Adjuvant treatment of chronic plaque psoriasis in adults by a herbal combination: Open German trial and review of the literature
Authors: Katlein Fran√ßa
Michael Tirant
Torello Lotti
Uwe Wollina
Journal: Dermatologic Therapy (2018)
Discipline: CLINICAL MEDICINE
Keywords: PASI; Soratinex¬Æ; clinical trials; herbal complex; psoriasis
Affiliations: Department of Dermatology and Venereology, Academic Teaching Hospital Dresden, Dresden, Germany., Department of Dermatology and Cutaneous Surgery, Institute for Bioethics & Health Policy, University of Miami Miller School of Medicine, Miami, Florida., Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, Florida., Centro Studi per la Ricerca Multidisciplinare e Rigenerativa, Universit√† Degli Studi "G. Marconi", Rome, Italy., Psoriasis and Skin Clinic, Melbourne, Victoria, Australia.

Abstract:  Psoriasis is a chronic inflammatory skin disease affecting up to 6% of the World population. Skin care is the basic approach to restore epidermal barrier function, provide symptomatic relief, and ensure remission-free periods. We performed an open trial using herbal complex Soratinex¬Æ (also known as Dr Michaels¬Æ) in adult patients with mild-to-moderate chronic plaque psoriasis without further improvement to previous treatments in the last 6 weeks. The products Cleansing Gel, Scalp &amp; Body Ointment, and Skin Conditioner were applied twice daily for 8 weeks. All patients achieved a Psoriasis Area and Severity Index (PASI) 50 response, 94.4% achieved a PASI 75, 66.7% achieved PASI 90, and 22.2% achieved a PASI 100. In week 8, 94.4% of patients were satisfied or very satisfied with the treatment that was well tolerated. We performed a literature review on published trials in children and adults suffering from psoriasis. Herbal complex Soratinex¬Æ achieved a PASI 50 or more in about 50-90% of patients. It ensures prolonged relapse-free periods and improves the quality of life. Adverse events are mild and seen in a minority of patients only. In conclusion, herbal complex allows safe and effective self-treatment of patients with psoriasis and improves patient's autonomy. 

Retracted: No

PubPeer comments:
 In this study, 18 psoriasis patients were enrolled in a single-center open trial at the Academic Teaching Hospital Dresden. They were treated with Soratinex (Dr. Michaels) herbal skin care products for a period of 8 weeks. The study was funded by Frankl Pharma, manufacturer of Soratinex. The paper states  This research received unrestricted financial supp (sic), suggesting that FP not only provided a couple of bottles of gel, but maybe paid salaries or honoraria to the authors. This makes it less likely that the study was done independently from the manufacturer s claims. In fact, the last author on this paper is the founder of Soratinex (source: https: www.franklpharma.co.uk article professortirant or https: www.soratinex.com professor-tirant ; both pages have been archived at archive.is). That is a huge conflict of interest. Yet, the authors write that there is no conflict of interest.  * How is there no conflict of interest if one of the authors of the paper is the founder of the company of the product the study investigates? * Did the authors receive money or other forms of compensation (e.g. hotel or airfare tickets) from FP? * Do any of the authors own stock options in Soratinex? There was no control group in which the patients received e.g. an ointment without the active ingredients. Maybe the paraffin in the ointment, not the herbal oil, was already enough to achieve the improvement of the psoriasis. Maybe going to the doctor for a check up every 2 weeks might already have helped with the severity of the symptoms (placebo effect). * Could the authors comment on a possible placebo effect? Even though this was a clinical trial, there is no statement about IRB approval or patient consent, even though the journal requires this, and although photos of patients bodies were used in the paperr. * Could the authors please comment on this lack of consent or other statements? The Results state:  No severe adverse events were recorded. Two patients reported a temporary mild pruritus at week 2. But the Discussion state that  Only mild adverse events were recorded such as itch, folliculitis, and skin rash in a minority of patients. * Could the authors please list all side effects and in how many patients they occurred? These two statements do not appear to be quite in agreement with each other. The effect of the treatment was measured by the affected body surface area (BSA) and Psoriasis Area and Severity Index (PASI) score. The score went to close to 0 for all patients, as shown in Figure 1. Yet, Figure 2 shows, although quite improved, still some affected skin in particular in d. * Assuming the authors showed the best results in Figure 2, how could this be scored as 0-1 in Figure 1? Were the photos reviewed by an independent reviewer who was blinded to knowing from which timepoint these were taken?  , 
 #1  , 
 In 2016, the entire [Volume 30, No. 2 (Supplement 3)] .pdf) of the J. Biol. Regul. Homeost. Agents was a series of advertisements for Dr Tirant s products written by the same authors.   Abstracts here. https: www.biolifesas.org jbrha abstracts30-2(S3).pdf ,