Gastrointestinal Symptom Scores Research Articles

Wirksamkeit und Unbedenklichkeit des Phytopharmakons STW 5 versus Metoclopramid bei funktioneller Dyspepsie unter Praxisbedingungen - eine retrolektive Kohortenstudie

The objective of this study was to assess the efficacy and safety of the phytopharmacon STW 5 versus metoclopramide in functional dyspepsia. A retrolective, epidemiological cohort study with parallel groups in 23 randomised centres where both drugs were used routinely was performed. The main outcome variable was improvement of 10 dyspepsia-specific symptoms of a valid gastrointestinal symptom score (GIS) during therapy. For inclusion, patients had to suffer from at least three of these symptoms before therapy. Secondary outcome variables were change of single symptoms, time till complete symptom relief, investigators' judgement of efficacy and tolerability, duration of inability to work and occurrence of adverse events. The per protocol collective comprised 490 STW 5 and 471 MCP patients. Anamnestic data were comparable. 439 of patients had taken MCP as drops. There was no relevant difference in median treatment duration. Significantly more patients were symptom-free after STW 5 treatment (71.6 vs. 62.8% p = 0,012). Additionally, the extent of symptom improvement (excluding nausea and vomiting) and median duration of inability to work (1 vs. 3 days) were significantly different in favour of STW 5. More physicians assessed STW 5 as effective (71.6 vs. 63.1% p<0.01) and very well tolerated (90 vs. 70.6% p<0.001). Adverse drug reactions were documented only under MCP. The present study illustrates a comparable to higher efficacy of STW 5 vs. MCP with better tolerability in treating functional dyspepsia under practice conditions, especially regarding complete symptom improvement, symptom duration and quality of life. The study confirms the results of prospective trials for STW 5 as being an appropriate alternative to the frequently administered antacids and prokinetics.

Preliminary Study of a Self-Administered Treatment for Irritable Bowel Syndrome: Comparison to a Wait List Control Group

Despite the accumulation of efficacy data for cognitive-behavioral treatment of Irritable Bowel Syndrome (IBS), efforts to investigate methods for increasing access to psychological treatments are in their infancy. The current study examined the efficacy of self-administered treatment in comparison to a wait list control. Twenty-eight participants monitored gastrointestinal (GI) symptoms and completed measures of quality of life (QOL) and psychological distress prior to randomized assignment to self-help treatment or wait list. Wait listed participants later received treatment. A 3 month post-treatment follow-up was included. Seven participants completed immediate treatment; nine the wait list. The self-help treatment significantly decreased composite GI symptom scores in comparison to the wait list, but did not lead to significant improvements in QOL or distress. In the entire treated sample, including wait list crossovers, analyses showed significant improvement in abdominal pain, average GI symptoms, and perceived health and well-being. Interpretation of these results should be considered in the context of several limitations, including small sample size, brief baseline symptom monitoring, and high drop out rate. Despite these limitations, this study is an important first step in empirically validating low-cost, self-administered treatments as a first line psychological intervention for IBS.

Predictors of Clinical Response to Gluten-Free Diet in Patients Diagnosed With Diarrhea-Predominant Irritable Bowel Syndrome

Gluten sensitivity might cause abdominal symptoms in the absence of villous atrophy. We examined the prevalence of celiac disease-associated serum antibodies in diarrhea-dominant irritable bowel syndrome (d-IBS) patients and their efficacy in combination with HLA-DQ2 expression to predict the response to gluten-free diet. HLA-DQA1*0501/DQB1*0201 expression and celiac disease-associated IgA and IgG serum antibodies against gliadin and tissue-transglutaminase were measured in 145 patients with d-IBS, 74 patients with untreated and treated celiac disease, and 57 patients with active IBD. Follow-up antibody levels, stool frequency, and gastrointestinal symptom scores were determined in 41 d-IBS patients (26 women, 15 men; median age, 46 years, range, 30-67 years) who participated in a nonrandomized evaluation of 6 months of gluten-free diet. Increased celiac disease-associated serum IgG, but not IgA, was found in the majority of patients with treated (55%) as in most patients with untreated celiac disease (97%). In d-IBS patients, celiac disease-associated serum IgG antibodies (37%) and HLA-DQ2 expression (39%) were more frequent than in IBD patients (18% and 23%, respectively). After 6 months of gluten-free diet, stool frequency and gastrointestinal symptom score returned to normal values in 60% of d-IBS patients who were positive and in 12% who were negative for HLA-DQ2 and celiac disease-associated serum IgG; both parameters combined yielded positive and negative predictive values of 56% (95% confidence interval, 30%-80%) and 88% (69%-97%), respectively. Celiac disease-associated serum IgG and HLA-DQ2 expression can identify likely responders to gluten-free diet in d-IBS patients.

The Influence of Alexithymia on Persistent Symptoms of Dyspepsia after Laparoscopic Cholecystectomy

The aim of this study was to evaluate whether preoperative alexithymia might play a role in the persistence of gastrointestinal symptoms after laparoscopic cholecystectomy. A sample of 52 consecutive patients with gallstone disease and symptoms of dyspepsia were assessed with validated scales for alexithymia (20-item Toronto Alexithymia Scale), and psychological (90-item Symptom Checklist) and gastrointestinal (GI) (Gastrointestinal Symptom Rating Scale) symptoms before surgery. GI symptoms were evaluated also one year after surgery. Change from preoperative to postoperative GI symptoms and level of GI symptoms after surgery were used to form groups of improved (n = 31) and unimproved (n = 21) patients. Unimproved patients had significantly higher preoperative alexithymia, psychological distress, and gastrointestinal symptom scores than patients who had improved. Regression analyses showed that alexithymia predicted the persistence of gastrointestinal symptoms more strongly than did psychological distress, even after controlling for preoperative gastrointestinal symptoms. Alexithymia played a substantial and predictive role in the persistence of GI symptoms in gallstone patients after surgery. Treatment planning and outcome of gallstone disease might be improved by preoperative assessment of alexithymia.

STW 5, a Phytopharmacon for Patients With Functional Dyspepsia: Results of a Multicenter, Placebo-Controlled Double-Blind Study

Functional dyspepsia (FD) constitutes a complex picture with a variety of epigastric symptoms. No standard therapy is currently available for FD. This multicenter, placebo-controlled, double-blind study evaluated the efficacy and tolerability of the herbal drug STW 5, mainly comprising a fresh plant extract from Iberis amara. Patients with FD were included. Gastrointestinal endoscopy, H. pylori-status, and a 7-day run-in phase were required. A total of 315 patients were treated with 3 x 20 drops/day of either STW 5 or placebo. Symptom assessment: day 0, 2, 4, and 8 wk of treatment. The principal outcome criterion was the change in a validated Gastrointestinal Symptom Score (GIS). Symptom severity was rated using the Likert scale. A total of 315 patients remained in the safety population. Of them, 158 were treated with STW 5 and 157 with placebo. The intention-to-treat population comprised 308 patients. Dropout number was similar in both groups. GIS showed improvement during the treatment period. The STW 5 group improved 6.9+/-4.8 points up to day 56, placebo group by 5.9+/-4.3 (P<0.05). H. pylori did not influence the results. Drug tolerability and safety were similar in both groups. This placebo-controlled study with an 8-wk treatment period documents the efficacy of STW 5 in FD.

Transcutaneous Electrical Nerve Stimulation (TENS) Improves Upper GI Symptoms and Balances the Sympathovagal Activity in Scleroderma Patients

To assess the impact of transcutaneous electrical nerve stimulation (TENS) at gastrointestinal (GI) acupoints on GI symptoms and quality of life in scleroderma patients, 17 patients filled out SF-36 and GI symptom questionnaires before the electrocardiogram was recorded for two intervals: baseline and TENS. At home, patients applied TENS for 14 days, then were reassessed. Acutely, TENS application significantly increased sympathetic and vagal activities vs. baseline (P=0.02 and P=0.004), respectively. Prolonged TENS application normalized the sympathovagal balance (P=0.04), decreased GI symptom scores (P=0.02) and increased the physical functioning score (SF36), which strongly correlated with the change in the sympathovagal balance (r=0.6, P=0.02). In conclusion, TENS at GI acupoints offers a potential option in the treatment of upper GI symptoms, but further study is necessary.

Internet-based assessment of bowel symptoms and quality of life

We wished to determine the value of an open-access internet questionnaire for assessment of upper and lower gastrointestinal symptoms and health-related quality of life. Between January 2002 and June 2005, a symptom scale for upper gastrointestinal and lower gastrointestinal symptoms was placed on a genuine website (www.gesundheits-umfrage.de) and linked to the website of the German irritable bowel syndrome patient group (www.Reizdarmselbsthilfe.de). Patients were asked to report gastrointestinal symptoms that had occurred during the last month. Patients who finished this symptoms questionnaire and acknowledged more than two of a total of eight upper gastrointestinal symptoms and/or more than two of 16 lower gastrointestinal symptoms were immediately offered the assessment of their health-related quality of life by a validated general quality of life scale--the patient general well-being inventory--a 22-item scale with six subscales (anxiety, depression, general well-being, self-control, health, and vitality) and a global scale. Total patient general well-being inventory scores and subscale values were correlated to upper gastrointestinal and lower gastrointestinal symptom scores including the Rome I definition of the irritable bowel syndrome, and to social variables. Five thousand two hundred and fifty-six individuals completed symptom assessment. Out of these, 4431 had three or more upper gastrointestinal symptoms, the mean number of upper gastrointestinal symptoms reported was 3.2+/-2.0; 4456 had three or more lower gastrointestinal symptoms (mean: 10.3+/-3.3), and 3187 met the Rome I criteria for irritable bowel syndrome. A total of 3316 individuals completed the patient general well-being inventory assessment (1156 men, 2160 women, mean age: 37.7+/-12.3 years). Upper gastrointestinal, lower gastrointestinal, and total symptom score were higher in women than in men (P < 0.001), and significantly correlated to the global quality of life assessment. Family status affected the symptom scores (higher in singles) and quality of life scores (lower in people living in partnership for health, but higher for vitality and depression). Age correlated negatively with upper gastrointestinal, lower gastrointestinal, and with total symptom scores as well as with some patient general well-being inventory scores. Symptom and quality of life assessment using an open internet questionnaire is feasible and generates data which are, in large, comparable to those from other sources of assessment, despite the fact that the population addressed is, on average, moderately younger than previously studied cohorts.

Does laparoscopic Nissen fundoplication lead to chronic gastrointestinal dysfunction?

Laparoscopic Nissen fundoplication (LNF) efficiently controls the symptoms of gastroesophageal reflux disease (GERD); however, other nonspecific gastrointestinal (GI) symptoms have been reported following LNF. The aim of this study was to evaluate the long-term effects of LNF on nonspecific GI complaints. The basis for this study is the prospective follow-up of 515 patients (mean age 46 +/- 13 years) who underwent a LNF between 1992 and 1998. A questionnaire was designed to evaluate GERD symptoms (i.e., heartburn, epigastric pain, regurgitation, dysphagia, and fullness, score 0-60) and nonspecific GI symptoms (i.e., vomiting, diarrhea, constipation, and lack of appetite, score 0-48). Patients were assessed before surgery, at 6 months, 2 years, and 5 years after surgery. Laparoscopic Nissen fundoplication was associated with a significant decrease in both GERD and nonspecific GI symptoms score at 6 months and up to 5 years, in the whole group (p < 0.001). 360 patients (69.7%) had preoperative nonspecific GI symptoms and experienced a significant reduction in these symptoms following the surgery and lasting up to 5 years. The other 155 patients (30.3%) had no preoperative GI symptoms (GI symptoms score of 0). In this group, there was a small but statistically significant increase in GI symptoms score (p < 0.001). It was, however, clinically significant (defined as a score >12) in only 9.9% of the patients. Laparoscopic Nissen fundoplication provides an efficient treatment of GERD up to 5 years, and in a majority of patients, it is not associated with any significant increase in nonspecific GI complaints. New nonspecific bowel symptoms can develop after LNF in some patients but are unlikely to be clinically significant.

Conversion from mycophenolate mofetil to enteric-coated mycophenolate sodium in patients with gastrointestinal side effects: case studies

The potential benefit of the current mycophenolic acid, mycophenolate mofetil, has not yet been fully achieved in clinical transplantation because of its gastrointestinal side effects. Dose splitting, dose reduction, and drug discontinuation are strategies that are used to manage gastrointestinal symptoms. However, recently reported registry data suggest these alterations result in inadequate graft protection, leading to increased late acute rejection rates and decreased longterm graft survival. To investigate the potential use of the new enteric-coated formulation of mycophenolic acid therapy, mycophenolate sodium, and its suggested improved side effects profile. Five patients who previously had or were currently experiencing gastrointestinal side effects while taking mycophenolate mofetil were selected at random. These patients were initially switched to an equimolar dose of enteric-coated mycophenolate sodium. An increase in mycophenolate sodium doses was attempted according to symptoms. Changes in kidney function and gastrointestinal symptom scores were recorded before and after conversion. No episodes of acute rejection were observed in any patients during or after conversion. All patients experienced an overall improvement in gastrointestinal symptom scores following conversion, and an increase in mycophenolate sodium dose was achieved in 1 patient.

Conversion from Mycophenolate Mofetil to Enteric-Coated Mycophenolate Sodium in Patients with Gastrointestinal Side Effects: Case Studies

The potential benefit of the current mycophenolic acid, mycophenolate mofetil, has not yet been fully achieved in clinical transplantation because of its gastrointestinal side effects. Dose splitting, dose reduction, and drug discontinuation are strategies that are used to manage gastrointestinal symptoms. However, recently reported registry data suggest these alterations result in inadequate graft protection, leading to increased late acute rejection rates and decreased longterm graft survival. To investigate the potential use of the new enteric-coated formulation of mycophenolic acid therapy, mycophenolate sodium, and its suggested improved side effects profile. Five patients who previously had or were currently experiencing gastrointestinal side effects while taking mycophenolate mofetil were selected at random. These patients were initially switched to an equimolar dose of enteric-coated mycophenolate sodium. An increase in mycophenolate sodium doses was attempted according to symptoms. Changes in kidney function and gastrointestinal symptom scores were recorded before and after conversion. No episodes of acute rejection were observed in any patients during or after conversion. All patients experienced an overall improvement in gastrointestinal symptom scores following conversion, and an increase in mycophenolate sodium dose was achieved in 1 patient.

4 Gastric electrical stimulation for gastroparesis: experience with higher settings

Introduction: Gastric electrical stimulation is a safe and efficient treatment option in medically refractory gastroparesis. Several controlled and open label trials have shown the effectiveness of gastric electrical stimulation in symptom palliation for patients with gastroparesis. Initial settings were established based on experiences in the animal model. We reviewed our experience using higher stimulator settings on symptom reduction after implantation of gastric electrical stimulators.Methods: 42 consecutive patients (38 females and 4 males, mean age 43 ± 1.8 years) with medically refractory gastroparesis were followed after implantation of gastric electrical stimulator between 1999 and 2005. The 42 patients included 29 patients with idiopathic gastroparesis and 13 patients with diabetic gastroparesis Baseline stimulation settings were 14 Hz, 5 mAmps, 330 micro‐sec pulse width, 0.1 sec on, and 5 sec off. At each follow‐up gastrointestinal symptom scores were assessed. If symptoms were unsatisfactory, stimulator settings were increased according to a standardized protocol. Dose response relationships were evaluated.Results: After a mean follow‐up of 19 ± 2.6 months, 83% of patients had higher settings (p &lt; 0.001, Fisher's exact test). Solid gastric emptying time during this period decreased from 195 ± 45 to 106 ± 38 minutes (T1/2 value, p &lt; 0.05, paired t‐test) along with an average weight change from 64 ± 5.3 to 62 ± 5.6 kg (p &gt; 0.05, paired t‐test). There were 258 stimulator interrogations with a stepwise improvement in total symptom score (R2 = 0.08, p &lt; 0.001). Multivariate regression analysis showed that frequency of electric stimulation was independently associated with improvement of total symptom score (R2 = 0.06, p &lt; 0.02). A prolonged cycle on time correlated with worsening of nausea score (R2 = 0.09, p &lt; 0.02) and vomiting score (R2 = 0.13, p &lt; 0.001). A measurement of high impedance independently correlated with a low vomiting score (R2 = 0.19, p &lt; 0.0001). Though not statistically significant, most patients’ symptoms were optimized at mean current of 10 mAmps, frequency of 55 Hz, pulse width of 330 micro‐sec, cycle on time of 0.1 sec, and cycle off time of 1 sec.Conclusion: The majority of patients seem to benefit from higher than baseline settings. Optimal settings of the implanted device must be determined on an individual basis, but based upon experience in humans seem to be 10 mAmps, 55 Hz, 0.1 sec on, 0.4 to 1 sec off.

46 The feasibility of duodenum electrical stimulation to produce gastrointestinal symptoms in a clinical trial

Introduction: Proximal duodenal electrical stimulation with various energy parameters has been investigated as a possible treatment for various gastrointestinal (GI) myoelectrical diseases. Wide pulse width (millisecond) stimulation in the proximal duodenum can disrupt or entrain the normal myoelectrical rhythm and provide a potential feedback pathway to alter normal gastric function such as emptying, fundus tone, and intra‐gastric pressure and subsequently produce specific symptoms that could affect eating behaviors. A specific level of electrical stimulation is necessary to elicit symptoms and serve as an indicator that energy parameters are adequate. However, there has been no published data correlating electrical threshold stimulation with symptom characterization. The goal of this study was to determine the average minimum pulse width necessary to elicit GI symptoms.Methods: Eight patients underwent endoscopic placement of intraluminal electrodes in the proximal duodenum. Each patient received electrical stimulation in the millisecond (ms) range starting with a pulse width of 100 ms that was increased by intervals of 100 ms up to a maximum pulse width of 500 ms. The pulse repetition frequency was fixed at 12 CPM and each regimen was repeated for amplitudes ranging from 2 milliamps (mA) to 10 mA. Gastrointestinal symptom scores consisting of nausea, vomiting, satiety, fullness, pain, bloating and other, were taken at baseline and after each regimen change.Results: There was an average minimum threshold necessary for elicitation of symptoms (293.7 + 41.7 ms, p‐value = 0.063). The three most frequently reported GI symptoms were crampy abdominal pain, fullness, and bloating.Conclusions: Electrical stimulation of the duodenum is feasible. A certain minimum threshold of duodenal electrical stimulation is necessary to elicit GI symptoms in patients. The intensity and patient tolerability of each specific GI symptom was able to be adjusted by changing a certain energy parameter within a regimen. Further research is warranted to evaluate the ability of duodenal electrical stimulation to produce GI symptoms that may alter eating behaviors.

Quality Indicators for Colonoscopy

The optimal approach for management of patients with dyspepsia has not been determined. The aim of this study was to compare the efficacy of three strategies for management of dyspepsia: empirical antisecretory therapy, testing for Helicobacter pylori (H. pylori), or a combination of the two.Cluster-randomized trial in general practices. Initial treatment with proton pump inhibitor (PPI) was performed in 222 patients, H. pylori test-and-eradicate in 250 patients, and PPI followed by H. pylori-testing if symptoms improved in 250 patients. Symptoms, quality of life, patient satisfaction, and use of resources were recorded during a 1-yr follow-up.The prevalence of H. pylori infection was 24%. We found no difference among the three strategies (p=0.16) in terms of the proportion of days without dyspeptic symptoms. After 1 yr gastrointestinal symptom scores and quality-of-life scores had improved significantly and equally in the three groups (p<0.001), but no statistically significant differences were found among the groups. The mean use of endoscopies per patient after 1 yr was higher in the PPI group (0.36 [95% CI 0.30-0.43]) than in the test-and-eradicate group (0.28 [95% CI 0.23-0.34]) and the combination group (0.22 [95% CI 0.17-0.27]), p=0.02. H. pylori-positive patients given eradication therapy had more days without dyspeptic symptoms (p<0.001), used less antisecretory therapy (p<0.01), and were more satisfied (p<0.001) than H. pylori-negative patients.The strategies based on H. pylori test enjoyed similar symptom resolution, but reduced endoscopic workload and lower 1-yr total costs compared with empirical antisecretory therapy.

Impaired gastric motility and its relationship to gastrointestinal symptoms in patients with chronic renal failure

Gastrointestinal (GI) symptoms are common in patients with chronic renal failure (CRF), but the pathogenesis of these symptoms is unclear. Gastric motor function in CRF patients remains controversial, and the correlation between GI symptoms and gastric motility is also unclear. The aim of this study was to elucidate the relationship between gastric motility and GI symptoms in patients with CRF. Gastric motility was evaluated with cutaneously recorded electrogastrographs (EGGs) and gastric emptying of a solid meal, using 13C-octanoic acid breath testing, in 21 patients with predialysis endstage CRF and in 21 matched healthy controls. GI symptom severity was quantified in all patients. The CRF patients had a significantly lower incidence of normogastria postprandially and a lower power ratio than did healthy controls on the EGGs, with the CRF patients showing delayed gastric emptying. Three patients with normal gastric motility had no GI symptoms, and ten patients with both abnormal EGG and delayed gastric emptying had significantly higher GI symptom scores than the patients without abnormalities. The patients with CRF showed gastric hypomotility, including impaired gastric myoelectrical activity and delayed gastric emptying. Gastric hypomotility appears to be an important factor in the generation of GI symptoms in patients with CRF.

Global endpoints in functional gastrointestinal disease

Sirs, We read the article by Adam et al.1 with great interest. Proper selection of an endpoint is a key determinant for a successful clinical trial. As discussed in the paper, the Gastrointestinal Symptom Score (GIS) appears to be a valuable new tool for the clinical assessment of symptom severity among patients with functional dyspepsia. Methods for the development and initial psychometric evaluation of the GIS as reported are generally consistent with standard approaches. However, we are concerned with the implication that the GIS is superior to global response ratings for assessing treatment response when, in fact, the GIS has not been directly compared with a global rating. Patient-reported global assessments of change in symptom severity measure are both critical for the assessment of treatment response and distinct from clinician-administered measures such as the GIS. In particular, global measures allow patients to weigh the relative importance of their various symptoms when providing a response. The use of a simple sum score for the GIS assumes that each of the 10 items is of equal importance, which is unlikely to be the case. For example, we expect that many patients would be more bothered by ‘vomiting’ than ‘loss of appetite’, but each of these items is given equal weight in the GIS. An additional concern regarding scoring of the GIS is that the authors’ factor analysis revealed ‘four independent factors’ and the number of items per factor was not consistent. As a result, several factors or domains are given greater weight than others in the computation of the total score. Therefore, either further justification or modification of the GI scoring algorithm is warranted, including a comparison of model fit between the one-factor model implied by the current algorithm and the four-factor model described in the paper, as well as an assessment of internal consistency. We also consider it a great benefit to have patients directly assess changes in the severity of their symptoms in response to treatment. Treatment response data collected within the context of a clinical interview, as required for completion of the GIS, are subject to bias in several regards – not only is a patient likely to want to please the clinician by reporting improvements, but clinicians also want to see their patients’ symptoms alleviated. The utilization of self-completed assessments greatly minimizes, if not eliminates, these potential sources of bias. While the GIS could be adapted for self-completion, additional psychometric evaluation would be required. There are several general methods for evaluating responsiveness or the sensitivity of an instrument to change. One is to compare the scores of responders and non-responders as described in Adam et al.;1 the other is to compare the scores of patients who receive an active or superior treatment to those who receive placebo or an inferior treatment. The latter method is preferred when assessing an instrument intended for use in clinical trials. While bias due to interviewer administration of the GIS may have minimal impact on the method utilized by Adam et al.,1 this potential source of measurement error is more likely to limit the ability of the GIS to demonstrate differences among treatment groups by inflating the rate of placebo response. Therefore, we recommend that the authors utilize the clinical trial data described in their study to evaluate whether or not the GIS is sensitive to differences between patients treated with STW 5 and placebo and supplement their previous responsiveness analysis. Although the GIS appears to be a well-developed and useful tool, it is not appropriate to declare it ‘valid’ based on a single evaluation. Instead, instrument validation is considered ‘an ongoing process of conducting various studies to confirm various hypotheses regarding the internal structure of the construct and its relationships with other variables’.2 A patient-reported global assessment of change in symptom severity is a critical component of any evaluation of a new treatment for a condition that relies on patients’ reports of symptoms, such as functional dyspepsia. Indeed, in a condition related to functional dyspepsia, irritable bowel syndrome, the global endpoint of ‘adequate relief’ fulfils many of the validation criteria described in the present study. Adequate relief responses repeatedly produce the same result (test–retest reliability), are able to detect clinically relevant changes (responsiveness), and move in the same direction as other meaningful measures (convergent validity).3-6 The adequate relief endpoint has also been used in a therapeutic trial of functional dyspepsia and was able to show statistically significant benefit over placebo.7

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.

Validation of the gastrointestinal symptom score for the assessment of symptoms in patients with functional dyspepsia

To validate the gastrointestinal symptom score as an outcome measure for functional dyspepsia. In focus groups, 10 dyspepsia-specific items including nausea, sickness, vomiting, bloating, abdominal cramps, early satiety, acidic eructation/heartburn, loss of appetite, retrosternal discomfort, epigastric pain/upper abdominal pain were identified. Ninety-five patients with functional dyspepsia and 56 healthy controls were recruited and responsiveness evaluated by analysing gastrointestinal symptom score data from 357 patients from previous placebo-controlled trials. Gastrointestinal symptom score response data were correlated with the patient's global assessments of efficacy. Convergent validity was assessed by correlating the gastrointestinal symptom score with the results obtained by the Nepean Dyspepsia Index. Sensitivity: In patients and healthy controls gastrointestinal symptom score yielded consistently different scores (all P < 0.0001). TEST-RETEST RELIABILITY: Gastrointestinal symptom score determined at the two time points were significantly correlated (r-values ranging from 0.842 to 0.901). CONVERGENCE VALIDITY: Gastrointestinal symptom score of both rating groups were significantly correlated with the symptom-specific component of the Nepean Dyspepsia Index (r-vales ranging from 0.666 to 0.764, P < 0.01). RESPONSIVENESS: Responses of gastrointestinal symptom score during treatment were different for patients with a global self assessment as responders compared with non-responders (all P < 0.0055). The gastrointestinal symptom score is a valid and reliable instrument to assess symptom intensities in patients with functional dyspepsia.

Pilot Study on Gastric Electrical Stimulation on Surgery-associated Gastroparesis: Long-term Outcome

Patients with postgastric surgery gastroparesis are often unresponsive to conventional medical therapy. Gastric electrical stimulation (GES) with the use of high-frequency and low-energy neural stimulation is an approved technique for patients with idiopathic and diabetic gastroparesis. We hypothesized that GES would improve symptoms, health resource utilization, and gastric emptying in six patients with postsurgical gastroparesis from a variety of surgical procedures. Patients were evaluated by means of the following criteria: symptoms, health-related quality of life, and gastric emptying tests at baseline over time. All patients noted improvements after device implantation for up to 46 months: the frequency score for weekly vomiting went from a baseline of 3.2 down to 0.4 immediately after treatment before settling at 1.4 by the long-term follow up. Total gastrointestinal symptom score went from 36.5 at baseline down to 12.3 before settling at 20.5 at long-term follow up. Improvements were also seen in health-related quality of life and solid and liquid gastric emptying. We conclude that GES is associated with clinical improvements in this group of patients with either postsurgical or surgery-associated gastroparesis. This pilot study with long-term outcomes offers evidence for a new therapy for otherwise refractory patients with gastroparesis associated with previous surgery.

Randomized clinical trial of laparoscopic Nissen fundoplication compared with proton-pump inhibitors for treatment of chronic gastro-oesophageal reflux

Both laparoscopic Nissen fundoplication (LNF) and proton-pump inhibitor (PPI) therapy are established in the treatment of gastro-oesophageal reflux disease (GORD). The aim of this study was to compare these two treatments in a randomized clinical trial. Between July 1997 and August 2001, 340 patients with a history of GORD for at least 6 months were investigated by endoscopy, 24-h pH monitoring and manometry. Of these, 217 were randomized, 109 to LNF and 108 to PPI therapy. The two groups were well matched for age, sex, weight and severity of reflux. Twenty-four-hour pH monitoring and manometry were performed 3 months after treatment, and quality of life was assessed in both groups using the Psychological General Well-being Index and the Gastrointestinal Symptom Rating Scale at 3 and 12 months after treatment. At 3 months there was an improvement in lower oesophageal sphincter pressure from 6.3 to 17.2 mmHg in the LNF group but no change in the PPI group (8.1 and 7.9 mmHg before and after treatment respectively) (P < 0.001). The mean DeMeester acid exposure score improved from 42.7 to 8.6 (P < 0.001) in the LNF group and from 36.9 to 17.7 in the PPI group (P < 0.001). The mean gastrointestinal symptom and general well-being scores improved from 31.7 and 95.4 respectively before treatment to 37.0 and 106.2 at 12 months after LNF, compared with changes from 34.3 and 98.5 to 35.0 and 100.4 respectively in the PPI group. The differences in both of these scores were significant between the two groups at 12 months (P = 0.003). LNF leads to significantly less acid exposure of the lower oesophagus at 3 months and significantly greater improvements in both gastrointestinal and general well-being after 12 months compared with PPI treatment.

Improvements with Esomeprazole in Patients with Upper Gastrointestinal Symptoms Taking Non-Steroidal Antiinflammatory Drugs, Including Selective COX-2 Inhibitors

Upper gastrointestinal (GI) symptoms are common in patients using non-steroidal antiinflammatory drugs (NSAIDs) including selective cyclooxygenase (COX)-2 inhibitors and may be acid related. We therefore assessed esomeprazole treatment for upper GI symptoms in these patients. A total of 794 and 848 continuous NSAID users, free of gastroduodenal ulcers, erosive esophagitis, and Helicobacter pylori, were enrolled into two identical, multinational, multicenter double-blind studies (NASA1, SPACE1). Moreover, 608 and 556 patients were randomized to receive 4 wk esomeprazole 20 mg, or 40 mg, or placebo once daily. The primary variable was the patient-reported change in the upper GI symptom (pain, discomfort, or burning in the upper abdomen) score on a 7-graded severity scale (0-6) from the 7 days prior to treatment to the last 7 days in the study. Esomeprazole was associated with highly significant symptom improvement compared to placebo. Symptom improvements were 2.30 mean [SD 1.63] on esomeprazole 20 mg and 2.03 [1.56] on esomeprazole 40 mg versus 1.64 [1.57] on placebo in NASA1 and 2.17 [1.34] and 2.12 [1.48]versus 1.56 [1.26], respectively, in SPACE1 (all placebo comparisons at least p < 0.001). Esomeprazole-improved symptoms in patients taking selective COX-2 inhibitors, with changes of 2.21 [1.46] and 1.92 [1.38]versus 1.64 [1.46] in NASA1 and 2.20 [1.26] and 2.24 [1.62]versus 1.58 [1.37] in SPACE1 (all placebo comparisons at least p < 0.05), as well as those on non-selective NSAIDs. Esomeprazole was well tolerated and associated with significant improvements in HRQL. Esomeprazole 20 mg and 40 mg improve upper GI symptoms associated with continuous, daily NSAID therapy, including selective COX-2 inhibitors.