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Effect of a mixture of diosmin, coumarin glycosides, and triterpenes on bleeding, thrombosis, and pain after stapled anopexy: a prospective, randomized, placebo-controlled clinical trial

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Abstract

Purpose

We evaluated the efficacy of oral administration of a mixture of diosmin, coumarin glycosides, and Centella asiatica (Venoplant®) in preventing bleeding, pain, and thrombosis of internal and external hemorrhoids after stapled anopexy (SA).

Methods

SA was conducted in 182 patients with third-degree hemorrhoids. Preoperatively, patients were randomized evenly into two groups. Group A patients were administered Venoplant for 30 days post-SA, and group B received a placebo for 30 days post-SA. Patients received paracetamol for postoperative pain. Visit (v)1, v2, and v3 took place 7, 15, and 30 days postoperatively, respectively; bleeding (clinical examination), visual analog scale (VAS), thrombosis (clinical examination), and pain (paracetamol dosage, VAS) were evaluated.

Results

At v1, v2, and v3, the numbers of patients with bleeding in groups A and B were 21 and 46, 3 and 25, and 1 and 5, respectively (p < 0.05). At v1, v2, and v3, the numbers of patients in groups A and B with thrombosed internal hemorrhoids were 3 and 13, 2 and 11, and 1 and 8, respectively (p < 0.05). The number of patients who took at least one paracetamol tablet was similar in both groups at v1 but was significantly greater in group B than group A at v2 and v3 (p < 0.05); pain VAS scores were equivalent at v1 and significantly greater in group B than group A at v2 and v3 (p < 0.05).

Conclusions

Venoplant effectively reduced bleeding after SA, decreased the incidence of thrombosed internal hemorrhoids, and decreased postoperative pain.

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Acknowledgments

We thank Mr. Simone Teso, MD (University of Padua, Italy), for performing the statistical analyses.

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Correspondence to Michele Schiano di Visconte.

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Conflict of interest

Aesculapius Pharmaceuticals (Brescia, Italy) provided Venoplant, the placebo, and paracetamol tablets. The authors enrolled patients independently and did not provide access to data or results to staff from Aesculapius Pharmaceuticals. Statistical analyses were undertaken in a blinded fashion by an independent statistician who communicated the results to the authors only at the end of the study.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study.

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Schiano di Visconte, M., Nicolì, F., Del Giudice, R. et al. Effect of a mixture of diosmin, coumarin glycosides, and triterpenes on bleeding, thrombosis, and pain after stapled anopexy: a prospective, randomized, placebo-controlled clinical trial. Int J Colorectal Dis 32, 425–431 (2017). https://doi.org/10.1007/s00384-016-2698-z

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