A real world evaluation of a treatment for infant colic based on the experience and perceptions of 4004 parents.

Infant colic (IC) is a common condition in young babies seen by primary care health professionals, especially health visitors. Nevertheless, the diagnostic criteria for IC are vague, which has resulted in a lack of clarity in published guidance on its causes and treatment. Credence has been given to alternative therapies, while health professionals are sceptical about the efficacy of over-the-counter treatments. Some 4004 parents of babies considered to have IC participated in this retrospective real world evidence study on the efficacy of a simeticone suspension in the treatment of IC. They were recruited via social media sources and were eligible for inclusion if their baby had received at least one dose of the simeticone suspension. Data were collected via an online questionnaire. The results showed that crying and discomfort-associated behaviour reduced and the babies' sleeping patterns improved following use of the suspension. More than two-thirds (69.7%) of respondents, who either used the suspension on its own or alongside another treatment, reported improvements in the signs of IC within one day. Almost all (93.2%) considered that its use was associated with either complete resolution of IC or had some effect on symptoms.

Evaluation of Clensia®, a new low-volume PEG bowel preparation in colonoscopy: Multicentre randomized controlled trial versus 4L PEG.

BACKGROUND: Success of colonoscopy is linked to the adequacy of bowel cleansing. Polyethylene glycol 4L (PEG 4L) solutions are widely used for colonic cleansing but with limitations concerning tolerability and acceptability. AIM: To demonstrate the equivalence of a new low-volume PEG containing citrates and simeticone (Clensia) versus a standard PEG 4L. METHODS: In this, multicentre, randomised, observer-blind trial, patients received either Clensia 2L or PEG 4L solution. Primary endpoint was the proportion of patients with colon cleansing evaluated as excellent or good. RESULTS: 422 patients received Clensia (n=213) or PEG 4L (n=209). Rate of excellent/good bowel cleansing was 73.6% and 72.3% in Clensia and PEG 4L group respectively. Clensia was demonstrated to be equivalent to PEG 4L. No SAEs were observed. Clensia showed better gastrointestinal tolerability (37.0% vs 25.4%). The acceptability was significantly better with Clensia in terms of proportion of subjects who felt no distress (Clensia 72.8% vs PEG 4L 63%, P=0.0314) and willingness-to-repeat (93.9% vs 82.2%, P=0.0002). The rate of optimal compliance was similar with both formulations (91.1% for Clensia vs 90.9% for PEG 4L, P=0.9388). CONCLUSIONS: The low-volume Clensia is equally effective and safe in bowel cleansing compared to the standard PEG 4L, with better gastrointestinal tolerability and acceptability.