International, multidisciplinary Delphi consensus recommendations on non-pharmacological interventions for fibromyalgia.

OBJECTIVES: To develop evidence-based expert recommendations for non-pharmacological treatments for pain, fatigue, sleep problems, and depression in fibromyalgia. METHODS: An international, multidisciplinary Delphi exercise was conducted. Authors of EULAR and the Canadian Fibromyalgia Guidelines Group, members of the American Pain Society and clinicians with expertise in fibromyalgia were invited. Participants were asked to select non-pharmacological interventions that could be offered for specific fibromyalgia symptoms and to classify them as either core or adjunctive treatments. An evidence summary was provided to aid the decision making. Items receiving >70% votes were accepted, those receiving <30% votes were rejected and those obtaining 30-70% votes were recirculated for up to two additional rounds. RESULTS: Seventeen experts participated (Europe (n = 10), North America (n = 6), and Israel (n = 1)) in the Delphi exercise and completed all three rounds. Aerobic exercise, education, sleep hygiene and cognitive behavioural therapy were recommended as core treatments for all symptoms. Mind-body exercises were recommended as core interventions for pain, fatigue and sleep problems. Mindfulness was voted core treatment for depression, and adjunctive treatment for other symptoms. Other interventions, namely music, relaxation, hot bath, and local heat were voted as adjunctive treatments, varying between symptoms. CONCLUSIONS: This study provided evidence-based expert consensus recommendations on non-pharmacological treatments for fibromyalgia that may be used to individualise treatments in clinical practice targeting the diverse symptoms associated with fibromyalgia.

Effectiveness and Safety of Ayurvedic Medicines in Type 2 Diabetes Mellitus Management: A Systematic Review and Meta-Analysis.

Introduction: Many Ayurvedic medicines have the potential for managing type 2 diabetes mellitus (T2DM), with previous systematic reviews demonstrating effectiveness and safety for specific Ayurvedic medicines. However, many of the reviews need updating and none provide a comprehensive summary of all the Ayurvedic medicines evaluated for managing T2DM. Objective: The objective of this systematic review was to evaluate and synthesize evidence on the effectiveness and safety of Ayurvedic medicines for managing T2DM. Inclusion criteria: Published and unpublished RCTs assessing the effectiveness and safety of Ayurvedic medicines for managing T2DM in adults. Methods: The JBI systematic review methodology was followed. A comprehensive search of sources (including 18 electronic databases) from inception to 16 January 2021 was made. No language restrictions were applied. Data synthesis was conducted using narrative synthesis and random effects meta-analyses, where appropriate. Pooled results are reported as mean differences (MD) with 95% confidence intervals (CI). Results: Out of 32,519 records identified from the searches, 219 articles were included in the systematic review representing 199 RCTs (21,191 participants) of 98 Ayurvedic medicines. Overall, in the studies reviewed the methodology was not adequately reported, resulting in poorer methodological quality scoring. Glycated hemoglobin (HbA1c) was reduced using Aegle marmelos (L.) Corrêa (MD -1.6%; 95% CI -3 to -0.3), Boswellia serrata Roxb. (-0.5; -0.7 to -0.4), Gynostemma pentaphyllum (Thunb.) Makino (-1; -1.5 to -0.6), Momordica charantia L. (-0.3; -0.4 to -0.1), Nigella sativa L. (-0.4; -0.6 to -0.1), Plantago ovata Forssk. (-0.9; -1.4 to -0.3), Tinospora cordifolia (Willd.) Hook.f. and Thomson (-0.5; -0.6 to -0.5), Trigonella foenum-graecum L. (-0.6; -0.9 to -0.4), and Urtica dioica L. (-1.3; -2.4 to -0.2) compared to control. Similarly, fasting blood glucose (FBG) was reduced by 4-56 mg/dl for a range of Ayurvedic medicines. Very few studies assessed health-related quality of life (HRQoL). Adverse events were not reported in many studies, and if reported, these were mostly none to mild and predominately related to the gastrointestinal tract. Conclusion: The current evidence suggests the benefit of a range of Ayurvedic medicines in improving glycemic control in T2DM patients. Given the limitations of the available evidence and to strengthen the evidence base, high-quality RCTs should be conducted and reported.

Identifying Potential Classification Criteria for Calcium Pyrophosphate Deposition Disease: Item Generation and Item Reduction.

OBJECTIVE: Classification criteria for calcium pyrophosphate deposition (CPPD) disease will facilitate clinical research on this common crystalline arthritis. Our objective was to report on the first 2 phases of a 4-phase process for developing CPPD classification criteria. METHODS: CPPD classification criteria development is overseen by a 12-member steering committee. Item generation (phase I) included a scoping literature review of 5 literature databases and contributions from a 35-member combined expert committee and 2 patient research partners. Item reduction and refinement (phase II) involved a combined expert committee meeting, discussions among clinical, imaging, and laboratory advisory groups, and an item-rating exercise to assess the influence of individual items toward classification. The steering committee reviewed the modal rating score for each item (range -3 [strongly pushes away from CPPD] to +3 [strongly pushes toward CPPD]) to determine items to retain for future phases of criteria development. RESULTS: Item generation yielded 420 items (312 from the literature, 108 from experts/patients). The advisory groups eliminated items that they agreed were unlikely to distinguish between CPPD and other forms of arthritis, yielding 127 items for the item-rating exercise. Fifty-six items, most of which had a modal rating of +/- 2 or 3, were retained for future phases. As numerous imaging items were rated +3, the steering committee recommended focusing on imaging of the knee and wrist and 1 additional affected joint for calcification suggestive of CPP crystal deposition. CONCLUSION: A data- and expert-driven process is underway to develop CPPD classification criteria. Candidate items comprise clinical, imaging, and laboratory features.

Efficacy of nonpharmacological interventions for individual features of fibromyalgia: a systematic review and meta-analysis of randomised controlled trials.

ABSTRACT: Fibromyalgia is a highly heterogeneous condition, but the most common symptoms are widespread pain, fatigue, poor sleep, and low mood. Nonpharmacological interventions are recommended as first-line treatment of fibromyalgia. However which interventions are effective for the different symptoms is not well understood. The objective of this study was to assess the efficacy of nonpharmacological interventions on symptoms and disease-specific quality of life. Seven databases were searched from their inception until June 1, 2020. Randomised controlled trials comparing any nonpharmacological intervention to usual care, waiting list, or placebo in people with fibromyalgia aged >16 years were included without language restriction. Fibromyalgia Impact Questionnaire (FIQ) was the primary outcome measure. Standardised mean difference and 95% confidence interval were calculated using random effects model. The risk of bias was evaluated using the modified Cochrane tool. Of the 16,251 studies identified, 167 randomised controlled trials (n = 11,012) assessing 22 nonpharmacological interventions were included. Exercise, psychological treatments, multidisciplinary modality, balneotherapy, and massage improved FIQ. Subgroup analysis of different exercise interventions found that all forms of exercise improved pain (effect size [ES] -0.72 to -0.96) and depression (ES -0.35 to -1.22) except for flexibility exercise. Mind-body and strengthening exercises improved fatigue (ES -0.77 to -1.00), whereas aerobic and strengthening exercises improved sleep (ES -0.74 to -1.33). Psychological treatments including cognitive behavioural therapy and mindfulness improved FIQ, pain, sleep, and depression (ES -0.35 to -0.55) but not fatigue. The findings of this study suggest that nonpharmacological interventions for fibromyalgia should be individualised according to the predominant symptom.

Efficacy of prolotherapy in comparison to other therapies for chronic soft tissue injuries: A systematic review and network meta-analysis.

INTRODUCTION: Prolotherapy and other injections, primarily acting on pathways associated with maladaptive tissue repair, are recommended for recalcitrant chronic soft tissue injuries (CSTI). However, selection of injection is challenging due to mixed results. This network meta-analysis (NMA) aimed to compare prolotherapy with other therapies, particularly injections, for CSTI and establish robustness of the results. METHODOLOGY: Pubmed, Medline, SPORTDiscus and Google scholar were searched from inception to 4th January 2021 for randomised controlled trials (RCTs) involving injection therapies (e.g. blood derivatives, corticosteroid, hyaluronic acid, botulinum toxin) for CSTI. The primary and secondary outcomes were pain and function, respectively, at (or nearest to) 6 months. Effect size (ES) was presented as standardised mean difference with 95% confidence interval (CI). Frequentist random effect NMA was used to generate the overall estimates, subgroup estimates (by region and measurement time point) and sensitivity analyses. RESULTS: A total of 91 articles (87 RCTs; 5859 participants) involving upper limb (74%), lower limb (23%) and truncal/hip (3%) injuries were included. At all time points, prolotherapy had no statistically significant pain benefits over other therapies. This observation remained unchanged when tested under various assumptions and with exclusion of studies with high risk of bias. Although prolotherapy did not offer statistically significant functional improvement compared to most therapies, its ES was consistently better than non-injections and corticosteroid injection for both outcomes. At selected time points and for selected injuries, prolotherapy demonstrated potentially better pain improvement over placebo (<4 months: shoulder [ES 0.65; 95% CI 0.00 to 1.30]; 4-8 months: elbow [ES 0.91; 95% CI 0.12 to 1.70]; >8 months: shoulder [ES 2.08; 95% CI 1.49, to 2.68]). Injections generally produced greater ES when combined with non-injection therapy. CONCLUSION: While clinical outcomes were generally comparable across types of injection therapy, prolotherapy may be used preferentially for selected conditions at selected times.

Neurological and Musculoskeletal Features of COVID-19: A Systematic Review and Meta-Analysis.

Importance: Some of the symptoms of COVID-19 are fever, cough, and breathing difficulty. However, the mechanism of the disease, including some of the symptoms such as the neurological and musculoskeletal symptoms, is still poorly understood. Objective: The aim of this review is to summarize the evidence on the neurological and musculoskeletal symptoms of the disease. This may help with early diagnosis, prevention of disease spread, and treatment planning. Data Sources: MEDLINE, EMBASE, Web of Science, and Google Scholar (first 100 hits) were searched until April 17, 2020. The key search terms used were "coronavirus" and "signs and symptoms." Only studies written in English were included. Study Selection: The selection was performed by two independent reviewers using EndNote and Rayyan software. Any disagreement was resolved by consensus or by a third reviewer. Data Extraction and Synthesis: PRISMA guidelines were followed for abstracting data and assessing the quality of the studies. These were carried out by two and three independent reviewers, respectively. Any disagreement was resolved by consensus or by a third reviewer. The data were analyzed using qualitative synthesis and pooled using a random-effect model. Main Outcome(s) and Measure(s): The outcomes in the study include country, study design, participant details (sex, age, sample size), and neurological and musculoskeletal features. Result: Sixty studies (n = 11, 069) were included in the review, and 51 studies were used in the meta-analysis. The median or mean age ranged from 24 to 95 years. The prevalence of neurological and musculoskeletal manifestations was 35% for smell impairment (95% CI 0-94%; I 2 99.63%), 33% for taste impairment (95% CI 0-91%; I 2 99.58%), 19% for myalgia (95% CI 16-23; I 2 95%), 12% for headache (95% CI 9-15; I 2 93.12%), 10% for back pain (95% CI 1-23%; I 2 80.20%), 10% for dizziness (95% CI 3-19%; I 2 86.74%), 3% for acute cerebrovascular disease (95% CI 1-5%; I 2 0%), and 2% for impaired consciousness (95% CI 1-2%; I 2 0%). Conclusion and Relevance: Patients with COVID-19 present with neurological and musculoskeletal symptoms. Therefore, clinicians need to be vigilant in the diagnosis and treatment of these patients.

Report from the Hand Osteoarthritis Working Group at OMERACT 2018: Update on Core Instrument Set Development.

OBJECTIVE: To evaluate hand osteoarthritis tools for core instrument set development. METHODS: For OMERACT 2018, a systematic literature review and advances in instrument validation were presented. RESULTS: Visual analog and numerical rating scales were considered valuable for pain and patient's global assessment, despite heterogeneous phrasing and missing psychometric evidence for some aspects. The Modified Intermittent and Constant Osteoarthritis Pain scale was lacking evidence. The Michigan Hand Outcomes Questionnaire had advantages above other pain/function questionnaires. The Hand Mobility in Scleroderma scale was valid, although responsiveness was questioned. Potential joint activity instruments were evaluated. CONCLUSION: The development of the core instrument set is progressing, and a research agenda was also developed.

The effectiveness of exercise-based vestibular rehabilitation in adult patients with chronic dizziness: A systematic review.

Background: Dizziness is a non-specific term used by patients to describe several symptoms ranging from true vertigo, light headedness, disorientation or sense of imbalance. Vestibular rehabilitation (VR) is a specific form of exercise-based therapy programme aimed at alleviating the primary and secondary problems of a vestibular pathology. The aim of this study was to investigate the effectiveness of exercise-based vestibular rehabilitation in adult patients with chronic dizziness. Methods: The following five databases were searched: the Cochrane Central Register of Controlled Trials (CENTRAL, the Cochrane Library), MEDLINE, PubMed, the Physiotherapy Evidence Database (PEDro) and Scopus (Elsevier). Two investigators independently reviewed all articles and a systematic review of literature was performed using the PRISMA guidelines (Preferred Reporting Items for Systematic Reviews and Meta-Analyses). The articles were included if they met the following inclusion criteria: (1) randomised controlled trial, (2) people with chronic dizziness, (3) adults aged 18 or over, (4) exercise-based VR, (5) VR exercises compared with sham or usual care, non-treatment or placebo and (6) only studies published full text in English. Results: The initial search identified 304 articles, four of which met the criteria for analysis. All studies involved some form of vestibular rehabilitation, including vestibular compensation, vestibular adaptation and substitution exercises. These exercises were compared with usual medical care (three studies) or placebo eye exercise (one study). The Vertigo Symptom Scale was the most commonly used outcome measure to assess subjective perception of symptoms of dizziness (three studies). According to the PEDro scale, three studies were considered to be of high quality, and one was rated as fair.  Conclusions: This review suggests that exercise-based vestibular rehabilitation shows benefits for adult patients with chronic dizziness with regard to improvement in the vertigo symptom scale, fall risk, balance and emotional status.