Relative Efficacy and Safety of Tanezumab for Osteoarthritis: A Systematic Review and Meta-analysis of Randomized Controlled Trials.
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ABSTRACT: Objectives
The aim of this meta-analysis was to evaluate the efficacy and safety of tanezumab for the treatment of patients with knee or hip osteoarthritis (OA).Methods
PubMed, Embase, Cochrane Central Register of Controlled Trials and Web of Science were searched from inception to July 2020. Randomized controlled trials (RCTs) comparing tanezumab with placebo or nonsteroidal anti-inflammatory drugs (NSAIDs) in patients with OA. Two investigators identified studies and independently extracted data, and conventional meta-analyses were conducted with Review Manager 5.3. The outcomes were pain relief, functional improvement and risk of adverse events (AEs).Results
A total of 8 articles, comprising 9 RCTs, were included. Overall, tanezumab was superior to placebo for relieving pain and improving function, as well as in the patient's global assessment (PGA). Tanezumab also had significant advantages over NSAIDs for relieving pain and improving function, as well as in the PGA. Significantly more patients discontinued treatment due to AEs after treatment with tanezumab. However, the differences in serious AEs and total joint replacement (TJR) were not significant. Moreover, tanezumab-treated patients suffer from significantly more rapid progression of osteoarthritis (RPOA).Discussion
Tanezumab can alleviate pain and improve function for patients with OA of the hip or knee. Although tanezumab does not cause serious AEs, RPOA occurred in a small number of participants, so more clinical trials are needed to explore its safety.
SUBMITTER: Zhang B
PROVIDER: S-EPMC8579990 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:We conducted meta-analyses of findings from randomized, placebo-controlled, short-term trials for acute mania in manic or mixed states of DSM (III-IV) bipolar I disorder in 56 drug-placebo comparisons of 17 agents from 38 studies involving 10,800 patients. Of drugs tested, 13 (76%) were more effective than placebo: aripiprazole, asenapine, carbamazepine, cariprazine, haloperidol, lithium, olanzapine, paliperdone, quetiapine, risperidone, tamoxifen, valproate, and ziprasidone. Their pooled effect size for mania improvement (Hedges' g in 48 trials) was 0.42 (confidence interval (CI): 0.36-0.48); pooled responder risk ratio (46 trials) was 1.52 (CI: 1.42-1.62); responder rate difference (RD) was 17% (drug: 48%, placebo: 31%), yielding an estimated number-needed-to-treat of 6 (all p<0.0001). In several direct comparisons, responses to various antipsychotics were somewhat greater or more rapid than lithium, valproate, or carbamazepine; lithium did not differ from valproate, nor did second generation antipsychotics differ from haloperidol. Meta-regression associated higher study site counts, as well as subject number with greater placebo (not drug) response; and higher baseline mania score with greater drug (not placebo) response. Most effective agents had moderate effect-sizes (Hedges' g=0.26-0.46); limited data indicated large effect sizes (Hedges' g=0.51-2.32) for: carbamazepine, cariprazine, haloperidol, risperidone, and tamoxifen. The findings support the efficacy of most clinically used antimanic treatments, but encourage more head-to-head studies and development of agents with even greater efficacy.
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Project description:BackgroundFibromyalgia is a chronic pain syndrome characterized by persistent and widespread musculoskeletal pain. Telerehabilitation is a promising treatment for patients with fibromyalgia through long-term monitoring, intervention, supervision, consultation, and education.ObjectiveThis study aimed to perform a comprehensive systematic review and meta-analysis of the efficacy and safety of telerehabilitation in patients with fibromyalgia.MethodsRandomized controlled trials (RCTs) related to fibromyalgia and telerehabilitation were systematically searched in the PubMed, PEDro, Cochrane Library, ScienceDirect, Ovid MEDLINE, Embase, and Web of Science databases from inception to November 13, 2022. Two independent researchers screened the literatures and evaluated the methodological quality using the Cochrane Risk of Bias Tool. The outcome measures included the Fibromyalgia Impact Questionnaire scale, pain intensity, depression, pain catastrophizing, quality of life (QoL), and adverse events. Pooled effect sizes were calculated by Stata SE 15.1; a fixed effects model was used when I2<50%, whereas a random effects model was used when I2≥50%.ResultsA total of 14 RCTs with 1242 participants were included in this meta-analysis. The pooled results indicated that the telerehabilitation improved the Fibromyalgia Impact Questionnaire score (weighted mean difference -8.32, 95% CI -11.72 to -4.91; P<.001), pain intensity (standardized mean difference [SMD] -0.62, 95% CI -0.76 to -0.47; P<.001), depression levels (SMD -0.42, 95% CI -0.62 to -0.22; P<.001), pain catastrophizing (weighted mean difference -5.81, 95% CI -9.40 to -2.23; P=.001), and QoL (SMD 0.32, 95% CI 0.18 to 0.47; P<.001) in patients with fibromyalgia compared to control interventions. Only 1 RCT reported a mild adverse event of telerehabilitation; the other 13 RCTs did not mention this.ConclusionsTelerehabilitation can improve the symptoms and QoL of fibromyalgia. However, the safety of telerehabilitation remains uncertain due to the lack of sufficient evidence for the management of fibromyalgia. More rigorously designed trials are needed in the future to verify the safety and efficacy of telerehabilitation in fibromyalgia.Trial registrationPROSPERO CRD42022338200; https://tinyurl.com/322keukv.
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Project description:ObjectiveTo investigate the efficacy and safety of paracetamol (acetaminophen) in the management of spinal pain and osteoarthritis of the hip or knee.DesignSystematic review and meta-analysis.Data sourcesMedline, Embase, AMED, CINAHL, Web of Science, LILACS, International Pharmaceutical Abstracts, and Cochrane Central Register of Controlled Trials from inception to December 2014.Eligibility criteria for selecting studiesRandomised controlled trials comparing the efficacy and safety of paracetamol with placebo for spinal pain (neck or low back pain) and osteoarthritis of the hip or knee.Data extractionTwo independent reviewers extracted data on pain, disability, and quality of life. Secondary outcomes were adverse effects, patient adherence, and use of rescue medication. Pain and disability scores were converted to a scale of 0 (no pain or disability) to 100 (worst possible pain or disability). We calculated weighted mean differences or risk ratios and 95% confidence intervals using a random effects model. The Cochrane Collaboration's tool was used for assessing risk of bias, and the GRADE approach was used to evaluate the quality of evidence and summarise conclusions.Results12 reports (13 randomised trials) were included. There was "high quality" evidence that paracetamol is ineffective for reducing pain intensity (weighted mean difference -0.5, 95% confidence interval -2.9 to 1.9) and disability (0.4, -1.7 to 2.5) or improving quality of life (0.4, -0.9 to 1.7) in the short term in people with low back pain. For hip or knee osteoarthritis there was "high quality" evidence that paracetamol provides a significant, although not clinically important, effect on pain (-3.7, -5.5 to -1.9) and disability (-2.9, -4.9 to -0.9) in the short term. The number of patients reporting any adverse event (risk ratio 1.0, 95% confidence interval 0.9 to 1.1), any serious adverse event (1.2, 0.7 to 2.1), or withdrawn from the study because of adverse events (1.2, 0.9 to 1.5) was similar in the paracetamol and placebo groups. Patient adherence to treatment (1.0, 0.9 to 1.1) and use of rescue medication (0.7, 0.4 to 1.3) was also similar between groups. "High quality" evidence showed that patients taking paracetamol are nearly four times more likely to have abnormal results on liver function tests (3.8, 1.9 to 7.4), but the clinical importance of this effect is uncertain.ConclusionsParacetamol is ineffective in the treatment of low back pain and provides minimal short term benefit for people with osteoarthritis. These results support the reconsideration of recommendations to use paracetamol for patients with low back pain and osteoarthritis of the hip or knee in clinical practice guidelines.Systematic review registrationPROSPERO registration number CRD42013006367.
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