scholarly journals The Clinical and Steroid-Free Remission of Fecal Microbiota Transplantation to Patients with Ulcerative Colitis: A Meta-Analysis

2019 ◽  
Vol 2019 ◽  
pp. 1-10 ◽  
Author(s):  
Wai Ching Lam ◽  
Chen Zhao ◽  
Wen Juan Ma ◽  
Liang Yao
Keyword(s):  
Ulcerative Colitis ◽  
Adverse Events ◽  
Cohort Studies ◽  
Clinical Response ◽  
Clinical Remission ◽  
Fecal Microbiota Transplantation ◽  
Fecal Microbiota ◽  
Controlled Trials ◽  
Serious Adverse Events ◽  
Randomized Controlled

Background and Purpose. Since the first case of fecal microbiota transplantation for the treatment of ulcerative colitis was described in the year 1989, there have been an increment of case reports, case series, cohort studies, and randomized controlled trials (RCTs). In this study, we were going to investigate general clinical remission, clinical response, and steroid-free remission of fecal microbiota transplantation. Methods. We searched Ovid Medline, Ovid EMBASE, and Cochrane Library, focusing prospective studies including randomized controlled trials and cohort studies. The outcomes were clinical remission, clinical response, steroid-free remission, and serious adverse events. We used RevMan 5.3 software for meta-analyses. Key Results. A total of 4 RCTs and 2 cohort studies (340 cases from 5 countries) were included. We found that FMT might be more effective than placebo on clinical remission (OR, 3.85 [2.21, 6.7]; P<0.001; I2=0%) and clinical response (OR, 2.75 [1.33, 5.67]; P=0.006; I2=49%), but no statistical difference on steroid-free remission (OR, 2.08 [0.41, 10.5]; P=0.37; I2=69%) and serious adverse events (OR, 2.0 [0.17, 22.97]; P=0.44; I2=0%). Conclusions and Inferences. Fecal microbiota transplantations were associated with significant clinical remission and response in ulcerative colitis patients while there was no significant difference found between FMT and placebo in steroid-free remission. Moreover, a common consensus on the route, volume, timing, preferred donor characteristics, and frequency of fecal administration is necessary to achieve remission.

scholarly journals Fecal Microbiota Transplantation as Therapy for Treatment of Active Ulcerative Colitis: A Systematic Review and Meta-Analysis

2021 ◽  
Vol 2021 ◽  
pp. 1-13
Author(s):  
Xiaolei Liu ◽  
Yan Li ◽  
Kaichun Wu ◽  
Yongquan Shi ◽  
Min Chen
Keyword(s):  
Systematic Review ◽  
Ulcerative Colitis ◽  
Adverse Events ◽  
Clinical Remission ◽  
Fecal Microbiota Transplantation ◽  
Meta Analysis ◽  
Fecal Microbiota ◽  
Serious Adverse Events ◽  
Significant Difference ◽  
Endoscopic Remission

Aim. Increasing evidence supports the role of the gut microbiota in the etiology of ulcerative colitis (UC). Fecal microbiota transplantation (FMT) is a highly effective treatment against recurrent Clostridium difficile infection; however, its efficacy in UC is still controversial. A systematic review and meta-analysis was conducted to evaluate the efficacy and safety of FMT for treatment of active UC. Methods. We searched Cochrane, Medline, Web of Science, and Embase from inception to February 2020. Randomized controlled trials (RCTs) recruiting adults with active UC, which compared FMT with controls, were eligible. The primary outcome was combined clinical remission with endoscopic remission/response. Secondary outcomes included clinical remission, endoscopic remission, and serious adverse events. Relative risk (RR) with 95% confidence interval (CI) is reported. Results. Five RCTs with 292 participants were eligible for inclusion. When data were pooled for all patients, FMT was associated with a higher combined clinical remission with endoscopic remission/response; the RR of combined outcome not achieving after FMT vs. control was 0.79 (95% CI 0.70-0.88). FMT delivered via lower gastrointestinal route was superior to upper gastrointestinal route with regard to combined clinical remission with endoscopic remission/response ( RR = 0.79 , 95% CI 0.70-0.89). FMT with pooled donor stool ( RR = 0.69 , 95% CI 0.56-0.85) and higher frequency of administration ( RR = 0.76 , 95% CI 0.62-0.93) may be more effective with regard to clinical remission. There was no statistically significant difference in serious adverse events with FMT compared with controls ( RR = 0.98 , 95% CI 0.93-1.03). Conclusion. FMT shows a promising perspective with comparable safety and favorable clinical efficacy for the treatment of active UC in the short term. However, further larger, more rigorously conducted RCTs of FMT in UC are still needed in order to resolve the controversial questions.

scholarly journals Intranasal Ketamine for Depression in Adults: A Systematic Review and Meta-Analysis of Randomized, Double-Blind, Placebo-Controlled Trials

2021 ◽  
Vol 12 ◽  
Author(s):  
Dongjiao An ◽  
Changwei Wei ◽  
Jing Wang ◽  
Anshi Wu
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Clinical Response ◽  
Clinical Remission ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Major Depressive ◽  
Double Blind ◽  
Madrs Score ◽  
Randomized Controlled

BackgroundThere is growing interest in glutamatergic agents as a treatment for depression, especially intranasal ketamine, which has become a hot topic in recent years. We aim to assess the efficacy and safety of intranasal ketamine in the treatment of major depressive disorder (MDD), especially treatment-resistant depression (TRD).MethodsWe searched Medline, EMBASE, and the Cochrane Library until April 1, 2020 to identify double-blind, randomized controlled trials with allocation concealment evaluating intranasal ketamine in major depressive episodes. Clinical remission, response, and depressive symptoms were extracted by two independent raters. The outcome measures were Montgomery–Asberg Depression Rating Scale (MADRS) score improved from baseline, clinical response and remission, dissociative symptoms, and common adverse events. The analyses employed a random-effects model.ResultsData were synthesized from five randomized controlled trials (RCTs) employing an intranasal esketamine and one RCT employing intranasal ketamine, representing 840 subjects in parallel arms, and 18 subjects in cross-over designs (n = 858 with MDD, n = 792 with TRD). The weighted mean difference of MADRS score was observed to decrease by 6.16 (95% CI 4.44–7.88) in 2–4 h, 9.96 (95% CI 8.97–10.95) in 24 h, and 4.09 (95% CI 2.18–6.00) in 28 day. The pooled relative risk (RR) was 3.55 (95% CI 1.5–8.38, z = 2.89, and p &lt; 0.001) for clinical remission and 3.22 (95% CI 1.85–5.61, z = 4.14, and p &lt; 0.001) for clinical response at 24 h, while the pooled RR was 1.7 (95% CI 1.28–2.24, z = 3.72, and p &lt; 0.001) for clinical remission and 1.48 (95% CI 1.17–1.86, z = 3.28, and p &lt; 0.001) for clinical response at 28 day. Intranasal ketamine was associated with the occurrence of transient dissociative symptoms and common adverse events, but no persistent psychoses or affective switches.ConclusionOur meta-analysis suggests that repeated intranasal ketamine conducted a fast-onset antidepression effect in unipolar depression, while the mild and transient adverse effects were acceptable.Systematic Review RegistrationPROSPERO, CRD42020196856.

scholarly journals Effect of SGLT-2 Inhibitors on Cardiovascular Outcomes Among Patients With Heart Failure and Type 2 Diabetes Mellitus: A Systemic Review and Meta-Analysis of Randomized Controlled Trials

2020 ◽  
Author(s):  
Yuan Lu ◽  
Yu Yang ◽  
Yong Fan ◽  
Chenzong Li ◽  
Min Zhang ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Heart Failure ◽  
Adverse Events ◽  
Standard Care ◽  
Sensitivity Analyses ◽  
Controlled Trials ◽  
Serious Adverse Events ◽  
Randomized Controlled ◽  
Patients With Heart Failure

Abstract Background Sodium-glucose cotransporter-2 inhibitors (SGLT-2i) are significantly effective in reducing cardiovascular events in patients with type 2 diabetes mellitus (T2DM). However, the magnitude of the effect of SGLT-2i on cardiovascular outcomes in established heart failure (HF) patients with T2DM remains undefined. Methods We systematically searched the PubMed, Embase, Cochrane Central and Web of Science databases for articles published prior to 09 April 2020 to identify randomized controlled trials that compared SGLT-2i with placebo in patients with heart failure concomitant with T2DM. Efficacy outcomes included the composite of cardiovascular death (CVD) or hospitalization for heart failure (HHF), individual CVD, individual HHF, and all-cause mortality (ACM). Hazard ratios (HRs) with 95% confidence intervals (95% CIs) were pooled across trials by using the generic inverse variance method. Sensitivity analyses were conducted by excluding specific studies or using risk ratios (RRs) with 95% CIs as measures of the effect size. Serious adverse events served as safety outcomes. Results A total of 5 large trials comprising 6945 patients with HF and T2DM were enrolled. Pooled data demonstrated that SGLT-2i significantly reduced the risk for the primary composite outcome of CVD or HHF by 13% (HR: 0.87, 95% CI: 0.83–0.91, I2: 0%, P < 0.00001) in patients with HF concomitant with T2DM. Similarly, the use of SGLT-2i was associated with a statistically significant 14% reduction in HHF (pooled HR: 0.86, 95% CI: 0.81–0.91, I2: 0%, P < 0.00001) and a 10% reduction in ACM (pooled HR: 0.90, 95% CI: 0.86–0.96, I2: 16%, P < 0.0005) but was not significantly associated with a reduction in CVD (HR: 0.91, 95% CI: 0.81–1.02, I2: 60%, P = 0.11). Sensitivity analyses indicted consistent results. Compared with placebo plus standard care, the SGLT-2i group had a lower proportion of serious adverse events (weighted proportions: 44.3% vs 50.3%; RR 0.88, 95% CI 0.82–0.95, I2: 22%, p = 0∙006). Conclusions SGLT-2i significantly reduced the risk of HHF and ACM in a broad range of HF patients concomitant with T2DM. Compared with standard care, SGLT-2i plus standard therapy was associated with a reduction in serious adverse events.

scholarly journals Matching between Donors and Ulcerative Colitis Patients Is Important for Long-Term Maintenance after Fecal Microbiota Transplantation

2020 ◽  
Vol 9 (6) ◽  
pp. 1650
Author(s):  
Koki Okahara ◽  
Dai Ishikawa ◽  
Kei Nomura ◽  
Shoko Ito ◽  
Keiichi Haga ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Response ◽  
Fecal Microbiota Transplantation ◽  
Fecal Microbiota ◽  
Post Treatment ◽  
Age Difference ◽  
Maintenance Rate ◽  
Term Efficacy ◽  
Term Maintenance

We previously demonstrated that fresh fecal microbiota transplantation (FMT) following triple antibiotic therapy (amoxicillin, fosfomycin, metronidazole (AFM); A-FMT) resulted in effective colonization of Bacteroidetes species, leading to short-term clinical response in ulcerative colitis (UC). Its long-term efficacy and criteria for donor selection are unknown. Here, we analyzed the long-term efficacy of A-FMT compared to AFM monotherapy (mono-AFM). AFM was administered to patients with mild to severe UC for 2 weeks until 2 days before fresh FMT. Clinical response and efficacy maintenance were defined by the decrease and no exacerbation in clinical activity index. The population for intention-to-treat analysis comprised 92 patients (A-FMT, n = 55; mono-AFM, n = 37). Clinical response was observed at 4 weeks post-treatment (A-FMT, 56.3%; mono-AFM, 48.6%). Maintenance rate of responders at 24 months post-treatment was significantly higher with A-FMT than mono-AFM (p = 0.034). Significant differences in maintenance rate according to the age difference between donors and patients were observed. Additionally, sibling FMT had a significantly higher maintenance rate than parent–child FMT. Microbial analysis of patients who achieved long-term maintenance showed that some exhibited similarity to their donors, particularly Bacteroidetes species. Thus, A-FMT exhibited long-term efficacy. Therefore, matching between donors and UC patients may be helpful in effectively planning the FMT regimen.

scholarly journals P547 Safety and efficacy of vedolizumab in the treatment of patients with moderate to severe Ulcerative Colitis: a systematic review and meta-analysis

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S516-S517
Author(s):  
M Khorshid Fasge ◽  
M Alboraie ◽  
W Abbas ◽  
Z E Sayed ◽  
M El-Nady
Keyword(s):  
Systematic Review ◽  
Ulcerative Colitis ◽  
Cohort Studies ◽  
Clinical Response ◽  
Clinical Remission ◽  
Assessment Tool ◽  
Meta Analysis ◽  
P Value ◽  
Severe Ulcerative Colitis ◽  
Significant Difference

Abstract Background To perform a systematic review and meta-analysis discussing the efficacy and safety of vedolizumab (VDZ) treatment in patients with active moderate to severe ulcerative colitis (UC). Methods Using relevant keywords, we searched PubMed, Web of Science, Scopus, and Cochrane Central databases, until June 2020. We included interventional and observational cohort studies which assessed the safety and effectiveness of VDZ 300 mg intravenous infusion, in patients with active moderate to severe UC. We used the Cochrane risk of bias assessment tool and the Newcastle-Ottawa scale to assess the quality of included interventional and cohort studies, respectively. Dichotomous outcomes were pooled as proportion, 95% Confidence interval (CI), and p-value under the random-effects model in the open meta-analyst software. Results We found 10 interventional studies and 35 cohort studies, including 4,794 patients eligible for our review. Most of the included citations were single-arm studies. Our meta-analysis showed that VDZ therapy could induce a significant clinical response in UC patients up to 54 weeks (proportion 0.516, 95% CI [0.453, 0.578], p &lt; 0.001). VDZ was associated with clinically significantly clinical remission and steroid-free clinical remission after 54 weeks (p &lt; 0.0001). Durable clinical remission, histological remission, and endoscopic response rates were maintained in UC patients taking VDZ at the 52nd week. There was no significant difference between VDZ and placebo regarding the incidence of drug-related serious adverse events (p = 0.113) and death rates (p = 0.085). Conclusion Our systematic review and meta-analysis showed that the use of VDZ in patients with active moderate to severe UC was associated with high percentages of clinical response and remission rates in induction and maintenance treatment stages. VDZ seems to be well tolerated in UC patients, apart from some infections and inflammations. Future RCTs should compare VDZ to active treatments for longer follow-up periods with larger sample size.

scholarly journals Oral Adjuvant Curcumin Therapy for Attaining Clinical Remission in Ulcerative Colitis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Nutrients ◽  
2018 ◽  
Vol 10 (11) ◽  
pp. 1737 ◽  
Author(s):  
Maria Grammatikopoulou ◽  
Konstantinos Gkiouras ◽  
Xenophon Theodoridis ◽  
Eleni Asteriou ◽  
Alastair Forbes ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Adjuvant Therapy ◽  
Randomized Controlled Trials ◽  
Random Effects ◽  
Clinical Remission ◽  
Grey Literature ◽  
Secondary Outcome ◽  
Controlled Trials ◽  
Random Effects Model ◽  
Randomized Controlled

Curcumin has demonstrated anti-inflammatory properties and has been investigated as an adjuvant therapy of ulcerative colitis (UC). The scope of this study was to systematically review and meta-analyze the efficacy of oral curcumin administration as an adjuvant therapy of UC. MEDLINE, Cochrane/CENTRAL, ClinicalTrials.gov, WHO-ICT Registry, EMBASE and grey literature were searched for relevant randomized controlled trials (RCTs). The primary outcome was clinical remission (attainment) and the secondary outcome was clinical response (maintenance/failure). Risk of bias was assessed with the Cochrane tool. Odds ratios (OR) were calculated with a Mantel-Haenszel (M-H) random effects model and with a beta-binomial (B-B) random effects model when zero events/cells occurred. Four RCTs met the criteria, but one was removed from the analyses due to inconsistency in protocol details. With the M-H method, treatment with curcumin was significantly superior to placebo in attaining remission in the per-protocol (PP) analysis (OR = 5.83, 95%CI = 1.24–27.43), but not in the intention-to-treat (ITT) analysis (OR = 4.33, 95%CI = 0.78–24.00). However, with the more accurate B-B method, both analyses were insignificant (for PP OR = 4.26, 95%CI = 0.59–31.00, for ITT OR = 3.80, 95%CI = 0.55–26.28). Based on the current available evidence, oral curcumin administration does not seem superior to placebo in attaining remission in patients with UC. Future RCTs should be planned more cautiously with sufficient size and adhere to the ITT analysis in all outcomes.

scholarly journals Tofacitinib in Treatment-Refractory Moderate to Severe Ulcerative Colitis: Real-World Experience from a Retrospective Multicenter Observational Study

2020 ◽  
Vol 9 (7) ◽  
pp. 2177
Author(s):  
Peter Hoffmann ◽  
Anna-Maria Globig ◽  
Anne K. Thomann ◽  
Maximilian Grigorian ◽  
Johannes Krisam ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Adverse Events ◽  
Clinical Response ◽  
Real World ◽  
Clinical Remission ◽  
Safety Data ◽  
Colon Perforation ◽  
Severe Ulcerative Colitis ◽  
Emergency Colectomy

(1) Background: Tofacitinib is approved in Europe for the treatment of adults with moderately to severely active ulcerative colitis since 2018. Real-world efficacy and safety data are currently scarce. (2) Methods: We performed a retrospective multicenter study at three German tertiary outpatient clinics for inflammatory bowel diseases and included all patients who started tofacitinib therapy between August 2018 and March 2020. The primary endpoint was a combined endpoint of steroid-free clinical remission, steroid-free clinical response, or clinical response at week 8. Secondary endpoints were biochemical response at week 8, as well as steroid-free clinical remission, steroid-free clinical response or clinical response at week 24, respectively, adverse events by week 24, and need for colectomy by the end of follow-up. (3) Results: Thirty-eight patients with moderate-to-severe ulcerative colitis were included. Eleven patients (28.9%) achieved steroid-free clinical remission at week 8. Fifty-three percent of the patients were primary non-responders at week 8. Three severe adverse events (pneumonia, hospitalization for aggravation of ulcerative colitis, emergency colectomy due to colon perforation), and 12 adverse events were documented by week 8 of therapy. By the end of follow-up, seven patients (18.4%) had undergone colectomy.

scholarly journals P372 Effectiveness and safety of immunosuppressants for pouch disorders: results from the RESERVO Study of GETECCU

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S388-S390
Author(s):  
F Mesonero Gismero ◽  
Y Zabana ◽  
A Fernández-Clotet ◽  
E Leo ◽  
B Caballol ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Adverse Events ◽  
Clinical Response ◽  
Clinical Remission ◽  
Activity Index ◽  
Disease Activity Index ◽  
Multicentric Study ◽  
Previous Diagnosis

Abstract Background Pouchitis and other inflammatory disorders of the pouch (IDP), such as Crohn′s-like disease of the pouch (CDP), are frequent in patients operated for a previous diagnosis of ulcerative colitis. Many different therapies have been used, but the effectiveness of immunosupresants (IMM) has been poorly explored in this setting. Our aim was to evaluate the use, efficacy and safety of IMM in patients with pouchitis or another IDP. Methods Retrospective and multicentric study of a Spanish cohort of pouch-carrying patients with previous diagnosis of ulcerative colitis, and subsequent diagnosis of IDP, following ECCO diagnostic criteria. Patients who used IMM to treat these conditions were selected. Clinical effectiveness was evaluated at long-term. We defined clinical remission as returning to the previous stool frequency, no pain or defecatory urgency, clinical response as the improvement in these parameters without the achievement of remission, and non-response as no improvement or worsening symptoms. Endoscopic response was evaluated when possible using modified pouchitis disease activity index (PDAI) endoscopic subscore. Adverse events were collected. We used descriptive statistics. Results In the overall cohort of 338 patients with IDP, 93 (27%) were treated with IMM. Of those, 57% males, median age 40 (20-71) ys, and 72% non-smokers. Colectomy was performed at a median age of 31 (18-63) ys and IPD was diagnosed 25 (1-235) months after ileostomy closure. IMM used were thiopurines (n=86), methotrexate (n=4), cyclosporine (n=2) and tacrolimus (n=1). IMM were used as monotherapy in 66 (71%) cases and were indicated as treatment of pouchitis (n=60, 65%), CDP (n=32, 34.4%) and cuffitis (n=1, 1%). Effectiveness was evaluated only for thiopurine monotherapy (n=62). After a median follow-up of 23 (1-234) months, clinical remission was achieved in 31%, clinical response in 31% and non-response in 38% (Figure 1). There were no differences in effectiveness between pouchitis and CDP (63.9% vs 57.7%, p= 0.62). Endoscopic response was evaluated in 19 (30.6%) cases. After a median of 9 months of follow-up median PDAI endoscopic subscore dropped from 3 (range 2-4) to 1 (range 0-3), (Figure 2). Adverse events related with treatment appeared in 28 patients (45%). Thiopurines were discontinued in 39 cases (63%) due to failure (17), toxicity (16) and long remission (6 cases). Conclusion In our cohort, thiopurines were used in 27% of patients with IDP, with long-term benefit (remission or response) in around two-thirds of them. This therapy could be one more option to manage these disorders.

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