Type of evaluation
The clinical evaluation is based on scientific literature available and clinical investigations reported in literature. Comprehensive laboratory tests preceded the pre-clinical and clinical trials and confirmed that polymethylsiloxane polyhydrate, in its medical form known as Enterosgel, has sufficiently high adsorption capacity towards substances of various molecular weight to be considered an adsorbent comparable with other materials used as oral (entero-) sorbents. Its distinctive feature is the high adsorption capacity towards large molecular weight substances, which can be considered as model biological toxins, and thus their removal from the organism by adsorption could be potentially beneficial for patients.
Clinical data generated and held by the manufacturer
According to the information obtained from Bioline Products s.r.o., they are currently undertaking new clinical trials and additional laboratory trials in the UK in order to generate new data, via Enteromed Ltd., the official UK distributor of Enterosgel®.
Enteromed Ltd., Company number 09055281, is registered at the official address: 10 John Street, London, WC1N 2EB, incorporated on 23rd May 2014.
Current ongoing clinical trials in the UK are:
– Randomised, multi-centre study to assess efficacy, tolerability and safety of Enterosgel® in treatment of acute diarrhoea in adults, Letter of HRA approval, 6th December 2016, IRAS project ID: 199390, Protocol number ENT02UK, REC reference: 16/NW/0818.
More than 450 scientific papers of Enterosgel efficacy are available
Clinical data from literature
The manufacturer has collected most of the information available about the laboratory and clinical research on Enterosgel and polymethylsiloxane, published in English, Russian and Ukrainian since the conception of this product back in late 1980s. The majority of clinical data and some laboratory data have been combined in three collections of papers in English (Enterosgel® 2013, 2014 and 2015), however some of the publications collected in these three sources are shorter versions of more comprehensive papers published earlier in the Russian and Ukrainian sources. Since the evaluator is fluent in both Slavic languages, these collections provided a useful guidance and source to find the original publications and reports. In the clinical review presented here, the references are given to the publication in one of the three Enterosgel® collections of papers and the original sources. The websites www.enteromed.eu, www.enteromed.co.uk, www.medsilica.com are linked to the manufacturer’s website and also provide a useful link to a significant number of publications. Access to the information about clinical studies is password protected but it is available for healthcare professionals who can request a password via e-mail to Enteromed Ltd or Medsilica Ltd. websites.
Further literature search was carried out using:
– key words and author names of the main databases such as Medline, Web of Science and Scopus;
– cited literature;
– patent search of EPO and USPO databases;
– internet searches
Search terms and key words used: diarrhoeal (diarrheal) diseases, diarrhea (diarrhea), irritable bowel syndrome, gastroenteritis, enterosgel, oral sorbent and oral sorption, enterosorbent and enterosorption, intestinal adsorption, anti-diarrhoeal (anti-diarrheal), polymethylsiloxane. Also taking into account a number of publications in Russian and Ukrainian, the equivalent key words in these languages were also used in literature search. This was also important because some of the English translations were not always clear and verification of the English translation in the language of origin was necessary.