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F Pace

Publications and source records attributed to F Pace.

At least 55 records · Page 3Linked to original sources
PubMed1995

Meta-analysis of the effect of placebo on the outcome of medically treated reflux esophagitis.

BACKGROUND: To ascertain the placebo-induced effect in the treatment of reflux esophagitis, we reviewed all the English-language literature concerning the results of placebo-controlled trials of erosive/ulcerative esophagitis from 1976 to 1990. Twenty-two studies fulfilled our meta-analytic criteria. RESULTS: After 4 to 8 weeks of treatment, active drugs (cimetidine, ranitidine, nizatidine, omeprazole, metoclopramide, sucralfate) were significantly more effective than placebo in the healing of esophagitis, with a pooled rate difference (PRD) of 0.22 in favor of the active drug, an odds ratio (OR) of 2.57 (confidence interval (CI) = 2.0-3.3). Pooled mean healing rate (+/- SD) with the active drug was 47.3 +/- 24.0%, as compared with 26.8 +/- 18.0% obtained with placebo after 4 to 8 weeks of treatment. With regard to symptomatic response, complete disappearance of symptoms was observed in an average of 31.6% active-treated patients and in 11.8% of placebo-treated patients, respectively. The PRD was 0.20, and the OR 2.25 (CI = 1.65-3.06). The incidence of side effects was not statistically different for the two treatment groups. CONCLUSION: Placebo is a relatively inactive drug in the short-term treatment of erosive ulcerative reflux and does not appear to change the natural history of the disease.

Anti-Ulcer Agents↗
PubMed1995

Short and long-term outcome of medically treated reflux esophagitis.

The purpose of this retrospective study was to characterize the clinical course of medically-treated reflux esophagitis and to identify factors related to acute healing and relapse of the disease. We investigated 77 patients (56 males, 21 females, mean age 46.9 years) suffering from esophagitis (grade I-IV according to Savary and Miller), who were referred to our Unit during the period between January 1984 and December 1988. Typical GER symptoms were present in 63 patients, 51 of whom had esophageal 24-hour pH-monitoring suggestive of pathological GER, defined as total time with pH < 4 equal to or greater than 7%. All patients received 3 to 6 months of treatment (H2-antagonists = 68, antacids = 6, prokinetic drugs = 1, omeprazole = 2). After 3 months of therapy 39/88 patients (50.7%) had healed, and this figure increased to 56/77 patients (72.7%) after 6 months. The majority of these patients (N = 49) subsequently underwent a 24-week course of treatment, mostly with low-dose H2-antagonists (N = 44). At the end of treatment, 34/49 patients (69.3%) remained healed, while 15/49 (30.7%) relapsed, 40% asymptomatically. 14/21 patients (66.7%) who were not healed after 6 months' therapy, healed when the same treatment was prolonged up to 18 months (median: 11 months). The only factor found to influence acute healing significantly was the type of therapy, while none of the variables analyzed were seen to correlate with disease relapse.

Adolescent↗
PubMed1993

Features of symptomatic gastroesophageal reflux in elderly patients.

Scarce information is available on gastroesophageal reflux disease in elderly patients. In this study we investigated patterns of gastroesophageal reflux and esophageal lesions in 24 elderly patients with typical gastroesophageal reflux symptoms and a mean age of 69 years (range, 65-76 years), as compared with 147 symptomatic younger patients with a mean age of 45 years (range, 21-64 years). The results of 24-h pH-monitoring and endoscopy showed that the elderly patients had pathologic reflux and reflux esophagitis more frequently than the young patients. The percentage time with pH < 4 in elderly patients with reflux esophagitis was 32.5% in 24 h, as compared with 12.9% in the younger patients with reflux esophagitis (P < 0.05). The elderly patients with reflux esophagitis had more prolonged periods of acid reflux in both the upright and supine positions than the younger patients. Endoscopy showed that 20.8% of elderly patients had grade III/IV esophagitis, whereas only 3.4% of younger patients had grade III/IV esophagitis (p < 0.002). The percentages of grade I/II esophagitis in the two groups were 12.5% and 26.5%, respectively (p < 0.002). We concluded that, compared with younger subjects, elderly patients have more severe gastroesophageal reflux and esophageal lesions.

Adult↗
PubMed1993

Gastric acid secretion and pattern of gastroesophageal reflux in patients with esophagitis and concomitant duodenal ulcer. A multivariate analysis of pathogenetic factors.

This study was designed to assess the relationship between gastric acid output (GAO) and both pattern of gastroesophageal reflux (GER) and severity of esophageal lesions. Gastric acid secretory testing and 24-h intraesophageal pH-monitoring were performed in 31 patients with esophagitis and concomitant duodenal ulcer (E+DU) and compared with those of 72 patients with esophagitis (E). The second aim of this study was to evaluate the role of GAO and other potential pathogenetic factors in the development of esophagitis. The results of the study showed that GAO in patients with E+DU was significantly higher than in patients with E (p < 0.05). There was no significant difference between the two groups of patients with regard to endoscopic findings or GER variables (p < 0.05). Multiple regression analysis with stepwise deletion showed that the presence of hiatal hernia, GER in the upright position and age appear to correlate significantly with the presence of esophagitis. We conclude that no parallel relationship exists between GAO and severity of GER or esophageal lesions in patients with E+DU and that GAO is not a major pathogenetic factor in GER disease.

Adult↗
PubMed1992

Short-term treatment of refractory reflux esophagitis with different doses of omeprazole or ranitidine.

Sixty patients who presented with erosive/ulcerative refractory reflux esophagitis were randomized to receive a 4- to 8-week treatment with omeprazole 20 mg daily, or ranitidine 150 mg twice daily. Patients not healed after treatment were given the same drugs at doubled doses for a second period of equal duration. Patients still unhealed after this received open treatment with omeprazole 20 mg twice daily for a third period of 4 to 8 weeks. Endoscopic assessment and clinical and laboratory evaluation were performed every 4 weeks until there was complete esophageal mucosal repair. After 4 weeks, complete healing was observed in 50% of patients on omeprazole 20 mg daily, compared with 20.7% on ranitidine 150 mg twice per day (p < 0.01). After 8 weeks, the figures were 79.3% versus 34.5% (p < 0.5). With doubled doses after 4 weeks, complete healing was achieved in 96.6% of patients on omeprazole 40 mg daily, compared with 64.2% on ranitidine 300 mg twice per day (p < 0.05). The eight still "refractory" patients (one omeprazole, seven ranitidine) healed completely with 8 more weeks of omeprazole 20 mg twice daily. Patients treated with omeprazole experienced faster relief of heartburn, which disappeared in 60% of patients after 4 weeks, as compared to 21% of patients treated with ranitidine (p < 0.006). Apart from the mode of treatment, the only factor that proved to be related to healing at multivariate analysis was the pretreatment severity of gastroesophageal reflux, as measured by esophageal pH monitoring. Our study confirms that omeprazole, even at a low dosage, is the choice for refractory reflux esophagitis.

Adult↗
PubMed1992

pH fluctuations versus reflux episodes in patients with gastroesophageal reflux disease: their optimal thresholds and significance in diagnosis.

In physiological and pathological conditions, pH monitoring in the esophagus shows small variations as well as more pronounced deflections. However, only the latter are traditionally taken into account in 24-hour pH monitoring analysis. The present study was designed to establish optimal thresholds of pH fluctuations versus reflux episodes in separating physiological and pathological gastroesophageal reflux (GER) and to evaluate their significance in the diagnosis. Twenty-four-hour intraesophageal pH monitoring and endoscopy were performed in 62 patients with GER symptoms and in 42 healthy controls. The results showed that the percentages of the time with pH fluctuations in patients with and without esophagitis and in healthy controls were, on average, 12.65, 9.5 and 2.76% in 24 h, respectively, and the respective percentages of the time with reflux episodes in the same groups in 24 h were, on average, 3.12, 2.04 and 0.18%, respectively. Using a receiver-operating-characteristic curve analysis, less than 6.7% of the time with pH fluctuations and less than 0.1% of the time with reflux episodes were defined as the combined thresholds for physiological versus pathological reflux. The sensitivity of the combined thresholds for the detection of GER patients with and without esophagitis was 96.7 and 90%, respectively, and their specificity for the diagnosis of patients with abnormal GER was 100%. It is concluded that pH fluctuations and reflux episodes, when evaluated together, are more useful for classifying patients with GER and their combined thresholds yield higher diagnostic accuracy in assessing patients with gastroesophageal disease.

Adolescent↗
PubMed1991

[Reflux esophagitis: therapy with H2-blockers, and motility disorders].

In order to investigate the response of gastroesophageal reflux after medically induced healing of esophagitis and its relation to the occurrence of relapse during prophylactic treatment, 20 patients with erosive/ulcerative esophagitis underwent 24 hour esophageal pH monitoring before and after healing achieved with 12 to 24 weeks with ranitidine 150 or 300 mg bd. Compared with pretreatment values, after macroscopic healing, a significant reduction in daytime median percentage of reflux time and median number of reflux episodes lasting more than 5 min were observed, whereas during the night time reflux frequency and severity did not change. During maintenance treatment with ranitidine at half the acute dosage five of the six patients who had shown no improvement in gastroesophageal reflux after acute healing, relapsed. These results suggest that, in contrast to previous work, a decrease in gastroesophageal reflux in patients with reflux esophagitis can be achieved after macroscopic healing obtained with H2-antagonists, and that the occurrence of such a reduction after acute healing is predictive of a good response to long-term treatment.

Esophagitis, Peptic↗
PubMed1991

Natural history of gastro-oesophageal reflux disease without oesophagitis.

This retrospective study was undertaken to characterise the clinical course and reflux pattern of patients with gastro-oesophageal reflux without evidence of oesophagitis. We investigated 33 patients (12 women, 21 men; mean age 36 years) with typical symptoms, a negative oesophagoscopy, and a 24 hour oesophageal pH-metry indicative of pathological gastro-oesophageal reflux. All patients received antacids or prokinetic drugs or both for three to six months. Nineteen of 33 patients still had symptoms at the end of treatment, of whom five had developed erosive changes of the oesophageal mucosa. The other 14 discontinued treatment and remained asymptomatic during a six month follow up period. Comparison of the pretreatment pH-metry data of the 19 symptomatic patients and the 14 asymptomatic patients showed no differences in the pattern of gastro-oesophageal reflux in the two groups. We conclude that in a substantial proportion of patients with pathological reflux without oesophagitis symptoms may persist and mucosal lesions may develop during conventional treatment without any apparent change in the reflux. Patients who developed endoscopic oesophagitis did not have a more severe pretreatment pattern of gastro-oesophageal reflux when compared with those who did not develop oesophageal mucosal damage.

Adult↗
PubMed1991

Failure of sucralfate in the treatment of refractory esophagitis versus high-dose famotidine. An endoscopic study.

Scarce data exist on the medical treatment of patients with peptic esophagitis who are non-responders to conventional or higher doses of H2-blocker agents, and no controlled trial on such patients has been published so far. We conducted a randomized single-blind study on the effects of 1 g sucralfate four times daily (n = 8), a mucosa-protective agent, versus 40 mg famotidine twice daily (n = 8), a new H2-blocker agent, administered for 12 weeks, in the treatment of peptic esophagitis (grades I to IV in accordance with Savary and Miller) refractory to a 6-month therapy with ranitidine at a dosage of 150 or 300 mg twice daily. Complete healing of the esophageal lesions was observed in none of eight patients receiving sucralfate, as compared with five of eight taking famotidine (p less than 0.05, Fisher exact test). Three of eight patients treated with sucralfate and three of eight with famotidine had complete disappearance of symptoms, whereas improvement was observed in two and three of eight, respectively (p less than 0.05 in both cases). We conclude that anti-secretory therapy is more effective than mucosal protection in the treatment of refractory peptic esophagitis.

Adult↗
PubMed1991

High-dose famotidine in the maintenance treatment of refractory esophagitis: results of a "medium-term" open study.

Forty-four patients with esophagitis refractory to standard H2-blocker therapy, who had healed after a 4- to 16-wk course with either 20-40 mg omeprazole or ranitidine at doses of 300-600 mg daily in a randomized double-blind study, commenced a 3-month maintenance course of therapy with 40 mg bid famotidine. The aims of this investigation were to assess the effectiveness of this regimen in preventing recurrence of esophagitis lesions and symptoms in this subgroup of patients with therapy-resistant disease and to verify whether patients previously healed with omeprazole have a higher recurrence rate than those healed with ranitidine. The results of the study show that, despite the high dose of famotidine, 48% of patients relapsed within 3 months, a third of whom were asymptomatic. Moreover, previous omeprazole treatment is associated with a significantly higher risk of recurrence.

Adult↗
PubMed1990

Daytime reduction of gastro-oesophageal reflux after healing of oesophagitis and its value as an indicator of favourable response to maintenance treatment.

In order to investigate the response of gastro-oesophageal reflux after medically induced healing of oesophagitis and its relation to the occurrence of relapse during prophylactic treatment, 20 patients with erosive/ulcerative oesophagitis underwent 24 hour oesophageal pH monitoring before and after healing achieved with 12 to 24 week treatment with ranitidine 150 or 300 mg twice daily. Compared with pretreatment values, after macroscopic healing, a significant reduction in daytime median percentage of reflux time (10.0 v 6.5; p less than 0.05) and median number of reflux episodes lasting more than 5 minutes (5-5 v 1.0; p less than 0.05) were observed, whereas during night time reflux frequency and severity did not change. During maintenance treatment with ranitidine 150 or 300 mg nocte, five of the six patients, who had shown no improvement in gastro-oesophageal reflux after acute healing, relapsed. These results suggest that, in contrast with previous work, a decrease in gastro-oesophageal reflux in patients with reflux oesophagitis can be achieved after macroscopic healing, and that the occurrence of such a reduction after acute healing is predictive of a good response to longterm treatment.

Circadian Rhythm↗
PubMed1990

Pattern of acid reflux in patients with reflux esophagitis 'resistant' to H2-receptor antagonists.

Ambulatory 24-h esophageal pH monitoring was carried out in 54 patients with erosive/ulcerative reflux esophagitis before a 12- to 24-week treatment with either ranitidine, 150 to 300 mg twice daily, or famotidine, 20 to 40 mg twice daily. After this period, 21 patients continued to present endoscopic evidence of esophagitis. Patients who did not respond to the therapy showed a more severe pretreatment pattern of acid reflux than those who healed, with regard to both median percentage time of reflux (16.2% versus 11.0%, respectively, p less than 0.05) and median number of reflux episodes (88.0 versus 55.0; p less than 0.05). Ambulatory 24-h esophageal pH-metry is therefore to be recommended in all patients with acid reflux symptoms, even in those who already show endoscopic lesions of the esophageal mucosa, since this test is a valid prognostic indicator of response to treatment.

Esophagitis, Peptic↗
PubMed1990

Short and long-term effect of two different dosages of ranitidine in the therapy of reflux oesophagitis.

Many clinical trials on the effects of H2-antagonist drugs on reflux oesophagitis have shown unsatisfactory healing rates after conventional therapy, i.e. 4 to 12-week administration of 400 or 150mg bd of cimetidine or ranitidine, respectively. In order to verify if longer periods of treatment and/or higher dosage of drug can increase the healing rate, we performed a single-center double blind trial of 12 to 24 week duration on 75 patients with erosive/ulcerative reflux oesophagitis, comparing two ranitidine regimens, 150 vs 300mg bd. Patients who were healed after this period entered a 12 month maintenance treatment with half the dose previously received, i.e. 150 vs 300mg at bedtime. Our results show that, with both dosages, prolongation of acute treatment from 12 to 24 weeks allows complete additional healing of almost one fourth of patients. Furthermore, the data show that, both in the short and long-term treatment of reflux oesophagitis, conventional doses of ranitidine are as effective as double doses.

Adult↗