Evidence map›Paper›PMID 32700140›Full record

ArticleOncology and therapy2018

Effectiveness, Tolerability, and Safety of Ectoine-Containing Mouthwash Versus Those of a Calcium Phosphate Mouthwash for the Treatment of Chemotherapy-Induced Oral Mucositis: A Prospective, Active-Controlled, Non-interventional Study.

Van Anh Dao, Andreas Bilstein, Sabrina Overhagen, Lajos Géczi, Zoltán Baráth, Ralph Mösges

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Oncology and therapy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02816515 (Non Interventional Clinical Investigation of Ectoin® Mouth Wash for the Prevention and Treatment of Chemotherapy-induced Oral Mucositis), which is not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
1.5field-weighted citation impact, top 17% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02816515 completednot on this map

Non Interventional Clinical Investigation of Ectoin® Mouth Wash for the Prevention and Treatment of Chemotherapy-induced Oral Mucositis

TypeobservationalSponsorBitop AGRan2016 to 2017Enrolled46ConditionsMucositis
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 24 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Radiochemotheraphy-induced oral mucositis: Ectoin solution as a new treatment.Journal of clinical and experimental dentistry · 2022
    Article
  5. Article
  6. Review
  7. Review
  8. Review
  9. Article
  10. Article
  11. Ectoine lozenges in the treatment of acute viral pharyngitis: a prospective, active-controlled clinical study.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2019
    Article
  12. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 4 institutions in 2 countries.

Van Anh DaoCRI - Clinical Research International Ltd., Genter Str. 7, 50672, Cologne, Germany.ORCID http://orcid.org/0000-0002-6174-8309
Andreas BilsteinBitop AG, Carlo-Schmid-Allee 5, 44263, Dortmund, Germany. bilstein@bitop.de.
Sabrina OverhagenBitop AG, Carlo-Schmid-Allee 5, 44263, Dortmund, Germany.
Lajos GécziDepartment of Oncological Internal Medicine and Clinical Pharmacology "C", National Institute of Oncology Hungary, Budapest, 1026, Hungary.
Zoltán BaráthNational Korányi Institute of TB and Pulmonology, Budapest, 1121, Hungary.
Ralph MösgesCRI - Clinical Research International Ltd., Genter Str. 7, 50672, Cologne, Germany.
Schmid (Germany) · DENational Institute of Oncology · HUOrszágos Korányi Tbc és Pulmonológiai Intézet · HUUniversity of Cologne · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionOral mucositis is a frequent complication of cancer chemotherapy and radiotherapy. Ectoine is a natural extremolyte that can stabilize biological membranes and counteract inflammatory reactions. This study investigated ectoine-containing mouthwash for the prophylaxis and the treatment of oral mucositis. Its effectiveness, tolerability, and safety were compared to those of the local standard-of-care calcium phosphate mouthwash.

methodsThis prospective, active-controlled, observational study was conducted in two study centers in Hungary from January 2016 to October 2017. Sixty patients undergoing chemotherapy were to be recruited and allocated to one of three treatment arms: prophylactic treatment with ectoine (20 patients), active treatment with ectoine (20 patients), or calcium phosphate (20 patients). The study lasted 21 days, comprising four visits on day 0, day 7, day 14, and day 21.

resultsIn all, 45 patients were included in the study (prophylactic ectoine, 10 patients; active ectoine, 20 patients; calcium phosphate, 15 patients). In the prophylactic ectoine group, few mucositis symptoms of mild or moderate severity occurred throughout the study. In the active ectoine and the calcium phosphate groups, symptoms of mild and moderate severity at inclusion were reduced significantly after 14 days of treatment and were mostly resolved at the end of the study. The difference between the active ectoine and the calcium phosphate groups was not significant. According to patients' assessments, ectoine mouthwash was more effective and tolerable than calcium phosphate mouthwash.

conclusionsEctoine mouthwash is safe, well tolerated, and effective for the active treatment of oral mucositis following chemotherapy. Its effectiveness is comparable to that of calcium phosphate. Patients prefer ectoine mouthwash to calcium phosphate mouthwash. TRIAL REGISTRATION NUMBER: NCT02816515.

fundingBitop AG (Dortmund, Germany). Plain language summary available for this article.

Indexed as

ChemotherapyEctoineMouthwashMucositisOral care

Identifiers

PMID32700140
PMCPMC7360009
OpenAlexW2800718276

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.