|Year : 2019 | Volume
| Issue : 4 | Page : 286-292
A novel mixture of curcumin paste and prednisolone for treating oral lichen planus: A case controlled comparative study
Shantala R Naik1, Prashant Gupta1, L Ashok2, Tanya Khaitan1, Anjani K Shukla1
1 Dental Institute, Rajendra Institute of Medical Sciences, Bariatu, Ranchi, Jharkhand, India
2 Bapuji Dental College and Hospital, MCC B Block, Davangere, Karnataka, India
|Date of Submission||30-Sep-2019|
|Date of Acceptance||20-Dec-2019|
|Date of Web Publication||03-Mar-2020|
Dr. Prashant Gupta
Department of Oral Medicine and Radiology, Dental Institute, Rajendra Institute of Medical Sciences, Bariatu, Ranchi, Jharkhand
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Background and Aims: This study was done to evaluate the clinical efficacy as a topical drug of a novel mixture of prednisolone and curcumin in oral lichen planus. Methods: Our study included 60 cases of symptomatic oral lichen planus. Patients were divided into two groups of 30 each. Group 1 received first mode of therapy of topical curenext gel. Group 2 received second mode of therapy of novel mixture of curenext gel and prednisolone. They were reviewed after 10 days and 20 days. Findings: Novel mixture effectively reduced the reticulation, erosion and pain and these differences were significant when compared with first mode of therapy. Conclusion: We would recommend the use of novel mixture for treatment of any case of symptomatic oral lichen planus than using curenext alone. Practical Implications: Topical curcumin alone is not effective against oral lichen planus. If this is mixed with a steroid, the mixture could give the benefits of steroid and curcumin together and hence appear to be more effective.
Keywords: Curcumin, novel mixture, oral lichen planus, prednisolone, topical application
|How to cite this article:|
Naik SR, Gupta P, Ashok L, Khaitan T, Shukla AK. A novel mixture of curcumin paste and prednisolone for treating oral lichen planus: A case controlled comparative study. J Indian Acad Oral Med Radiol 2019;31:286-92
|How to cite this URL:|
Naik SR, Gupta P, Ashok L, Khaitan T, Shukla AK. A novel mixture of curcumin paste and prednisolone for treating oral lichen planus: A case controlled comparative study. J Indian Acad Oral Med Radiol [serial online] 2019 [cited 2020 Apr 7];31:286-92. Available from: http://www.jiaomr.in/text.asp?2019/31/4/286/279857
| Introduction|| |
Oral lichen planus is one of the commonest mucosal disorder affecting the oral cavity and other mucosal sites. Lichen planus when occurs in oral cavity causes lot of discomfort. It affects patient's quality of life (QOL) by impairing mastication, taste and causing sleep disturbances.
OLP is a T cell mediated autoimmune mucosal disorder. It can occur on skin as well as mucosa. It commonly occurs in oral cavity. LP occurs in 6 different forms but the commonest ones are erosive and reticular, atropic associated with white striae. Common oral manifestations are like reticulating white striae, erosions, papules, erythema associated with varying degree of oral discomfort. Signs and symptoms could range from mild to no discomfort. It can cause severe discomfort in form of burning sensation and pain score of 10 on a VAS scale.
During this period, patients usually consult us for relief. Over the years treatment of OLP has evolved with researchers trying to explore newer and non-invasive mode of therapy for OLP. It can be treated with allopathic drugs and ancient medicines. Over the years different forms of herbal remedies have been tried for OLP.
There are lot of treatment modalities but steroid being most popular. Topical treatment is more preferred owing to the recurrent nature of the illness. Systemic steroid is used for full blown cases, recalcitrant cases. Steroids stay as main stream treatment modality owing to its strong anti-inflammatory properties. On the other hand, steroids are associated with side effects on long term use. That is the reason that researchers have been trying to find an alternative. Currently turmeric has been widely used and accepted.
Curcumin/turmeric has anti-inflammatory properties, antiseptic and anticarcinogenic properties. It has a chemopreventive effect in oral potentially malignant disorders. The anti-inflammatory property of curcumin benefits patients with oral lichen planus since OLP is described as autoimmune chronic inflammatory disease.
| Methods|| |
This study was conducted in the department of oral medicine and radiology of dental institute of Rajendra Institute of Medical Sciences, Ranchi, Jharkhand. Ethical approval was obtained from institutional review board before study was started. Patient consent too was obtained before they were enrolled into study.
This study was intended to observe the clinical efficacy of two modes of therapies for Oral lichen Planus.
First mode of therapy (for group 1)
Curenext oral gel (Abbot Pharmaceuticals, India) was prescribed for topical application. Patients were asked to apply gel onto cotton swab and place it against lesion for 15 mins, three times a day. Patients were recalled after 10 days for first follow up and 20 days later for second follow up. Patients who did not benefit after 15 days of treatment were later treated aggressively with systemic steroids.
Second mode of therapy (group 2)
Patients were asked to make a paste of crushed tablet of prednisolone (10 mg, 1 tab at one time) and curenext oral gel, use a cotton swab as carrier for paste and place it against the lesion for 15 min and three times a day. Patients were recalled after 10 days for 1st follow up and 20 days later for 2nd follow up.
Note: If lesions were present on multiple sites, that many cotton swabs were used. For gingival lesions, cotton rolls were used. One patient whose gingival score was 3 was given a special tray fabricated with cold cure acrylic.
Selection of patients
Patients were selected from OPD randomly and symptomatic OLP were included. Cases were clinically diagnosed as per revised WHO criteria. A total of 60 patients were included. 30 patients were treated with 1st mode of therapy and rest 30 with 2nd mode of therapy. Patients who didn't benefit with the above treatments even after 20 days were treated with systemic steroids.
Patients with any form of adverse habits, metallic restorations, patients on anti hypertensives and anti hypoglycemics drugs. None of the female patients included in the study were either pregnant or lactating.
Scoring of OLP
Scoring criteria was modified as per our study subjects. Clinically the OLP patients were assessed for following parameters [Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5].
|Figure 5: Of case 1 shows baseline lesion treated with mixture of curenext gel and prednisolone|
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- Reticulation (R)
- Erosion (E)
- Pain (VAS score for burning sensation) (p)
- Gingival score (G)
Reticulation was scored as:
- 1 = striae > 1 cm
- 2 = striae 2-3 cms
- 3=>3 cms
Erosion was scored as:
- 1 = lesion more than 1 cm
- 2 = lesion 2-3 cms
- 3 = entire buccal mucosa
Pain/burning sensation was assessed with:
- 0 = no symptoms
- 1 = mild discomfort
- 2 = mild burning on intake of spicy food
- 3 = moderate burning on intake of spicy food
- 4 = severe burning on intake of spicy food
- 5 = unbearable pain
- 1 = mild (involving < 6 teeth
- 2 = moderate (involving < 14 teeth)
- 3 = severe involving entire gingiva
RLP- reticular lichen planus
ELP- erosive lichen planus
DG- desquamative gingivitis
ALP- annular lichen planus
GROUP 1: tabulation of baseline, 1st follow up and 2nd follow up scores attached with appendix I
Group 2: tabulation of baseline, 1st follow up and 2nd follow up scores attached with appendix I
Study data were tabulated and subjected to following analysis. Descriptive statistical analysis that includes mean, standard deviation was used. Independent sample test was done using Levene's test for equality of variances and t test for equality of means, 95% confidence interval of difference. SPSS 22.0, IBM, USA was used for analysis.
| Results|| |
Our study included 60 cases of symptomatic oral lichen planus. Each group involved 30 cases each. As per our record there was equal gender distribution. Age of the patients ranged from 2nd decade to 7th decade of life [Table 1].
Erosive lichen planus was commonly encountered followed by desquamative gingivitis, reticular lichen planus and one case of annular lichen planus.
Both the study groups showed decreased reticulation on follow up days. But, patients in group 2 had a significant decrease in reticulation score on 2nd follow up (P value 0.028). Even patients in group 1 had reduction in reticulation but it was not significant [Table 2], [Graph 1] and [Figure 5], [Figure 6], [Figure 7], [Figure 8], [Figure 9], [Figure 10].
|Table 2: Comparative evaluation of Reticulation score between group I & II at different follow up|
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|Figure 6: Of case 1 shows lesion treated with mixture of curenext gel and prednisolone after 2nd follow up|
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|Figure 7: Of case 1 shows lesion treated with mixture of curenext gel and prednisolone after 1st follow up|
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The patients in both the groups were benefitted in terms of erosion. Although first follow up did not show any significant changes in the erosion score of both the groups. But, during 2nd follow up, group 2 patients showed tremendous resolution in erosion score and these changes when compared with group 1 cases and the differences was highly significant (P value 0.001) [Table 3], [Graph 2] and [Figure 5], [Figure 6], [Figure 7], [Figure 8], [Figure 9], [Figure 10].
|Table 3: Comparative evaluation of Erosion score between group I & II at different follow up|
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Pain reduction achieved by group 2 patients on 1st follow up and during 2nd follow up were highly significant (P value 0.001) when compared with group 1 cases [Table 4] [Graph 3].
The differences in gingival score on first and second follow up between group 1 and group 2 cases were not statistically significant [Table 5] [Graph 4].
|Table 5: Comparative evaluation of Gingival score between group I & II at different follow up|
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| Discussion|| |
Lichen planus is a chronic inflammatory muco cutaneous disease. Oral lichen planus is the mucosal counterpart of cutaneous lichen planus. It more commonly occurs in women in 4th decade of life., It occurs more commonly on buccal mucosa, gingiva and tongue. Sometimes the ventral aspect of tongue and floor of mouth could also be involved. It is T cell mediated and hence modulating the T cell activity and the inflammatory process is of therapeutic value. OLP is a chronic disease, runs a long course. It has spontaneous remissions and exacerbations. It compromises the patient's quality of life since it impedes food intake. Stress has been closely associated with LP. Although the etiology is unknown, primary care is palliative that would enable patient to eat food.
When searched in literature, there would be a lot of options for treating OLP. Researchers have tried and tested different kinds of allopathic and Ayurvedic medicines for treating OLP. Systemic steroids takes the first position since it acts as an anti-inflammatory agent. Its only because of their side effects, doctors have got cautious and tried topical drugs like steroid, curcumin. Nowadays even patients are well aware of side effects of various drugs (thanks to technology) and hence they also look out for any herbal or natural remedy. This has driven the researchers for considering Ayurveda into medicine. Systemic drugs have lot of side effects. Hence, topical medicine has been used tremendously. Neither all the patients nor all sites respond in the same way, hence local drug delivery has been utilized, that can attain 100 fold higher concentrations than systemic therapy.
Curcumin is a natural product which is nontoxic. It has several mechanism of actions. Important one being anti-inflammatory, anti-oxidant, anti-carcinogenic and anti-microbial activities. Curcumin is a strong antioxidant which acts on the oxidative stress in OLP. Thus it has a preventive and curative role in cancer, diabetes mellitus and atherosclerosis. Curcumin is considered to be safe when taken in high doses.
Curcumin is a hydrophobic polyphenol, obtained from rhizomes of curcuma longa (turmeric). It is a potent anti-inflammatory, anti-oxidant and anti-carcinogenic. It is a powerful anti-oxidant which is compared to vitamin C and E. It has significant preventive and curative effects in a number of diseases such as cancer, diabetes, atherosclerosis. It is potent scavenger of various reactive oxygen species including superoxide anion radicals and hydroxyl radicals that plays an important role in carcinogenesis. It mediates anti-inflammatory effects through the inhibition of different macromolecules involved in inflammation including phospholipase, cycloxygenase 2, lipoxygenase, prostaglandins, interleukins 1 and 2 and tumor necrosis factor. It also has immunomodulatory effect.
Although so many options of treatment are available, still OLP happens to be recalcitrant. Challenge would be handling these cases. We conducted this study to evaluate two regimes of topical treatment as described in methodology. We treated our patients with the novel mixture of 10 mg prednisolone with curenext gel. Systemic administration of steroids for long duration is associated with side effects, although it is the mainstay of treatment. We therefore wanted to increase the potency of topical application by combining steroid with curcumin a naturally occurring agent. This would eliminate the side effects of systemic administration of both drugs.
In our study, males although were more in number than females for OLP but it was not significantly high. Erosive lichen planus was more commonly encountered than any other types followed by other types. It is because, patients with reticular lichen planus often are asymptomatic and they do not seek any treatment and hence erosive is commonly encountered.
We found that group 2 patients who were given second mode of therapy had significant improvement (P value- 0.028) in terms of reticulation score when compared with group 1 patients. Second mode of treatment was found to be very effect in reducing the erosion subsequently on second follow up when compared to first mode of treatment in group 1 patients. This difference was highly significant (P value 0.001) suggesting topical steroid with curcumin to be more efficient rather using curcumin alone. This also shows the time taken to improve the erosions to be less when treated with second mode of therapy.
Pain is one feature that drags every patient to doctor to seek treatment. Since pain or burning sensation limits the patient's dietary intake and thereby compromises the patient's lifestyle. Any treatment that reduces pain is well desired by both patient and doctor. Second mode of therapy in group 2 patient was highly effective in reducing pain right from the first follow-up when compared with first mode of therapy. This suggests that time taken for initial improvement is less when treated with second mode of therapy. These differences between group 1 and group 2 patients on first and second follow-up was highly significant (P value- 0.001).
Gingival lesions are difficult to be treated and time taking too. These patients were treated using special trays to carry the drug to desired area. We followed them up till lesions healed and hence were asked to apply the medicine till symptoms resolved. Results displayed are of follow-up on the 20th day, but patients were followed till complete recovery which varied with individual. Although improvement was better with second mode of therapy when compared with first mode, but these differences were not significant.
A randomized placebo controlled double blind study with 2000 mg/day of curcumin compared with placebo found no significant differences. Curcumin was given orally in this study. Use of topical turmeric for 3 months in 10 patients reduced the VAS in nine patients and improved clinical symptoms. A randomized double blind clinical trial with high dose of curcumin 6000 mg/day in 3 divided doses given to 20 patients for 12 days yielded great results. Another randomized controlled study using topical triamcilonide (0.01%) and topical curenext gel applied for 3 times a day for 2 weeks showed significant improvement in patients who used curenext.
Our study demonstrated better results when curenext was combined with steroid. Since curenext alone was not helping patients, not even partially in the first week of follow up. Patients included in our study group were once who would have already consulted at least one doctor before reaching us and hence it was required to attend them carefully. When these patients who were advised first mode of therapy didn't find any improvement were tired running around and so they desired a definitive treatment for their problem. When they were treated with this novel mixture, it helped them and this improved patient compliance. All cases except one did not show any recurrence when followed for next 6 months. The one case which recurred was gingival lesion. Gingival lesions should further be treated with trays that carry the drug in to desired place. Since it is very difficult for the drug to retain.
| Conclusion|| |
Oral lichen planus can be treated in many ways. Various drugs are available which can be used systemically and topically. Systemic drugs are associated with adverse side effects and hence topical drugs are used. Topical drugs give faster results and improves patient compliance. This novel mixture of prednisolone and curenext has given very good clinical results. It was very efficient in reducing the erosions and burning sensation. This mixture did not show any side effects. Hence we recommend this mixture for treating oral lichen planus.
Any kind of financial support, either institutional, private or corporate was not availed for this study.
Declaration of patient consent
The authors certify that they have obtained all appropriate patient consent forms. In the form, the patient (s) has/have given his/her/their consent for his/her/their images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6], [Figure 7], [Figure 8], [Figure 9], [Figure 10]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]