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.

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.

[Socioepidemic analysis of sources of information and medical care for a subpopulation of female and male participants in a nationwide informative campaign in Germany on "Danger Signal: Heartburn"]. / Sozialepidemiologische Analyse von Informationsquellen und medizinischer Versorgung einer Subpopulation von Teilnehmerinnen und Teilnehmern einer bundesweiten Informationskampagne "Alarmzeichen Sodbrennen"

Whilst the prevalence of gastroesophageal reflux is increasing, most people are unaware of its possible consequences. Therefore, in Autumn 2000 a nationwide information campaign was launched on the symptoms of gastroesophageal reflux and its possible treatments. One part of the information campaign was a telephone hotline which was followed by an interview by phone or a mailed questionnaire. The objective of this was to find out more about the people concerned and their complaints. The subjects of both data sets were on average 53 respectively 57 years old, half of them were female and over 60 % had had heartburn for more than two years. The interview showed that 53 % took notice of the hotline by a press release. The interviewed persons gathered information in general about health-related issues primarily from newspapers and TV reports and from their physician. 81.7 % of the questionnaire sample had already at least one gastroscopy. Another 9.5 % made use of medical services because of their complaints in the last year. 8.8 % used exclusively over-the-counter medication for relief from their complaints. These three groups of different degrees of utilisation differed in respect of age, intensity and duration of the symptom heartburn and lifestyle-factors such as smoking. Those who had a gastroscopy were older, symptoms were more prolonged, more severe, more often and comprised a wider range of symptoms and less cigarette consumption. The analysis of both samples showed that the telephone hotline was used mainly by people who had had their symptoms for a long time and had already been in medical care. The chosen means of information stated by the sample indicate that media are prominently involved in disseminating information and educating the public.

[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.

[The Body-Mass-Index (BMI) has no impact on the frequency of typical reflux symptoms -- results of a nationwide telephone-based informing campaign in Germany]. / Der Bodymass-Index (BMI) hat keinen Einfluss auf die Häufigkeit von Refluxbeschwerden -- Ergebnisse einer deutschlandweiten Aufklärungskampagne.

BACKGROUND AND AIM: The effects of obesity on the gastrooesophageal reflux disease (GERD) are controversial. The aim of the study was to assess the relationship between the BMI and the frequency of reflux symptoms in a population with typical GERD symptoms. METHODS: Based upon a nationwide informing campaign up to 5,000 subjects contacted the informing calling center. Subjects were included if they had heartburn and acid regurgitation. Age, gender, height, weight and the frequency of reflux symptoms were assessed by telephone interviewing. RESULTS: 1,296 subjects (668 female) with mean age of 54 +/- 14 years and a mean BMI of 26 +/- 4 were included in the study. 41.2% of the subjects had a BMI up to 25, 41.4 % between 25 to 30, and 13 % greater than 30. 74.5 % of all subjects reported reflux episodes daily and several times a week. 74.6 % of the subjects had reflux symptoms for more than one year. Both the frequency and pattern of reflux symptoms did not differ significantly in the three BMI-classes (p > 0.05, table). CONCLUSION: In the present population with typical and frequent GERD symptoms the BMI showed no impact on the frequency of reflux symptoms. A high BMI does not appear to be a risk indicator for GERD. Interventional studies are needed to assess whether a high BMI is also no risk factor for GERD.

[Is it irritable bowel syndrome? Validating the diagnosis]. / Ist es ein Reizdarm? Wie Sie die Diagnose sichern.

Irritable bowel syndrome is characterised by constant or recurrent abdominal complaints over more than three months, in the absence of any pathological changes in the routinely employed examination procedures. The diagnosis is established on the basis of typical symptoms and specific exclusion of relevant differential diagnoses. The heart of the diagnostic evaluation comprises a limited routine laboratory investigation, and endoscopic exploration to exclude organic disease of the gastrointestinal tract. Diagnostic re-evaluation is necessary only when there is a change in the patient's symptoms. A psychosomatic diagnostic evaluation and, where necessary, psychotherapy is indicated in about 5% of the patients. For IBS, causal treatment is not available. Apart from symptomatic drug treatment, intensive counseling and regular interviews are of particular importance.

[Symptomatic therapy of irritable bowel syndrome. Which drug for which symptoms?]. / Symptomatische Therapie des Reizdarmsyndroms. Welches Medikament für welche Beschwerden?

After establishing the diagnosis, reassuring the patient, and applying non-drug measures, pharmacotherapy forms a major pillar in the treatment of IBS, despite the fact that because the pathophysiology is still unknown, we have no causal drug treatment available. In the first instance, medication is a recommended supportive measure for application during the symptom-free intervals. It is oriented to the patient's leading complaints, and is directed towards the regulation of bowel movements, treatment of flatulency, and amelioration of painful motility disorders (e.g. spasms).

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.

Pantoprazole 20 mg is an effective maintenance therapy for patients with gastro-oesophageal reflux disease.

OBJECTIVES: To compare the efficacy of 20 mg with 40 mg pantoprazole in maintaining symptomatic and endoscopic remission in patients with gastro-oesophageal reflux disease (GORD). STUDY DESIGN: Patients (18-84 years old; n = 433) with healed GORD II or III were included in this prospective multi-centre, randomized, parallel, double-blind study. Pantoprazole was administered once daily for up to 1 year as either a 20 mg or 40 mg enteric-coated tablet to 221 and 212 patients, respectively. Symptoms of GORD were assessed every 3 months. Endoscopy was performed at entry, after 6 and 12 months, or when symptoms of GORD were perceived on at least three consecutive days. The primary efficacy parameter was the time until endoscopically proven relapse of GORD occurred (stage I or greater); the secondary parameters included tolerability, safety, and time until symptomatic relapse occurred. RESULTS: In the 20 mg treatment group, 87% and 75% of patients were in endoscopic remission after 6 and 12 months, respectively; the corresponding rates in the 40 mg treatment group were 91% and 78%. In both treatment groups, GORD stage I accounted for about 50% of endoscopic relapses. The symptomatic remission rates in the 20 mg group were estimated as 85% and 77% after 6 and 12 months, respectively; the corresponding values in the 40 mg group were 87% and 76%. No correlation was seen either between the endoscopically proven relapse and perception of symptoms, or between the severity of the pre-treatment stage of GORD and the maintenance dose of pantoprazole. Both doses were well tolerated. CONCLUSIONS: Both the 20 mg and 40 mg doses of pantoprazole are safe and effective in maintaining patients with healed reflux oesophagitis in remission. Moreover, for the majority of patients, the 20 mg dose provides adequate long-term therapeutic efficacy at a minimal drug exposure and lower costs.

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).