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Surgical Oncology Dec 2020Selective Internal Radiation Therapy (SIRT) is a therapeutic modality in patients with hepatocellular carcinoma or liver metastases. Complications due to SIRT-induced...
BACKGROUND
Selective Internal Radiation Therapy (SIRT) is a therapeutic modality in patients with hepatocellular carcinoma or liver metastases. Complications due to SIRT-induced gastric ulcers are seen in less than 5% of patients but there is no consensus for management of this rare side effect. We conducted a systematic review to analyze the efficacy of medical treatment of SIRT-induced ulcers.
METHODS
This systematic review was conducted in accordance with the PRISMA guidelines. We developed the research question following the population, intervention, comparison, outcome, and study design (PICOS) format. We identified studies and cases reporting patients with gastric and/or duodenal (=population) ulcers treated with medical therapy with proton pump inhibitor (PPI), antacid, or sucralfate, alone or in combination (=intervention). We did not require that studies include a control group. We included studies reporting the evaluation of the medical and/or surgical treatment (=outcomes).
RESULTS
Out of 219 articles, 29 articles were included, resulting in analysis of data for a total of 51 patients who had a SIRT-induced gastric and/or duodenal ulcer treated with medication, surgery, or both. Twenty-eight patients (55%) were reported to have SIRT-induced ulcers that improved after initiation of PPI, antacid, or sucralfate treatment (alone or in combination). Twenty-three patients (45%) were reported to be refractory to medical treatment and surgery was performed in 7 out of 23 patients (30%).
CONCLUSIONS
About 45% of SIRT-induced gastroduodenal ulcers are refractory to medical treatment with PPI, antacid, or sucralfate, alone or in combination. Surgery is an effective treatment in patients who are refractory to medical treatment and who have intense symptoms.
Topics: Anti-Ulcer Agents; Humans; Liver Neoplasms; Peptic Ulcer; Radiotherapy
PubMed: 33157433
DOI: 10.1016/j.suronc.2020.10.014 -
PloS One 2019Several clinical prediction rules (CPRs) for complications and mortality of Clostridioides difficile infection (CDI) have been developed but only a few have gone through...
BACKGROUND
Several clinical prediction rules (CPRs) for complications and mortality of Clostridioides difficile infection (CDI) have been developed but only a few have gone through external validation, and none is widely recommended in clinical practice.
METHODS
CPRs were identified through a systematic review. We included studies that predicted severe or complicated CDI (cCDI) and mortality, reported at least an internal validation step, and for which data were available with minimal modifications. Data from a multicenter prospective cohort of 1380 adults with confirmed CDI were used for external validation. In this cohort, cCDI occurred in 8% of the patients and 30-day all-cause mortality occurred in 12%. The performance of each tool was assessed using individual outcomes, with the same cut-offs and standard parameters.
RESULTS
Seven CPRs were assessed. Three predictive scores for cCDI showed low sensitivity (25-61%) and positive predictive value (PPV; 9-31%), but moderate specificity (54-90%) and negative predictive value (NPV; 82-95%). One model [using age, white blood cell count (WBC), narcotic use, antacids use, and creatinine ratio > 1.5× the normal level as covariates] showed a probability of 25% of cCDI at the optimal cut-off point with 36% sensitivity and 84% specificity. Two scores for mortality had low sensitivity (4-55%) and PPV (25-31%), and moderate specificity (71-78%) and NPV (87-92%). One predictive model for 30-day all-cause mortality [Charlson comorbidity index, WBC, blood urea nitrogen (BUN), diagnosis in ICU, and delirium] showed an AUC-ROC of 0.74. All other CPRs showed lower AUC values (0.63-0.69). Errors in calibration ranged from 12%- 27%.
CONCLUSIONS
Included CPRs showed moderate performance for clinical use in a large validation cohort with a majority of patients infected with ribotype 027 strains and a low rate of cCDI and mortality. These data show that better CPRs need to be developed and validated.
Topics: Clinical Decision Rules; Clostridioides difficile; Clostridium Infections; Humans; Predictive Value of Tests; Sensitivity and Specificity
PubMed: 31846487
DOI: 10.1371/journal.pone.0226672 -
Animal Health Research Reviews Dec 2019A systematic review and network meta-analysis were conducted to assess the relative efficacy of internal or external teat sealants given at dry-off in dairy cattle.... (Meta-Analysis)
Meta-Analysis
A systematic review and network meta-analysis were conducted to assess the relative efficacy of internal or external teat sealants given at dry-off in dairy cattle. Controlled trials were eligible if they assessed the use of internal or external teat sealants, with or without concurrent antimicrobial therapy, compared to no treatment or an alternative treatment, and measured one or more of the following outcomes: incidence of intramammary infection (IMI) at calving, IMI during the first 30 days in milk (DIM), or clinical mastitis during the first 30 DIM. Risk of bias was based on the Cochrane Risk of Bias 2.0 tool with modified signaling questions. From 2280 initially identified records, 32 trials had data extracted for one or more outcomes. Network meta-analysis was conducted for IMI at calving. Use of an internal teat sealant (bismuth subnitrate) significantly reduced the risk of new IMI at calving compared to non-treated controls (RR = 0.36, 95% CI 0.25-0.72). For comparisons between antimicrobial and teat sealant groups, concerns regarding precision were seen. Synthesis of the primary research identified important challenges related to the comparability of outcomes, replication and connection of interventions, and quality of reporting of study conduct.
Topics: Animals; Antacids; Anti-Bacterial Agents; Bismuth; Cattle; Female; Mammary Glands, Animal; Mastitis, Bovine; Network Meta-Analysis
PubMed: 32081124
DOI: 10.1017/S1466252319000276 -
World Journal of Gastroenterology Oct 2019Allicin (2-propene-1-sulfinothioic acid S-2-propenyl ester, diallyl thiosulfinate) extracted from garlic, has proven activity against () infection. In recent years,... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Allicin (2-propene-1-sulfinothioic acid S-2-propenyl ester, diallyl thiosulfinate) extracted from garlic, has proven activity against () infection. In recent years, clinical trials have explored its utility as an add-on therapy with variable outcomes reported.
AIM
To perform a systemic review of allicin as an add-on treatment for infection and assess its efficacy in randomized controlled trials (RCTs).
METHODS
Electronic databases including MEDLINE, EMBASE, the Web of Science, the Cochrane Database, the China National Knowledge Infrastructure Database, Chinese VIP Information Databases, Chinese Medical Databases, and the Wan-Fang Database were searched for keywords including "allicin", "", "randomized clinical trials", and their synonyms. A meta-analysis was performed using the fixed-effects model for low heterogeneity and the random-effects model for high heterogeneity with sensitivity analysis. Bias was evaluated using Egger's tests. Trial sequential analysis (TSA) was used to evaluate information size and treatment benefits. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) was used to assess the level of quality, and studies were classed as "high quality", "moderate quality", "low quality", and "very low quality".
RESULTS
A total of eight RCTs consisting of 867 participants (435 from the allicin group and 432 from the control group) were included. Eradication rate in the allicin group (93.33%, 406/435) was significantly higher than that of the control group (83.56%, 361/432) [ = 0%, odds ratio (OR) = 2.75, 95% confidence interval (CI): 1.74-4.35, < 0.001]. The healing rate of ulcers following therapy in the allicin group (86.17%, 349/405) was significantly higher than that of the control group (75.87%, 305/402) [ = 0%, OR = 2.05, 95%CI: 1.39-3.03, < 0.001]. The total remission rate of peptic ulcers across all allicin groups was 97.16%, which was significantly higher than that of controls [96.05% (389/405) 86.55% (360/402), = 0, OR = 3.04, 95%CI: 1.51-6.12, = 0.015]. No significant differences in side effects were observed. TSA suggested that the trials were of sufficient standard to draw reliable conclusions. The quality of outcomes including eradication rates and side effects was graded as "very low" due to downgrades for "risk of bias" and "indirectness". Other outcomes such as ulcer healing rates and total ulcer remission rates were graded as "low" due to downgrades for "risk of bias".
CONCLUSION
Allicin as an add-on therapy improves eradication, healing of ulcers, and remission of symptoms. These results are suggested to be treated with caution due to limited quality.
Topics: Antacids; Anti-Bacterial Agents; Anti-Infective Agents; Clinical Trials as Topic; Disulfides; Drug Therapy, Combination; Gastric Mucosa; Helicobacter Infections; Helicobacter pylori; Humans; Proton Pump Inhibitors; Remission Induction; Stomach Ulcer; Sulfinic Acids; Treatment Outcome
PubMed: 31660038
DOI: 10.3748/wjg.v25.i39.6025 -
Frontiers in Endocrinology 2022To assess the benefit and harm of Chinese medicine Xianling Gubao (XLGB) capsule compared to conventional medication or placebo to inform clinical practice. (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To assess the benefit and harm of Chinese medicine Xianling Gubao (XLGB) capsule compared to conventional medication or placebo to inform clinical practice.
METHODS
We included randomized controlled trials (RCTs) with Jadad score ≥3 of XLGB capsule compared to pharmaceutical medication, placebo, or no treatment for primary osteoporosis. We conducted searches in EMBASE, Cochrane CENTRAL, MEDLINE, China National Knowledge Infrastructure, VIP, Wanfang, and Chinese Biomedical Literature Database (Sino-Med) from their inception till November 13, 2021. Study selection and data extraction were done by two authors independently. The methodological quality of the RCTs was assessed using Cochrane's risk of bias tool. The effect size was presented as risk ratio (RR) or mean difference (MD) with their 95% confidence interval (CI).
RESULTS
Our searches identified 2292 records and after exclusions, eight trials involving 846 participants were included. There was no statistically significant difference between conventional medications with or without XLGB on new fracture (RR: 0.50, 95% CI: [0.13, 1.87]). Quality of life by SF-36 questionnaire of XLGB plus calcium carbonate, vitamin D, and calcitriol was improved than that of without XLGB (MD: 6.72 scores, 95% CI: [2.82, 10.62]). XLGB increased bone mineral density similarly as calcium carbonate plus vitamin D (MD: 0.21, 95% CI: [-0.16, 0.58]) or as alendronate sodium, calcium carbonate plus vitamin D (MD: 0.00, 95% CI: [-0.10, 0.10]), but it had no additional effect as an add-on treatment to conventional medications (MD: 0.13, 95% CI: [-0.12, 0.37]). XLGB relieved pain visual analog scale more effectively when combined with medications (MD: -1.55 score, 95% CI: [-2.47, -0.63]). XLGB as monotherapy did not increase adverse events (RR: 0.63, 95% CI: [0.28, 1.41]), or as an add-on treatment (RR: 0.25, 95% CI: [0.03, 2.16]).
CONCLUSION
This systematic review shows that XLGB capsule appears to be safe and has a beneficial effect on the quality of life and pain relief when used alone or in combination with conventional medications in osteoporosis patients. Further large, rigorous trials are warranted to test its long-term benefit.
Topics: Calcium Carbonate; Humans; Osteoporosis; Pain; Randomized Controlled Trials as Topic; Vitamin D
PubMed: 35464071
DOI: 10.3389/fendo.2022.870277 -
Clinical and Experimental Allergy :... Mar 2021Hard domestic water has been reported to worsen atopic eczema (AE) and may contribute to its development in early life. (Meta-Analysis)
Meta-Analysis
BACKGROUND
Hard domestic water has been reported to worsen atopic eczema (AE) and may contribute to its development in early life.
OBJECTIVE
To review the literature on the relationship between the effect of water hardness (high calcium carbonate; CaCO ) on (a) the risk of developing AE, (b) the treatment of existing AE and (c) skin barrier function in human and animal studies.
DESIGN , DATA SOURCES AND ELIGIBILITY CRITERIA
We systematically searched databases (MEDLINE, Embase, Cochrane CENTRAL, GREAT and Web of Science) from inception until 30/6/2020. Human and animal observational and experimental studies were included. The primary outcomes were risk of AE and skin barrier function. Studies were meta-analysed using a random effects model. Evidence certainty was evaluated using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach.
RESULTS
Sixteen studies were included. Pooled observational data from seven studies on 385,901 participants identified increased odds of AE in children exposed to harder versus softer water (odds ratio 1.28, 95% CI 1.09, 1.50; GRADE certainty: very low). Two mechanistic studies in humans reported higher deposition of the detergent sodium lauryl sulphate in those exposed to harder versus softer water. Two randomized controlled trials comparing water softeners with standard care did not show a significant difference in objective AE severity with softened water (standardized mean difference 0.06 standard deviations higher, 95% CI 0.16 lower to 0.27 higher; GRADE certainty: moderate).
CONCLUSIONS & CLINICAL RELEVANCE
There was a positive association between living in a hard water (range: 76 to > 350 mg/L CaCO ) area and AE in children. There is no evidence that domestic water softeners improve objective disease severity in established AE. There may be a role of water hardness in the initiation of skin inflammation in early life, but there is a need for further longitudinal and interventional studies.
Topics: Animals; Calcium Carbonate; Dermatitis, Atopic; Detergents; Humans; Severity of Illness Index; Skin; Sodium Dodecyl Sulfate; Surface-Active Agents; Water; Water Softening
PubMed: 33259122
DOI: 10.1111/cea.13797 -
Clinical Pharmacokinetics May 2024Managing drug-food interactions is essential for optimizing the effectiveness and safety profile of quinolones. Following PRISMA guidelines, we systematically reviewed...
BACKGROUND AND OBJECTIVE
Managing drug-food interactions is essential for optimizing the effectiveness and safety profile of quinolones. Following PRISMA guidelines, we systematically reviewed the influence of dietary interventions on the bioavailability of 22 quinolones.
METHODS
All studies describing or investigating the impact of food, beverages, antacids, and mineral supplements on pharmacokinetic parameters or pharmacokinetic/pharmacodynamic indices of orally taken quinolones were considered for inclusion. We excluded reviews, in vitro and in silico studies, studies performed on animals, and those involving alcohol. We performed the search in Medline (via PubMed), Embase, and Cochrane Library, covering reports from database inception to December 2022. We used the following tools to assess the risk of bias: version 2 of the Cochrane risk-of-bias tool for parallel trials, the Cochrane risk-of-bias tool for cross-over studies, and the NIH quality assessment tool for before-after studies. We performed quantitative analyses for each quinolone if two or more food-effect studies with specified and comparable study designs were available. If meta-analyses were not applicable, we qualitatively summarized the results.
RESULTS
We included 109 studies from 101 reports. Meta-analyses were conducted for 12 antibiotics and qualitative synthesis was employed for the remaining drugs. Of the studies, 60.5% were open-label, cross-over, as recommended by FDA. We judged 46% of studies as having a high risk of bias and only 4% of having a low risk of bias. Among 19 quinolones with available food impact data, 14 (74%) had potentially clinically important interactions. For nalidixic acid, oxolinic acid, and tosufloxacin, food exerted a high positive impact on bioavailability (AUC or C increased by > 45%), whereas, for all the remaining drugs, postprandial absorption was lower. The most significant negative influence of food (AUC or C decreased by > 40%) occurred for delafloxacin capsules and norfloxacin, whereas the moderate influence (AUC or C decreased by 30-40%) occurred for nemonoxacin and rufloxacin. All 14 analysed quinolones showed a substantial reduction in bioavailability when co-administered with antacids and mineral supplements, except for calcium preparations. The impact of beverages was evaluated for 10 quinolones, with 50% experiencing significantly reduced absorption in the presence of milk (the highest negative impact for ciprofloxacin). Moreover, both ciprofloxacin and levofloxacin demonstrated compromised bioavailability when consumed with orange juice, particularly calcium-fortified.
DISCUSSION
Several factors may influence interactions, including the physicochemical characteristics of quinolones, the type of intervention, drug formulation, and the patient's health status. We assessed the quality of evidence as low due to the poor actuality of included studies, their methodological diversity, and uneven data availability for individual drugs.
PubMed: 38807006
DOI: 10.1007/s40262-024-01377-0 -
European Journal of Nuclear Medicine... Jan 2020To summarise data with radium-223 dichloride (RaCl), a mechanism-mediated targeted alpha therapy (TAT), in metastatic castration-resistant prostate cancer (mCRPC) and to...
PURPOSE
To summarise data with radium-223 dichloride (RaCl), a mechanism-mediated targeted alpha therapy (TAT), in metastatic castration-resistant prostate cancer (mCRPC) and to chart the development of TAT in mCRPC and in other tumour types.
METHODS
Literature for this systematic review was identified using a PubMed search: ("targeted alpha therapy" or "targeted alpha particle therapy") or (213-bismuth or bismuth-213 or 213Bi) or (225-actinium or actinium-225 or 225Ac) or (211-astatine or astatine-211 or 211At) or (212-lead or lead-212 or 212Pb) or (227-thorium or thorium-227 or 227Th) or (223-radium or radium-223 or 223Ra or alpharadin) and (malignancy or cancer). Results were limited to English-language publications in humans, with the article type "clinical trial".
RESULTS
Forty-one publications were included (30 from the literature search and 11 from manual searches/reviews). In clinical trials in mCRPC, RaCl monotherapy is well tolerated, with significantly longer overall survival than placebo and improved quality of life. Clinical trial data have been reinforced by findings from real-world studies. RaCl has also shown promise in other tumour types with bone metastases, including advanced breast cancer and advanced renal cell carcinoma (in combination with anti-vascular endothelial growth factor). Several astatine-211- and bismuth-213-labelled molecules have demonstrated anti-tumour activity and acceptable toxicity in other tumour types.
CONCLUSIONS
RaCl has demonstrated "proof of concept" for use of TAT in cancer in clinical practice. The efficacy and safety of RaCl monotherapy have been demonstrated in mCRPC, and RaCl combination therapies are under investigation in various tumours. TAT has broad applicability across tumour types.
Topics: Actinium; Astatine; Bismuth; Bone Neoplasms; Humans; Lead Radioisotopes; Male; Prostatic Neoplasms, Castration-Resistant; Quality of Life; Radioisotopes; Radium; Thorium
PubMed: 31471713
DOI: 10.1007/s00259-019-04475-5 -
The Journal of Laryngology and Otology Jul 2021This systematic review aimed to establish the evidence behind the use of pre-operative calcium, vitamin D or both calcium and vitamin D to prevent post-operative...
OBJECTIVE
This systematic review aimed to establish the evidence behind the use of pre-operative calcium, vitamin D or both calcium and vitamin D to prevent post-operative hypocalcaemia in patients undergoing thyroidectomy.
METHOD
This review included prospective clinical trials on adult human patients that were published in English and which studied the effects of pre-operative supplementation with calcium, vitamin D or both calcium and vitamin D on the rate of post-operative hypocalcaemia following total thyroidectomy.
RESULTS
Seven out of the nine trials included reported statistically significantly reduced rates of post-operative laboratory hypocalcaemia (absolute risk reduction, 13-59 per cent) and symptomatic hypocalcaemia (absolute reduction, 11-40 per cent) following pre-operative supplementation.
CONCLUSION
Pre-operative treatment with calcium, vitamin D or both calcium and vitamin D reduces the risk of post-operative hypocalcaemia and should be considered in patients undergoing total thyroidectomy.
Topics: Calcitriol; Calcium; Calcium Carbonate; Calcium-Regulating Hormones and Agents; Cholecalciferol; Humans; Hydroxycholecalciferols; Hypocalcemia; Postoperative Complications; Preoperative Care; Thyroidectomy; Vitamin D; Vitamins
PubMed: 34120662
DOI: 10.1017/S0022215121001523 -
The Turkish Journal of Gastroenterology... Jun 2022This study aimed to evaluate the efficacy and safety of high-dose dual therapy for Helicobacter pylori (H. pylori) eradication compared to bismuth-containing quadruple... (Meta-Analysis)
Meta-Analysis
BACKGROUND
This study aimed to evaluate the efficacy and safety of high-dose dual therapy for Helicobacter pylori (H. pylori) eradication compared to bismuth-containing quadruple therapy.
METHODS
The electronic database of PubMed, Embase, and Cochrane Library were searched from inception to March 18, 2021. Randomized, controlled trials that evaluated high-dose dual therapy versus bismuth-containing quadruple therapy for H. pylori infection were included.
RESULTS
We included 6 studies containing 1677 patients with H. pylori infection. This meta-analysis demonstrated that high-dose dual therapy achieved similar eradication rate compared with bismuth-containing quadruple therapy (intention-to-treat: 84.6% vs 83.7%, relative risk (RR) = 1.01, 95% CI: 0.97-1.06, P = .49; per-protocol = 88.4% vs 89.0%, RR = 1.00, 95% CI: 0.97-1.04, P = .99). However, highdose dual therapy showed fewer side effects (13.1% vs 32.0%, RR = 0.51, 95% CI: 0.34-0.78, P = .002) and better compliance (96.1% vs 93.3%, RR = 1.03, 95% CI: 1.00-1.05, P = .03) compared to bismuth-containing quadruple therapy.
CONCLUSION
This meta-analysis demonstrated that high-dose dual therapy is equally effective with bismuth-containing quadruple therapy in eradicating H. pylori, with fewer side effects and better compliance.
Topics: Anti-Bacterial Agents; Bismuth; Drug Therapy, Combination; Helicobacter Infections; Helicobacter pylori; Humans
PubMed: 35786612
DOI: 10.5152/tjg.2022.21579