Abstract
Nigella sativa, Conyza bonariensis, and Alchemilla vulgaris are highly recommended in Greco-Arab traditional medicine as anti-hemorrhoid medicinal plants. The efficacy and safety of a topical cream (HPC) consisting of water–ethanol extracts of these three plants were evaluated here in vitro and in a randomized, double-blind, placebo-controlled study (RDBPC). HPC showed no significant cytotoxic effects in fibroblast cell line 3T3 (LDH-release and MTT assay); it inhibited the nitric oxide production by cultured monocyte cell line THP-1 in a dose-dependent manner (reaching the control levels of untreated cells at a concentration of 100 μg/mL). HPC showed a dose-dependent antibacterial activity against Escherichia coli (60% inhibition compared to Ampicillin at 5 mg/disc) and a significant vasoconstriction effect on intestinal vein rings (40% increase compared to phenylephrine). In a RDBPC with 77 hemorrhoidal disease (patients ages 19–61 years with a median grade of hemorrhoids of 2.0), we determined the anti-hemorrhoid efficacy and safety of HPC. The patients were randomly assigned to the HPC group (54 patients) or the placebo group (23 patients). They were asked to apply 2–3 mL of HPC or placebo twice daily for 6 days. The degree of hemorrhoidal disease severity, hemorrhage severity, pain, and itching served as an evaluation of the HPC efficacy. Compared to the placebo group, the obtained results showed that 6 days of treatment with HPC reduced the indexes of hemorrhage severity, severity of pain, and severity of itching to 0–1, 1, and 1 after 6 days, respectively. In conclusion, patients treated with HPC had a significant clinical improvement in all disease severity parameters compared to placebo. In vitro evaluations proved HPC to have significant antimicrobial, anti-inflammatory, and vasoconstriction effects. Therefore, HPC represents an interesting alternative treatment for hemorrhoidal disease.
Highlights
Hemorrhoids are characterized by enlargement, bleeding, and protrusion of clusters of veins in the anus located under the membrane that lines the lowest part of the rectum and anus
There is a plethora of medicinal plants and their therapeutic uses are mentioned in traditional Greco-Arab herbal medicine scripts written by famous medieval scholars such as Avicenna, Rhazes, and Ibn al-Bitar [6]
Most of these medicinal plants have a long history of traditional use, they lack sufficient evidence-based scientific data that are needed for approval as a new drug at the current time
Summary
Hemorrhoids are characterized by enlargement, bleeding, and protrusion of clusters of veins in the anus located under the membrane that lines the lowest part of the rectum and anus. 50% of people over the age of 50 having experienced symptoms of hemorrhoidal disease (HD). Pathologic symptoms of HD include fissures, fistulae, abscesses, or irritation and Immuno 2022, 2, 132–150. Immuno 2022, 2 itching [1,2,3]. Hemorrhoids can be either internal or external. The former occur inside the rectum and are usually not painful because this area lacks sensitive nerve endings. External hemorrhoids occur outside of the anal verge and are usually painful, accompanied by pruritus, itching, swelling, and burning sensations [1,2]
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