Abstract | OBJECTIVE: PATIENTS AND DESIGN: In this randomised, double-blind, pilot study a total of 30 patients of either sex with chemoradiation-induced oral mucositis were randomised to receive MF 5232 (n = 15) or a matching placebo (n = 15) after food three times a day for 7-10 days. Patients were evaluated using validated and standardised scoring systems at baseline and after 7-10 days of treatment. RESULTS: There were 11 evaluable patients in each treatment group. There was a significant reduction in mean mucositis scores with MF 5232 as follows: WHO (from 3.0 to 1.8), Radiation Therapy Oncology Group (gross score: from 2.8 to 1.8; functional score: from 2.9 to 1.0), and Objective Scoring System (ulceration score: from 7.4 to 4.4; erythema score: from 13.7 to 7.0). There were no significant changes in scores for placebo recipients. The treatments were well tolerated, with the exception of two patients in the treatment group who reported a burning sensation in the mouth after dissolving the wafer. CONCLUSION: This pilot study provided positive evidence for the efficacy of MF 5232 therapy in chemoradiation-induced mucositis. This was probably a result of its local analgesic, antioxidant and immunomodulatory activity and wound-healing properties. Further in-depth analysis in a larger number of patients is required to confirm these positive results.
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Authors | M U R Naidu, G Venkat Ramana, S Venkat Ratnam, T Sudhavani, K Jaganath Rao Naidu, P Roy, P Suresh, P Usha Rani, I Krishna Mohan |
Journal | Drugs in R&D
(Drugs R D)
Vol. 6
Issue 5
Pg. 291-8
( 2005)
ISSN: 1174-5886 [Print] New Zealand |
PMID | 16128599
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Gels
- Plant Extracts
- Plant Preparations
- mucotrol
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Topics |
- Administration, Oral
- Double-Blind Method
- Female
- Gels
- Humans
- Male
- Middle Aged
- Oral Hygiene
- Pilot Projects
- Plant Extracts
(administration & dosage, therapeutic use)
- Plant Preparations
(administration & dosage, therapeutic use)
- Prospective Studies
- Stomatitis
(drug therapy, etiology)
- Treatment Outcome
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