The effect of HESA-A on psoriasis vulgaris

Journal of Drugs in Dermatology, June, 2008 by Amrollah Ahmadi, Babak Barikbin, Mohsen Naseri, Mohammadali Mohagheghi

Abstract

Background: Psoriasis vulgaris is one of the most common chronic skin disorders without any curative treatment. The aim of this study was to investigate the efficacy and safety of HESA-A in the treatment of psoriasis.

Methods: In a randomized, double-blind clinical trial, 28 patients (11 male, 17 female) with chronic plaque-type psoriasis were randomly assigned to treatment and placebo groups. Patients in treatment group received HESA-A tablet 25 mg/kg twice a day orally and control group received placebo with the same method for 6 months and were followed clinically during the study.

Results: At the end of study, in the treatment group psoriatic plaques were absent (no evidence of psoriasis or complete remission) in 9 cases (64-2%) and was very mild (controlled, but not entirely cleared) in 5 cases (35.8%). Disease relief was observed in 10 (71.4%) patients after 4 months, in 2 cases (14.3%) after 5 months and in 2 (14.3%) other patients after 6 months while none of the controls showed disease improvement.

Conclusion: This study showed rapid and good efficacy and safety of HESA-A in the treatment of plaque-type psoriasis.

Introduction

Psoriasis vulgaris is one of the most common chronic inflammatory skin disorders with unknown etiology that is characterized by erythematous scaly plaques. (1) Psoriasis is a multifactorial disorder, with both genetic and environmental factors. Psoriasis affects 1% to 3% of the world's population (2) and causes considerable disability. (3) There is no exact information about the prevalence of psoriasis in Iran.

Psoriasis impairs all aspects of the health-related quality of life of patients which is comparable to the reduction in quality of life with other diseases because it is a chronic disease and requires long-term treatment. (3), (4) Although various drugs have been developed, (5-7) there is no cure for psoriasis.8 Treating the inflammation is an important component of psoriasis management.

HESA-A is a drug of herbal-marine origin manufactured by Osveh Drug Co and is available for prescription in Iran. HESA-A contains nonorganic elements, such as CaO (43.787%), [P.sub.2][O.sub.5] (6.63%), N[a.sub.2]0 (3.689%), MgO (2.897%), S[O.sub.3], (2.193%), [K.sub.2]O (1.988%), Si[O.sub.2], (1.09%), F[e.sub.2][O.sub.3], (0.375%), A[l.sub.2][O.sub.3] (0.354%), organic elements (Tm, Zn, Cu, Ag, As, Mn, Ti, St, Br, Ca, Se, Te, Cd, Cs, Er, Lu), and other trace elements at very low quantities (9), (10); the physiological properties of these components may be able to accelerate the healing process. Some studies have demonstrated the antitumor properties of some of these elements. (11) The anticancer effects of HESA-A has been the subject of in vivo and in vitro studies. (9), (10), (12) in addition, the hepatoprotective effect of HESA-A against hepatic damage in rabbits was revealed in a previous study. (13)

This study was designed to investigate the clinical efficacy, safety, and adverse events of HESA-A in the treatment of psoriasis vulgaris.

Material and Methods

This randomized, double-blind clinical trial was conducted with a sample of 28 patients with psoriasis vulgaris. Patients were selected from a cohort of hospital outpatients and a private dermatology clinic between April 2006 and March 2007. Patients with a clinical diagnosis of plaque-form psoriasis vulgaris of the trunk and/or limbs were enrolled in the study and randomly assigned to the case group (14 patients) or control group (14 patients).

The study protocol was approved by the Cancer Institute Research Center, Tehran University of Medical Sciences, and each patient gave informed consent before enrollment in the study.

Patients with psoriasis other than chronic plaque-type (ie, guttate, erythrodermic, pustular, or arthritic psoriasis), patients with any skin infections, patients receiving any systemic and/or topical antipsoriatic treatment in the 8-week prior to the study, patients receiving any phototherapy (including psoralen ultraviolet A [PUVA] or narrow-band ultraviolet B [UVB]), patients with severe anxiety disorder, and pregnant or breastfeeding patients were excluded from the study.

Patients in the treatment group received a HESA-A tablet (25 mg/kg) twice a day and patients in the control group received a placebo with the same method for 6 months. Patients and physicians were blinded from the drug and placebo group.

Assessments

All examinations and assessments were performed by a single observer. After the initial assessment, patients were reassessed every 4 weeks for disease severity on a 6-pofnt scale: absent (no evidence of psoriasis); very mild (controlled, but not entirely cleared); mild (lesions of slight redness, thickness and scaliness); moderate (red lesions with moderate thickness and scaliness); severe (very red lesions with severe thickness and scaliness); and very severe (extremely red lesions with very severe thickness and scaliness) for a period of 6 months. After 6 months of treatment, patients were evaluated for any relapse or flaring of the disease.