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Human Clinical Study I(9)
Epidemiologic studies have suggested the habit of areca quid chewing is a major etiologic factor for the development of oral submucosal fibrosis (OSF) among the Southeast Asian countries(10). Without proper treatment, chronic OSF can progress to a malignant state resulting in cancers of the mouth, pharynx, esophagus and stomach.

Tai et al. (2001) divided 46 OSF patients into a control group (oral habit intervention) and an treatment group (45 g S100 Milk twice a day plus oral habit intervention) for a 3-month clinical study.

The percentages of patients in the S100 Milk group experiencing improvements in symptoms and signs at study completion were in the 20 to 80% range (Table 3). The percentage of patients with improvements in intolerance to spices, xerostomia and leukoplakia or erythroplakia were significantly higher in the treatment group compared to the control group. The study also showed a significant increase in the ability to open the mouth after 3 months in the S100 Milk treatment group versus the control group (Table 4).

Tai et al. suggested that the active anti-inflammatory components in S100 Milk might result in local and systematic down regulation of the fibrogenic cytokines and up regulation of the antifibrotic cytokines. The author theorized that subsequent inhibition of collagen synthesis softened the rigid and stiff lesional oral mucosa and eventually allowed the observed increase in mouth opening in OSF patients receiving S100 Milk.


  Treatment group (n=26) Control group (n=20)
Symptom or sign Patients with
complaint at baseline
Case no. (%)
Patients with
at exit Case no. (%)
Patients with
complaint at ba seline
Case no. (%)
Patients with
complaint at ba seline
Case no. (%)
Intolerance to spices 20 (76.9%)* 16 (80%) 17 (85%) 3 (17.6%)
Xerostomia 18 (69.2%)** 13 (72.2%) 13 (65%) 2 (15.4%)
Vesicles or ulcers 12 (46.2%) 7 (58.3%) 11 (55%) 5 (45.5%)
Burning sensation 9 (34.6%) 7 (77.8%) 7 (35%) 4 (57.1%)
Impaired tongue
22 (84.6%) 5 (22.7%) 16 (80%) 0 (0%)
Depapillation 13 (50%) 3 (23.1%) 12 (60%) 0 (0%)
Leukoplakia or
7 (26.9%)*** 5 (71.4%) 5 (25%) 0 (0%)

Table 3. The treatment group was lower than the control group by 8% with respect to total cholesterol, by 4% with respect to LDL cholesterol and by 8% with respect to atherogenic index (total cholesterol/HDL cholesterol)(9). * p<0.001, ** p<0.005, *** p<0.05

  Mouth Opening at Exit
≦20mm 21-30mm 31-44mm Total p value*
≦20mm 4 8 0 12 0.002
21-30mm 0 5 5 10  
31-39mm 0 0 4 4  
Total 4 13 9 26  

Table 4. Mouth opening measurements of OSF patients in treatment group at baseline and at study completion(9). *Chi-squared test.



Human Clinical Study II(11)
Hirokawa et al. (2009) asked 24 subjects (17 men and 7 women: 31-61 years old) to drink S100 Milk for five months, at a dosage of 30-60g daily. Subjects were evaluated prior to consuming S100 Milk, after three months consumption and after five months consumption, respectively.

Test of immunity Testing value Score
T cell/μl 500 1
Multiplication coefficient of T cell 0.57 1
CD4+T cell/CD8+T cell 2.32 3
Naive T cell/μl 111 1
Naive T cell/memory T cell 0.58 2
CD8+ CD+28 T cell/μl 120 2
B cell/μl 168 3
NK cell/μl 241 2
Total score of immunity 15/24
Table 5. The 8 markers used for the "standard of immunity" scores(11).

In the study, 8 biochemical markers that are strongly influenced by age and stress were chosen for testing. Each of the 8 markers were scored on a scale of 1 to 3, with 3 being the highest possible score, 2 being the middle score and 1 being the lowest score. Possible cumulative scores could range from 8 to 24. These cumulative scores were referred to as "the standard of immunity" (Table 5). Based on the cumulative scores, subjects received one of five health grades: "In danger", "Requiring attention", "Requiring observation", "Safe", and "Very healthy" (Fig. 5). The health grades were then used to judge the overall status of the immune system. Results showed that five months later, only 9 subjects remained among the 16 subjects who were originally graded as "Requiring observation" or lower, while 8 subjects who were originally graded as "Safe" or higher increased to 15 subjects.

An analysis of the comprehensive judgment and assessment of the immunological health of the 24 subjects before and after they consumed S100 Milk (Fig. 6), showed that after five months' of consuming S100 Milk, overall scores were increased by 1 on average. Scores of the 16 subjects who were previously at the level below "Requiring observation" increased by an average of 1.5, while scores of the 8 subjects who were at the level above "Safe" previously, showed no significant increase in their test scores. This trend demonstrates that S100 Milk had a positive effect on improving immune function for subjects with weak immune function, while subjects with strong immune function did not experience an excessive increase in their already strong immune systems(11).

Fig. 5. Before and after subjects consumed S100 Milk,comprehensive judgment and assessment scores demonstrating that S100 Milk can improve immune function(11).

Fig. 6. After consuming S100 Milk for five months, subjects with low immune function scores showed large increases in scores, while subjects with high immune function scores showed no change in scores, demonstrating that S100 Milk didn’t cause an excessive increase in their already strong immune systems. Therefore, it can be concluded that S100 Milk helps maintain a healthy level of immune function(11).



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