scholarly journals Efficacy and safety of azithromycin and amoxicillin/clavulanate for otitis media in children: a systematic review and meta-analysis of randomized controlled trials

Author(s):  
Gabriel Dawit ◽  
Solomon Mequanent ◽  
Eyasu Makonnen

Abstract Background Resistance, prolonged therapy, and more adverse reactions made amoxicillin less preferred for treating otitis media. This study aimed to compare the efficacy and safety of azithromycin and amoxicillin/clavulanate for the treatment of otitis media in children. Methodology This study was a systematic review and meta-analysis. PubMed, Cochrane library, and Google scholar databases were searched. Comparative randomized clinical trial studies between azithromycin and amoxicillin/clavulanate to treat otitis media in children published up to 30 September 2019 were included. The risk of bias was assessed and Data was extracted by the first author and checked by the 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. Result 751 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 no statistically significant difference in 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 years (OR 0.96 95% CI (0.49–2.29), and greater than 2 years (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 statistically significant difference. The clinical adverse events are more in the amoxicillin/clavulanate group than in the azithromycin with a statistical significant difference OR 0.46 95% CI (0.43–0.56). Conclusion Azithromycin is comparable to amoxicillin/clavulanate to treat otitis media in children, and it is safer and more tolerable.

2021 ◽  
Author(s):  
Gabriel Tesfai ◽  
Solomon Abay ◽  
Eyasu Makonnen

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.


2021 ◽  
Vol 2021 ◽  
pp. 1-15
Author(s):  
Ximing Zhang ◽  
Xiumei Tian ◽  
Yuezi Wei ◽  
Hao Deng ◽  
Lichun Ma ◽  
...  

In clinical practice, tegafur, gimeracil, and oteracil potassium (S-1) therapy is commonly administered to treat nasopharyngeal carcinoma (NPC). However, its efficacy and safety remain controversial in both randomized controlled trials (RCTs) and non-RCTs. We aimed to evaluate the efficacy and safety of S-1 treatment for NPC. We searched PubMed, Ovid, EMBASE, the Cochrane Library, China National Knowledge Infrastructure, Wanfang Database, and VIP databases for RCTs of chemotherapy with or without S-1 for NPC, from 2001 to 2020. A meta-analysis was performed using RevMan5.3 and Stata15. Randomized controlled trials published in journals were included irrespective of blinding and language used. Patients were diagnosed with NPC through a clinicopathological examination; patients of all cancer stages and ages were included. Overall, 25 trials and 1858 patients were included. There were significant differences in the complete remission (OR = 2.42, 95% CI (1.88–3.10), P < 0.05 ) and overall response rate (OR = 2.68, 95% CI (2.08–3.45), P < 0.05 ) between the S-1 and non-S-1 groups. However, there was no significant difference in partial remission (OR = 1.10, 95% CI (0.87–1.39), P = 0.42 ) and seven adverse reactions (leukopenia, thrombocytopenia, nausea and vomiting, diarrhea, dermatitis, oral mucositis, and anemia) between the S-1 and non-S-1 groups. Additionally, statistical analyses with six subgroups were performed. S-1 was found to be a satisfactory chemotherapeutic agent combined with radiotherapy, intravenous chemotherapy, or chemoradiotherapy for NPC. As an oral medicine, the adverse reactions of S-1, especially gastrointestinal reactions, can be tolerated by patients, thereby optimizing their quality of life. S-1 may be a better choice for the treatment of NPC. This trial is registered with CRD42019122041.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 7045-7045
Author(s):  
Jan Philipp Bewersdorf ◽  
Amar Sheth ◽  
Shaurey Vetsa ◽  
Alyssa Grimshaw ◽  
Smith Giri ◽  
...  

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.


2020 ◽  
Vol 2020 ◽  
pp. 1-13
Author(s):  
Yuzhao Huang ◽  
Qiufang Deng ◽  
Liuqing Yang ◽  
Jiahui Ma ◽  
Ziyang Wang ◽  
...  

Background. Knee osteoarthritis (KOA) is a common degenerative disease associated with joint dysfunction and pain. Ultrasound-guided radiofrequency (RF) may be a promising therapy in the treatment of chronic pain for KOA patients. Objective. To evaluate the efficacy and safety of ultrasound-guided RF treatment for chronic pain in patients with KOA. Design. A systematic review was conducted, and a meta-analysis was carried out when possible. Setting. We examined the studies evaluating the clinical efficiency of ultrasound-guided RF on chronic pain in KOA population. Method. A systematic review for the efficacy and safety of ultrasound-guided RF treatment for pain management of KOA patients was carried out in PubMed, EMBASE, Cochrane Library, Web of Science, Wanfang Data, and China National Knowledge Infrastructure (CNKI) from the date of inception to February 2020, and a meta-analysis was conducted. The primary outcomes of pain intensity (visual analogue scale or numerical rating scale) and knee function [the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)] were evaluated from baseline to various follow-up times by random-effects model. Heterogeneity was assessed by I2 statistic and the potential sources of heterogeneity by subgroup and metaregression analyses, respectively. Results. Eight publications with 256 patients were included in the meta-analysis. RF could relieve pain with −4.196 of pooled mean difference and improve knee function by decreasing 23.155 points in WOMAC. Three patients had ecchymosis, two with hypoesthesia and one with numbness after the procedure, and improved within 6 months. Furthermore, study design and treatment target were the sources of heterogeneity by subgroup and metaregression analyses, accounting for 37% and 74% of variances, respectively. Target of genicular nerve achieved better pain relief than intra-articular or sciatic nerve. Sensitivity analysis showed that removal of any single study was unlikely to overturn the findings. Limitations. There were some limitations in the study. Firstly, the small number of relevant studies limited the confidence level of the meta-analysis. Also, the significant heterogeneity may not be explained due to the limited data. Secondly, the direct comparison of two different guidance methods (ultrasound vs. fluoroscopy) for RF therapy is lacking. In addition, the outcomes were blindly assessed in the meta-analysis from all studies according to evaluation of bias, which could affect the reality of the data. Finally, most of the studies only provided short follow-up times, so we could not analyze the long-term effectiveness of ultrasound-guided RF in the treatment of patients with KOA. Conclusions. Ultrasonography is an effective, safe, nonradiative, and easily applicable guidance method for RF in pain relief and functional improvement in KOA patients.


2016 ◽  
Vol 75 (11) ◽  
pp. 1971-1978 ◽  
Author(s):  
Toby O Smith ◽  
Kun Zou ◽  
Natasya Abdullah ◽  
Xi Chen ◽  
Sarah R Kingsbury ◽  
...  

ObjectivesIt is thought that the clinical trial benefits of oral non-steroidal anti-inflammatory drugs (NSAIDs) may relate to flare designs. The aim of this study was to examine the difference in NSAID (including cyclooxygenase-2 (COX-2) inhibitors) response in osteoarthritis (OA) trials based on different designs.MethodsSystematic review was undertaken of the databases MEDLINE, EMBASE, AMED, CINAHL and the Cochrane library till February 2015. Randomised controlled trials assessing pain, function and/or stiffness following commencement of NSAIDs in flare and non-flare designs were eligible. Trials were assessed using the Cochrane Risk of Bias tool. Meta-analyses were conducted to assess the effect sizes (ES) of NSAIDs for OA with flare versus non-flare trial designs.ResultsFifty-seven studies including 33 263 participants assessing 26 NSAIDs were included. Twenty-two (39%) were flare design, 24 (42%) were non-flare designs, 11 (19%) were possible flare designs. On meta-analysis, there was no statistically significant difference in ES of NSAIDs versus placebo between flare and non-flare trial designs for absolute pain and function or stiffness at immediate-term (1 week), short-term (2–4 week) or longer-term (12–13 week) follow-up periods (p>0.05). However there was a lower ES for mean change in pain in flare and possible flare trials compared with non-flare trials at short-term follow-up (0.36 vs 0.69; p=0.05).ConclusionsContrary to previous understanding, flare trial designs do not result in an increased treatment effect for NSAIDs in people with OA compared with non-flare design. Whether flare design influences other outcomes such as joint effusion remains unknown.


2021 ◽  
Vol 12 ◽  
Author(s):  
Anji Xiong ◽  
Deng Liu ◽  
Huini Chen ◽  
Guancui Yang ◽  
Chen Xiong ◽  
...  

Background: Although infliximab has been recommended for the second-line treatment of seronegative spondyloarthropathy- or juvenile idiopathic arthritis-related uveitis, the issue of its systemic efficacy and safety in a broader diversity of refractory noninfectious uveitis is debatable. To assess the short-term and relatively long-term efficacy of infliximab in refractory noninfectious uveitis, we performed a systematic review and meta-analysis of observational studies.Methods: PubMed, Cochrane Library, EMBASE, and Wanfang Med Online were systematically searched from January 2005 to March 2020. Two investigators independently assessed eligibility. Data were independently collected by two investigators. The pooled proportions were estimated with patients for intraocular inflammation control and improvement of visual acuity. Pooled proportions with 95% credible intervals were computed. Study homogeneity was investigated using I2 statistics to quantify the percentage of variation across studies. To pool the results, the Mantel–Haenszel fixed-effects or random-effects models were used.Results: Of 2316 studies identified, 16 unique studies with 509 unique participants were included in the meta-analysis. The pooled proportions of intraocular inflammation control reached 92% (95% CI: 87%–98%; I2: 1%; p=0.42) and 95% (95% CI: 93%–97%; I2: 0%; p=0.91) in groups of ≤6- and ≥12-month follow-up durations. During the relatively long follow-up period, the pooled proportions of maintaining visual acuity stable or increasing at least one line reached 99% (95% CI: 96%–100%; I2: 0%; p=0.54) in the involved eyes. The corticosteroid-sparing effect of infliximab was also well demonstrated, with the proportion of corticosteroid-sparing success reaching 85.5% (112/131). Besides, about serious adverse events, 2.6% (13/500) of patients experienced hypersensitivity reactions, 2.4% (12/500) of patients experienced serious infections, 1.8% (9/500) of patients experienced autoimmune diseases, and 0.6% (3/500) of patients experienced neoplasia.Conclusions: This meta-analysis provided evidence that infliximab might be a promising choice in controlling inflammatory activity, gaining visual acuity, and sparing corticosteroid use with relatively few side effects when applied in treating refractory noninfectious uveitis.Systematic Review Registration: [website], identifier [registration number]


Thorax ◽  
2019 ◽  
Vol 75 (1) ◽  
pp. 17-27 ◽  
Author(s):  
Biren B Kamdar ◽  
Rajat Suri ◽  
Mary R Suchyta ◽  
Kyle F Digrande ◽  
Kyla D Sherwood ◽  
...  

BackgroundSurvivors of critical illness often experience poor outcomes after hospitalisation, including delayed return to work, which carries substantial economic consequences.ObjectiveTo conduct a systematic review and meta-analysis of return to work after critical illness.MethodsWe searched PubMed, Embase, PsycINFO, CINAHL and Cochrane Library from 1970 to February 2018. Data were extracted, in duplicate, and random-effects meta-regression used to obtain pooled estimates.ResultsFifty-two studies evaluated return to work in 10 015 previously employed survivors of critical illness, over a median (IQR) follow-up of 12 (6.25–38.5) months. By 1–3, 12 and 42–60 months’ follow-up, pooled return to work prevalence (95% CI) was 36% (23% to 49%), 60% (50% to 69%) and 68% (51% to 85%), respectively (τ2=0.55, I2=87%, p=0.03). No significant difference was observed based on diagnosis (acute respiratory distress syndrome (ARDS) vs non-ARDS) or region (Europe vs North America vs Australia/New Zealand), but was observed when comparing mode of employment evaluation (in-person vs telephone vs mail). Following return to work, 20%–36% of survivors experienced job loss, 17%–66% occupation change and 5%–84% worsening employment status (eg, fewer work hours). Potential risk factors for delayed return to work include pre-existing comorbidities and post-hospital impairments (eg, mental health).ConclusionApproximately two-thirds, two-fifths and one-third of previously employed intensive care unit survivors are jobless up to 3, 12 and 60 months following hospital discharge. Survivors returning to work often experience job loss, occupation change or worse employment status. Interventions should be designed and evaluated to reduce the burden of this common and important problem for survivors of critical illness.Trial registration numberPROSPERO CRD42018093135.


2020 ◽  
Vol 12 ◽  
pp. 175883592090754
Author(s):  
Miao Liu ◽  
Guiyue Wang ◽  
Yuhang Li ◽  
Hongliang Wang ◽  
Haitao Liu ◽  
...  

Background: Thrombosis is a common complication in patients with cancer. Whether thromboprophylaxis could benefit patients with cancer is unclear. The aim of this systematic review was to determine the efficacy and safety of thromboprophylaxis in patients with cancer undergoing surgery or chemotherapy. Methods: We searched the Cochrane Library, EMBASE, MEDLINE, EBSCOhost, and Web of Science for studies published before May 2018 to investigate whether thromboprophylaxis measures were more effective than a placebo in patients with cancer. Results: In total, 33 trials with 11,942 patients with cancer were identified. In patients with cancer undergoing surgery, the administration of thromboprophylaxis was associated with decreasing trends in venous thromboembolism (VTE) [relative risk (RR) 0.51, 95% confidence interval (CI) 0.32–0.81] and DVT (RR 0.53, 95% CI 0.33–0.87). In patients with cancer undergoing chemotherapy, the administration of thromboprophylaxis reduced the incidences of VTE, DVT, and pulmonary embolism compared with no thromboprophylaxis (RR 0.54, 95% CI 0.40–0.73; RR 0.47, 95% CI 0.31–0.73; RR 0.51, 95% CI 0.32–0.81, respectively). The pooled results regarding major bleeding showed no significant difference between prophylaxis and no prophylaxis in either the surgical or the chemotherapy groups (RR 2.35, 95% CI 0.74–7.52, p = 0.1482, I2 = 0%; RR 1.30, 95% CI 0.93–1.83, p = 0.1274, I2 = 0%, respectively). Conclusion: Thromboprophylaxis did not increase major bleeding events or the incidence of thrombocytopenia. All-cause mortality was not significantly different between those who received thromboprophylaxis and those who did not. This meta-analysis provides evidence that thromboprophylaxis can reduce the number of VTE and DVT events, with no apparent increase in the incidence of major bleeding in patients with cancer.


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.


2017 ◽  
Vol 2017 ◽  
pp. 1-17 ◽  
Author(s):  
Yunkai Dai ◽  
Yunzhan Zhang ◽  
Danyan Li ◽  
Jintong Ye ◽  
Weijing Chen ◽  
...  

Modified Banxia Xiexin decoction (MBXD) is a classical Chinese herbal formula in treating gastroesophageal reflux disease (GERD) for long time, but the efficacy of it is still controversial. This study is to evaluate the efficacy and safety of MBXD for the treatment of GERD in adults. The search strategy was carried out for publications in seven electronic databases. RevMan software version 5.3 and the Cochrane Collaboration’s risk of bias tool were performed for this review. Twelve RCTs were included for the analysis. The results of overall clinical efficacy and efficacy under gastroscope demonstrated that MBXD was superior to conventional western medicine. Meanwhile, the results of subgroup analysis showed clinical heterogeneity between the two groups. However, there was no statistically significant difference in acid regurgitation between the two groups. But in the improvement of heartburn and sternalgia, the results showed statistically significant differences for the comparison between two groups. In addition, the adverse reactions of the experiment groups were not different from those of the control groups. This systematic review indicates that MBXD may have potential effects on the treatment of patients with GERD. But because the evidence of methodological quality and sample sizes is weak, further standardized researches are required.


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