Bardy 2012

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

Bardy

2012

Br J Oral Maxillofac Surg

a 2-arm, double-blind, randomised, controlled

trial

n = 131

UK

Oral or oropharyngeal cancer

Manuka honey vs. Golden syrup

Median age (years): 59 (39–85) vs. 58 (38–83)

Sex

Male: 53 vs. 46

Female: 11 vs. 17

Manuka honey

(n = 64)

Golden syrup

(n = 63)

main aim: effect of active manuka honey on the grade and duration of mucositis

Secondary aims: assessment of the microbiological flora in the mouth,

the requirements for antimicrobial drugs and analgesia, the degree of weight loss, and the need for tube feeding

incidence of grade 3 mucositis:

no difference (p = 0.64) in AMH 51/64 (80%) vs. placebo 47/63 (75%)

severity or duration of mucositis

no significant difference (p = 0.79)

AMH group vs. the golden syrup group

Honey (n = 64) vs. Syrup (n = 63)

New cases of MRSA:  5/63 (8%) vs. 4/60 (7%)

Fungal colonisation: 40/64 (63%) vs. 45/63 (71%)

Bacterial colonisation: 18/64 (28) vs. 17 (27%)

Need for antifungals: 40 (63%) vs. 45 (71%)

Need for antibiotics: 44/64 (69%) vs. 44/63 (70%)

Need for opiate analgesics: 52/64 (81%) vs. 52/63 (83%)

Weight loss (%) & median range: 8% (0–24%) vs. 9 (0–22%)

Need for tube feeding: 23/64 (36%) vs. 22/63 (35%)

-

2b

Endpoint failed
poor compliance

"This large randomised controlled trial failed to show that honey ameliorated radiation-induced mucositis, but there was a notable reduction in the incidence of bacterial infections in both arms. Compliance was a problem once mucositis had developed, so the findings require clarification in large multicentre trials. A different formulation of honey should be used for future studies, and we recommend using only the active ingredients and using a more liquid formula."