Data from: 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. The trial itself involved the once-daily oral administration of a
placebo or mYJ for 3 months as an adjunct to non-surgical periodontal
therapy. Several periodontal parameters, including radiographic alveolar
bone density, were measured by computer-assisted densitometric image
analysis (CADIA) on selected sites, and CM signs of SH and KYD were
followed from their baseline values to various time points up to 12 months
or the end of study. Results: Twenty-five smokers (consumed 25.0 ± 15.3
smoking-pack years, ranged 7.5–80; aged 46.3 ± 6.8 years) with
periodontitis and SH and KYD were recruited (Placebo, n = 14; mYJ, n =
11). All of the participants showed good tolerance towards the CM recipe.
All of the periodontal parameters had improved after 12-month follow-up,
and no statistically significant differences were detected between the
control group and test group, except for the higher CADIA values observed
compared with the baseline at 12 months for test sites (P = 0.025). 4/3/3
test vs 14/13/13 control participants had persisting SH and KYD at 6, 9
and 12 months (P < 0.001), respectively. Conclusions: The
adjunctive use of mYJ preserved the post-treatment increases in the
radiographic alveolar bone density at the study sites and led to an
overall improvement in SH and KYD compared with the controls.