A double-blind, randomised-controlled trial compared the efficacy and safety of PHGG with placebo in adults with functional or IBS-associated chronic constipation1. The included participants (n=160) received 10 gr of PHGG daily or a matching placebo. The primary endpoint was the frequency of spontaneous bowel movements per week after 6 weeks of therapy. Dr Silvia Delgado-Aros (Nestle Health Sciences, Switzerland) presented the results.
At week 6, participants in the active arm had a mean increase in spontaneous bowel movements per week of 1.57, as compared with an increase of 1.14 in the placebo arm (P=0.034), meeting the primary endpoint. Also, the rate of responders, i.e. participants who had at least 3 spontaneous bowel movements per week and had an increase of at least 1 over the study period, was larger in the active arm than in the placebo arm (34.2% vs 17.7%; P=0.018). “To give a more practical result, the ‘number needed to treat’ in the active arm was 6,” according to Dr Delgado-Aros.
There were no reported serious adverse events (AEs) or discontinuations due to AEs. The AE rates were comparable in the placebo arm and the active arm, with 37.5% and 42.5% of the participants experiencing at least 1 AE, respectively. “The non-absorbable water-soluble fibre PHGG seems to have a place in the fibre recommendation space in patients with functional or IBS-associated chronic constipation,” concluded Dr Delgado-Aros.
Medical writing support was provided by Robert van den Heuvel.