Risk-adjusted treatment selection and outcome of patients with acute cholecystitis.

PURPOSE: Age and comorbidities increase the surgical risk for patients with acute cholecystitis and impact on the initial treatment selection. The aim of this article is the implementation of objective risk criteria that may be used to select the most appropriate treatment. METHODS: We carried out a prospective cohort study of all patients who were admitted to the hospital with a diagnosis of acute cholecystitis during 2014. They were initially allocated to three different treatment groups according to cholecystitis grade, number of days from clinical onset, and surgical risk scores as follows: immediate surgery by sepsis (EmergS), early surgery (EarlyS), or medical treatment group (MedT). Differences in the outcomes between the treatment groups were evaluated using bivariate and logistic regression analyses. RESULTS: A total of 149 patients were admitted; 44 % were >80 years old and 40 % were American Society of Anesthesiologists (ASA) > II. The mortality rate of the series was 0 % in EarlyS, 17 % in MedT, and 19 % in EmergS. The mortality rate was significantly associated with a higher degree of cholecystitis, age, and worse score values in risk scales and Charlson index. Logistic regression identified that the only independent predictors of death at the time of admission were the degree of cholecystitis (OR 2.87, p = 0.018) and the Portsmouth Physiological and Operative Severity Score for the enumeration of Mortality and Morbidity (P-POSSUM) score (OR 1.14, p = 0.001). CONCLUSION: The evaluation for the initial treatment in acute cholecystitis should include a systematic determination of the degree of cholecystitis and a surgical risk assessment. Tokyo guideline recommendations should be reviewed.

Variability of MELD score during the year before liver transplantation.

Model for end-stage liver disease (MELD) score is a good parameter to establish the patient survival before liver transplantation and give priority to the sickest patients. The aim of this study was to evaluate the variability and potential regression of MELD score during the months before liver transplant. From the 350 patients waitlisted for transplantation, we evaluated the 124 patients who had enough blood tests during 12 months before the final event (transplantation, death, removal from list due to improvement or worsening). We considered month 12 as the final event and blood tests from 0, 3, 6, and 12 months were analyzed. MELD score was calculated and compared using ANOVA for repeated measures test. To determine variability of MELD and its components, intraclass correlation coefficient (ICC) was calculated for 0, 3, and 6 months. The degree of constancy was defined by proximity of ICC to 1. Two groups by initial MELD (< or =17 or >17) were considered. Patient data are: mean age, 53 +/- 9 years; sex: 70% men, etiology, 28% hepatitis C, 11% alcohol and hepatitis C, 16% alcohol, 28% hepatocellular carcinoma, 6% hepatitis B, 11% others; Initial Child-score, 8.5 +/- 2.0; Initial MELD score, 15.2 +/- 4.9; mean time on waiting list, 8.1 +/- 5.7 months. MELD score from 6 and 12 months was significantly higher than the initial one. The most constant parameter was creatinine (ICC:0.89); bilirubin (ICC:0.58) and INR (ICC:0.59) were the most variable ones. MELD score ICC was 0.79. In only one patient did MELD score decrease 5 points below the initial one. For initial MELD < or = 17 and >17, variability was lower in the former. In conclusion, MELD became significantly higher 6 months after the basal determination. This score is reliable as it does not tend to decrease in time. In high MELD scores (>17), 3-month survival was lower and variability greater so that more careful follow-up and prioritizing are needed.

Efficacy and safety of thiopurinic immunomodulators (azathioprine and mercaptopurine) in steroid-dependent ulcerative colitis.

BACKGROUND: The efficacy of azathioprine in the management of steroid-dependent ulcerative colitis is taken for granted. However, study populations frequently include together steroid-dependent and refractory patients. AIM: To assess the efficacy and safety of thiopurinic immunomodulators in strictly defined steroid-dependent ulcerative colitis. METHODS: Survey of 34 patients with steroid-dependent ulcerative colitis, treated with azathioprine according to protocol. Therapeutical success: glucocorticoid withdrawal within 12 months, without steroid requirements during another year. RESULTS: Mean age was 39.1 +/- 17 years. Pancolitis and extensive colitis accounted for 50% of cases. Therapeutic success of immunomodulator treatment reached 70.6%, intention to treat analysis (confidence interval 95%: 52-84%) and 72.7%, as per protocol (confidence interval 95%: 54-86%). Mean time to steroid withdrawal was 4.6 months. In therapy successes, mean corpuscular volume and total serum bilirubin increased with treatment time (P = 0.0001). Fifteen adverse effects were observed in 13 patients (38%). Azathioprine was withdrawn in seven cases (20.6%); in four of them (with liver toxicity), treatment with mercaptopurine was indicated. CONCLUSIONS: Therapy with thiopurinic immunomodulators (azathioprine) represents the first option in the management of steroid-dependent ulcerative colitis. Its efficacy (70%) and its acceptable safety support this view. Increasing mean corpuscular volume and serum bilirubin values may be a surrogate marker of a beneficial effect.

Seven-day proton pump inhibitor, amoxicillin and clarithromycin triple therapy. factors that influence Helicobacter pylori eradications success.

AIM: To evaluate which factors influence eradication success with standard triple therapy for Helicobacter pylori. PATIENTS AND METHODS: A prospective study was made of 891 patients infected by H. pylori and diagnosed with duodenal ulcer (n=422), gastric ulcer (n=221), or functional dyspepsia (n=248). Initially, an endoscopy with biopsies of antrum and body (haematoxylin-eosin stain), and a 13C-urea breath test were performed. All patients were treated for seven days with either omeprazole 20 mg twice daily in 442 patients (OCA) or pantoprazole 40 mg twice daily in 449 patients (PCA), associated to clarithromycin (500 mg twice a day) and amoxicillin (1 g twice a day). Two months after completing therapy urea breath test was repeated to confirm eradication. RESULTS: Mean age +/- SD was 51.6 +/- 15 years, 61% were male. Overall eradication rate was 73.7% (95% CI 69-77%) and 80.8% (77-84%) with OCA and PCA therapy, respectively, showing significant difference between treatment regimens (chi 2 =6.3; p= 0.01). As refers to underlying diseases, H. pylori eradication was achieved in 77.4% (74-80%) of peptic ulcers and 77% (71-82%) of functional dyspepsia (p=n.s.). With our two treatment regimens (OCA/PCA) eradication success was 74/81% in peptic ulcer (p=0.03), and 72/80% in functional dyspepsia (p=0.1). In the multivariate analysis, type of therapy was the only variable that correlated with eradication success (odds ratio 1.5; 95% CI: 1.1-2.1) (chi2 model: 6,4; p=0.01). CONCLUSIONS: Standard triple therapy containing a proton pump inhibitor, clarithromycin and amoxicillin for seven days achieves in our community a moderate eradication success; this result could improve by using pantoprazole instead of omeprazole. This therapy is equally effective in patients with peptic ulcer and functional dyspepsia.

Healing of Helicobacter pylori gastric ulcers: only eradication matters.

INTRODUCTION: some authors suggest that Helicobacter pylori eradication favors gastric ulcer healing. OBJECTIVE: to study which factors influence ulcer healing in patients suffering from gastric ulcer with H. pylori infection. SUBJECTS AND METHODS: a prospective study of 230 patients with gastric ulcer associated to H. pylori infection. Chronic ingestion of non-steroidal anti-inflammatory drugs was considered as an exclusion. In an initial endoscopy, malignancy was histologically excluded and two biopsies each of antrum and body were obtained. Also, ELISA IgG serology and a 13C-urea breath test were performed. Eradication therapy with omeprazole (20 mg twice a day), clarithromycin (500 mg twice a day) and amoxicillin (1 g twice a day) was administered for seven days, followed by omeprazole 20 mg once a day for five more weeks. Endoscopy was repeated after 6 weeks of treatment and breath test was repeated 2 month after completing therapy. RESULTS: overall gastric ulcer healing was achieved in 80.8% (95% CI: 75-85%) of cases by intention-to-treat, and in 82.6% (77-87%) per protocol. Ulcer healing was achieved in 94.3% (90-97%) of patients with eradication success, but only in 40.8% (28-54%) of patients with eradication failure (p<0.0001). In the multivariate analysis, H. pylori eradication was the only variable that correlated with ulcer healing (odds ratio 24; 95% CI: 10-56; p<0.0001) (x2 model: 64.4; p<0.0001). Additional variables (age, sex, sporadic ingestion of NSAIDs, smoking, previous ulcer disease, ulcer size and location) were not related to healing. CONCLUSION: H. pylori eradication favors ulcer healing in patients with gastric ulcer, which is an argument in favor of the etiological role of the microorganism in this disease. Other factors did not influence ulcer healing.

Prevention of de novo hepatitis B infection in liver allograft recipients with previous hepatitis B infection or hepatitis B vaccination.

OBJECTIVES: To assess de novo hepatitis B virus (HBV) transmission from liver donors with HBV serum markers (HBM) to their recipients and the need for HBV vaccination before liver transplantation. METHODS: A total of 108 orthotopic liver transplantations for nonviral disease and the risk of developing de novo hepatitis B based on HBMs before transplantation have been studied. Of the 108 patients, 94 met the study criteria and were divided into two groups: 27 who had HBMs before transplantation (from past infection or by previous vaccination) and 67 who had no HBM. Development of de novo hepatitis B was determined by analytical, serological, and histological parameters. RESULTS: No case (0%) of de novo hepatitis B was detected in the pretransplantation HBM group, whereas there were 10 cases (14.5%) in the other group (p < 0.005). CONCLUSIONS: The presence of pretransplantation HBM in liver transplant recipients protects these patients against the development of de novo hepatitis B. This is especially important considering that there is a high prevalence of donors with positive hepatitis B core antibody (especially in some countries), and that these donors transmit HBV infection to recipients without HBM in a significant number of cases. Thus, vaccination against HBV in patients who are candidates for liver transplantation is fundamental to avoid cases of de novo hepatitis B.

Efficacy of quadruple therapy with pantoprazole, bismuth, tetracycline and metronidazole as rescue treatment for Helicobacter pylori infection.

AIM: To study the efficacy of a 7-day quadruple regimen combining pantoprazole, bismuth, tetracycline and metronidazole as rescue treatment for Helicobacter pylori infection after failure of standard triple therapy. METHODS: A prospective study was made of 140 patients infected with H. pylori and diagnosed with peptic ulcer or non-ulcer dyspepsia in whom triple therapy with proton pump inhibitor, clarithromycin and amoxicillin had failed. The patients were treated with quadruple therapy including pantoprazole, 40 mg twice daily, colloidal bismuth subcitrate, 120 mg four times daily, tetracycline, 500 mg four times daily, and metronidazole, 500 mg three times daily, for 7 days. Two months after completion of therapy, a 13C-urea breath test was performed to confirm eradication. RESULTS: With quadruple therapy, the H. pylori eradication rates were 82% (95% confidence interval (CI), 75-88%) by 'intention-to-treat' and 85% (95% CI, 79-91%) by 'per protocol'. No major side-effects were observed. No differences in eradication success were observed in relation to underlying disease (peptic ulcer: 85% (95% CI, 76-91%) vs. non-ulcer dyspepsia: 83% (95% CI, 68-93%)) or smoking habits (smokers: 86% (95% CI, 75-93%) vs. non-smokers: 83% (95% CI, 71-91%)). CONCLUSION: Quadruple therapy with pantoprazole, bismuth, tetracycline and metronidazole for 7 days is an effective H. pylori eradication treatment for patients in whom standard triple therapy has failed.

[Evolution and treatment response in microscopic colitis]. / Curso evolutivo y respuesta al tratamiento de las colitis microscópicas.

AIM: To study the clinical characteristics, treatment response and evolution in patients with microscopic colitis. MATERIAL AND METHODS: We performed a retrospective analysis of 24 patients (15 with collagenous colitis and 9 with lymphocytic colitis). Clinical and diagnostic features, treatment response and evolution according to the presence of maintenance therapy were evaluated. RESULTS: The mean age of the patients was 59.7 years and most were male. Nine patients took non-steroidal anti-inflammatory drugs (NSAID). No significant association was found with other drugs. Four patients presented associated rheumatological disease. Most patients presented insidious-onset diarrhea without pathological products, which was frequently associated with other symptoms (abdominal pain, bloating, weight loss, asthenia, tenesmus, and incontinence). Seven patients showed a slight increase in globular sedimentation rate. Fat in stools and radiological investigations (transit and opaque enema) were normal in patients who underwent these tests. Endoscopy revealed non-specific alterations in 42% of the patients while results were normal in the remaining patients. One patient showed clinical improvement on withdrawal of NSAIDs and 4 patients improved spontaneously. Clinical response was achieved in 7 of 13 patients treated with antimotility drugs, in 8 of 9 patients treated with salicylates, in 3 treated with oral corticoids, in 1 treated with cholestyramine and in 1 treated with topical budesonide. Nineteen patients required no maintenance therapy, 4 were administered salicylates and 1 was administered cholestyramine. After a mean follow-up of 42 months, evolution was chronic and intermittent in 14 patients and chronic and continuous in 1; 9 patients presented a single episode. No significant differences were found between patients administered maintenance therapy and those who were not or between collagenous colitis and lymphocytic colitis in the parameters analyzed. CONCLUSIONS: Microscopic colitis constitutes a group of diseases characterized by chronic diarrhea, few systemic effects and minimal radiological and/or endoscopic alterations. Evolution is characterized by recurrent episodes, with good response to treatment with cholestyramine, salicylates or corticoids when required.

[Risk of hepatitis B virus transmission from hepatitis B core antibody-positive liver donors]. / Riesgo de transmisión del virus de la hepatitis B de donantes de hígado anti-HBc positivos.

BACKGROUND: To study the hepatitis B virus (HBV) transmission from donors HBsAg-/AntiHBc+ to liver transplant recipients. PATIENTS AND METHOD: We studied retrospectively the HBV serological markers in 43 donors from our center and also the serological condition of the 41 recipients. The HBV serological markers were analyzed by ELISA and HBV DNA was detected by hybridation assays. RESULTS: 13 donors samples showed some HBV serological markers: 6 anti-HBc and anti- HBs (13.9%), 4 anti-HBc (9%) and 3 anti- HBs (6.9%). There were no cases of hepatitis B among liver recipients from donors with negative serological markers. Among the 13 recipients with HBV serological markers, 9 were followed during 39 (SD 17) months. The 5 recipients with no HBV markers, who received an anti- HBc+ with or without anti- HBs (100%) developed hepatitis B. The two liver recipients with anti-HBs solely, did not developed infection (0%). Of the 41 recipients, 15 had some HBV markers before transplant and two of them received an anti-HBc+ and did not develop the infection (0%). CONCLUSIONS: In our study, the prevalence of serological HBV infection in donors and recipients was of 30.2 and 31.7%, respectively. Anti-HBc with or without anti-HBs donors transmitted the HBV infection in all the cases (100%) to the susceptible recipients. The presence of anti-HBs in recipients protected these against the infection. Only the anti-HBs positive donors did not trasmit the HBV infection.

[Effects of Helicobacter pylori eradication on the recurrence of gastric ulcer during a 12-month follow up]. / Efecto de la erradicación de Helicobacter pylori sobre la recurrencia de la úlcera gástrica a lo largo de 12 meses.

BACKGROUND: To study the influence of Helicobacter pylori eradication on the incidence of ulcer recurrence during 12 months of follow-up in gastric ulcer patients. PATIENTS AND METHOD: Seventy-three patients with gastric ulcer were prospectively studied. At endoscopy two biopsies from both antrum and body for haematoxylin-eosin staining and one for rapid urease test were obtained. Likewise, serology and 13C-urea breath test were carried out. Fifty-six H. pylori infected patients were monitored after giving an eradication therapy with omeprazole, clarithromycin and amoxicillin. A first control endoscopy was performed immediately after completing treatment to confirm ulcer healing. A second control endoscopy (with histologic study) and a breath test were performed one month after completing therapy (eradication was defined as the absence of H. pylori by both methods). Finally, an endoscopy was repeated at 6 and 12 months to study ulcer recurrences. RESULTS: Mean age was 54 +/- 13 years (69% males). Cumulative ulcer recurrence rate for 12 months, respectively for patients with eradication success and failure, was 2.3% (95% CI, 0-12%) and 70% (34-93%) (chi 2: 23.9; p < 0.0001). Comparison between Kaplan-Meier curves for ulcer recurrence depending on H. pylori eradication showed significant differences (log-rank test; chi 2: 33.8; p < 0.0001). A patient successfully treated underwent ulcer recurrence while receiving treatment with acetylsalicylic acid, without recurrence of the infection. CONCLUSIONS: H. pylori eradication is associated with a dramatic reduction on the recurrence of gastric ulcer, with a cumulative recurrence rate during 12 months of only 2.3%, which suggests that definitive cure of gastric ulcer disease is possible by means of microorganism eradication.

Long-term effects of ursodeoxycholic acid in primary biliary cirrhosis: results of a double-blind controlled multicentric trial. UDCA-Cooperative Group from the Spanish Association for the Study of the Liver.

BACKGROUND/AIM: The aim of this study was to assess the efficacy of ursodeoxycholic acid (UDCA) for primary biliary cirrhosis in a randomized, double-blind placebo-controlled trial. METHODS: Consecutive patients (n=192) were randomized to receive 14-16 mg UDCA/kg/day or placebo. Patients underwent a complete history, physical examination, liver chemistries, immunological determinations and liver biopsy at entry and at the end of the trial, which lasted for at least 2 years. Patients were seen every 3 months and the median follow-up was 3.4 years (range 0.3 to 6.1 years). RESULTS: Patients receiving UDCA (99) or placebo (93) were comparable with regard to age, sex, biochemical parameters and liver histology. UDCA treatment was associated with decreases in alkaline phosphatase, gammaglutamyl transferase, alanine aminotransferase, and cholesterol levels, effects which were conspicuous after 3 months of treatment and remained similar during the follow-up. During the study 31 patients (10 receiving UDCA and 21 placebo) discontinued the trial because of noncompliance (n=11), voluntary withdrawal (n=19) or adverse effects (n=1). Treatment failure (death or liver transplantation) was observed in 17 patients receiving UDCA and in 11 patients receiving placebo. Times to death or liver transplantation and to clinical complications were not significantly different in patients receiving UDCA or placebo. Histological analysis indicates that UDCA improved portal inflammation and prevented histological stage progression. By contrast, histological stage as well as ductular proliferation and ductopenia progressed in patients receiving placebo. CONCLUSIONS: Although UDCA treatment did not significantly affect time to death or liver transplantation and to clinical complications, the effects on both cholestasis and liver histology suggest that UDCA is safe and may be useful for preventing the progression of primary biliary cirrhosis.

Re-treatment after Helicobacter pylori eradication failure.

AIM: Currently, highly effective Helicobacter pylori eradication therapies are used, and although eradication failures still appear in a considerable proportion of cases, the therapeutic efficacy in such refractory cases has been only exceptionally studied. Therefore, our aim was to evaluate the appropriate attitude when eradication therapy fails. METHODS: In 127 duodenal ulcer patients, several therapies with omeprazole (O) plus one or two antibiotics [amoxycillin (A), clarithromycin (C), metronidazole (M)] had failed to eradicate H. pylori. Re-treatment was administered depending on initial therapy; in no case was the same regimen repeated, and antibiotics with resistance risk (as C or M) were only re-administered using combination regimens with bismuth (B): O + A + C + B (when C was re-administered) and O + bismuth triple therapy (BTT) (when M was re-administered). RESULTS: First therapy and eradication rates, with the corresponding second therapy, were: CONCLUSION: BTT re-treatment in O + A failure achieves a relatively low eradication rate, probably lower than BTT for the first time, suggesting that other regimens should be tried. The following re-treatments are recommended in H. pylori eradication failure: in O + A failure, BTT (or O + BTT, as BTT re-treatment could be less effective than the initial BTT treatment); in O + C failure, O + A + M; in O + A + C failure, O + BTT; in O + A + M failure, O + A + C; and, finally, in O + C + M failure, O + BTT (or O + A + C + B).

[Antral biopsy is sufficient to confirm Helicobacter pylori eradication with the "new" one-week long triple treatments]. / La obtención de biopsias antrales es suficiente para confirmar la erradicación de Helicobacter pylori con las "nuevas" terapias triples de una semana de duración.

BACKGROUND: To evaluate whether antral biopsies are enough for confirming Helicobacter pylori eradication with the "new" one week triple therapies with omeprazole. PATIENTS AND METHODS: 229 duodenal ulcer patients were treated with omeprazole for 7 days plus two antibiotics. Eradication was confirmed with histology (two biopsies from both gastric antrum and body) and 13C-urea breath test one month after the end of therapy. RESULTS: H. pylori eradication was achieved in 76.9% of the patients (95% CI: 71-82%). Histology at antrum was highly reliable to detect eradication failure: in all but in one case in which H. pylori was observed at gastric body, was the microogranism also observed at antrum. Infection prevalences at both locations were not homogeneous (McNemar: 6.4; p < 0.05). Concordance between antral biopsies and breath test for H. pylori diagnosis after therapy was excellent (kappa: 0.91; SE: 0.07), and both prevalences were homogeneous (McNemar: 1.3; p > 0.05). CONCLUSIONS: Taking antral biopsies is enough for confirming H. pylori eradication with the "new" one week triple therapies.

[Helicobacter pylori and digestive hemorrhage due to duodenal ulcer: the prevalence of the infection, the efficacy of 3 triple therapies and the role of eradication in preventing a hemorrhagic recurrence]. / Helicobacter pylori y hemorragia digestiva por úlcera duodenal: prevalencia de la infección, eficacia de tres terapias triples y papel de la erradicación en la prevención de la recidiva hemorrágica.

BACKGROUND: To report the prevalence of Helicobacter pylori in patients with bleeding duodenal ulcer and to verify the effect of eradication on hemorrhage recurrence. To evaluate the efficacy on H. pylori eradication and on ulcer healing of three one-week triple therapies and to compare their efficacy with that of a dual therapy. PATIENTS AND METHODS: One-hundred and eleven patients with bleeding duodenal ulcer not taking gastroerosive drugs were prospectively studied. At endoscopy, biopsies from gastric antrum and body were obtained (haematoxylin-eosin), and a 13C-urea breath test was also performed. Both diagnostic methods were repeated one month after completing one of the following treatments (randomized study): omeprazole (20 mg/12 h), amoxycillin (1 g/12 h) and clarithromycin (500 mg/12 h) (OAC, n = 27); omeprazole (20 mg/12 h), clarithromycin (500 mg/12 h) and metronidazole (500 mg/12 h) (OCM, n = 27); lansoprazole (30 mg/12 h), amoxycillin (1 g/12 h) and clarithromycin (500 mg/12 h) (LAC, n = 27); and lansoprazole (30 mg/12 h) and clarithromycin (500 mg/8 h) (LC, n = 27). The first three therapies were administered for one week, and LC for two weeks. Once eradication was confirmed no antisecretory therapy was administered. A breath test was performed in the follow-up at 6 months and at one year. RESULTS: The prevalence of H. pylori infection was 97.3% (95% CI: 92-99%). Five patients were lost from the study during follow-up. The eradication efficacy (intention-to-treat) was: OAC, 89% (72-96%); OCM: 93% (77-98%); LAC, 93% (77-98%), and LC, 70% (51-84%). Overall triple therapy efficacy was higher than that of dual therapy (91% vs 70%; p < 0.05). Thirteen patients needed a 2nd or 3rd therapy, and eradication success was finally achieved in all cases. The type of therapy was the only variable which influenced on H. pylori eradication (OR: 4.5; 95% CI: 1.4-14%; p < 0.01) and H. pylori eradication was the only variable which influenced on ulcer healing (OR: 4.7; 95% CI: 1.2-19%; p < 0.05). The yearly reinfection rate was 2.8% (0.9-7.8%). No hemorrhage recurrences occurred during the one year follow-up period. CONCLUSIONS: H. pylori prevalence in bleeding doudenal ulcer is almost 100%. These patients will be spared of hemorrhage recurrence at least for one year if infection is eradicated. Therefore, eradication therapy is the therapy of choice, and maintenance therapy with antisecretory drugs is no longer needed. One-week triple therapies with a proton pump inhibitor and two antibiotics (clarithromycin plus amoxycillin or metronidazole) have a high efficacy in patients with bleeding duodenal ulcer.

Recurrence of Helicobacter pylori infection after eradication: incidence and variables influencing it.

BACKGROUND: Our aim was to study the incidence of Helicobacter pylori recurrence in our country and to assess the different variables that might influence it. METHODS: We studied prospectively 331 duodenal ulcer patients (mean age, 48 +/- 14 years, 71% male) in whom H. pylori had been eradicated. Several therapies were used, classified as low-efficacy (omeprazole + amoxycillin, 32% eradication rate; omeprazole + amoxycillin + metronidazole, 56%) and high-efficacy therapies (omeprazole + clarithromycin + amoxycillin or metronidazole, 88%; bismuth triple therapy, 77%). One month after completion of therapy an endoscopy with biopsies and/or 13C-urea breath test was performed. A breath test was carried out again at 6 months, 1 year, and 2 years, to study H. pylori recurrences. Endoscopy (with biopsies) was performed only to confirm recurrences. Multiple logistic regression analysis was used. Differences between Kaplan-Meier curves were evaluated with the log-rank test. RESULTS: Sixty-seven patients were followed up for 6 months, 136 for 1 year, and 128 for 2 years, giving 425 patient-years of follow-up. A total of 18 H. pylori recurrences was observed (12 at 6 months, 4 at 1 year, and 2 after 2 years), yielding a yearly recurrence of 4.2% patient-years(-1). The respective risk of H. pylori recurrence for each period was 3.6% (95% confidence interval (CI), 2.1%-6.2%), 1.5% (0.6%-3.8%), and 1.5% (0.4%-5.5%). The probability of being H. pylori-negative at 6 months, 1 year, and 2 years was, respectively, 96.4% (94.4%-98.4%), 94.9% (92.5%-97.4%), and 93.4% (90.3%-96.6%). Duodenal ulcer was found in half of the reinfected patients. The recurrence rate at 6 months was 10.3% (5.7%-18%) in patients <40 years old and only 0.85% (0.2%-3.1%) in those > or =40 years old (P = 0.0002). Of the patients who became reinfected at 6 months 27% (6%-61%) had delta breath test values between 3 per thousand and 5 per thousand 1 month after therapy, whereas only 4.6% (2.7%-7.7%) of non-reinfected patients had delta after eradication > or =3 per thousand (P = 0.0097). H. pylori recurrence at 6 months was 8.2% (4.5%-15%) in patients previously treated with low-efficacy therapies and only 1.7% (0.7%-4.3%) when high efficacy therapies were used (P = 0.0098). In the multivariate analysis age (odds ratio (OR), 0.9; 95% CI, 0.8-0.96; P = 0.0008), the delta breath test value after therapy (OR, 2.2; CI, 1.2-4.1; P = 0.0076), and therapy regimen (OR, 6.4; CI, 1.5-27; P = 0.0109) were the only variables that correlated with H. pylori recurrence at 6 months. Differences were observed when Kaplan-Meier curves were compared, depending on age (<40 or > or =40 years; P = 0.0054), breath test value (delta) 1 month after therapy (<3 or > or =3 per thousand; P = 0.0089), and therapy regimen (high or low efficacy; P = 0.0006). CONCLUSIONS: Risk of post-eradication H. pylori recurrence is higher during the first 6 months, which suggests that most recurrences during this period are recrudescences and not true reinfections. Patients who have H. pylori recurrence tend to be younger and have higher delta 13C-urea breath test values after therapy, which suggests that a 'negative' value between 3 per thousand and 5 per thousand needs to be confirmed. Recurrence of H. pylori is more frequent in patients treated with low-efficacy therapies but is exceptional when high-efficacy therapies are used, in which case post-therapy eradication can be safely confirmed at 4 weeks. Finally, recurrence of H. pylori is clinically relevant, as ulcer recurrence is observed in a considerable proportion of these patients.

[Omeprazole plus 2 antibiotics for the eradication of H. pylori, are 5 days of treatment sufficient?]. / Omeprazol más dos antibióticos para la erradicación de H. pylori, son suficientes cinco días de tratamiento?

OBJECTIVE: Combinations of omeprazole plus two antibiotics for seven days have repeatedly been studied and high Helicobacter pylori eradication rates have been obtained, ranging from 80% and 90% in our country. Our objective was to verify whether length of such therapies (with omeprazole, metronidazole and clarithromycin or amoxicillin) can be shortened to five days with no loss of efficacy. DESIGN: randomized clinical trial. PATIENTS: forty-eight consecutive patients with duodenal ulcer were prospectively studied. The exclusion criteria were previous administration of antibiotics, bismuth or gastroerosive drugs, and associated diseases. During the initial endoscopy biopsy specimens from antrum and corpus were obtained (haematoxylin-eosin). Two therapies were administered for five days: omeprazole (20 mg/12 h) and clarithromycin (500 mg/12 h) plus metronidazole (500 mg/12 h) (n = 24) or amoxicillin (1 g/12 h) (n = 24). One month after therapy was completed a new endoscopy was performed, biopsy specimens were obtained, and the 13C-urea breath test was performed. Compliance of therapy was assessed by questioning the patient and counting the residual medication. DATA ANALYSIS: multiple logistic regression and "intention-to-treat" analysis. OUTCOME VARIABLE: eradication was defined as the absence of H. pylori by all diagnostic methods. RESULTS: Mean age +/- SD was 48 +/- 10 years, 73% were males. Twenty-three patients in each group completed the protocol and the distribution of investigated parameters was similar in both groups. Eradication was obtained in 91.7% (95% CI = 74%-98%) in the metronidazole group and 70.8% (51%-85%) in the amoxicillin group (chi 2 = 2.19; p = 0.13). In the multivariate analysis, OR for the effect of type of therapy on eradication was 4.5 (CI = 0.83-24.7; p = 0.077). No relevant secondary effects were reported. The most common secondary effect was a metallic taste of medication, which was perceived by half of patients in each group. CONCLUSION: The combination of omeprazole, clarithromycin, and metronidazole for only five days has a high eradicating efficacy (approximately 90%), similar to that obtained in previous studies with seven days of therapy. Nevertheless, the association of omeprazole, clarithromycin, and amoxicillin should probably be administered at least for one week to reach an optimal eradicating efficacy.