The selective serotonin reuptake inhibitor fluoxetine does not change rectal sensitivity and symptoms in patients with irritable bowel syndrome: a double blind, randomized, placebo-controlled study. Clinical and functional evaluation of the efficacy of otilonium bromide: a multicenter study in Italy. Clinical trial: the effect of amitriptyline in patients with diarrhoea-predominant irritable bowel syndrome. [Treatment of irritable bowel syndrome with peppermint oil. A double-blind study with a placebo]. Treatment of irritable bowel syndrome with lorazepam, hyoscine butylbromide, and ispaghula husk. Symptom relief with amitriptyline in the irritable bowel syndrome. The effect of fluoxetine in patients with pain and constipation-predominant irritable bowel syndrome: a double-blind randomized-controlled study. Oral cimetropium bromide, a new antimuscarinic drug, for long-term treatment of irritable bowel syndrome. Is bran efficacious in irritable bowel syndrome? A double blind placebo controlled crossover study. [The value of adding an antispasmodic musculotropic agent in the treatment of painful constipation in functional colopathies with bran. Double-blind study]. Otilonium bromide in irritable bowel syndrome: a double-blind, placebo-controlled, 15-week study. Irritable colon and depression. Treatment of the irritable bowel syndrome with Bentyl (dicyclomine hydrochloride). Enteric-coated peppermint-oil capsules in the treatment of irritable bowel syndrome: a prospective, randomized trial. A double-blind, randomized, placebo-controlled trial of paroxetine controlled-release in irritable bowel syndrome. Double blind study of ispaghula in irritable bowel syndrome. A controlled crossover study of the selective serotonin reuptake inhibitor citalopram in irritable bowel syndrome. A clinical trial of trimebutine (Mebutin) in spastic colon. Irritable bowel syndrome: assessment of psychological disturbance and its influence on the response to fibre supplementation. The effect of trimipramine in patients with the irritable bowel syndrome. A double-blind study. Effects of a high-fiber diet on symptoms of irritable bowel syndrome: a randomized clinical trial. Irritable bowel syndrome treatment using pinaverium bromide as a calcium channel blocker. A randomized double-blind placebo-controlled trial. Antidepressant therapy (imipramine and citalopram) for irritable bowel syndrome: a double-blind, randomized, placebo-controlled trial. Double blind trial of ispaghula/poloxamer in the Irritable Bowel Syndrome. [Pinaverium bromide and functional colonic disease (double-blind study]. Double blind trial of trimebutine in the irritable bowel syndrome. Alverine citrate fails to relieve the symptoms of irritable bowel syndrome: results of a double-blind, randomized, placebo-controlled trial. Longterm treatment of irritable bowel syndrome with cimetropium bromide: a double blind placebo controlled clinical trial. A double-blind trial of the effect of wheat bran on symptoms of irritable bowel syndrome. [The treatment of irritable colon. Efficacy and tolerance of buscopan plus, buscopan, paracetamol and placebo in ambulatory patients with irritable colon]. Prifinium bromide in the treatment of the irritable colon syndrome. Cognitive-behavioral therapy versus education and desipramine versus placebo for moderate to severe functional bowel disorders. Psyllium therapy in the irritable bowel syndrome. A double-blind trial. Paroxetine to treat irritable bowel syndrome not responding to high-fiber diet: a double-blind, placebo-controlled trial. Different therapeutic regimens in irritable bowel syndrome. Effects of cimetropium bromide on gastrointestinal transit time in patients with irritable bowel syndrome. Ispaghula therapy in irritable bowel syndrome: improvement in overall well-being is related to reduction in bowel dissatisfaction. Peppermint oil (Mintoil) in the treatment of irritable bowel syndrome: a prospective double blind placebo-controlled randomized trial. The non-effect of pirenzepine in dietary resistant irritable bowel syndrome. Randomised-controlled trial of a fibre supplement on the symptoms of irritable bowel syndrome. Comparison of the therapeutic effect of wheat bran, mebeverine and placebo in patients with the irritable bowel syndrome. Double-blind placebo-controlled trial of amitriptyline for the treatment of irritable bowel syndrome in adolescents.
Although widely prescribed, the evidence for the use of antidepressants for the treatment of irritable bowel syndrome (IBS) is limited. In this study, we hypothesized that fluoxetine (Prozac), a selective serotonin reuptake inhibitor, has visceral analgesic properties, leading to increased sensory thresholds during rectal distention and improvement of symptoms, in particular in IBS patients with visceral hypersensitivity.
                Forty non-depressed IBS patients underwent a rectal barostat study to assess the sensitivity to rectal distention before and after 6 weeks of treatment with fluoxetine 20 mg or placebo. Abdominal pain scores, individual gastrointestinal symptoms, global symptom relief, and psychologic symptoms were assessed before and after the intervention.
                At baseline, 21 of 40 patients showed hypersensitivity to rectal distention. Fluoxetine did not significantly alter the threshold for discomfort/pain relative to placebo, either in hypersensitive (19 +/- 3 vs. 22 +/- 2 mm Hg above MDP) or in normosensitive (34 +/- 2 vs. 39 +/- 4 mm Hg above MDP) IBS patients. Overall, 53% of fluoxetine-treated patients and 76% of placebo-treated patients reported significant abdominal pain scores after 6 weeks (not significant). In contrast, in hypersensitive patients only, fluoxetine significantly reduced the number of patients reporting significant abdominal pain. Gastrointestinal symptoms, global symptom relief, and psychologic symptoms were not altered.
                Fluoxetine does not change rectal sensitivity in IBS patients. Possible beneficial effects on pain perception need to be confirmed in larger trials. Seventy-two patients complaining of abdominal pain were studied in a double blind trial with otilonium bromide (OB) (40 mg tid or placebo). In our patients we performed, before and after the treatment, a clinical evaluation (symptom variations) and functional studies (sigmoid manometry during bowel distension). As regards clinical parameters, otilonium bromide significantly reduced abdominal pain and bloating and significantly increased (p less than 0.02) the pain threshold. However the comparison with the placebo group did not show any difference between the two groups. Sigmoid motility during distension was significantly reduced (p less than 0.05) in OB group, whereas it did not change in the placebo group. We can conclude that, in irritable bowel syndrome (IBS) patients, OB is able to improve symptoms and to reduce stimulated motor activity of the sigmoid. Irritable bowel syndrome is the most common disorder diagnosed by gastroenterologists. Although several randomized-controlled trials have assessed the therapeutic role of antidepressant drugs, there is insufficient evidence to support their use.
                To compare the effects of low-dose amitriptyline in the treatment of diarrhoea-predominant irritable bowel syndrome in a double-blind randomized-controlled trial.
                Fifty-four patients who fulfilled Rome II criteria for diarrhoea-predominant irritable bowel syndrome were included in this study. Organic causes were ruled out by standard laboratory and radiological tests, and rectosigmoidoscopy. Patients were randomly assigned to receive either 10 mg amitriptyline daily or placebo. Subjects were followed up for 2 months and symptoms were assessed using a questionnaire. Intention-to-treat and per-protocol analysis was performed.
                Fifty patients completed the study. At 2 months, the amitriptyline group showed greater (P < 0.05) reduction in the incidence of loose stool and feeling of incomplete defecation. Patients receiving amitriptyline showed greater complete response, defined as loss of all symptoms, compared with those receiving placebo (68% vs. 28%, P = 0.01). Adverse effects were similar between the two groups.
                Amitriptyline may be effective in the treatment of diarrhoea-predominant irritable bowel syndrome and at low dose is well tolerated. nan A double-blind controlled therapeutic trial of factorial design was used to study the therapeutic effects of lorazepam, hyoscine butylbromide, and ispaghula husk in 12 randomised blocks of eight patients with the irritable bowel syndrome (IBS). Each of the three agents caused a sustained symptomatic improvement in some of the patients, although only with ispaghula was the difference between the real and dummy preparation statistically significant. When the eight possible combinations of treatment were analysed none of the 12 patients who received only dummy preparations of the three agents had maintained any improvement over the three months of the trial. Seven patients improved among the 12 who received potent preparations of all three agents, and between four and six patients improved in the groups receiving one or two of the potent preparations. These therapeutic results, though far from perfect, show that the types of drug commonly used to treat IBS are of some value and may be additive in their effects. Similar combinations of other therapeutic agents may be more effective, but it will be possible to determine this only by carrying out factorial therapeutic trials. Anti-depressants have been reported to be useful in the management of the Irritable Bowel syndrome. We studied the efficacy of amitriptyline for 12 weeks in a randomized double-blind placebo-controlled trial. Forty patients who met predefined criteria entered the trial. They received 25 mg amitriptyline for the first week, 50 mg for the second week and 75 mg nightly thereafter until the end of the 12th week. The drug and placebo groups were comparable in all major pretreatment variables. Amitriptyline was found to be significantly more effective than placebo in producing global improvement, increasing feelings of well-being, reducing abdominal pain and increasing satisfaction with bowel movements. Younger age and increasing extroversion predicted a better response to amitriptyline. Severity of depressive and anxiety symptoms and other personality variables did not influence outcome. Irritable bowel syndrome has been treated with selective serotonin reuptake inhibitors but there is not enough evidence from controlled trials to prove their effectiveness.
                To compare the effects of fluoxetine and placebo in the treatment of pain and constipation-predominant irritable bowel syndrome in a double-blind randomized-controlled trial.
                Forty-four cases meeting Rome II criteria for irritable bowel syndrome with predominance of pain and constipation were included in this study. Organic causes were ruled out by detailed history, physical examination, laboratory tests and colonoscopy. Participants were then randomly assigned to receive either fluoxetine or placebo for 12 weeks. Symptoms addressed by the Rome II criteria were recorded during treatment and 4 weeks after termination of treatment.
                Fluoxetine was significantly more effective than placebo in decreasing abdominal discomfort, relieving feeling and sense of bloating, increasing frequency of bowel movements and decreasing consistency of stool. Mean number of symptoms per patient decreased from 4.6 to 0.7 in the fluoxetine group vs. 4.5 to 2.9 in controls (P < 0.001).
                Fluoxetine is an effective and well-tolerated short-term treatment for pain and constipation-predominant irritable bowel syndrome. Most drugs are ineffective for the long-term treatment of irritable bowel syndrome (IBS). The beneficial effects of medical treatment of IBS are poor and last for only a relative short time. Over a period of 6 months, we investigated the effectiveness of cimetropium bromide, a new antimuscarinic compound, in patients with IBS. Forty-eight patients were treated at random and in double-blind fashion with cimetropium bromide (50 mg, tid) or placebo for 6 months. Personal diary cards and monthly check-ups guaranteed the monitoring of symptoms (mainly pain). In addition, personality patterns (MHQ-CBA tests) were obtained for the patients before and after therapy, both to detect possible psychoneurotic traits and to observe the changes in these traits in relation to the changes in pain symptoms. Three patients on placebo and one on cimetropium dropped out. At the end of therapy, pain scores had decreased an average of 16% in the placebo group and 87% in the cimetropium group (p less than 0.01). Twenty patients (87%) on cimetropium versus five patients (24%) on placebo considered themselves to be globally improved (p less than 0.01). The MHQ test showed significant improvement in the anxiety score in the cimetropium group only. The CBA test confirmed a significant decrease in anxiety state (STAI-X-1) after cimetropium treatment. Eleven patients (48%) on cimetropium reported side effects (mainly dry mouth and sleepiness), but none withdrew from the study. The results of this trial indicate that long-term treatment of IBS with cimetropium bromide significantly improves symptoms and associated psychological disorders. Twenty eight patients with classical irritable bowel syndrome completed a double blind placebo controlled crossover trial in which they added to their normal diet a daily supplement of either 12 bran biscuits (1 = 1.3 g fibre) or 12 placebo biscuits (1 = 0.23 g fibre). Each biscuit was given for three months in random order with crossover to the alternative biscuit at three months. After the initial three months therapy, there was a significant symptomatic improvement compared with pretreatment in both the bran treated (p less than 0.01) and placebo treated groups (p less than 0.01), but there was no significant difference in symptom scores between these two groups. There was no further improvement in either group after the second three months treatment with the alternative therapy. When crossover data for all 28 subjects were combined, symptoms scores after three months bran therapy and after three months placebo therapy did not differ significantly. Twenty four patients completed three day stool collections in both treatment periods. When the symptomatic response to bran among 15 subjects in whom stool weights rose on bran was compared with that among nine subjects whose stool weights were static or fell on the bran, it was shown that symptomatic improvement was independent of an increase in stool weight. These data suggest that in irritable bowel syndrome, especially that associated with abdominal pain, the beneficial effects of bran are due to a placebo response which is independent of an increase in stool weight. nan To evaluate the efficacy of otilonium bromide, a spasmolytic agent, in the treatment of irritable bowel syndrome using modern and validated diagnostic criteria.
                Three hundred and seventy-eight patients with irritable bowel syndrome were enrolled in the study. At entry, endoscopy/barium enema, clinical examination and laboratory tests were used to rule out organic diseases. After a 2-week placebo run-in, 325 patients were randomly assigned to receive either otilonium bromide 40 mg t.d.s. or placebo for 15 weeks. Abdominal pain, abdominal distension and disturbed defecation were scored at the beginning of the study and every 5 weeks. A global determination of well-being by visual analogue scale and the tenderness of the sigmoid colon were also scored.
                The reduction in the number of abdominal pain episodes was significantly higher (P < 0.01) in otilonium bromide patients (55.3%) than in those taking placebo (39.9%) as was the severity of abdominal distension (42.0%, vs. 30.2%; P < 0.05). Bowel disturbance improved in both groups. but without any statistically significant difference. The visual analogue scale of well-being revealed a significant improvement (P < 0.05) in patients taking otilonium bromide. The investigators' global positive assessment was in favour of otilonium bromide (65.2%) compared with placebo (49.6%) (P < 0.01).
                Otilonium bromide may represent an effective treatment for irritable bowel syndrome because it reduces its predominant symptom (abdominal pain/ discomfort) more than placebo does. nan The effectiveness of Bentyl (dicyclomine hydrochloride) 40 mg 4 times daily was evaluated in an ambulatory population with recent irritable bowel syndrome (IBS). During the 2-week double-blind study, the effects of dicyclomine hydrochloride compared to placebo were assesed by: 1) physicians' global evaluation of treatment, 2) patients' self-evaluation of treatment, and 3) patients' evaluation of duration of abdominal pain. It was concluded that over a 2-week period dicyclomine hydrochloride 40 mg 4 times a day is superior to placebo in improving the overall condition of the patient, decreasing abdominal pain, decreasing abdominal tenderness, and improving bowel habits. The majority of adverse effects reported were related to the anti-cholinergic activity of the drug. To determine the efficacy and tolerability of an enteric-coated peppermint-oil formulation (Colpermin), we conducted a prospective, randomized, double-blind, placebo-controlled clinical study in 110 outpatients (66 men/44 women; 18-70 years of age) with symptoms of irritable bowel syndrome. Patients took one capsule (Colpermin or placebo) three to four times daily, 15-30 min before meals, for 1 month. Fifty-two patients on Colpermin and 49 on placebo completed the study. Forty-one patients on Colpermin (79%) experienced an alleviation of the severity of abdominal pain (29 were pain-free); 43 (83%) had less abdominal distension, 43 (83%) had reduced stool frequency, 38 (73%) had fewer borborygmi, and 41 (79%) less flatulence. Corresponding figures for the placebo group were: 21 patients (43%) with reduced pain (4 were pain-free), 14 (29%) with reduced distension, 16 (32%) with reduced stool frequency, 15 (31%) with fewer borborygmi, and 11 (22%) with less flatulence. Symptom improvements after Colpermin were significantly better than after placebo (P < 0.05; Mann-Whitney U-test). One patient on Colpermin experienced heartburn (because of chewing the capsules) and one developed a mild transient skin rash. There were no significant changes in liver function test results. Thus, in this trial, Colpermin was effective and well tolerated. Irritable bowel syndrome (IBS) is a functional gastrointestinal (GI) disease that causes significant impairment in quality of life and accounts for $8 billion per year to the healthcare system and loss of productivity in the workplace.
                The authors examined the efficacy and safety of paroxetine controlled-release (paroxetine-CR) in patients with IBS.
                Seventy-two patients with IBS participated in a 12-week, double-blind, randomized, placebo-controlled study of paroxetine-CR (12.5 mg-50 mg/day). Efficacy was measured by Composite Pain Scores (primary outcome) and the Clinical Global Impression-Improvement (CGI-I) and Severity (CGI-S) ratings.
                In intent-to-treat analyses, there were no significant differences between paroxetine-CR (N=36) and placebo (N=36) on reduction in Composite Pain Scores, although the proportion of responders on CGI-I was significantly higher in the paroxetine-CR group. The treatment was well tolerated.
                The study did not demonstrate a statistically significant benefit for paroxetine-CR over placebo on the primary outcome measure, although there was improvement in secondary outcome measures. Overall, paroxetine-CR seems to have potential benefit in IBS. Studies with adequate samples may clarify the role of paroxetine-CR in IBS. A double blind placebo controlled trial of ispaghula husk in 80 patients with irritable bowel syndrome is reported. Global assessment judged treatment to be satisfactory in 82% of patients receiving ispaghula and 53% of the placebo group (p less than 0.02). Bowel habit was unchanged in the placebo group, while constipation significantly improved in patients taking ispaghula (p = 0.026). Transit time decreased significantly in those taking ispaghula compared with placebo (p = 0.001), especially in patients with initially high transit times. Abdominal pain and bloating improved in both groups, with no significant differences between ispaghula and placebo. Four of the eight withdrawals on ispaghula and 10 of the 15 withdrawals on placebo were because of treatment failure. Ispaghula significantly improves overall well being in patients with irritable bowel syndrome, and in those with constipation favourably affects bowel habit and transit time. Selective serotonin reuptake inhibitors (SSRIs) are frequently used in the treatment of irritable bowel syndrome (IBS) although evidence of their efficacy is scarce.
                Twenty three non-depressed IBS patients were recruited from a tertiary care centre and included in a crossover trial comparing six weeks of treatment with the SSRI citalopram (20 mg for three weeks, 40 mg for three weeks) with placebo. IBS symptom severity was the primary outcome measure, and depression and anxiety scores were also measured. The effect of acute administration of citalopram on colonic sensitivity and on colonic response to feeding was investigated as a putative predictor of symptomatic response to the drug.
                After three and six weeks of treatment, citalopram significantly improved abdominal pain, bloating, impact of symptoms on daily life, and overall well being compared with placebo. There was only a modest effect on stool pattern. Changes in depression or anxiety scores were not related to symptom improvement. The effect of acute administration of citalopram during a colonic barostat study did not predict clinical outcome. Analysis of the first treatment period as a double blind parallel arm study confirmed the benefit of citalopram over placebo.
                The SSRI citalopram significantly improves IBS symptoms, including abdominal pain, compared with placebo. The therapeutic effect is independent of effects on anxiety, depression, and colonic sensorimotor function. Twenty adult Indian patients suffering from the spastic form of irritable colon, i.e. abdominal pain and constipation, were given trimebutine (Mebutin), 2-phenyl, 2-dimethylamino-n-butyl 3, 4, 5-trimethoxybenzoate. Patients were given treatment with 200 mg trimebutine three times daily, or placebo for 4 weeks, and then crossed over. In addition, stool transit times were assessed by the single stool transit time (SST) method of Cummings. Results showed a statistical improvement in abdominal pain and constipation with both trimebutine and placebo after 4 weeks, but only with trimebutine after 8 weeks. Single stool transit time was significantly reduced after trimebutine. This study describes the effect of fibre supplementation on the gastrointestinal symptoms and general wellbeing of patients with constipated irritable bowel syndrome. In a single centre, double blind, placebo controlled trial of 3 months duration, a daily supplement of 4.1 g fibre produced no greater change in gastrointestinal symptoms than placebo. Pretreatment constipation was related to baseline fibre intake. Overall outcome was the same in treated and control groups; a considerable placebo response was evident. This level of fibre supplementation is not a useful treatment; improving neither constipation nor other symptoms. At the outset pain severity correlated with depression score on psychometric testing. Those who felt better at the end of the study scored significantly lower for depression at outset than those who felt no better. In irritable bowel syndrome a depressive emotional state profile is a powerful determinant of outcome, shaping the response to treatment, which includes a considerable placebo element. After organic disease had been excluded as far as possible by clinical examination, including laboratory tests, analysis of faeces, and X-ray examination or endoscopy of the upper and lower gastrointestinal tract, 61 patients were given either 50 mg trimipramine at bedtime or identically looking coded placebo in a prospective study for 4 weeks. The complaints were graded on an analogue scale by both the patients and the physicians. The results showed that the complaint scores were significantly reduced to about half in the placebo group. In the group treated with trimipramine a significantly greater reduction was found for the scores of vomiting, sleeplessness, depression, and for the mucus content of stools. The scores for tiredness during treatment had decreased less in the group receiving trimipramine than in the one receiving placebo. These improvements occurred already during the first week of treatment. No adverse side effect was recorded. We investigated the effects of dietary fiber on symptoms of irritable bowel syndrome.
                A single-blind randomized clinical trial was designed. Fifty-six subjects with irritable bowel syndrome were prospectively and randomly assigned to one of two groups: group 1 received a diet containing 10.4 g/d of fiber and group 2 received a diet containing 30.5 g/d of fiber. Patients' body weights, nutritional intakes as assessed with 3-d written food records, and symptom scores were assessed at baseline and at 3 mo.
                There were no dropouts during the study. Total energy intake and the distribution of macronutrients were not significantly different between groups. Total dietary fiber intake did not reach recommended levels in either group but was higher in group 2 than in group 1 (25.95 +/- 2.12 g/d versus 6.06 +/- 2.7 g/d, P < 0.05). Initial fiber intake did not differ significantly between groups. Pain scores, bowel scores, and general scores improved in both groups (from baseline to 3 mo), and no significant differences were detected between groups.
                A modest fiber intake in patients with irritable bowel syndrome relieved symptoms, but this therapeutic benefit of fiber may have been due to a placebo effect because the results were similar in the low-fiber group. Irritable bowel syndrome is one of the principal causes of days lost from work. As there has been no effective treatment up to now, sufferers turn to various doctors and try all sorts of medicines over extended periods that last for years. Thus irritable bowel syndrome has become a serious socio-economic problem that affects the family and the workplace.
                We conducted a randomized, double-blind, placebo-controlled trial among 40 consecutive irritable bowel syndrome patients (mean age: 31.4 +/- 1.8, range 17-52 year; females). Pinaverium bromide (50 mg) or placebo was taken orally t.i.d with food.
                Pinaverium bromide diminished pain duration from several hours to a few minutes (P Text:nav2]Conclusions. Pinaverium bromide is safe, and produce a significant benefit in the quality of the patients life, hence may be a valuable drug for the treatment of irritable bowel syndrome patients. The efficacy of antidepressants in irritable bowel syndrome (IBS) is controversial. No trials have directly compared a tricyclic with a selective serotonin reuptake inhibitor. Our aim was to determine whether imipramine and citalopram are efficacious in IBS.
                This was a randomized, double-blind, placebo-controlled, parallel group pilot trial with imipramine (50 mg) and citalopram (40 mg).
                Of 51 IBS patients randomized, baseline characteristics were comparable among the treatment arms; the majority was diarrhea-predominant. Adequate relief of IBS symptoms (primary endpoint) was similar for each treatment arm. Improvements in bowel symptom severity rating for interference (P = 0.05) and distress (P = 0.02) were greater with imipramine versus placebo, but improvements in abdominal pain were not. There was a greater improvement in depression score (P = 0.08) and in the SF-36 Mental Component Score (P = 0.07), with imipramine. Citalopram was not superior to placebo. Approximately 20% of the variance in scores was explained by treatment differences for abdominal pain, bowel symptom severity disability, depression and the mental component of the SF-36.
                Neither imipramine nor citalopram significantly improved global IBS endpoints over placebo. nan nan nan Alverine citrate has been used in the treatment of irritable bowel syndrome for many years.
                To compare the efficacy and safety of a new formulation of alverine citrate, a 120-mg capsule, with placebo given three times daily for 12 weeks.
                One hundred and seven patients with irritable bowel syndrome were entered into this three-centre, double-blind, randomized, placebo-controlled, parallel group trial. The primary end-point was relief of abdominal pain indicated by improvement in the scores for severity and frequency. Secondary efficacy variables included scores for other clinical symptoms and for overall well-being.
                The severity and frequency of abdominal pain improved in 66% and 68% of patients treated with alverine citrate vs. 58% and 69% of the placebo group, but these differences were not significant. The mean percentage reduction in the scores for abdominal pain from baseline to the final assessment, although greater in the alverine citrate group (43.7%) compared with the placebo group (33.3%), was not statistically significant.
                Alverine citrate is no better than placebo at relieving the symptoms of irritable bowel syndrome. Future trials should be designed to take into account the high and persistent placebo response seen in this condition. The aim of this study was to evaluate the efficacy of cimetropium bromide, a new antimuscarinic compound, in relieving symptoms of patients with irritable bowel syndrome over a three month period. Seventy consecutive outpatients were given cimetropium (50 mg tid) or placebo according to a double blind, randomised, parallel groups design. Symptoms were evaluated initially and at monthly intervals up to the end of the study period. One patient receiving placebo withdrew because of treatment failure. Pain score decreased by 40, 66, 85% in the cimetropium group, at the end of the first, second and third months respectively, compared with 26, 32 and 52% reductions among controls (p = 0.0005). At the end of treatment there was a 86% reduction in the number of abdominal pain episodes per day in the cimetropium group compared with 50% in the placebo group (p = 0.001). Constipation and diarrhoea scores decreased by 59 and 49% in the cimetropium treated patients, compared with 37 and 39% in controls, the differences between being not significant. At the end of the study 89% of the patients treated with cimetropium considered themselves as globally improved as opposed to 69% in the placebo group (p = 0.039). The corresponding 95% confidence intervals for the differences between the proportion of improved patients in the two groups were from 11% to 29%. Six patients taking cimetropium complained of slight dry mouth. The results of this study showed that cimetropium bromide is effective in relieving pain in patients with irritable bowel syndrome. 59 outpatients with irritable bowel syndrome participated in a randomised double-blind trial. The patients in the treatment group received three biscuits daily each containing 10 g of ordinary miller's bran, whereas the patients in the control group received wheat biscuits of a similar appearance. The treatment period was 6 weeks. 52% of the patients in the treatment group noted subjective improvement compared with 65% in the control group. The results of this trial do not support the routine use of miller's bran in irritable bowel syndrome. A double-blind, randomized parallel group trial comparison involving 712 patients with irritable bowel syndrome was performed. Over a treatment period of 4 weeks hyoscine-N-butylbromide (30 mg/day p.o.) plus paracetamol (1 500 mg/day p.o.), hyoscine-N-butylbromide (30 mg/day p.o.), paracetamol (1. 500 mg/day p.o.) or placebo (3 tablets/day p.o.) were administered. Patients kept a diary and entered a daily rating of their symptoms (visual analogue scale). At the end of the four weeks 81% of the patients in the Buscopan plus group were deemed "responder" (marked or some improvement in symptoms). In the Buscopan group 76%, in the paracetamol group 72% and in the placebo group 64% of the patients were responders. The differences between the Buscopan plus group and the placebo group, and between the Buscopan group and the placebo group were statistically significant. The daily rating on the analogue scale showed a statistically significant improvement in abdominal pain intensity in the Buscopan plus group versus the placebo group and in the Buscopan plus group versus the paracetamol group. Thirty-eight patients ( = 5%, no differences between the treatment groups) experienced adverse effects, that did not require treatment. Buscopan plus and Buscopan are suitable for the treatment of the irritable bowel syndromes. Eighteen patients with irritable colon syndrome were treated with a new anticholinergic drug (prifinium bromide) and with a placebo in a 6-wk, randomized, double-blind cross-over study. The drug was orally administered in a daily dose of 90 mg before meals. Three manifestations (pain, flatulence, constipation, and/or diarrhea), scored weekly, were used as assessment criteria. Mean over-all ratings showed a difference in favor of the drug, and were statistically significant. Side effects were rare and mild. We have come to the conclusion that this anticholinergic drug may be of benefit to patients with pain-predominant forms of irritable colon syndrome. Studies of antidepressants and psychological treatments in functional bowel disorders (FBD) are methodologically limited. The aim of this study was to assess the clinical efficacy and safety of cognitive-behavioral therapy (CBT) against education (EDU) and desipramine (DES) against placebo (PLA) in female patients with moderate to severe FBD (irritable bowel syndrome, functional abdominal pain, painful constipation, and unspecified FBD). We also evaluated the amenability of clinically meaningful subgroups to these treatments.
                This randomized, comparator-controlled, multicenter trial enrolled 431 adults from the University of North Carolina and the University of Toronto with moderate to severe symptoms of FBD. Participants received psychological (CBT vs. EDU) or antidepressant (DES vs. PLA) treatment for 12 weeks. Clinical, physiologic, and psychosocial assessments were performed before and at the end of treatment.
                The intention-to-treat analysis showed CBT as significantly more effective than EDU (P = 0.0001; responder rate, 70% CBT vs. 37% EDU; number needed to treat [NNT ], 3.1). DES did not show significant benefit over PLA in the intention-to-treat analysis (P = 0.16; responder rate, 60% DES vs. 47% PLA; NNT, 8.1) but did show a statistically significant benefit in the per-protocol analysis (P = 0.01; responder rate, 73% DES vs. 49% PLA; NNT, 5.2), especially when participants with nondetectable blood levels of DES were excluded (P = 0.002). Improvement was best gauged by satisfaction with treatment. Subgroup analyses showed that DES was beneficial over PLA for moderate more than severe symptoms, abuse history, no depression, and diarrhea-predominant symptoms; CBT was beneficial over EDU for all subgroups except for depression.
                For female patients with moderate to severe FBD, CBT is effective and DES may be effective when taken adequately. Certain clinical subgroups are more or less amenable to these treatments. A randomized, double-blind trial of a psyllium preparation was initiated in 77 patients with painful irritable bowel syndrome. Sixty-patients finished and submitted symptom data for 8 weeks while taking placebo (n = 34) or psyllium (n = 26). Increase in normal stools and decrease in pain severity (p less than 0.05) occurred equally in both groups. Subjective improvement was reported by 24 of 34 patients on placebo and 20 or 26 on psyllium (p greater than 0.05). Five symptom variables were significantly correlated (p less than 0.05) with patient's subjective global assessment (R = 0.64). Discriminant analysis of Minnesota Multiphasic Personality Inventory variables yielded overall rates of correct prediction of 66.1% for whether patients got "much better" and 77.9% for whether they voluntarily dropped from the study. A major placebo effect occurs in patients with painful irritable bowel syndrome and is probably responsible for the efficacy of psyllium. Personality factors influence the magnitude of therapeutic response and whether patients discontinue treatment within 8 weeks. The purpose of the trial was to determine whether a high-fiber diet (HFD) alone or in combination with paroxetine or placebo was effective treatment for patients with irritable bowel syndrome (IBS).
                Design: Trial of HFD alone (Group 1) followed by a randomized, double-blind trial of HFD with paroxetine or placebo (Group 2). Setting: Gastroenterology office in a 524-bed university-affiliated community hospital in Pittsburgh. Patients: Men and women, aged 18-65 yr, previously diagnosed with IBS but otherwise healthy. Intervention: Institution of HFD in 98 participants consuming low- or average-fiber diets. Allocation of paroxetine to 38 and placebo to 43 symptomatic participants consuming HFDs. Measurements: Overall well-being, abdominal pain, and abdominal bloating (Groups 1 and 2); food avoidance, work functioning, and social functioning (Group 2).
                In Group 1, overall well-being improved in 26% patients, and abdominal pain and bloating decreased in 22% and 26% patients, respectively, with an HFD. In Group 2, overall well-being improved more with paroxetine than with placebo (63.3%vs 26.3%; p= 0.01), but abdominal pain, bloating, and social functioning did not. With paroxetine, food avoidance decreased (p= 0.03) and work functioning was marginally better (p= 0.08). Before unblinding, more paroxetine recipients than placebo recipients wanted to continue their study medication (84%vs 37%; p < 0.001).
                The difference in overall well-being found in our paroxetine/placebo trial is greater than that found in previously published drug/placebo trials for IBS. Moreover, the difference in well-being applied to nondepressed recipients of paroxetine. nan Cimetropium bromide is a new antimuscarinic compound with strong antispasmodic activity. The aim of this study was to evaluate the effects of oral cimetropium bromide on total gut transit time in patients with irritable bowel syndrome. Forty patients, divided according to their initial total gastrointestinal transit times and presenting symptoms, were treated with cimetropium bromide 50 mg t.d.s. or placebo for 1 month according to a double-blind, parallel group design. Before and after treatment all subjects ingested 24 radio-opaque markers. The total intestinal transit time was determined by evaluating the rate of disappearance of markers from plain X-ray films of the abdomen taken every 24 h for 4 days. Pain and bowel habits were also monitored. Seven patients did not complete the study. Cimetropium bromide significantly (P less than 0.01) shortened the whole gut transit time in patients with prolonged transit time (80.8 +/- 4.0 h before vs 60.8 +/- 6.7 h after treatment) and improved the global clinical condition significantly compared with placebo (P = 0.029). In patients with a short total intestinal transit time, cimetropium bromide had no effect on whole gut transit time and did not significantly improve symptoms. The results of this study indicate that oral cimetropium bromide is effective both objectively and subjectively in a subgroup of irritable bowel syndrome patients with constipation. This placebo controlled, double-blind, cross-over trial involving 20 patients was conducted to assess the effect of ispaghula husk on the major bowel symptoms and the whole gut transit time in irritable bowel syndrome (IBS) and to determine if changes in these parameters were related to global improvement. All 20 patients were interviewed at the end of the treatment periods and 14 patients kept concurrent daily records. Ispaghula therapy resulted in improvement in global symptoms and satisfying bowel movements (P less than 0.001) but produced no change in abdominal pain or flatulence. There was a correlation between the improvement of well-being and the number of days of satisfying bowel movements (P less than 0.001) but not with the indexes of pain, stool frequency or changes in the transit time. The easing of bowel dissatisfaction appears to be a major reason for the therapeutic success of ispaghula in IBS. The use of peppermint oil in treating the irritable bowel syndrome has been studied with variable results probably due to the presence of patients affected by small intestinal bacterial overgrowth, lactose intolerance or celiac disease that may have symptoms similar to irritable bowel syndrome.
                The aim of the study was to test the effectiveness of enteric-coated peppermint oil in patients with irritable bowel syndrome in whom small intestinal bacterial overgrowth, lactose intolerance and celiac disease were excluded.
                Fifty-seven patients with irritable bowel syndrome according to the Rome II criteria, with normal lactose and lactulose breath tests and negative antibody screening for celiac disease, were treated with peppermint oil (two enteric-coated capsules twice per day or placebo) for 4 weeks in a double blind study. The symptoms were assessed before therapy (T(0)), after the first 4 weeks of therapy (T(4)) and 4 weeks after the end of therapy (T(8)). The symptoms evaluated were: abdominal bloating, abdominal pain or discomfort, diarrhoea, constipation, feeling of incomplete evacuation, pain at defecation, passage of gas or mucus and urgency at defecation. For each symptom intensity and frequency from 0 to 4 were scored. The total irritable bowel syndrome symptoms score was also calculated as the mean value of the sum of the average of the intensity and frequency scores of each symptom.
                At T(4), 75% of the patients in the peppermint oil group showed a >50% reduction of basal (T(0)) total irritable bowel syndrome symptoms score compared with 38% in the placebo group (P<0.009). With peppermint oil at T(4) and at T(8) compared with T(0) a statistically significant reduction of the total irritable bowel syndrome symptoms score was found (T(0): 2.19+/-0.13, T(4): 1.07+/-0.10*, T(8): 1.60+/-0.10*, *P<0.01 compared with T(0), mean+/-S.E.M.), while no change was found with the placebo.
                A 4 weeks treatment with peppermint oil improves abdominal symptoms in patients with irritable bowel syndrome. No subjective or objective evidence of beneficial effect was observed from the use of Pirenzepine in irritable bowel syndrome (IBS) patients who had not responded to a high fibre diet. The aim of this study was to assess the effect of coarse wheat bran on specific bowel function parameters and symptoms in patients with irritable bowel syndrome (IBS). A longitudinal, prospective, randomised, placebo-controlled trial was undertaken. The duration of treatment was eight to 12 weeks and this consisted of 10-20 g/day of coarse wheat bran or a low fibre placebo taken in addition to the normal diet. Twenty-eight outpatients fulfilling the Rome criteria for constipation-predominant IBS were recruited to the trial (14 in the treatment group; 14 in the placebo group). Twelve people completed the trial in the treatment group and ten in the placebo group. The main outcome measures included changes in symptoms recorded in a diary, changes in objective measurements of bowel function and subjective overall feelings of improvement. The bran group significantly increased their non-starch polysaccharide (NSP) intake over that of the placebo group (p < 0.05). Mean stool wet weight increased significantly more in the bran group than in the placebo group (p < 0.05), but other bowel function measurements and all recorded symptoms were not different. Many patients reported changes in bowel habit that were not reflected in the objective measurements. The addition of coarse wheat bran to the diet increased NSP ingestion and stool wet weight in this group of IBS patients, but no evidence was obtained that such treatment was of benefit to these patients, other than a placebo effect on symptoms. There is no generally accepted treatment in the irritable bowel syndrome (IBS), probably because of a lack of convincing therapeutic trials. In the present study, 120 outpatients with IBS participated in a prospective randomized therapeutic trial. According to a double-blind design, 40 patients received 400 mg/day mebeverine and 40 patients received a placebo. In an open branch of the trial, 40 patients were treated with 15 g/day wheat bran. The effects of treatment on symptoms were noted after 4, 8, 12 and 16 weeks of therapy. A significantly superior symptomatic effect of bran in comparison to mebeverine and placebo was demonstrated after 12 weeks, but could not be confirmed at the end of the study. There was no significant difference between the symptomatic effect of mebeverine and placebo. The compliance with the therapy was about 80% for 4 weeks, but dropped to about 50% at the end of the trial. This points to a particular difficulty in the management of patients with IBS. The results of this trial suggest that bran and mebeverine are no ideal therapy for patients with IBS but they support the therapeutic use of bran in patients with IBS. To determine the efficacy of amitriptyline (AMI) in treating irritable bowel syndrome (IBS) in adolescents.
                Adolescents 12 to 18 years with newly diagnosed IBS were surveyed with a symptom checklist, pain rating scale, visual analog scale, and IBS quality of life (QOL) questionnaire. Subjects were randomized in a double-blinded fashion to receive AMI or placebo, and again completed surveys at 2, 6, 10, and 13 weeks.
                Thirty-three patients (24 female) were enrolled. Patients receiving AMI were more likely to experience improvement from baseline in overall QOL at 6, 10, and 13 weeks (P = .019, .004, and .013). Patients receiving AMI were also more likely to experience a reduction in IBS-associated diarrhea at 6 and 10 weeks (P = .029 for both), a reduction in periumbilical pain at 10 weeks (P = .018), and a reduction in right lower quadrant pain at 6, 10, and 13 weeks (P = .014, .039, and .004).
                AMI significantly improves overall QOL in adolescents with IBS and should be a therapeutic option for adolescents with this disorder.
There is no evidence that bulking agents are effective for treating IBS.  There is evidence that antispasmodics are effective for the treatment of IBS. The individual subgroups which are effective include: cimetropium/dicyclomine, peppermint oil, pinaverium and trimebutine. There is good evidence that antidepressants are effective for the treatment of IBS. The subgroup analyses for SSRIs and TCAs are unequivocal and their effectiveness may depend on the individual patient. Future research should use rigorous methodology and valid outcome measures.