Long-term effectiveness of lycopene in the management of oral submucous fibrosis (OSMF): A 3 year follow-up study.
J Oral Pathol Med. 2020 Jul 11. Epub 2020 Jul 11. PMID: 32652683
BACKGROUND: Long-term follow-ups after receiving lycopene therapy for management of Oral Submucous Fibrosis (OSMF) are scarce. The study aimed to assess the long-term efficacy of lycopene for management of OSMF symptoms.
METHODS: In this prospective clinical study, 400 clinically diagnosed early OSMF patients were assessed for the efficacy of lycopene in alleviation of burning sensation (BS) and reduced mouth opening (MO) symptoms in comparison to placebo. After one year follow up, group A (lycopene group) was divided equally into Group A1 and Group A2. Group A1 patients were retreated with lycopene and the A2 group was followed without retreatment. After 2 years follow up, the Group A2 patients were advised retreatment but not followed as most of the patient did not agree for follow-up. However, group A1 patients were continued to follow up every 6 months for a total 3 years. Statistical analysis was by independent sample t-test and p-value less than 0.05 were considered as significant.
RESULTS: A statistically significant difference (p<0.05) in BS and MO was found between group A and B with lycopene showing better results. At one year follow up, a statistically significant recurrence in the symptoms was found (p<0.05) in lycopene group (group A). After the second intervention, there was a statistically significant difference in the improvement of symptoms between the group A1 and A2 at 6-months and one year (p<0.05) with group A1 (retreatment) showing better results.
CONCLUSIONS: Treatment with lycopene led to improvement in the symptoms of OSMF in the present study. The results highlight the importance of retreatment of lycopene for its long-term effect on alleviation the symptoms of OSMF.