Clinical effects of benzydamine hydrochloride gargle preparation (NIK-237) on oral mucosal lesions A well-controlled comparative study with placebo

KEN-ICHI MICHI; HIROMICHI AKIZUKI; HIROSHI TAKAI; YASUSHI TAKEMOTO; YASUNOBU UCHIDA; YOSHIHIRO NARITA; KENJI HASHIMOTO; NOBUYUKI TANAKA; HIROSHI SATO; MASAAKI TERAKADO; YOSHIO HISANO; YASUHIDE OSHIMA; HIROYASU NOMA; TAKAHIKO SHIBAHARA; MASAO NAGUMO; SHIGEYO SAKURADA; KATSUNORI ISHIBASHI; ETSURO KIMORI; JIRO SASAKI; MASATAKA UEMATSU; NOBUYA OGAWA

doi:10.11263/jsotp1982.6.207

Clinical effects of benzydamine hydrochloride gargle preparation (NIK-237) on oral mucosal lesions

A well-controlled comparative study with placebo

KEN-ICHI MICHI, HIROMICHI AKIZUKI, HIROSHI TAKAI, YASUSHI TAKEMOTO, YASUNOBU UCHIDA, YOSHIHIRO NARITA, KENJI HASHIMOTO, NOBUYUKI TANAKA, HIROSHI SATO, MASAAKI TERAKADO, YOSHIO HISANO, YASUHIDE OSHIMA, HIROYASU NOMA, TAKAHIKO SHIBAHARA, MASAO NAGUMO, SHIGEYO SAKURADA, KATSUNORI ISHIBASHI, ETSURO KIMORI, JIRO SASAKI, MASATAKA UEMATSU, NOBUYA OGAWA

Author information

KEN-ICHI MICHI
First Department of Oral and Maxillofacial Surgery, School of Dentistry, Showa University
HIROMICHI AKIZUKI
First Department of Oral and Maxillofacial Surgery, School of Dentistry, Showa University
HIROSHI TAKAI
First Department of Oro-Maxillo-Facial Surgery, Tohoku Dental University
YASUSHI TAKEMOTO
First Department of Oro-Maxillo-Facial Surgery, Tohoku Dental University
YASUNOBU UCHIDA
Department of Oral Surgery, Tokyo Medical College
YOSHIHIRO NARITA
Department of Oral Surgery, Tokyo Medical College
KENJI HASHIMOTO
The First Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Tokyo Medical and Dental University
NOBUYUKI TANAKA
The First Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Tokyo Medical and Dental University
HIROSHI SATO
Second Department of Oral Surgery, Nihon University School of Dentistry
MASAAKI TERAKADO
Second Department of Oral Surgery, Nihon University School of Dentistry
YOSHIO HISANO
The Nippon Dental University, School of Dentistry at Tokyo, Department of Oral and Maxillofacial Surgery I
YASUHIDE OSHIMA
The Nippon Dental University, School of Dentistry at Tokyo, Department of Oral and Maxillofacial Surgery I
HIROYASU NOMA
First Department of Oral and Maxillofacial Surgery, Tokyo Dental College
TAKAHIKO SHIBAHARA
First Department of Oral and Maxillofacial Surgery, Tokyo Dental College
MASAO NAGUMO
Second Department of Oral and Maxillofacial Surgery, School of Dentistry, Showa University
SHIGEYO SAKURADA
Second Department of Oral and Maxillofacial Surgery, School of Dentistry, Showa University
KATSUNORI ISHIBASHI
Second Department of Oral and Maxillofacial Surgery, School of Dental Medicine, Tsurumi University
ETSURO KIMORI
Second Department of Oral and Maxillofacial Surgery, School of Dental Medicine, Tsurumi University
JIRO SASAKI
Department of Oral Surgery, School of Medicine, Tokai University
MASATAKA UEMATSU
Department of Oral Surgery, School of Medicine, Tokai University
NOBUYA OGAWA
Department of Pharmacology, Ehime University, School of Medicine

Keywords: Benzydamine hydrochloride gargle preparation (NIK-237), Lesion of oral mucosa, Analgesic effect, Comparative study, Placebo

JOURNAL FREE ACCESS

1987 Volume 6 Issue 3 Pages 207-225

DOI https://doi.org/10.11263/jsotp1982.6.207

Details

Abstract

The analgesic effects and safety of a 0.15% benzydamine gargle preparation (NIK-237) on aphtha and lichen planus lesions were investigated in a controlled study using placebo. The clinical effects of each drug were evaluated in 149 patients (NIK-237-treated group: 75, placebo-treated group : 74), and the following results were obtained.
1) Analgesic effect according to the judgment of the physician in charge : The NIK-237-treated group was superior, with a significant difference being observed (p<0.05) compared to the placebo-treated group.
2) Analgesic effect by scoring: The NIK-237-treated group was superior, with a significant difference being observed (p<0.05) compared to the placebo-treated group.
3) Overall safety rating : Both groups were judged to produce no side effects.
4) Usefulness : The NIK-237-treated group was superior, with a significant difference being observed (p<0.05) compared to the placebo-treated group.
5) Improvement rating of spontaneous pain with time : The NIK-237-treated group was superior (p<0.05) or tended to be superior (p<0.1) to that of the placebo-treated group 15, 60 and 120 minutes after administration of the drugs.
6) Effect on pain at the time of eating : The NIK-237-treated group tended to be superior (p<0.1) to that of the placebo-treated group.
From the above results, it is concluded that NIK-237 is highly useful for the treatment of oral mucosal diseases.

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