School of Preclinical Medicine, Beijing University of Chinese Medicine, No. 11, Beisanhuan Donglu, Chaoyang District, P.O. Box 83, Beijing 100029, China.
Evid Based Complement Alternat Med. 2013;2013:807801. doi: 10.1155/2013/807801. Epub 2013 Oct 20.
Objective. Evaluation of the efficacy of Crest Herbal Crystal Toothpaste in "clearing internal heat." Methods. This was a randomized, double-blind, controlled parallel design clinical test of a product that was already on the market. 72 subjects were randomly assigned to control group (group A with Colgate Herbal Salty Toothpaste) or treatment group (group B with Crest Herbal Crystal Toothpaste) with ratio of 1 : 2. Subjects were instructed to brush with 1g toothpaste for 2 minutes each time, 2 times per day in a 4-aweek test period; measurement with the rating scale on the efficacy of "clearing internal heat" for the herbal toothpaste was done at baseline, 2 weeks, and 4 weeks of toothpaste usage. Results. The rating scale on efficacy of "clearing internal heat" for the herbal toothpaste reveals that the primitive points of 72-case intention-to-treat (ITT) analysis and 67-case per-protocol (PP) analysis for subjects in group A and subjects in group B were found to be reduced progressively with statistical significance (P < 0.05). The overall effective rates for group A and group B were, respectively, 62.50%, 56.25% (ITT) and 62.50%, 60.64% (PP). The statistical results indicated that the symptoms of fire-heat for both groups of subjects have been improved after application of toothpaste. Conclusion. The efficacy of Crest Herbal Crystal Toothpaste in "clearing internal heat" was confirmed by the trial as compared to Colgate Herbal Salty Toothpaste. And its efficacy was objectively evaluated by the rating scale on efficacy of "clearing internal heat."
目的。评估佳洁士草本水晶牙膏在“清除内热”方面的功效。方法。这是一项已上市产品的随机、双盲、对照平行设计临床试验。72 名受试者被随机分为对照组(A 组,使用高露洁草本咸牙膏)或治疗组(B 组,使用佳洁士草本水晶牙膏),比例为 1:2。受试者被指导每次使用 1g 牙膏刷牙 2 分钟,每天刷牙 2 次,为期 4 周。在基线、使用牙膏 2 周和 4 周时,使用功效评分量表评估草药牙膏“清除内热”的功效。结果。使用牙膏 2 周和 4 周后,A 组和 B 组 72 例意向治疗(ITT)分析和 67 例符合方案(PP)分析受试者的功效评分量表上的“清除内热”原始评分均呈逐渐降低趋势,差异有统计学意义(P<0.05)。A 组和 B 组的总有效率分别为 62.50%、56.25%(ITT)和 62.50%、60.64%(PP)。统计结果表明,两组受试者的火热症状在使用牙膏后均有所改善。结论。与高露洁草本咸牙膏相比,试验证实佳洁士草本水晶牙膏在“清除内热”方面具有功效。并且通过“清除内热”功效评分量表客观评估了其功效。