Sucralfate in the treatment and prevention of gastric ulcer: multicentre double blind placebo controlled study.

A randomised controlled multicentre trial was performed in 160 patients with gastric ulcer, proved by endoscopy and biopsy, to compare ulcer healing with sucralfate and ranitidine (double blind double dummy design) and to assess the effect of maintenance treatment with sucralfate on ulcer recurrence (double blind placebo controlled design). The healing rates were similar with 4 g sucralfate suspension per day and 300 mg ranitidine per day (82% and 88% after 12 weeks, respectively). Of the 109 patients with healed ulcers, 92 were entered into the maintenance trial and treated with sucralfate tablets (2 g per day) or placebo tablets. Maintenance treatment with sucralfate delayed symptoms of gastric ulcer recurrence. Lifetable analysis showed significant differences between sucralfate and placebo, both after six months (p = 0.018) and after 12 months (p = 0.044). The rates of symptom recurrences were 13% and 34% after six months and 34% and 55% after 12 months for sucralfate and placebo, respectively. The rate of asymptomatic recurrences after 12 months was similar in the two groups (9% and 10%, respectively). The recurrence rate was higher in patients who had never taken non-steroidal anti-inflammatory drugs than in those who had but had stopped on admission to the study. It was also higher in patients with recurrent ulcer and in those with scarring deformation and narrowing of the pylorus. Maintenance treatment with sucralfate slowed the appearance of symptom recurrences of gastric ulcer.     

Ulcer recurrence among Filipino patients: Clinical profile and risk factors

Abstract Patients with endoscopic diagnosis of gastric and/or duodenal ulcers who eventually had endoscopic confirmation of ulcer healing after any anti-ulcer medication were entered in a 3 year study to determine ulcer recurrence rate, onset of ulcer recurrence and factors associated with ulcer recurrence. Patients from two participating centres who are not on any maintenance treatment had endoscopic examinations at 3, 6 and 12 months after ulcer healing or at any time of symptom recurrence. There were 144 patients entered into the study. The 1 year recurrence rate observed among 125 Filipino patients who completed the study was 73% wherein 71% occurred within the first six months. This was comparable with those reported in the world literature. Thirty-three per cent of those with recurrent ulcers were asymptomatic. The difference in the recurrence rate between gastric and duodenal ulcers was not statistically significant. The only risk factors found to be associated with ulcer relapse were history of smoking and alcohol intake. CLO test for Helicobacter pylori done in 45 patients with recurrent ulcers were all positive, suggesting a strong association between H. pylori and ulcer recurrence.     

Ranitidine 150 mg at night in the prevention of gastric ulcer relapse.

After healing of a gastric ulcer, 53 patients were randomly allocated to either 12 months maintenance treatment with ranitidine 150 mg at night or an identical placebo. Fifty patients completed the trial. The patients were interviewed every third month. If symptoms indicated a relapse, endoscopy was done; and if an ulcer was found the maintenance trial was terminated. All remaining patients were endoscoped after one year. The accumulated relapse rate in the ranitidine group (36%) was significantly lower (p less than 0.01) than in the placebo group (76%), as also was the antacid consumption (p less than 0.01). Four of the six ulcers found at the final one year endoscopy were asymptomatic. In all but two of the 26 patients with relapse of symptoms an ulcer was found at endoscopy. The patients that suffered a recurrence had significantly (p less than 0.05) higher maximal acid output than those without ulcer recurrence. The time needed for healing of the relapse ulcers (four or eight weeks) corresponded to that needed for healing of the preinclusion ulcers. It is concluded that ranitidine 150 mg at night significantly reduces the gastric ulcer recurrence rate, and that relapsing ulcers are similar to the initial ones in healing response.     

Significance of Helicobacter Pylori Infection in Human Peptic Ulcers

Abstract: Experimental studies have suggested that the continuous administration of 0.02% NH, solution, induced by Helicobacter pylori (H, Pylori), leads to a glandular atrophy of the gastric mucosa, and adversely affects healing of acetic acid ulcers in rats, because of the suppression of cell kinetics of the regenerative epithelial cells and connective tissues at ulcer margins. To visualize the distribution of H. pylori in human gastric mucosa, a phenol red dye spraying endoscopy was performed in 45 patients with gastric ulcers, and 43 patients with duodenal ulcers, who were medicated with a full dose of H₂-blocker until ulcer healing, and with half doses thereafter. In the H. pylori negative cases, 8 (88.9%) of 9 gastric ulcers healed within 3 months after medication, with no relapse discernible up to 6 months after healing of the preceding ulcer. The relapse rate was 25% up to 12 months after ulcer healing. In contrast, only 22 (66.1%) of 36 gastric ulcers healed within 3 months after medication in the H. pylori positive cases. The relapse rate was 12.5% up to 3 months, 30.4% UP to 6 months and 63.6% up to 12 months after ulcer healing. In addition, all 6 duodenal ulcers healed within 2 months after medication in the H. pylori negative cases, with no relapse discernible up to 12 months after healing of the preceding ulcer. In contrast, in the H. pylon positive cases, 20 (53.1%) of 37 duodenal ulcers healed within 2 months, and the relapse rate was 14.3%, 33.3%, and 66.7% up to 3, 6 and 12 months respectively after healing of the preceding ulcer. These data suggest that H. pylori is likely to interfer with ulcer healing, and promotes peptic ulcer relapse.     

Duodenal ulcer treated with omeprazole: healing and relapse rates. Does treatment duration influence subsequent remission?

One hundred and twenty-nine patients were studied with regard to healing of duodenal ulcers with 30 mg omeprazole once daily, recurrence rates after 2 and 4 weeks' treatment in patients with ulcers healed after 2 weeks, and recurrences in rapid and slow healers. Cumulative healing rates were 77% and 98% after 2 and 4 weeks, respectively. Eighty-one patients (65%) were without ulcer symptoms after 2 weeks, and 43 (34%) were improved. Seven of 45 patients (16%; 95% confidence limits, 6-30%) with ulcers healed after 2 weeks had relapsed after another 2 weeks of placebo; 3 were asymptomatic. The overall relapse rate after 6 months was 62%. There were no statistically significant differences in relapse rates between 2 and 4 weeks' treatment of patients with ulcers healed after 2 weeks or between rapid and slow healers. Ulcer size, smoking habits, and alcohol consumption were not significantly related to healing or relapse.     

Spontaneous healing of duodenal ulcers

Ninety-one patients with duodenal, pyloric, or prepyloric ulcers were studied endoscopically. Spontaneous ulcer healing was seen in 29 patients within 2 weeks (rapid healing) and in 23 patients within 6 weeks (slow healing). More ulcers healed spontaneously in women than in men (P less than 0.05). Spontaneous healing in men was related to a low gastric peak acid output (P less than 0.05). During follow-up study for 2 years of patients with spontaneously healed ulcers 13 patients had no recurrence, whereas 19 patients had 1 or 2 recurrences, which also healed spontaneously; 11 patients had to be given active treatment, and 9 patients did not complete the study. Cigarette smoking was more frequently recorded in the group receiving active treatment than in the group with spontaneous healing. In men ulcers needing active treatment during the follow-up period were related to a high peak acid output (P less than 0.05).     

Deduction of duodenal ulcer recurrence by healing with cimetidine plus sulpiride.

The effect of combined treatment with sulpiride plus cimetidine was compared against that of cimetidine alone on the healing of duodenal ulcer and on the subsequent relapse rate. In a double blind study, 35 patients with duodenal ulcer diagnosed by endoscopy were randomly assigned to receive cimetidine 800 mg daily and 38 patients to receive cimetidine 800 mg plus sulpiride 200 mg daily. Sixty patients whose ulcers were healed at three months continued to be observed after stopping treatment and underwent endoscopy to detect recurrences when symptomatic or at three and at six months if asymptomatic. Recurrence was observed in 18 (72%) of 25 patients whose ulcers had healed on cimetidine alone, but in only 11 (38%) of 29 patients whose ulcers healed on cimetidine plus sulpiride.     

Image Processing for the Evaluation of Gastric Ulcer Scars Using a Personal Computer

Abstract: Image processing of gastric ulcer scars was conducted using a computer-equipped electronic endoscope in order to quantitatively classify the quality of gastric ulcer scars. Frontal images of 66 gastric ulcer scars (red scar stage), in 60 patients, obtained by electronic endoscopy were fed into a desktop computer system. Ulcer scars were classified according to the standard deviation of green signal intensity and unevenness of the scar surface, following repeated application of smoothing, into three groups. Group I: ulcer scars with a standard deviation of green signal intensity less than or equal to 15 and a flat surface after smoothing had been carried out 10 times. Group II: ulcers other than Group I or III. Group III: ulcers with a standard deviation greater than or equal to 25 and markedly uneven features after smoothing had been carried out 20 times. Follow-up gastroscopy examinations were performed at 2-week intervals and the cumulative recurrence rate, as well as the transition from red scar stage to white scar phase, were determined 7 months after initial healing. There were 15 Group I, 28 Group II and 23 Group III ulcer scars. The proportion of ulcer relapse was 6.7% in Group I, 35.7% in Group II and 47.5% in Group III. Regarding the relationship between the transition rate from red scar to white scar and the scar classification, 66.7% of Group I, 28.6% of Group II and 17.4% of Group III ulcer scars progressed to the white scar stage. This classification of gastric ulcer scars provides a representative index of the quality of ulcer healing, which is potentially useful for planning maintenance treatment.     

Factors Influencing the Relapse of Gastric Ulcers During H2-Receptor Antagonist Maintenance Therapy

Abstract: We performed H₂-receptor antagonist maintenance therapy for 2 years on 146 patients with healed gastric ulcers (including those with concurrent duodenal ulcers), and determined the cumulative endoscopic and symptomatic recurrence rates. We also investigated the factors involved in ulcer recurrence in the first 12 months of maintenance therapy. The cumulative endoscopic non-recurrence rate was 70.0% at 12 months and 57.2% at 24 months, while the cumulative symptomatic non-recurrence rate was 84.8% at 12 months and 75.0% at 24 months. The factors contributing to endoscopic recurrence were the presence of a concomitant disease, the presence of duodenal ulcer, the type of ulcer, and the endoscopic stage at healing. The factors related to symptomatic recurrence were smoking and the type of ulcer. Multivariate analysis showed that the type of ulcer, smoking, and the endoscopic stage at healing influenced the risk of recurrence.     

Effect of treatment of Helicobacter pylori infection on the long-term recurrence of gastric or duodenal ulcer. A randomized, controlled study.

OBJECTIVE: To determine the effect of treating Helicobacter pylori infection on the recurrence of gastric and duodenal ulcer disease. DESIGN: Follow-up of up to 2 years in patients with healed ulcers who had participated in randomized, controlled trials. SETTING: A Veterans Affairs hospital. PARTICIPANTS: A total of 109 patients infected with H. pylori who had a recently healed duodenal (83 patients) or gastric ulcer (26 patients) as confirmed by endoscopy. INTERVENTION: Patients received ranitidine, 300 mg, or ranitidine plus triple therapy. Triple therapy consisted of tetracycline, 2 g; metronidazole, 750 mg; and bismuth subsalicylate, 5 or 8 tablets (151 mg bismuth per tablet) and was administered for the first 2 weeks of treatment; ranitidine therapy was continued until the ulcer had healed or 16 weeks had elapsed. After ulcer healing, no maintenance antiulcer therapy was given. MEASUREMENTS: Endoscopy to assess ulcer recurrence was done at 3-month intervals or when a patient developed symptoms, for a maximum of 2 years. RESULTS: The probability of recurrence for patients who received triple therapy plus ranitidine was significantly lower than that for patients who received ranitidine alone: for patients with duodenal ulcer, 12% (95% CI, 1% to 24%) compared with 95% (CI, 84% to 100%); for patients with gastric ulcer, 13% (CI, 4% to 31%) compared with 74% (44% to 100%). Fifty percent of patients who received ranitidine alone for healing of duodenal or gastric ulcer had a relapse within 12 weeks of healing. Ulcer recurrence in the triple therapy group was related to the failure to eradicate H. pylori and to the use of nonsteroidal anti-inflammatory drugs. CONCLUSIONS: Eradication of H. pylori infection markedly changes the natural history of peptic ulcer in patients with duodenal or gastric ulcer. Most peptic ulcers associated with H. pylori infection are curable.     

Spontaneous Healing of Duodenal Ulcers

Ninety-one patients with duodenal, pyloric, or prepyloric ulcers were studied endoscopically. Spontaneous ulcer healing was seen in 29 patients within 2 weeks (rapid healing) and in 23 patients within 6 weeks (slow healing). More ulcers healed spontaneously in women than in men (P < 0.05). Spontaneous healing in men was related to a low gastric peak acid output (P < 0.05). During follow-up study for 2 years of patients with spontaneously healed ulcers 13 patients had no recurrence, whereas 19 patients had 1 or 2 recurrences, which also healed spontaneously; 11 patients had to be given active treatment, and 9 patients did not complete the study. Cigarette smoking was more frequently recorded in the group receiving active treatment than in the group with spontaneous healing. In men ulcers needing active treatment during the follow-up period were related to a high peak acid output (P < 0.05).     

Role of Helicobacter pylori in ulcer healing and recurrence of gastric and duodenal ulcers in longterm NSAID users. Response to omeprazole dual therapy.

BACKGROUND: The relation between Helicobacter pylori infection and non-steroidal anti-inflammatory drug (NSAID)-associated peptic ulcers remains unclear; in particular, it is not known whether H pylori plays a part in the healing and recurrence of these ulcers. AIMS: To evaluate prospectively in a consecutive series of arthritis patients receiving longterm NSAID treatment the prevalence of peptic ulcer as well as the effect of H pylori eradication on the healing and recurrence of gastric and duodenal ulcer found. PATIENTS: Some 278 consecutive patients underwent gastroscopy with multiple biopsies of the gastric antrum and corpus for histological examination and rapid urease test. One hundred peptic ulcers (59 gastric ulcers, 39 duodenal ulcers, and two gastric ulcers concomitant with a duodenal ulcer) were found. Seventy per cent of these ulcers were H pylori positive. METHODS: According to their H pylori status, ulcer patients were randomised to one of the following treatments: H pylori negative ulcers received omeprazole 20 mg twice daily for four to eight weeks, whereas H pylori positive lesions were treated with omeprazole 20 mg twice daily plus amoxycillin 1 g twice daily (the second of these for the first two weeks) or omeprazole alone for four to eight weeks while continuing NSAID therapy. Patients with healed ulcers were endoscopically followed up for six months after stopping antiulcer therapy while continuing NSAIDs. RESULTS: Endoscopic healing rates for gastric and duodenal ulcers in the three different groups were similar both at four and eight weeks. H pylori eradication did not influence healing, which occurred in 14 of 20 (70%) of patients in whom H pylori was eradicated, compared with 14 of 17 (82%) of patients with persistent infection. Cumulative recurrence rates at six months did not statistically differ among the three different groups (27% in H pylori negative, 46% in H pylori positive, and 31% in those where H pylori was eradicated during the healing phase), although a numerical trend in favour of a higher recurrence rate in infected patients was evident. CONCLUSIONS: H pylori eradication does not confer any significant advantage on the healing of gastric and duodenal ulcers associated with longterm NSAID use. It remains to be established with certainty whether eradication may be helpful in the reduction of recurrence in a specific subset of NSAID associated ulcer.     

Influence of Helicobacter pylori Infection on Healing and Relapse of Acetic Acid Ulcers in Mongolian Gerbils

Both Helicobacter pylori and NSAIDs play important roles in the healing and relapse of peptic ulcers in man. We examined how H. pylori infection, indomethacin, and their combination affects the healing of gastric ulcers and whether or not such factors provoke a relapse of healed gastric ulcers in Mongolian gerbils. Gastric ulcers were induced by serosal application of an acetic acid solution. H. pylori (ATCC43504) was orally administered once into animals with active and healed ulcers. Ulcers healed within eight weeks and remained healed for the following six months. H. pylori infection significantly delayed ulcer healing four weeks following infection. Indomethacin treatment showed a tendency to delay ulcer healing. Ulcer healing in H. pylori-infected Mongolian gerbils was significantly delayed by indomethacin. H. pylori infection resulted in a relapse of healed ulcers from one to six months after infection, with a gradual increase in size. By the fourth month following a relapse, the serum gastrin level had significantly increased. H. pylori-induced ulcers in the posterior wall coexisted with relapsed ulcers in the anterior wall five and six months later. Omeprazole markedly prevented the ulcer relapse caused by H. pylori infection. It is concluded that, in Mongolian gerbils, H. pylori infection delayed the healing of preexisting gastric ulcers and resulted in the relapse of healed ulcers, yet indomethacin had little or no effect on ulcer healing or relapse.     

Incompletely and completely healed duodenal ulcers' outcome in maintenance treatment: a double blind controlled study.

A six month, double blind, controlled study was performed in 107 asymptomatic duodenal ulcer patients who, after short term cimetidine treatment, showed complete or incomplete endoscopic healing. Patients were stratified according to the type of healing and randomly allocated to cimetidine (200 mg at lunch, 400 mg at bedtime) or placebo. Endoscopic examinations were carried out after six months or when symptoms recurred. Eighty seven patients completed the maintenance trial. Of the 56 patients admitted to the study with complete healing, 30 were placed on cimetidine and 26 on placebo. Of the 31 patients admitted with incomplete healing, 15 were placed on cimetidine, and 16 on placebo. Results showed that, regardless of maintenance treatment, patients with incompletely healed ulcers had a higher ulcer crater recurrence rate, than patients with complete healing (71% vs 34%; p less than 0.005). A significantly higher ulcer crater recurrence was observed in incompletely healed ulcer patients, even when cimetidine or placebo treatment groups were considered separately. Irrespective of the type of healing, ulcer crater recurrence was more frequent in placebo treated patients than in those treated with cimetidine (67% vs 29%; p less than 0.001). We conclude that, in order to prevent a high ulcer recurrence rate, maintenance treatment should start only after the assessment of a complete endoscopic healing of duodenal ulcers.     

Relapse of Duodenal Ulcer after Treatment with Trimipramine/Antacids or Cimetidine/Antacids

Ninety-three patients with duodenal ulcer were treated with trimipramine. 25 mg at night; Cimetidine. 400 mg at night; or cimetidine. 1000mg/day. In addition, all patients were given 20 ml antacids 1 and 3 h after meals. The healing rates after 6 weeks' treatment were 86%, 85%, and 100% in the three groups, respectively (differences not significant). After healing of the ulcers 88 of the patients were checked monthly during 1 year to study relapse rate. Endoscopy was performed on recurrence of symptoms suggesting relapse and after 6 and 12 months in all asymptomatic patients. Relapse was diagnosed in 64% of the patients in the trimipramine-treated group, in 48% in the 400 mg Cimetidine group, and in 54% in the 1000 mg Cimetidine group (differences not significant). The results suggest that ulcer recurrence is not commoner after treatment with a standard dose of Cimetidine than after a low dosage of Cimetidine or trimipramine.     

Evidence for the essential role of Helicobacter pylori in gastric ulcer disease.

Helicobacter pylori (H pylori) eradication heals chronic active type B gastritis and dramatically changes the natural history of duodenal ulcer disease. There are few data concerning the role of anti-H pylori treatment in gastric ulcer disease. A total of 83 patients presenting with H pylori positive active gastric ulcer disease were treated with omeprazole and antibiotics (amoxicillin, ciprofloxacin, roxithromycin) in seven different clinical protocols, each of which included the attempt to eradicate H pylori infection and to evaluate the post-therapeutic course of ulcer disease. The overall proportion of H pylori eradication was 67.9% (53 of 78 patients available for follow up). Best results were obtained with two week treatment regimens comprising omeprazole 20 mg twice daily and amoxicillin 500 mg four times a day or 1000 mg twice daily (eradication > 80%). Eradication of H pylori speeds up ulcer healing, with a six week healing rate of 84.9% compared with 60% in patients with persistent H pylori infection (p = 0.0148). In a subgroup of 11 patients with refractory ulcers, H pylori eradication (n = 10) was associated with ulcer healing on continued acid suppression in nine cases. One male patient with chronic antral ulcer did not respond to treatment within the next six months (H pylori and ulcer persistence), and in one female patient a resistant body ulcer was identified as gastric lymphoma. Fifty patients with healed ulcers were followed up for one year. Patients with (n = 32) and without (n = 18) bacterial eradication had similar demographic and clinical characteristics. H pylori eradication was associated with a statistically significant reduction of ulcer recurrences (3.1 v 55.6%, p<0.001). This study concludes that H pylori eradication considerably changes the natural history of H pylori associated gastric ulcer disease. In addition, H pylori eradication speeds up ulcers healing and is associated with healing of previously refractory ulcers. Thus, treatment aimed at bacterial eradication should be considered in all patients with gastric ulcers severe enough to contemplate further treatment options.     

Endoscopic evaluation of the effect of sucralfate therapy and other clinical parameters on the recurrence rate of gastric ulcers

A randomized controlled clinical study was conducted to determine (a) whether basic aluminum sucrose sulfate (sucralfate) is effective in preventing or reducing gastric ulcer recurrence, and (b) the clinical parameters contributing to ulcer recurrence after endoscopically proved healing has been effected. A total of 167 patients were assigned on a random basis to either of two treatment groups, control (aluminum hydroxide and magnesium oxide) or sucralfate, and given these medications for 6 months. At the end of this period all medication was withdrawn from both groups and the patients were followed for an additional 12 months. Each patient was examined endoscopically at bimonthly intervals throughout the 18-month observation period. Treatment (sucralfate), ulcer history, size of previous ulcer(s), prestudy healing time, and prestudy healing stage attained (red or white scarring) were associated with a significant reduction in recurrence rate. Ulcer recurrence was markedly reduced in sucralfate patients as compared to control when the pretreatment ulcers had healed slowly (P<0.001).     

Prophylactic effect of cimetidine in gastric ulcer patients.

Nineteen patients entered a double-blind randomized trial of the prophylactic effect of cimetidine in gastric ulcer disease. The diagnosis of gastric ulcer had been established endoscopically prior to the trial, but at the time of entry the patients were symptom-free and their ulcers had healed. The patients received either cimetidine, 400 mg twice daily or inactive tablets. Ten cimetidine-treated patients completed 12 months' treatment without suffering a recurrence of symptoms, whereas 5 of 9 placebo-treated patients suffered a symptomatic relapse after 7 to 18 weeks (P less than 0.025). In 4 of the 5 patients an ulcer was found at gastroscopy. It is concluded that maintenance treatment with cimetidine helps to prevent symptomatic relapses in gastric ulcer patients.     

Effects of Helicobacter pylori Infection on Healing and Recurrence of Gastric Ulcers

Objectives : The effects of Helicobacter pylori infection on the healing and recurrence of gastric ulcers were investigated. Methods : Eighty-five and 17 patients with endoscopically-proven gastric ulcer with and without H. pylori infection, respectively, received 800 mg of cimeti-dine daily. Healing of ulcer and H. pylori infection were assessed at wk 12. After the 12-wk-treatment period, 67 and 16 patients with healed ulcer positive and negative for H. pylori infection, respectively, received maintenance treatment (cimetidine 400 mg daily). Ulcer recurrence and H. pylori infection were assessed at or within 24 wk from the beginning of maintenance treatment. Variables influencing ulcer healing and recurrence were analyzed by multiple regression analysis. Results : Ulcer healing at wk 12 was similar in patients with and without H. pylori infection, occurring in 16 (89%) of 18 patients without H. pylori infection, compared with 67 (87%) of 77 patients with H. pylori infection. At or within 24 wk from the start of maintenance therapy, ulcer recurrence was significantly more frequent in patients with H. pylori infection than in those without: it occurred in three (20%) of 15 patients without H. pylori infection, but in 37 (58%) of 64 patients with infection. Multiple regression analysis showed that H. pylori infection was related most closely to ulcer recurrence independently. Conclusion: H. pylori infection had a significant independent influence on gastric ulcer recurrence, but not initial ulcer healing.     

Circulating vaspin and its relationship with insulin sensitivity,adiponectin and liver histology in subjects with non-alcoholic steatohepatitis

During the study period 1972-74 gastric ulcer was demonstrated by endoscopy in 114 patients, 54 of whom were included in the present study. Forty-two were excluded because of ulcer showing incipient healing, superficial erosions, manifest or suspected malignancy, or indication for surgery. Eighteen patients were not included because of advanced age, complicating diseases, or refusal to have further examinations. The study comprises a treatment phase and a follow-up phase. The treatment phase ran from the first endoscopic demonstration of gastric ulcer until complete healing. During this period the patient was treated with antacids and anticholinergics and, if required by his condition, admission to hospital. During the treatment phase, endoscopy was performed at intervals of from 3 to 6 weeks until healing. During the follow-up phase endoscopy was carried out in the event of dyspeptic complaints that might indicate recurrent ulcer. The healing and recurrence rates for various periods were calculated by the aid of the life-table method. After 1 mo. of treatment 13% of the aptients exhibited healing, after 2 mo. 29%, after 3 mo. 41%, and after 12 mo. 79%. In one month 9% of the primarily healed ulcers had recurred, in 2 mo. 15%, in 3 mo. 22%, and in 12 mo. 43%. The healing rate is appreciably lower than results reported in the literature, whereas the recurrence rate is in closer accordance with previous studies.