OBJECTIVES: To evaluate and compare the therapeutic response of lycopene and curcumin with placebo in patients suffering from oral submucous fibrosis (OSMF) and to correlate the habit variables of smoked and smokeless tobacco products in OSMF. METHODS: A randomized placebo-controlled parallel clinical study was conducted on ninety OSMF patients, who were divided into three treatment groups using computer-generated randomization. Group A patients (n = 30) were given curcumin tablet (300 mg) twice daily, Group B patients (n = 30) received lycopene capsules (8 mg) twice daily, and for Group C (n = 30), placebo capsules were given once daily for a period of six months. Both the participant and outcome assessor were blinded. Pre- and post-treatment comparison of mouth opening, burning sensation, tongue protrusion, and cheek flexibility was analyzed at periodic follow-up of 9 months. RESULTS: The overall improvement in mouth opening, burning sensation, tongue protrusion, and cheek flexibility was 3.9 ± 4.9 mm, 4.8 ± 2.6, 5.0 ± 7.2 mm, & 0.36 ± 0.71 mm, respectively, for curcumin and 4.1 ± 4.2 mm, 5.0 ± 2.3, 2.4 ± 3.5 mm, & 0.66 ± 0.80 mm, respectively, for lycopene with the p value <0.05. CONCLUSION: Statistically significant improvement in clinical findings was observed in both curcumin and lycopene treatment groups in comparison with placebo. However, the therapeutic efficacy of curcumin and lycopene was found to be almost equal in OSMF patients.
RCT Entities:
OBJECTIVES: To evaluate and compare the therapeutic response of lycopene and curcumin with placebo in patients suffering from oral submucous fibrosis (OSMF) and to correlate the habit variables of smoked and smokeless tobacco products in OSMF. METHODS: A randomized placebo-controlled parallel clinical study was conducted on ninety OSMF patients, who were divided into three treatment groups using computer-generated randomization. Group A patients (n = 30) were given curcumin tablet (300 mg) twice daily, Group B patients (n = 30) received lycopene capsules (8 mg) twice daily, and for Group C (n = 30), placebo capsules were given once daily for a period of six months. Both the participant and outcome assessor were blinded. Pre- and post-treatment comparison of mouth opening, burning sensation, tongue protrusion, and cheek flexibility was analyzed at periodic follow-up of 9 months. RESULTS: The overall improvement in mouth opening, burning sensation, tongue protrusion, and cheek flexibility was 3.9 ± 4.9 mm, 4.8 ± 2.6, 5.0 ± 7.2 mm, & 0.36 ± 0.71 mm, respectively, for curcumin and 4.1 ± 4.2 mm, 5.0 ± 2.3, 2.4 ± 3.5 mm, & 0.66 ± 0.80 mm, respectively, for lycopene with the p value <0.05. CONCLUSION: Statistically significant improvement in clinical findings was observed in both curcumin and lycopene treatment groups in comparison with placebo. However, the therapeutic efficacy of curcumin and lycopene was found to be almost equal in OSMF patients.