Foote 1994
Supportive Therapie · Version 2.1
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Referenz (Autor, Jahr, Journal) |
Studientyp Mono- vs. Multizentrisch, Verblindung, Randomisierung, Arme, Fallzahl n, Land, Zeitraum |
Patienten-merkmale Indikation, Alter, Geschlecht (m/w) |
Intervention Fallzahl n, Beschreibung der präventiven bzw. therapeutischen Maßnahme Kontrolle Fallzahl n, Beschreibung der präventiven Maßnahme bzw. therapeutischen Maßnahme |
Zielgrößen Primärer Endpunkt Sekundäre(r) Endpunkt(e) |
Primärer Endpunkt Angaben für Intervention vs. Kontrolle Sekundäre(r) Endpunkt(e) Angaben für Intervention vs. Kontrolle |
Finanzierung |
Evidenzstufe Bei Abwertung: Angabe von Gründen Bewertung des Autors |
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Foote
1994
J Clin Oncol
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three-arm, placebo-controlled, randomized clinical trial
N = 52
May 1991 and April 1993 |
Patients scheduled to receive radiation therapy to include greater than one third of the oral cavity mucosa were selected for study
Age, years Median CM: 67.0 PM: 8.0 Mean CM: 64.5 PM: 59.7
Sex Female CM: 24 PM: 19 Male CM: 76 PM: 81
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n = 25 chlorhexidine mouthwash (CM) n = 27 placebo mouthwash (PM) |
Alleviation of Radiation-Induced Mucositis |
% of Patients Chlorhexidine Mouthwash vs. Placebo Mouthwash Maximum stomatitis severity graded by healthcare provider p = 0 .82 None CM:0 vs. PM: 4 Mild CM: 12 vs. PM: 19 Moderate CM: 32 vs. PM: 22 Severe CM: 48 vs. PM: 44 Very severe CM: 8 vs. PM: 11
% of Patients Chlorhexidine Mouthwash vs. Placebo Mouthwash Severity of mouthwash-induced discomfort P < .0001 None CM: 4 vs. PM 67 Mild CM 16 vs. PM:15 Moderate CM: 52 vs. PM: 15 Severe CM: 28 vs. PM:4 |
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2b endpoint failed
"In contrast to the prestudy hypothesis that a chlorhexidine mouthwash might provide benefit for patients receiving radiation therapy to the oral mucosa, this study provides strong evidence suggesting that a chlorhexidine mouthwash is detrimental in this clinical situation." |