Recurrent aphthous ulcers are the most common recurrent oral mucosal lesions characterized by recurrence and pain. The aim of this research is to evaluate the short-term curative effect of the traditional Chinese medicine “Pudilan anti-inflammatory oral liquid” on mild recurrent aphthous ulcers. A total of 234 patients were divided into a treatment group and a control group. Both groups used vitamin B2 as the basis of treatment. The treatment group took a Pudilan anti-inflammatory oral solution for 8 days while the control group was given a liquid placebo. The ulcer size, pseudomembrane, peripheral congestion, and pain scores of the treatment group were lower than before treatment. The curative effect on the Pudilan group was statistically significant compared with the control group. The final therapeutic effect on the treatment group was better than that on the control group. The healing time of mild recurrent aphthous ulcers can be shortened by Pudilan anti-inflammatory oral liquid, and pain is relieved without adverse reactions. Pudilan provides a new reference drug for the treatment of mild recurrent oral ulcers.
Recurrent aphthous ulcer (RAU) is the most common oral mucosal disease worldwide, with a prevalence of 0.5%–75%. It is especially common among 10–30-year-old females, manifesting mainly as mild, recurrent aphthous ulcers of the stomatitis type, accounting for 70%–80% of all cases [
In this study, a stratified random grouping method was employed. From April to October 2016, a total of 234 patients meeting the inclusion criteria were recruited from the Shengjing Hospital and the Hospital of Stomatology affiliated to China Medical University, the Stomatology Hospital of Shandong University, and the Second Affiliated Hospital of Zhejiang University School of Medicine. The protocol of the research was approved by the Ethics Committee of China Medical University. The experimental group (group A) consisted of 177 patients. The control group (group B) contained 57 patients who met the inclusion criteria of RAU. All subjects received the basic treatment of vitamin B2 tablets (20 mg, three times per day). The experimental group, in addition, received Pudilan anti-inflammatory oral liquid (Jumpcan Pharmaceutical Group Co., Ltd., Jiangsu, China), at a dosage of 10 mL three times per day; tablets were kept in the mouth for 5 min before the patient swallowed them. The control group was given a placebo (with the same packaging as the experimental group).
General information obtained included age; gender; marital status; nationality; occupation; smoking, health, medical treatment, and allergy history; source of infection, duration, severity, and treatment history of this disease; concurrent diseases and medication. Women of childbearing age were given a urine pregnancy test.
Unified mild recurrent aphthous ulcers grading scales.
Ulcer scores | Grading | |||
---|---|---|---|---|
0 (normal) | 2 (mild) | 4 (moderate) | 6 (severe) | |
Ulcer diameter | None | ≤3 mm | >3 mm and ≤5 mm | >5 mm |
Pseudomeninx | None | Yellow | Grayish yellow | Gray-white |
Hyperemia | None | Linear | Zonal | Zonal over ulcer diameter |
Pain | None | VAS scores: 1–3 | VAS scores: 4–6 | VAS scores: 7–10 |
The data were processed by SPSS 19.0 statistical software (SPSS Inc., Armonk, NY, USA), and the measurement data were presented as the mean ± SD, with between-group comparisons carried out using a
The age exhibited no significant differences between the experimental group and the control group. 78 male and 99 female participants were in the treatment group, and 26 male and 31 female participants were in the control group. There was no significant difference in the gender (
Comparison of the general data of the two groups before treatment.
Day 0 | Groups | | Mean | SD | | |
---|---|---|---|---|---|---|
Age | A | 177 | 42.25 | 15.13 | 0.574 | 0.567 |
B | 57 | 43.66 | 15.96 | |||
Course of diseases (hours) | A | 177 | 34.34 | 12.535 | 1.086 | 0.279 |
B | 57 | 36.94 | 10.263 | |||
Ulcer sizes (mm) | A | 177 | 3.26 | 1.161 | 1.357 | 0.176 |
B | 57 | 3.52 | 1.328 | |||
Pseudomeninx scores | A | 177 | 3.05 | 1.157 | 0.187 | 0.853 |
B | 57 | 3 | 1.629 | |||
Hyperemia scores | A | 177 | 3.18 | 1.49 | 1.543 | 0.128 |
B | 57 | 2.72 | 1.97 | |||
Pain scores | A | 177 | 3.98 | 2.244 | 0.822 | 0.412 |
B | 57 | 3.7 | 1.741 |
Comparing the number of days required for ulcer healing and pain abatement between the two groups showed a statistically significant difference (
The curative effect analysis of the two groups.
Groups | | Mean | SD | | | |
---|---|---|---|---|---|---|
Pain disappearance (days) | A | 177 | 5.51 | 1.17 | 2.297 | 0.023 |
B | 57 | 6.16 | 1.421 | |||
Healing days | A | 177 | 5.28 | 1.907 | 2.184 | 0.03 |
B | 57 | 6.1 | 1.461 |
The curative efficacy on the experimental group was significantly better than that on the control group (
After 8 days of treatment using Pudilan anti-inflammatory oral liquid, the ulcer size of the experimental group was significantly decreased; the vast majority of ulcerous pseudomembranes had desquamated, the peripheral congestion of the ulcer was relieved, and the ulcer pain score had significantly decreased compared with before treatment (Table
Comparison of the ulcer sizes, pseudomeninx, hyperemia, and pain scores in the Pudilan group.
Days | | Mean | SD | | Sig. (double) | |
---|---|---|---|---|---|---|
Ulcer sizes (mm) | 0 | 177 | 3.26 | 1.161 | 21.341 | 0.000 |
8 | 177 | 0.67 | 1.223 | |||
Pseudomeninx scores | 0 | 177 | 3.05 | 1.157 | 18.706 | 0.000 |
8 | 177 | 0.57 | 1.169 | |||
Hyperemia scores | 0 | 177 | 3.18 | 1.49 | 17.793 | 0.000 |
8 | 177 | 0.51 | 1.172 | |||
Pain scores | 0 | 177 | 3.98 | 2.244 | 16.419 | 0.000 |
8 | 177 | 0.65 | 1.426 |
After 8 days of basic treatment, the ulcer size of patients in the control group had decreased, the ulcerous pseudomembrane had partially desquamated, there was reduced congestion surrounding the ulcers, and there was a decreased VAS score compared with that before treatment (Table
Comparison of the ulcer sizes, pseudomeninx, hyperemia, and pain scores in the control group.
Days | | Mean | SD | | Sig. (double) | |
---|---|---|---|---|---|---|
Ulcer sizes (mm) | 0 | 57 | 3.52 | 1.328 | 11.864 | 0.000 |
8 | 57 | 0.71 | 1.271 | |||
Pseudomeninx scores | 0 | 57 | 3 | 1.629 | 11.323 | 0.000 |
8 | 57 | 0.38 | 1.064 | |||
Hyperemia scores | 0 | 57 | 2.72 | 1.97 | 7.943 | 0.000 |
8 | 57 | 0.42 | 0.919 | |||
Pain scores | 0 | 57 | 3.7 | 1.741 | 10.946 | 0.000 |
8 | 57 | 0.52 | 1.337 |
Before treatment, there were no significant differences in size, scope, pseudomembrane formation, congestion, or pain between the experimental group and the control group (
Comparison of related indicators of the two groups before and after treatment.
Days | Group A | Group B | | |
---|---|---|---|---|
Ulcer sizes (mm) | 0 | 3.26 ± 1.161 | 3.52 ± 1.328 | 0.1506 |
8 | 1.161 ± 1.223 | 0.71 ± 1.271 | 0.7763 | |
Pseudomeninx scores | 0 | 3.05 ± 1.157 | 3 ± 1.629 | 0.9864 |
8 | 0.57 ± 1.169 | 0.38 ± 1.064 | 0.3864 | |
Hyperemia scores | 0 | 3.18 ± 1.49 | 2.72 ± 1.97 | 0.0943 |
8 | 0.51 ± 1.172 | 0.42 ± 0.919 | 0.7638 | |
Pain scores | 0 | 3.98 ± 2.244 | 3.7 ± 1.741 | 0.3889 |
8 | 0.65 ± 1.426 | 0.52 ± 1.337 | 0.6608 |
Comparison of the VAS scores, pseudomeninx scores, hyperemia scores, and ulcer sizes in the control and Pudilan groups
Comparison of the healing time and healing rate in the control and Pudilan groups
RAU is caused by many factors, such as immune factors, physiological and psychological factors, trauma, family history, nutritional factors, and long-term use of antitumor drugs. Generally, the treatment principle aims to reduce the inflammation, pain, and ulcer duration and prevent recurrence [
Immune cells can be activated by a variety of flavonoids contained in
Taraxacum contains a variety of active ingredients such as caffeic acid, chlorogenic acid, ferulic acid, cichoric acid, and sterol, the effective components of which are mainly organic acids and sterols, including organic acids such as caffeic acid and chlorogenic acid with obvious antibacterial effects and ferulic acid with antibacterial, antiviral, antioxidant, and other pharmacological effects. Lipopolysaccharide-induced inflammatory responses can be inhibited by organic acid complexes regulating the TLR4/IKK/NK-
Clinical study has shown that short-term usage of Pudilan toothpaste may promote healing of minor aphthous ulcers, relieving ulcer pain [
Pudilan anti-inflammatory oral liquid is safe and effective in treating minor RAU and can be used as a first-line treatment.
The authors declare that they have no conflicts of interest regarding the publication of this paper.
Ying Jin and Xiaoping Lin participated in literature search, study design, data collection, and data analysis and wrote the manuscript. Liming Song and Mengnan Liu coordinated the study and analyzed the data. Ying Zhang, Xiangmin Qi, and Danping Zhao carried out the data collection. All authors reviewed the results and approved the final version of the manuscript.
The authors are thankful to Wang Zhao and Xiaofeng Chen, for helping with the follow-up of participants.