Adjunctive use of modified Yunu-Jian in the non-surgical treatment of male smokers with chronic periodontitis: a randomized double-blind, placebo-controlled clinical trial

Background: Yunu-Jian (YJ) is a Chinese medicine (CM) heat purging formula, which is used to reduce wei huo (stomach-heat, SH) and enrich shen yin (kidney-yin, KY). This formula is also commonly used to manage diabetes mellitus and gum/oral inflammation. The activity of YJ can be modified or refined by the addition of other CM herbs and/or minor changes to one of its five key ingredients. The aim of this study was to evaluate the adjunctive use of modified YJ (mYJ) or YJ containing additional osteoblast-stimulating and inflammation-modulating CM herbs in the non-surgical periodontal treatment of smokers with chronic periodontitis in a randomized, double-blind, prospective, placebo-controlled study. Methods: Healthy adult male smokers with untreated chronic periodontitis who showed CM syndrome of SH and KY deficiency (KYD) whilst attending a dental teaching hospital from October to December, 2005, were invited to participate in a randomized double-blind, placebo-controlled clinical trial...背景：玉女煎（Yunu-Jian, YJ）是一种中药（Chinese medicine, CM）清热方剂，其功效为清泻胃火（stomach-heat, SH）与滋补肾阴（kidney-yin, KY）。该方剂亦常用于治疗糖尿病及牙龈/口腔炎症。通过添加其他中药材或调整其5种核心成分之一，可对YJ的药效进行优化或改良。本研究旨在通过一项随机、双盲、前瞻性、安慰剂对照临床试验，评估加味玉女煎（modified YJ, mYJ）或添加了促成骨、抗炎中药材的YJ作为辅助疗法，用于慢性牙周炎吸烟者的非手术牙周治疗的效果。方法：2005年10月至12月期间，于某口腔教学医院就诊的、符合中医胃火盛与肾阴亏虚（kidney-yin deficiency, KYD）证型、未接受过治疗的成年男性慢性牙周炎吸烟者被邀请参与本项随机双盲安慰剂对照临床试验……