scholarly journals The Efficacy and Safety of Levamisole in African Children With Idiopathic Nephrotic Syndrome: A Protocol for Systematic Review and Meta-Analysis

Author(s):  
Christie Divine Akwaowo ◽  
Emmanuel Okechukwu Nna ◽  
Henrietta Uchenna Okafor ◽  
Adanze Onyenonachi Asinobi ◽  
Ann Ebele Aronu ◽  
...  

Abstract BackgroundNephrotic syndrome (NS) is one of the most common childhood renal disorders globally, with an incidence of 2 to 7 cases per 100,000 children. A characteristic feature is massive proteinuria which may rapidly progress to end stage kidney failure, if uncontrolled. Most of the cases in children are steroid sensitive but associated with frequent relapses. Levamisole, a cheap antihelminthic has been used as steroid sparing agent in steroid sensitive NS (SSNS). This study assesses the efficacy and safety of Levamisole in African children with idiopathic nephrotic syndrome.MethodsWe will conduct a systematic review and meta-analysis of all Randomised controlled trials which reported African children with Idiopathic nephrotic syndrome who were on Levamisole compared to other drugs. Ten databases including PubMed, African Journals Online, Google Scholar, Cumulative Index to Nursing and Allied Health Literature, EMBASE, Cochrane Library, Web of Science, Scopus, Clinicaltrial.gov and Research Gate will be searched using a search strategy. The search will have no time restrictions, but studies must have been conducted among African children residing in Africa and are retrievable in the English Language. Studies will be selected based on inclusion and exclusion criteria by two independent reviewers without blinding. The study quality will be assessed using the Pedro scale and risk of bias evaluated using the Cochrane Risk of Bias tool. Eligible screened studies will be inlcuded for meta-analysis using the CMA Software. Statistical, clinical and methodological heterogeneity will be tested. Subgroup analyses and meta-regression will be performed on rate of relapses, adverse event and drug dose.DiscussionThe primary outcome will be the proportion of children with remissions and or relapses within 6 -12 months post initiation of levamisole or comparators with effect size being the relative risk. Safety of Levamisole will be measured using reported adverse events. Moderating effects of age, gender, duration of illness, and dosage of Levamisole on the duration of remission, frequency of relapses and adverse events will be examined.Systematic Review RegistrationThis protocol has been registered in PROSPERO, with registration number CRD42020213327.

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e047344
Author(s):  
Qingwu Wu ◽  
Lianxiong Yuan ◽  
Huijun Qiu ◽  
Xinyue Wang ◽  
Xuekun Huang ◽  
...  

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.


2021 ◽  
Vol 15 ◽  
Author(s):  
Xinglin Ruan ◽  
Fabin Lin ◽  
Dihang Wu ◽  
Lina Chen ◽  
Huidan Weng ◽  
...  

Background: Movement fluctuations are the main complication of Parkinson's disease (PD) patients receiving long-term levodopa (L-dopa) treatment. We compared and ranked the efficacy and safety of dopamine agonists (DAs) with regard to motor fluctuations by using a Bayesian network meta-analysis (NMA) to quantify information from randomized controlled trials (RCTs).Methods and Findings: We carried out a systematic review and meta-analysis, and only RCTs comparing DAs for advanced PD were included. Electronic databases (PubMed, Embase, and Cochrane Library) were systematically searched for relevant studies published until January 2021. Two reviewers independently extracted individual study data and evaluated studies for risk of bias using the Cochrane Risk of Bias tool. Network meta-analyses using a Bayesian framework were used to calculate the related parameters. The pre-specified primary and secondary outcomes were efficacy (“ON” time without troublesome dyskinesia, “OFF” time, “ON” time, “UPDRS-III,” and “UPDRS-II”) and safety [treatment-emergent adverse events (TEAE) and other adverse events] of DAs. The results are presented as the surface under the cumulative ranking (SUCRA) curve. A total of 20 RCTs assessing 6,560 patients were included. The general DA effects were ranked from high to low with respect to the amount of “ON” time without troublesome dyskinesia as follows: apomorphine (SUCRA = 97.08%), pramipexole_IR (probability = 79.00%), and ropinirole_PR (SUCRA = 63.92%). The general safety of DAs was ranked from high to low with respect to TEAE as follows: placebo (SUCRA = 74.49%), pramipexole_ER (SUCRA = 63.6%), sumanirole (SUCRA = 54.07%), and rotigotine (SUCRA = 53.84%).Conclusions: This network meta-analysis shows that apomorphine increased “ON” time without troublesome dyskinesia and decreased “OF” time for advanced PD patients. The addition of pramipexole, ropinirole, or rotigotine to levodopa treatment in advanced PD patients with motor fluctuations increased “ON” time without troublesome dyskinesia, improved the UPDRS III scores, and ultimately ameliorated the UPDRS II scores, thereby maximizing its benefit. This NMA of pramipexole, ropinirole, and rotigotine represents an effective treatment option and has an acceptable safety profile in patients with advanced PD.


2021 ◽  
Vol 12 ◽  
Author(s):  
Qiqi Wu ◽  
Hantong Hu ◽  
Dexiong Han ◽  
Hong Gao

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.


2021 ◽  
Author(s):  
Jingxin Zhou ◽  
Wenhua Zhang ◽  
Jie Yang ◽  
Qiaoqiao Liu ◽  
Yizhen Lu ◽  
...  

Abstract Background: Diabetic kidney disease (DKD), which is a serious complication of diabetes and the leading cause of end-stage renal disease, becomes a major health concern worldwide. Keluoxin capsule, a Chinese patent medicine used for DKD, has been widely used in diabetic kidney disease, but its efficacy and safety have not yet been clarified. Therefore, the aim of this systematic review and meta-analysis is to summarize the efficacy and safety of Keluoxin capsule in the treatment of DKD. Methods: A systematic literature search will be conducted in PubMed, Cochrane Library, EMBASE, China National Knowledge Infrastructure, WANFANG database, VIP, SinoMED, and Chinese Biomedical Literature Database (CBM) to ensure all possible randomized controlled trials (RCT) studies on K eluoxin capsule to November 1, 2021. The primary outcome to be assessed will include the change in albuminuria and estimated glomerular filtration rate (eGFR), while secondary outcomes will be serum creatinine, blood urea nitrogen, glycated hemoglobin, total cholesterol, low-density lipoprotein cholesterol, and triglycerides, etc and adverse events. The quality of the included studies and the risk of bias will be independently assessed by two reviewers using the risk of bias assessment tool from Cochrane Handbook. We will conduct random-effects model meta-analysis using Review Manager software (Revman5.3). Discussion: This systematic review and meta-analysis will objectively evaluate the effect of Keluoxin capsule for DKD, and provide evidence for Keluoxin capsule in the treatment of DKD. Ethics and dissemination : Ethics approval is not required for this study. We aim to publish the results of this systematic review in a peer-reviewed journal. INPLASY registration number: INPLASY 2021110067.


2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Chan-Young Kwon ◽  
Boram Lee ◽  
Sun-Yong Chung ◽  
Jong Woo Kim ◽  
Aesook Shin ◽  
...  

Abstract This systematic review and meta-analysis aimed to analyze the efficacy and safety of Sihogayonggolmoryeo-tang (SGYMT), a classical herbal medicine consisting of 11 herbs, for treatment of post-stroke depression (PSD). Thirteen databases were comprehensively searched from their inception dates until July 2019. Only randomized controlled trials (RCTs) using SGYMT as a monotherapy or adjunctive therapy for PSD patients were included. Where appropriate data were available, meta-analysis was performed and presented as risk ratio (RR) or mean difference (MD) with 95% confidence intervals (CIs). We assessed the quality of RCTs using the Cochrane risk of bias tool and the Jadad scale. The quality of evidence for each main outcome was evaluated using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. Twenty-one RCTs with 1,644 participants were included. In the comparison between the SGYMT and antidepressants groups, the SGYMT group scored significantly lower on both the Hamilton Depression Scale (HAMD) (8 studies; MD −2.08, 95% CI −2.62 to −1.53, I2 = 34%) and the National Institutes of Health Stroke Scale (NIHSS) (2 studies; MD −0.84, 95% CI −1.40 to −0.29, I2 = 19%), and significantly higher on the Barthel index (3 studies; MD 4.30, 95% CI 2.04 to 6.57, I2 = 66%). Moreover, the SGYMT group was associated with significantly fewer adverse events (6 studies; RR 0.13, 95% CI 0.05 to 0.37, I2 = 0%) than the antidepressants group. In the subgroup analysis, SGYMT treatment consistently reduced HAMD scores within the first 8 weeks of treatment, but thereafter this difference between groups disappeared. Comparisons between SGYMT combined with antidepressants, and antidepressants alone, showed significantly lower scores in the combination group for both HAMD (7 studies; MD = −6.72, 95% CI = −11.42 to −2.01, I2 = 98%) and NIHSS scores (4 studies; MD −3.03, 95% CI −3.60 to −2.45, I2 = 87%). In the subgroup analysis, the reductions of HAMD scores in the SGYMT combined with antidepressants group were consistent within 4 weeks of treatment, but disappeared thereafter. The quality of RCTs was generally low and the quality of evidence evaluated by the GRADE approach was rated mostly “Very low” to “Moderate.” The main causes of low quality ratings were the high risk of bias and imprecision of results. Current evidence suggests that SGYMT, used either as a monotherapy or an adjuvant therapy to antidepressants, might have potential benefits for the treatment of PSD, including short-term reduction of depressive symptoms, improvement of neurological symptoms, and few adverse events. However, since the methodological quality of the included studies was generally low and there were no large placebo trials to ensure reliability, it remains difficult to draw definitive conclusions on this topic. Further well-designed RCTs addressing these shortcomings are needed to confirm our results.


2021 ◽  
Vol 12 ◽  
Author(s):  
Xuelin Feng ◽  
Zubiao Song ◽  
Mengli Wu ◽  
Yanmei Liu ◽  
Sushan Luo ◽  
...  

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.


2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Laurie Mallery ◽  
Tanya MacLeod ◽  
Michael Allen ◽  
Pamela McLean-Veysey ◽  
Natasha Rodney-Cail ◽  
...  

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.


Author(s):  
Wang Zuqing ◽  
Li Yan

Background: Warming acupuncture (WA) is widely used in the management of Cervical spondylotic radiculopathy (CSR)in China and obtains desirable efficacy. Therefore, the aim of this study is to systematically assess the efficacy and safety whether using WA alone or combined with traditional Chinese medicine (TCM) therapy for the treatment of CSR. <br><br> Methods: PubMed, EMBASE, Sinomed, the Cochrane Library, CNKI, VIP and Wangfang databases were searched from their inception through 30 September 2020. All the retrieved records were screened or excluded based on the criteria that were pre-established, and the results that meet the criteria were assessed by the Cochrane risk of bias tool and Meta-analysis was conducted by using RevMan5.3 software. <br><br> Results: Fourteen RCTs (1021patients) were included in the meta-analysis. The effective rate of WA alone or combination with TCM therapy was analyzed in comparison with the treatment of regular therapy. The results indicated that compared with regular therapy, WA alone or in combination with TCM therapy increased clinical effective rate (Odds ratio (OR)=4.43,95%CI 2.85 to 6.90, P<0.01). Additionally decreased VAS score (mean difference (MD)=-1.21,95%CI -1.68 to -0.73, P<0.01), PPI (MD=-1.34, 95% CI -2.08 to -0.61) and PRI (MD=-0.55,95% CI -0.72 to -0.37, P<0.001). However, adverse events of WA were not specially reported in all studies. <br> Conclusions: WA as the main treatment for CSR can improve the clinical effective rate and reduce the level of VAS score, PPI and PRI. Further research is needed to determine the effectiveness of WA for CSR treatment, rigorously and unambiguously.


2021 ◽  
Vol 9 (9) ◽  
pp. 232596712110266
Author(s):  
Zhongcheng Liu ◽  
Qiong Yi ◽  
Liangzhi He ◽  
Changjiang Yao ◽  
Lanfang Zhang ◽  
...  

Background: Medial patellofemoral ligament (MPFL) reconstruction, MPFL repair, and nonoperative treatment are important treatments for patients with patellar dislocation. However, it is unclear which treatment leads to better outcomes. Purpose: To determine the efficacy and safety of the 3 treatments in the treatment of patellar dislocation and compare the effect of MPFL reconstruction with MPFL repair, MPFL reconstruction with nonoperative treatment, and MPFL repair with nonoperative treatment. Study Design: Systematic review; Level of evidence, 3. Methods: The PubMed, Web of Science, Cochrane Library, Embase, CNKI (China National Knowledge Infrastructure), and Wanfang databases were searched from inception to December 2020. Included were clinical studies that described the efficacy and safety of 2 of the 3 treatments, studies directly comparing the clinical effects of the 2 operative techniques, or studies comparing the effects of reconstruction or repair with nonoperative treatment. Two reviewers independently extracted data and assessed the quality of the included studies with the Cochrane risk-of-bias tools. The outcomes evaluated were postoperative redislocation rate, revision rate, complications, and Kujala score. We used traditional direct pairwise meta-analysis as well as network meta-analysis for comprehensive efficacy of all 3 treatment measures. Results: Twelve studies were included: 5 compared MPFL reconstruction with MPFL repair, 2 compared MPFL reconstruction with nonoperative treatment, and 5 compared MPFL repair with nonoperative treatment. The risk of bias was serious in 4, moderate in 4 and low in 4 articles. MPFL reconstruction led to significantly reduced redislocation and improved Kujala scores compared with MPFL repair and nonoperative treatment. MPFL repair led to reduced redislocation rates compared with nonoperative treatment but did not show an obvious benefit in primary dislocations. There was no significant difference among the 3 treatments in terms of revision rate and incidence of complications, although we found that treatment-related complications were least likely to occur in nonoperative treatment. Conclusion: The results of this review indicate that MPFL reconstruction decreases recurrent dislocation compared with MPFL repair or nonoperative treatment, but it has a higher possibility of complications. MPFL repair resulted in less postoperative redislocation than nonoperative treatment but did not show an obvious benefit in primary dislocation.


2021 ◽  
Vol 8 ◽  
Author(s):  
Xianlin Zhu ◽  
Hongbai Wang ◽  
Su Yuan ◽  
Yinan Li ◽  
Yuan Jia ◽  
...  

Background: The aim of this systematic review and meta-analysis was to investigate the efficacy and safety of remimazolam in clinical endoscopic procedure sedation.Methods: The authors searched the databases of PubMed, Embase, and Cochrane Library for studies published until January 2, 2021, that reported remimazolam sedation for endoscopic procedures. The sedative efficiency and the incidence of adverse events were assessed as outcomes. Cochrane Review Manager Software 5.3 was used to perform the statistical analyses.Results: Seven relevant studies involving a total of 1,996 patients were identified. We conducted a meta-analysis of the different controls used in the studies, that is, the placebo, midazolam, and propofol. The results demonstrated that remimazolam had a strong sedative effect, and its sedative efficiency was significantly higher than that of placebo [OR = 0.01, 95% CI: (0.00, 0.10), I2 = 30%, p &lt;0.00001]. The sedative efficiency of remimazolam was significantly higher than that of midazolam [OR = 0.12, 95% CI: (0.08, 0.21), I2 = 0%, p &lt; 0.00001] but lesser than that of propofol [OR = 12.22, 95% CI: (1.58, 94.47), I2 = 0%, p = 0.02]. Regarding the adverse events, remimazolam is associated with a lower incidence of hypotension than placebo and midazolam. Similarly, remimazolam was associated with a lower incidence of hypotension and hypoxemia than propofol.Conclusions: Remimazolam is a safe and effective sedative for patients undergoing endoscopic procedures. The sedative efficiency of remimazolam was significantly higher than that of midazolam but slightly lower than that of propofol. However, the respiration and circulation inhibitory effects of remimazolam were weaker than those of midazolam and propofol.


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