-
1.
Effects of Olive Oil Consumption on Cardiovascular Risk Factors in Patients with Fibromyalgia.
Rus, A, Molina, F, Martínez-Ramírez, MJ, Aguilar-Ferrándiz, ME, Carmona, R, Del Moral, ML
Nutrients. 2020;(4)
Abstract
We have recently reported that patients with fibromyalgia (FM) may be at increased risk for cardiovascular disease. Olive oil reportedly has cardioprotective effects. We examined the influence of olive oil consumption on cardiovascular risk factors in FM. This preliminary study was performed on blood samples of women with FM who consumed 50 mL of organic olive oil daily for 3 weeks. Patients were randomized into two groups: 15 women ingested extra virgin olive oil (EVOO) and 15 refined olive oil (ROO). Cardiovascular risk markers were measured at baseline (pre measure) and after consumption of olive oil (post measure). Red blood cell count and erythrocyte sedimentation rate (ESR; both p < 0.05) declined significantly post-treatment in the EVOO group. Consumption of ROO increased mean platelet volume and reduced platelet distribution width (PDW), neutrophil-to-lymphocyte ratio, ESR and fibrinogen (all p < 0.05). Significant differences were found in pre-post change between the EVOO and ROO groups for cortisol and PDW (both p < 0.05). Our results have shown that consumption of olive oil may have antithrombotic and antiinflammatory properties in patients with FM, thereby improving a number of cardiovascular risk markers. Both EVOO and ROO may be useful as adjuvants for the prevention and/or treatment of cardiovascular disorders in these patients.
-
2.
Brief Acceptance and Commitment Therapy for Fibromyalgia: Feasibility and Effectiveness of a Replicated Single-Case Design.
Gómez-Pérez, MC, García-Palacios, A, Castilla, D, Zaragozá, I, Suso-Ribera, C
Pain research & management. 2020;:7897268
Abstract
OBJECTIVE Overall, the literature on the effectiveness of psychological treatments in general and those for fibromyalgia in particular has been dominated by research designs that focus on large groups and explore changes on average, so the treatment impact at the individual level remains unclear. In this quasi-experimental, replicated single-case design, we will test the feasibility and effectiveness of a brief acceptance and committed therapy intervention using ecological momentary assessment supported by technology. METHODS The sample comprised 7 patients (3 in the individual condition and 4 in the group condition) who received a brief, 5-week psychological treatment. Patient evolution was assessed one week prior to treatment onset and during the whole study with a smartphone app. Because ecological momentary assessment and the use of an app are not frequent practices in routine care, we also evaluated the feasibility of this assessment methodology (i.e., compliance with the app). Change was investigated with a nonoverlap of all pairs index. Outcomes were pain interference with sleep and social activities, fatigue, sadness, and pain intensity. RESULTS Patient change was not uniform across outcomes. Four patients (two in each condition) showed relatively moderate levels of change (approximately 60% nonoverlap in several outcomes). The remaining patients showed more modest improvements which affected a reduced number of outcomes. Based on nonoverlapping indices, there was no clear evidence in favor of any treatment format. CONCLUSIONS An alternative design to large-scale trials, one that focuses on the individual change, exists and it can be implemented in pain research. The use of technology (e.g., smartphones) simplifies such designs by facilitating ecological momentary assessment. Based on our findings showing that changes were not homogeneous across patients or outcomes, more single-case designs and patient-centered analyses (e.g., responder and moderation analyses) are required.
-
3.
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.
-
4.
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.
-
5.
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.
-
6.
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.
-
7.
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.
-
8.
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.
-
9.
[Treatment of fibromyalgia syndrome with gamma-hydroxybutyrate : A randomized controlled study].
Reuter, E, Tafelski, S, Thieme, K, West, C, Haase, U, Beck, L, Schäfer, M, Spies, C
Schmerz (Berlin, Germany). 2017;(2):149-158
Abstract
BACKGROUND The etiology of fibromyalgia syndrome is not yet fully understood. Current hypotheses suggest a potential role of gamma-hydroxybutyrate (GHB) in influencing endocrinological abnormalities in patients with fibromyalgia. OBJECTIVE The aim of the study was to investigate whether low dose GHB as a growth-hormone releasing substance reduces pain intensity and improves depressive mood, physical impairment and sleep quality in outpatients with fibromyalgia. Additionally, adverse events were recorded. MATERIAL AND METHODS The pilot study was conducted in the outpatient clinic for pain at the clinic for anesthesiology and surgical intensive care of the Charité Universitätsmedizin Berlin. In the study 25 female patients with fibromyalgia according to the criteria of the American College of Rheumatology were randomized into 2 groups. Over 15 weeks patients of the intervention group received 25 mg/kg body weight oral GHB before going to bed and were compared with a placebo control group. In addition, all patients participated in operant behavioral pain treatment in a group setting. Dependent variables were pain intensity, depressive mood, physical impairment and quality of sleep. RESULTS There were no group differences in the course of pain intensity (p = 0.61), depressive mood (p = 0.16), physical impairment (p = 0.25) and quality of sleep (p = 0.44); however, all symptoms improved across the groups from pretherapy to posttherapy. Low dose GHB did not increase growth hormone blood concentrations. The number of adverse events that were reported more than two times was similar in both groups. DISCUSSION Administration of low dose GHB did not yield clinical improvements in female outpatients with fibromyalgia. General improvement in the course of treatment may have resulted from operant behavioral pain therapy. Future studies on GHB should control hypothetical risk factors for identification of non-responders.
-
10.
Functional status, physical activity level, and exercise regularity in patients with fibromyalgia after Multidisciplinary treatment: retrospective analysis of a randomized controlled trial.
Salvat, I, Zaldivar, P, Monterde, S, Montull, S, Miralles, I, Castel, A
Rheumatology international. 2017;(3):377-387
Abstract
Multidisciplinary treatments have shown to be effective for fibromyalgia. We report detailed functional outcomes of patients with fibromyalgia who attended a 3-month Multidisciplinary treatment program. The hypothesis was that patients would have increased functional status, physical activity level, and exercise regularity after attending this program. We performed a retrospective analysis of a randomized, simple blinded clinical trial. The inclusion criteria consisted of female sex, a diagnosis of fibromyalgia, age 18-60 and 3-8 years of schooling. Measures from the Fibromyalgia Impact Questionnaire (FIQ) and the COOP/WONCA Functional Health Assessment Charts (WONCA) were obtained before and at the end of the treatment and at 3-, 6-, and 12-month follow-ups. Patients recorded their number of steps per day with pedometers. They performed the six-minute walk test (6 MW) before and after treatment. In total, 155 women participated in the study. Their median (interquartile interval) FIQ score was 68.0 (53.0-77.0) at the beginning of the treatment, and the difference between the Multidisciplinary and Control groups was statistically and clinically significant in all of the measures (except the 6-month follow-up). The WONCA charts showed significant clinical improvements in the Multidisciplinary group, with physical fitness in the normal range across almost all values. In that group, steps/day showed more regularity, and the 6 MW results showed improvement of -33.00 (-59.8 to -8.25) m, and the differences from the Control group were statistically significant. The patients who underwent the Multidisciplinary treatment had improved functional status, physical activity level, and exercise regularity. The functional improvements were maintained 1 year after treatment completion.