SARS-CoV-2 has caused a global health crisis and mass vaccination programmes provide the best opportunity for controlling transmission and protecting populations. Despite the impressive clinical trial results of the BNT162b2 (Pfizer/BioNTech), ChAdOx1 nCoV-19 (Oxford/AstraZeneca), and mRNA-1273 (Moderna) vaccines, important unanswered questions remain, especially in patients with pre-existing conditions. In this position statement endorsed by the British Society of Gastroenterology Inflammatory Bowel Disease (IBD) section and IBD Clinical Research Group, we consider SARS-CoV-2 vaccination strategy in patients with IBD. The risks of SARS-CoV-2 vaccination are anticipated to be very low, and we strongly support SARS-CoV-2 vaccination in patients with IBD.Based on data from previous studies with other vaccines, there are conceptual concerns that protective immune responses to SARS-CoV-2 vaccination may be diminished in some patients with IBD, such as those taking anti-TNF drugs. However, the benefits of vaccination, even in patients treated with anti-TNF drugs, are likely to outweigh these theoretical concerns. Key areas for further research are discussed, including vaccine hesitancy and its effect in the IBD community, the effect of immunosuppression on vaccine efficacy, and the search for predictive biomarkers of vaccine success.
Study design: Postal survey. Objectives: To describe bowel management in community-dwelling spinal cord-injured (SCI) individuals and to explore associations between age, injury, dependency, problems, interventions and satisfaction. Setting: Outpatients of a single SCI unit, in the United Kingdom. Methods: Postal questionnaire to all outpatients with SCI for at least 1 year, of any level or density, aged 18 years or more. Results: Response rate was 48.6% (n ¼ 1334). Median age was 52 years, median duration of injury 18 years. The most common intervention was digital evacuation (56%). Up to 30 min was spent on each bowel care episode by 58% of respondents; 31-60 min by 22%; 14% spent over 60 min. Reported problems included constipation (39%), haemorrhoids (36%) and abdominal distension (31%). Reduced satisfaction with bowel function was associated with longer duration of each bowel care episode, faecal incontinence, greater number of interventions used and more problems reported (all Pp0.001); 130 (9.7%) had undergone any type of surgical bowel intervention. Impact of bowel dysfunction on the respondent's life was rated as significantly greater than other aspects of SCI (Pp0.001). Conclusions: Managing SCI bowel function in the community is complex, time consuming and remains conservative. Despite potential for bias from a low response, for this large group of responders, bowel dysfunction impacted most on life compared with other SCI-related impairments. The study findings demand further exploration of bowel management to reduce impact, minimize side effects and increase the choice of management strategies available.
Background Most people who begin statins abandon them, most commonly because of side effects. Objectives The purpose of this study was to assess daily symptom scores on statin, placebo, and no treatment in participants who had abandoned statins. Methods Participants received 12 1-month medication bottles, 4 containing atorvastatin 20 mg, 4 placebo, and 4 empty. We measured daily symptom intensity for each using an app (scale 1-100). We also measured the “nocebo” ratio: the ratio of symptoms induced by taking statin that was also induced by taking placebo. Results A total of 60 participants were randomized and 49 completed the 12-month protocol. Mean symptom score was 8.0 (95% CI: 4.7-11.3) in no-tablet months. It was higher in statin months (16.3; 95% CI: 13.0-19.6; P < 0.001), but also in placebo months (15.4; 95% CI: 12.1-18.7; P < 0.001), with no difference between the 2 (P = 0.388). The corresponding nocebo ratio was 0.90. In the individual-patient daily data, neither symptom intensity on starting (OR: 1.02; 95% CI: 0.98-1.06; P = 0.28) nor extent of symptom relief on stopping (OR: 1.01; 95% CI: 0.98-1.05; P = 0.48) distinguished between statin and placebo. Stopping was no more frequent for statin than placebo (P = 0.173), and subsequent symptom relief was similar between statin and placebo. At 6 months after the trial, 30 of 60 (50%) participants were back taking statins. Conclusions The majority of symptoms caused by statin tablets were nocebo. Clinicians should not interpret symptom intensity or timing of symptom onset or offset (on starting or stopping statin tablets) as indicating pharmacological causation, because the pattern is identical for placebo. (Self-Assessment Method for Statin Side-effects Or Nocebo [SAMSON]; NCT02668016 )
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