Systematic review and meta-analysis of second-generation antidepressants for the treatment of older adults with depression: questionable benefit and considerations for frailty

Abstract Background Frail older adults are commonly prescribed antidepressants. Yet, there is little evidence to determine the efficacy and safety of antidepressants to treat depression with concomitant frailty. To better understand this issue, we examined the efficacy and safety of second-generation antidepressants for the treatment of older adults with depression and then considered implications for frailty. Methods Due to the absence of therapeutic studies of frail older adults with depression, we conducted a systematic review and meta-analysis of double-blind, randomized controlled trials that compared antidepressants versus placebo for adults with depression, age 65 years or older. We searched PubMed/MEDLINE, Cochrane Library, reference lists from meta-analyses/studies, hand searches of publication lists, and related articles on PubMed. Outcomes included rates of response, remission, and adverse events. After evaluating the data, we applied a frailty-informed framework to consider how the evidence could be applied to frailty. Results Nine trials were included in the meta-analysis (n = 2704). Subjects had moderate to severe depression. For older adults with depression, there was no statistically significant difference in response or remission to second-generation antidepressants compared to placebo. Response occurred in 45.3% of subjects receiving an antidepressant compared to 40.5% receiving placebo (RR 1.15, 95% CI: 0.96 – 1.37, p = 0.12, I2 = 71%). Remission occurred in 33.1% with antidepressant versus 31.3% with placebo (RR 1.10, 95% CI: 0.92 – 1.31, p = 0.30, I2 = 56%) (Figure 2 and 3). There were more withdrawals due to adverse events with antidepressants, 13% versus 5.8% (RR 2.30, 95% CI: 1.45–3.63; p < 0.001; I2 = 61%; NNH 14, 95% CI:10–28). Implications for frailty Subjects in the meta-analysis did not have obvious characteristics of frailty. Using framework questions to consider the implications of frailty, we hypothesize that, like older adults, frail individuals with depression may not respond to antidepressants. Further, observational studies suggest that those who are frail may be less responsive to antidepressants compared to the non-frail. Given the vulnerability of frailty, adverse events may be more burdensome. Conclusions Second-generation antidepressants have uncertain benefit for older adults with depression and cause more adverse events compared to placebo. Until further research clarifies benefit, careful consideration of antidepressant prescribing with frailty is warranted.

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Efficacy and safety of omalizumab in chronic rhinosinusitis with nasal polyps: a systematic review and meta-analysis of randomised controlled trials

BMJ Open ◽

10.1136/bmjopen-2020-047344 ◽

2021 ◽

Vol 11 (9) ◽

pp. e047344

Author(s):

Qingwu Wu ◽

Lianxiong Yuan ◽

Huijun Qiu ◽

Xinyue Wang ◽

Xuekun Huang ◽

...

Keyword(s):

Systematic Review ◽

Adverse Events ◽

Chronic Rhinosinusitis ◽

Randomised Controlled Trials ◽

Nasal Polyps ◽

Meta Analysis ◽

Cochrane Library ◽

Controlled Trials ◽

Efficacy And Safety ◽

Randomised Controlled

ObjectivesTo assess the efficacy and safety of omalizumab for chronic rhinosinusitis with nasal polyps (CRSwNP) and to identify evidence gaps that will guide future research on omalizumab for CRSwNP.DesignSystematic review and meta-analysis.Data sourcesA comprehensive search was performed in PubMed, Embase, Web of Science and the Cochrane Library on 13 October 2020.Eligibility criteriaRandomised controlled trials (RCTs) comparing omalizumab with placebo, given for at least 16 weeks in adult patients with CRSwNP.Data extraction and synthesisTwo independent authors screened search results, extracted data and assessed studies using the Cochrane risk of bias tool. Data were pooled using the inverse-variance method and expressed as mean differences (MDs) with 95% CIs. Heterogeneity was assessed by the χ2 test and the I2 statistic.ResultsA total of four RCTs involving 303 participants were identified. When comparing omalizumab to placebo, there was a significant difference in Nasal Polyps Score (MD=−1.20; 95% CI −1.48 to −0.92), Nasal Congestion Score (MD=−0.67; 95% CI −0.86 to −0.48), Sino-Nasal Outcome Test-22 (MD=−15.62; 95% CI −19.79 to −11.45), Total Nasal Symptom Score (MD=−1.84; 95% CI −2.43 to −1.25) and reduced need for surgery (risk ratio (RR)=5.61; 95% CI 1.99 to 15.81). Furthermore, there was no difference in the risk of serious adverse events ((RR=1.40; 95% CI 0.29 to 6.80), adverse events (RR=0.83; 95% CI 0.60 to 1.15) and rescue systemic corticosteroid (RR=0.52; 95% CI 0.17 to 1.61).ConclusionsThis was the first meta-analysis that identified omalizumab significantly improved endoscopic, clinical and patient-reported outcomes in adults with moderate to severe CRSwNP and it was safe and well tolerated.PROSPERO registration numberCRD42020207639.

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A Systematic Review and Meta-Analysis of Therapeutic Efficacy and Safety of Alirocumab and Evolocumab on Familial Hypercholesterolemia

BioMed Research International ◽

10.1155/2021/8032978 ◽

2021 ◽

Vol 2021 ◽

pp. 1-16

Author(s):

Xiaoyue Ge ◽

Tiantian Zhu ◽

Hao Zeng ◽

Xin Yu ◽

Juan Li ◽

...

Keyword(s):

Clinical Trials ◽

Adverse Events ◽

Familial Hypercholesterolemia ◽

Meta Analysis ◽

Density Lipoprotein ◽

Apolipoprotein A1 ◽

Cochrane Library ◽

Efficacy And Safety ◽

Apo B ◽

Significant Difference

Objectives. The aim of this study was to provide the first study to systematically analyze the efficacy and safety of PCSK9-mAbs in the treatment of familial hypercholesterolemia (FH). Methods. A computer was used to search the electronic Cochrane Library, PubMed/MEDLINE, and Embase databases for clinical trials using the following search terms: “AMG 145”, “evolocumab”, “SAR236553/REGN727”, “alirocumab”, “RG7652”, “LY3015014”, “RN316/bococizumab”, “PCSK9”, and “familial hypercholesterolemia” up to November 2020. Study quality was assessed with the Cochrane Collaboration’s tool, and publication bias was evaluated by a contour-enhanced funnel plot and the Harbord modification of the Egger test. After obtaining the data, a meta-analysis was performed using R software, version 4.0.3. Results. A meta-analysis was performed on 7 clinical trials (926 total patients). The results showed that PCSK9-mAbs reduced the LDL-C level by the greatest margin, WMD −49.14%, 95% CI: −55.81 to −42.47%, on FH versus control groups. PCSK9-mAbs also significantly reduced lipoprotein (a) (Lp (a)), total cholesterol (TC), triglycerides (TG), apolipoprotein-B (Apo-B), and non-high-density lipoprotein cholesterol (non-HDL-C) levels and increased HDL-C and apolipoprotein-A1 (Apo-A1) levels of beneficial lipoproteins. Moreover, no significant difference was found between PCSK9-mAbs treatment and placebo in common adverse events, serious events, and laboratory adverse events. Conclusion. PCSK9-mAbs significantly decreased LDL-C and other lipid levels with satisfactory safety and tolerability in FH treatment.

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Repurposing of drugs for Covid-19: a systematic review and meta-analysis

10.1101/2020.06.07.20124677 ◽

2020 ◽

Cited By ~ 1

Author(s):

Pinky Kotecha ◽

Alexander Light ◽

Enrico Checcucci ◽

Daniele Amparore ◽

Cristian Fiori ◽

...

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Adverse Events ◽

Clinical Improvement ◽

Case Reports ◽

Meta Analysis ◽

Case Series ◽

Cochrane Library ◽

Control Group ◽

Significant Difference

AbstractObjectiveThe aim of this systematic review is to evaluate the data currently available regarding the repurposing of different drugs for Covid-19 treatment. Participants with suspected or diagnosed Covid-19 will be included. The interventions being considered are drugs being repurposed, and comparators will include standard of care treatment or placebo.MethodsWe searched Ovid-MEDLINE, EMBASE, Cochrane library, clinical trial registration site in the UK(NIHR), Europe (clinicaltrialsregister.eu), US (ClinicalTrials.gov) and internationally (isrctn.com), and reviewed the reference lists of articles for eligible articles published up to April 22, 2020. All studies in English that evaluated the efficacy of the listed drugs were included. Cochrane RoB 2.0 and ROBINS-I tool were used to assess study quality. This systematic review adheres to the PRISMA guidelines. The protocol is available at PROSPERO (CRD42020180915).ResultsFrom 708 identified studies or clinical trials, 16 studies and 16 case reports met our eligibility criteria. Of these, 6 were randomized controlled trials (763 patients), 7 cohort studies (321 patients) and 3 case series (191 patients). Chloroquine (CQ) had a 100% discharge rate compared to 50% with lopinavir-ritonavir at day 14, however a trial has recommended against a high dosage due to cardiotoxic events. Hydroxychloroquine (HCQ) has shown no significant improvement in negative seroconversion rate which is also seen in our meta-analysis (p=0.68). Adverse events with HCQ have a significant difference compared to the control group (p=0.001). Lopinavir-ritonavir has shown no improvement in time to clinical improvement which is seen in our meta-analyses (p=0.1). Remdesivir has shown no significant improvement in time to clinical improvement but this trial had insufficient power.DiscussionDue to the paucity in evidence, it is difficult to establish the efficacy of these drugs in the treatment of Covid-19 as currently there is no significant clinical effectiveness of the repurposed drugs. Further large clinical trials are required to achieve more reliable findings. A risk-benefit analysis is required on an individual basis to weigh out the potential improvement in clinical outcome and viral load reduction compared to the risks of the adverse events. (1-16)

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Clinical Efficacy and Safety of Omalizumab in the Treatment of Allergic Rhinitis: A Systematic Review and Meta-analysis of Randomized Clinical Trials

American Journal of Rhinology and Allergy ◽

10.1177/1945892419884774 ◽

2019 ◽

Vol 34 (2) ◽

pp. 196-208 ◽

Cited By ~ 7

Author(s):

Chenjie Yu ◽

Kaijian Wang ◽

Xinyan Cui ◽

Ling Lu ◽

Jianfei Dong ◽

...

Keyword(s):

Allergic Rhinitis ◽

Adverse Events ◽

Symptom Score ◽

Meta Analysis ◽

Cochrane Library ◽

Control Group ◽

Life Questionnaire ◽

Efficacy And Safety ◽

Significant Difference ◽

Symptom Scores

Background Patients with moderate to severe allergic rhinitis (AR) who are treated according to the current rhinitis management guidelines may be inadequately controlled. These patients are at risk of serious comorbidities, such as asthma and chronic sinusitis. These symptoms, sneezing and an itchy, runny, stuffy nose, may have a negative impact on patients’ daily functioning. Omalizumab is being developed as a new choice for the treatment of AR. We therefore undertook a meta-analysis to assess the efficacy and safety of omalizumab in the treatment of AR. Methods We systematically searched PubMed, Cochrane Library, and MEDLINE databases for randomized controlled studies on the treatment of AR with omalizumab. Our evaluation outcomes were symptom scores, medication efficacy, combined symptom and medication scores, and adverse events. We descriptively summarized and quantitatively synthesized original data to evaluate the efficacy and safety of omalizumab in the treatment of AR by using Stata12.0 software for meta-analyses. Results The results of our meta-analysis showed that there were statistically significant differences between the omalizumab group and the control group in the following aspects: daily nasal symptom score (standardized mean difference [SMD] = –0.443, 95% confidence interval [CI]: –0.538 to –0.347, P < .001); daily ocular symptom score (SMD = –0.385, 95% CI: –0.5 to –0.269, P < .001); daily nasal medication symptom scores (SMD = –0.421, 95% CI: –0.591 to –0.251, P < .001); proportion of days of emergency drug use (risk ratio [RR] = 0.488, 95% CI: 0.307 to 0.788, P < .005); rhinoconjunctivitis-specific quality of life questionnaire (SMD = –0.286, 95% CI: –0.418 to –0.154, P < .001); and overall evaluation (RR = 1.435, 95% CI: 1.303–1.582, P < .001). There was no statistically significant difference in safety indicator: adverse events (RR = 1.026, 95% CI: 0.916–1.150, P = .655). Conclusion Omalizumab is effective and relatively safe in patients with AR; omalizumab used in conjunction with special immunotherapy has shown promising results, especially in reducing adverse events.

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Efficacy and safety of pharmacological cachexia interventions: systematic review and network meta-analysis

BMJ Supportive & Palliative Care ◽

10.1136/bmjspcare-2020-002601 ◽

2020 ◽

pp. bmjspcare-2020-002601

Author(s):

Manit Saeteaw ◽

Phitjira Sanguanboonyaphong ◽

Jukapun Yoodee ◽

Kaitlyn Craft ◽

Ratree Sawangjit ◽

...

Keyword(s):

Systematic Review ◽

Adverse Events ◽

Meta Analysis ◽

Total Body Weight ◽

Megestrol Acetate ◽

High Dose ◽

Efficacy And Safety ◽

Pharmacological Interventions ◽

Serious Adverse Events ◽

Significant Difference

AimsRandomised controlled trials (RCTs) demonstrated benefits of pharmacological interventions for cachexia in improving weight and appetite. However, comparative efficacy and safety are not available. We conducted a systematic review and network meta-analysis (NMA) to evaluate the relative efficacy and safety of pharmacological interventions for cachexia.MethodsPubMed, EmBase, Cochrane, and ClinicalTrials.gov were searched for RCTs until October 2019. Key outcomes were total body weight (TBW) improvement, appetite (APP) score and serious adverse events. Two reviewers independently extracted data and assessed risk of bias. NMA was performed to estimate weight gain and APP score increase at 8 weeks, presented as mean difference (MD) or standardised MD with 95% CI.Results80 RCTs (10 579 patients) with 12 treatments were included. Majority is patients with cancer (7220). Compared with placebo, corticosteroids, high-dose megestrol acetate combination (Megace_H_Com) (≥400 mg/day), medroxyprogesterone, high-dose megestrol acetate (Megace_H) (≥400 mg/day), ghrelin mimetic and androgen analogues (Androgen) were significantly associated with MD of TBW of 6.45 (95% CI 2.45 to 10.45), 4.29 (95% CI 2.23 to 6.35), 3.18 (95% CI 0.94 to 5.41), 2.66 (95% CI 1.47 to 3.85), 1.73 (95% CI 0.27 to 3.20) and 1.50 (95% CI 0.56 to 2.44) kg. For appetite improvement, Megace_H_Com, Megace_H and Androgen significantly improved standardised APP score, compared with placebo. There is no significant difference in serious adverse events from all interventions compared with placebo.ConclusionsOur findings suggest that several pharmacological interventions have potential to offer benefits in treatment of cachexia especially Megace_H and short-term use corticosteroids. Nonetheless, high-quality comparative studies to compare safety and efficacy are warranted for better management of cachexia.

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Outcomes of allogeneic hematopoietic cell transplantation in patients with myelofibrosis: A systematic review and meta-analysis.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.7045 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. 7045-7045

Author(s):

Jan Philipp Bewersdorf ◽

Amar Sheth ◽

Shaurey Vetsa ◽

Alyssa Grimshaw ◽

Smith Giri ◽

...

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Meta Analysis ◽

Controlled Vocabulary ◽

Hematopoietic Cell ◽

Cochrane Library ◽

Free Text ◽

Cell Transplant ◽

Efficacy And Safety ◽

Significant Difference

7045 Background: Allogeneic hematopoietic cell transplant (allo-HCT) remains the only potentially curative therapeutic modality for patients with primary or secondary myelofibrosis (MF). However, many patients (pts) are ineligible for allo-HCT and transplant-related mortality can be substantial. Data on the efficacy and safety of allo-HCT are mixed and largely derived from retrospective studies. Methods: To synthesize the available evidence, we conducted a systematic review and meta-analysis searching Cochrane Library, Google Scholar, Ovid Medline, Ovid Embase, PubMed, Scopus, and Web of Science Core Collection from inception to October 11, 2020 for studies on allo-HCT in MF. Databases were searched using a combination of controlled vocabulary and free text terms for relevant studies on the efficacy and safety of allo-HCT in pts with primary and secondary MF. This study protocol has been registered on PROSPERO (CRD42020188706). Random-effects models were used to pool response rates for the co-primary outcomes of 1-year, 2-year and 5-year overall survival (OS). Results: We identified 4247 studies after duplicate removal. 393 studies were assessed as full-texts for eligibility and 43 studies (38 retrospective, 1 prospective study, 4 phase II clinical trials) with 8739 pts were included in this meta-analysis. Study quality was limited by the absence of randomized clinical trials and retrospective design of most studies. Rates of 1-year, 2-year, and 5-year OS were 66.7% (95% confidence interval: 63.5-69.8%), 64.4% (57.6-70.6%), and 55.0% (51.8-58.3%), respectively. Rates of 1-year, 2-year, and 5-year non-relapse mortality were 25.9% (23.3-28.7%), 29.7% (24.5-35.4%), and 30.5% (25.9-35.5%), respectively. Among evaluable studies, rates of 1-year, 2-year, and 5-year relapse-free survival were 65.3% (56.5-73.1%), 56.2% (41.6-69.8%), and 53.6% (39.9-66.9%), respectively. Adverse events related to all-HCT were manageable with rates of acute and chronic graft-versus-host disease in 44.0% (39.6-48.4%; grade III/IV: 15.2%) and 46.5% of patients (42.2-50.8%; extensive or moderate/severe: 26.1%), respectively. Subgroup analyses did not show any significant difference between conditioning regimen intensity (myeloablative vs reduced-intensity), median patient age, and proportion of DIPSS-intermediate-2/high pts. Conclusions: Given the poor prognosis of patients not receiving transplant and in the absence of curative non-transplant therapies, our results support consideration of allo-HCT for eligible pts with MF. However, additional studies in pre- and post-allo-HCT setting are necessary to enhance patient selection (e.g. by incorporation of molecular markers), to optimize transplant strategies (e.g. peri-transplant ruxolitinib, conditioning regimens, and donor selection), symptom management and decrease non-relapse mortality.

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Efficacy and Safety of Moxibustion for Postherpetic Neuralgia: A Systematic Review and Meta-Analysis

Frontiers in Neurology ◽

10.3389/fneur.2021.676525 ◽

2021 ◽

Vol 12 ◽

Author(s):

Qiqi Wu ◽

Hantong Hu ◽

Dexiong Han ◽

Hong Gao

Keyword(s):

Systematic Review ◽

Herbal Medicine ◽

Adverse Events ◽

Postherpetic Neuralgia ◽

Outcome Measure ◽

Meta Analysis ◽

Current Evidence ◽

Cochrane Library ◽

Efficacy Rate ◽

Efficacy And Safety

Background: Postherpetic neuralgia (PHN) is one of the most common complications of herpes zoster (HZ), and there is still a lack of effective therapies. An increasing number of studies have found that compared to traditional therapy, moxibustion treatment is beneficial for the treatment of PHN, although current evidence remains inconclusive. This systematic review and meta-analysis of randomized controlled trials (RCTs) aimed to evaluate the efficacy and safety of moxibustion for PHN.Methods: We conducted a broad literature review of a range of databases from inception to December 2020, including the Cochrane Library, PubMed, EMBASE, Web of Science, Clinical Trails, China National Knowledge Infrastructure (CNKI), VIP Database for Chinese Technical Periodicals (VIP), China Biomedical Network Information, and Wanfang databases. We included RCTs that compared moxibustion to pharmacological therapies, herbal medicine, or no treatment for treating PHN. The main outcome measure was efficacy rate and Visual Analog Scale (VAS); the secondary outcome measure was adverse events. Data accumulation and synthesis included meta-analysis, publication bias, sensitivity analysis, risk-of-bias assessment, and adverse events.Results: We included 13 RCTs involving 798 patients. Compared with the controls (pharmacological therapies, herbal medicine, or no treatment), moxibustion achieved a significantly higher efficacy rate (odds ratio [OR]: 3.65; 95% [confidence interval]: [2.32, 5.72]; P < 0.00001). Subgroup analysis of the distinct moxibustion modalities showed that both Zhuang medicine medicated thread and thunder-fire moxibustions obtained higher clinical efficacy than the control group. Compared with the controls, moxibustion resulted in significantly lower scores on the VAS (Weighted Mean Difference (MD) = −1.79; 95% CI: [−2.26, −1.33]; P < 0.00001). However, there was no significant difference in terms of safety between moxibustion and the controls (OR = 0.33; 95% CI [0.06, 1.77]; P = 0.19).Conclusion: Due to the lack of methodological quality as well as the significant heterogeneity of the included studies, it remains difficult to draw a firm conclusion on the efficacy and safety of moxibustion for the treatment of PHN. Future high-quality studies are urgently needed.

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Hydroxychloroquine plus standard of care compared with standard of care alone in COVID-19: a meta-analysis of randomized controlled trials

Scientific Reports ◽

10.1038/s41598-021-91089-3 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Bahman Amani ◽

Ahmad Khanijahani ◽

Behnam Amani

Keyword(s):

Adverse Events ◽

Randomized Controlled Trials ◽

Meta Analysis ◽

Length Of Hospital Stay ◽

Standard Of Care ◽

Cochrane Library ◽

Controlled Trials ◽

Efficacy And Safety ◽

Randomized Controlled ◽

Significant Difference

AbstractThe efficacy and safety of Hydroxychloroquine (HCQ) in treating coronavirus disease (COVID-19) is disputed. This systematic review and meta-analysis aimed to examine the efficacy and safety of HCQ in addition to standard of care (SOC) in COVID-19. PubMed, the Cochrane Library, Embase, Web of sciences, and medRxiv were searched up to March 15, 2021. Clinical studies registry databases were also searched for identifying potential clinical trials. The references list of the key studies was reviewed to identify additional relevant resources. The quality of the included studies was evaluated using the Cochrane Collaboration tool and Jadad checklist. Meta-analysis was performed using RevMan software (version 5.3). Eleven randomized controlled trials with a total number of 8161 patients were identified as eligible for meta-analysis. No significant differences were observed between the two treatment groups in terms of negative rate of polymerase chain reaction (PCR) (Risk ratio [RR]: 0.99, 95% confidence interval (CI) 0.90, 1.08; P = 0.76), PCR negative conversion time (Mean difference [MD]: − 1.06, 95% CI − 3.10, 0.97; P = 0.30), all-cause mortality (RR: 1.09, 95% CI 1.00, 1.20; P = 0.06), body temperature recovery time (MD: − 0.64, 95% CI − 1.37, 0.10; P = 0.09), length of hospital stay (MD: − 0.17, 95% CI − 0.80, 0.46; P = 0.59), use of mechanical ventilation (RR: 1.12, 95% CI 0.95, 1.32; P = 0.19), and disease progression (RR = 0.82, 95% CI 0.37, 1.85; P = 0.64). However, there was a significant difference between two groups regarding adverse events (RR: 1.81, 95% CI 1.36, 2.42; P < 0.05). The findings suggest that the addition of HCQ to SOC has no benefit in the treatment of hospitalized patients with COVID-19. Additionally, it is associated with more adverse events.

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Efficacy and safety of Azithromycin and Amoxicillin/clavulanate for otitis media in children: a systematic review and meta-analysis of randomized controlled trials

10.21203/rs.3.rs-267554/v1 ◽

2021 ◽

Author(s):

Gabriel Tesfai ◽

Solomon Abay ◽

Eyasu Makonnen

Keyword(s):

Systematic Review ◽

Otitis Media ◽

Meta Analysis ◽

Cochrane Library ◽

Efficacy And Safety ◽

Statistical Significant Difference ◽

Effect Measure ◽

Significant Difference ◽

Amoxicillin Clavulanate

Abstract BackgroundResistance, prolonged therapy and more adverse reactions made amoxicillin less preferred for treating otitis media. The aim of this study was to compare the efficacy and safety of azithromycin and amoxicillin/clavulanate for treatment of otitis media in children.MethodologyThis study was a systematic review and meta-analysis. PubMed, Cochrane library and Google scholar databases were searched. Comparative RCT studies between azithromycin and amoxicillin/clavulanate to treat otitis media in children published up to 30 September 2019 were included. Risk of bias was assessed and Data was extracted by the first author and checked by second author. Meta-analysis was performed by STATA software version 16, and Mantel-Haenszel statistical method with effect measure odds ratio was employed for analysis.Result751 records were identified and 14 studies were eligible for analysis. In 12 studies azithromycin had equivalent clinical efficacy and 2 had less to amoxicillin/clavulanate. Meta-analysis results showed small statistical difference on efficacy in favor of amoxicillin/clavulanate after completion of treatment OR 0.75, 95% CI (0.62–0.91). On subgroup analysis for children less than 2 year (OR 0.96 95% CI (0.49–2.29), and greater than 2 year (OR 1.40 95% CI (0.93–2.11) and also efficacy on follow up (OR 0.97 95% CI (0.83–1.15) there is no statistical significant difference. The clinical adverse events are more in amoxicillin/clavulanate group than in azithromycin with statistical significant difference OR 0.46 95% CI (0.43–0.56).ConclusionAzithromycin is not inferior to amoxicillin/clavulanate to treat otitis media in children, and it is safer and more tolerable.

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Efficacy and Safety of Immunotherapies in Refractory Myasthenia Gravis: A Systematic Review and Meta-Analysis

Frontiers in Neurology ◽

10.3389/fneur.2021.725700 ◽

2021 ◽

Vol 12 ◽

Author(s):

Xuelin Feng ◽

Zubiao Song ◽

Mengli Wu ◽

Yanmei Liu ◽

Sushan Luo ◽

...

Keyword(s):

Systematic Review ◽

Adverse Events ◽

Myasthenia Gravis ◽

Daily Living ◽

Primary Outcome ◽

Meta Analysis ◽

Cochrane Library ◽

Efficacy And Safety ◽

Disease Exacerbation ◽

Post Intervention

Introduction: Approximately 10–20% of patients WITH myasthenia gravis (MG) are refractory to conventional immunotherapies. The purpose of this study was to conduct a systematic review and meta-analysis to explore the optimal therapies for refractory MG.Method: Correlative studies were performed through a search in PubMed, Cochrane Library, and Embase databases. The primary outcome was defined by changes in the quantitative myasthenia gravis score (QMG). Secondary outcomes were defined by the Myasthenia Gravis Activities of Daily Living Scale (MG-ADL), Myasthenia Gravis Foundation of America (MGFA) post intervention status, adverse events, and disease exacerbation after treatment.Result: A total of 16 studies were included with 403 patients with refractory MG on therapies with rituximab, eculizumab, tacrolimus, and cladribine. Therapeutic efficacy of rituximab and eculizumab was identified with an estimated reduction in QMG score (4.158 vs. 6.928) and MG-ADL (4.400 vs. 4.344), respectively. No significant changes were revealed in efficacy or exacerbation density between the two independent therapeutic cohorts. The estimated adverse event density of eculizumab was more significant than that in the rituximab group (1.195 vs. 0.134 per patient-year), while the estimated serious event density was similar.Conclusion: The efficacy and safety of rituximab and eculizumab have been approved in patients with refractory MG. Rituximab had a superior safety profile than eculizumab with a lower incidence of adverse events.Systematic Review Registration:https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021236818, identifier CRD42021236818.

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