" frequently associated with dysesthesias. From that perspective, these sensations can also have painful characteristics. By the same token, the presence of comorbid diseases as predicted by a higher prevalence RLS/WED, have many of them with pain as an important complaint. Pain is a multidimensional response involving several levels of expression ranging from somatosensory to emotional. The potential shared mechanisms between RLS/WED and pain may involve sleep deprivation/fragmentation effect, inducing an increase in markers of inflammation and reduction in pain thresholds. These are modulated by several different settings of neurotransmitters with a huge participation of monoaminergic dysfunctional circuits. A thorough comprehension of these mechanisms is of utmost importance for the correct approach and treatment choices.
-
9.
Non-pharmacological therapy and complementary and alternative medicine in fibromyalgia.
Braz, Ade S, de Paula, AP, Diniz, Mde F, de Almeida, RN
Revista brasileira de reumatologia. 2011;(3):269-82
Abstract
Fibromyalgia is a chronic painful syndrome that affects up to 5% of the world population. It is associated with sleep and mood disorders, fatigue, and functional disability. Its pathogenesis involves a disorder of the central modulation of pain, impairment of the descending inhibitory system, and hyperactivity of substance P. Because of the extensive symptomatology of patients with fibromyalgia and its multifactorial pathogenesis, its ideal treatment requires a multidisciplinary approach including the association of pharmacological and non-pharmacological therapies. The pharmacological therapy currently recommended for the syndrome includes antidepressants, calcium-channel modulators, muscle relaxants, and analgesics. In most cases, the non-pharmacological treatment consists of patient education, supervised aerobic physical activity, and cognitive-behavioral therapy. However, many patients do not respond satisfactorily, or have side effects associated with the long-term use of drugs, in addition to reporting difficulties in adhering to a therapy based on exercises and physical medicine. Thus, physicians and patients are increasingly interested in an alternative and complementary therapy for fibromyalgia. This review approaches the different therapeutic modalities used in fibromyalgia, emphasizing the evidence of non-pharmacological therapy and use of alternative and complementary medicine for these patients.
-
10.
Herbal medicine in the treatment of rheumatic diseases.
Ernst, E
Rheumatic diseases clinics of North America. 2011;(1):95-102
Abstract
Herbal medicines are popular, self-prescribed treatments for rheumatic conditions. A recent US survey suggested that approximately 90% of arthritic patients use alternative therapies such as herbal medicines. This article provides a brief overview of the evidence on herbal medicines for 4 common rheumatic conditions: back pain, fibromyalgia, osteoarthritis, and rheumatoid arthritis.