<p>To evaluate efficacy of lycopene in oral leukoplakia (OLK) management, both clinically and histologically, in comparison to other conventional therapeutic approaches<b>.</b> Review adhered to PRISMA 2020 guidelines and PROSPERO (CRD42024543213) registration was done. Databases like PubMed, EBSCOhost and SCOPUS were searched since inception till April 2025 for studies comparing effect lycopene in OLK management compared to other conventional modalities for reduction in lesion size, clinical improvement (complete improvement, partial improvement and stable response) and histological improvement (atypical hyperplasia, mild dysplasia and moderate dysplasia). Quality assessment was performed using Cochrane risk of bias (ROB) -2 tool through Review Manager (RevMan) software version 5.3. The standardized mean difference (SMD), risk ratio (RR) and odds ratio (OR) was used as summary measure employing random effect model (p &lt; 0.05). Four studies underwent qualitative synthesis and two studies for meta-analysis with data evaluated from 439 patients with oral homogenous leukoplakia. Lycopene was compared with other conventional modalities like placebo, selenium, vitamin E, curcumin and <i>Calendula officinalis</i><b>.</b> Upon quality assessment, studies demonstrated a range of moderate to low risk of bias. Meta-analysis showed that no significant difference for reduction in lesion size (SMD = -0.64 (-1.39 – 0.12, p &gt; 0.05) while overall clinical and histologic improvements were seen more with lycopene (p &lt; 0.05*). Lycopene demonstrated superior efficacy in improving clinical and histologic parameters in patients with OLK, even when compared to other conventional treatment modalities. While lesion size reduction alone was not significantly different, the overall clinical response and histologic improvement suggest lycopene as a promising and effective chemo-preventive option for OLK management<b>.</b> This study highlights the clinical translational value of lycopene as an affordable, safe, and well-tolerated intervention for early-stage OLK. Given its potential to improve patient outcomes and reduce morbidity without reported adverse effects, lycopene may serve as an adjunct or alternative to conventional therapy, bridging the gap between preventive and therapeutic oral cancer strategies.</p>

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Efficacy of Lycopene in Oral Leukoplakia Management: A Systematic Review and Meta-Analysis

  • Amar Kumar Shaw,
  • Mahwish Rizwan,
  • Abhijeet V. Jadhav,
  • Prashant Rao,
  • Smita R. priyadarshini,
  • Sovesh Das

摘要

To evaluate efficacy of lycopene in oral leukoplakia (OLK) management, both clinically and histologically, in comparison to other conventional therapeutic approaches. Review adhered to PRISMA 2020 guidelines and PROSPERO (CRD42024543213) registration was done. Databases like PubMed, EBSCOhost and SCOPUS were searched since inception till April 2025 for studies comparing effect lycopene in OLK management compared to other conventional modalities for reduction in lesion size, clinical improvement (complete improvement, partial improvement and stable response) and histological improvement (atypical hyperplasia, mild dysplasia and moderate dysplasia). Quality assessment was performed using Cochrane risk of bias (ROB) -2 tool through Review Manager (RevMan) software version 5.3. The standardized mean difference (SMD), risk ratio (RR) and odds ratio (OR) was used as summary measure employing random effect model (p < 0.05). Four studies underwent qualitative synthesis and two studies for meta-analysis with data evaluated from 439 patients with oral homogenous leukoplakia. Lycopene was compared with other conventional modalities like placebo, selenium, vitamin E, curcumin and Calendula officinalis. Upon quality assessment, studies demonstrated a range of moderate to low risk of bias. Meta-analysis showed that no significant difference for reduction in lesion size (SMD = -0.64 (-1.39 – 0.12, p > 0.05) while overall clinical and histologic improvements were seen more with lycopene (p < 0.05*). Lycopene demonstrated superior efficacy in improving clinical and histologic parameters in patients with OLK, even when compared to other conventional treatment modalities. While lesion size reduction alone was not significantly different, the overall clinical response and histologic improvement suggest lycopene as a promising and effective chemo-preventive option for OLK management. This study highlights the clinical translational value of lycopene as an affordable, safe, and well-tolerated intervention for early-stage OLK. Given its potential to improve patient outcomes and reduce morbidity without reported adverse effects, lycopene may serve as an adjunct or alternative to conventional therapy, bridging the gap between preventive and therapeutic oral cancer strategies.