Clinical Research
Background:
An open label study of a herbal topical drug (Psirelax) for patients with chronic plaque psoriasis
Joseph Shiri, Assi A Cicurel, Arnon D Cohen
Clalit Health Services, Siaal Research Center for Family Medicine and Primary Care, Faculty of Health Sciences, Ben-Gurion University, Beer-Sheva, Israel
Recently recommended by Maccabi Health Services.
The study was supported by an unrestricted grant fromcircle ltd. funded.
ABSTRACT
Background: Psirelax is an herbal topical medication used to treat patients with psoriasis.
Aims: To determine the efficacy of Psirelax in patients with chronic plaque psoriasis.
Methods: In an open study, patients with chronic plaque psoriasis were treated twice daily with Psirelax over a period of 4 weeks. Clinical assessment was performed using the Psoriasis Area and Severity Index (PASI).
Results: The study included 22 patients (15 men, 7 women) with a mean age of 48.9 ± 11.8 years. Psirelax was well tolerated and there were no local or systemic side effects. The PASI decreased by 59% from a mean of 5.9 ± 4.0 before treatment to 2.4 ± 2.4 after treatment (p<0.001). In 8 patients (36%) the PASI score decreased by more than 75% (PASI75). In 16 patients (73%) the PASI score decreased by more than 50% (PASI50).
Conclusions: Treatment with Psirelax psoriasis was well tolerated in patients with chronic plaque psoriasis. Psirelax use was associated with a decrease in disease severity, as judged by patients and physicians.
INTRODUCTION
Psoriasis is a chronic disease affecting 2% of the general population. Patients with psoriasis have a reduced quality of life and comparatively high rates of depression. Patients with mild to moderate psoriasis are usually treated with topical medications, while systemic therapy is usually reserved for those with moderate to severe disease.
In recent years, complementary and alternative medicine has been used by patients with psoriasis. In a study from Israel, Ben-Arye et al. Shown that many patients with psoriasis use herbal treatments (1).
Psirelax is an herbal topical medication used to treat patients with psoriasis. Psirelax contains natural ingredients: quince seed jelly, base cream, antioxidants (e.g. palm oil, wheat germ oil), skin emollients (e.g. sweet almond oil), absorption aids (e.g. jojoba oil), tissue regenerating and protective agents (e.g. grape seed oil), preservatives (e.g paraben) and thickeners (e.g. beeswax).
Preliminary uncontrolled observations have shown a beneficial effect of Psirelax in some patients with psoriasis. The main objective of this study was to determine the effectiveness of topical treatment with Psirelax in patients with chronic plaque psoriasis.
PATIENTS AND METHODS
This was an open label study to evaluate the tolerability of Psirelax treatment. Approval for the study was obtained from an institutional review board and each patient received written informed consent prior to enrollment in the study. The study was conducted in accordance with the ethical principles outlined in the Declaration of Helsinki and the GCP Guidelines.
Population
The study included men and women between the ages of 18 and 75 with a clinical diagnosis of psoriasis. All patients were in good general health and free of any disease or physical condition that may have interfered with assessment of plaque psoriasis. Excluded from the study were women who were pregnant, breastfeeding, planning to become pregnant, or women of childbearing potential who had not successfully used the same medically acceptable contraceptive methods in the past 3 months, patients using topical anti-psoriasis therapy on the areas who are to be treated within 1 week before the start of the study, patients who have received systemic biological therapy for the treatment of psoriasis within 12 weeks before the start of the study, patients who have received systemic psoriasis therapy within 4 weeks before the start of the study study, patients who received phototherapy within 4 weeks prior to the start of the study, patients with a recent history (within the past 12 months) of alcohol or drug abuse, patients with a history of non-compliance with medical treatment regimens, and patients with serious or unstable disease Adverse medical or mental conditions that, in the opinion of the investigator, could affect the subject’s safety or be successful in participating in the study.
Treatment
Psirelax is an herbal topical medication used to treat patients with psoriasis. Psirelax contains the following ingredients: 5%-15% quince seed jelly, 10%-40% natural base cream (e.g. Ferntree Cottage Pure Base Cream), 55%-75% blend of natural antioxidants (e.g. vitamin E, wheat germ) oil, safflower oil), natural skin emollients (e.g. sweet almond oil, sesame oil), natural absorption aids (e.g. jojoba oil, vegetable squalene), natural tissue regenerating and protecting agents (e.g. grapeseed oil, sunflower oil), natural preservatives (e.g. paraben , Tea Trea Essential Oil, Thyme Essential Oil, Grapefruit Seed Extract, Vitamin E) and natural thickeners (e.g. beeswax, aloe vera, medicinal petroleum jelly, coconut oil, guar gum, palm oil, borax).
Study design
The study was designed as an open-label study and included efficacy and safety assessments at weeks 2 and 4 after study enrollment.
Efficacy Ratings
Clinical response was measured using the Psoriasis Area and Severity Index (PASI). The PASI ranges from 0 to 72 and is based on an equation that combines percentage of body surface area (BSA) affected with an assessment of the extent and severity (erythema, desquamation, and induration) of psoriatic lesions at four anatomical sites (head), upper extremities, trunk and lower extremities).
Another objective of this study was to assess the tolerability of Psirelax, which was achieved by assessing local and systemic side effects at each visit.
Calculation of sample size
A calculation assuming a 40% response rate in patients treated with Psirelax indicated that a target sample size of 20 patients is sufficient to demonstrate preliminary treatment efficacy.
Statistical Analysis
Safety analyzes were performed on all patients receiving Psirelax for a patient
The analyzes of the effectiveness measures were based on the intent-to-treat cohort. Descriptive statistics were used to summarize the efficacy endpoints. Continuous variable results are presented as mean ± SD. To analyze statistically significant differences in the continuous parameters before and after treatment, the Wilcoxon test was used. Dichotomous variables were analyzed using Fisher exact tests. Logistic and linear regressions were used for multivariate analyses. P values ≤ 0.05 were considered statistically significant.
RESULTS
The study included 22 patients (15 men, 7 women) with a mean age of 48.9 ± 11.8 years. Psirelax was well tolerated and there were no local or systemic side effects. All patients included in the study completed the 4-week follow-up period. The screening process identified 3 additional patients who were excluded from the analysis for technical reasons.
Psirelax use was associated with a decrease in disease severity as assessed by PASI. The PASI decreased by 59% from a mean of 5.9 ± 4.0 before treatment to 2.4 ± 2.4 after treatment (p = 0.0001). In 8 patients (36%) the PASI score decreased by more than 75% (PASI75). In 16 patients (73%) the PASI score decreased by more than 50% (PASI50). The reduction in PASI was pronounced in women compared to men (57% of women achieved PASI75 compared to 26% in men) and showed a trend toward better outcomes in patients under 40 years of age (PASI75 was 40% in patients under 40 years of age, 36% in patients between 40-60 years and 33% in patients over 60 years) (Table I).
DISCUSSION
In the current study, we tested the safety and efficacy of a novel herbal topical drug (Psirelax) in patients with chronic plaque psoriasis. Psirelax contains natural ingredients such as quince seeds, sweet almond oil, jojoba oil, grapeseed oil and beeswax.
The results of the study show that Psirelax was well tolerated. No adverse events were observed. Psirelax use was associated with a decrease in disease severity, as judged by patients and physicians.
Complementary medicine includes therapeutic modalities derived from traditional and philosophical systems of medicine, and considers health and disease in the context of the human totality of body and mind. The effect of Psirelax observed in our patients thus shows the beneficial effect of this new complementary drug in patients with psoriasis.
Psirelax contains a unique blend of natural herbal oils and seeds that oil and emulsify the skin with potential anti-inflammatory and immune modulating activities.
Psirelax ingredients include sunflower oil, which contains high levels of essential fatty acids (e.g. linoleic acid) that improve the skin barrier. A sunflower oleodistillate has been shown to increase key epidermal lipid synthesis and reduce inflammation in vitro and in animal models. Sunflower oleodistillate has been shown to activate peroxisome proliferatively activated receptor-alpha in vitro, which stimulates keratinocyte differentiation, improves barrier function and improves lipid metabolism in the skin. Some studies have shown the effectiveness of sunflower oil in atopic dermatitis (4).
Psirelax also contains wheat germ oil, which has never been studied in the treatment of psoriasis. A study showing improvement in rheumatoid arthritis patients taking wheat germ suggested that modulation of apoptosis is responsible for the effect (6). Other natural oils used in Psirelax include sweet almond oil and jojoba oil. The oil form makes these natural oils effective as an emollient and moisturizer for human skin (7). Sweet almond oil has a weak antibacterial effect and can be used as a demulsifier, while jojoba oil has healing effects on acne, sunburn and chapped skin. Small studies have shown that sweet almond oil and jojoba oil have beneficial effects in patients with psoriasis through the inflammatory process of the skin. Patients treated with the oils showed clinical improvement after treatment (7-9).
Quince is used topically as compression for injuries, joint inflammation, nipple injuries and skin injuries. A topical lotion is used to soothe the eyes. Sweet almond is used topically as an emollient for chapped skin, to soothe mucous membranes, and as a weak antibacterial agent (7). Aloe Vera (Barbadensis) has been studied to treat psoriasis. Topical application of aloe extract 0.5% cream topically 3 times a day for 4 weeks significantly improved and increased the resolution of psoriatic plaques compared to placebo (10). Aloe extract cream appears to reduce desquamation, erythema, and infiltration and produce significant improvement in lesions in double-blind, placebo-controlled studies (11-12).
Beeswax is used by honey bees to build their honeycomb cells. Beeswax protects human skin from contact irritants and allergens (13-14). The benefits of beeswax for the treatment of psoriasis are supported by a study examining the healing effects of the combination of beeswax, honey, and olive oil in patients with psoriasis and atopic dermatitis (15).
It is possible that the Psirelax treatment outcome observed in the current study is due to the placebo effect or the smearing effect of the Psirelax formula. However, these preliminary results are encouraging and suggest that a double-blind, placebo-controlled study should be conducted to further evaluate the effectiveness of Psirelax in patients with psoriasis.