Clinical Trial of G-32 in the Treatment of Oral Leukoplakla
Y. C. SRIVASTAVA, B.D.S., M.D.S. (Oral Surg.)
Medical Officer In charge, Dept. of Dental Surgery,
Paper presented at
33rd Indian Dental Conference,
CURRENT MEDICAL PRACTICE
Oral Leukoplakia is a common condition frequently met with (Chawla et al 1969). The lesion has been known to undergo malignant changes and, although it is painless and seemingly innocuous, if it is neglected 10%-30% of the patients develop epidermoid carcinoma.
The high incidence of oral cancer present in our country has
led in recent years to an increased effort to combat it. Social patterns of
life, economic factors and traditional customs have all combined to make this
lesion fairly common in our country and especially in Uttar Pradesh. The
disease is presumed by most investigators to be a prtcancerous
condition and as such it should not be neglected (Srivastava,
1973). As such, its correlation with the use of tobacco is of particular
In the Eastern districts of U.P., the high incidence of oral leukoplakia and oral cancer is attributed to the peculiar chewing habits of tobacco, betelnut, betel leaf and lime, or a combination of these by the people and these habits are also responsible for poor oral hygiene.
Various measures are suggested to treat leukoplakia and these can be divided broadly into
two major groups, i. Surgical methods ii. Non surgical methods, or combination of both. The paramount factor, whatever may be the measures adopted, is to first remove all recognizable causes of leukoplakia and all those factors likely to cause irritation in the oral cavity.
The greatest drawback with the available standard surgical procedures is the delicate technique necessary to execute them. The reluctance on the pact of the dental surgeons to perform surgery on the oral mucosa also contribute to their not being widely practiced (Pradhan et al, 1974).
Selection of the drug for the clinical trial:
G-32 an Ayurvedic drug is stated to have astringent, antiseptic, anti-inflammatory, anodyne, styptic, deodorant, aromatic, cooling and healing properties. G-32 has been tried extensively by Dental and Oral Surgeons in this country in lesions of the gums etc. with promising results. However, in our review, we could not set my report of the use of G-32 in the treatment or prevention of oral leukoplakia. In our view, as G-32 has met the requirements for treating most of the common ailments of the oral cavity that we get in our daily practice, we decided to try G-32 in casts of oral leukoplakia.
Composition of G-32 tablets:
G-32 is available in easily crushable tablet form. The tablet is to be crushed to powder and applied to the gums etc and a gentle massage is advised. It contains the ingredients reported to have astringent, antiseptic, anti-inflammatory, anodyne, styptic, deodorant, aromatic and cooling properties.
MATERIAL AND METHODS
G-32 was subjected to clinical trial on 50 cases of oral
leukoplakia during 1976-77 at the Dental Dept. of the
The above information along with the presence of any mucosal lesion, cheek biting, sharp or malposed teeth, angular dentures or any other significant fact were recorded. The patients were examined under a good light using two month mirrors. The lesion was diagnosed entirely on a clinical basis using the following criteria - Leukoplakia is defined as a well demarcated elevated white patch of 5 mm or more in diameter that cannot be scrapped off and cannot be attributed to some other disease simultaneously present.
Pre-requisite oral prophylaxis was carried out for all the patients and all traumatic factors t were eliminated and the oral habit was also broken. The trial period was 12 months. The patient was called at intervals of four months and evaluated. The third and last evaluation was at the end of the trial of 12 months. The aim was to ascertain whether G-32 has any beneficial effects in reducing the presenting and associated symptoms of oral leukoplakia. Those who were irregular or did not turn up were not included in the final analysis. However those who were regular, and did not turn up at the 11 checkup, but were present for the III and final checkup were included in the study.
Use of G-32:
Normally, the patients were advised to crush two tablets of G-32 and apply it to the lesion and gently massage over the entire region. They were instructed not to gargle, or eat or drink anything for one hour. 2 tablets of G-32 three times a day, were advised to be used as above. No other drug was used during G-32 clinical trial for this condition. Results were recorded at the end of 4 months, 8 months and 12 months.
The largest number of patients with laukoplakia was in the age groups of 41-50 years with 26 cases (52.0%). There was a gradual decline after this age in the incidence of leukoplakia. The youngest patient was aged 26 years, and the eldest patient was aged 71 years. There were 36 males and 14 females, a ratio 2.5:1. The details are given in Table 1.
TABLE 1 Cases of leukoplakia according to age and sex
Age Group Male Female Total %
26 years 1 - 1 2.0%
31-40 years 3 2 5 10.0%
41-50 years 18 8 26 52.0%
51-60 years 8 3 11 22.0%
61-70 years 5 1 6 12.0%
71 years 1 - 1 2.0%
Total 36 14 50 100.0%
% 72.0% 28.0% 100.0%
Site of Leukoplakia:
The commonest site of leukoplakia was at the angle of the mouth, with 24 cases (48 %), and the buccat mucosa was second with 13 cases (26.0%). The least common site of leukoplakia was the tongue, with 3 cases (6.0%). Difference in sex had no special significance as to the site of leukoplakia. The details are given in Table 2.
TABLE 2 Site of leukoplakia in males and females
Site Male Female Total %
1. Angle of the mouth 18 6 24 48.0%
2. Buccal mucosa 10 3 13 26.0%
3. Internal labial mucosa 4 2 6 12.0%
4. Tongue 2 1 3 6.0%
5. Multiple lesions 2 2 4 8.0%
Total 36 14 50 100.0%
Oral habits prevalent in this part of U.P. area smoking, quid chewing, pan (betal) chewing and drinking of alcoholic beverages.
Smoking Habits: Cigarette : Indian
brands of cigarettes contain blends of various proportions and grades of
Bidi : An indigenous cigarette about 5 cm in length containing crude tobacco, rolled up in the dried leaf of diospyrosmelanoxylon and tied with cotton thread.
Hooka : This is an elaborate Oriental water pipe in which the tobacco smoke is filtered through a water chamber.
Chilum : It is conica1 earthenware pipe about four inches long. A pebble is inserted from above to prevent tobacco pan dropping down when it is filled and lighted.
Quid chewing Habit : The quid is prepared by nulling slaked lime powder and crushed dried tobacco leaf in the palms. The quid is retained in the mandibular labial sulcus for as long as -I- 2 hours at a time, night and day.
Pan Habit : Pan is made by coating the betel leaf with slaked lime and cathechu sprinkled with small pieces of betel nut. Bits of cured tobacco leaf are added as desired. This is folded into a packet which is chewed.
Drink Habit : Alcoholic drinks are of two main varieties. The upper class drinks refined spirits like whiskey, etc., while the lower classes indulge- in home brewed or country liquors like toddy.
Distribution of Habits :
i) Single Habit : 30 cases had single, 11 cases had two habits and 6 cases had three habits, only three cases had no habits.
Among single habit, 5 (10%) had pan habit, 5 (l0%) had tobacco habit. Betal nut quid chewers were 3 (6%) and tobacco quid chewers were 2 (4%,). Among smokers; the largest number was 8 cases (16%) of bidi smokers, 5 cases (10%) were cigarette smokers, (2%) was hooka smoker and 1 case (2%) was a chilum smoker.
ii) Two Habits : Among the 11 cases with two habits, there were 4 cases with bidi -1- quid habit, 2 cases with bidi + pan habit, 3 cases of pan -1- tobacco quid and 2 cases of pan -F cigarettes.
iii. Three Habits : Among the three habit cases (6 there were 4 cases of bidi + pan + tobacco quid habit and 2 cases of cigarettes + pan + tobacco quid habit. The details are given in Table 3.
Distribution of Leukoplakia as to the Site and Number of Habits:
Leukoplakia at the angle of the mouth was the most common site in cases of number of habits (66.7 % )and single habit (56.7%). Leuko plakia at the buccal mucosa was the most common site in cases of two habits (36.4%). Leukoplakia at the internal labial . mucosa was the most common site in cases of two habits (18.2
TABLE 3 Distributions of Habits
I. No Habits 3 6.0%
II. Single Habit (30)
a. Chewing Habits
i. Regular Pan 5 10.0%
ii. Tobacco 5 10.0%
b. Smoking Habits
iii. Bidi 8 16.0%
iv. Cigarettes 5 10.0%
v. Hooka 1 2.0%
vi. Chilum 1 2.0%
c. Quid Habit
vii. Betelnut quid 3 6.0%
viii. Tobacco quid 2 4.0%
III. Two Habits (11)
ix. Bidi + Tubacco quid 4 8.0%
x. Bidi + Pan 2 8.0%
xi. Pan + Tubacco quid 3 6.0%
xii. Pan + Cigarettes 2 4.0%
IV. Three Habits
xiii. Bidi + Pan + Tobacco quid 4 8.0%
xiv. Cigarette + Pan +- Tub. quid 2 4.0%
Total 50 100.0%
Leukoplakia at the site of the tongue was the most common site in cases of three habits (16.7%). Multiple lesions were most common in cases of three habits (16.7%). The details are given in Table 4.
The localization of the lesions emphasizes the association of leukoplakia with pan and tobacco use, the majority of lesions were found in the labial commissures and bucca1 mucosa. Leukoplakias seen in the tobacco users were located in the power part of the cheek probably because the quid is habitually kept in the lower buccal grove. In 1969, I found the buccal mucosa to be the commonest site of oral carcinoma in U.P.
The most common presenting symptom was the ulcer in 40 patients, that is 80 % of cases, and the next in order was irritation by spices in 36 cases, (72 %) of cases. There were two cases with difficulty in deglutition and these belonged to leukoplakia of the tongue. Total habits were 145, giving a mean number of habits per case as 2.9. Sitewise distribution of presenting symptoms are given in Table 5.
Effect of G-32 Therapy - Results:
Cases of leukoplakia were examined regularly at the interval of every four months for 12 months. Those who were irregular in using G-32 or dropped out were not taken into consideration for the final assessment of results. However, those who were regular, and did not come for II check-up but were present at the III and final checkup were included in the study.
There was no improvement in 1 case of ulcer, 2 cases of irritation by spices and in 1 case of difficulty of deglutition. All other cases were improved with G-32 showing an over-all improvement of 95.7 % and partial or no improvement of 4.3 %. Most of the presenting symptoms disappeared even during the first follow-up of four months. Results of G-32 treatment, during I, II, III check-ups, and over-all improvement are given in Table 6.
Oral leukoplakia is an epithelial lesion which is simple to diagnose on a clinical basis, but some times histopathological examination becomes obligatory in order to differentiate it from conditions which present with some what similar clinical picture like lichenplanus, white sponge nerves etc Pnidbog et al (1967).
Schwimmer in 1877 is credited with having coined the term leukoplakia and defining it as a white raised lesion of the oral mucosa.
TABLE 4 Showing the distribution leukoplakia as to site and the number of habits
Total No % Single % Two % Three %
Cases habits habits habits habits
1. Angle of the mouth 24 2 66.7% 17 56.7% 4 36.4% 1 16.7%
2. Buccal mucosa 13 1 33.3% 6 20.0% 4 36.4% 2 33.3%
3. Internal labial mucosa 6 - - 3 10.0% 2 18.2% 1 16.7%
4. Tongue 3 - - 1 3.3% 1 9.1% 1 16.7%
5. Multiple lesions 4 - - 3 10.0% - - 1 16.7%
Total 50 3 100% 30 100% 11 100% 6 100.0%
% 100% 6% 60% 22% 12%
TABLE 5 Showing Site-wise distribution of presenting symptoms - (N=5O cases)
Symptom Total Angle of Buccal Internal Tongue Multiple
Cases mouth mucosa labial mucosa (max=13) lesions
(max=24) (max=13) (max=6) (max=4)
1. Ulcer 40 22 12 2 2 2
2. Irritation by spices 36 20 12 4 - -
3. Foreign body sensation 22 14 6 - 1 1
4. Pain 16 10 2 - 2 2
5. Trismus 15 2 8 5 - -
6. Salivation 14 8 1 - 3 2
7. Difficulty in deglutition 2 - - - 2 -
Total 145 76 41 11 10 7
TABLE 6 Showing the degree of improvement, I, II, III, follow-up
Total Not Foll % Improvement % Partial %
cases follo wed I II III or no
4M 8M 12M improv
1. Ulcer 40 3 37 100% 28 4 4 36 97.3% 1 2.7%
2. Irritation by spices 36 4 32 100% 22 - 8 30 93.8% 2 6.2%
3. Foreign body sensation 22 2 20 100% 12 4 4 20 100% - -
4. Pain 16 - 16 100% 12 - 4 16 100% - -
S. Trismus 15 1 14 100% 10 2 2 14 100% - -
6. Salivation 14 2 12 100% 10 2 - 12 100% - -
7. Difficulty in deglutition 2 - 2 100% 1 - - 1 5O% 1 50%
Overall 50 4 46 100% - - - 44 95.7% 2 4.3%
Schaffer in 1952 stated, leukoplakia is descriptive of the principle feature so the lesion, the white colour and its various slides of grey play an active role as an objective sign in the disease of mucosa.
Kollar et al (1954) accepted the term leukoplakia as a partial clinical description of a whitish area on the mucous membrane.
Bernier (1959) stated that only those lesions should be defined as leukoplakia which shows definite dysskeratosis.
At present, there is a trend towards application of the term leukoplakia to a white patch on the mucosa Pindberg et al (1967) gave a most convincing definition of oral leukoplakia which is followed in the present trial as Any well demarcated elevated white patch of 5mm or more in diameter, could not be scrapped off and could not be attributed to some other disease simultaneously present.
The author is convinced that G-32 application and massage in oral leukoplakia cases has shown a wide sphere of action. Ulcer healed in all cases except in one giving beneficial result of 97.3 %. This may be due to antiseptic and stimulant properties of Laving, Fatakadi, Mayaphal Kulinjan, Pipar which are the major ingredients of G-32 tablets. There was also relief in irritation by spices (93.8%). This results maybe due local astringent and cooling effects of Sonageru, Mayaphal, Jiru, Vividange, Pipda lakh and Kutu. Laving also help in relieving soreness of the mouth and throat and further strengthens the oral mucosa. Jiru alters the circulation of the oral ulcerative mucosa.
Complete relief was seen in Foreign body sensation, pain, trismus and salivation. This all may be due to the collective effect of all the 23 different ingredients of G-32 tablets. Only one case out of two cases of difficulty in deglution did not improve.
The study has indicated that most common site of leukoplakia was the angle of the mouth and bettal mucosa was the next in order. Leuko plakia at the site of tongue or multiple lesions were common among the cases of three habits. This is in conformity with the finding of other workers. Among symptoms, ulcer was the most common one (80%) and the next common symptom was irritation by spices (72 %).
Most of the relief was obtained with first four months of treatment of G-32. Overall response was 95.7% and partial or no response in 4.3 %. No side or aftereffects were observed in the use of G-32.
These findings strengthened the general agreement upon discontinuance of the oral habits as an essential pre-requisite for successful treatment of oral leukoplakia.
As leukoplakia is considered a precancerous condition as early relief will help as prophylaxis to this condition. Also G-32 maintained good oral hygiene which is also very important. Treatment of oral leukoplakia with the topical application and massage of G-32 is effective, simple and safe.
It is conveniently carried out as an outpatient procedure and can be taken up by Dental and Medical Practitioners as one of the standard procedure for the treatment of oral leukoplakia.
I am thankful to the superintendent,
I am also thankful to Mr. P. G. Shukia
of Alarsin Pharmaceuticals,
and untiring efforts in the smooth completion of trials and supply of G-32.
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