Evidence map›Paper›PMID 31367460›Full record

ArticleJournal of pharmaceutical health care and sciences2019

The effectiveness of rebamipide mouthwash therapy for radiotherapy and chemoradiotherapy-induced oral mucositis in patients with head and neck cancer: a systematic review and meta-analysis.

Shinsuke Akagi, Takashi Fujiwara, Mai Nishida, Akiko Okuda, Yuka Nagao, Toshikatsu Okuda, Hidenori Tokuda, Kazunobu Takayanagi

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Journal of pharmaceutical health care and sciences, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06084624 (Evaluation of Topical Rebamipide Versus Topical Betamethasone for Management of Oral Ulcers in Behcet's Disease), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
2.6field-weighted citation impact, top 9% 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.

NCT06084624 phase1 / phase2unknown statusnot on this mapstarted 2023, after this paper: background citation

Evaluation of Topical Rebamipide Versus Topical Betamethasone for Management of Oral Ulcers in Behcet's Disease: A Randomized Clinical Trial

TypeinterventionalSponsorCairo UniversityRan2023 to 2025Enrolled40ConditionsOral Ulceration Due to Behçet's DiseaseArmsRebamipide mouthwash, Betamethasone mouthwash
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 24 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Rebamipide in gastric mucosal protection and healing: An Asian perspective.World journal of gastrointestinal pharmacology and therapeutics · 2025
    Review
  6. Review
  7. Evaluation of 5% Amlexenox Oral Paste and Rebamipide Tablets in Treatment of Recurrent Apthous Stomatitis and Comparison with Dologel CT.Indian journal of otolaryngology and head and neck surgery : official publication of the Association of Otolaryngologists of India · 2022
    Article
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

8 authors at 1 institution in 1 country.

Shinsuke Akagi1Department of Pharmacy, Ohara Healthcare Foundation Kurashiki Central Hospital, Okayama, Japan.ORCID 0000-0001-9065-8057
Takashi Fujiwara2Department of Otolaryngology/Head and Neck Surgery, Ohara Healthcare Foundation Kurashiki Central Hospital, Okayama, Japan.
Mai Nishida1Department of Pharmacy, Ohara Healthcare Foundation Kurashiki Central Hospital, Okayama, Japan.
Akiko Okuda1Department of Pharmacy, Ohara Healthcare Foundation Kurashiki Central Hospital, Okayama, Japan.
Yuka Nagao1Department of Pharmacy, Ohara Healthcare Foundation Kurashiki Central Hospital, Okayama, Japan.
Toshikatsu Okuda1Department of Pharmacy, Ohara Healthcare Foundation Kurashiki Central Hospital, Okayama, Japan.
Hidenori Tokuda1Department of Pharmacy, Ohara Healthcare Foundation Kurashiki Central Hospital, Okayama, Japan.
Kazunobu Takayanagi1Department of Pharmacy, Ohara Healthcare Foundation Kurashiki Central Hospital, Okayama, Japan.
Kurashiki Central Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOral mucositis is a frequent and severe adverse event in patients undergoing chemoradiotherapy for head and neck cancers, especially grade 3 or 4 mucositis. Occurrence may result in drop-out from treatment, thereby reducing survival. We aimed to clarify the effectiveness and safety of rebamipide mouthwash for oral mucositis in patients with head and neck cancer receiving treatment.

methodsWe carried out a systematic review and meta-analysis of patients with head and neck cancer who were treated with rebamipide mouthwash. We searched PubMed, EMBASE, and Cochrane Central Register of Controlled Trials (CENTRAL), and the World Health Organization (WHO) International Clinical Trial Registry Platform. The primary outcome was the incidence of severe oral mucositis, and secondary outcomes were time from treatment start to onset of oral mucositis, the response rate of radiotherapy, and any adverse events.

resultsWe included three studies comparing rebamipide versus placebo, all of which evaluating chemoradiotherapy induced oral mucositis. The chemotherapeutic agent was docetaxel in one study and cisplatin in the remaining two. Radiotherapy in each study consisted of 3D-conformal radiation therapy, intensity modulated radiation therapy and conventional radiation therapy, respectively. The calculated odds ratio was 0.29 [95% confidence interval (CI): 0.15 to 0.55], showing a positive association in the three studies between the incidence of grade 3-4 oral mucositis and chemotherapy for head and neck cancer. One study reported an onset of oral mucositis and the time to onset was 14.6 ± 6.4 days for the rebamipide group and 11.2 ± 4.4 days for placebo. One study reported a complete response of 8.3% for placebo and 16.7% for the rebamipide the group, and the partial response was 91.7 and 75.0%, respectively. Adverse events were reported in two studies to be 6.1 and 11.6% for placebo, and 19.4 and 26.0% in the rebamipide group, respectively.

conclusionsRebamipide mouthwash is effective in the prevention of severe mucositis and stomatitis. However, evaluation of adverse events in observational studies are needed.

Indexed as

Adverse eventChemoradiotherapyChemotherapyHead and neck cancerMeta-analysisMouthwashMucositisRebamipide

Identifiers

PMID31367460
PMCPMC6657071
OpenAlexW2963041904

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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.