Comparing the Efficacy of Sequential and Standard Quadruple Therapy for Eradication of H. Pylori Infection.

BACKGROUND: The aim of this study was comparison the effectiveness of sequential and standard quadruple therapy on eradication of H. pylori infection. METHODS: This clinical trial study was conducted on 160 patients with dyspepsia or gastroduodenal ulcer. Patients were randomly divided into two groups. Group A (standard regimen) received omeprazole, amoxicillin, clarithromycin and bismuth subcitrate for 2 weeks. Group B (sequential regimen) received omeprazole and amoxicillin in 5 days and omeprazole, tinidazole and levofloxacin in 5 days. After the end of treatment regimens, 20 mg omeprazole was administered twice daily for 3 weeks. H. pylori eradication was assessed 2 months after antibiotic treatment via fecal antigen. RESULTS: Frequency of H. pylori eradication in group A and B was observed in 55 (68.8%) and 63 patients (78.8%), respectively. No significant difference was seen between two groups, regarding H. pylori eradication (p = 0.15). The most common side effects in group A, B were bitterness of mouth (63.8%) and nausea (16.2%), respectively (p H. pylori infection, higher rate of H. pylori eradication was seen in group B than group A. Thus, sequential regimen was a more appropriate regimen with fewer complications.

Tinidazole: Another Therapeutic Option for Syphilis?

After the incidental observation of an almost complete resolution of maculopapular eruption in a patient having simultaneously secondary syphilis and trichomonas vaginalis infection, we extended the treatment with tinidazole (500 mg 4 times daily for 7 days) to 10 other early syphilis patients before the start of the conventional penicillin treatment. All patients showed marked improvement of their lesions in a few days. After the introduction of the conventional penicillin regimen, the lesions further improved and VDRL titers declined at least 4-fold within 6 months in all patients. Tinidazole is a 5-nitroimidazole derivative as well as metronidazole but with a longer plasma half-life. It is activated intracellularly by bacterial/parasitic enzymes to a redox cytotoxic intermediate that damages large protein molecules and inhibits repair and transcription of DNA affecting also the cell wall. With this action, tinidazole might also have a synergic action with penicillin and doxycycline, facilitating the entry of such drugs. It is possible that tinidazole has the same bactericidal action on spirochetes other than Borrelia, such as Treponema pallidum, explaining its rapid therapeutic action on the lesions of early syphilis. Whether this action could be confirmed by studies on larger series of patients, tinidazole might be considered in case of allergy to penicillin or other antibiotics usually prescribed in syphilis.

Sequential Helicobacter pylori eradication therapy in Myanmar; a randomized clinical trial of efficacy and tolerability.

BACKGROUND AND AIM: There is little published research to examine the best approach to the management of Helicobacter pylori in Myanmar. This study aimed to determine the relative efficacy and tolerability of sequential eradication therapy compared to Myanmar's current recommendation of a concomitant four drug regimen. METHODS: Patients were screened for H. pylori using monoclonal Stool Antigen Testing (SAT). Those testing positive were randomized 1:1 to receive receive Myanmar's first-line regimen of 14 days of concomitant rabeprazole, clarithromycin, amoxycillin and tinidazole (140 pills, cost US$23) or 10 days of sequential rabeprazole, clarithromycin, amoxycillin and tinidazole (60 pills, cost US$10). Adherence and adverse effects were recorded, and the efficacy of the regimens assessed with repeat SAT. RESULTS: Of the 1011 patients screened for H. pylori infection, 313 (31%) tested positive. There was no statistical difference in the cure rates of the two regimens in either intention-to-treat: 128/157 (82%; 95% confidence interval (CI): 75-87%) receiving sequential therapy versus 123/156 (79%; 95% CI: 72-85%) receiving concomitant therapy (P = 0.55) or per-protocol analysis: 125/131 (95%; 95% CI: 90-98) receiving sequential therapy versus 121/130 (93%; 95% CI: 87-96) receiving concomitant therapy (P = 0.42). Side effects of therapy were reported in 54/157 (47%) patients taking sequential therapy compared with 62/156 (53%) taking concomitant therapy, but this difference did not reach statistical significance (P = 0.33). CONCLUSIONS: In this high-burden, resource-poor setting, less expensive sequential therapy was as effective and as well tolerated as the currently recommended concomitant four drug regimen for eradication of H. pylori.

Therapy of B-ultrasound-guided puncture for incision infection after total abdominal hysterectomy.

OBJECTIVE: This paper aims to investigate the clinical efficacy of B-ultrasound-guided puncture in the treatment of incision infection after total abdominal hysterectomy (TAH) and to provide references for the clinical treatment. PATIENTS AND METHODS: 116 patients with uterine incision infection after TAH were selected and randomly divided into the observation group and the control group, with 58 cases in each group. The patients in the control group received an intravenous drip of ceftazidime and tinidazole to prevent infection, and the patients in the observation group received B-ultrasound-guided puncture treatment on the basis of the treatment plan of the control group. The clinical therapeutic effects between the two groups were compared. RESULTS: The cure rate of excellence in the observation group was 84.48%, and the cure rate in the control group was 53.45%, while the difference between the two groups was statistically significant (p<0.05). The total effective rate in the observation group was 98.28%, and that in the control group was 87.93%, but there was no statistically significant difference between the two groups. The hospital stay was (9.5±1.6) days in the observation group and (12.3±2.1) days in the control group, and the mean hospital stay in the observation group was significantly shorter than that in the control group; the difference between the two groups was statistically significant (p<0.05). CONCLUSIONS: TAH should be performed on patients when they are in the best physical condition, and strictly according to the operation steps to reduce the duration of surgery. The application of B-ultrasound-guided puncture can effectively improve the excellent recovery rate of the incision infection after TAH and shorten the hospitalization time. It is worth popularizing in clinical practice.

[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.

Protocol for a randomized clinical trial exploring the effect of antimicrobial agents on the penile microbiota, immunology and HIV susceptibility of Ugandan men.

BACKGROUND: The foreskin is the main site of HIV acquisition in a heterosexual uncircumcised man, but many men in endemic countries are reluctant to undergo penile circumcision (PC). Observational studies suggest that proinflammatory anaerobic bacteria are enriched on the uncircumcised penis, where they may enhance HIV susceptibility through increased foreskin inflammatory cytokines and the recruitment of HIV-susceptible CD4+ target cells. This trial will examine the impact of systemic and topical antimicrobials on ex vivo foreskin HIV susceptibility. METHODS/DESIGN: This randomized, open-label clinical trial will randomize 125 HIV-negative Ugandan men requesting voluntary PC to one of five arms (n = 25 each). The control group will receive immediate PC, while the four intervention groups will defer PC for 1 month and be provided in the interim with either oral tinidazole, penile topical metronidazole, topical clindamycin, or topical hydrogen peroxide. The impact of these interventions on HIV entry into foreskin-derived CD4+ T cells will be quantified ex vivo at the time of PC using a clade A, R5 tropic HIV pseudovirus assay (primary endpoint); secondary endpoints include the impact of antimicrobials on immune parameters and the microbiota of the participant's penis and of the vagina of their female partner (if applicable), assessed by multiplex enzyme-linked immunosorbent assay and 16S rRNA sequencing. DISCUSSION: There is a critical need to develop acceptable, simple, and effective means of HIV prevention in men unwilling to undergo PC. This trial will provide insight into the causative role of the foreskin microbiota on HIV susceptibility, and the impact of simple microbiota-focused clinical interventions. This may pave the way for future clinical trials using low-cost, nonsurgical intervention(s) to reduce HIV risk in uncircumcised heterosexual men. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03412071 . Retrospectively registered on 26 January 2018.

Sequential therapy for first-line Helicobacter pylori eradication: 10- or 14-day regimen?

BACKGROUND AND AIM: Standard 10-day sequential therapy is advised as first-line therapy for Helicobacter pylori (H. pylori) eradication by current Italian guidelines. Some data suggested that a 14-day regimen may achieve higher eradication rates. This study compared the efficacy of sequential therapy administered for either 10- or 14-days. METHODS: This prospective, multicenter, open-label study enrolled patients with H. pylori infection without previous treatment. Patients were receiving a sequential therapy for either 10 or 14 days with esomeprazole 40 mg and amoxicillin 1 g (5 or 7 days) followed by esomeprazole 40 mg, clarithromycin 500 mg and tinidazole 500 mg (5 or 7 days), all given twice daily. Bacterial eradication was checked using 13C-urea breath test. Eradication cure rates were calculated at both Intention-to-treat (ITT) and per-protocol (PP) analyses. RESULTS: A total of 291 patients were enrolled, including 146 patients in 10-day and 145 in the 14-day regimen. The eradication rates were 87% (95% CI = 81.5-92.4) and 90.3% (95% CI = 85.5-95.1) at ITT analysis with the 10- and 14-day regimen, respectively, and 92.7% (95% CI = 88.3-97) and 97% (95% CI = 94.2-99.9) at PP analysis (p =0.37). Among patients, who earlier had interrupted therapy, bacterial eradication was achieved in 8 out of 9 who completed the first therapy phase and performed at least >/=3 days of triple therapy in the second phase. CONCLUSION: This study found that both 10- and 14-day sequential therapies achieved a high eradication rate for first-line H. pylori therapy in clinical practice.

Controlled delivery of the antiprotozoal agent (tinidazole) from intravaginal polymer matrices for treatment of the sexually transmitted infection, trichomoniasis.

Microporous polymeric matrices prepared from poly(ɛ-caprolactone) [PCL] were evaluated for controlled vaginal delivery of the antiprotozoal agent (tinidazole) in the treatment of the sexually transmitted infection, trichomoniasis. The matrices were produced by rapidly cooling co-solutions of PCL and tinidazole in acetone to -80 °C to induce crystallisation and hardening of the polymer. Tinidazole incorporation in the matrices increased from 1.4 to 3.9% (w/w), when the drug concentration in the starting PCL solution was raised from 10 to 20% (w/w), giving rise to drug loading efficiencies up to 20%. Rapid 'burst release' of 30% of the tinidazole content was recorded over 24 h when the PCL matrices were immersed in simulated vaginal fluid. Gradual drug release occurred over the next 6 days resulting in delivery of around 50% of the tinidazole load by day 7 with the released drug retaining antiprotozoal activity at levels almost 50% that of the 'non-formulated' drug in solution form. Basic modelling predicted that the concentration of tinidazole released into vaginal fluid in vivo from a PCL matrix in the form of an intravaginal ring would exceed the minimum inhibitory concentration against Trichomonas vaginalis. These findings recommend further investigation of PCL matrices as intravaginal devices for controlled delivery of antiprotozoal agents in the treatment and prevention of sexually transmitted infections.

Systematic Review with Meta-Analysis: Concomitant Therapy vs. Triple Therapy for the First-Line Treatment of Helicobacter pylori Infection.

BACKGROUND: Whether concomitant therapy is superior to triple therapy of various treatment lengths for the first-line treatment of H. pylori remains controversial. The objective of this study is to compare the efficacy of concomitant therapy and triple therapy given for 5-14 days. METHODS: Randomized control trials (RCTs) comparing the efficacy of concomitant therapy for 5-14 days and proton pump inhibitor-amoxicillin-clarithromycin (PAC)-based triple therapy for 5-14 days in the first-line treatment of adult patients with H. pylori infection published from 1990 to January 2018 were searched from the PubMed, Cochrane Library, and Embase. Abstracts from international annual conferences were also searched. The primary and secondary outcomes were the eradication rate according to the intention-to-treat analysis and the adverse effects, respectively. Subgroup analyses were also performed according to treatment length. This study is registered with PROSPERO, number CRD42017081328. RESULTS: Of the 639 articles identified, 23 RCTs including 3305 patients in the concomitant therapy group and 3327 patients in the triple therapy group were eligible. Overall, concomitant therapy was superior to triple therapy [risk ratio (RR): 1.15; 95% confidence interval (CI): 1.09-1.21; p < 0.001]. However, there were significant heterogeneity (I2 = 74.0%, p < 0.001). In the subgroup analysis, 5-day concomitant therapy was superior to 5-day triple therapy (RR: 1.30; 95% CI: 1.04-1.62; p = 0.02), 5- or 7-day concomitant therapy was superior to 7-day triple therapy (RR: 1.16; 95% CI: 1.12-1.21; p < 0.001), and 5- or 7-, or 10- or 14-day concomitant therapy was superior to 10-day triple therapy (RR: 1.15; 95% CI: 1.08-1.23; p < 0.001). However, 5- or 10-day concomitant therapy was not superior to 14-day triple therapy (RR: 1.02; 95% CI: 0.89-1.16; p = 0.796). The frequency of adverse effects was significantly higher in concomitant therapy than triple therapy (RR: 1.19; 95% CI: 1.06-1.34; P = 0.004). CONCLUSIONS: Concomitant therapy given for 5 or 10 days was superior to 5- or 7-, or 10-day PAC-based triple therapy, but was not superior to 14-day triple therapy.

Comparative study of tinidazole versus metronidazole in treatment of amebic liver abscess: A randomized control trial.

BACKGROUND: Metronidazole is a drug of choice for amebic liver abscess (ALA), but has long course and significant side effects. Thus, drugs like tinidazole with a better tolerability record need evaluation. METHODS: We conducted a randomized controlled trial at the Department of Gastroenterology, SMS Hospital, Jaipur, India. One hundred and fifty admitted patients were randomized into two treatment groups, metronidazole (group M, n = 75) and tinidazole (group T, n = 75). Patients were observed for clinical response, laboratory parameters, imaging, and side effects. Early clinical response (ECR) was defined as the absence of fever and abdominal pain within 72 h of treatment. Symptomatic clinical response (SCR) was defined as the absence of fever and abdominal pain irrespective of duration of treatment required. Follow up was done at 1, 3, and 6 months. RESULTS: ECR was 62.3% in group T vs. 37.7% in group M (p = 0.02). SCR was shorter in group T than group M (3.29 ± 1.61 days vs. 5.67 ± 2.93, p ≤ 0.001). Mean residual volume at the end of 1 month was lower in group T (130.7 ± 108.1 vs. 184.7 ± 143.3 mL, p = 0.01) and no significant difference was seen at 3 and 6 months. Tinidazole was better tolerated with fewer side effects. Low socioeconomic status, baseline abscess volume > 500 mL, hypoalbuminemia, pleural effusion, and history of ethanol use were associated with a late clinical response on univariate analysis of which low socioeconomic status was the only associated factor. CONCLUSION: Tinidazole, as compared to metronidazole, has early clinical response, shorter treatment course, favorable rate of recovery, and high tolerability; thus, tinidazole can be preferred over metronidazole in ALA.

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.

Comparison between daily single-dose triple therapy and conventional triple therapy on patient compliance and Helicobacter pylori eradication: A randomized controlled trial.

OBJECTIVE: The poor compliance to treatment of Helicobacter pylori-infected patients is well-known. We evaluated the efficacy of daily single-dose triple therapy as compared to conventional triple therapy on patient compliance and eradication of H. pylori infection. METHODS: In the study group, 105 patients received esomeprazole 40 mg, tinidazole 1 g, and levofloxacin 500 mg once-daily for 14 days. One hundred and seven patients in the control group received lansoprazole 30 mg, amoxicillin 1 g, and clarithromycin 500 mg twice-daily for 14 days. Four weeks after completing therapy, urea breath test was performed to assess the eradication of H. pylori infection. RESULTS: The eradication rates by intention-to-treat analysis were 86% and 90.2% and by per-protocol analyses were 90.5% and 95.3% in the control and study groups, respectively, with no significant differences. Drug compliance was significantly better in the study group compared to the control group (p = 0.04). Overall, 44.7% of the patients in the study and 47.6% in the control groups had at least one adverse event. The most common adverse event was the dysgeusia in both the groups. The occurrence of diarrhea, nausea and vomiting was significantly higher in the control group and that of arthralgia was higher in the study group. The presence of periodontal disease and drug compliance was independently associated with treatment failure. CONCLUSION: The use of single-dose PPI-based triple therapy improves drug compliance and eradication rate to standard PPI-based triple therapy. Presence of periodontal disease and drug compliance had negative influence on the eradication rate. TRIAL REGISTRATION: NCT02711176 ᅟ ᅟ.

The effectiveness of empirical anti-parasitic treatment in returning travellers with persistent abdominal symptoms.

BACKGROUND: Persistent abdominal symptoms (PAS) are common among returning-travellers. In the absence of sensitive tests to identify intestinal parasites, gastrointestinal (GI) symptoms often remain a diagnostic challenge. In this study we examined the effectiveness of empirical anti-parasitic treatment in returning-travellers with PAS despite no positive stool-test. METHODS: A retrospective study among returning travellers who approached the clinic between the years 2014 and 2016 with GI complaints without a positive stool-test. The empirical treatment included broad-spectrum anti-parasitic agents-oral Tinidazole and Albendazole. A follow-up questionnaire was performed at least 6 months post-treatment. RESULTS: A total of 102 patients responded the questionnaire-50% women; average age 31.14 (±12.20) years. The average duration of complaints before treatment was 16.52 (±30.06) months. Common GI symptoms included abdominal pain (83.3%) and diarrhoea (78.4%); 67.6% of the patients complained of extreme fatigue. Overall, 69% of the patients reported an improvement in GI symptoms, 37% of them reported full recovery within a few weeks post-treatment. Furthermore, there was an improvement in the energy level and general well-being in 68% and 70% of the patients, respectively. Only 33% of the patients reported minor side effects related to the treatment. CONCLUSIONS: The improvement in GI symptoms, energy level and general well-being shortly after anti-parasitic treatment justifies this empirical approach in returning-travellers with PAS despite negative stool-tests. The association between fatigue and PAS post-travel and the improvement in both as a response to treatment defines fatigue as part of a new syndrome-'Post-travel fatigue and abdominal symptoms'.

Randomized, double-blind, comparative study of oral metronidazole and tinidazole in treatment of bacterial vaginosis.

OBJECTIVE: To compare the efficacy and tolerability of oral metronidazole and tinidazole in patients with bacterial vaginosis (BV) using Amsel's criteria. PATIENTS AND METHODS: This was a randomized double-blind study, conducted by the Departments of Pharmacology and Gynecology of a tertiary care teaching hospital. Patients diagnosed with BV received either tablet metronidazole 500 mg twice daily for 5 days or tablet tinidazole 500 mg once daily + one placebo for 5 days and instructed to come for follow-up at the 1st week and 4th week. They were categorized as cured, partially cured, and not cured based on Amsel's criteria at the end of the study and compared between two groups using Chi-square test. RESULTS: A total 120 women were enrolled in the study, of which 114 completed the study. The treatment arms were comparable. The cure rate with low-dose tinidazole was significantly more compared to metronidazole at 4th week (P = 0.0013), but not at 1st week (P = 0.242). The adverse drug reactions were less with tinidazole compared to metronidazole. CONCLUSION: Tinidazole at lower dose offers a better efficacy than metronidazole in long-term cure rates and in preventing relapses with better side effect profile.

Synthesis, characterization and evaluation of tinidazole-loaded mPEG-PDLLA (10/90) in situ gel forming system for periodontitis treatment.

Traditional in situ gel forming systems are potential applications for parenteral administration but always accompanied with burst release. To overcome this limitation, the tinidazole (TNZ)-loaded in situ gel forming system using a diblock copolymer, monomethoxy poly(ethylene glycol)-block-poly(d,l-lactide) (mPEG-PDLLA), was designed. The formulation of the mPEG-PDLLA-based TNZ in situ gel forming system contained 5% (w/w) TNZ, 0.4% glycerol, 5 ml N-methyl pyrrolidone (NMP) and 35% (w/w) mPEG-PDLLA. The in situ gel forming system showed sustained TNZ release over 192 h with low burst effect (around 7% in the first 8 h) in the in vitro release study. Additionally, in vivo studies were performed on rabbits with ligature-induced periodontitis, and the concentration of TNZ in the gingival crevicular fluid (GCF) as well as the pharmacokinetic parameters was calculated and the pharmacological effect of TNZ-loaded in situ gel forming (mPEG-PDLLA)-based system was found effective. Finally, histological studies revealed that the gel was a safe formulation with low irritation. The desirable drug release kinetics combined with the excellent in vivo characteristics highlight the potential of the gel in the treatment of periodontitis. Therefore, these results confirmed that the TNZ-loaded in situ gel forming mPEG-PDLLA-based system could reduce burst release of TNZ and act as a sustained-release and injectable drug depot for periodontitis treatment.

Comparison of 10-day sequential therapy with 7-day standard triple therapy for Helicobacter pylori eradication in inactive peptic ulcer disease and the efficiency of sequential therapy in inactive peptic ulcer disease and non-ulcer dyspepsia.

BACKGROUND: Eradication rates of standard triple therapy for Helicobacter pylori infections have decreased in recent years due to a worldwide increase in bacterial resistance. Sequential therapy has the advantage of a two-phase treatment regimen and achieves a superior result for H. pylori eradication in peptic ulcer disease. However, no study has yet compared the efficacy of sequential therapy for H. pylori eradication exclusively in inactive duodenal ulcer (iDU) or non-ulcer dyspepsia (NUD). METHOD: We retrospectively recruited 408 patients with endoscopic proven iDU (170 patients) or NUD (238 patients) infected with H. pylori. Patients with iDU were assigned into two groups: iDU triple therapy group, 44 patients treated with 40 mg pantoprazole, 1000 mg amoxicillin and 500 mg clarithromycin, twice daily for 7 days; iDU sequential therapy group, 126 patients treated with 40 mg pantoprazole and 1000 mg amoxicillin, twice daily for the first 5 days, followed by 40 mg pantoprazole, 500 mg clarithromycin and 500 mg tinidazole, twice daily for the next 5 days. All patients with NUD were treated with sequential therapy and assigned as the NUD sequential group. Post-treatment H. pylori status was confirmed by a (13)C-urea breath test. RESULT: The eradication rates of intention-to-treat (ITT) and per-protocol (PP) analysis were 77.3 % (95 % CI 64.9-89.7 %) and 85.0 % (95 % CI 73.9-96.1 %) in the iDU triple therapy group and 87.3 % (95 % CI 81.5-93.1 %) and 92.4 % (95 % CI 87.6-97.2 %) in the iDU sequential therapy group. The overall eradication efficacy was superior in the sequential group than in the triple group, both with ITT analysis (83.5 % vs. 77.3 %, P = 0.29) and PP analysis (88.1 % vs. 85.0 %, P = 0.57). Eradication rates for ITT and PP analysis were 81.5 % (95 % CI 76.6-86.4 %) and 85.8 % (95 % CI 83.5-88.2 %) in the NUD sequential therapy group. Eradication rate was statistically better in the iDU sequential therapy group than the NUD sequential therapy group according to per protocol analysis (P = 0.04). Eradication rate was not significantly different between the iDU sequential- and iDU triple therapy groups according to protocol analysis (P = 0.14). CONCLUSION: The sequential regimen has a better eradiation rate in the iDU group than in the NUD group. There is no statistically difference between 10-day sequential therapy and 7-day standard triple in iDU group.