Observational Study
Copyright ©The Author(s) 2019. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. May 7, 2019; 25(17): 2133-2143
Published online May 7, 2019. doi: 10.3748/wjg.v25.i17.2133
Efficacy of Detoxsan® powder on diarrhea caused by gastrointestinal neuroendocrine tumors
Thomas Langbein, Wilfried Dathe, Anika Deuerling, Richard P Baum
Thomas Langbein, Anika Deuerling, Richard P Baum, Theranostics Center for Molecular Radiotherapy and Molecular Imaging, Zentralklinik Bad Berka, Bad Berka D-99437, Germany
Wilfried Dathe, Scientific Managment, Heck Bio-Pharma GmbH, Winterbach D-73650, Germany
Author contributions: Langbein T, Dathe W, Deuerling A, and Baum RP contributed to study design; Langbein T and Baum RP contributed to patient recruitment; Dathe W and Deuerling A contributed to data collection, data analysis; Dathe W wrote the first draft of the paper; Langbein T and Baum RP contributed to critical revision of the paper; Baum RP contributed to final approval of article.
Institutional review board statement: The study was reviewed and approved by the scientific direction of the Theranostics Center for Molecular Radiotherapy and Molecular Imaging, Zentralklinik Bad Berka in Germany.
Informed consent statement: All study participants, or their legal guardians, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: The authors declare that they have no conflict of interest. Dathe W is an external advisor for Heck Bio-Pharma GmbH and licenser for Detoxsan®.
Data sharing statement: No additional data are available.
STROBE statement: The authors declare that the STROBE statement was followed in the article entitled ‘Efficacy of Detoxsan® powder on diarrhea caused by gastrointestinal neuroendocrine tumors’ according to the checklist of items.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Corresponding author: Wilfried Dathe, PhD, DSc, Doctor, External Consultant in Medical Research, Scientific Managment, Heck Bio-Pharma GmbH, Gerberstraße 15, Winterbach D-73650, Germany. wilfried.dathe@gmx.de
Telephone: +49-177-2401817 Fax: +49-345-6846110
Received: November 25, 2018
Peer-review started: November 26, 2018
First decision: December 28, 2018
Revised: March 27, 2019
Accepted: March 29, 2019
Article in press: March 30, 2019
Published online: May 7, 2019
ARTICLE HIGHLIGHTS
Research background

Therapy-refractory diarrhea in neuroendocrine tumor (NET) patients reduces quality of life, strongly restricts their daily routine and is therefore a highly clinical unmet need.

Research motivation

Motivation of this investigation was reduce bowel movements in chronic diarrhea patients and by this to achieve a significant improvement in their quality of life.

Research objectives

To overcome the therapy-refractory diarrhea of patients with NETs by the zeolite containing medical advice Detoxsan® powder.

Research methods

For this purpose, patients were offered a well characterized zeolite product which is known to adsorb biogenic amines and water in large extent and it does not enter into the blood stream. The patients have been informed in detail about the product, the individual adaptation of the dosage and the documentation in a predefined table. Due to the fact that diarrhea syndrome is a disturbance of the daily routine the patients enrolled in this clinical trial respected these recommendations and showed an excellent compliance. In addition to the clinical trial, we determined some biochemical parameters in order to monitor if some undesired changes occur.

Research results

It is the first time that a well characterized zeolite product is able to reduce bowel movements in patients suffered by therapy-refractory diarrhea caused by NETs over a long time. In 14 of 20 patients (70%) enrolled in the trial bowel movement rate could be normalized. The application time to reach an acceptable bowel movement oscillated between few weeks up to a permanent or intermittent use. Also the dosage oscillated between 3 g per day up to three times 3 g per day. All of the 14 responder patients appreciated the normalization of the bowel movements in spite of the individual adaptation of dosage and time. There were no side effects. However, it is not clear which factors influence the reduction of diarrhea. At least one component namely serotonin seems to be involved in this physiological process. Therefore, the adsorption of this biogenic amine by this type of zeolite is under investigation. Furthermore, the serotonin metabolite 5-hydroxyindoleacetic acid should be determined in a 24-h urine collection. Using this method the natural serotonin secretion can be determined indirectly.

Research conclusions

The new finding of this study is the effective application of a well characterized zeolite product in patients suffered by therapy-refractory diarrhea caused by NETs. The attractive properties of the lattice structure of this mineral for excellent binding capacity for water, amines and harmful substances seem to possess a key function in overcome diarrhea symptoms in both temporary application and long term use. The individual dosage and period of application in order to receive the best reduction of diarrhea indicate that the physiological process of these symptoms is not fully understood and requires further investigations. For the clinical practice it is important to accept the individuality of this treatment to overcome patient’s diarrhea and improve their daily routine.

Research perspectives

We observed that a well characterized natural zeolite is able to overcome therapy-refractory diarrhea caused by NETs via passing the gastrointestinal tract only. However not all effects could be answered satisfactorily. Therefore, future research should be focused on the one hand to the adsorption of serotonin and other trigger substances for diarrhea by this zeolite. On the other hand the clinical treatment of NETs patients requires the determination of the biochemical factors in both blood and faeces in correlation the resected bowel part and the effect of this zeolite. The aim of these investigations should be the selective dosage of the mineral product on the basis of biochemical values and/or surgical data.