Randomized trial of rifabutin-based triple therapy and high-dose dual therapy for rescue treatment of Helicobacter pylori resistant to both metronidazole and clarithromycin.

BACKGROUND: The clinical management of Helicobacter pylori infected patients who failed standard eradication therapies remains a challenge. AIM: To investigate the efficacy of rifabutin-based triple therapy and high-dose dual therapy for rescue treatment of H. pylori, and the correlation between cytochrome P450 2C19 (CYP2C19) polymorphisms and treatment outcome. METHODS: Patients infected with H. pylori resistant to both metronidazole and clarithromycin (n = 145) were randomized to either esomeprazole 20 mg, rifabutin 150 mg and amoxicillin 1 g, each given b.d. for 7 days (ERA), or to omeprazole 40 mg and amoxicillin 1000 mg, each given t.d.s. for 14 days (OA). Crossover therapy was offered in cases of persistent infection. CYP2C19 polymorphisms were determined by polymerase chain reaction restriction fragment length polymorphism. RESULTS: Intention-to-treat and per-protocol eradication rates were: ERA 74% (62.4-83.6) and 78% (66.7-87.3); high-dose OA 70% (57.5-79.7) and 75% (62.5-84.5). Crossover therapy was successful in seven of 10 patients with ERA and in eight of 10 patients with OA. Premature discontinuation of treatment occurred in 2% and 5% of patients, respectively. There was only a non-significant trend to lower eradication rates in homozygous extensive metabolizers. CONCLUSIONS: Triple therapy with esomeprazole, rifabutin and amoxicillin and high-dose omeprazole/amoxicillin are comparable and effective and safe for rescue therapy of H. pylori regardless of the patient's CYP2C19 genotype.

Efficacy and tolerability of potato juice in dyspeptic patients: a pilot study.

In Europe, use of potatoes (Solani tuberosi tuberecens) is a traditional remedy for stomach complaints. We performed a pilot study on the effectiveness and tolerability of freshly squeezed potato juice in patients suffering from dyspeptic symptoms. After informed written consent, 44 patients with various dyspeptic symptoms were enrolled, to drink for 1 week twice daily 100ml or more of potato juice (Biotta, if complaints persisted, a further 100ml was recommended. Validated outcome measures included the gastrointestinal symptom (GIS) profile, a disease-specific health assessment questionnaire (QOLRAD) and self-rated treatment success (efficacy, a 5-point Likert Scale). The study was completed by 42 patients. The GIS and QOLRAD scores improved significantly by 41.9+/-40.8% (p=0.001) and 50.7+/-36.1% (p<0.001), respectively (ITT); the absolute values changed from 11.5+/-5.1 to 6.3+/-5.3 (GIS) and 62.0+/-25.7 to 32.0+/-28.8 (QORAD). Sixteen, 18 and 26 patients, respectively, rated the effectiveness of the treatment as very good or good on the GIS, QOLRAD (improvements >60%) and on efficacy, respectively. Poor treatment success was achieved in 13 (GIS), 11 (QOLRAD) and 10 (Efficacy), not necessarily by the same patients. Since about two-thirds of the patients benefited to some extent from the treatment, potato juice in its present formulation may be useful for self-treatment. However, placebo-controlled studies with a longer treatment period are needed to confirm this.

Treatment of functional dyspepsia with a herbal preparation. A double-blind, randomized, placebo-controlled, multicenter trial.

BACKGROUND: We aimed to assess the efficacy and safety of a herbal preparation STW 5-II containing extracts from bitter candy tuft, matricaria flower, peppermint leaves, caraway, licorice root and lemon balm for the treatment of patients with functional dyspepsia. METHODS: 120 patients with functional dyspepsia were randomly assigned to 1 of 4 treatment groups. Each patient received the treatment for three consecutive 4-week treatment blocks. The first two treatment blocks were fixed. For the third treatment period, medication was based upon the investigator's judgement of symptom improvement during the preceding treatment period. In patients without adequate control of symptoms, the treatment was switched, or if symptoms were controlled, the treatment was continued. The primary outcome measure was the improvement of a standardized gastrointestinal symptom score (GIS). FINDINGS: During the first 4 weeks, the GIS significantly decreased in subjects on active treatment compared to the placebo (p < 0.001). During the second 4-week period, symptoms further improved in subjects who continued on active treatment or who switched to the active treatment (p < 0.001), while symptoms deteriorated in subjects who switched to placebo. After 8 weeks 43.3% on active treatment and 3.3% on placebo reported complete relief of symptoms. (p < 0.001 vs. placebo). CONCLUSION: In patients with functional dyspepsia, the herbal preparation tested improved dyspeptic symptoms significantly better than placebo.

Treatment of irritable bowel syndrome with herbal preparations: results of a double-blind, randomized, placebo-controlled, multi-centre trial.

BACKGROUND: Herbal medications have been used in many countries for the treatment of patients with irritable bowel syndrome. Controlled data supporting the efficacy of these treatments in patients with irritable bowel syndrome are lacking. AIM: To assess the efficacy and safety of a commercially available herbal preparation (STW 5) (nine plant extracts), the research herbal preparation STW 5-II (six plant extracts) and the bitter candytuft mono-extract in patients with irritable bowel syndrome. METHODS: Two hundred and eight patients with irritable bowel syndrome were recruited after standardized diagnostic work-up into a double-blind, placebo-controlled, multi-centre trial and were randomly assigned to receive one of four treatments: commercially available herbal preparation STW 5 (n = 51), research herbal preparation STW 5-II (n = 52), bitter candytuft mono-extract (n = 53) or placebo (n = 52). The main outcome variables were the changes in total abdominal pain and irritable bowel syndrome symptom scores. RESULTS: Two hundred and three patients completed the trial. STW 5 and STW 5-II were significantly better than placebo in reducing the total abdominal pain score (intention-to-treat: STW 5, P = 0.0009; STW 5-II, P = 0.0005) and the irritable bowel syndrome symptom score (intention-to-treat: STW 5, P = 0.001; STW 5-II, P = 0.0003) at 4 weeks. There were no statistically significant differences between the bitter candytuft mono-extract group and the placebo group (P = 0.1473, P = 0.1207). CONCLUSIONS: The commercially available herbal preparation STW 5 and its research preparation STW 5-II are both effective in alleviating irritable bowel syndrome symptoms.

[5-Fluorouracil-induced colitis--a review based upon consideration of 6 cases]. / 5-Fluorouracil-assoziierte Kolitis--eine Ubersicht unter Berücksichtigung einer eigenen Sammlung von 6 Fällen.

BACKGROUND: At increasing use of high-dose 5-fluorouracil-based chemotherapy for metastatic colorectal and gastric cancer complicated drug-induced colitis is observed more frequently. From May 1998 to November 2000 we observed 6 cases of 5-fluorouracil-induced colitis, in which we looked for involvement of small intestine. We report summing up on the 6 cases including both endoscopic and histological findings in both sites of the gut. CASE REPORTS: In 2 men and 4 women (age 49-78 years) with advanced colon (n = 2), gastric (n = 3 ) and gallbladder (n = 1) cancer a palliative weekly high-dose infusional 5-fluorouracil (2,6 g/m(2)/24 h) and folinic acid (500 mg/m(2)/2 h) chemotherapy was performed. Few days after 1-5 chemotherapy courses the patients were admitted to our hospital with abdominal pain and partly severe watery diarrhea (up to 20 times evacuations/per day). The stool cultures were negative and there were no proof both of clostridium difficile and his toxin A and B. In 4 patients colonoscopy showed different grades of colitis up to diffuse erythema and microlesions, 2 patients had no visible lesions. In 4 patients endoscopy of the upper GI-tract showed a severe inflammation (n = 1) and a fibrinopurulent exsudate, severe edema and isolated ulcerations (n = 3) of jejunum after gastrectomy or duodenum with intact stomach. In the histological assessment different grades of 5-FU-induced colitis without (n = 2) or with (n = 4) involvement of the upper small intestine destruction of the superficial mucosa and crypts (epitheliumapoptosis) were found. 5 patients were treated by antibiotics (vancomycin n = 2, metronidazole n = 3), glucocorticoids (n = 5) and Saccaromyces cerevisiae (n = 3). After 8-10 days the patients were complete free of symptoms. One patient died due to the enterocolitis. CONCLUSIONS: The present cases demonstrate that high-dose 5-fluorouracil-based chemotherapy not only induces a colitis but also may involve the upper small intestine tract. Consequently, it represents an increasing and serious adverse event of high-dose chemotherapy. The etiology of the enterocolitis (drug- or bacterial-induced) needs further investigations in order to find a causal therapy and/or prophylaxis.

Short-term changes in Helicobacter pylori gastritis and bulbitis during and after 2 weeks of treatment with omeprazole and amoxicillin in duodenal ulcer patients.

OBJECTIVE: To evaluate the dynamics of histological changes in the mucosa of the stomach and duodenal bulb during and after completion of a 14-day course of Hp-eradication dual treatment with high-dose omeprazole and amoxicillin. PATIENTS: 12 patients (mean age 53 +/- 16 years SD, 9 male, 3 female) with an acute Hp-positive duodenal ulcer were included in this open, prospective, single-centre study. METHOD: Patients were given omeprazole 40 mg b.i.d. and amoxicillin 1,500 mg b.i.d. for a period of 14 days. Endoscopic biopsies were obtained on days 3, 7, 14, 28, 42 as well as at following endoscopies performed a mean of 17 months after treatment. RESULTS: The Hp-eradication rate achieved 4 weeks after treatment was 82%. On day 14, 88% of the ulcers were healed. Already on day 7 Hp had almost completely disappeared from the antrum, corpus and duodenal bulb, and the activity of gastritis in the antrum and corpus and the activity of bulbitis in the duodenal bulb was almost nonexistent. The decrease in the grade of gastritis was much lower by day 42. CONCLUSIONS: Our study shows for the first time that in all patients signs of primarily successful Hp-eradication treatment during the first days of treatment are consistently demonstrable and complete already after one week of therapy, irrespective of the subsequent cure or persistence of Hp-infection. In the patients with persistence of Hp-infection Hp-colonization and activity of gastritis quickly increased within 2-4 weeks after cessation of treatment. Checks to evaluate complete eradication or recrudescence of Hp-infection should be carried out not earlier than 28 days after cessation of treatment.

[A plant extract and its modified preparation in functional dyspepsia. Results of a double-blind placebo controlled comparative study]. / Ein Phytotherapeutikum und seine modifizierte Rezeptur bei funktioneller Dyspepsie. Ergebnisse einer doppelblinden plazebokontrollierten Vergleichsstudie.

AIMS: To assess the efficacy and safety of the commercially available herbal preparation (Iberogast, STW-5*) containing extracts from bitter candy tuft, chamomile flower, peppermint leaves, caraway fruit, licorice root, lemon balm leaves, angelica root, celandine herbs, milk thistle fruit and its research preparation STW-5-S (without bitter candy tuft) in patients with functional dyspepsia. PATIENTS AND METHODS: After a standardized diagnostic work-up and at least 7 days free of medication, 60 patients, diagnosed with functional dyspepsia, were recruited in a multicenter trial and randomly assigned to one of 3 treatment groups (STW-5, STW-5-S or placebo). Each patient received the treatment for 4 weeks. The main outcome variables were the improvement of a gastrointestinal symptom score (GIS), a sumscore consisted of 10 dyspeptic symptoms rated on a Likert scale. Dyspeptic symptoms were assessed at baseline, 2 and 4 weeks after treatment. RESULTS: 60 patients completed the trial (mean age 46.8 years, range 25-70, female 38 patients). Compared with placebo-group both herbal preparations STW-5 and STW-5-S showed a clinically significant improvement of GIS after 2 and 4 weeks of treatment (p < 0.001). No statistically significant difference could be observed between the efficacy of STW-5 and STW-5 S (p > 0.05), but a solid improvement of gastrointestinal symptoms could be achieved earlier with STW-5 than with its research preparation STW-5-S without bitter candy tuft (p = 0.023). CONCLUSIONS: In patients with functional dyspepsia, the commercially available herbal preparation STW-5 and its modified dispense STW-5-S tested improved dyspeptic symptoms significantly better than placebo. The extract bitter candy tuft appeared to have an additive effect on dyspeptic symptoms.

Treatment of functional dyspepsia with a fixed peppermint oil and caraway oil combination preparation as compared to cisapride. A multicenter, reference-controlled double-blind equivalence study.

The therapeutic equivalence of a fixed combination preparation consisting of peppermint oil and caraway oil (PCC, Enteroplant) and the prokinetic agent cisapride (CIS, CAS 81098-60-4) was investigated in a four-week randomized controlled double-blind study with planned adaptive interim analysis. The study comprised 120 outpatients with functional dyspepsia. The efficacy was evaluated in 118 patients. Of these, 60 patients received the enteric-coated combination preparation (2 x 1 capsule containing 90 mg peppermint oil +50 mg caraway oil per day) and 58 patients received the reference preparation cisapride (3 x 10 mg/day). The mean reduction of the pain score (primary variable) recorded on a visual analog scale (VAS) during the four-week treatment was 4.62 points with the peppermint oil/caraway oil preparation. This score was comparable with the mean reduction under cisapride (4.60 points) (p = 0.021; test for equivalence). Equivalence was also found in the secondary variable "frequency of pain" with a reduction by 4.65 points under PCC and by 4.16 points under cisapride carried out on an exploratory basis (p = 0.0034). Comparable results were attained with both treatments in the Dyspeptic Discomfort Score which included the other dyspeptic symptoms as well as intestinal and extraintestinal autonomic symptoms, in the prognosis as appraised by the physician and in the CGI scales (Clinical Global Impressions). Corresponding results were also found in Helicobacter pylori-positive patients and patients with initially intense epigastric pain in the two treatment groups. The combination preparation consisting of peppermint oil and caraway, oil appears to be comparable with cisapride and provides an effective means for treatment of functional dyspepsia. Both medications were tolerated well (adverse events were reported in 12 patients of the PCC group and in 14 patients of the CIS group).