• The Journal of the Korean dental association
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• v.53 no.7
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• pp.476-484
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• 2015

Purpose: This study intended to analyze the validity of clinical effectiveness data of clinical trials testing systemic titrated extract of Zea Mays L. unsaponifiable fraction chemotherapeutic agent. Material and Methods: Among 5 clinical trials claimed as proof of clinical effectiveness on the Web site of the manufacturer of this chemotherapeutic agent, a review of 4 clinical trials, written in either Korean or English, was conducted. Data were extracted from studies for the following variables: year of publication, age, sample size, follow-up period, combination with contemporary periodontal treatments, randomization, randomization check, blinded measurement, and statistical test type. Results: The study subjects' age intervals were too diverse to decide a common target population to generalize the findings. No study stated clearly the rationale for the sample size determination. Follow-up period to observe the start of clinical effectiveness was inconsistent and decided without any rationale of pathophysiological latent period. Randomization to make the comparisons on the same start line was performed but failed in a study. Randomization effect was not checked in 4 studies. Performance of blinded measurement of clinical outcomes to prevent bias was unclear in 2 studies. Type of statistical test was inappropriate in 3 studies. Conclusions: Based on the analysis of the validity of data on clinical and demographic variables, the four available clinical trials have not demonstrated compelling evidence of therapeutic effectiveness of systemic titrated extract of Zea Mays L. unsaponifiable fraction chemotherapeutic agent to improve prognosis of periodontal disease either with the contemporary periodontal treatment or without it.

• YAKHAK HOEJI
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• v.44 no.6
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• pp.578-587
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• 2000

The purpose of the present study was to design and prepare the optimum formulation for the oral administration of titrated extract of the unsaponifiable fraction of Zea mays L. (ETIZM). For this purpose, we simulated the blood concentration of ETIZM after its oral administration, changing the dissolution rate constants $(0.05{\sim}20\;hr^{-1})$. In vivo parameters, such as absorption rate constant $(k_a)$, elimination rate constant (k) and volume of distribution (Vd), were incorporated in the simulation on the basis of the experiments and literatures. When the dissolution rate constant $(k_r)$ is over $5\;hr^{-1}$, the absorption process appears to be the rate limiting step for the transport of ETIZM from the G.I. ract to the blood circulation. While less than $5\;hr^{-1}$, the dissolution rate considered to be the rate limiting step. Moreover, the optimum blood concentration was shown in the range from 1 to $5\;hr^{-1}$ of $k_r$ in the simulation. To design and prepare the tablets on the basis of the above results, 7 formula containing HPMC, PEG 4000 and PEG 6000 (1-5%, respectively) were prepared and evaluated. The tablets containing PEG 4000 (1%), PEG 6000 (1%) or PEG 4000 (5%) satisfy the optimum $k_r$ range ($1-5\;hr^{-1}$). These formulations, therefore, will be able to show the more effective blood concentration, compared with the commercial products after the oral administration.