Numerous drugs have been tried in the treatment of peptic ulcer, but very few have survived the test. Antacids and anticholinergic drugs, while useful in the relief of acute ulcer symptoms, do not appear to be of any value in the promotion of ulcer healing. Carbenoxolone sodium, which was synthesized from the glycyrrhizinic acid fraction of liquorice in 1959, has been tried extensively in Western countries and found to be effective in promoting gastric ulcer healing. In contrast to the good results obtained in Western reports, a recent controlled trial in Chinese subjects with gastric ulcer has shown carbenoxolone to have no beneficial effect. This difference in response suggests the possibility that the race affects the rate of healing of gastric ulcer in carbenoxolone therapy. Nevertheless, there is no available data on the clinical efficacy of carbenoxolone in Korea.
So a clinical study of carbenoxolone was carried out in 27 Korean subjects with gastric ulcer diagnosed by the endoscopy in Han-il Hospital and Seoul National University Hospital from April 1975 to August 1976. Patient with significant cardiovascular, renal or hepatic disease were excluded from the trial. Before entering the trial, the patients were assessed clinically, and the blood pressure, weight, serum Na and serum K were checked. The study period was 4 weeks. Patients were seen weekly. Carbenoxolone was administered 100 mg 3 times daily, one hour before each meal for the first week and 50mg 3 times daily during the next 3 weeks. Antacids and other drugs were not permitted. At weekly examinations patients were questioned about ulcer symptoms, and weight gain, blood pressure, serum Na and serum K were checked.
The evaluation of the therapeutic effect was made by endoscopic examination when each patient first enters the trial and subsequently at the end of the 4th weeks. The ulcer healed in 13(48%o) patients, improved in 12(44%) patients and remained unchanged in 2(8%) patients. Relatively good symptomatic response was also obtained. It is considered carbenoxolone to be of beneficial effect, although double blind controlled study was not carried out.
Regarding side effects, an increase of more than 2Kg body weight was observed in 7 cases, (26%) of the 27. An increase in blood pressure of more than 20mmHg was found in 6 cases (22%). Serum K decreased in 7 cases (26%), but hypokalemia developed in 1 case (4%). Serum sodium increased in 19 cases (70%), but no patient showed hypernatremia. Weight gain and increase of blood pressure were easily controlled by a thiazide diuretic. In one case of hypokalemia serum K returned to normal after KCl supplement.
On the basis of these results, it can be concluded that carbenoxolone is effective in accelerating the healing of gastric ulcer among Korean and may cause adverse reactions occasionally. And these adverse reactions are predictable, easily recognized and controllable by appropriate concomitant therapy.
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