Int J Stomatol ›› 2022, Vol. 49 ›› Issue (6): 633-640.doi: 10.7518/gjkq.2022099

• Original Articles • Previous Articles     Next Articles

Oral beta-carotene in the treatment of non-erosive oral lichen planus: a randomized controlled trial

Zhang Shenyi1(),Wang Xiangjian1,2,Shi Liran1,Shi Jiahong1,Wang Yuhong1,3(),Zhou Hongmei1   

  1. 1.State Key Laboratory of Oral Diseases & National Center of Stomatology & National Clinical Research Center for Oral Diseases & Frontier Innovation Center for Dental Medicine Plus & Dept. of Oral Medicine, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China
    2.Dept. of Oral Medicine, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou 310009, China
    3.Dept. of Oral Medicine, School of Stomatology, The Air Force Medical University, Xi’an 710032, China
  • Received:2022-02-05 Revised:2022-06-02 Online:2022-11-01 Published:2022-11-03
  • Contact: Yuhong Wang E-mail:2019224035147@stu.scu.edu.cn;wangyuhonghuaxi@163.com
  • Supported by:
    National Natural Science Foundation of China(82071124)

Abstract:

Objective This study aims to illustrate the efficacy and safety of oral beta-carotene in the treatment of non-erosive oral lichen planus (OLP) by designing and conducting a randomized controlled clinical trial. Methods A total of 74 patients with non-erosive OLP and widespread white lesions were randomized into the experimental group (n=38) who received oral beta-carotene soft capsules (6 mg p.o. q.d.) or the control group (n=36) who received oral vitamin E soft capsules (100 mg p.o. q.d.) for 6 months continuously. Then, the white area, keratotic degree, pain level, and adverse effects were recorded at the first visit and after 3 and 6 months of treatment. If the white lesions disappeared, any recurrence du-ring the follow-up period was recorded. Results The final diminution in white lesion areas (both P<0.001) and keratotic degree scores (P=0.018, P=0.001) were significantly greater with beta-carotene than with vitamin E after 3 and 6 months of treatment, respectively. However, the intergroup differences in the reduction of pain level were not significant (P>0.05). No severe adverse reactions were found in both groups. Recurrence rates did not significantly differ between groups (P>0.05). Conclusion Oral beta-carotene is an effective and safe alternative for the treatment of non-erosive OLP.

Key words: oral lichen planus, beta-carotene, vitamin E, white lesions, non-erosive type

CLC Number: 

  • R 781.5

TrendMD: 

Fig 1

A graphical semi-quantitative scoring system for the keratotic degree score of white lesions in OLP"

Fig 2

Flow diagram of the trial process"

Tab 1

Comparison of baseline characteristics of the patients enrolled in this trial"

测量项目试验组(n=38)对照组(n=36)P
年龄/岁xˉ±s40.6±12.741.2±11.10.824
范围18.0~60.021.0~60.0
性别/例(%)17(44.7)15(41.7)0.790
21(55.3)21(58.3)
病程/月xˉ±s16.6±7.917.0±10.80.825
范围2.0~36.02.0~48.0
白色病损面积/cm2xˉ±s11.6±6.39.8±5.30.252
角化程度评分xˉ±s2.2±0.62.4±0.50.404
NRS评分xˉ±s1.9±1.02.0±1.10.421

Tab 2

Comparison of white lesion areas, degree of keratinization, and NRS scores of the patients who completed the trial"

测量项目观察期分组例数下四分位数中位数上四分位数ZP
白色病损面积/cm2治疗前

试验组

对照组

33

34

6.4

5.2

10.0

8.7

14.9

12.5

-1.186a0.236
治疗3个月后

试验组

对照组

33

34

0.8

2.5

2.2

4.8

5.3

11.1

-4.918b

-4.623b

0.000

0.000

3个月内差值

试验组

对照组

33

34

3.8

0.5

6.1

1.4

11.0

4.8

-3.903a0.000
治疗6个月后

试验组

对照组

33

34

0.0

0.0

0.0

2.5

0.6

8.3

-5.012b

-5.087b

0.000

0.000

6个月内差值

试验组

对照组

33

34

5.9

2.6

9.1

4.1

14.3

8.2

-3.945a0.000
角化程度评分治疗前

试验组

对照组

33

34

2.0

2.0

2.0

2.0

3.0

3.0

-0.860a0.390
治疗3个月后

试验组

对照组

33

34

1.0

1.0

1.0

1.0

1.0

2.0

-5.248b

-5.488b

0.000

0.000

3个月内差值

试验组

对照组

33

34

1.0

1.0

1.0

1.0

1.0

1.0

-2.358a0.018
治疗6个月后

试验组

对照组

33

34

0.0

0.0

0.0

1.0

1.0

2.0

-5.143b

-4.466b

0.000

0.000

6个月内差值

试验组

对照组

33

34

1.5

0.0

2.0

1.0

2.0

2.0

-3.295a0.001
NRS评分治疗前

试验组

对照组

33

34

1.0

2.0

2.0

2.0

3.0

3.0

-0.762a0.446
治疗3个月后

试验组

对照组

33

34

1.0

1.0

2.0

2.0

3.0

3.0

-0.046b

-1.547b

0.963

0.122

3个月内差值

试验组

对照组

33

34

-1.0

0.0

0.0

0.0

1.0

1.0

-1.082a0.279
治疗6个月后

试验组

对照组

33

34

1.0

1.8

2.0

2.0

2.0

3.0

-0.778b

-0.688b

0.437

0.491

6个月内差值

试验组

对照组

33

34

-0.5

0.0

0.0

0.0

1.0

1.0

-0.162a0.871

Fig 3

Efficacy after 3-month and 6-month treatment with oral beta-carotene"

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