Curaderm
– or is it? Revisited
The
Conspiracy to Subdue Curaderm-BEC5 is Rampant
Some time ago an article was submitted to the Medical Journal of Australia (MJA) to be considered for publication as a response to a previous “Letter to the Editor”.
The title of
the article was Curaderm – or is it? Revisited. Unfortunately
the Editor refused to publish this letter stating that MJA had limited
space available. This is rather strange because MJA usually encourage
responses to Letters published by them. Because the original Letter
by Francis et al had questioned the validity of Curaderm BEC5 and this
information is on the internet we have elected to bring the response
to their letter “Curaderm – or is it?” entitled
“Curaderm – or is it? Revisited” (our letter) to
the attention of the public. The article is self explanatory and
hopefully gives an
unbiased
opinion of the true effectiveness of Curaderm BEC5 for the treatment
of non melanoma skin cancers.
Curaderm – or is it? Revisited
Correspondence: Dr Bill Cham Ph.D. “Villa Del Aripo”, 353 Woodlands Drive, Sheldon Qld 4157 Australia Email: bill.cham@gmail.com
To the Editor:
The Department of Dermatology at the Royal Brisbane Hospital have previously
reported in this Journal that Curaderm was not a satisfactory treatment
for BCCs (1, 2). The deficiencies of their studies have previously
been addressed (3). Curaderm contains lower concentrations of solasodine
glycosides (BEC) than is found in edible fruit. In Australia,
Curaderm has been approved for the indication of keratosis by prescription.
. The product Curaderm is an effective topical cream for the treatment
of keratosis, basal cell carcinoma (BCC) and squamous cell carcinoma
(SCC) (4). Other published articles reported that solasodine glycosides
from the plant genus Solanum, such as the devil’s apple, kangaroo
apple and aubergine, have antineoplastic activities (4).
A multicentre, double blind, vehicle-controlled, randomised, parallel group study to assess the efficacy and safety of BEC 5 in the treatment of patients with BCC has now been completed. Instead of the brand name Curaderm, the preparation was termed BEC 5 in the clinical trial, because in Europe, another unrelated substance is registered as Curaderm. Curaderm and BEC5 essentially contain 50 mg of the active ingredient (BEC) per kg cream. All of the investigators were dermatologists (Table). Patients with BCCs applied the BEC 5 or vehicle cream twice daily for 8 weeks and were followed up for 14 months from the start of the treatment. The efficacy was defined by complete healing, confirmed by clinical and histological examination after 8 weeks ± 3 days of treatment. More BEC 5-treatment patients [41 out of 62 patients (66.1%)] were classed as successes than in the vehicle group of patients [8 out of 32 patients (25%)] at week 8 (p<0.001; Cochran-Mantel-Haenszyl test). BEC 5 was safe and generally well tolerated.
Subsequently, an open study comprising 41 patients was carried out at the Royal London Hospital. The trial included BEC 5 treatment of superficial and morpheoic (invasive) BCCs. The success rate of these lesions was 78%. The investigators concluded:
“BCC is a slow growing, locally invasive malignant skin tumour which mainly affects Caucasians. Dermatologists, plastic surgeons and radiotherapists jointly manage the afflictions. Such management usually involves surgery. The risks of surgical intervention are well known. Moreover, excision of BCC from the facial area often involves reconstructive surgery, which can be both time consuming and costly. Hence an alternative, safe and efficacious method of treatment of BCC that does not require physician or hospital attendance must be encouraged. In our view and experience BEC 5 is a topical preparation, which is safe and effective, ideal therapy for outpatient treatment. Hence BEC 5 is a much-needed alternative to surgery for BCC. It is a cost effective treatment for both primary and secondary skin care”.
The efficacy rates of the open trial paralleled the multi-centre efficacy rates. Success was defined as zero presence of BCC after histological examination of samples extracted from the lesion site by punch biopsy.
The results of these recent trials confirm the work with Curaderm published over a decade ago (4). In the earlier studies longer duration therapy, up to 13 weeks, resulted in removal of all BCC lesions that were treated.
To date no independent Phase III trials or open studies on SCC lesions have been conducted. However, earlier studies clearly indicate that Curaderm is also effective in eradicating SCC (4). The cosmetic end results of Curaderm-treated SCC lesions are very impressive. The Figure shows the clinical results of a Curaderm-treated pronounced SCC. No recurrence of the SCC lesion occurred after 5 years follow-up.
Our group predicated that the antineoplastic mode of action of the solasodine glycosides (BEC) was mediated through endocytic endogenous lectins (EELs) receptors on cancerous cells, culminating in lysosomotropic action of the solasodine glycosides resulting in tumour cell death (4). This hypothesis has been confirmed by independent groups (5) and is currently being widely investigated as a novel approach for cancer treatments.
In November 2003, approvals
have been obtained to commence human clinical trials on internal cancers
with solasodine glycosides at Sir Charles Gardiner Hospital in Perth,
Western Australia. The approval of these trials is based on the
promising antineoplastic, low toxicity results of the solasodine glycosides,
obtained in human cell culture and whole animal studies (4).
This Phase I/IIa trial will evaluate the safety, tolerability and pharmacokinetics of solasodine glycosides in patients with advanced tumours such as mesothelioma and malignant melanoma.
In conclusion, the question
regarding Curaderm – or is it? (2) Has now been answered
Curaderm – it sure is!
References
- Beardmore, G., Hart, V., Wilson, P. and Francis, D.B. (1989). Curaderm preliminary findings. Med. J. Australia, 150, 46 (Letter).
- Francis, D.B., Hart, V., Wilson, P. and Bearmore, G. (1989). Curaderm – or is it? Med. J. Australia, 151, 541-542 (Letter).
- Cham, B.E., Daunter, B. and Evans, R. (1990). Curaderm. Med. J. Austral. 152, 329-330.
- Cham, B.E. (1994). Solasodine glycosides as anti-cancer agents: Pre-clinical and clinical studies. Asia Pacif. J. Pharmacol. 9, 113-118.
- Nakamura, T., Komori, C., Lee, Y., et al (1996). Cytotoxic activities of Solanum steroidal glycosides. Biol. Biopharm. Bull 19, 546-566
Table
Centre number Investigator Study Centre – Dermatology Department
- Professor A Finlay University of Wales College of Medicine, Cardiff
- Dr R A C Graham-Brown Leicester Royal Infirmary, Leicester
- Dr R Cerio The Royal London Hospital, London
- Dr L J Cook St Mary’s Hospital, Portsmouth
- Dr J Hawk St Thomas Hospital, London
- Dr M Rustin Royal Free Hospital, London
- Dr D L Roberts Singleton Hospital, Swansea
- Dr G R Sharpe Royal Liverpool Hospital, Liverpool
- Dr P Kersey Derriford Hospital, Plymouth
- Professor C E M Griffiths Hope Hospital, Manchester
