The effect of leek (Allium iranicum (Wendelbo)) leaves extract cream on hemorrhoid patients: A double blind randomized controlled clinical trial

IntroductionConsidering the known pharmacological effects of Allium iranicum and the use of this herb in traditional Persian medicine (TPM) as an antihemorrhoid agent, we evaluated the efficacy of A. iranicum leaf extract cream for management of hemorrhoids in a double blind randomized placebo control trial.MethodsEighty patients with symptomatic hemorrhoids were randomly allocated to three groups to receive topical leek cream or placebo cream or routine cream for the management of hemorrhoids (antihemorrhoid) for a period of 3 weeks. Bleeding severity (primary), pain, defecation discomfort, anal itching severity, and overall subjective improvement (secondary) were assessed as outcomes of this study.ResultsA significant reduction was observed in the bleeding severity, anal pain, defecation discomfort and anal itching of all patients. The leek cream group had significantly less bleeding severity than standard antihemorrhoid and placebo groups at the end of the study (0.26 ± 0.75, 0.83 ± 1.09, 0.35 ± 0.93, respectively P = 0.04). The number of patients with more than 50% subjective improvement was also significantly more in the leek cream group compared to other groups (12, 5, 6, respectively P = 0.04). The mean reductions in pain, defecation discomfort and anal itching showed no significant difference between the three groups (P = 0.07, 0.39, 0.33, respectively).ConclusionThe current study showed significantly better outcomes for the leek group compared to the standard antihemorrhoid and placebo groups for bleeding severity and overall subjective improvement. However, there was no difference among topical use of leek, routine antihemorrhoid and placebo creams symptomatic relief of pain, defecation discomfort and itching. This trial was registered by Iranian Registry of Clinical Trials with the code: IRCT2014010816143N1 and also registered in ClinicalTrials.gov with identifier: NCT02301052.