ABSTRACT
Randomised controlled clinical trials (RCTs) offer a unique opportunity to obtain controlled efficacy and safety data to support clinical decisions. However, most RCT reporting has a stronger focus on efficacy rather than safety. This study aimed to identify the safety profile of both probiotic and drug interventions in irritable bowel syndrome (IBS). In connection to this paper, an accompanying paper was published in which a meta-analysis was conducted to evaluate the efficacy of probiotic interventions compared to that of drug interventions in IBS. Together, these two studies provide a first assessment regarding the feasibility to determine a burden to benefit ratio for both probiotic and drug interventions in IBS. RCTs including participants (>18 years old) with IBS and comparing probiotic or drugs interventions with control groups were identified by a systematic search of MEDLINE (January 2015 - Jan 2021). Reported safety profiles in drug studies were completer and more detailed as compared with studies on probiotics. Several inconsistencies in safety reporting were identified between and within drug and probiotic studies, such as: didn't report on safety; only reported adverse reactions (ARs) or adverse events (AEs) with a certain severity; didn't report the total number of AEs; didn't split in the control- or experimental arm; didn't specify AEs; and used different thresholds for 'common' AEs. Hence, it is difficult to compare safety data from drug and probiotic RCTs across and between different studies. On the current approaches to safety reporting, we could not establish an unambiguous safety profile for neither probiotic and drug interventions in IBS. These shortcomings hamper a critical comparison of the burden to benefit ratio for IBS intervention.
Subject(s)
Irritable Bowel Syndrome , Probiotics , Adolescent , Humans , Irritable Bowel Syndrome/drug therapy , Probiotics/adverse effects , Randomized Controlled Trials as Topic , Treatment OutcomeABSTRACT
In a prospective study of 132 patients with an average age of 35 years, unstable intra-articular fractures of the distal radius were treated by external fixator. Only 15 cases required limited open reduction. Follow-up was for a mean of 42 months. There were few complications and 83% of patients had good or excellent results. There was a statistically significant correlation between the severity of the fracture and the clinical outcome, irrespective of radiological restoration. Articular and soft-tissue damage following violent compressive forces may lead to a degree of functional impairment.
Subject(s)
Fracture Fixation , Radius Fractures/surgery , Wrist Injuries/surgery , Adolescent , Adult , External Fixators , Female , Fracture Fixation/adverse effects , Fracture Fixation/methods , Humans , Male , Middle Aged , Radiography , Radius Fractures/complications , Radius Fractures/diagnostic imaging , Wrist Injuries/diagnostic imagingABSTRACT
In rat urine collected in all-glass metabolism cages, at least four strains of intestinal microflora were found: two types of E. coli, Enterobacter cloaceae and Proteus vulgaris. The number of bacteria of each strain increased with time. 2. The pH of the urine increased from 6-9 after 24 h to 8-95 after 120 h. The pH of the urine of neomycin-treated rats remained nearly constant over a period of two days. 3. Nitroreductase activity was present in the rat urine. Added p-nitrobenzoic acid was reduced within the first 24 h. Nitroreductase activity in the urine of neomycin-treated rats was significantly lower than in the urine of normal rats, during the second 24-h period only. 4. Collection of urine at -10 degrees prevented the consequences of contamination.
