Effect of L. extract on functional constipation: A randomized, double-blind, placebo-controlled trial.

BACKGROUND

: This study aimed to investigate the efficacy of P. oleracea in the management of patients with functional constipation.

METHODS

: A total of 60 patients with functional constipation as defined by the Rome IV criteria were enrolled in this randomized, double-blind, placebo-controlled study; 70% ethanol extracts of the aerial parts of P. oleracea were used for the intervention. Patients were randomly assigned to the P. oleracea or placebo groups. Treatment response, quality of life, and changes in colonic transit time (CTT) were evaluated.

RESULTS

: Complete spontaneous bowel movement (CSBM) improved significantly in the P. oleracea group compared with that in the placebo group over 8 weeks of treatment (P = 0.003). Overall Patient Assessment of Constipation Quality of Life (PAC-QOL) and Patient Assessment of Constipation Symptoms (PAC-SYM) score improvements were observed in the P. oleracea group (P < 0.05). Moreover, CTT decreased from 44.5 ± 22.0 h to 33.7 ± 22.7 h in the P. oleracea group after 7 weeks of treatment (P = 0.04). There were no significant differences in the Bristol Stool Form Scale (BSFS) or adverse events between the groups.

CONCLUSIONS

: Compared to placebo, the use of P. oleracea in patients with functional constipation significantly improved CSBM, severity of symptoms, and quality of life. Further large studies are required to assess the benefits of P. oleracea in the treatment of functional constipation.