Treatment of duodenal ulcer with carbenoxolone sodium: a double-masked endoscopic trial. 1979

G P Young, and D J St John, and D A Coventry

In a double-masked trial, 43 patients with an endoscopically confirmed, symptomatic duodenal ulcer were allocated at random to treatment with either carbenoxolone sodium or placebo, both provided in identical "positioned-release" capsules. The 40 patients who satisfactorily completed the trial were evenly distributed between the two treatment groups. The groups were well matched with regard to clinical features and initial ulcer size. Endoscopic review of ulcer healing after six weeks' treatment showed that 12 patients (60%) receiving carbenoxolone had healed ulcers, compared with five (25%) receiving placebo (P = 0.05). Symptomatic remission occurred by the fourth week in 17 patients (85%) receiving carbenoxolone, compared with six (30%) receiving placebo (P less than 0.001). The mean (geometric) serum carbenoxolone level in patients with healed ulcers was 31.11 microgram/mL compared with 17.75 microgram/mL in those with unhealed ulcers (P less than 0.005). Side effects of carbenoxolone therapy were observed, but they did not necessitate withdrawal of the drug and were readily controlled in every instance. These results confirm the therapeutic efficacy of carbenoxolone sodium in duodenal ulcer. In addition, a relationship between serum carbenoxolone levels and the occurrence of ulcer healing was observed.

UI MeSH Term Description Entries
D010919 Placebos Any dummy medication or treatment. Although placebos originally were medicinal preparations having no specific pharmacological activity against a targeted condition, the concept has been extended to include treatments or procedures, especially those administered to control groups in clinical trials in order to provide baseline measurements for the experimental protocol. Sham Treatment
D002229 Carbenoxolone An agent derived from licorice root. It is used for the treatment of digestive tract ulcers, especially in the stomach. Antidiuretic side effects are frequent, but otherwise the drug is low in toxicity. Carbenoxalone,18alpha-Carbenoxolone,18alpha-Glycyrrhetinic Acid 3beta-O-Hemisuccinate,Biogastrone,Bioral,Carbeneoxolone,Carbenoxolone Disodium Salt,Carbenoxolone Sodium,Carbosan,Duogastrone,Glycyrrhetinic Acid 3-O-hemisuccinate,Pharmaxolon,Sanodin,18alpha Carbenoxolone,18alpha Glycyrrhetinic Acid 3beta O Hemisuccinate,3-O-hemisuccinate, Glycyrrhetinic Acid,3beta-O-Hemisuccinate, 18alpha-Glycyrrhetinic Acid,Acid 3-O-hemisuccinate, Glycyrrhetinic,Acid 3beta-O-Hemisuccinate, 18alpha-Glycyrrhetinic,Glycyrrhetinic Acid 3 O hemisuccinate
D002986 Clinical Trials as Topic Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries. Clinical Trial as Topic
D004311 Double-Blind Method A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment. Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D004381 Duodenal Ulcer A PEPTIC ULCER located in the DUODENUM. Curling's Ulcer,Curling Ulcer,Curlings Ulcer,Duodenal Ulcers,Ulcer, Curling,Ulcer, Duodenal,Ulcers, Duodenal
D004724 Endoscopy Procedures of applying ENDOSCOPES for disease diagnosis and treatment. Endoscopy involves passing an optical instrument through a small incision in the skin i.e., percutaneous; or through a natural orifice and along natural body pathways such as the digestive tract; and/or through an incision in the wall of a tubular structure or organ, i.e. transluminal, to examine or perform surgery on the interior parts of the body. Endoscopic Surgical Procedures,Surgical Procedures, Endoscopic,Endoscopic Surgical Procedure,Endoscopy, Surgical,Surgical Endoscopy,Surgical Procedure, Endoscopic,Procedure, Endoscopic Surgical,Procedures, Endoscopic Surgical
D006034 Glycyrrhetinic Acid An oleanolic acid from GLYCYRRHIZA that has some antiallergic, antibacterial, and antiviral properties. It is used topically for allergic or infectious skin inflammation and orally for its aldosterone effects in electrolyte regulation. Enoxolone,Glycyrrhetic Acid,Rhetinic Acid,Uralenic Acid,Arthrodont,Glyciram,Glycyram,Jintan,Po 12,12, Po,Acid, Glycyrrhetic,Acid, Glycyrrhetinic,Acid, Rhetinic,Acid, Uralenic
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man

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