title: [Gastroduodenal tolerance of tenoxicam versus diclofenac-Na: an endoscopy double-blind controlled study in healthy probands].
abstract: The gastroduodenal tolerability of tenoxicam vs diclofenac-Na was evaluated in a double-blind, parallel group study in 36 healthy male volunteers. The doses used were 20 mg tenoxicam vs 100 mg diclofenac-Na in a retard formulation daily over a period of 14 days. Gastric tolerability was assessed by using upper endoscopy. Gastroscopy was performed at base-line after the dosing period of 14 days and again after a follow-up period of 14 days without any treatment. The mucosal lesions were scored using modified Lanza criteria. In comparison to diclofenac-Na, tenoxicam was significantly better tolerated after a 14-day dosing period (mean gastric score: tenoxicam: 1.3 +/- 0.7; diclofenac-Na: 2.2 +/- 1.1 p = 0.0143). Both treatment groups had comparable scores at base-line and post-study assessments. Tenoxicam and diclofenac-Na were generally well tolerated. Only two volunteers reported intermittent lack of appetite, heartburn, and a feeling of pressure in the stomach. In summary, tenoxicam given as a 20 mg single oral morning dose over a 14-day period was significantly better tolerated than diclofenac 100 mg with regard to gastroduodenal mucosal damage.
authors.affiliation: Medizinische Universitätsklinik Heidelberg, Gastroenterologische Abteilung.
authors.forename: P
authors.initials: P
authors.lastname: Müller
authors.forename: H G
authors.initials: HG
authors.lastname: Dammann
authors.forename: E
authors.initials: E
authors.lastname: Marinis
authors.forename: B
authors.initials: B
authors.lastname: Simon
mesh_terms: D000293:Adolescent; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000633:toxicity*; D004008:Diclofenac / Q000633:toxicity*; D004311:Double-Blind Method; D004386:Duodenum / Q000187:drug effects*; D005753:Gastric Mucosa / Q000187:drug effects*; D005773:Gastroscopy; D006801:Humans; D007413:Intestinal Mucosa / Q000187:drug effects*; D008297:Male; D010894:Piroxicam / Q000031:analogs & derivatives* / Q000633:toxicity; D016032:Randomized Controlled Trials as Topic
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D010894:Piroxicam; D004008:Diclofenac; C032801:tenoxicam
vernacular_title: Gastroduodenale Verträglichkeit von Tenoxicam versus Diclofenac-Na: Eine endoskopisch-kontrollierte Doppelblindstudie an gesunden Probanden.