Abstract
OBJECTIVES: Conservative treatment for hemorrhoids may be long-term, but there are only a few studies that have reported on the long-term use of corticosteroid-containing preparations. Therefore, the aim of this study was to conduct a clinical investigation into the long-term use and safety of Killed Escherichia coli suspension-hydrocortisone combination ointment for the treatment of hemorrhoids. METHODS: A review of 578 hemorrhoid patients who experienced an adverse reaction to Killed Escherichia coli suspension-hydrocortisone combination ointment at Coloproctology Center Takano Hospital between June 2019 and December 2019 was conducted. RESULTS: Of the 578 patients included in the analysis, 430 patients (74.4%) had internal hemorrhoids and the median duration from the date of initial diagnosis was 0.70 months. The median prescription period of patients treated with Killed Escherichia coli suspension-hydrocortisone combination ointment was 20 days, and no adverse reactions were observed. When the prescription period of patients treated with Killed Escherichia coli suspension-hydrocortisone combination ointment was categorized into a within 30-day period (n=332), a 31-90-day period (n=63), and a ≥91-day period (n=23), the median disease duration at initial diagnosis was 0.46 months, 1.00 months, and 8.00 months, respectively. These findings indicate that the prescription period tended to be longer as the disease duration increased. CONCLUSIONS: In this study, the onset of adverse reactions to the use of Killed Escherichia coli suspension-hydrocortisone combination ointment in the treatment of hemorrhoids could not be confirmed. Further studies to investigate the safety of the long-term use of this treatment needs to be conducted.