A clinical trial of antioxidant supplements in the treatment of oral leukoplakia

Kaugars, George E.; Silverman, Sol; Lovas, John G.L.; Brandt, Richard B.; Riley, William T.; Dao, Quyen; Singh, Vir; Gallo, John

doi:10.1016/0030-4220(94)90039-6

Cited by 69 publications

(33 citation statements)

References 28 publications

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“…This modest experience is thus consistent with and corroborates reports from other groups that cite advantages of ''Antioxidant Therapy'' in treatment of leukoplakia [1,[27][28][29][30][31].…”

Section: Does Antioxidant Therapy Influence Lipid Peroxidase?supporting

confidence: 90%

Role of Measurement of Antioxidant Enzymes in Evaluation of Antioxidant Therapy in Tobacco Abusers with Oral Leukoplakia

Jain

Singh

et al. 2011

Indian J Otolaryngol Head Neck Surg

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Antioxidants are widely used in chemoprevention of malignancy. Numerous studies in medical literature have reported the evaluation of this treatment protocol by indirect methodology-epidemiology, invitro studies, pharmacology and animal models etc. However, there is a paucity of literature on the measurement of antioxidant enzymes as a parameter for assessing the outcome of antioxidant therapy. This study explores the efficacy and outcome of antioxidant enzyme assay in relation to antioxidant therapy in tobacco abusers, hitherto unreported in medical literature. A prospective cohort study with control in 50 patients carried out at a tertiary care teaching Institution (Institute of Medical Sciences, Banaras Hindu University, Varanasi, India). Out of these patients, 10 patients acted as control, rest 40 patients-all tobacco users in some form, were divided into three groups on the basis of histopathological grading of dysplasia-no dysplasia, mild or moderate dysplasia. The levels of Lipid peroxidase (LPO), Superoxide dismutase (SOD) and Catalase (CAT) in mucosa and serum were assayed in each group, and re-evaluated at the end of 3 months after intervention with antioxidant treatment. To detect any alteration in degree of dysplasia a repeat biopsy was also done at the end of 3 months. The results were statistically analysed using paired t test. A statistically significant decrease in level of LPO and SOD, and an increase in CAT levels were recorded both in mucosa and serum. However, no change in dysplasia and no new case of dysplasia were observed. Further, antioxidant treatment was continued for a year and the final out come of the lesion was assessed by ''Carter's criteria''. A final success rate of 74.19% was recorded in terms of partial or complete regression of the lesion. This study confirms the therapeutic efficacy of antioxidants in oral leukoplakia, and cites the importance of LPO, SOD and CAT in evaluating the efficacy of antioxidant treatment. However, the study failed to elucidate any relationship between enzyme measurement and the final outcome of the lesion.

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Section: Does Antioxidant Therapy Influence Lipid Peroxidase?supporting

confidence: 90%

Role of Measurement of Antioxidant Enzymes in Evaluation of Antioxidant Therapy in Tobacco Abusers with Oral Leukoplakia

Jain

Singh

et al. 2011

Indian J Otolaryngol Head Neck Surg

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“…Beta-carotene has been said to be efficacious against oral leukoplakia in previous studies, 30 although the reported outcomes are diverse; the overall response rates range from 27.5 to 73% [31][32][33][34][35][36] and none had adopted CONSORT guidelines. Table 4 shows the summary of RCTs that reported on systematic chemoprevention trials using retinoids and carotenoids for the treatment of oral leukoplakia.…”

Section: Discussionmentioning

confidence: 99%

Treatment of oral leukoplakia with a low‐dose of beta‐carotene and vitamin C supplements: A randomized controlled trial

Nagao

Warnakulasuriya

Nakamura

et al. 2014

Intl Journal of Cancer

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Management of oral leukoplakia-a potentially malignant disorder-is currently not evidence-based. Of the few randomized trials that have been reported, most have negative data. Therefore, a multi-centre, randomized, double-blind controlled trial (RCT) was undertaken to evaluate the use of low-dose beta-carotene combined with vitamin C supplements for the treatment and to prevent malignant transformation of oral leukoplakia. 46 Japanese participants with oral leukoplakia were allocated randomly either to an experimental arm (10 mg day 21 of beta-carotene and 500 mg day 21 of vitamin C) or placebo arm (50 mg day 21 of vitamin C). Current or ex-smokers within 3 months of cessation were excluded. The supplements were continued over a period of 1 year. The primary endpoint was clinical remission at 1-year and the likelihood of malignant transformation during a 5-year follow-up period as a secondary endpoint. The overall clinical response rate in the experimental arm was 17.4% (4/23) and 4.3% (1/23) in the placebo arm (p 5 0.346). During the median 60-month follow-up period, two subjects in the experimental arm and three in the control arm developed oral cancer. Under the intention-to-treat principle, relative risk by supplementing with beta-carotene and vitamin C was 0.77 (95%CI: 0.28-1.89) (p 5 0.580) by the Cox proportional hazards model. No unfavorable side-effects were noted. Beta-carotene (10 mg day 21 ) and vitamin C were neither effective for clinical remission, nor for protection against the development of cancer. Data from this RCT does not support the hypothesis that chemoprevention with this treatment is effective for oral leukoplakia.Oral leukoplakia-a potentially malignant disorder of the oral cavity-is associated with an increased risk of oral cancer. 1 Although a number of options for treatment of oral leukoplakia are available, 2 there is a lack of consensus on the most appropriate method of management and ways to minimize malignant transformation. 3 Tobacco and alcohol misuse are significant risk factors for the development of oral leukoplakia. 4 While it is possible to treat tobacco dependence, 5 the compliance of users and resources offered by healthcare delivery systems have been disappointing. Surgical and laser treatment of oral leukoplakia, although reducing the risk of malignant transformation, is at times associated with recurrences. 6 In this context, a medical treatment for leukoplakia is attractive, particularly if a chemopreventive agent that is effective and safe, and produces lasting benefit, can be found. 7,8 In 1981, Peto et al. hypothesized that high dietary intake of carotenoids may reduce cancer among humans. 9 Observational studies on diet suggest that its role in cancer prevention is mainly related to antioxidants in foods and/or beverages. 10,11 The incidence of a number of cancer types (i.e. lung, oral, pharyngeal and stomach) are inversely related to beta-carotene intake or blood concentrations. 12,13 A Japanese population study reported that high serum beta-carotene levels wer...

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“…A clinical trial of 79 patients with oral leukoplakia receiving antioxidant supplements of 30 mg beta-carotene as well as 1,000 mg ascorbic acid and 800 IU vitamin E or alpha-tocopherol (α-TF) for 9 months showed clinical improvements in 56% of those patients [39].…”

Section: Beta-carotenementioning

confidence: 99%

Advances in Chemoprevention of Head and Neck Cancer

2004

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Head and neck squamous cell carcinoma is a devastating disease with a poor outcome in advanced stages, accounting for approximately 3% of all malignancies, with an estimated 37,200 new cases and 11,000 deaths annually in the U.S. Second primary tumors are estimated to occur at an annual rate of 3%-10% and are significant threats to long-term survivors. Chemoprevention is an appealing strategy, and its success has been demonstrated in breast cancer and familial adenomatous polyposis. High-dose retinoids have been shown to be active against oral premalignant lesions and in prevention of second primary tumors in the head and neck. New targets include the epidermal growth factor receptor, cyclooxygenase-2, and other molecular targets. Challenges in future head and neck cancer chemoprevention investigations include achieving long-lasting efficacy with retinoids and/or new agents, and determining the optimal dose and duration of therapy while maintaining acceptable toxicities. The Oncologist 2004;9:302-311

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A clinical trial of antioxidant supplements in the treatment of oral leukoplakia

Cited by 69 publications

References 28 publications

Role of Measurement of Antioxidant Enzymes in Evaluation of Antioxidant Therapy in Tobacco Abusers with Oral Leukoplakia

Role of Measurement of Antioxidant Enzymes in Evaluation of Antioxidant Therapy in Tobacco Abusers with Oral Leukoplakia

Treatment of oral leukoplakia with a low‐dose of beta‐carotene and vitamin C supplements: A randomized controlled trial

Advances in Chemoprevention of Head and Neck Cancer

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