Efficacy and Safety of 4% Hibiscus rosa-sinensis Leaf Extract Ointment as an Adjunct Treatment to Compression Stockings on the Closure of Venous leg Ulcers

A Pilot Study

Martha Joy Maralit Bruan, MD; Elizabeth Amelia Tianco, MD

Disclosures

Wounds. 2019;31(9):236-241. 

In This Article

Abstract and Introduction

Abstract

Introduction: Venous leg ulcers (VLUs), the most common leg ulceration worldwide, are caused by venous hypertension due to venous reflux, the failure of the calf muscle to pump, and venous flow obstruction. They are associated with a reduced quality of life, particularly in relation to pain and physical function. Hibiscus rosa-sinensis is commonly employed because of its many medicinal properties, and studies have shown Hibiscus contains phytochemicals that have antimicrobial, antioxidant, and anti-inflammatory properties that promote wound healing.

Objective: The authors evaluate the efficacy and safety of 4% gumamela leaf extract ointment in the closure of VLUs among patients seen in a dermatology outpatient department in the Philippines.

Materials and Methods: The study included male or female patients with leg ulcers confirmed by duplex scan to be venous in origin and willing to have elastic compression therapy. Patients were instructed to clean the wound with normal saline solution and to apply the extract twice daily. The study was conducted for 12 weeks or until wound closure. Wounds were evaluated and photographed at baseline and every subsequent 2 weeks. Efficacy of therapy was evaluated based on ulcer area size using planimetry method at each visit. Safety was assessed using a 4-point grading system to monitor possible adverse reactions, namely pruritus, rash, burning, and urticaria.

Results: Twelve patients were included in the study; 5 patients had an initial ulcer area of > 10 cm2 and 7 had an initial ulcer area of ≤ 10 cm2. By the end of the study, 10 patients (83.3%) achieved complete ulcer closure in < 12 weeks, 1 patient (8.3%) had a decrease in ulcer area > 50% by week 12, and 1 patient (8.3%) had < 50% decrease in ulcer area at the end of the study.

Conclusions: Data showed compression stockings with 4% gumamela leaf extract ointment application could close VLUs in < 12 weeks. Applied with compression stockings, the ointment shows potential use in VLU management.

Introduction

The most common cause of chronic lower extremity ulceration is venous insufficiency, with about 600 000 new venous leg ulcers (VLUs) developing annually.[1] It accounts for nearly 80%[2–4] of all lower extremity ulcers, with an overall prevalence of 1% to 2%.[2] Venous leg ulcers are caused by venous hypertension due to venous reflux, failure of the calf muscle to pump, and venous flow obstruction. It is considered a chronic wound since the normal process of wound healing does not occur.[5] Instead, it goes through repairs but without restoring a functional skin barrier.

Currently, VLU management poses a significant burden on patients, their families, and the health care system.[4] Chronic venous insufficiency is associated with a reduced quality of life,[5] depression,[6] and social isolation.[6] In a population study conducted in the United Kingdom,[7] the median duration of ulceration was 9 months. The study also noted 20% of ulcers will not heal within 2 years and 66% of patients will have an ulcer lasting more than 5 years.[7] Venous ulcers have caused the loss of 2 million working days per year[8] and are estimated to account for 1% to 3% of the total health care budget in countries with a developed health care system.[6,9] Treating VLUs costs between $2.5 to $3.5 billion in the United States[10] and £1298 to £1526 in the United Kingdom annually.[11,12]

Venous ulcers of the lower extremity are a chronic, long-term problem and recurrence rates are as high as 70%.[3] The mainstay in the treatment of VLUs involves the use of compression therapy to reduce venous hypertension,[13,14] and multilayer compression bandaging is considered the gold standard of treatment.[15,16] However, only 30% of patients with VLUs will heal within 1 year with compression stockings alone.[17] Clinicians should consider other treatment modalities for unresponsive or noncomplaint patients, but there is no concensus on what second-line therapy is recommended. Although considered only as second-line treatment, wound dressings containing antiseptics, antimicrobials, cleansing agents, or autolytic debriding agents heal wounds by regulating or moisturizing the wound surface by moisture retention or exudate absorption protecting the wound base and periwound tissue.[1,7,18]

Traditionally, plant materials have been used to treat and heal wounds for thousands of years.[19] Among the plants that are known to have medicinal use, Hibiscus rosa-sinensis is one of those that are commonly employed because of its many medicinal properties. Wound healing is one of the reasons why it is commonly used all over the world. In a review conducted on various medicinal plants in India, animals treated with the ethanolic extract of the flowers of H rosa-sinensis exhibited an 86% reduction in the wound area compared with controls, who exhibited a 75% reduction.[19]H rosa-sinensis belongs to the family Malvacea and is commonly known as tropical hibiscus or Queen of the Tropics. In the Philippines, it is called gumamela. Its petals and leaves are crushed to create a paste that is applied on the wound twice daily until healed.[20,21] Studies have shown H rosa-sinensis contains phytochemicals that promote wound healing[22] and has anti-inflammatory, antioxidant, and antimicrobial properties that heal chronic wounds.[23]

The general objective of the present study is to determine the efficacy and safety of 4% gumamela leaf extract ointment in the closure of VLUs among patients seen in a dermatology outpatient department. The specific objectives were to determine (1) the proportion of patients who had a healed ulcer, (2) at what week complete healing of ulcer will occur with 4% gumamela leaf extract, (3) the adverse effects of 4% gumamela leaf extract ointment, and (4) the proportion of patients who had an adverse effect with 4% gumamela leaf extract.

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