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KMID : 0362720150530070476
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Journal of the Korean Dental Association
2015 Volume.53 No. 7 p.476 ~ p.484
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Analysis of the statistical validity of clinical effectiveness data of a systemic titrated extract of Zea Mays L. unsaponifiable fraction chemotherapeutic agent (Insadol)
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Choi Yong-Geun
Eckert Steven E.
Lee Jeong-Yol
Shin Sang-Wan
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Abstract
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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.
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KEYWORD
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Clinical effectiveness, Titrated extract of Zea Mays L. unsaponifiable fraction, Periodontal disease
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