Fecal Microbiota Transplantation in the Treatment of Chronic Pouchitis: A Systematic Review

The objective was to evaluate available literature on treatment of chronic pouchitis with fecal microbiota transplantation (FMT) focusing on clinical outcomes, safety, and different approaches to FMT preparation and delivery. A systematic review of electronic databases was conducted using Medline, EMBASE, and the Cochrane Central Register of Controlled Trials Library from inception through April 2020. Human studies of all study types reporting results of FMT to treat chronic pouchitis were included. Nine studies, reporting FMT treatment of 69 patients with chronic pouchitis were found eligible for the review. Most studies were case series and cohort studies rated as having fair to poor quality due to high risk of bias and small sample size. Only one randomized controlled trial was included, finding no beneficial effect of FMT. In total clinical response after FMT was reported in 14 (31.8%) out of 44 evaluated patients at various timepoints after FMT, and clinical remission in ten (22.7%) patients. Only minor self-limiting adverse events were reported. FMT varied greatly regarding preparation, length of treatment, and route of delivery. The effects of FMT on symptoms of chronic pouchitis are not established, though some studies show promising results. Future controlled well-designed studies are warranted.

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DIAGNOSIS OF ENDOCRINE DISEASE: The diagnostic performance of adrenal biopsy: a systematic review and meta-analysis

Acta Endocrinologica ◽

10.1530/eje-16-0297 ◽

2016 ◽

Vol 175 (2) ◽

pp. R65-R80 ◽

Cited By ~ 40

Author(s):

Irina Bancos ◽

Shrikant Tamhane ◽

Muhammad Shah ◽

Danae A Delivanis ◽

Fares Alahdab ◽

...

Keyword(s):

Systematic Review ◽

Diagnostic Performance ◽

Small Sample Size ◽

Controlled Trial ◽

Meta Analysis ◽

Small Sample ◽

Cochrane Central Register ◽

Moderate Risk ◽

Adrenal Biopsy ◽

Adrenocortical Carcinomas

ObjectiveTo perform a systematic review of published literature on adrenal biopsy and to assess its performance in diagnosing adrenal malignancy.MethodsMedline In-Process and Other Non-Indexed Citations, MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trial were searched from inception to February 2016. Reviewers extracted data and assessed methodological quality in duplicate.ResultsWe included 32 observational studies reporting on 2174 patients (39.4% women, mean age 59.8 years) undergoing 2190 adrenal mass biopsy procedures. Pathology was described in 1621/2190 adrenal lesions (689 metastases, 68 adrenocortical carcinomas, 64 other malignancies, 464 adenomas, 226 other benign, 36 pheochromocytomas, and 74 others). The pooled non-diagnostic rate (30 studies, 2013 adrenal biopsies) was 8.7% (95%CI: 6–11%). The pooled complication rate (25 studies, 1339 biopsies) was 2.5% (95%CI: 1.5–3.4%). Studies were at a moderate risk for bias. Most limitations related to patient selection, assessment of outcome, and adequacy of follow-up. Only eight studies (240 patients) could be included in the diagnostic performance analysis with a sensitivity and specificity of 87 and 100% for malignancy, 70 and 98% for adrenocortical carcinoma, and 87 and 96% for metastasis respectively.ConclusionsEvidence based on small sample size and moderate risk of bias suggests that adrenal biopsy appears to be most useful in the diagnosis of adrenal metastasis in patients with a history of extra-adrenal malignancy. Adrenal biopsy should only be performed if the expected findings are likely to alter the management of the individual patient and after biochemical exclusion of catecholamine-producing tumors to help prevent potentially life-threatening complications.

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Dietary Interventions in the Management of Fibromyalgia: A Systematic Review and Best-Evidence Synthesis

Nutrients ◽

10.3390/nu12092664 ◽

2020 ◽

Vol 12 (9) ◽

pp. 2664

Author(s):

Ethan Lowry ◽

Joanne Marley ◽

Joseph G. McVeigh ◽

Emeir McSorley ◽

Philip Allsopp ◽

...

Keyword(s):

Systematic Review ◽

Small Sample Size ◽

Evidence Synthesis ◽

Nutritional Intervention ◽

Poor Quality ◽

Chronic Widespread Pain ◽

Small Sample ◽

Vegan Diet ◽

Poor Sleep ◽

Best Evidence Synthesis

Fibromyalgia syndrome (FMS) is characterised by chronic widespread pain alongside fatigue, poor sleep quality and numerous comorbidities. It is estimated to have a worldwide prevalence of 1.78%, with a predominance in females. Treatment interventions for fibromyalgia have limited success, leading to many patients seeking alternative forms of treatment, including modifications to their diet and lifestyle. The effectiveness of dietary changes in fibromyalgia has not been widely researched or evaluated. This systematic review identified twenty-two studies, including 18 randomised control trials (RCTs) and four cohort studies which were eligible for inclusion. In total these studies investigated 17 different nutritional interventions. Significant improvements in reported pain were observed for those following a vegan diet, as well as with the low fermentable oligo di-mono-saccharides and polyols (FODMAP) diets. Supplementation with Chlorella green algae, coenzyme Q10, acetyl-l-carnitine or a combination of vitamin C and E significantly improved measures of pain. Interpretation of these studies was limited due to the frequent poor quality of the study design, the wide heterogeneity between studies, the small sample size and a high degree of bias. Therefore, there is insufficient evidence to recommend any one particular nutritional intervention for the management of fibromyalgia and further research is needed.

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Are antifungal non-inferiority trials at risk of eroding effectiveness because of bio-creep? A secondary analysis of a systematic review

Antimicrobial Agents and Chemotherapy ◽

10.1128/aac.01627-21 ◽

2021 ◽

Author(s):

Adam S. Komorowski ◽

Anthony D. Bai ◽

Anna Cvetkovic ◽

Omar Mourad ◽

Carson K.L. Lo ◽

...

Keyword(s):

Systematic Review ◽

Small Sample Size ◽

Controlled Trial ◽

Secondary Analysis ◽

Small Sample ◽

Risk Of Bias ◽

Effective Control ◽

Erosion Risk ◽

Randomized Controlled ◽

Over Time

Non-inferiority randomized controlled trial (RCT) effectiveness may erode when results favour the active control over time, and when a decreasingly effective control arm is used in serial trials. We analyzed 32 antifungal noninferiority RCTs (NI-RCTs) for these scenarios in this secondary analysis of a systematic review. Our exploratory analysis suggests that the erosion risk in the effectiveness of antifungal non-inferiority trials is uncommon. Findings are limited by small sample size, and overall risk of bias.

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What is the evidence for mirtazapine in treating cancer-related symptomatology? A systematic review

Supportive Care in Cancer ◽

10.1007/s00520-019-05229-7 ◽

2019 ◽

Vol 28 (4) ◽

pp. 1597-1606 ◽

Cited By ~ 1

Author(s):

Guillaume Economos ◽

Natasha Lovell ◽

Anna Johnston ◽

Irene J. Higginson

Keyword(s):

Systematic Review ◽

Small Sample Size ◽

Poor Quality ◽

Small Sample ◽

Assessment Tools ◽

Data Synthesis ◽

Small Sample Sizes ◽

Randomised Controlled ◽

Multiple Symptoms ◽

The Impact

Abstract Purpose Cancer patients often experience multiple distressing symptoms which are challenging to manage. It would therefore be helpful to find a treatment that alleviates more than one symptom, to avoid polypharmacy: mirtazapine has been used in several studies for this purpose. The objective of this study was to assess the effectiveness and safety of mirtazapine in alleviating one or more frequently encountered cancer-related symptoms. Methods Systematic review of clinical trials in English or French. Eight databases were searched. Included studies assessed the effectiveness of mirtazapine in alleviating one or more frequently encountered cancer-related symptoms. Comparator and validated assessment tools were required. Studies were independently appraised by two investigators before data synthesis. Results The search yielded 1898 references, from which we identified 12 relevant articles evaluating highly heterogeneous outcomes. These were two randomised-controlled (RCTs), three non-randomised controlled, and seven non-randomised non-controlled trials. In total, 392 participants were included and 185 were in RCTs. No study assessed the effectiveness of mirtazapine in alleviating symptoms at the same time, but some considered more than one symptom. Overall, the data was of poor quality, limited by small sample size and bias. However, mirtazapine showed effectiveness in treating depression, anxiety, sleep disorders, emesis and neuropathic pain. Across all studies, mirtazapine is safe to use, with drowsiness and dizziness the most common side-effects. Conclusion Study design and small sample sizes limit the ability to interpret results. Trials to assess the impact of mirtazapine or other medicines in alleviating multiple symptoms would be valuable.

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Topiramate reduces nocturnal eating in sleep-related eating disorder

SLEEP ◽

10.1093/sleep/zsaa060 ◽

2020 ◽

Vol 43 (9) ◽

Cited By ~ 1

Author(s):

John W Winkelman ◽

Benjamin Wipper ◽

Julia Purks ◽

Leslie Mei ◽

Laura Schoerning

Keyword(s):

Clinical Trial ◽

Eating Disorder ◽

Side Effects ◽

Small Sample Size ◽

Controlled Trial ◽

Case Series ◽

Study Groups ◽

Small Sample ◽

Drop Out ◽

Intention To Treat

Abstract Study Objectives Sleep-related eating disorder (SRED) is a parasomnia characterized by partial arousals from sleep with compulsive consumption of food with impaired level of awareness and memory for the event. Small case series’ have demonstrated efficacy of topiramate in SRED. We conducted a placebo-controlled randomized clinical trial of topiramate to assess efficacy in SRED. Methods Thirty-four participants with an ICSD-2/ICSD-3 diagnosis of SRED with >6 months of symptoms and ≥3 sleep-related eating episodes per week were randomized to placebo or topiramate with flexible dosing to a maximum dosage of 300 mg for 13 weeks. Primary outcomes were percentage of nights with eating and Clinician Global Impression-Improvement (CGI-I). Intention-to-treat last observation carried forward (ITT LOCF) analysis was conducted. Results Mean age was 39.5 years, 74% were female, with mean duration of sleep-related eating of 13.7 years. SRED symptoms were significantly reduced with topiramate (74.7% to 33.2% nights/week; n = 15) compared to placebo (77.0% to 57.4%; n = 17) (p = 0.035). There were significantly more CGI-I responders on topiramate (71%) than placebo (27%) (p = 0.016). Level of wakefulness (r = −0.49) and memory for nighttime eating (r = −0.58) at baseline predicted topiramate response. The topiramate group lost significantly more weight than the placebo group (−8.5 lbs vs. +1.0 lbs, p = 0.001). The most common side effects were paresthesias and cognitive dysfunction. Conclusions This first randomized controlled trial demonstrating efficacy for treatment of SRED supports preliminary data on the use of topiramate for SRED. Side effects were prominent for topiramate. Limitations include a small sample size and a high drop-out rate in both study groups. Clinical Trial Information NCT00606411

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A Multi-Factorial Observational Study on Sequential Fecal Microbiota Transplant in Patients with Medically Refractory Clostridioides difficile Infection

Cells ◽

10.3390/cells10113234 ◽

2021 ◽

Vol 10 (11) ◽

pp. 3234

Author(s):

Tanya M. Monaghan ◽

Niharika A. Duggal ◽

Elisa Rosati ◽

Ruth Griffin ◽

Jamie Hughes ◽

...

Keyword(s):

Fecal Microbiota Transplantation ◽

Small Sample Size ◽

Fecal Microbiota ◽

Small Sample ◽

Microbial Interactions ◽

Intestinal Microbiome ◽

Significant Heterogeneity ◽

Fecal Microbiota Transplant ◽

Clostridioides Difficile ◽

Clostridioides Difficile Infection

Fecal microbiota transplantation (FMT) is highly effective in recurrent Clostridioides difficile infection (CDI); increasing evidence supports FMT in severe or fulminant Clostridioides difficile infection (SFCDI). However, the multifactorial mechanisms that underpin the efficacy of FMT are not fully understood. Systems biology approaches using high-throughput technologies may help with mechanistic dissection of host-microbial interactions. Here, we have undertaken a deep phenomics study on four adults receiving sequential FMT for SFCDI, in which we performed a longitudinal, integrative analysis of multiple host factors and intestinal microbiome changes. Stool samples were profiled for changes in gut microbiota and metabolites and blood samples for alterations in targeted epigenomic, metabonomic, glycomic, immune proteomic, immunophenotyping, immune functional assays, and T-cell receptor (TCR) repertoires, respectively. We characterised temporal trajectories in gut microbial and host immunometabolic data sets in three responders and one non-responder to sequential FMT. A total of 562 features were used for analysis, of which 78 features were identified, which differed between the responders and the non-responder. The observed dynamic phenotypic changes may potentially suggest immunosenescent signals in the non-responder and may help to underpin the mechanisms accompanying successful FMT, although our study is limited by a small sample size and significant heterogeneity in patient baseline characteristics. Our multi-omics integrative longitudinal analytical approach extends the knowledge regarding mechanisms of efficacy of FMT and highlights preliminary novel signatures, which should be validated in larger studies.

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Dental Implant Placement in Patients with a History of Medications Related to Osteonecrosis of the Jaws: A Systematic Review

Journal of Oral Implantology ◽

10.1563/aaid-joi-d-19-00351 ◽

2020 ◽

Author(s):

Judd Sher ◽

Kate Kirkham-Ali ◽

Denny Luo ◽

Catherine Miller ◽

Dileep Sharma

Keyword(s):

Systematic Review ◽

At Risk ◽

Drug Therapy ◽

Dental Implant ◽

Case Series ◽

Cochrane Central Register ◽

Bisphosphonate Treatment ◽

Implant Placement ◽

Increased Risk ◽

History Of

The present systematic review evaluates the safety of placing dental implants in patients with a history of antiresorptive or antiangiogenic drug therapy. The Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines were followed. PubMed, Cochrane Central Register of Controlled Trials, Scopus, Web of Science, and OpenGrey databases were used to search for clinical studies (English only) to July 16, 2019. Study quality was assessed regarding randomization, allocation sequence concealment, blinding, incomplete outcome data, selective outcome reporting, and other biases using a modified Newcastle-Ottawa scale and the Joanna Briggs Institute critical appraisal checklist for case series. A broad search strategy resulted in the identification of 7542 studies. There were 28 studies reporting on bisphosphonates (5 cohort, 6 case control, and 17 case series) and one study reporting on denosumab (case series) that met the inclusion criteria and were included in the qualitative synthesis. The quality assessment revealed an overall moderate quality of evidence among the studies. Results demonstrated that patients with a history of bisphosphonate treatment for osteoporosis are not at increased risk of implant failure in terms of osseointegration. However, all patients with a history of bisphosphonate treatment, whether taken orally for osteoporosis or intravenously for malignancy, appear to be at risk of ‘implant surgery-triggered’ MRONJ. In contrast, the risk of MRONJ in patients treated with denosumab for osteoporosis was found to be negligible. In conclusion, general and specialist dentists should exercise caution when planning dental implant therapy in patients with a history of bisphosphonate and denosumab drug therapy. Importantly, all patients with a history of bisphosphonates are at risk of MRONJ, necessitating this to be included in the informed consent obtained prior to implant placement. The James Cook University College of Medicine and Dentistry Honours program and the Australian Dental Research Foundation Colin Cormie Grant were the primary sources of funding for this systematic review.

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Risk of colectomy after conservative treatment of diverticulitis of the left hemicolon complicated by abdominal or pelvic abscess: protocol of a systematic review and meta-analysis

BMJ Open ◽

10.1136/bmjopen-2020-042350 ◽

2020 ◽

Vol 10 (12) ◽

pp. e042350

Author(s):

Maximilian Sohn ◽

Ayman Agha ◽

Igors Iesalnieks ◽

Anna Tiefes ◽

Alfred Hochrein ◽

...

Keyword(s):

Systematic Review ◽

Emergency Surgery ◽

Case Reports ◽

Acute Diverticulitis ◽

Meta Analysis ◽

Case Series ◽

Pelvic Abscess ◽

Risk Of Bias ◽

Cochrane Central Register ◽

Review Manager

IntroductionAcute diverticulitis of the sigmoid colon is increasingly treated by a non-operative approach. The need for colectomy after recovery from a flare of acute diverticulitis of the left colon, complicated diverticular abscess is still controversial. The primary aim of this study is to assess the risk of interval emergency surgery by systematic review and meta-analysis.Methods and analysisThe systematic review and meta-analysis will be conducted in accordance to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols statement. PubMed/MEDLINE, Cochrane Central Register of Controlled Trials and EMBASE will be screened for the predefined searching term: (Diverticulitis OR Diverticulum) AND (Abscess OR pelvic abscess OR pericolic abscess OR intraabdominal abscess) AND (surgery OR operation OR sigmoidectomy OR drainage OR percutaneous drainage OR conservative therapy OR watchful waiting). All studies published in an English or German-speaking peer-reviewed journal will be suitable for this analysis. Case reports, case series of less than five patients, studies without follow-up information, systematic and non-systematic reviews and meta-analyses will be excluded. Primary endpoint is the rate of interval emergency surgery. Using the Review Manager Software (Review Manager/RevMan, V.5.3, Copenhagen, The Nordic Cochrane Centre, The Cochrane Collaboration, 2012) meta-analysis will be pooled using the Mantel-Haenszel method for random effects. The Risk of Bias in Non-randomized Studies of Interventions tool will be used to assess methodological quality of non-randomised studies. Risk of bias in randomised studies will be assessed using the Cochrane developed RoB 2-tool.Ethics and disseminationAs no new data are being collected, ethical approval is exempt for this study. This systematic review is to provide a new insight on the need for surgical treatment after a first attack of acute diverticulitis, complicated by intra-abdominal or pelvic abscesses. The results of this study will be presented at national and international meetings and published in a peer-reviewed journal.PROSPERO registration numberCRD42020164813.

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Comprehensive Geriatric Care to Improve Mobility after Hip Fracture: An RCT

Gerontology ◽

10.1159/000510903 ◽

2020 ◽

Vol 66 (6) ◽

pp. 542-548

Author(s):

Wendy L. Cook ◽

Penelope M.A. Brasher ◽

Pierre Guy ◽

Stirling Bryan ◽

Meghan G. Donaldson ◽

...

Keyword(s):

Hip Fracture ◽

Small Sample Size ◽

Controlled Trial ◽

Geriatric Care ◽

Small Sample ◽

Community Dwelling ◽

Post Discharge ◽

Mobility Performance ◽

Discharge Care ◽

Comprehensive Geriatric Care

Background: Comprehensive geriatric care (CGC) for older adults during hospitalization for hip fracture can improve mobility, but it is unclear whether CGC delivered after a return to community living improves mobility compared with usual post-discharge care. Objective: To determine if an outpatient clinic-based CGC regime in the first year after hip fracture improved mobility performance at 12 months. Methods: A two-arm, 1:1 parallel group, pragmatic, single-blind, single-center, randomized controlled trial at 3 hospitals in Vancouver, BC, Canada. Participants were community-dwelling adults, aged ≥65 years, with a hip fracture in the previous 3–12 months, who had no dementia and walked ≥10 m before the fracture occurred. Target enrollment was 130 participants. Clinic-based CGC was delivered by a geriatrician, physiotherapist, and occupational therapist. Primary outcome was the Short Physical Performance Battery (SPPB; 0–12) at 12 months. Results: We randomized 53/313 eligible participants with a mean (SD) age of 79.7 (7.9) years to intervention (n = 26) and usual care (UC, n = 27), and 49/53 (92%) completed the study. Mean 12-month (SD) SPPB scores in the intervention and UC groups were 9.08 (3.03) and 8.24 (2.44). The between-group difference was 0.9 (95% CI –0.3 to 2.0, p = 0.13). Adverse events were similar in the 2 groups. Conclusion: The small sample size of less than half our recruitment target precludes definitive conclusions about the effect of our intervention. However, our results are consistent with similar studies on this population and intervention.

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Treatment strategies for cerebrospinal shunt infections: a systematic review of observational studies

BMJ Open ◽

10.1136/bmjopen-2020-038978 ◽

2020 ◽

Vol 10 (12) ◽

pp. e038978

Author(s):

Joan L Robinson ◽

Dolores Freire ◽

Liza Bialy

Keyword(s):

Systematic Review ◽

Small Sample Size ◽

Treatment Strategies ◽

Small Sample ◽

Cochrane Library ◽

Csf Shunt ◽

Entry Site ◽

Recurrence Rates ◽

Ovid Medline ◽

Shunt Infections

ObjectiveA systematic review was conducted of studies comparing time to cerebrospinal fluid (CSF) sterilisation or rate of recurrence with different treatment strategies for CSF shunt infections.MethodsA librarian-directed search was conducted of Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Ovid Medline Daily and Ovid Medline, Ovid Embase, Wiley Cochrane Library, CINAHL Plus with Full Text via EBSCOhost, Scopus Advanced Search, and Web of Science Core Collection from 1990 to May 2019. Studies of any design that compared outcomes in groups of any age with different management strategies were included. Studies that compared complete versus incomplete shunt removal were excluded. Quality assessment was performed with the Newcastle-Ottawa Scale.ResultsThe search identified 2208 records, of which 8 met the inclusion criteria. All were cohort studies of moderate quality. Four studies compared the duration of antibiotics; none demonstrates that a longer course prevented recurrences. Two studies analysed addition of rifampin, with one showing a decrease in recurrences while the other had a small sample size. No studies analysed the addition of intraventricular antibiotics, but one showed equally good results with once versus twice daily administration. One study reported no difference in recurrences with placement of antibiotic-impregnated catheters. Recurrence rates did not differ with shunt replacement minimum of 7 days vs less than 7 days after CSF became sterile. There were no recurrences in either group when shunt replacement was performed after sterile CSF cultures were obtained at 24 vs 48 hours after antibiotics were discontinued. A new shunt entry site did not decrease recurrences.DiscussionThe main limitations are the lack of high-quality studies, the small sample sizes and the heterogeneity which precluded meta-analysis. Addition of rifampin for staphylococcal infections may decrease relapse but requires further study.

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