Abstract
Dried flowers and buds of Sophora japonica (Huaihua) are used in China, Japan and Korea for treating haematemesis and bleeding haemorrhoids. This study compared the clinical safety and efficacy of a Sophora flower formula with a placebo for the conservative treatment of symptomatic haemorrhoids. The study was a prospective, double-blind, randomized placebo-controlled trial. The clinical effective rate, symptom score and the incidence of important clinical events were used as observation indices to evaluate the effect of the Sophora flower formula. The results showed that after 7 days of treatment, improvement was observed in 87.0% of the patients' major symptoms in the Sophora flower formula group compared with 81.8% of those in the placebo group. After 14 days, 78.2% patients in the Sophora flower formula group were asymptomatic, whereas 40.9% of those in the placebo group exhibited residual symptoms. However, the difference between both groups was not statistically significant. As the bowel habits of the patients improved and as the patients took sitz baths, their symptoms improved drastically, regardless of the use of the Sophora flower formula. These findings indicate that the traditional Chinese Sophora flower formula is clinically safe; however, its effects on haemorrhoids need to be studied in a larger sample size and with different dosages. The present study results may be a potential clinical reference for physicians prescribing medications for patients with symptomatic haemorrhoids.
Highlights
Haemorrhoids are a common condition and are defined as vascular structures that extend from the subcutaneous arteriovenous vascular plexus (Lao et al, 2005; Loder et al, 1994; Thulesius and Gjores, 1973) in the anal region to the smooth muscle of the anal sphincter through the conjoined longitudinal muscle (Hansen, 1976; Thomson, 1975)
A total of 45 patients with symptomatic haemorrhoids completed the clinical trial, 40 of these patients experienced the major symptom of anal haemorrhage
The patients were randomly assigned to the Sophora flower formula group or placebo group by the Chinese and Western Clinical Trial Centre at our institution
Summary
Haemorrhoids are a common condition and are defined as vascular structures that extend from the subcutaneous arteriovenous vascular plexus (Lao et al, 2005; Loder et al, 1994; Thulesius and Gjores, 1973) in the anal region to the smooth muscle of the anal sphincter through the conjoined longitudinal muscle (Hansen, 1976; Thomson, 1975). They generate 15%–20% anal resting pressure and contribute to the complete closure of the anus (Lestar et al, 1989). There is scope for improvement in the field of medical treatment of haemorrhoids (Tchacondo et al, 2011)
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