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
Abstract
BACKGROUND

Patients with neuroendocrine tumors (NETs) of the gastrointestinal tract suffer frequently from chronic diarrhea. A well characterized medical advice containing zeolite (Detoxsan® powder) was applied to patients suffered from therapy-refractory diarrhea either by its frequency or by watery stool, despite receiving standard pharmacotherapy according to the guidelines for carcinoid syndrome and comorbidities. Detoxsan® powder acts as an adsorbent and might reduce significantly symptoms of diarrhea in patients suffering from NETs.

AIM

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

METHODS

A total of 20 patients (12 female and 8 male) suffering from diarrhea either by its frequency or from watery stool caused by NETs were included. In each patient, the diagnosis had been confirmed by histology and somatostatin receptors expression proven by positron emission tomography/computed tomography using Ga-68-labeled somatostatin analogs. All patients received standard-of-care pharmacotherapy and were additionally given Detoxsan® powder as an extemporaneous drug containing 90% natural Cuban zeolite and 10% magnesium aspartate. Recommended daily dosage ranges between 3 g once to three times per day. Each day dose and bowel movements were documented by the patients themselves in a pre-defined table. Additionally to the bowel movements quantitative determinations of serotonin, urea, creatinine and single ions were performed within the serum of the patients by commercially available equipment used as a matter of routine in the clinic.

RESULTS

All patients enrolled in this pilot study did not only suffer from NETs, but also from comorbidities and treatment-resistant diarrhea. There was insufficient control of diarrhea, most probably due to the secretion of hormones like serotonin produced by the slowly growing and highly differentiated NETs. All patients only took Detoxsan® powder as an antidiarrheal drug. In general, response effects need several days to become perceptible and require an intake of Detoxsan® powder for an extended time period or intermittently, if persisting stabilization of bowel movements could not be achieved. A correlation between NET grade, part and size of bowel resection and functionality of the tumor could not be demonstrated. Therefore, diarrhea seemed to be based on the metabolic activity of the well-differentiated NETs, which eventually led to treatment resistance. In summary, 14 out of the 20 patients (70%) declared to be very content with using Detoxsan® powder and observed a significant reduction of diarrhea, while the effective dose and intake period that resulted in a symptom relief varied individually.

CONCLUSION

Detoxsan® powder is able to reduce significantly symptoms of NET-related diarrhea in the majority of patients. The duration of taking Detoxsan® powder and its dosage vary individually.

Keywords: Neuroendocrine tumor, Diarrhea, Carcinoid syndrome, Treatment, Clinoptilolite, Mordenite, Zeolite

Core tip: A well characterized zeolite (Detoxsan® powder) was applied to patients with neuroendocrine tumors (NETs) of the gastrointestinal tract suffered from therapy-refractory diarrhea either by its frequency or by watery stool, despite receiving standard pharmacotherapy according to the guidelines for carcinoid syndrome and comorbidities. In 14 of 20 patients (70%) bowel movement rate could be normalized. Thus, Detoxsan® powder acts as an adsorbent and is able to reduce significantly symptoms of diarrhea in patients suffering from NETs. However, dose and period of intake have to be individually adjusted.