scholarly journals Efficacy of Intralesional Purified Protein Derivative for Cutaneous Warts: A Meta-analysis

2019 ◽  
Vol 53 (4) ◽  
Author(s):  
Sarah Faye V. Obbus ◽  
Jay-V James G. Barit ◽  
Claudine Yap-Silva
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
Recurrence Rate ◽  
Clearance Rate ◽  
Therapeutic Option ◽  
Good Evidence ◽  
Controlled Clinical Trials ◽  
Purified Protein Derivative ◽  
Significant Difference ◽  
Cutaneous Warts

Introduction. Intralesional purified protein derivative (PPD) is an affordable therapeutic option that has been studied for cutaneous warts. However, the lack of good evidence precludes its widespread use. Objective. To determine the efficacy and safety of intralesional PPD in the treatment of cutaneous warts. Methods. A systematic search for controlled clinical trials comparing intralesional PPD and placebo or any conventional therapy was conducted using electronic databases. The included studies were assessed for risk of bias, and data such as clearance rate of target and distant lesions, recurrence rate, and adverse events were extracted. Analysis was done through RevMan v5.3 Results. Four controlled clinical trials composed of 205 patients were included. All of the studies compared intralesional PPD to placebo as comparator. Intralesional PPD had a significantly higher clearance rate of target wart (RR=0.43[0.22,0.84], P=0.01) and a significantly higher clearance rate of distant lesions (RR=0.59[0.41,0.85], P=0.005) as compared to placebo. However, there was no significant difference in the recurrence rate (RR=0 [-0.07,0.07], P=0.98). Adverse events reported were only considered minor. Conclusion. Intralesional PPD is an effective and safe treatment option for cutaneous warts. However, more well-structured RCTs with longer follow-up period and those comparing it with conventional treatment are needed to further support its use.

Types, frequencies, and burden of nonspecific adverse events of drugs: analysis of randomized placebo-controlled clinical trials

2017 ◽  
Vol 26 (7) ◽  
pp. 731-741 ◽  
Author(s):  
Alfred Mahr ◽  
Clara Golmard ◽  
Emilie Pham ◽  
Laura Iordache ◽  
Laure Deville ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
Controlled Clinical Trials ◽  
Drugs Analysis

scholarly journals The Effectiveness of Oral Mini-Pulse Methylprednisolonein - the Treatment of Alopecia Areata in Vietnam

2019 ◽  
Vol 7 (2) ◽  
pp. 291-292
Author(s):  
Phuong Trinh Thi ◽  
Van Tran Cam ◽  
Anh Tran Lan ◽  
Phuong Tran Thu Ha ◽  
Thuong Nguyen Van ◽  
...  
Keyword(s):  
Side Effects ◽  
Adverse Events ◽  
Recurrence Rate ◽  
Alopecia Areata ◽  
Systemic Corticosteroid ◽  
Therapeutic Option ◽  
Pulse Therapy ◽  
Pulse Methylprednisolone ◽  
Pulse Methylprednisolone Therapy

BACKGROUND: Systemic corticosteroid is used to treat alopecia areata, but it is associated with side effects. Mini-pulse therapy is thought to be effective but able to reduce side effects. AIM: The study aimed to evaluate the effectiveness of oral mini-pulse methylprednisolone in the treatment of alopecia areata. METHODS: Patients received methylprednisolone 16 mg orally for 2 consecutive days every week. RESULTS: After 3 months, among patients, 40% recovered well, and 55.6% recovered fairly. After 6 months, 82.2% recovered well, 17.8% recovered fairly. No adverse events were detected, and the recurrence rate was low (2.2%). CONCLUSION: Oral mini-pulse methylprednisolone therapy is an effective and safe therapeutic option for alopecia areata without side effects, and the time of the treatment is short.

The Effect of Anti-Shock Garments on Prehospital Survival: The Need for Controlled Clinical Trials

1987 ◽  
Vol 3 (1) ◽  
pp. 40-45 ◽  
Author(s):  
Paul E. Pepe ◽  
William H. Bickell ◽  
Kenneth L. Mattox
Keyword(s):  
Clinical Trials ◽  
Survival Data ◽  
Trauma Center ◽  
Present Report ◽  
Early Report ◽  
Medical Personnel ◽  
The United States ◽  
Controlled Clinical Trials ◽  
Initial Field ◽  
Significant Difference

AbstractThere exists strong sentiment, among emergency medical personnel and physicians alike, that the pneumatic anti-shock garment (PASG) “saves lives.” As a result, controlled studies have been criticized as the “withholding of important therapy.” The purpose of this presentation is to confirm the need for controlled clinical trials of the PASG. Despite an early report that the PASG offered no advantage in terms of the presenting emergency center Trauma Score (TS), similar disparagements have continued, particularly because survival data were not discussed. The present report is a pilot analysis of the effect of the PASG on the prehospital survival of patients arriving at an urban trauma center in the United States. In the study, sixty-eight patients were assigned randomly to control and PASG groups in a prospective investigation involving injured patients with systemic hypotension. The 32 control patients, whose mean initial systolic blood pressure (BP) was 59 ± 32 mm Hg, and the 36 PASG-treated patients, whose mean initial BP was 55 ± 31 mm Hg, were found to be well matched for age, sex, type and location of injuries, initial field TS; response, field management, and transport times; and the total amount of intravenous crystalloid infused. The results demonstrated no significant difference between the control and PASG-treated groups in terms of those pronounced dead on arrival at the trauma center (9/32 vs. 10/36). Further studies are therefore justified to determine how the PASG affects the long-term morbidity and mortality of injury victims, particularly those within certain sub-groups such as penetrating abdominal versus those with penetrating thoracic injuries. This report reaffirms the need for early responsible, scientific scrutiny of prehospital interventions.

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

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.

scholarly journals Mycophenolate Mofetil Therapy in Lupus Nephritis

1999 ◽  
Vol 10 (4) ◽  
pp. 833-839
Author(s):  
MARY ANNE DOOLEY ◽  
FERNANDO G. COSIO ◽  
PATRICK H. NACHMAN ◽  
MICHAEL E. FALKENHAIN ◽  
SUSAN L. HOGAN ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Mycophenolate Mofetil ◽  
Lupus Nephritis ◽  
Adverse Events ◽  
Serum Creatinine ◽  
Lupus Erythematosus ◽  
Transplant Rejection ◽  
Initial Therapy ◽  
Controlled Clinical Trials ◽  
The Mean

Abstract. Controlled clinical trials in renal transplantation have demonstrated that mycophenolate mofetil is well tolerated and has lower renal transplant rejection rates than azathioprine regimens. This study reports on the clinical experiences at two institutions with mycophenolate mofetil (MMF) for severe lupus nephritis. Twelve patients with relapsing or resistant nephritis previously treated with cyclophosphamide therapy and one patient who refused cyclophosphamide as initial therapy for diffuse proliferative nephritis but accepted MMF were included. During combined MMF/prednisone therapy, serum creatinine values remained normal or declined from elevated values: mean change in serum creatinine was -0.26 ± 0.46 μM/L, P = 0.039. Proteinuria significantly decreased: mean change in urine protein-to-creatinine ratios was -2.53 ± 3.76, P = 0.039. Decreased serum complement component C3 and elevated anti-double-stranded DNA antibody levels at baseline improved in some, but not all, patients. The mean initial dose of MMF was 0.92 g/d (range, 0.5 to 2 g/d). The mean duration of therapy was 12.9 mo (range, 3 to 24 mo). Adverse events included herpes simplex stomatitis associated with severe leukopenia (n = 1), asymptomatic leukopenia (n = 2), nausea/diarrhea (n = 2), thinning of scalp hair (n = 1), pancreatitis (n = 1), and pneumonia without leukopenia (n = 1). Recurrence of the pancreatitis led to discontinuation of MMF in this patient; all other adverse events resolved with dose reduction. It is concluded that MMF is well tolerated and has possible efficacy in controlling major renal manifestations of systemic lupus erythematosus. Controlled clinical trials are needed to define the role of MMF in the management of lupus nephritis.

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

2020 ◽  
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)

scholarly journals Probiotics in the Management of Gingivitis and Periodontitis. A Review

2021 ◽  
Vol 2 ◽  
Author(s):  
Ulrich Schlagenhauf ◽  
Yvonne Jockel-Schneider
Keyword(s):  
Clinical Trials ◽  
Systematic Reviews ◽  
Therapeutic Option ◽  
Detailed Comparison ◽  
Controlled Clinical Trials ◽  
Therapeutic Measure ◽  
Health Promoting ◽  
Plaque Control ◽  
Comparison Of The Results ◽  
Meta Analyses

In the management of intestinal health problems, the targeted use of probiotic microorganisms is a common therapeutic measure with a long-standing tradition. In clinical dentistry however, probiotics-based therapy is still a rather new and developing field, whose usefulness for the control of gingivitis and periodontitis has been questioned by recent meta-analyses and systematic reviews. The purpose of the subsequent descriptive review is to provide an introduction to the concept of probiotic microorganisms and their multifaceted health-promoting interactions with the human host and microbial competitors, followed by a detailed comparison of the results of available controlled clinical trials assessing the use of probiotics in the control of gingival and periodontal inflammations. It aims at contributing to a deeper understanding of the unique capabilities of probiotics to resolve chronic plaque-induced inflammation even in the absence of mechanical plaque control and will discuss how possible misconceptions about the rationale for using probiotics may have led to the present controversies about their usefulness as a therapeutic option.

Management of Thrombosis in the Antiphospholipid Syndrome

Lupus ◽  
1996 ◽  
Vol 5 (5) ◽  
pp. 463-466 ◽  
Author(s):  
MA Khamashta
Keyword(s):  
Clinical Trials ◽  
Antiphospholipid Syndrome ◽  
Immunosuppressive Drugs ◽  
Good Evidence ◽  
Optimal Management ◽  
Controlled Clinical Trials ◽  
Definitive Answer ◽  
Antibody Levels ◽  
Term Benefit

Optimal management of patients with the antiphospholipid syndrome (APS) remains a problem. There is now good evidence that those with thrombosis will be subject to recurrences and require long-term, possibly lifelong, oral anticoagulation. Steroids and immunosuppressive drugs aiming at a reduction of the antibody levels have not provided long-term benefit. Only prospective and controlled clinical trials can give a definitive answer to the optimal thrombotic prophylaxis in patients with the APS.

scholarly journals Roux-en-Y and Billroth II Reconstruction after Pancreaticoduodenectomy: A Meta-Analysis of Complications

2020 ◽  
Vol 2020 ◽  
pp. 1-10
Author(s):  
Fulin Ma ◽  
Yong Fan ◽  
Lina Zhang ◽  
Zhiqiang Zhao ◽  
Yuanhua Nie ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Meta Analysis ◽  
Postoperative Bleeding ◽  
Operation Time ◽  
Cochrane Library ◽  
Controlled Clinical Trials ◽  
Billroth Ii ◽  
Billroth Ii Reconstruction ◽  
Significant Difference ◽  
The Cochrane Library

Objective. To evaluate Roux-en-Y and Billroth II reconstruction following pancreaticoduodenectomy (PD). Methods. PubMed, Embase, the Cochrane Library, and the Web of Science were searched to identify randomized controlled trials (RCTs) and controlled clinical trials that compared Roux-en-Y and Billroth II reconstruction following PD up to December 2019. RevMan 5.3 software was used for the statistical analysis. Results. Four RCTs and five controlled clinical trials were included, with a total of 1,072 patients (500 and 572 patients in the Roux-en-Y and Billroth II groups, respectively). No significant differences in delayed gastric emptying (DGE), A-grade DGE, B-grade DGE, or C-grade DGE were observed between the Roux-en-Y and Billroth II reconstruction groups after PD ( odds   ratio   OR = 1.01 , 95% confidence interval [CI]: 0.50–2.03, P = 0.98 ; OR = 0.49 , 95% CI: 0.17–1.45, P = 0.20 ; OR = 0.63 , 95% CI: 0.29–1.38, P = 0.25 ; and OR = 2.13 , 95% CI: 0.38–11.99, P = 0.39 ). No significant difference in the incidence of postoperative pancreatic fistula, abscess, bile leaks, infection, postoperative bleeding, or the length of the postoperative hospital stay was observed between the Roux-en-Y and Billroth II groups ( P > 0.05 ), but the operation time was significantly different ( mean   difference [MD] = 31.65 , 95% CI: 7.14–56.17, P = 0.01 ). Conclusions. Billroth II reconstruction after PD did not significantly reduce the incidence of DGE or other complications but shortened the operation time compared to Roux-en-Y reconstruction. However, the results must be verified by further high-quality, large RCTs or controlled clinical trials.

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