Rose geranium in sesame oil nasal spray to improve nasal vestibulitis symptoms: a randomized controlled trial.
Isotonic saline
Rose geranium
Sesame oil
Journal
Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer
ISSN: 1433-7339
Titre abrégé: Support Care Cancer
Pays: Germany
ID NLM: 9302957
Informations de publication
Date de publication:
24 May 2024
24 May 2024
Historique:
received:
01
12
2023
accepted:
14
05
2024
medline:
25
5
2024
pubmed:
25
5
2024
entrez:
24
5
2024
Statut:
epublish
Résumé
The purpose of this phase III randomized double-blinded controlled trial was to investigate the efficacy of a rose geranium in sesame oil (RG) nasal spray compared with an isotonic saline (IS) nasal spray for alleviating nasal vestibulitis symptoms among patients undergoing chemotherapy. Patients undergoing active chemotherapy who reported associated nasal symptoms were randomized 1:1 to receive RG or IS, administered twice daily for 2 weeks. Consenting participants completed nasal symptom questionnaires at baseline and then weekly while on treatment. The proportion of patients experiencing improvements in their nasal symptoms 2 weeks after initiating the nasal spray, using a six-point global impression of change score, was estimated within and between each randomized arm, and compared between arms, using Fisher's exact test. The estimated odds ratio was determined (95% confidence interval). One hundred and six patients consented to this study; 43 participants in the RG arm and 41 in the IS arm were evaluable for the primary endpoint. Participants had a mean age of 57.8 years (SD 13.9). Demographic characteristics and baseline nasal symptoms were similar between arms. Of the evaluable participants who received RG, 67.4% reported improved nasal symptoms, compared with 36.6% of the participants who received IS (P = 0.009). Adverse events were sparse and did not differ between arms. Rose geranium in sesame oil significantly improves nasal vestibulitis symptoms among patients undergoing chemotherapy. NCT04620369.
Identifiants
pubmed: 38789656
doi: 10.1007/s00520-024-08580-6
pii: 10.1007/s00520-024-08580-6
doi:
Substances chimiques
Nasal Sprays
0
Sesame Oil
8008-74-0
Antineoplastic Agents
0
Banques de données
ClinicalTrials.gov
['NCT04620369']
Types de publication
Journal Article
Randomized Controlled Trial
Clinical Trial, Phase III
Comparative Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
379Informations de copyright
© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.
Références
Ruiz JN, Belum VR, Boers-Doets CB et al (2015) Nasal vestibulitis due to targeted therapies in cancer patients. Support Care Cancer 23(8):2391–2398
doi: 10.1007/s00520-014-2580-x
pubmed: 25876156
pmcid: 4536911
Cathcart-Rake E, Smith D, Zahrieh D, Jatoi A, Yang P, Loprinzi CL (2018) Nasal vestibulitis: an under-recognized and under-treated side effect of cancer treatment? Support Care Cancer 26(11):3909–3914
doi: 10.1007/s00520-018-4261-7
pubmed: 29797079
Cathcart-Rake EJ, Zahrieh D, Smith D et al (2021) Natural history of nasal vestibulitis associated with paclitaxel, docetaxel, and other chemotherapy agents: a Minnesota Cancer Clinical Trials Network (MNCCTN) study. Support Care Cancer 29(11):6253–6258
doi: 10.1007/s00520-021-06190-0
pubmed: 33851235
King D, Mitchell B, Williams CP, Spurling GK (2015) Saline nasal irrigation for acute upper respiratory tract infections. Cochrane Database Syst Rev 4:CD006821
Adappa ND, Wei CC, Palmer JN (2012) Nasal irrigation with or without drugs: the evidence. Curr Opin Otolaryngol Head Neck Surg 20(1):53–57
doi: 10.1097/MOO.0b013e32834dfa80
pubmed: 22143336
Chong LY, Head K, Hopkins C et al (2016) Saline irrigation for chronic rhinosinusitis. Cochrane Database Syst Rev 4:CD011995
pubmed: 27115216
Reh DD, Hur K, Merlo CA (2013) Efficacy of a topical sesame/rose geranium oil compound in patients with hereditary hemorrhagic telangiectasia associated epistaxis. Laryngoscope 123(4):820–822
doi: 10.1002/lary.23736
pubmed: 23401038
Bjork-Eriksson T, Gunnarsson M, Holmstrom M, Nordqvist A, Petruson B (2000) Fewer problems with dry nasal mucous membranes following local use of sesame oil. Rhinology 38(4):200–203
pubmed: 11190757
Johnsen J, Bratt BM, Michel-Barron O, Glennow C, Petruson B (2001) Pure sesame oil vs isotonic sodium chloride solution as treatment for dry nasal mucosa. Arch Otolaryngol Head Neck Surg 127(11):1353–1356
doi: 10.1001/archotol.127.11.1353
pubmed: 11701073
Kim JY, Jung JW, Choi JC, Shin JW, Park IW, Choi BW (2014) Recurrent lipoid pneumonia associated with oil pulling [Correspondence]. Int J Tuberc Lung Dis 18(2):251–252
doi: 10.5588/ijtld.13.0852
pubmed: 24429325
Kuroyama M, Kagawa H, Kitada S, Maekura R, Mori M, Hirano H (2015) Exogenous lipoid pneumonia caused by repeated sesame oil pulling: a report of two cases. BMC Pulm Med 15:135
doi: 10.1186/s12890-015-0134-8
pubmed: 26518258
pmcid: 4628246
ClinicalTrials.gov. Identifier NCT04620369, Rose geranium in sesame oil nasal spray as an agent to improve symptoms of nasal vestibulitis: a phase III double blinded randomized controlled trial. Published 2020. https://classic.clinicaltrials.gov/ct2/show/NCT04620369
Pocock SJ, Simon R (1975) Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics 31(1):103–115
doi: 10.2307/2529712
pubmed: 1100130
Cathcart-Rake EJ, Smith D, Zahrieh D et al (2020) Rose geranium in sesame oil nasal spray: a treatment for nasal vestibulitis? BMJ Support Palliat Care 10:411–413