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The Cochrane Database of Systematic... Aug 2023Despite potential analgesic benefits from topical ophthalmic amides and esters, their outpatient use has become of concern because of the potential for abuse and... (Review)
Review
BACKGROUND
Despite potential analgesic benefits from topical ophthalmic amides and esters, their outpatient use has become of concern because of the potential for abuse and ophthalmic complications.
OBJECTIVES
To assess the effectiveness and safety of topical ophthalmic anesthetics compared with placebo or other treatments in persons with corneal abrasions.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE; Embase.com; Latin American and Caribbean Health Sciences (LILACS); ClinicalTrials.gov; and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP), without restriction on language or year of publication. The search was performed on 10 February 2023.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) of topical ophthalmic anesthetics alone or in combination with another treatment (e.g. nonsteroidal anti-inflammatory drugs (NSAIDs)) versus a non-anesthetic control group (e.g. placebo, non-treatment, or alternative treatment). We included trials that enrolled participants of all ages who had corneal abrasions within 48 hours of presentation.
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methodology.
MAIN RESULTS
We included nine parallel-group RCTs with a total of 556 participants (median number of participants per study: 45, interquartile range (IQR) 44 to 74), conducted in eight countries: Australia, Canada, France, South Korea, Turkey, New Zealand, UK, and USA. Study characteristics and risk of bias Four RCTs (314 participants) investigated post-traumatic corneal abrasions diagnosed in the emergency department setting. Five trials described 242 participants from ophthalmology surgery centers with post-surgical corneal defects: four from photorefractive keratectomy (PRK) and one from pterygium surgery. Study duration ranged from two days to six months, the most common being one week (four RCTs). Treatment duration ranged from three hours to one week (nine RCTs); the majority were between 24 and 48 hours (five RCTs). The age of participants was reported in eight studies, ranging from 17 to 74 years of age. Only one participant in one trial was under 18 years of age. Of four studies that reported funding sources, none was industry-sponsored. We judged a high risk of bias in one trial with respect to the outcome pain control by 48 hours, and in five of seven trials with respect to the outcome complications at the furthest time point. The domain for which we assessed studies to be at the highest risk of bias was missing or selective reporting of outcome data. Findings The treatments investigated included topical anesthetics compared with placebo, topical anesthetic compared with NSAID (post-surgical cases), and topical anesthetics plus NSAID compared with placebo (post-surgical cases). Pain control by 24 hours In all studies, self-reported pain outcomes were on a 10-point scale, where lower numbers represent less pain. In post-surgical trials, topical anesthetics provided a moderate reduction in self-reported pain at 24 hours compared with placebo of 1.28 points on a 10-point scale (mean difference (MD) -1.28, 95% confidence interval (CI) -1.76 to -0.80; 3 RCTs, 119 participants). In the post-trauma participants, there may be little or no difference in effect (MD -0.04, 95% CI -0.10 to 0.02; 1 RCT, 76 participants). Compared with NSAID in post-surgical participants, topical anesthetics resulted in a slight increase in pain at 24 hours (MD 0.82, 95% CI 0.01 to 1.63; 1 RCT, 74 participants). One RCT compared topical anesthetics plus NSAID to placebo. There may be a large reduction in pain at 24 hours with topical anesthetics plus NSAID in post-surgical participants, but the evidence to support this large effect is very uncertain (MD -5.72, 95% CI -7.35 to -4.09; 1 RCT, 30 participants; very low-certainty evidence). Pain control by 48 hours Compared with placebo, topical anesthetics reduced post-trauma pain substantially by 48 hours (MD -5.68, 95% CI -6.38 to -4.98; 1 RCT, 111 participants) but had little to no effect on post-surgical pain (MD 0.41, 95% CI -0.45 to 1.27; 1 RCT, 44 participants), although the evidence is very uncertain. Pain control by 72 hours One post-surgical RCT showed little or no effect of topical anesthetics compared with placebo by 72 hours (MD 0.49, 95% CI -0.06 to 1.04; 44 participants; very low-certainty evidence). Proportion of participants with unresolved epithelial defects When compared with placebo or NSAID, topical anesthetics increased the number of participants without complete resolution of defects in trials of post-trauma participants (risk ratio (RR) 1.37, 95% CI 0.78 to 2.42; 3 RCTs, 221 participants; very low-certainty evidence). The proportion of placebo-treated post-surgical participants with unresolved epithelial defects at 24 to 72 hours was lower when compared with those assigned to topical anesthetics (RR 0.14, 95% CI 0.01 to 2.55; 1 RCT, 30 participants; very low-certainty evidence) or topical anesthetics plus NSAID (RR 0.33, 95% CI 0.04 to 2.85; 1 RCT, 30 participants; very low-certainty evidence). Proportion of participants with complications at the longest follow-up When compared with placebo or NSAID, topical anesthetics resulted in a higher proportion of post-trauma participants with complications at up to two weeks (RR 1.13, 95% CI 0.23 to 5.46; 3 RCTs, 242 participants) and post-surgical participants with complications at up to one week (RR 7.00, 95% CI 0.38 to 128.02; 1 RCT, 44 participants). When topical anesthetic plus NSAID was compared with placebo, no complications were reported in either treatment arm up to one week post-surgery (risk difference (RD) 0.00, 95% CI -0.12 to 0.12; 1 RCT, 30 participants). The evidence is very uncertain for safety outcomes. Quality of life None of the included trials assessed quality of life outcomes.
AUTHORS' CONCLUSIONS
Despite topical anesthetics providing excellent pain control in the intraoperative setting, the currently available evidence provides little or no certainty about their efficacy for reducing ocular pain in the initial 24 to 72 hours after a corneal abrasion, whether from unintentional trauma or surgery. We have very low confidence in this evidence as a basis to recommend topical anesthetics as an efficacious treatment modality to relieve pain from corneal abrasions. We also found no evidence of a substantial effect on epithelial healing up to 72 hours or a reduction in ocular complications when we compared anesthetics alone or with NSAIDs versus placebo.
Topics: Humans; Adolescent; Young Adult; Adult; Middle Aged; Aged; Anesthetics, Local; Anti-Inflammatory Agents, Non-Steroidal; Analgesics; Corneal Injuries; Pain, Postoperative
PubMed: 37555621
DOI: 10.1002/14651858.CD015091.pub2 -
Frontiers in Pharmacology 2023To comprehensively reassess the efficacy and safety of different concentrations of atropine for retarding myopia progression and seek the most appropriate therapeutic...
To comprehensively reassess the efficacy and safety of different concentrations of atropine for retarding myopia progression and seek the most appropriate therapeutic concentration for clinical practice. We searched PubMed, Cochrane Library, Embase, Chinese Science and Technology Periodicals (VIP) and China National Knowledege Infrastructure (CNKI) from their inception to 23 March 2023, to obtain eligible randomized controlled trials (RCTs) and cohort studies that had atropine in at least one treatment arm and placebo/no intervention in another arm. We evaluated the risk of bias of the RCTs according to the recommendations of the Cochrane Collaboration for RCTs and quality of cohort studies by the Newcastle‒Ottawa Scale. Weighted mean difference (WMD), 95% confidence interval were calculated for meta-analysis. All data analyses were performed using Review Manager 5.3, STATA 12.0 and SPSS 26.0 software. A total of 44 studies were included in the meta-analysis. Weighted mean difference (WMD) were 0.73 diopters (D), 0.65 D, 0.35 D per year in refraction progression ( = 14.63, = 86.3%; < 0.001) and -0.26 mm, -0.37 mm, -0.11 mm per year in axial length progression ( = 5.80, = 65.5%; = 0.06) for high (0.5%-1%), moderate (0.1%-0.25%), and low (0.005%-0.05%) dose atropine groups, respectively. Logarithmic dose‒response correlations were found between atropine and their effect on change of refraction, axial length, accommodation and photopic pupil diameter. Through these curves, we found that atropine with concentrations ≤0.05% atropine resulted in a residual value of accommodation of more than 5 D and an increase in pupil diameter no more than 3 mm. Higher doses of atropine resulted in a higher incidence of adverse effects, of which the incidence of photophobia was dose-dependent ( = 0.477, = 0.029). Both the efficacy and risk of adverse events for atropine treatment of myopia were mostly dose dependent. Comprehensively considered the myopia control effect and safety of each dose, 0.05% may be the best concentration of atropine to control myopia progression at present, at which myopia is better controlled and the side effects are tolerable. https://www.crd.york.ac.uk/PROSPERO/#recordDetails, CRD42022377705.
PubMed: 37767401
DOI: 10.3389/fphar.2023.1227787 -
Alimentary Pharmacology & Therapeutics Aug 2023We conducted a systematic review to assess medical therapy for the treatment and prevention of pouchitis. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND AND AIMS
We conducted a systematic review to assess medical therapy for the treatment and prevention of pouchitis.
METHODS
Randomised controlled trials (RCTs) of medical therapy in adults with or without pouchitis were searched to March 2022. Primary outcomes included clinical remission/response, maintenance of remission and prevention of pouchitis.
RESULTS
Twenty RCTs (N = 830) were included. Acute pouchitis: One study compared ciprofloxacin with metronidazole. At 2 weeks, 100% (7/7) of ciprofloxacin participants achieved remission, compared with 67% (6/9) of metronidazole participants (RR: 1.44, 95% CI: 0.88-2.35, very low certainty evidence). One study compared budesonide enemas with oral metronidazole. Fifty percent (6/12) of budesonide participants achieved remission compared with 43% (6/14) of metronidazole participants (RR: 1.17, 95% CI: 0.51-2.67, low certainty evidence). Chronic pouchitis: Two studies (n = 76) assessed De Simone Formulation. Eighty-five percent (34/40) of De Simone Formulation participants maintained remission at 9-12 months compared with 3% (1/36) placebo participants (RR: 18.50, 95% CI: 3.86-88.56, moderate certainty evidence). One study assessed vedolizumab. Thirty-one percent (16/51) of vedolizumab participants achieved clinical remission at 14 weeks compared with 10% (5/51) of placebo participants (RR: 3.20, 95% CI: 1.27-8.08, moderate certainty evidence).
PROPHYLAXIS
Two studies assessed De Simone Formulation. Ninety percent (18/20) of De Simone Formulation participants did not develop pouchitis compared with 60% (12/20) of placebo participants (RR: 1.50, 95% CI: 1.02-2.21, moderate certainty evidence).
CONCLUSIONS
Apart from vedolizumab and the De Simone formulation, the effects of other medical interventions for pouchitis are uncertain.
Topics: Adult; Humans; Metronidazole; Remission Induction; Pouchitis; Ciprofloxacin; Budesonide; Randomized Controlled Trials as Topic
PubMed: 37246609
DOI: 10.1111/apt.17568 -
JAMA Jul 2023Lipid screening in childhood and adolescence can lead to early dyslipidemia diagnosis. The long-term benefits of lipid screening and subsequent treatment in this... (Meta-Analysis)
Meta-Analysis
IMPORTANCE
Lipid screening in childhood and adolescence can lead to early dyslipidemia diagnosis. The long-term benefits of lipid screening and subsequent treatment in this population are uncertain.
OBJECTIVE
To review benefits and harms of screening and treatment of pediatric dyslipidemia due to familial hypercholesterolemia (FH) and multifactorial dyslipidemia.
DATA SOURCES
MEDLINE and the Cochrane Central Register of Controlled Trials through May 16, 2022; literature surveillance through March 24, 2023.
STUDY SELECTION
English-language randomized clinical trials (RCTs) of lipid screening; recent, large US cohort studies reporting diagnostic yield or screen positivity; and RCTs of lipid-lowering interventions.
DATA EXTRACTION AND SYNTHESIS
Single extraction, verified by a second reviewer. Quantitative synthesis using random-effects meta-analysis.
MAIN OUTCOMES AND MEASURES
Health outcomes, diagnostic yield, intermediate outcomes, behavioral outcomes, and harms.
RESULTS
Forty-three studies were included (n = 491 516). No RCTs directly addressed screening effectiveness and harms. Three US studies (n = 395 465) reported prevalence of phenotypically defined FH of 0.2% to 0.4% (1:250 to 1:500). Five studies (n = 142 257) reported multifactorial dyslipidemia prevalence; the prevalence of elevated total cholesterol level (≥200 mg/dL) was 7.1% to 9.4% and of any lipid abnormality was 19.2%. Ten RCTs in children and adolescents with FH (n = 1230) demonstrated that statins were associated with an 81- to 82-mg/dL greater mean reduction in levels of total cholesterol and LDL-C compared with placebo at up to 2 years. Nonstatin-drug trials showed statistically significant lowering of lipid levels in FH populations, but few studies were available for any single drug. Observational studies suggest that statin treatment for FH starting in childhood or adolescence reduces long-term cardiovascular disease risk. Two multifactorial dyslipidemia behavioral counseling trials (n = 934) demonstrated 3- to 6-mg/dL greater reductions in total cholesterol levels compared with the control group, but findings did not persist at longest follow-up. Harms reported in the short-term drug trials were similar in the intervention and control groups.
CONCLUSIONS AND RELEVANCE
No direct evidence on the benefits or harms of pediatric lipid screening was identified. While multifactorial dyslipidemia is common, no evidence was found that treatment is effective for this condition. In contrast, FH is relatively rare; evidence shows that statins reduce lipid levels in children with FH, and observational studies suggest that such treatment has long-term benefit for this condition.
Topics: Adolescent; Child; Humans; Cholesterol; Dyslipidemias; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Lipids; Mass Screening; Hypercholesterolemia
PubMed: 37462700
DOI: 10.1001/jama.2023.8867 -
The Journal of Maternal-fetal &... Dec 2023L-Arginine (L-Arg)/Nitric Oxide (NO) system is involved in the pathophysiology of relevant Obstetric conditions. This review aims at summarizing the effects of L-Arg... (Review)
Review
BACKGROUND/AIM OF THE STUDY
L-Arginine (L-Arg)/Nitric Oxide (NO) system is involved in the pathophysiology of relevant Obstetric conditions. This review aims at summarizing the effects of L-Arg supplementation in pregnancy looking at safety and efficacy.
METHODS
We conducted a systematic review of the literature utilizing PubMed for studies published from inception to September 2022. The search included human and animal studies where L-Arg was supplemented pre-conceptionally or during pregnancy, by either oral or intravenous route. The main perinatal outcomes were focused.
RESULTS
Among 1028 publications, 51 studies were eligible for inclusion, 25 were performed in women, and the remnant in animals. Compared to controls/placebo, the supplementation with L-Arg reduced the development of pre-eclampsia (four studies), decreased blood pressure, and reduced the need for antihypertensive drugs in women with Hypertensive Disorders of Pregnancy (HDP, eight studies). In women carrying growth retarded fetuses, L-Arg improved fetoplacental circulation, birth weight and neonatal outcomes (five studies), while in the case of threatened preterm birth, L-Arg reduced uterine contractions (two studies). In several animal species, L-Arg supplementation in pregnancy improved reproductive performance by increasing the litter number and size. Moreover, in pre-eclamptic and metabolic syndrome experimental models, maternal hypertension and fetal growth were improved.
CONCLUSION
L-Arg displays biological activities in pregnancies complicated by HDP and growth restriction, both in women and animal models. L-Arg administration is safe and could be a candidate as an intervention beneficial to maternal and fetal outcomes, at least in moderate clinical disorders.
Topics: Pregnancy; Animals; Infant, Newborn; Female; Humans; Premature Birth; Dietary Supplements; Pre-Eclampsia; Fetus; Arginine
PubMed: 37258415
DOI: 10.1080/14767058.2023.2217465 -
The Cochrane Database of Systematic... Dec 2023This is an updated version of a Cochrane Review last updated in 2020. Epilepsy is a common neurological disorder, affecting 0.5% to 1% of the population. In nearly 30%... (Review)
Review
BACKGROUND
This is an updated version of a Cochrane Review last updated in 2020. Epilepsy is a common neurological disorder, affecting 0.5% to 1% of the population. In nearly 30% of cases, epilepsy is resistant to currently available drugs. Pharmacological treatment remains the first choice to control epilepsy. Lamotrigine is a second-generation antiseizure medication. When used as an add-on (in combination with other antiseizure medications), lamotrigine can reduce seizures, but with some adverse effects.
OBJECTIVES
To evaluate the benefits and harms of add-on lamotrigine, compared with add-on placebo or no add-on treatment in people with drug-resistant focal epilepsy.
SEARCH METHODS
For this update, we searched the Cochrane Register of Studies (CRS Web) and MEDLINE (Ovid) on 3 October 2022 with no language restrictions. CRS Web includes randomised and quasi-randomised controlled trials from PubMed, Embase, ClinicalTrials.gov, the World Health Organization International Clinical Trials Registry Platform (ICTRP), Cochrane Central Register of Controlled Trials (CENTRAL), and the Specialised Registers of Cochrane Review Groups, including Epilepsy.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) that investigated add-on lamotrigine versus add-on placebo or no add-on treatment in people of any age with drug-resistant focal epilepsy. We used data from the first period of eligible cross-over trials.
DATA COLLECTION AND ANALYSIS
For this update, two review authors independently selected trials and extracted data. Our primary outcome was 50% or greater reduction in seizure frequency. Our secondary outcomes were treatment withdrawal, adverse effects, cognitive effects, and quality of life. Primary analyses were by intention-to-treat. We performed sensitivity best- and worse-case analyses to account for missing outcome data. We calculated pooled risk ratios (RRs) with 95% confidence intervals (95% Cls) for dichotomous outcomes.
MAIN RESULTS
We identified no new studies for this update, so the results and conclusions of the review are unchanged. We included five parallel-group studies in adults or children, eight cross-over studies in adults or children, and one parallel study with a responder-enriched design in infants. In total, these 14 studies enroled 1806 eligible participants (38 infants, 199 children, 1569 adults). Baseline phases ranged from four to 12 weeks and treatment phases ranged from eight to 36 weeks. We rated 11 studies (1243 participants) at low overall risk of bias and three (697 participants) at unclear overall risk of bias due to lack of information on study design. Four studies (563 participants) reported effective blinding. Lamotrigine compared with placebo probably increases the likelihood of achieving 50% or greater reduction in seizure frequency (RR 1.80, 95% CI 1.45 to 2.23; 12 trials, 1322 participants (adults and children); moderate-certainty evidence). There is probably little or no difference in risk of treatment withdrawal for any reason among people treated with lamotrigine versus people treated with placebo (RR 1.11, 95% CI 0.91 to 1.37; 14 trials; 1806 participants; moderate-certainty evidence). Lamotrigine compared with placebo is probably associated with a greater risk of ataxia (RR 3.34, 99% Cl 2.01 to 5.55; 12 trials; 1525 participants; moderate-certainty evidence), dizziness (RR 1.76, 99% Cl 1.28 to 2.43; 13 trials; 1768 participants; moderate-certainty evidence), nausea (RR 1.81, 99% CI 1.22 to 2.68; 12 studies, 1486 participants; moderate-certainty evidence), and diplopia (RR 3.79, 99% Cl 2.15 to 6.68; 3 trials, 944 participants; moderate-certainty evidence). There is probably little or no difference in the risk of fatigue between lamotrigine and placebo (RR 0.82, 99% CI 0.55 to 1.22; 12 studies, 1552 participants; moderate-certainty evidence).
AUTHORS' CONCLUSIONS
Lamotrigine as an add-on treatment for drug-resistant focal seizures is probably effective for reducing seizure frequency. Certain adverse effects (ataxia, dizziness, diplopia, and nausea) are probably more likely to occur with lamotrigine compared with placebo. There is probably little or no difference in the number of people who withdraw from treatment with lamotrigine versus placebo. The trials were of relatively short duration and provided no long-term evidence. In addition, some trials had few participants. Further trials are needed to assess the long-term effects of lamotrigine and to compare lamotrigine with other add-on drugs.
Topics: Adult; Child; Humans; Lamotrigine; Diplopia; Dizziness; Drug Therapy, Combination; Anticonvulsants; Seizures; Drug Resistant Epilepsy; Ataxia; Drug-Related Side Effects and Adverse Reactions; Nausea; Epilepsies, Partial
PubMed: 38078494
DOI: 10.1002/14651858.CD001909.pub4 -
European Journal of Pain (London,... Apr 2024The magnitude of placebo effects from physical and psychological 'sham' is unknown but could impact efficacy trials and treatment understanding. To quantify placebo... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The magnitude of placebo effects from physical and psychological 'sham' is unknown but could impact efficacy trials and treatment understanding. To quantify placebo effects, this systematic review of three-armed randomised controlled trials (RCTs) of physical and psychological interventions for pain compared outcomes in 'sham' control intervention and non-exposure arms.
METHODS
RCTs with treatment, 'sham' control intervention, and non-exposure groups were included, enrolling adults with any pain. A protocol was pre-registered (PROSPERO: CRD42023413324), and twelve databases searched from 2008 to July 2023. Trial methods and blinding were analysed descriptively and risk of bias assessed. Meta-analysis of pain measures at short-, medium- and long-term was performed with random-effects models of standardised mean differences (SMD).Studies were sub-grouped according to control intervention type.
RESULTS
Seventeen RCTs were included. The average short-term placebo effect was small (0.21 SMD, 0.1-0.33 95% CI, p = 0.0002, 1440 participants). It showed no heterogeneity (Tau = 0.1, I = 11%, p = 0.3), preventing meta-regression analyses of effect modifiers. However, sub-group analyses revealed larger placebo effects in manual control interventions compared to disabled devices and miscellaneous control interventions. Overall, placebo analgesia accounted for 39% of treatments' short-term effectiveness. No placebo effects were found at medium-term (7 RCTs, 381 participants) or long-term follow-up (3 RCTs, 173 participants).
CONCLUSIONS
The observed placebo analgesia has mechanistic and methodological implications, though its clinical importance may be limited. Control intervention design affects placebo effects, highlighting the importance of considering methodology in RCT interpretation. Review limitations include a small number of long-term studies and sample heterogeneity.
SIGNIFICANCE
This systematic review directly quantifies placebo effects from physical and psychological 'sham' control interventions and compares them to treatments' overall effectiveness. By doing so, the review enhances our understanding of placebo effects, their relative contribution in clinical trials, and their susceptibly to trial design. It poses further questions regarding the influence of blinding, participant expectations, and features of the therapeutic context. Overall, the insights provided by this review carry methodological significance and are important for the interpretation and synthesis of efficacy trials in this field.
Topics: Adult; Humans; Analgesia; Pain
PubMed: 37985188
DOI: 10.1002/ejp.2205 -
British Journal of Sports Medicine Dec 2023To investigate the effects of pharmacological and non-pharmacological therapies on pain intensity and disability for plantar fasciitis. (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To investigate the effects of pharmacological and non-pharmacological therapies on pain intensity and disability for plantar fasciitis.
DESIGN
Systematic review of randomised controlled trials (RCTs).
DATA SOURCES
AMED, MEDLINE, PEDro, Cochrane, SPORTDiscus, CINAHL, EMBASE and PsycINFO without language or date restrictions up to 3 February 2023.
ELIGIBILITY CRITERIA
RCTs that evaluated the efficacy of any pharmacological and non-pharmacological therapies compared with control (placebo, sham, waiting list or no intervention) on pain intensity and disability in people with plantar fasciitis. Two reviewers independently screened eligible trials, extracted data, assessed the methodological quality of included trials and assessed the certainty of the evidence using the Grading of Recommendations, Assessment, Development and Evaluations framework. Mean differences (MDs) with 95% CIs were reported.
RESULTS
Seventeen different therapies investigated in 28 trials were included in the quantitative analysis. For non-pharmacological therapies, moderate certainty evidence showed short-term effects of customised orthoses on pain intensity when compared with control (MD of -12.0 points (95% CI -17.1 to -7.0) on a 0-100 scale). Low certainty evidence showed short-term effects of taping on pain intensity (-21.3 (95% CI -38.6 to -4.0)). Long-term effects and effects on disability are still uncertain. For pharmacological therapies, low to very low quality evidence from few trials with small samples was inconclusive and supports that high-quality trials are needed.
CONCLUSIONS
Moderate-quality and low-quality evidence demonstrates customised orthoses and taping, respectively, reduce pain intensity in the short term in patients with plantar fasciitis.
PROSPERO REGISTRATION NUMBER
CRD42021224416.
Topics: Humans; Fasciitis, Plantar; Pain Measurement; Orthotic Devices; Quality of Life
PubMed: 37620126
DOI: 10.1136/bjsports-2022-106403 -
The Journal of Dermatological Treatment Dec 2023This study aimed to evaluate the efficacy and safety of bimekizumab for psoriasis. (Meta-Analysis)
Meta-Analysis Review
AIM
This study aimed to evaluate the efficacy and safety of bimekizumab for psoriasis.
METHODS
The PubMed, Web of Science, Cochrane Library, and Embase databases were systematically searched until November 20, 2022, to identify randomized controlled trials (RCTs) reporting the efficacy and safety of bimekizumab. The identified studies were screened according to inclusion and exclusion criteria, and a meta-analysis was performed on the selected studies using the Stata (version 17.0) software to investigate the efficacy and safety of bimekizumab.
RESULTS
Six studies involving 1252 participants were considered. Compared with the control group which received placebo, the bimekizumab group had a larger number of patients with improvement in Psoriasis Area and Severity Index (PASI) of at least 75% (PASI75) (RR: 20.54, 95%CI: 12.41-33.99; = .000), at least 90% (PASI90) (RR:16.99, 95%CI: 7.09-40.68; = .000) and 100%(PASI100) (RR:14.57; 95%CI: 5.26-40.35; = .000) and a larger number with improvement in Investigator Global Assessment (IGA) response (RR:22.57; 95%CI: 12.74-39.98; = .000). There was no obvious difference between the bimekizumab and placebo groups in treatment of emergent adverse events (TEAEs) (RR:1.17; 95%CI: 0.93-1.47; > .05) and serious TEAEs (RR: 0.67; 95%CI: 0.28-1.61; > .05).
CONCLUSIONS
Bimekizumab shows promising efficacy for the treatment of psoriasis with favorable safety records.
Topics: Humans; Randomized Controlled Trials as Topic; Psoriasis; Antibodies, Monoclonal, Humanized; Severity of Illness Index
PubMed: 37010492
DOI: 10.1080/09546634.2023.2199106 -
The Cochrane Database of Systematic... Aug 2023The coronavirus disease 2019 (COVID-19) pandemic has impacted healthcare systems worldwide. Multiple reports on thromboembolic complications related to COVID-19 have... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The coronavirus disease 2019 (COVID-19) pandemic has impacted healthcare systems worldwide. Multiple reports on thromboembolic complications related to COVID-19 have been published, and researchers have described that people with COVID-19 are at high risk for developing venous thromboembolism (VTE). Anticoagulants have been used as pharmacological interventions to prevent arterial and venous thrombosis, and their use in the outpatient setting could potentially reduce the prevalence of vascular thrombosis and associated mortality in people with COVID-19. However, even lower doses used for a prophylactic purpose may result in adverse events such as bleeding. It is important to consider the evidence for anticoagulant use in non-hospitalised people with COVID-19.
OBJECTIVES
To evaluate the benefits and harms of prophylactic anticoagulants versus active comparators, placebo or no intervention, or non-pharmacological interventions in non-hospitalised people with COVID-19.
SEARCH METHODS
We used standard, extensive Cochrane search methods. The latest search date was 18 April 2022.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) comparing prophylactic anticoagulants with placebo or no treatment, another active comparator, or non-pharmacological interventions in non-hospitalised people with COVID-19. We included studies that compared anticoagulants with a different dose of the same anticoagulant. We excluded studies with a duration of under two weeks.
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methodological procedures. Our primary outcomes were all-cause mortality, VTE (deep vein thrombosis (DVT) or pulmonary embolism (PE)), and major bleeding. Our secondary outcomes were DVT, PE, need for hospitalisation, minor bleeding, adverse events, and quality of life. We used GRADE to assess the certainty of the evidence.
MAIN RESULTS
We included five RCTs with up to 90 days of follow-up (short term). Data were available for meta-analysis from 1777 participants. Anticoagulant compared to placebo or no treatment Five studies compared anticoagulants with placebo or no treatment and provided data for three of our outcomes of interest (all-cause mortality, major bleeding, and adverse events). The evidence suggests that prophylactic anticoagulants may lead to little or no difference in all-cause mortality (risk ratio (RR) 0.36, 95% confidence interval (CI) 0.04 to 3.61; 5 studies; 1777 participants; low-certainty evidence) and probably reduce VTE from 3% in the placebo group to 1% in the anticoagulant group (RR 0.36, 95% CI 0.16 to 0.85; 4 studies; 1259 participants; number needed to treat for an additional beneficial outcome (NNTB) = 50; moderate-certainty evidence). There may be little to no difference in major bleeding (RR 0.36, 95% CI 0.01 to 8.78; 5 studies; 1777 participants; low-certainty evidence). Anticoagulants probably result in little or no difference in DVT (RR 1.02, 95% CI 0.30 to 3.46; 3 studies; 1009 participants; moderate-certainty evidence), but probably reduce the risk of PE from 2.7% in the placebo group to 0.7% in the anticoagulant group (RR 0.25, 95% CI 0.08 to 0.79; 3 studies; 1009 participants; NNTB 50; moderate-certainty evidence). Anticoagulants probably lead to little or no difference in reducing hospitalisation (RR 1.01, 95% CI 0.59 to 1.75; 4 studies; 1459 participants; moderate-certainty evidence) and may lead to little or no difference in adverse events (minor bleeding, RR 2.46, 95% CI 0.90 to 6.72; 5 studies, 1777 participants; low-certainty evidence). Anticoagulant compared to a different dose of the same anticoagulant One study compared anticoagulant (higher-dose apixaban) with a different (standard) dose of the same anticoagulant and reported five relevant outcomes. No cases of all-cause mortality, VTE, or major bleeding occurred in either group during the 45-day follow-up (moderate-certainty evidence). Higher-dose apixaban compared to standard-dose apixaban may lead to little or no difference in reducing the need for hospitalisation (RR 1.89, 95% CI 0.17 to 20.58; 1 study; 278 participants; low-certainty evidence) or in the number of adverse events (minor bleeding, RR 0.47, 95% CI 0.09 to 2.54; 1 study; 278 participants; low-certainty evidence). Anticoagulant compared to antiplatelet agent One study compared anticoagulant (apixaban) with antiplatelet agent (aspirin) and reported five relevant outcomes. No cases of all-cause mortality or major bleeding occurred during the 45-day follow-up (moderate-certainty evidence). Apixaban may lead to little or no difference in VTE (RR 0.36, 95% CI 0.01 to 8.65; 1 study; 279 participants; low-certainty evidence), need for hospitalisation (RR 3.20, 95% CI 0.13 to 77.85; 1 study; 279 participants; low-certainty evidence), or adverse events (minor bleeding, RR 2.13, 95% CI 0.40 to 11.46; 1 study; 279 participants; low-certainty evidence). No included studies reported on quality of life or investigated anticoagulants compared to a different anticoagulant, or anticoagulants compared to non-pharmacological interventions.
AUTHORS' CONCLUSIONS
We found low- to moderate-certainty evidence from five RCTs that prophylactic anticoagulants result in little or no difference in major bleeding, DVT, need for hospitalisation, or adverse events when compared with placebo or no treatment in non-hospitalised people with COVID-19. Low-certainty evidence indicates that prophylactic anticoagulants may result in little or no difference in all-cause mortality when compared with placebo or no treatment, but moderate-certainty evidence indicates that prophylactic anticoagulants probably reduce the incidence of VTE and PE. Low-certainty evidence suggests that comparing different doses of the same prophylactic anticoagulant may result in little or no difference in need for hospitalisation or adverse events. Prophylactic anticoagulants may result in little or no difference in risk of VTE, hospitalisation, or adverse events when compared with antiplatelet agents (low-certainty evidence). Given that there were only short-term data from one study, these results should be interpreted with caution. Additional trials of sufficient duration are needed to clearly determine any effect on clinical outcomes.
Topics: Humans; Anticoagulants; Platelet Aggregation Inhibitors; COVID-19; Venous Thromboembolism; Aspirin; Pulmonary Embolism
PubMed: 37591523
DOI: 10.1002/14651858.CD015102.pub2