Efficacy and safety of adalimumab in hidradenitis suppurativa: A systematic review and meta-analysis of randomized controlled trials

Background:Adalimumab is used as a first-line biologic agent in the management of moderate-to-severe hidradenitis suppurativa (HS). The objective of the present study was to evaluate the efficacy and safety of adalimumab in patients with moderate-to-severe HS.Methods:We performed a systematic review and meta-analysis according to Preferred Reporting Items for Systematic reviews and Meta-Analysis guidelines. Pooled estimates, namely standardized mean difference (SMD) and relative risk (RR), were calculated using random-effect model with trial sequential analysis. Small study effects were examined using the Doi plot. Certainty of evidence (CoE) was assessed using “The Grading of Recommendations Assessment, Development, and Evaluation” approach, and number-needed-to-treat (NNT) was calculated.Results:Five randomized controlled trials, involving 1014 patients, were included. We performed subgroup analysis of adalimumab administered subcutaneously both weekly and every other week. Adalimumab administered weekly was associated with better clinical response achievement (RR 1.76, 95% confidence interval [95% CI] 1.35–2.29; trial sequential analysis TSA-adjusted CI 1.01–3.08; CoE: low; NNT = 5) and a significant improvement in modified Sartorius score (SMD = −0.45, 95% CI = −0.76 to −0.13; CoE: very low; NNT = 10) and dermatology life quality index (DLQI) (SMD −0.47, 95% CI −0.61 to −0.32; CoE: low; NNT = 10). Nevertheless, adalimumab administered every other week showed an improvement only in modified Sartorius score. The pooled RRs of adverse events in both groups revealed no statistical significance when compared with the placebo.Conclusions:Adalimumab administered weekly resulted in not only better clinical responses than placebo but also significantly improved disease severity and quality of life of patients with moderate-to-severe HS. Our study provides supporting evidence to the current guidelines and aids decision-making in the application of adalimumab in HS management.     

Acupoint injection treatment for non-dialysis dependent chronic kidney disease: A meta-analysis of randomized controlled trials

Aim:To analyze the effects of acupoint injection in the treatment of non-dialysis dependent chronic kidney disease through a systematic review with meta-analysis.Methods:This systematic review with meta-analysis was conducted following the recommendations of the declaration of PRISMA. Full-text literature of randomized controlled trial of acupoint injection therapy for non-dialysis chronic kidney disease was searched in PubMed, Embase, Cochrane Library, China National Knowledge Internet, the Chinese Scientific Journal Database, the Wanfang Database, China Biology Medicine database. The efficacy and safety of acupoint injection for non-dialysis chronic kidney disease were evaluated.Results:Seventeen studies containing 1414 patients met the criteria. The results shows that acupoint injection combined with basic treatment can significantly improve the levels of Ccr (WMD = 4.81; 95% CI:2.54 to 7.08) and Hb (WMD = 4.56; 95% CI:1.72 to 7.39), reduce the levels of BUN (WMD = −0.90; 95% CI: −1.26 to −0.54)and Scr (WMD = −7.66; 95% CI: −12.39 to −2.93), and improve the effective rate (OR = 3.12; 95% CI: 2.29 to 4.26).Conclusion:Our current analysis showed that combined acupoint injection therapy can reduce the levels of BUN and Scr, and increase Ccr and Hb in non-dialysis CKD patients. However, the existing evidence is still insufficient due to the high risk of included trial bias, and future research needs to improve methodological quality.Registration number: CRD42020168143.     

Topical diclofenac therapy for osteoarthritis: a meta-analysis of randomized controlled trials

The objective of this study was to evaluate the efficacy and safety of topical diclofenac therapy for osteoarthritis (OA). A meta-analysis of randomized controlled trials was conducted. A comprehensive literature search, covering the databases of Medline, the Cochrane Central Register of Controlled Trials, and EMBASE, was conducted in September 2014 to identify the randomized controlled trials which adopted the topical diclofenac therapy for OA. A total of nine papers were included in this meta-analysis. Topical diclofenac appears to be effective in both pain relief (standard mean differences (SMD)?=?0.40; 95 % confidence interval (CI) 0.19 to 0.62; P?=?0.0003) and function improvement (SMD?=?0.23; 95 % CI 0.03 to 0.43; P?=?0.03) when compared with the control group. The sensitivity analysis and subgroup analysis showed that the result of pain intensity was stable and reliable, while the result of physical function improvement was vague. With respect to safety, topical diclofenac demonstrated a higher incidence of adverse events such as dry skin, rash, dermatitis, neck pain, and withdrawal. Topical diclofenac is effective in pain relief as a treatment of OA. It may also have a potential effect in function improvement, which needs further studies to be explored. Although, some adverse effects were observed in the application of topical diclofenac, none of them was serious.     

Blood pressure-lowering effects of biofeedback treatment in hypertension: a meta-analysis of randomized controlled trials.

To examine the blood pressure-lowering effects of biofeedback treatment in patients with essential hypertension, a meta-analysis was conducted on studies published between 1966 and 2001. A total of 22 randomized controlled studies with 905 essential hypertensive patients were selected for review. Compared with clinical visits or self-monitoring of blood pressure (non-intervention controls), biofeedback intervention resulted in systolic and diastolic blood pressure reductions that were greater by 7.3 mmHg (for systole; 95% confidence interval: 2.6 to 12.0) and 5.8 mmHg (for diastole; 95% confidence interval: 2.9 to 8.6). Compared with sham or non-specific behavioral intervention controls, the net reductions in systolic and diastolic blood pressures by biofeedback intervention were 3.9 (95% confidence interval: -0.3 to 8.2) and 3.5 (-0.1 to 7.0) mmHg, respectively. The results of multiple regression analysis also indicated that biofeedback intervention decreased systolic and diastolic blood pressures more than non-intervention controls (p < 0.001), but not more than sham or non-specific behavioral intervention controls (p > 0.05), when controlling for the effects of initial blood pressures. When biofeedback intervention types were classified into two types, simple biofeedback and relaxation-assisted biofeedback, only the relaxation-assisted biofeedback significantly decreased both systolic and diastolic blood pressures (p < 0.05) compared with those in sham or non-specific behavioral intervention controls. The results suggested that biofeedback was more effective in reducing blood pressure in patients with essential hypertension than no intervention. However, the treatment was only found to be superior to sham or non-specific behavioral intervention when combined with other relaxation techniques. Further studies will be needed to determine whether biofeedback itself has an antihypertensive effect beyond the general relaxation response.     

降钙素原指导抗生素治疗策略在社区获得性下呼吸道感染中应用的荟萃分析

目的 评价降钙素原指导抗生素治疗策略在下呼吸道感染治疗中的有效性及安全性.方法 以procalcitonin、lower respiratory tract infections、community acquired pneumonia、exacerbations of COPD、exacerbations of chronic obstructive pulmonary diseases、acute bronchitis及asthma为检索词,检索PubMed、Embase数据库(检索时间为1990年1月至2010年12月)及Cochrane图书馆临床对照试验数据库(2010年第8期).以降钙素原、下呼吸道感染、社区获得性肺炎、慢性阻塞性肺病急性加重期、慢性阻塞性肺病急性加重、急性支气管炎、支气管哮喘为检索词,检索万方数据库、中国期刊全文数据库及中国生物医学文献数据库,检索时间为1990年1月至2010年12月,同时检索纳入文献的参考文献,对纳入文献逐个进行质量评价和资料提取.进行统计学分析时,计数资料采用优势比,计量资料采用加权均数差.采用RevMan 4.2.2软件对数据合并进行统计分析.结果 纳入5篇文献,共2322例患者.降钙素原指导治疗组较常规治疗组抗生素使用天数下降[加权均数差( WMD)为2.58 d,95％ CI为-3.13～ -2.04,Z=9.36,P＜0.001],抗生素处方率下降(OR =0.23,95％ CI为0.12～0.44,Z=4.52,P＜0.001),治疗过程中抗生素的费用下降(WMD为- 91.72美元,95％ CI为- 109.44～ - 74.00,Z=10.15,P＜0.001),月内随访感染再发率下降(OR=0.70,95％ CI为0.5～0.97,Z=2.13,P＜0.05),差异均具有统计学意义;而治疗过程中ICU入住率下降(OR =0.8,95％ CI为0.59～ 1.09,Z=1.41,P＞0.05),院内病死率上升(OR=1.01,95％ CI为0.69～1.48,Z=0.07,P＞0.05),住院总天数减少(WMD为-0.27 d,95％ CI为-0.9～0.35,Z=0.86,P＞0.05),治疗成功率上升(OR =1.04,95％ CI为0.65 ～ 1.65,Z=0.16,P＞0.05).结论 对于急诊以及住院治疗的下呼吸道感染患者,使用降钙素原指导抗生素治疗策略可明显减少抗生素的使用,且对疗效和住院时间的影响不明显.     

PDE5 inhibitor sildenafil in the treatment of heart failure: A meta-analysis of randomized controlled trials

Background

Clinical trials have evaluated the use of phosphodiesterase (PDE) 5 inhibitors sildenafil as a potential adjunct in the treatment of heart failure (HF) with mixed results. Thus, we undertook a meta-analysis to evaluate the clinical viability of sildenafil in HF.

Methods

Relevant studies were searched and identified in the MEDLINE and EMBASE databases. Randomized clinical trials (RCT) comparing sildenafil to placebo, in heart failure patients, reporting at least one outcome of interest were included. Data were extracted regarding the characteristics and clinical outcomes.

Results

We identified 9 RCTs enrolling 612 HF patients. There were no significant differences in adverse events between sildenafil group and placebo group (RR = 1.10, 95% CI = 0.74 to 1.65, P = 0.41), whereas sildenafil therapy was associated with a marked improvement in hemodynamic parameter peak VO₂ (MD = 3.25, 95% CI = 2.07 to 4.42, P < 0.00001) in HF with reduced ejection fraction (HFrEF) patients but not in HF with preserved ejection fraction (HFpEF) patients. Also, sildenafil therapy improved VO₂ at anaerobic threshold (AT) (MD = 3.47, 95% CI = 1.68 to 5.27, P = 0.0002), VE/VCO₂ slope (MD = − 7.06, 95% CI = − 8.93 to − 5.19, P < 0.00001) and LV ejection fraction (MD = 5.43, 95% CI = 3.66 to 7.20, P < 0.00001) compared to placebo in HF patients, which had no impact on blood pressure and heart rate. For quality of life (emotional function, fatigue and breathlessness), there was no significant difference between the two groups.

Conclusions

Sildenafil improved hemodynamic parameters particularly in HFrEF patients when compared to placebo, with no increase in adverse events. Sildenafil treatment was well tolerated and had no impact on quality of life.     

Insulin therapy for critically ill hospitalized patients: a meta-analysis of randomized controlled trials

BACKGROUND: Hyperglycemia is common in critically ill hospitalized patients, and it is associated with adverse outcomes, including increased mortality. The objective of this meta-analysis was to determine the effect of insulin therapy initiated during hospitalization on mortality in adult patients with a critical illness. METHODS: An electronic search in the English-language articles of MEDLINE and the Cochrane Controlled Clinical Trials Register and a hand search of key journals and relevant review articles were performed. Randomized controlled trials that reported mortality data on critically ill hospitalized adult patients who were treated with insulin were selected. Data on patient demographics, hospital setting, intervention (formulation and dosage of insulin, delivery method, and duration of therapy), mortality outcomes, adverse events, and methodological quality were extracted. RESULTS: Thirty-five trials met the inclusion criteria. Combining data from all trials using a random-effects model showed that insulin therapy decreases short-term mortality by 15% (relative risk [RR], 0.85; 95% confidence interval [CI], 0.75-0.97). In subgroup analyses, insulin therapy decreased mortality in the surgical intensive care unit (RR, 0.58; 95% CI, 0.22-0.62), when the aim of therapy was glucose control (RR, 0.71; 95% CI, 0.54-0.93), and in patients with diabetes mellitus (RR, 0.73; 95% CI, 0.58-0.90). A near-significant trend toward decreasing mortality was seen in patients with acute myocardial infarction who did not receive reperfusion therapy (RR, 0.84; 95% CI, 0.71-1.00). No randomized trials of insulin in the medical intensive care unit were identified. CONCLUSION: Insulin therapy initiated in the hospital in critically ill patients has a beneficial effect on short-term mortality in different clinical settings.     

Efficacy and safety of oral and early-switch therapy for community-acquired pneumonia: a randomized controlled trial

PURPOSE: We sought to determine the safety, efficacy, and cost of oral therapy for patients with community-acquired pneumonia. In patients with nonsevere pneumonia, conventional (parenteral) treatment was compared with the oral route; in patients with severe pneumonia, conventional treatment was compared with early switch from parenteral to oral therapy. SUBJECTS AND METHODS: We randomly assigned 85 hospitalized patients with nonsevere pneumonia to one of two groups: 41 received oral antimicrobials from admission, and 44 received parenteral antimicrobials until they had been afebrile for 72 hours before switching to oral treatment. We randomly assigned 103 patients with severe pneumonia who had initially been treated with parenteral antimicrobials to one of two groups: 48 were switched to oral therapy after 48 hours of treatment (early switch), and 55 received a full 10-day course of parenteral antibiotics. RESULTS: Among patients with nonsevere pneumonia, there were no deaths in the oral treatment group, and one death (2%) in the parenteral treatment group (95% confidence interval [CI] for between-group [oral minus parenteral] difference: -7% to 2%, P = 0.3). The time to resolution of morbidity was < or =5 days in 34 (83%) patients in the oral treatment group and 39 (88%) patients in the parenteral treatment group (P = 0.5); there were treatment failures in 4 (10%) patients in the oral treatment group and 14 (32%) patients in the parenteral treatment group (P = 0.02). Among patients with severe pneumonia, there was one (2%) death in the early-switch group and no deaths in the full course of parenteral antibiotics groups (95% CI for between-group [early switch vs. full course] difference: -2% to 6%, P = 0.5). The time to resolution of morbidity was < or =5 days in 38 (79%) patients in the early-switch group and 41 (75%) in the full-course group (P = 0.3). There were 12 (25%) treatment failures in the early-switch group and 13 (24%) in the full-course group (P = 0.9). There were fewer adverse events in the oral and early-switch groups, primarily due to lower rates of infusion-related phlebitis. Significant cost savings, mainly due to a shorter hospitalization, occurred among patients with severe pneumonia in the early-switch group. CONCLUSION: Inpatients with nonsevere community-acquired pneumonia can be effectively and safely treated with oral antimicrobials from the time of admission, whereas those with severe pneumonia can be treated with early-switch therapy.     

Efficacy of central nervous system stimulant treatment for cocaine dependence: a systematic review and meta-analysis of randomized controlled clinical trials

AIMS: To evaluate the efficacy of central nervous system (CNS) stimulants compared with placebo for the treatment of cocaine dependence. METHODS: A systematic review and meta-analysis was carried out. Bibliographic databases were searched, reference lists of retrieved studies were hand-searched and the first authors of each study were contacted. All randomized controlled clinical trials (RCCT) comparing the efficacy of any CNS stimulant with placebo in cocaine-dependent patients were included. Quantitative data synthesis was performed for each single CNS stimulant and for all CNS stimulants. RESULTS: Nine RCCT met the inclusion criteria. These RCCT included 640 patients and compared five CNS stimulants: mazindol, dextroamphetamine, methylphenidate, modafinil and bupropion with placebo. No CNS stimulant improved study retention [RR = 0.94 (0.81-1.09)] or cocaine use [RR = 0.90 (0.79-1.02)]. An exploratory analysis using indirect estimations of cocaine use showed that the proportion of cocaine-positive urine screens was lower with dexamphetamine than with placebo [RR = 0.73 (0.60-0.90)] and that all CNS stimulants pooled together also suggested a significant decrease of cocaine use [RR = 0.87 (0.77-0.99)]. Data on craving could not be meta-analysed due to heterogeneity, but no RCCT found differences in cocaine craving between active drug and placebo except one, whose outcome favoured dexamphetamine. No serious adverse event (AE) was reported. Average of AE-induced dropouts was low and was greater for CNS stimulants than placebo: 4.4% versus 1.3% (P = 0.03). CONCLUSION: The main outcomes of this study do not support the use of CNS stimulants for cocaine dependence. Nevertheless, secondary analyses provide some hopeful results that encourage further research with these drugs, mainly with dexamphetamine and modafinil.     

Efficacy and safety of corticosteroid in the treatment of hand osteoarthritis: a systematic review and meta-analysis of randomized controlled trials

Clinical Rheumatology - To assess the efficacy and safety of corticosteroid therapy including oral corticosteroid and intra-articular corticosteroid in patients with hand osteoarthritis (OA), to...     

Platelet reactivity-adjusted antiplatelet therapy in patients with percutaneous coronary intervention: a meta-analysis of randomized controlled trials

Numerous number of evidences show that high on-treatment platelet reactivity is a well-known risk factor for adverse events in patients after percutaneous coronary intervention (PCI). Controversial situations still exist regarding the effectiveness of tailoring antiplatelet therapy according to platelet function monitoring. The PubMed, Embase, and Cochrane Central databases were searched for randomized trials comparing platelet reactivity-adjusted antiplatelet therapy with conventional antiplatelet therapy in patients undergoing PCI. The primary end point was all-cause mortality, major adverse cardiac events (MACE) including cardiovascular (CV) death, nonfatal myocardial infarction (MI), definite/probable stent thrombosis (ST), revascularization, and stroke or transient ischemic attack (TIA). The safety end point was defined as major bleeding events. We derived pooled risk ratios (RRs) with fixed-effect models. Six studies enrolling 6347 patients were included. Compared with conventional treatment, tailoring antiplatelet failed to reduce all-cause mortality (RR: 0.89, 95% confidence interval [CI]: 0.63–1.24, P = 0.48), MACE (RR: 1.02, 95% CI: 0.92–1.14, P = 0.69), MI (RR: 1.07, 95% CI: 0.95–1.21, P = 0.24), CV death (RR: 0.69, 95% CI: 0.40–1.19, P = 0.09), ST (RR: 0.83, 95% CI: 0.50–1.38, P = 0.23), stroke or TIA (RR: 1.08, 95% CI: 0.55–2.12, P = 0.83), revascularization (RR: 0.96, 95% CI: 0.69–1.33, P = 0.79), and major bleeding events (RR: 0.79, 95% CI: 0.53–1.17, P = 0.24).

Compared with traditional antiplatelet treatment, tailoring antiplatelet therapy according to platelet reactivity testing failed to reduce all-cause mortality, MACE, and major bleeding events in patients undergoing PCI.     

Restrictive vs liberal transfusion for upper gastrointestinal bleeding:A meta-analysis of randomized controlled trials

AIM:To compare the outcome of upper gastrointestinal bleeding(UGIB) between patients receiving restrictive and liberal transfusion.METHODS:PubMed,EMBASE,and Cochrane Library databases were employed to identify all relevant randomized controlled trials regarding the outcome of UGIB after restrictive or liberal transfusion. Primary outcomes were death and rebleeding. Secondary outcomes were length of hospitalization,amount of blood transfused,and hematocrit and hemoglobin at discharge or after expansion.RESULTS:Overall,4 papers were included in this meta-analysis. The incidence of death was significantly lower in patients receiving restrictive transfusion than those receiving liberal transfusion(OR:0.52,95%CI:0.31-0.87,P = 0.01). The incidence of rebleeding was lower in patients receiving restrictive transfusion than those receiving liberal transfusion,but this difference did not reach any statistical significance(OR:0.26,95%CI:0.03-2.10,P = 0.21). Compared with those receiving liberal transfusion,patients receiving restrictive transfusion had a significantly shorter length of hospitalization(standard mean difference:-0.17,95%CI:-0.30--0.04,P = 0.009) and a significantly smaller amount of blood transfused(standard mean difference:-0.74,95%CI:-1.15--0.32,P = 0.0005) with a lower hematocrit and hemoglobin level at discharge or after expansion.CONCLUSION:Restrictive transfusion should be employed in patients with UGIB.     

降钙素原指导社区获得性肺炎用药的Meta分析

目的 探讨降钙素原(PCT)指导社区获得性肺炎的用药时机和标准.方法 计算机检索Medline、Embase、万方数据库和中国知网中关于降钙素原和社区获得性肺炎的随机对照试验,同时筛选纳入文献的参考文献.对文献质量进行严格评价和资料提取,对符合质量标准的随机对照试验进行Meta分析.结果 5项研究符合纳入标准,包括1613名社区获得性肺炎患者.抗生素暴露率在PCT组(根据血清PCT浓度而决定)较对照组(按惯例接受抗生素治疗)低[RR=0.90,95％ CI(0.87,0.92),P＜0.01].PCT组可以缩短抗生素使用时间[SMD=-1.41d,95％ CI(-1.45,-0.90),P＜0.01].结论 PCT对指导社区获得性肺炎患者的抗生素治疗有重要的意义,可以缩短治疗时间,减少抗生素的滥用.