PMID- 33389001
OWN - NLM
STAT- MEDLINE
DCOM- 20210804
LR  - 20210804
IS  - 1434-4726 (Electronic)
IS  - 0937-4477 (Linking)
VI  - 278
IP  - 9
DP  - 2021 Sep
TI  - Evaluating the safety of oral methylene blue during swallowing assessment: a 
      systematic review.
PG  - 3155-3169
LID - 10.1007/s00405-020-06509-3 [doi]
AB  - OBJECTIVE: Methylene blue (MB) is frequently administered during fiberoptic 
      endoscopic evaluation of swallowing (FEES) to enhance visualization of pharyngeal 
      bolus transit. However, the safety of MB is being questioned since serious 
      adverse events (AEs) such as hemodynamic instability, hemolysis, and serotonin 
      syndrome were reported. The aim of this study is a systematic analysis of the 
      literature to obtain an evidence-based overview of AEs due to oral administration 
      of MB and to determine its safety as a food dye during swallowing assessment. 
      METHODS: A systematic literature search was carried out in PubMed, Embase, and 
      Cochrane Library. Two reviewers independently selected articles describing oral 
      administration of MB as a main diagnostic/therapeutic intervention, dosage, and 
      AEs. Expert opinions, conference papers, sample size < 10, and animal studies 
      were excluded. Level of evidence of the included studies was determined. RESULTS: 
      A total of 2264 unduplicated articles were obtained. Seventeen studies met the 
      inclusion criteria with 100% agreement between the two reviewers. Among these, 
      twelve studies were randomized controlled trials. In a pooled population of 1902 
      patients receiving oral MB, three serious AEs were reported related to MB. 
      Non-serious AEs showed a dose-related trend and were usually mild and 
      self-limiting. A meta-analysis could not be performed as studies were 
      methodologically too heterogeneous. CONCLUSION: Serious AEs due to oral 
      administration of MB are rare (n = 3, 0.16%). MB-related non-serious AEs are 
      mild, self-limiting, and show a dose-related trend. These findings indicate that 
      it is safe to use small amounts of MB as a food dye during swallowing 
      examinations.
CI  - (c) 2021. Springer-Verlag GmbH Germany, part of Springer Nature.
FAU - Tariq, Bina
AU  - Tariq B
AUID- ORCID: 0000-0002-8476-9946
AD  - Department of Otorhinolaryngology, Head and Neck Surgery, Maastricht University 
      Medical Center, Maastricht, The Netherlands. bina.tariq@outlook.com.
FAU - Simon, Sorina R
AU  - Simon SR
AD  - Department of Otorhinolaryngology, Head and Neck Surgery, Maastricht University 
      Medical Center, Maastricht, The Netherlands.
AD  - School for Oncology and Developmental Biology, GROW, Maastricht University, 
      Maastricht, The Netherlands.
AD  - Department of Radiology and Nuclear Medicine, Maastricht University Medical 
      Center, Maastricht, The Netherlands.
FAU - Pilz, Walmari
AU  - Pilz W
AD  - Department of Otorhinolaryngology, Head and Neck Surgery, Maastricht University 
      Medical Center, Maastricht, The Netherlands.
AD  - School for Mental Health and Neuroscience, MHeNs, Maastricht University, 
      Maastricht, The Netherlands.
FAU - Maxim, Andra
AU  - Maxim A
AD  - Department of Otorhinolaryngology, Head and Neck Surgery, Maastricht University 
      Medical Center, Maastricht, The Netherlands.
FAU - Kremer, Bernd
AU  - Kremer B
AD  - Department of Otorhinolaryngology, Head and Neck Surgery, Maastricht University 
      Medical Center, Maastricht, The Netherlands.
AD  - School for Oncology and Developmental Biology, GROW, Maastricht University, 
      Maastricht, The Netherlands.
FAU - Baijens, Laura W J
AU  - Baijens LWJ
AD  - Department of Otorhinolaryngology, Head and Neck Surgery, Maastricht University 
      Medical Center, Maastricht, The Netherlands.
AD  - School for Oncology and Developmental Biology, GROW, Maastricht University, 
      Maastricht, The Netherlands.
LA  - eng
PT  - Journal Article
PT  - Review
PT  - Systematic Review
DEP - 20210102
PL  - Germany
TA  - Eur Arch Otorhinolaryngol
JT  - 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
JID - 9002937
RN  - T42P99266K (Methylene Blue)
SB  - IM
MH  - *Deglutition
MH  - Humans
MH  - *Methylene Blue/adverse effects
MH  - Pharynx
OTO - NOTNLM
OT  - Adverse events
OT  - Dysphagia
OT  - Fiberoptic endoscopic evaluation of swallowing
OT  - Methylene blue
OT  - Safety
EDAT- 2021/01/04 06:00
MHDA- 2021/08/05 06:00
CRDT- 2021/01/03 20:36
PHST- 2020/09/24 00:00 [received]
PHST- 2020/11/17 00:00 [accepted]
PHST- 2021/01/04 06:00 [pubmed]
PHST- 2021/08/05 06:00 [medline]
PHST- 2021/01/03 20:36 [entrez]
AID - 10.1007/s00405-020-06509-3 [pii]
AID - 10.1007/s00405-020-06509-3 [doi]
PST - ppublish
SO  - Eur Arch Otorhinolaryngol. 2021 Sep;278(9):3155-3169. doi: 
      10.1007/s00405-020-06509-3. Epub 2021 Jan 2.