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Safety of Symptomatic Slow-Acting Drugs for Osteoarthritis: Outcomes of a Systematic Review and Meta-Analysis.
Honvo, G, Reginster, JY, Rabenda, V, Geerinck, A, Mkinsi, O, Charles, A, Rizzoli, R, Cooper, C, Avouac, B, Bruyère, O
Drugs & aging. 2019;(Suppl 1):65-99
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Abstract
BACKGROUND Symptomatic slow-acting drugs for osteoarthritis (SYSADOAs) are an important drug class in the treatment armamentarium for osteoarthritis (OA). OBJECTIVE We aimed to re-assess the safety of various SYSADOAs in a comprehensive meta-analysis of randomized placebo-controlled trials, using, as much as possible, data from full safety reports. METHODS We performed a systematic review and random-effects meta-analyses of randomized, double-blind, placebo-controlled trials that assessed adverse events (AEs) with various SYSADOAs in patients with OA. The databases MEDLINE, Cochrane Central Register of Controlled Trials (Ovid CENTRAL) and Scopus were searched. The primary outcomes were overall severe and serious AEs, as well as AEs involving the following Medical Dictionary for Regulatory Activities (MedDRA) system organ classes (SOCs): gastrointestinal, cardiac, vascular, nervous system, skin and subcutaneous tissue, musculoskeletal and connective tissue, renal and urinary system. RESULTS Database searches initially identified 3815 records. After exclusions according to the selection criteria, 25 studies on various SYSADOAs were included in the qualitative synthesis, and 13 studies with adequate data were included in the meta-analyses. Next, from the studies previously excluded according to the protocol, 37 with mainly oral nonsteroidal anti-inflammatory drugs (NSAIDs) permitted as concomitant medication were included in a parallel qualitative synthesis, from which 18 studies on various SYSADOAs were included in parallel meta-analyses. This post hoc parallel inclusion was conducted because of the high number of studies allowing concomitant anti-OA medications. Indeed, primarily excluding studies with concomitant anti-OA medications was crucial for a meta-analysis on safety. The decision for parallel inclusion was made for the purpose of comparative analyses. Glucosamine sulfate (GS), chondroitin sulfate (CS) and avocado soybean unsaponifiables (ASU; Piascledine®) were not associated with increased odds for any type of AEs compared with placebo. Overall, with/without concomitant OA medication, diacerein was associated with significantly increased odds of total AEs (odds ratio [OR] 2.22; 95% confidence interval [CI] 1.58-3.13; I2 = 52.8%), gastrointestinal disorders (OR 2.85; 95% CI 2.02-4.04; I2 = 62.8%) and renal and urinary disorders (OR 3.42; 95% CI 2.36-4.96; I2 = 17.0%) compared with placebo. In studies that allowed concomitant OA medications, diacerein was associated with significantly more dermatological disorders (OR 2.47; 95% CI 1.42-4.31; I2 = 0%) and more dropouts due to AEs (OR 3.18; 95% CI 1.85-5.47; I2 = 13.4%) than was placebo. No significant increase in serious or severe AEs was found with diacerein versus placebo. CONCLUSIONS GS and CS can be considered safe treatments for patients with OA. All eligible studies on ASU included in our analysis used the proprietary product Piascledine® and allowed other anti-OA medications; thus, the safety of ASU must be confirmed in future studies without concomitant anti-OA medications. Given the safety concerns with diacerein, its usefulness in patients with OA should be assessed, taking into account individual patient characteristics.
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Dietary supplements for treating osteoarthritis: a systematic review and meta-analysis.
Liu, X, Machado, GC, Eyles, JP, Ravi, V, Hunter, DJ
British journal of sports medicine. 2018;(3):167-175
Abstract
OBJECTIVE To investigate the efficacy and safety of dietary supplements for patients with osteoarthritis. DESIGN An intervention systematic review with random effects meta-analysis and meta-regression. DATA SOURCES MEDLINE, EMBASE, Cochrane Register of Controlled Trials, Allied and Complementary Medicine and Cumulative Index to Nursing and Allied Health Literature were searched from inception to April 2017. STUDY ELIGIBILITY CRITERIA Randomised controlled trials comparing oral supplements with placebo for hand, hip or knee osteoarthritis. RESULTS Of 20 supplements investigated in 69 eligible studies, 7 (collagen hydrolysate, passion fruit peel extract, Curcuma longa extract, Boswellia serrata extract, curcumin, pycnogenol and L-carnitine) demonstrated large (effect size >0.80) and clinically important effects for pain reduction at short term. Another six (undenatured type II collagen, avocado soybean unsaponifiables, methylsulfonylmethane, diacerein, glucosamine and chondroitin) revealed statistically significant improvements on pain, but were of unclear clinical importance. Only green-lipped mussel extract and undenatured type II collagen had clinically important effects on pain at medium term. No supplements were identified with clinically important effects on pain reduction at long term. Similar results were found for physical function. Chondroitin demonstrated statistically significant, but not clinically important structural improvement (effect size -0.30, -0.42 to -0.17). There were no differences between supplements and placebo for safety outcomes, except for diacerein. The Grading of Recommendations Assessment, Development and Evaluation suggested a wide range of quality evidence from very low to high. CONCLUSIONS The overall analysis including all trials showed that supplements provided moderate and clinically meaningful treatment effects on pain and function in patients with hand, hip or knee osteoarthritis at short term, although the quality of evidence was very low. Some supplements with a limited number of studies and participants suggested large treatment effects, while widely used supplements such as glucosamine and chondroitin were either ineffective or showed small and arguably clinically unimportant treatment effects. Supplements had no clinically important effects on pain and function at medium-term and long-term follow-ups.
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Oral herbal medicines marketed in Brazil for the treatment of osteoarthritis: A systematic review and meta-analysis.
Del Grossi Moura, M, Lopes, LC, Biavatti, MW, Kennedy, SA, de Oliveira E Silva, MC, Silva, MT, de Cássia Bergamaschi, C
Phytotherapy research : PTR. 2017;(11):1676-1685
Abstract
Herbal medications are commonly used to manage symptoms associated with osteoarthritis (OA). This systematic review evaluated the effectiveness and safety of oral medications used in Brazil for the treatment of OA. Randomized clinical trials involving adults with OA treated by a herbal medicine or a control group were eligible. The primary outcomes measured were pain, physical function, swelling, stiffness and quality of life; and the secondary outcomes were adverse events, activity limitations and treatment satisfaction. Sixteen studies were included (n = 1,741 patients) in the systematic review and nine studies in the meta-analysis, representing 6 of the 13 herbal medicines studied: Boswellia serrata (n = 2), Curcuma longa (n = 3), Harpagophytum procumbens (n = 1), Salix daphnoides (n = 3), Uncaria guianensis (n = 2) and Zingiber officinale (n = 5). B. serrata was more effective than both placebo and valdecoxib for improvement of pain and physical function. No difference was observed for H. procumbens, C. longa and U. guianensis compared with control. Z. officinale showed improvement of pain over placebo. The evidence was insufficient to support the effective and safe use of these herbal medicines, because the quality of evidence of studies was low. This study guides managers of the Brazilian public health system and prescribers in decision-making regarding the use of these herbal medicines for OA. Copyright © 2017 John Wiley & Sons, Ltd.
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Osteoarthritis and mortality: A prospective cohort study and systematic review with meta-analysis.
Veronese, N, Cereda, E, Maggi, S, Luchini, C, Solmi, M, Smith, T, Denkinger, M, Hurley, M, Thompson, T, Manzato, E, et al
Seminars in arthritis and rheumatism. 2016;(2):160-167
Abstract
OBJECTIVES Osteoarthritis (OA) is a leading cause of disability, but the relationship with premature mortality remains uncertain. We aimed to investigate the relationship between OA and mortality from any cause and from cardiovascular disease (CVD). METHODS Electronic literature databases searches were conducted to identify prospective studies comparing mortality in a sample of people with and without OA. Risk of all-cause and CVD mortality were summarized using adjusted hazard ratios (HRs) for joint specific (hand, hip, and knee) and joint non-specific OA. New data from the Progetto Veneto Anziani (PRO.V.A.) study were also included. RESULTS From the PRO.V.A. study (N = 2927), there was no significant increase in mortality risk for participants with any joint OA (N = 1858) compared to non-OA (all-cause, HR = 0.95, 95% CI: 0.77-1.15 and CVD, HR = 1.12, 95% CI: 0.82-1.54). On meta-analysis, seven studies (OA = 10,018/non-OA = 18,541), with a median 12-year follow-up, reported no increased risk of any-cause mortality in those with OA (HR = 1.10, 95% CI: 0.97-1.25). After removing data on hand OA, a significant association between OA and mortality was observed (HR = 1.18, 95% CI: 1.08-1.28). There was a significant higher risk of overall mortality for (1) studies conducted in Europe, (2) patients with multi-joint OA; and (3) a radiological diagnosis of OA. OA was associated with significantly higher CVD mortality (HR = 1.21, 95% CI: 1.10-1.34). CONCLUSIONS People with OA are at increased risk of death due to CVD. The relationship with overall mortality is less clear and may be moderated by the presence of hand OA.
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Efficacy and safety of ginger in osteoarthritis patients: a meta-analysis of randomized placebo-controlled trials.
Bartels, EM, Folmer, VN, Bliddal, H, Altman, RD, Juhl, C, Tarp, S, Zhang, W, Christensen, R
Osteoarthritis and cartilage. 2015;(1):13-21
Abstract
The aim of this study was to assess the clinical efficacy and safety of oral ginger for symptomatic treatment of osteoarthritis (OA) by carrying out a systematic literature search followed by meta-analyses on selected studies. Inclusion criteria were randomized controlled trials (RCTs) comparing oral ginger treatment with placebo in OA patients aged >18 years. Outcomes were reduction in pain and reduction in disability. Harm was assessed as withdrawals due to adverse events. The efficacy effect size was estimated using Hedges' standardized mean difference (SMD), and safety by risk ratio (RR). Standard random-effects meta-analysis was used, and inconsistency was evaluated by the I-squared index (I(2)). Out of 122 retrieved references, 117 were discarded, leaving five trials (593 patients) for meta-analyses. The majority reported relevant randomization procedures and blinding, but an inadequate intention-to-treat (ITT) analysis. Following ginger intake, a statistically significant pain reduction SMD = -0.30 ([95% CI: [(-0.50, -0.09)], P = 0.005]) with a low degree of inconsistency among trials (I(2) = 27%), and a statistically significant reduction in disability SMD = -0.22 ([95% CI: ([-0.39, -0.04)]; P = 0.01; I(2) = 0%]) were seen, both in favor of ginger. Patients given ginger were more than twice as likely to discontinue treatment compared to placebo ([RR = 2.33; 95% CI: (1.04, 5.22)]; P = 0.04; I(2) = 0%]). Ginger was modestly efficacious and reasonably safe for treatment of OA. We judged the evidence to be of moderate quality, based on the small number of participants and inadequate ITT populations. Prospero: CRD42011001777.
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Balneotherapy (or spa therapy) for rheumatoid arthritis.
Verhagen, AP, Bierma-Zeinstra, SM, Boers, M, Cardoso, JR, Lambeck, J, de Bie, R, de Vet, HC
The Cochrane database of systematic reviews. 2015;(4):CD000518
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Abstract
BACKGROUND No cure for rheumatoid arthritis (RA) is known at present, so treatment often focuses on management of symptoms such as pain, stiffness and mobility. Treatment options include pharmacological interventions, physical therapy treatments and balneotherapy. Balneotherapy is defined as bathing in natural mineral or thermal waters (e.g. mineral baths, sulphur baths, Dead Sea baths), using mudpacks or doing both. Despite its popularity, reported scientific evidence for the effectiveness or efficacy of balneotherapy is sparse. This review, which evaluates the effects of balneotherapy in patients with RA, is an update of a Cochrane review first published in 2003 and updated in 2008. OBJECTIVES To perform a systematic review on the benefits and harms of balneotherapy in patients with RA in terms of pain, improvement, disability, tender joints, swollen joints and adverse events. SEARCH METHODS We searched the Cochrane 'Rehabilitation and Related Therapies' Field Register (to December 2014), the Cochrane Central Register of Controlled Trials (2014, Issue 1), MEDLIINE (1950 to December 2014), EMBASE (1988 to December 2014), the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (1982 to December 2014), the Allied and Complementary Medicine Database (AMED) (1985 to December 2014), PsycINFO (1806 to December 2014) and the Physiotherapy Evidence Database (PEDro). We applied no language restrictions; however, studies not reported in English, Dutch, Danish, Swedish, Norwegian, German or French are awaiting assessment. We also searched the World Health Organization (WHO) International Clinical Trials Registry Platform for ongoing and recently completed trials. SELECTION CRITERIA Studies were eligible if they were randomised controlled trials (RCTs) consisting of participants with definitive or classical RA as defined by the American Rheumatism Association (ARA) criteria of 1958, the ARA/American College of Rheumatology (ACR) criteria of 1988 or the ACR/European League Against Rheumatism (EULAR) criteria of 2010, or by studies using the criteria of Steinbrocker.Balneotherapy had to be the intervention under study, and had to be compared with another intervention or with no intervention.The World Health Organization (WHO) and the International League Against Rheumatism (ILAR) determined in 1992 a core set of eight endpoints in clinical trials concerning patients with RA. We considered pain, improvement, disability, tender joints, swollen joints and adverse events among the main outcome measures. We excluded studies when only laboratory variables were reported as outcome measures. DATA COLLECTION AND ANALYSIS Two review authors independently selected trials, performed data extraction and assessed risk of bias. We resolved disagreements by consensus and, if necessary, by third party adjudication. MAIN RESULTS This review includes two new studies and a total of nine studies involving 579 participants. Unfortunately, most studies showed an unclear risk of bias in most domains. Four out of nine studies did not contribute to the analysis, as they presented no data.One study involving 45 participants with hand RA compared mudpacks versus placebo. We found no statistically significant differences in terms of pain on a 0 to 100-mm visual analogue scale (VAS) (mean difference (MD) 0.50, 95% confidence interval (CI) -0.84 to 1.84), improvement (risk ratio (RR) 0.96, 95% CI 0.54 to 1.70) or number of swollen joints on a scale from 0 to 28 (MD 0.60, 95% CI -0.90 to 2.10) (very low level of evidence). We found a very low level of evidence of reduction in the number of tender joints on a scale from 0 to 28 (MD -4.60, 95% CI -8.72 to -0.48; 16% absolute difference). We reported no physical disability and presented no data on withdrawals due to adverse events or on serious adverse events.Two studies involving 194 participants with RA evaluated the effectiveness of additional radon in carbon dioxide baths. We found no statistically significant differences between groups for all outcomes at three-month follow-up (low to moderate level of evidence). We noted some benefit of additional radon at six months in terms of pain frequency (RR 0.6, 95% CI 0.4 to 0.9; 31% reduction; improvement in one or more points (categories) on a 4-point scale; moderate level of evidence) and 9.6% reduction in pain intensity on a 0 to 100-mm VAS (MD 9.6 mm, 95% CI 1.6 to 17.6; moderate level of evidence). We also observed some benefit in one study including 60 participants in terms of improvement in one or more categories based on a 4-point scale (RR 2.3, 95% CI 1.1 to 4.7; 30% absolute difference; low level of evidence). Study authors did not report physical disability, tender joints, swollen joints, withdrawals due to adverse events or serious adverse events.One study involving 148 participants with RA compared balneotherapy (seated immersion) versus hydrotherapy (exercises in water), land exercises or relaxation therapy. We found no statistically significant differences in pain on the McGill Questionnaire or in physical disability (very low level of evidence) between balneotherapy and the other interventions. No data on improvement, tender joints, swollen joints, withdrawals due to adverse events or serious adverse events were presented.One study involving 57 participants with RA evaluated the effectiveness of mineral baths (balneotherapy) versus Cyclosporin A. We found no statistically significant differences in pain intensity on a 0 to 100-mm VAS (MD 9.64, 95% CI -1.66 to 20.94; low level of evidence) at 8 weeks (absolute difference 10%). We found some benefit of balneotherapy in overall improvement on a 5-point scale at eight weeks of 54% (RR 2.35, 95% CI 1.44 to 3.83). We found no statistically significant differences (low level of evidence) in the number of swollen joints, but some benefit of Cyclosporin A in the number of tender joints (MD 8.9, 95% CI 3.8 to 14; very low level of evidence). Physical disability, withdrawals due to adverse events and serious adverse events were not reported. AUTHORS' CONCLUSIONS Overall evidence is insufficient to show that balneotherapy is more effective than no treatment, that one type of bath is more effective than another or that one type of bath is more effective than mudpacks, exercise or relaxation therapy.
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Oral herbal therapies for treating osteoarthritis.
Cameron, M, Chrubasik, S
The Cochrane database of systematic reviews. 2014;(5):CD002947
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Abstract
BACKGROUND Medicinal plant products are used orally for treating osteoarthritis. Although their mechanisms of action have not yet been elucidated in full detail, interactions with common inflammatory mediators provide a rationale for using them to treat osteoarthritic complaints. OBJECTIVES To update a previous Cochrane review to assess the benefits and harms of oral medicinal plant products in treating osteoarthritis. SEARCH METHODS We searched electronic databases (CENTRAL, MEDLINE, EMBASE, AMED, CINAHL, ISI Web of Science, World Health Organization Clinical Trials Registry Platform) to 29 August 2013, unrestricted by language, and the reference lists from retrieved trials. SELECTION CRITERIA Randomised controlled trials of orally consumed herbal interventions compared with placebo or active controls in people with osteoarthritis were included. Herbal interventions included any plant preparation but excluded homeopathy or aromatherapy products, or any preparation of synthetic origin. DATA COLLECTION AND ANALYSIS Two authors used standard methods for trial selection and data extraction, and assessed the quality of the body of evidence using the GRADE approach for major outcomes (pain, function, radiographic joint changes, quality of life, withdrawals due to adverse events, total adverse events, and serious adverse events). MAIN RESULTS Forty-nine randomised controlled studies (33 interventions, 5980 participants) were included. Seventeen studies of confirmatory design (sample and effect sizes pre-specified) were mostly at moderate risk of bias. The remaining 32 studies of exploratory design were at higher risk of bias. Due to differing interventions, meta-analyses were restricted to Boswellia serrata (monoherbal) and avocado-soyabean unsaponifiables (ASU) (two herb combination) products.Five studies of three different extracts from Boswellia serrata were included. High-quality evidence from two studies (85 participants) indicated that 90 days treatment with 100 mg of enriched Boswellia serrata extract improved symptoms compared to placebo. Mean pain was 40 points on a 0 to 100 point VAS scale (0 is no pain) with placebo, enriched Boswellia serrata reduced pain by a mean of 17 points (95% confidence interval (CI) 8 to 26); number needed to treat for an additional beneficial outcome (NNTB) 2; the 95% CIs did not exclude a clinically significant reduction of 15 points in pain. Physical function was 33 points on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) 0 to 100 point subscale (0 is no loss of function) with placebo, enriched Boswellia serrata improved function by 8 points (95% CI 2 to 14); NNTB 4. Assuming a minimal clinically important difference of 10 points, we cannot exclude a clinically important benefit in some people. Moderate-quality evidence (one study, 96 participants) indicated that adverse events were probably reduced with enriched Boswellia serrata (18/48 events versus 30/48 events with placebo; relative risk (RR) 0.60, 95% CI 0.39 to 0.92). Possible benefits of other Boswellia serrata extracts over placebo were confirmed in moderate-quality evidence from two studies (97 participants) of Boswellia serrata (enriched) 100 mg plus non-volatile oil, and low-quality evidence from small single studies of a 999 mg daily dose of Boswellia serrata extract and 250 mg daily dose of enrichedBoswellia serrata. It was uncertain if a 99 mg daily dose of Boswellia serrata offered benefits over valdecoxib due to the very low-quality evidence from a small single study. It was uncertain if there was an increased risk of adverse events or withdrawals with Boswellia serrata extract due to variable reporting of results across studies. The studies reported no serious adverse events. Quality of life and radiographic joint changes were not measured.Six studies examined the ASU product Piasclidine®. Moderate-quality evidence from four studies (651 participants) indicated that ASU 300 mg produced a small and clinically questionable improvement in symptoms, and probably no increased adverse events compared to placebo after three to 12 months treatment. Mean pain with placebo was 40.5 points on a VAS 0 to 100 scale (0 is no pain), ASU 300 mg reduced pain by a mean of 8.5 points (95% CI 1 to 16 points); NNTB 8. ASU 300 mg improved function (standardised mean difference (SMD) -0.42, 95% CI -0.73 to -0.11). Function was estimated as 47 mm (0 to 100 mm scale, where 0 is no loss of function) with placebo, ASU 300 mg improved function by a mean of 7 mm (95% CI 2 to 12 mm); NNTB 5 (3 to 19). There were no differences in adverse events (5 studies, 1050 participants) between ASU (53%) and placebo (51%) (RR 1.04, 95% CI 0.97 to 1.12); withdrawals due to adverse events (1 study, 398 participants) between ASU (17%) and placebo (15%) (RR 1.14, 95% CI 0.73 to 1.80); or serious adverse events (1 study, 398 participants) between ASU (40%) and placebo (33%) (RR 1.22, 95% CI 0.94 to 1.59). Radiographic joint changes, measured as change in joint space width (JSW) in two studies (453 participants) did not differ between ASU 300 mg treatment (-0.53 mm) and placebo (-0.65 mm); mean difference of -0.12 (95% CI -0.43 to 0.19). Moderate-quality evidence from a single study (156 participants) confirmed possible benefits of ASU 600 mg over placebo, with no increased adverse events. Low-quality evidence (1 study, 357 participants) indicated there may be no differences in symptoms or adverse events between ASU 300 mg and chondroitin sulphate. Quality of life was not measured.All other herbal interventions were investigated in single studies, limiting conclusions. No serious side effects related to any plant product were reported. AUTHORS' CONCLUSIONS Evidence for the proprietary ASU product Piasclidine® in the treatment of osteoarthritis symptoms seems moderate to high for short term use, but studies over a longer term and against an apparently active control are less convincing. Several other medicinal plant products, including extracts of Boswellia serrata, show trends of benefits that warrant further investigation in light of the fact that the risk of adverse events appear low.There is no evidence that Piasclidine® significantly improves joint structure, and limited evidence that it prevents joint space narrowing. Structural changes were not tested for with any other herbal intervention.Further investigations are required to determine optimum daily doses producing clinical benefits without adverse events.
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[A systematic review regarding the effects of different kinds of selenium supplementations on Kaschin-Beck disease].
Shi, CH, Tian, HL, Tian, JH, Zeng, R, Yang, KH, Wu, TX, Liao, YJ
Zhonghua liu xing bing xue za zhi = Zhonghua liuxingbingxue zazhi. 2013;(5):507-14
Abstract
OBJECTIVE To systematically assess the efficacy of different programs regarding the selenium supplementation formulae used for prevention and treatment of Kaschin-Beck disease (KBD) in children. METHODS PubMed, EMBASE, Cochrane Library, SCI expanded, CNKI (Chinese National Knowledge Infrastructure), VIP (Chinese Science and Technique Journals Database), CBM (The Chinese Biomedical Database), Wanfang Database, CSCD (Chinese Science Citation Database) had been electronically searched. All the searching processes were up-dated to Dec 2012 to identify randomized trials (RCTs) and non-RCTs to compare the selenium supplementation formulae with placebo or with no intervention. Two reviewers assessed the methodological quality of the study design, including RCTs or non-RCTs according to Cochrane Handbook for Systematic Reviews of Interventions 5.1 or a checklist described by Deeks JJ, et al, respectively. Data was extracted independently. RESULTS There were 14 RCTs and 12 non-RCTs papers included, but showing low methodological quality. Data from Meta analysis showed that selenium supplementation had caused the following progresses: radiologic improvement (RR = 3.28, 95%CI: 2.06 - 5.22), higher hair selenium (SMD = 2.05, 95%CI: 1.00 - 3.11) lower new radiologic lesions (OR = 0.18, 95%CI: 0.09 - 0.36) than in the placebo or with no treatment groups. Both selenium and vitamin C supplementation did not show differences in radiologic improvement of metaphysis (RR = 1.01, 95%CI: 0.84 - 1.22). Combination of selenium and vitamin E supplementation showed higher radiologic improvement than the placebo group. Combination of selenium and vitamin C supplementation had no influence on the difference in radiologic improvement or hair selenium than selenium supplementation. Selenium-enriched yeast showed higher radiologic improvement than sodium selenite (70.83% vs. 48.84%, P < 0.05). Selenium fertilization showed higher radiologic improvement than the non-treatment group (RR = 3.98, 95%CI: 2.25 - 7.05). Comprehensive intervention program and 'grain drying approach' also showed certain effects. CONCLUSION Selenium supplementation could lead to better radiologic improvement and hair selenium, with lower new radiologic lesions. Current evidence supported its benefits on prevention and treatment of KBD. Large sample sized and well-designed trials together with the reporting on adverse outcome remained necessary.
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Nutraceuticals in the management of osteoarthritis : a critical review.
Ragle, RL, Sawitzke, AD
Drugs & aging. 2012;(9):717-31
Abstract
Osteoarthritis (OA) is a chronic, highly prevalent and disabling disease that is expected to increase in prevalence secondary to longer life expectancy and a disproportionately aging population. Treatment of OA is only marginally effective and has been focused primarily on symptom control using weight loss, physical therapy, nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, intra-articular steroids or viscosupplementation, topical NSAIDs and analgesics, diacerein (an oral interleukin-1β inhibitor) and finally joint replacement surgery. The use of nutraceuticals in the treatment of OA is common, and scientific studies examining the effects of nutraceuticals on the pathogenesis and treatment of OA are increasing. This review examines the efficacy and safety of select nutraceuticals for the treatment of OA. The reviewed nutraceuticals include glucosamine, chondroitin, collagen hydrolysates (CHs) and avocado-soybean unsaponifiables (ASUs). There have been several clinical trials examining the efficacy of these products and the results demonstrate significant heterogeneity. Significant improvements in pain, function and structural outcomes have been shown for some of the treatment arms or subgroups of patients, but the effects are not consistent across the studies. Glucosamine, chondroitin and the two in combination have been the most extensively studied. Significant improvement in pain and functional indices and a decrease in the loss of joint space width were demonstrated in some but not all studies. CHs showed significant improvement in pain and functional indices for several subgroups of patients, but these findings were not pervasive amongst the treatment arms. ASU has demonstrated positive results with respect to decreased NSAID use in several studies and functional and pain end points in most of the reviewed studies; however, in the two studies examining structural end points, the results were mixed. The safety of these nutraceuticals has been demonstrated across all of the reviewed trials, and there were no significant issues with tolerance. Given the good safety profile of nutraceuticals, the marginal efficacy of conventional treatments, the high prevalence and rate of disability from OA and the possible benefit of nutraceuticals to patients with OA, use of nutraceuticals in select patients is appropriate. An overall recommendation to use nutraceuticals in the treatment of all patients with OA is not strongly supported by the available data. Future studies should focus on standardization of symptomatic and structural outcome measures, be of longer duration and pay careful attention to the content of the investigational product.
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10.
Diclofenac sodium topical solution 1.5% w/w with dimethyl sulfoxide compared with placebo for the treatment of osteoarthritis: pooled safety results.
Roth, SH, Fuller, P
Postgraduate medicine. 2011;(6):180-8
Abstract
Oral nonsteroidal anti-inflammatory drugs (NSAIDs) and cyclooxygenase-2-selective inhibitors are frequently recommended for management of osteoarthritis (OA). However, serious gastrointestinal and cardiovascular systemic adverse events (AEs) are associated with oral NSAIDs and can be treatment limiting. The efficacy of diclofenac sodium topical solution 1.5% w/w with dimethyl sulfoxide (TDiclo) has been established as superior to placebo and comparable with oral NSAIDs in the management of OA. This study characterizes the safety and tolerability profile of TDiclo compared with placebo through a pooled analysis of data from 1252 patients in 7 randomized controlled trials across 61 centers in the United States and 97 centers in Canada. Patients received TDiclo (n = 911) or placebo (n = 341) for 4 to 12 weeks for management of OA of the hand or knee. The most frequently reported AE was dry skin, occurring in 33.0% of patients receiving TDiclo and 5.0% of patients receiving placebo (P < 0.001). Dyspepsia was the most common gastrointestinal reaction, reported by 7.7% of patients receiving TDiclo and 2.9% of patients receiving placebo (P = 0.002). Changes in vital signs and laboratory assessments of hepatic and renal function were similar between the 2 groups; TDiclo did not increase mean blood pressure, nor was it associated with hypertension. The rate of serious AEs favored placebo in both groups (0.9% for TDiclo vs 1.5% for placebo; P = 0.358), as did the rate of severe AEs (4.4% vs 7.6%; P = 0.023). The most common reason for study discontinuation was dry skin (2.5% vs 0.3%). Results from this analysis suggest that TDiclo is well tolerated in a large population and may offer an alternative to oral NSAID therapy for OA of the knee or hand, particularly for patients at increased risk for serious systemic AEs. Larger head-to-head, long-term, multicenter trials would be beneficial to further evaluate safety data comparing both topical and oral NSAIDs.