[Comparison of the traditional triple and a new bismuth-containing quadruple therapy in the first-line eradication of Helicobacter pylori]. / A Helicobacter pylori-fertozés elso vonalbeli megszüntetésére alkalmazott hagyományos hármas és egy új, bizmuttartalmú négyes kezelés összehasonlítása.

Introduction and aim: As the efficacy of the first-line traditional treatment used to eradicate Helicobacter pylori (H. p.) decreased below 75% in Hungary, a new protocol had to be created. Method: Supposing the success rate of the traditional therapy (14-day double dose of proton pump inhibitor [PPI], 1000 mg amoxicillin b.i.d., 500 mg clarithromycin b.i.d. [PAC]) to be 75% and the efficacy of the new protocol (10-day 120 mg bismuth dicitrate q.i.d., double dose PPI b.i.d., 500 mg tetracycline q.i.d. and 500 mg tinidazole b.i.d. [BQT]) to be 90%, we calculated 109 patients on each arm. Patients were recruited after upper gastrointestinal endoscopy from 5 endoscopic units in Vas county. The heterogeneity of groups, success rate and side effects of both therapies were evaluated by Fisher exact test; p<0.05 was considered significant. Results: 110 patients were included in the BQT and 109 patients in the PAC group. There was no heterogeneity between the two groups in age, gender and indication of eradication. H. p. eradication was successful in 103/110 (93.6%) in the BQT and 81/109 (74.3%) in the PAC group (p<0.001). The odds ratio in the BQT group for successful eradication was 5.05 (95% confidence interval: 2.02-14.42) as compared to the PAC group (p<0.001). The side effects of the two groups were similar, in the BQT group the frequency was 34.5%. Conclusion: 10 day-long BQT containing double dose PPI with 120 mg bismuth dicitrate q.i.d., 500 mg tetracycline q.i.d. and 500 mg tinidazole b.i.d. is recommended as the first-line treatment for the eradication of H. p. because of its high efficacy and tolerable side effects. Orv Hetil. 2019; 160(34): 1340-1345.

Intravenous metronidazole, liquid tinidazole, and intra-vaginal boric acid to cure trichomonas in a patient with gastric bypass surgery.

This study presents a case report of a female patient with symptomatic refractory Trichomonas vaginalis infection who was not able to clear her infection with high-dose oral metronidazole, oral tinidazole, intra-vaginal zinc sulfate, intra-vaginal metronidazole, intra-vaginal tinidazole, and intra-vaginal boric acid. She was unable to tolerate intra-vaginal paromomycin. A combination of intravenous metronidazole, oral tinidazole liquid suspension, and intra-vaginal boric acid for 14 days subsequently achieved a complete symptomatic and laboratory cure.

Pylera and sequential therapy for first-line Helicobacter pylori eradication: a culture-based study in real clinical practice.

BACKGROUND AND AIMS: Italian guideline suggests 10-day sequential or bismuth-based quadruple therapies for first-line Helicobacter pylori treatment. Comparison between these regimens is lacking. We assessed the efficacy of these therapies in clinical practice and evaluated the role of primary bacterial resistance toward clarithromycin and metronidazole. PATIENTS AND METHODS: Consecutive patients with H. pylori infection were enrolled. Bacterial culture with antibiotics susceptibility testing was attempted in all cases. Patients received either a sequential therapy with esomeprazole 40 mg for 10 days plus amoxicillin 1000 mg for the first 5 days followed by clarithromycin 500 mg and tinidazole 500 mg (all twice daily) for the remaining 5 days, or bismuth-based therapy with esomeprazole 20 mg twice daily and Pylera 3 tablets four times daily for 10 days. H. pylori eradication was assessed by using C-urea breath test. RESULTS: A total of 495 patients were enrolled. Following sequential (250 patients) and quadruple (245 patients) therapies, the eradication rate were 92 and 91%, respectively, at intention-to-treat analysis and 96 and 97%, respectively, at per protocol analysis. Overall, the pattern of bacterial resistance did not significantly affect the cure rate, but the presence of clarithromycin and metronidazole dual resistance tended to reduce the success rate of both sequential (84.8 vs. 90.1%; P=0.4) and quadruple (85 vs. 94.1%; P=0.06) therapies. Adverse events occurred more frequently with the quadruple than with sequential therapy (56.9 vs. 25.8%; P<0.001). CONCLUSION: In our country, sequential and bismuth-based quadruple therapy achieved similarly high eradication rates as first-line treatments for H. pylori infection in clinical practice.

[Application of combined antibacterial preparations in the treatment of surgical intra-abdominal infections].

Experience of application of combined preparation Ciprolet A (ciprofloxacine 500 mg, tinidazol 600 mg) in 27 patients after performed reconstructive operations for surgical diseases of abdominal organs as well as in 50 patients in destructive forms of an acute cholecystitis was summarized. Possibility of the preparation application in ambulatory conditions constitutes its advantage.

A randomized trial comparing a polyherbal pessary (a complementary and alternative medicine) with Ginlac-V pessary (containing clotrimazole, tinidazole and lactobacilli) for treatment of women with symptomatic vaginal discharge.

BACKGROUND: Most women with abnormal vaginal discharge have infection due to candida species, bacterial vaginosis or trichomoniasis and often seek treatment without laboratory confirmation. In this context, a single agent effective against these infections would be useful. AIM: To compare the efficacy of two such agents: Praneem polyherbal pessary; a complementary and alternative medicine (CAM) with Ginlac-V pessary (containing clotrimazole, tinidazole and lactobacilli) for treatment of abnormal vaginal discharge. SETTINGS AND DESIGN: A randomized study in a tertiary care hospital in North India. METHODS: One hundred women were randomized for treatment with either of the two pessaries. Clinical examination and laboratory evaluation was done before and after treatment. STATISTICAL ANALYSIS: Mc-Nemar test and Chi-square test. RESULTS: Overall, 82% (82/100) reported symptomatic relief; 78% (39/50) with Praneem and 86% (43/50) with Ginlac-V. Only 36% (18/50 in each group) had laboratory-confirmed infection; 18% (18/100) candidosis, 17% (17/100) bacterial vaginosis, 1% (1/100) both; none had trichomoniasis. Among these, symptomatic improvement was seen in 72% (13/18) and laboratory cure in 78% (14/18) with Praneem; symptomatic improvement in 78% (14/18) and laboratory cure in 78% (14/18) with Ginlac-V. Clinical or laboratory criteria could assess treatment efficacy equally. Neither drug was efficacious in candidosis. Ginlac-V was efficacious in bacterial vaginosis (100%) and though Praneem showed a similar trend, it was not statistically significant. Vaginal irritation was more frequent with Praneem (16% vs 4% with Ginlac-V). CONCLUSION: Both Praneem and Ginlac-V provided symptomatic relief in most of the women. Either clinical or laboratory criteria could assess treatment efficacy of both drugs. Ginlac-V was efficacious for treating bacterial vaginosis.

Tinidazole for bacterial vaginosis.

Tinidazole has been used for bacterial vaginosis (BV) outside the USA for almost four decades. Tinidazole has recently been resurrected and FDA approved for trichomoniasis and BV in the USA and is being restudied as an alternative to metronidazole for BV. In vitro antimicrobial activity and pharmacokinetics studies indicate that when compared directly with metronidazole, tinidazole has minor but possibly relevant antimicrobial as well as pharmacokinetic advantages. Clinical comparisons have been infrequent, although the limited head-to-head studies indicate minimal therapeutic advantage with tinidazole. Perhaps the more relevant differences relate to the enhanced tolerance and reduced toxicity of tinidazole. Currently, studies are still ongoing directly comparing the clinical efficacy of metronidazole and tinidazole. These studies should establish the role of tinidazole in the treatment of BV; however, cure rates are unlikely to be significantly different.

Tinidazole for the treatment of vaginal infections.

Tinidazole has been used for vaginal infection worldwide but not in the US for > 40 years. Recently, tinidazole has been re-introduced and approved by the FDA for trichomoniasis and restudied as an alternative to metronidazole for bacterial vaginosis. In vitro antimicrobial activity and pharmacokinetics studies indicate that tinidazole has minor but possibly relevant antimicrobial as well as pharmacokinetic advantages when compared directly with metronidazole. Clinical comparison has been infrequent although the limited head-to-head studies indicate minimal therapeutic advantage with tinidazole. Perhaps the more relevant differences relate to the enhanced tolerance and reduced toxicity of tinidazole. Ongoing, as yet incomplete, studies directly comparing the clinical efficacy of metronidazole and tinidazole for bacterial vaginosis should clarify the status of tinidazole; however, cure rates are unlikely to be significantly different. Although uncommon, high-level trichomonal metronidazole resistance can be reliably cured by using tinidazole, which is an invaluable advantage.

Combined ciprofloxacin and tinidazole therapy in the treatment of chronic refractory pouchitis.

PURPOSE: Management of chronic refractory pouchitis, a common cause for pouch failure with pouch resection or diversion, is often challenging. The aim of this study was to assess the efficacy and safety of a combination therapy of ciprofloxacin and tinidazole in patients with chronic refractory pouchitis compared with mesalamine therapy. METHODS: Sixteen consecutive ulcerative colitis patients with chronic refractory pouchitis (disease>4 weeks and failure to respond to>4 weeks of single-antibiotic therapy) were treated with a four-week course of ciprofloxacin 1 g/day and tinidazole 15 mg/kg/day. A historic cohort of ten consecutive patients with chronic refractory pouchitis treated with oral (4 g/day), enema (8 g/day), or suppository (1 g/day) mesalamine served as controls. The Pouchitis Disease Activity Index, clinical remission, clinical response, the Cleveland Global Quality of Life, the Irritable Bowel Syndrome-Quality of Life, and the Short Inflammatory Bowel Disease Questionnaires scores were calculated before and after therapy and compared between the two treatment groups. RESULTS: Patients taking ciprofloxacin and tinidazole had a significant reduction in the total Pouchitis Disease Activity Index scores and subscores and a significant improvement in quality-of-life scores (P < 0.002). For patients in the mesalamine group, there was a significant reduction in the total Pouchitis Disease Activity Index scores only. Patients in the antibiotic group had a greater reduction in the total Pouchitis Disease Activity Index scores and a greater improvement in the quality-of-life scores than those in the mesalamine group (P

A study of 4- and 7-day triple therapy with rabeprazole, high-dose levofloxacin and tinidazole rescue treatment for Helicobacter pylori eradication.

BACKGROUND: Helicobacter pylori treatment failure is becoming an emergent problem in clinical practice. Shorter treatment duration should improve compliance to therapy and keep an acceptable H. pylori eradication rate. AIMS: To evaluate the efficacy of two rabeprazole, high-dose levofloxacin and tinidazole-based regimens as 'rescue' treatment for H. pylori eradication in an open-label, randomized, pilot study carried out in a clinical practice setting. METHODS: Eighty-five consecutive patients who have previously failed at least one H. pylori eradication attempt were randomized to receive rabeprazole (20 mg, b.d.), levofloxacin (500 mg, b.d.) and tinidazole (500 mg, b.d.) either for 4 (4-day RLT, n = 42) or 7 days (7-day RLT, n = 43). Cure of H. pylori infection was assessed by means of 13C-urea breath test. RESULTS: The 7-day RLT achieved 84% (95% CI: 69-93%) and 86% (95% CI: 72-95%) eradication rates in intention-to-treat and per-protocol analyses respectively. The shorter treatment obtained an 83% (95% CI: 69-93%) eradication rate in both intention-to-treat and per-protocol analysis. Both regimens were well tolerated, although patients who received the 4-day RLT reported fewer side-effects. CONCLUSIONS: In patients who have previously failed at least one H. pylori eradication attempt, both 4- and 7-day rabeprazole, high-dose levofloxacin, tinidazole-based regimens are effective in curing the infection in more than 80% of patients.

One-week versus two-week H2-receptor antagonist in combination with amoxicillin and tinidazole for eradication of Helicobacter pylori infection.

BACKGROUND/AIMS: Eradication regimens combining two antibiotics with a proton pump inhibitor have been studied intensively in Helicobacter pylori (H. pylori) infection; however, only a few reports have focused on the role of H2-receptor antagonists (H2-RAs) in eradication therapy. The mechanism involved in the synergy between antibiotics and H2RAs are still elusive. So we compared the efficacy of two regimens: a 1-week or 2-week course of high-dose H2-RA-based triple therapy in patients with H. pylori infection, and assessed the impact of primary resistance for metronidazole on the treatment outcome. METHODOLOGY: One hundred and twenty patients with peptic ulcers and nonulcer dyspepsia were randomly assigned to a one-week course of famotidine 40mg b.i.d., amoxicillin lg b.i.d. and tinidazole 500 mg b.i.d. (FAT1 group; n = 60) or a 2-week course of famotidine 40 mg b.i.d., amoxicillin lg b.i.d. and tinidazole 500 mg b.i.d. (FAT2 group; n = 60). Upper endoscopy was performed prior to treatment and at least 4 weeks after completion of treatment and discontinuation of the antisecretory therapy. H. pylori status was assessed by biopsy urease test, histology and culture. RESULTS: In the intention-to-treat analysis, eradication of H. pylori was achieved in 38 of 60 patients (63.3%; 95% CI: 51-76%) in the FAT1 group, compared to 48 of 60 patients (80%; 95% CI: 70-92%) in the FAT2 group (NS). In the per protocol analysis, eradication therapy was achieved in 38 of 54 patients (70.4%; 95% CI: 58-82%) in the FAT1 group and 48 of 53 patients (90.6%; 95% CI: 83-98%) in the FAT2 group (p < 0.05). The overall eradication rates for strains susceptible and resistant to metronidazole were 79.7% (95% CI: 71-89%) vs. 60% (95% CI: 44-74%) in the intention-to-treat analysis (p = 0.016) and 84% (95% CI: 76-92%) vs. 71.9% (95% CI: 56-88%) in the per protocol analysis (p = 0.12). Seven patients in the FAT1 group and six patients in the FAT2 group available for follow-up reported adverse events (11.7% and 10% respectively) without necessity of discontinuation of the study medications. Serious adverse events were not observed. CONCLUSIONS: A 2-week course of high-dose H2-RA-based triple therapy is well tolerated and sufficiently effective in eradicating H. pylori infection. Presence of metronidazole resistance has a negative impact on the treatment efficacy.

Management of metronidazole-resistant Trichomonas vaginalis--a new approach.

Metronidazole-resistant trichomoniasis is an infrequent but challenging problem with no universally successful treatment. Since 1994, we have been using a combination regimen consisting of high-dose tinidazole plus a broad-spectrum antibiotic, i.e. doxycycline or ampicillin, and clotrimazole pessaries, for 7--14 days in this condition. A retrospective case review identified 11 cases of resistant trichomonas between 1994 and 2002. In the absence of resistance testing, resistance was defined clinically. Nine of the 11 patients were cured; one patient did not attend follow-up. In the women who attended for follow-up, the cure rate was 90%. We have found the combination of tinidazole, a broad-spectrum antibiotic, and clotrimazole pessaries to be a tolerable and effective treatment for metronidazole-resistant Trichomonas vaginalis. Although a variety of total doses of tinidazole were used in our patients, based on our findings, and those of others, we would recommend giving tinidazole 2 g twice daily for 14 days (total dose 56 g).

Effectiveness and pharmaceutical cost of sequential treatment for Helicobacter pylori in patients with non-ulcer dyspepsia.

BACKGROUND: A novel 10-day sequential treatment regimen recently achieved a significantly higher eradication rate than standard 7-day therapy in both peptic ulcer disease and non-ulcer dyspepsia. Its higher performance has recently been confirmed using a halved clarithromycin dose in peptic ulcer disease. AIMS: To evaluate whether an acceptable eradication rate could also be obtained by halving the clarithromycin dose in dyspeptic patients and to assess the role of possible factors affecting the outcome of therapy. METHODS: In a prospective, open-label study, 162 patients with non-ulcer dyspepsia and Helicobacter pylori infection, assessed by rapid urease test and histology, were enrolled. Patients were randomized to receive either 10-day sequential therapy, comprising rabeprazole 20 mg b.d. plus amoxicillin 1 g b.d. for the first 5 days, followed by rabeprazole 20 mg b.d., clarithromycin 250 mg b.d. and tinidazole 500 mg b.d. for the remaining 5 days (low-dose therapy), or a similar schedule with clarithromycin 500 mg b.d. (high-dose therapy). Four to six weeks after therapy, H. pylori eradication was assessed by endoscopy/histology. RESULTS: A similar H. pylori eradication rate was observed following low- and high-dose regimens for both per protocol (94% vs. 95%; P = N.S.) and intention-to-treat (93% vs. 94%; P = N.S.) analyses. No major side-effects were reported. Halving the clarithromycin dose leads to a per patient saving in pharmaceutical costs of 24.6 euros. None of the variables examined affected the effectiveness of eradication of the sequential regimen. CONCLUSION: A reduction of the clarithromycin dose does not affect H. pylori eradication with the sequential regimen in non-ulcer dyspepsia and affords lower costs.

Pharmacokinetic evaluation of guar gum-based colon-targeted drug delivery systems of tinidazole in healthy human volunteers.

The aim of the present investigation was to determine the in vivo availability of guar gum-based colon-targeted tablets of tinidazole in comparison with immediate release tablets of tinidazole in human volunteers. Six healthy volunteers participated in the study, and a cross-over design was used. The plasma concentration of tinidazole was estimated by HPLC. The pharmacokinetic parameters were calculated from the plasma concentration of tinidazole versus time data. The immediate release tablets of tinidazole produced a peak plasma concentration (Cmax of 3239 +/- 428 ng/ml) at 1.04 +/- 0.32 hr (Tmax), whereas colon-targeted tablets produced peak plasma concentration (Cmax of 2158 +/- 78 ng/ml) at 14.9 +/- 1.6 hr. The delayed Tmax, decreased Cmax, and Ka, and unaltered bioavailability and elimination half-life of tinidazole from guar gum-based colon-targeted tinidazole tablets, in comparison with the immediate tablets, indicated that the drug was not released in the stomach and small intestine but delivered to the colon. Slow absorption of the drug from the less absorptive colon might result in the availability of the drug for local action in the colon. The guar gum-based colon-targeted tablets of tinidazole may be useful in providing an effective and safe therapy of intestinal amoebiasis.

Sequential treatment for Helicobacter pylori eradication in duodenal ulcer patients: improving the cost of pharmacotherapy.

BACKGROUND: Several studies have shown that Helicobacter pylori eradication rates with standard 7-day triple therapy are unsatisfactory. A novel 10-day sequential treatment regimen recently achieved a significantly higher eradication rate. To improve the pharmacotherapeutic cost, we evaluated whether an acceptable eradication rate could be achieved in peptic ulcer patients by halving the dose of clarithromycin. METHODS: In a prospective, open-label study, 152 duodenal ulcer patients with H. pylori infection, assessed by rapid urease test and histology, were enrolled. Patients were randomized to receive either a 10-day sequential treatment comprising rabeprazole 20 mg b.d. plus amoxicillin 1 g b.d. for the first 5 days, followed by rabeprazole 20 mg b.d., clarithromycin 500 mg b.d. and tinidazole 500 mg b.d. for the remaining 5 days (high-dose therapy), or a similar schedule with the clarithromycin doses halved to 250 mg b.d. (low-dose therapy). No further antisecretory drugs were offered. Four to six weeks after therapy, H. pylori eradication and ulcer healing rates were assessed by endoscopy. RESULTS: Similar H. pylori eradication rates were observed following high- and low-dose regimens for both per protocol (97.3% vs. 95.9%; P = N.S.) and intention-to-treat (94.7% vs. 92.2%; P = N.S.) analyses. No major side-effects were reported. At repeat endoscopy, peptic ulcer healing was observed in 93% and 93% of patients following high- and low-dose therapy, respectively. CONCLUSION: The cheaper low-dose sequential regimen may be suggested for H. pylori eradication in duodenal ulcer patients, even without continued proton pump inhibitor therapy after eradication treatment.

Ciprofloxacin-tinidazole combination, fluconazole- azithromicin-secnidazole-kit and doxycycline- metronidazole combination therapy in syndromic management of pelvic inflammatory disease: a prospective randomized controlled trial.

BACKGROUND: Pelvic inflammatory disease is a common problem faced by the gynecologists in there out patient department. AIM: The aim of the study was to evaluate the efficacy of three treatment combinations in the syndromic management of pelvic inflammatory disease in the out patient setting. SETTING DESIGN: In the medical college hospital patients presenting in gynecology out patient department were enrolled. MATERIAL AND METHODS: One hundred and sixty five women with diagnosis of pelvic inflammatory disease were randomized into three equal groups getting ciprofloxacin (500 mg) and tinidazole (600 mg) combination twice daily for 7 days (Group 1), a kit containing fluconazole (150 mg), azithromycin (1 gm) and secnidazole (2 mg) as one time dose (Group 2) and Doxycycline 100mg twice daily and metronidazole 200 mg thrice daily for seven days (Group 3). Severity score was determined on first visit and after 1 week and 4 weeks when patients were called for follow up. STATISTICAL ANALYSIS: Chisqare test, Krusker wallis test and Mann Whitney test. RESULTS: There was significant reduction in severity score after 1 week of treatment, which was further reduced after 4 weeks in all the three groups. Cure rate was highest in-group 1 (96%) followed by group 2 (93.5) and group 3 (91.3%) but the difference was not statistically significant. Resolution of inflammatory mass was highest in group 1. The incidence of side effects was highest and compliance was lowest in the doxycycline -metronidazole group, but the difference was not statistically significant. CONCLUSION: All the three treatment combinations were found to be equally effective in the syndromic management of pelvic inflammatory disease.

Famotidine versus omeprazole, in combination with amoxycillin and tinidazole, for eradication of Helicobacter pylori infection.

BACKGROUND: Eradication regimens combining two antibiotics with a proton pump inhibitor have been studied intensively. In contrast, only a few studies have focused on the possible role of H2-receptor antagonists in eradication therapy. The mechanism involved in the synergy between antibiotics and proton pump inhibitors is still controversial. OBJECTIVES: To compare the results of two triple-therapy regimens, different only in the antisecretory drugs used, in patients with Helicobacter pylori infection, and to assess the impact of primary resistance to metronidazole on treatment outcome. METHODS: A total of 120 patients with peptic ulcer and non-ulcer dyspepsia were randomly assigned to a 2-week course of either: famotidine 40 mg twice a day, amoxycillin 1 g twice a day and tinidazole 500 mg twice a day (FAT group; n = 60); or omeprazole 20 mg twice a day, amoxycillin 1 g twice a day and tinidazole 500 mg twice a day (OAT group; n = 60). Upper endoscopy was performed prior to treatment and at least 4 weeks after completion of treatment and discontinuation of the antisecretory therapy. H. pylori status was assessed by a biopsy urease test, histology and culture. RESULTS: In the intention-to-treat analysis, eradication of H. pylori was achieved in 48 of the 60 patients (80%; 95% confidence interval: 70-90%) in the FAT group, compared to 50 of the 60 patients (83.3%; 95% confidence interval: 74-93%) in the OAT group. In the per protocol analysis, eradication therapy was achieved in 48 out of 53 patients (90.6%; 95% confidence interval: 83-98%) treated with FAT and 50 out of 57 patients (87.7%; 95% confidence interval: 79-96%) treated with OAT (not significant). The primary metronidazole resistance was present in 28.8% of strains. Overall, per protocol eradication rates in strains resistant and susceptible to metronidazole were 83.3% and 91.3% respectively (P > 0.05). CONCLUSIONS: Two-week courses of either high-dose famotidine or omeprazole, both combined with amoxycillin and tinidazole, are equally effective for eradication of H. pylori infection. In a 2-week triple therapy, metronidazole resistance has no significant impact on eradication rates.

Role of antimicrobial susceptibility testing on efficacy of triple therapy in Helicobacter pylori eradication.

BACKGROUND: Helicobacter pylori treatment failure may be due to resistance to macrolides and 5-nitroimidazoles. AIM: To test whether a preliminary in vitro susceptibility test of H. pylori to tinidazole and clarithromycin and a consequent specific regimen could improve the eradication rate. METHODS: A total of 109 consecutive H. pylori-positive patients with dyspeptic symptoms were included. At endoscopy, biopsy from the antrum was obtained for H. pylori culture and antimicrobial susceptibility testing. Fifty-six patients were treated with omeprazole, tinidazole and clarithromycin for 10 days (group OTC) and 53 patients received therapy on the basis of the susceptibility test (group SUSC). Treatment success was evaluated by the 13C-urea breath test 1 month after the end of therapy. RESULTS: Eight patients dropped out. Overall primary resistance to clarithromycin, tinidazole and both antibiotics was 13%, 33% and 4%, respectively. In group OTC, H. pylori was eradicated in 81% and 75% of patients by per protocol and intention-to-treat analysis, respectively. Per protocol and intention-to-treat eradication rates for group SUSC were 98% and 91% (P < 0.05 vs. group OTC). CONCLUSIONS: These data show that in H. pylori infection, antibiotic therapy based on the results of culture and susceptibility testing gives, in comparison to standard therapy, a significant improvement in eradication rate.

Antibiotic prophylaxis for transrectal needle biopsy of the prostate: a randomized controlled study.

OBJECTIVES: To determine the effect of antibiotic prophylaxis on infective complications after transrectal needle biopsy of the prostate. PATIENTS AND METHODS: Between June 1996 and September 1998, 231 patients who satisfied the inclusion and exclusion criteria entered the study; the patients were randomized into three groups. Each patient underwent transrectal needle biopsy of the prostate after a cleansing enema at 06:00 hours. Patients in group 1 (75) then received a placebo tablet twice a day for 3 days; those in group 2 (79) were given a single dose of ciprofloxacin (500 mg) and tinidazole (600 mg), while those in group 3 (77) were given the same combination twice a day for 3 days. Urine cultures were obtained 48 h after the biopsy and blood cultures only from patients who developed fever. The complications (categorized as infective or noninfective) occurring in the three groups were compared using the chi-square test. RESULTS: Noninfective complications included were lower urinary tract symptoms, rectal bleeding, haematuria and perineal pain. The infective complications included urinary tract infection and fever. There was no significant difference among the three groups in noninfective complications (27, 29 and 31 in groups 1-3, respectively) but the incidence of infective complications (19, six and eight, respectively) was significantly higher in group 1 (P = 0.003). However, the difference was significant only for urinary tract infection (P = 0.01) and not for fever. CONCLUSIONS: In selected patients a single dose of ciprofloxacin-tinidazole is adequate prophylaxis for transrectal needle biopsy of the prostate. The present urinary infection rate was higher if no antibiotics were used. Continuing the antibiotic prophylaxis for 3 days offered no benefit over single-dose prophylaxis.

Five-day regimens containing ranitidine bismuth citrate plus high-dose clarithromycin and either amoxycillin or tinidazole for Helicobacter pylori infection.

BACKGROUND: Ranitidine bismuth citrate (RBC)-based triple therapies for a period of 7 days have proved to be an effective treatment for Helicobacter pylori. AIM: To investigate the eradication efficacy, safety profile and patient compliance of two RBC-based triple therapies given for 5 days. METHODS: Eighty H. pylori-positive patients with dyspeptic symptoms, referred to us for gastroscopy, were consecutively enrolled in this prospective, randomized, open-label study. These patients were randomly assigned to receive a 5-day course of RBC 400 mg b.d. plus clarithromycin 500 mg b.d. and either tinidazole 500 mg b.d. (RBCCT group) or amoxycillin 1 g b.d. (RBCCA group). The H. pylori status was assessed by means of histology and rapid urease test at entry, and by 13C-urea breath test 8 weeks after the completion of treatment. RESULTS: All enrolled patients completed the study. Thirty-seven of 40 patients treated with RBCCT (both PP and ITT analysis: 93%; 95% CI: 80-98%) and 35 of 40 in the RBCCA group (both PP and ITT analysis: 88%; 95% CI: 73-96%) returned H. pylori-negative. Slight or mild side-effects occurred in 4/40 patients (10%) in the RBCCT group and in 5/40 (12%) in the RBCCA group. CONCLUSIONS: This is the first study demonstrating the efficacy of RBC-based triple therapies given for only 5 days. RBC regimens containing high-dose clarithromycin and either amoxycillin or tinidazole prove to be well tolerated, safe and preserve good eradication rates even when administered for a shorter than conventional duration.

Antibiotic versus maintenance therapy in the prevention of duodenal ulcer recurrence. Results of a multicentric double-blind randomized trial.

OBJECTIVES: Reduction of gastric acid secretion by maintenance therapy and eradication of Helicobacter pylori by antibiotic treatment have been shown to reduce duodenal ulcer relapse. This study compared the effect of two regimens, a 6-month maintenance on an H2 receptor antagonist versus a one-week antibiotic therapy, on the rate of duodenal ulcer relapse in duodenal ulcer patients with gastric H. pylori infection. METHODS: We conducted a 30-week, double-blind, double-dummy, multicentric clinical trial involving 119 patients (97 M, 22 F, mean age 39 +/- 14 years) randomly assigned to a daily dose of 40 mg famotidine for 6 weeks supplemented with, during the first week, either antibiotics (500 mg amoxicillin q.i.d. and 500 mg tinidazole t.i.d.-antibiotic group) or their placebo (maintenance group). Healed patients after 6 weeks entered the 6-month maintenance phase: the maintenance group received 20 mg famotidine at bedtime and the antibiotic group, a placebo. Endoscopy with antral biopsies was performed to allow a rapid urease test, culture and histological examination upon entry, after 6 weeks, 3 months, and 6 months and, whenever symptoms recurred. H. pylori status was regarded as positive if any one of these three tests was positive, and negative if all tests were negative. RESULTS: The 2 treatment groups were well balanced for all baseline characteristics. After 6 weeks, H. pylori was eradicated in 25 (45%) patients in the antibiotic group, and in 1 (2%) in the maintenance group (P < 0.01). In term of intention-to-treat, there was no significant difference in the healing rate after 6 weeks (93 and 83% in the antibiotic and maintenance groups, respectively; P = 0.15) or in the relapse rate after 6 months (13 and 28% in the antibiotic and maintenance groups, respectively; P = 0.17 Log-rank test). However, the overall failure rate (absence of healing, relapse) was lower (P = 0.04, Log-rank test) in the antibiotic group in which all relapses but one were observed in H. pylori positive patients. The rate of ulcer relapse (1/20) in patients of antibiotic group who remained free of H. pylori during the study, was significantly (P < 0.01) lower compared with that of H. pylori positive patients in the maintenance group (11/44). During the first 6-week period, more side effects were observed in the antibiotic group than in the maintenance group (4 vs 1 patient, respectively). CONCLUSIONS: Our results indicate no significant difference between ulcer relapse rates after 6 months following a one-week antibiotic therapy or long-term maintenance therapy. Short-term antibiotic therapy should be considered as a valuable alternative to the long-term maintenance therapy.