OBJECTIVE: To observe the therapeutic effect of salvia miltiorrhiza and prednisolone on patients with oral submucous fibrosis (OSF). METHODS: A total of 60 medium-term OSF patients and 60 advanced stage OSF patients were randomly divided into the first group (treated with both salvia miltiorrhiza and prednisolone) and the second group (treated with prednisolone alone). The clinical effect was compared between each group after 3-month treatment. RESULTS: Difference was found in the lesion area of the medium-term cases and the advanced stage cases of the first group before the treatment [(10.37+/-3.40) cm2, (19.60+/-3.27) cm2] and after the treatment [(5.90+/-4.10) cm2, (16.33+/-4.02) cm2] (P<0.05). Significant difference was found in the mouth opening before the treatment [(3.41+/-0.77) cm, (1.98+/-0.39) cm] and after the treatment [(3.87+/-0.67) cm, (2.26+/-0.46) cm] (P<0.05) in the first group. There was significant difference in the lesion area and mouth opening of the medium-term cases of the second group before the treatment [(10.87+/-3.18) cm2, (3.57+/-0.75) cm] and after the treatment [(6.70+/-3.75) cm2, (3.97+/-0.69) cm] (P<0.05). No difference in the lesion area and mouth opening of the advanced stage cases of the second group was found (P>0.05). There was difference in the therapeutic efficacy between the first group (70%) and the second group (16.67%) of the advanced stage cases (P<0.05), but not in the clinical effect between the 2 groups of the medium-term cases (P>0.05). The side effect of prednisolone could be reduced while used together with salvia miltiorrhiza. CONCLUSION: There is obvious advantage in treating OSF by the combination of salvia miltiorrhiza and prednisolone.
RCT Entities:
OBJECTIVE: To observe the therapeutic effect of salvia miltiorrhiza and prednisolone on patients with oral submucous fibrosis (OSF). METHODS: A total of 60 medium-term OSF patients and 60 advanced stage OSF patients were randomly divided into the first group (treated with both salvia miltiorrhiza and prednisolone) and the second group (treated with prednisolone alone). The clinical effect was compared between each group after 3-month treatment. RESULTS: Difference was found in the lesion area of the medium-term cases and the advanced stage cases of the first group before the treatment [(10.37+/-3.40) cm2, (19.60+/-3.27) cm2] and after the treatment [(5.90+/-4.10) cm2, (16.33+/-4.02) cm2] (P<0.05). Significant difference was found in the mouth opening before the treatment [(3.41+/-0.77) cm, (1.98+/-0.39) cm] and after the treatment [(3.87+/-0.67) cm, (2.26+/-0.46) cm] (P<0.05) in the first group. There was significant difference in the lesion area and mouth opening of the medium-term cases of the second group before the treatment [(10.87+/-3.18) cm2, (3.57+/-0.75) cm] and after the treatment [(6.70+/-3.75) cm2, (3.97+/-0.69) cm] (P<0.05). No difference in the lesion area and mouth opening of the advanced stage cases of the second group was found (P>0.05). There was difference in the therapeutic efficacy between the first group (70%) and the second group (16.67%) of the advanced stage cases (P<0.05), but not in the clinical effect between the 2 groups of the medium-term cases (P>0.05). The side effect of prednisolone could be reduced while used together with salvia miltiorrhiza. CONCLUSION: There is obvious advantage in treating OSF by the combination of salvia miltiorrhiza and prednisolone.