A controlled crossover study of the selective serotonin reuptake inhibitor citalopram in irritable bowel syndrome. Antidepressant therapy (imipramine and citalopram) for irritable bowel syndrome: a double-blind, randomized, placebo-controlled trial. Oral cimetropium bromide, a new antimuscarinic drug, for long-term treatment of irritable bowel syndrome. Treatment of the irritable bowel syndrome with Bentyl (dicyclomine hydrochloride). Cognitive behaviour therapy in addition to antispasmodic treatment for irritable bowel syndrome in primary care: randomised controlled trial. Irritable bowel syndrome: therapeutic evaluation of indigenous drugs. A randomized controlled trial of cognitive behavior therapy, relaxation training, and routine clinical care for the irritable bowel syndrome. Cognitive-behavioral therapy versus education and desipramine versus placebo for moderate to severe functional bowel disorders. A comparison study of antidepressants and structured intensive group psychotherapy in the treatment of bulimia nervosa. Longterm treatment of irritable bowel syndrome with cimetropium bromide: a double blind placebo controlled clinical trial. 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. Anorexia nervosa. Treatment efficacy of cyproheptadine and amitriptyline. Comparison of the tolerability and efficacy of citalopram and amitriptyline in elderly depressed patients treated in general practice. Is there a role for selective monoamine oxidase inhibitor therapy in bulimia nervosa? A placebo-controlled trial of brofaromine. Enteric-coated, pH-dependent peppermint oil capsules for the treatment of irritable bowel syndrome in children. A double-blind study of the efficacy and safety of sertraline and clomipramine in outpatients with severe major depression. Enteric-coated peppermint-oil capsules in the treatment of irritable bowel syndrome: a prospective, randomized trial. Symptom management for irritable bowel syndrome: a pilot randomized controlled trial of acupuncture/moxibustion. Medication and psychotherapy in the treatment of bulimia nervosa. Treatment of irritable bowel syndrome with Chinese herbal medicine: a randomized controlled trial. [Observation on intestinal flora in patients of irritable bowel syndrome after treatment of Chinese integrative medicine]. Paroxetine to treat irritable bowel syndrome not responding to high-fiber diet: a double-blind, placebo-controlled trial. Behavioural psychotherapy in the treatment of irritable bowel syndrome. Treatment of irritable bowel syndrome with lorazepam, hyoscine butylbromide, and ispaghula husk. A randomized, controlled, single-blind study comparing furazolidone with trimethoprim-sulfamethoxazole in the empirical treatment of acute invasive diarrhea. The cost-effectiveness of psychotherapy and paroxetine for severe irritable bowel syndrome. "Prokinetic" treatment of constipation-predominant irritable bowel syndrome: a placebo-controlled study of cisapride. Citalopram for treatment-resistant obsessive-compulsive disorder. A double-blind comparative study of the clinical efficacy of fluvoxamine and chlorimipramine. The combination of medical treatment plus multicomponent behavioral therapy is superior to medical treatment alone in the therapy of irritable bowel syndrome. Social phobia: the clinical efficacy and tolerability of the monoamine oxidase -A and serotonin uptake inhibitor brofaromine. A double-blind placebo-controlled study. Symptom relief with amitriptyline in the irritable bowel syndrome. Drug therapy in the prevention of recurrences in unipolar and bipolar affective disorders. Report of the NIMH Collaborative Study Group comparing lithium carbonate, imipramine, and a lithium carbonate-imipramine combination. Two controlled evaluations of multicomponent psychological treatment of irritable bowel syndrome. An Asia-Pacific, double blind, placebo controlled, randomised study to evaluate the efficacy, safety, and tolerability of tegaserod in patients with irritable bowel syndrome. [Randomized controlled clinical study on effect of Chinese compound changjitai in treating diarrheic irritable bowel syndrome]. A randomised controlled trial assessing the efficacy and safety of repeated tegaserod therapy in women with irritable bowel syndrome with constipation. Evaluation of a psychological treatment for inflammatory bowel disease. Ciprofloxacin or trimethoprim-sulfamethoxazole as initial therapy for travelers' diarrhea. A placebo-controlled, randomized trial. Placebo-controlled comparison of the selective serotonin reuptake inhibitors citalopram and sertraline. The treatment of irritable bowel syndrome with hypnotherapy. A double-blind, randomized, placebo-controlled trial of paroxetine controlled-release in irritable bowel syndrome.
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. 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. 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. 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 assess the efficacy of cognitive behaviour therapy delivered in primary care for treating irritable bowel syndrome.
                Randomised controlled trial.
                10 general practices in London.
                149 patients with moderate or severe irritable bowel syndrome resistant to the antispasmodic mebeverine.
                Cognitive behaviour therapy delivered by trained primary care nurses plus 270 mg mebeverine taken thrice daily compared with mebeverine treatment alone.
                Primary measures were patients' scores on the irritable bowel syndrome symptom severity scale. Secondary measures were scores on the work and social adjustment scale and the hospital anxiety and depression scale.
                Of 334 referred patients, 72 were randomised to mebeverine plus cognitive behaviour therapy and 77 to mebeverine alone. Cognitive behaviour therapy had considerable initial benefit on symptom severity compared with mebeverine alone, with a mean reduction in score of 68 points (95% confidence interval 103 to 33), with the benefit persisting at three months and six months after therapy (mean reductions 71 points (109 to 32) and 11 points (20 to 3)) but not later. Cognitive behaviour therapy also showed significant benefit on the work and social adjustment scale that was still present 12 months after therapy (mean reduction 2.8 points (5.2 to 0.4)), but had an inconsistent effect on the hospital anxiety and depression scale.
                Cognitive behaviour therapy delivered by primary care nurses offered additional benefit over mebeverine alone up to six months, although the effect had waned by 12 months. Such therapy may be useful for certain patients with irritable bowel syndrome in primary care. Among 169 patients with irritable bowel syndrome (IBS), standard therapy (with clidinium bromide, chlordiazepoxide and isaphaghulla), a compound Ayurvedic preparation (with Aegle marmelos correa plus Bacopa monniere Linn) along with a matching placebo were given in a double blind randomised trial for 6 wk. The Ayurvedic preparation in 57 patients was found effective in 64.9 per cent, while standard therapy (60 patients) was useful in 78.3 per cent. Patients on placebo (52 patients) showed improvement in 32.7 per cent only. Ayurvedic therapy was particularly beneficial in diarrhoea predominant form as compared to placebo. The standard therapy was more useful in the painful form of IBS as compared to placebo and Ayurvedic preparation. In gas predominant form the effect of standard as well as Ayurvedic therapy, was similar to placebo. Long-term follow-up (greater than 6 months) showed that both forms of therapy were no better than placebo in limiting the relapse. Psychological treatments are considered to be useful in the irritable bowel syndrome (IBS), although the evidence is based on small, often flawed trials. Although cognitive behavior therapy (CBT) and relaxation therapy have both been promising, we hypothesized that CBT would be superior to relaxation and standard care alone in IBS patients. The objective of this study was to test this assumption by comparing the effects of cognitive behavior therapy with relaxation therapy and routine clinical care alone in individuals with IBS.
                Patients (n = 105) with Rome I criteria for IBS were recruited from advertisement (n = 51) and outpatient clinics (n = 54); those patients with resistant IBS were not included. A randomized controlled trial with three arms (standard care for all groups plus either CBT or relaxation) for 8 wk was conducted, which applied blinded outcome assessments using validated measures with 1 yr of follow-up. The primary outcome for this study was bowel symptom severity.
                Of 105 patients at the commencement of treatment, the mean bowel symptom frequency score for the whole sample was 21.1 and at the end of treatment had fallen to 18.1; this persisted at the 52-wk follow-up, with a significant linear trend for scores to change over time (F = 39.57 p < 0.001). However, there were no significant differences among the three treatment conditions. Significant changes over time were found for physical functioning (F = 4.37, p < 0.001), pain (F = 3.12, p < 0.05), general health (F = 2.71, p < 0.05), vitality (F = 2.94, p < 0.05), and the social functioning scales on the Medical Outcomes Study Short Form 36 (F = 4.08, p < 0.05); however, all three arms showed similar improvement. There were significant reductions in anxiety, depression, and locus of control scales, but no significant differences among the treatment groups were detected.
                Cognitive behavior and relaxation therapy seem not to be superior to standard care alone in IBS. 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. Previous research on the treatment of outpatients with bulimia nervosa has focused on two treatment strategies: (1) drug therapy, primarily using tricyclic antidepressants, and (2) psychotherapy, often employing behavioral and cognitive behavioral techniques. We report here the short-term treatment outcome of a 12-week comparison trial of bulimic outpatients who were randomly assigned to one of four treatment cells: (1) imipramine hydrochloride treatment, (2) placebo treatment, (3) imipramine treatment combined with intensive group psychotherapy, and (4) placebo treatment combined with intensive group psychotherapy. All three active treatment cells resulted in significant reductions in target-eating behaviors and in a significant improvement in mood relative to placebo treatment. However, the results also suggested that the amount of improvement obtained with the intensive group psychotherapy component was superior to that obtained with antidepressant treatment alone. The addition of antidepressant treatment to the intensive group psychotherapy component did not significantly improve outcome over intensive group psychotherapy combined with placebo treatment in terms of eating behavior, but did result in more improvement in the symptoms of depression and anxiety. 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. 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. Patients with anorexia nervosa have concurrent problems of emaciation and depression. Therefore, treatment with medications affecting both weight gain and depression seemed reasonable. Seventy-two anorectic patients were randomly assigned in a double-blind study to receive cyproheptadine hydrochloride, a weight-inducing drug, amitriptyline hydrochloride, a tricyclic antidepressant, or placebo. Overall, cyproheptadine had a marginal effect on decreasing the number of days necessary to achieve a normal weight. There was a differential drug effect present in the bulimic subgroups of the anorectic patients: cyproheptadine significantly increased treatment efficiency for the nonbulimic patients and significantly impaired treatment efficiency for the bulimic patients when compared with the amitriptyline- and placebo-treated groups. The differential cyproheptadine effect on the anorectic bulimic subgroups is the first pharmacologic evidence of the validity of these subgroups. Cyproheptadine had an anti-depressant effect demonstrated by a significant decrease in the Hamilton depression ratings. The enhanced sensitivity of the elderly to the side effects produced by tricyclic antidepressants (TCAs), and the frequency and type of adverse events, have made the treatment of depression in this group difficult. The selective serotonin reuptake inhibitors (SSRIs) have been reported to produce significantly fewer undesirable side effects and display better tolerance than TCAs. We compared the therapeutic actions and side effects produced by citalopram, the most selective SSRI available, with amitriptyline in a group of elderly patients (aged 65 and older) diagnosed with major depression. In a double-blind, double-dummy, parallel-group, multicenter comparison of citalopram (20 or 40 mg/day) and amitriptyline (50 or 100 mg/day), patients who did not respond to placebo during a 1-week single-blind phase were randomly assigned to receive citalopram or amitriptyline for 8 weeks. Efficacy measures included the Montgomery-Asberg Depression Rating Scale (MADRS), the Hamilton Depression Scale (HAMD), and Clinical Global Impressions. Both drug treatments produced equivalent time-related declines in severity of depression, so that by 8 weeks slightly more than 50% of the patients in each group experienced marked recovery, defined as MADRS scores < or = 12. Amitriptyline produced a greater overall incidence of adverse events, including a significantly higher (P < 0.001) percentage of patients reporting dry mouth (34% vs. 7%), as well as a significantly higher (P < 0.02) incidence of somnolence. Constipation and fatigue also occurred more frequently in the amitriptyline than in the citalopram group. For only one event (nausea) did the citalopram group report a significantly greater (P = 0.012) incidence (12.8% vs. 4.8%). On the basis of these results, it was concluded that citalopram is as effective an antidepressant as amitriptyline in the treatment of the depressed elderly. Because of its low incidence and low magnitude of side effects, citalopram seems especially useful in private practice. Pharmacologic and cognitive behavioral therapies have been advocated in the treatment of bulimia nervosa (BN). Brofaromine, a selective and reversible inhibitor of monoamine oxidase-A was selected for a double-blind, placebo-controlled evaluation because of previous demonstrated monoamine oxidase inhibitor efficacy in BN and because of its safer adverse reaction profile. Thirty-six female patients who met DSM-III-R criteria for BN were randomly assigned to the drug group (N = 19) or to the placebo group (N = 17) for an 8-week outpatient trial. Brofaromine produced a significant effect in decreasing episodes of vomiting throughout the trial, although comparable reductions in episodes of binge eating were found in both groups. Also, there were no advantages of drug over placebo on improvements in attitudinal measures and shape or on self-report ratings of depression and anxiety. However, a significant proportion of the subjects on brofaromine lost weight when compared with the placebo group. Methodologic issues including subjective assessment measures, placebo response rates, and the elucidation of responder subgroups are discussed. In a randomized, double-blind controlled trial, 42 children with irritable bowel syndrome (IBS) were given pH-dependent, enteric-coated peppermint oil capsules or placebo. After 2 weeks, 75% of those receiving peppermint oil had reduced severity of pain associated with IBS. Peppermint oil may be used as a therapeutic agent during the symptomatic phase of IBS. This study compared the efficacy and safety of the selective serotonin reuptake inhibitor sertraline with that of the tricyclic antidepressant clomipramine in patients with severe depression, as defined by a baseline 17-item Hamilton Depression Rating Scale (HAM-D) of at least 25. The study included 166 outpatients, randomized to double-blind treatment with sertraline (50-200 mg) or clomipramine (50-150 mg) for 8 weeks. The efficacy of both treatments was similar, 74% of patients in the sertraline group and 71% of clomipramine patients being classified as responders at the end-point, as defined by a Clinical Global Impression-Improvement (CGI-I) score of 1 or 2. Mean HAM-D scores fell from 29.8 at baseline to 12.3 at endpoint in the sertraline group, and from 29.6-12.7 in the clomipramine group. There were more withdrawals due to adverse events in the clomipramine group than in the sertraline group (17% versus 12%). Dry mouth, tremor, dizziness and constipation were all substantially more common in the clomipramine group, whereas diarrhoea/loose stools was more common in the sertraline group. Overall, sertraline was as effective as clomipramine in this group of severely depressed outpatients, and showed better tolerability. 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. The purpose of this pilot study was to assess the effect of an individualized traditional Chinese medicine (TCM) acupuncture and moxibustion (Acu/Moxa) treatment on symptom control in patients with irritable bowel syndrome (IBS) in a preliminary, randomized, sham/placebo-controlled trial. Twenty-nine men and women with IBS were randomized to either individualized Acu/Moxa (treatment group) or sham/placebo Acu/Moxa (control group). All subjects were assessed by a diagnostic acupuncturist for a TCM evaluation and individualized point prescription. Only those subjects assigned to the experimental group received the individually prescribed treatment. The diagnostic acupuncturist did not administer treatments and was blind to treatment assignments. All subjects kept a symptom diary for the duration of the study, enabling measurement of symptom frequency, severity, and improvement. The Clinical Global Impression Scale was administered preintervention to establish baseline severity and on completion of the 4-week, eight-session treatment intervention. After 4 weeks of twice-weekly Acu/Moxa treatment, average daily abdominal pain/discomfort improved whereas the control group showed minimal reduction. This between-group difference adjusted for baseline difference was statistically significant. The intestinal gas, bloating, and stool consistency composite score showed a similar pattern of improvement. The findings indicate that Acu/Moxa treatment shows promise in the area of symptom management for IBS. Two treatments for bulimia nervosa have emerged as having established efficacy: cognitive-behavioral therapy and antidepressant medication. This study sought to address 1) how the efficacy of a psychodynamically oriented supportive psychotherapy compared to that of cognitive-behavioral therapy; 2) whether a two-stage medication intervention, in which a second antidepressant (fluoxetine) was employed if the first (desipramine) was either ineffective or poorly tolerated, added to the benefit of psychological treatment; and 3) if the combination of medication and psychological treatment was superior to a course of medication alone.
                A total of 120 women with bulimia nervosa participated in a randomized, placebo-controlled trial.
                Cognitive-behavioral therapy was superior to supportive psychotherapy in reducing behavioral symptoms of bulimia nervosa (binge eating and vomiting). Patients receiving medication in combination with psychological treatment experienced greater improvement in binge eating and depression than did patients receiving placebo and psychological treatment. In addition, cognitive-behavioral therapy plus medication was superior to medication alone, but supportive psychotherapy plus medication was not.
                At present, cognitive-behavioral therapy is the psychological treatment of choice for bulimia nervosa. A two-stage medication intervention using fluoxetine adds modestly to the benefit of psychological treatment. Irritable bowel syndrome (IBS) is a common functional bowel disorder for which there is no reliable medical treatment.
                To determine whether Chinese herbal medicine (CHM) is of any benefit in the treatment of IBS.
                Randomized, double-blind, placebo-controlled trial conducted during 1996 through 1997.
                Patients were recruited through 2 teaching hospitals and 5 private practices of gastroenterologists, and received CHM in 3 Chinese herbal clinics.
                A total of 116 patients who fulfilled the Rome criteria, an established standard for diagnosis of IBS.
                Patients were randomly allocated to 1 of 3 treatment groups: individualized Chinese herbal formulations (n = 38), a standard Chinese herbal formulation (n = 43), or placebo (n = 35). Patients received 5 capsules 3 times daily for 16 weeks and were evaluated regularly by a traditional Chinese herbalist and by a gastroenterologist. Patients, gastroenterologists, and herbalists were all blinded to treatment group.
                Change in total bowel symptom scale scores and global improvement assessed by patients and gastroenterologists and change in the degree of interference in life caused by IBS symptoms assessed by patients.
                Compared with patients in the placebo group, patients in the active treatment groups (standard and individualized CHM) had significant improvement in bowel symptom scores as rated by patients (P=.03) and by gastroenterologists (P=.001), and significant global improvement as rated by patients (P=.007) and by gastroenterologists (P=.002). Patients reported that treatment significantly reduced the degree of interference with life caused by IBS symptoms (P=.03). Chinese herbal formulations individually tailored to the patient proved no more effective than standard CHM treatment. On follow-up 14 weeks after completion of treatment, only the individualized CHM treatment group maintained improvement.
                Chinese herbal formulations appear to offer improvement in symptoms for some patients with IBS. To observe the clinical efficacy of the combination of traditional Chinese medicine and western medicine in treating irritable bowel syndrome (IBS) and the result of intestinal flora regulation. Methods: Sixty IBS patients, 36 males and 24 females, were divided into two groups, with 30 patients in each group. Herbal formula of TongxieYaofang and clostridium butyricum (Cb) were used in the first group for four weeks, while only Cb was used for four weeks in the second group. We observed the changes of coliform group, enterococcus, lactobacillus, bifidobacterium after treatment.
                The effective rate of the Tongxie Yaofang and Cb treated group was significantly higher than that of the Cb treated group (P < 0.05). The numbers of bifidobacterium and lactobacillus increased, while the numbers of coliform group and enterococcus decreased after the treatment, and the changes of intestinal flora in the integrative medicine treated group were significantly greater than those in the Cb treated group.
                After treatment with the combination of traditional Chinese medicine and western medicine, the intestinal flora can be regulated to equilibrium state. 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. The irritable bowel syndrome is a highly prevalent condition whose underlying aetiology is not understood. While many patients respond to a combination of gastrointestinal antispasmodics, bulking agents and dietary manipulation, controlled clinical trials have suggested that the benefit is only marginal and is due mainly to the large placebo effect found in this condition, which has been calculated to range between 54 and 81%. Associations between the syndrome and psychological and social stresses suggest, however, that treatment involving a systematic approach to the management of symptoms may hold out real therapeutic possibilities. In the current study, 42 IBS patients were randomly allocated to either medical treatment or to behavioural psychotherapy with a nurse therapist. They were assessed initially and at 4 and 9 months. There was a general improvement over the 9 months on a number of physical and psychological symptoms measured. However, no differences were found between treatment groups except for changes in two avoidance scores. A significant correlation was found, however, between improvement in the bowel symptoms of IBS (stomach pain and diarrhoea) and improvement in the psychological symptoms measured by the Clinical Interview Schedule, suggesting a close interrelationship between the two. 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. An outpatient study of 125 children with acute invasive diarrhea was conducted at the Hospital Infantil de Mexico Federico Gomez. Through a single-blind randomization, we compared the efficacy of furazolidone, 7.5 mg/kg/day (49 patients), with trimethoprim-sulfamethoxazole (TMP-SMX), 8 mg/40 mg/kg/day (52 patients), each given for 5 days. A control group of 24 patients received no antimicrobials. Stool samples were collected from all patients at the time of admission, and active drugs were administered before the stool culture results were available. At baseline, 48 of 125 patients (38.5%) had negative stool cultures. In the other patients, the most frequently isolated pathogens were Shigella sp and enteropathogenic Escherichia coli. Of the total population who completed the study 43 of 49 (87.8%) of the patients in the furazolidone group and 43 of 52 (82.7%) of the patients in the TMP-SMX group achieved clinical cure by day 3, compared with 10 of 22 (45.5%) of the patients in the control group. Day 3 cure rates were similar between groups, independent of baseline stool culture results. Of those patients who had positive stool cultures on day 1, 20 of 34 (58.8%) in the furazolidone group and 19 of 29 (65.5%) in the TMP-SMX group had negative culture results on day 6, compared with 4 of 12 (33.3%) in the control group. Overall, clinical and bacteriologic success was achieved in 31 of 49 (63%) patients treated with furazolidone and in 36 of 52 (69%) patients treated with TMP-SMX, compared with 5 of 22 (23%) patients in the control group.(ABSTRACT TRUNCATED AT 250 WORDS) Psychotherapy and antidepressants are effective in patients with severe irritable bowel syndrome (IBS), but the cost-effectiveness of either treatment in routine practice has not been established.
                Patients with severe IBS were randomly allocated to receive 8 sessions of individual psychotherapy, 20 mg daily of the specific serotonin reuptake inhibitor (SSRI) antidepressant, paroxetine, or routine care by a gastroenterologist and general practitioner. Primary outcome measures of abdominal pain, health-related quality of life, and health care costs were determined after 3 months of treatment and 1 year later.
                A total of 257 subjects (81% response rate) from 7 hospitals were recruited; 59 of 85 patients (69%) randomized to psychotherapy and 43 of 86 (50%) of the paroxetine group completed the full course of treatment. Both psychotherapy and paroxetine were superior to treatment as usual in improving the physical aspects of health-related quality of life (SF-36 physical component score improvement, 5.2 [SEM, 1.26], 5.8 [SEM, 1.0], and -0.3 [SEM, 1.17]; P < 0.001), but there was no difference in the psychological component. During the follow-up year, psychotherapy but not paroxetine was associated with a significant reduction in health care costs compared with treatment as usual (psychotherapy, $976 [SD, $984]; paroxetine, $1252 [SD, $1616]; and treatment as usual, $1663 [SD, $3177]).
                For patients with severe IBS, both psychotherapy and paroxetine improve health-related quality of life at no additional cost. The effects of prokinetic treatment with cisapride in patients with constipation-predominant irritable bowel syndrome (IBS) were evaluated in a randomized, double-blind, placebo-controlled study. Sixty-nine IBS patients were assigned to a 12-week treatment with either 5 mg cisapride or placebo t.i.d.; this dosage could be changed if necessary. The mean weekly number of days on which a stool was passed in the cisapride and placebo group increased to 5.3 and 4.4 (p less than 0.05) during weeks 8-12 of treatment, and the number of days with stools of normal consistency increased to 3.5 and 1.9 (p less than 0.05), respectively. At week 12, the reduction in severity and frequency scores for abdominal pain was significantly greater (p less than or equal to 0.05) in the cisapride group (60 and 61%) than in the placebo group (40 and 32%), as it was for abdominal distension (p less than 0.05). Cisapride tended to be better than placebo in diminishing flatulence. In 71% versus 39% of the patients the overall rating for the response to treatment was good or excellent at week 12. Cisapride was well tolerated. These results suggest that the drug will be useful for the management of constipation-predominant IBS. We investigated the comparative efficacy of citalopram vs. citalopram administered with clomipramine, in treatment-resistant obsessive-compulsive disorder (OCD). Sixteen adult outpatients participated in a 90-day, randomized, open-label trial. Eligible patients were aged 18 to 45 years, had moderate to severe DSM-III-R OCD of >/= one year's duration, a baseline Yale-Brown scale (Y-BOCS) score of >/= 25 and no other active axis I diagnosis, and had failed adequate clomipramine and fluoxetine trials. The citalopram-plus-clomipramine group (n = 9) experienced a significantly larger percent decrease in mean Y-BOCS score by day 90 than the citalopram alone group (n = 7). Only one citalopram patient decreased her score by >/= 35%, and two by >/= 25%. All nine citalopram-plus-clomipramine patients experienced decreases of 35%. Side effects were mild to moderate in both groups. We also treated with citalopram six OCD patients who had not tolerated fluoxetine alone and clomipramine alone; three achieved Y-BOCS score decreases of >/= 35% at 90 days. Since citalopram does not significantly affect clomipramine metabolism, the improvement in the combined drug group is unlikely to have resulted from increased plasma clomipramine levels. Double-blind controlled trials are needed of citalopram in OCD, and of combining citalopram with clomipramine in treatment-resistant OCD. 1 We report the results of a comparative clinical trial of a new antidepressant drug fluvoxamine (a specific re-uptake inhibitor of 5-hydroxytryptamine (5-HT)) with chlorimipramine. Thirty-two patients with mixed depression received one or the other drug at the same daily dosage of 150 mg. 2 In both drug groups there was an overall clinically significant improvement for all items on the Hamilton Rating Scale for Depression (67% improvement in both groups). 3 In the chlorimipramine group there were more digestive symptoms and anticholinergic effects; the difference with the fluvoxamine group approached statistical significance. 4 No clinically important effects of either treatment were observed on heart-rate or blood pressure. Although the standard treatments for the irritable bowel syndrome (IBS) are medical, growing evidence indicates the substantial therapeutic value of psychological therapy. However, it has not been investigated whether the combination of multicomponent behavioral therapy plus medical treatment is more effective than medical treatment alone. The aim of this study was to investigate this question in patients consulting a tertiary gastrointestinal (GI) referral center.
                Twenty-four IBS outpatients were randomly assigned to the combination of standardized multicomponent behavioral therapy plus standard medical treatment (SMBT) or standard medical treatment alone (SMT). SMBT included IBS information and education, progressive muscle relaxation, training in illness-related cognitive coping strategies, problem-solving, and assertiveness training in 10 sessions over 10 wk. SMT included standardized symptom-oriented medical treatment and regular visits to a gastroenterologist every second week. Posttreatment outcome measures consisted of quantification of GI, vegetative, and psychological symptoms by means of daily symptom diaries and the assessment of changes in rectovisceral perception thresholds, as well as of questionnaire measures on psychological distress, overall well-being, illness-related coping abilities, and quality of life. Follow-ups were conducted at 3- and 6-month intervals.
                Pre- and posttreatment evaluations showed significantly (p < 0.01) greater IBS symptom reduction as measured by daily symptom diaries for the SMBT group than for the SMT group. Rectovisceral perception remained unchanged by either treatment. Overall well-being significantly improved in the SMBT group but remained unchanged in the SMT group. Subjects in the SMBT group, unlike those in the SMT group, felt significantly more in control of their health, and quality of life was significantly improved in the SMBT group but remained unchanged in the SMT group.
                The data provide evidence that the combination of medical treatment plus multicomponent behavioral treatment is superior to medical treatment alone in the therapy of IBS. Seventy-seven patients with a primary diagnosis of social phobia (DSM-III-R) were randomized to treatment with the reversible and selective monoamine oxidase type A inhibitor brofaromine (n = 37) or placebo (n = 40) for 12 weeks in a double-blind trial. A fixed dose of 150 mg/day or a matching placebo was given after a 2-week dose titration phase. Patients with additional diagnoses of simple phobia, generalized anxiety disorder, dysthymia or major depressive disorder currently in remission were accepted. Patients with other Axis I mental disorders were excluded. In the brofaromine group, 78% of the patients scored much or very much improved on the Clinical Global Impression scale compared with 23% in the placebo group. The anxiety and avoidance scores on the Liebowitz Social Anxiety Scale (LSAS) were significantly reduced in favor of brofaromine. The clinical effects were not significantly correlated with the plasma concentration of brofaromine. After 12 weeks the brofaromine group scored significantly lower than the placebo group on a core depression part of the Montgomery-Asberg Depression Rating Scale. After 12 weeks of treatment the brofaromine group had significantly higher total scores on the LSAS than an age- and gender-matched group of healthy controls. The brofaromine group improved further during 9-month follow-up treatment period, whereas 60% of the placebo responders who continued long-term treatment relapsed. The most common side effects in the brofaromine group were sleep disturbances, dry mouth and nausea. 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. In a double-blind, long-term follow-up study, 117 bipolar patients received lithium carbonate, imipramine hydrochloride, or both and 150 unipolar patients received lithium carbonate, imipramine, both lithium carbonate and imipramine, or placebo. With bipolar patients, lithium carbonate and the combination treatment were superior to imipramine in preventing manic recurrences and were as effective as imipramine in preventing manic recurrences and were as effective as imipramine in preventing depressive episodes. The combination treatment provided no advantage over lithium carbonate alone. With unipolar patients, imipramine and the combination treatment were more effective than lithium carbonate and placebo in preventing depressive recurrences. The combination treatment provided no advantage over imipramine alone. The lithium carbonate-treated group had fewer manic episodes than the other groups. Treatment outcome, which was evaluated primarily in terms of the occurrence of major depression or manic episodes, was significantly related to characteristics of the index episode, ie, the episode that brought the patient into the study. We report two controlled comparisons of a previously validated multicomponent (relaxation, thermal biofeedback, and cognitive therapy) treatment for irritable bowel syndrome (IBS) to an ostensible attention-placebo control (pseudo-meditation and EEG alpha suppression biofeedback) and to a symptom-monitoring control. In Study 1 (n = 10 per condition) there were nonsignificant trends for the multicomponent treatment to be superior to the attention-placebo condition. In Study 2 (n = 30 per condition), we found no advantage for the multicomponent treatment over the attention-placebo condition. Subjects in both treatment conditions showed significant reductions in GI symptoms, as measured by daily symptom diaries, and significant reductions in trait anxiety and depression. The GI symptom reductions held up over a 6 month follow-up. Possible explanations for the results are explored. Tegaserod has been shown to be an effective therapy for the multiple symptoms of irritable bowel syndrome (IBS) in Western populations. However, little information is available regarding the use of tegaserod in the Asia-Pacific population.
                To evaluate the efficacy, safety, and tolerability of tegaserod versus placebo in patients with IBS from the Asia-Pacific region.
                A total of 520 patients from the Asia-Pacific region with IBS, excluding those with diarrhoea predominant IBS.
                Patients were randomised to receive either tegaserod 6 mg twice daily (n=259) or placebo (n=261) for a 12 week treatment period. The primary efficacy variable (over weeks 1-4) was the response to the question: "Over the past week do you consider that you have had satisfactory relief from your IBS symptoms?" Secondary efficacy variables assessed overall satisfactory relief over 12 weeks and individual symptoms of IBS.
                The mean proportion of patients with overall satisfactory relief was greater in the tegaserod group than in the placebo group over weeks 1-4 (56% v 35%, respectively; p<0.0001) and weeks 1-12 (62% v 44%, respectively; p<0.0001). A clinically relevant effect was observed as early as week 1 and was maintained throughout the treatment period. Reductions in the number of days with at least moderate abdominal pain/discomfort, bloating, no bowel movements, and hard/lumpy stools were greater in the tegaserod group compared with the placebo group. Headache was the most commonly reported adverse event (12.0% tegaserod v 11.1% placebo). Diarrhoea led to discontinuation in 2.3% of tegaserod patients. Serious adverse events were infrequent (1.5% tegaserod v 3.4% placebo).
                Tegaserod 6 mg twice daily is an effective, safe, and well tolerated treatment for patients in the Asia-Pacific region suffering from IBS and whose main bowel symptom is not diarrhoea. To verify the clinical efficacy and safety of the proven Chinese Compound Changjitai (CJT), in treating the diarrheic irritable bowel syndrome (DIBS).
                Randomized controlled open clinical trial design was adopted, 45 patients were randomly divided into two groups, CJT and pinaverium bromide (PVB) were given as treated and control agent respectively. IBS scoring system (BSS), defecation state questionnaire (DSQ) were used to record the changes of the patients' main symptoms before and after treatment.
                The total effective rate of CJT group was 83.3%, while that of PVB was 73.3%. CJT was superior in efficacy to that of PVB in improving stool quality, reducing defecation episodes of diarrheic patients, alleviating tenesmus symptoms, decreasing bellyache days and ameliorating abdominal distention. Any drug-related adverse reaction was not seen.
                The efficacy of CJT in treating DIBS is definite and without any toxic and adverse effects. It has been proposed that treatments for irritable bowel syndrome with constipation (IBS-C) should provide rapid symptomatic relief, be intermittent, and effective upon repeated use.
                To evaluate the efficacy and safety of tegaserod on IBS symptoms, and its impact on quality of life and health economic measures.
                Women (> or = 18 years of age) with IBS-C according to the Rome II criteria.
                Prospective, double blind, placebo controlled, randomised trial. Women with IBS-C either received tegaserod 6 mg twice daily or placebo for one month. Patients with at least a partial response entered a treatment free interval. Upon symptom recurrence, tegaserod treated patients were re-randomised to tegaserod or placebo for an additional month. Primary efficacy variables were response (overall IBS symptoms and abdominal discomfort/pain) to first and repeated treatment. Analysis was by intention to treat.
                2660 patients and 1191 patients were randomised for first and repeated treatment respectively. Tegaserod was superior to placebo for each primary efficacy variable (first treatment: 33.7% v 24.2% responders respectively for relief of IBS symptoms and 31.3% v 22.1% for relief of abdominal discomfort/pain; repeated treatment: 44.9% v 28.7%, and 42.4% v 27.1%, all p < 0.0001). Tegaserod was superior to placebo for every secondary efficacy variable (relief of abdominal discomfort/pain, bloating and constipation; stool frequency and consistency). A response to tegaserod was observed within the first treatment week. Tegaserod produced greater satisfaction, work productivity, and improved quality of life than placebo (p < 0.05).
                Tegaserod provides rapid and sustained relief of IBS-C symptoms both during first and repeated treatment. Inflammatory bowel disease (IBD) encompasses two related gastrointestinal-tract diseases, ulcerative colitis (UC) and Crohn's Disease (CD). This study, a randomized controlled trial, compared the effectiveness of a multi-component behavioral treatment package (n = 11), which included IBD education, progressive muscle relaxation, thermal biofeedback, and training in use of cognitive coping strategies, to the effectiveness of symptom-monitoring (n = 10) as a control condition; 8 controls subsequently completed treatment. At posttreatment, the treatment group showed mean reductions on 5 symptoms, while the symptom monitoring controls showed mean reductions on all 8 symptoms. On a measure of Total Symptomatic change, the controls showed more improvement than the treated group; the treated controls at posttreatment, showed increases on all 8 symptoms. However, treated subjects perceived themselves as coping better with IBD, as feeling less IBD-related stress, and as experiencing less depression and anxiety. It is hypothesized that inherent differences may have existed between CD and UC subjects which could have led to the differences seen in treatment responses. The efficacy of ciprofloxacin was compared with that of trimethoprim-sulfamethoxazole in a placebo-controlled trial of the 5-day treatment of acute diarrhea among 181 adults recently arrived in Guadalajara, Mexico. Both antimicrobial agents were significantly (p less than 0.0001) more efficacious than placebo in the treatment of diarrhea, with the average duration of diarrhea being 29, 20, and 81 hours, respectively, in the ciprofloxacin, trimethoprim-sulfamethoxazole, and placebo treatment groups. The antimicrobial agents were also more efficacious than placebo in treating diarrhea caused by enterotoxigenic Escherichia coli, invasive enteropathogens, and unknown pathogens. Both antimicrobials were effective in treating mild-to-moderate and moderate-to-severe disease, and both were well tolerated. Ciprofloxacin appears to be a logical alternative to trimethoprim-sulfamethoxazole in the initial treatment of acute travelers' diarrhea. Previous comparative studies of the selective serotonin reuptake inhibitors (SSRIs) have rarely included a placebo control group and have rarely demonstrated significant between-group differences. The study reported on here was a placebo-controlled comparison of the antidepressant effects of two SSRIs, citalopram and sertraline.
                Three hundred twenty-three patients with DSM-IV-defined major depressive disorder were randomized to 24 weeks of double-blind treatment with citalopram (20-60 mg/day), sertraline (50-150 mg/day), or a placebo. The primary efficacy measure was the Hamilton Depression Rating Scale (HAMD) and the primary statistical analysis was an analysis of variance comparing the change from baseline to the last observation carried forward in each treatment group.
                Both citalopram and sertraline produced significantly greater improvement than placebo on the HAMD, the Montgomery-Asberg Depression Rating Scale, and the Clinical Global Impression Scale. Significant improvement was observed at earlier timepoints in the citalopram group than the sertraline group; however, sertraline treatment was associated with increased gastrointestinal side effects and a tendency toward early discontinuation, and analyses that excluded early dropouts revealed similar acute efficacy for the two active treatments. The Hamilton Anxiety Scale demonstrated a significant anxiolytic effect of citalopram, but not sertraline, relative to placebo.
                This study confirms the antidepressant efficacy of two SSRIs, citalopram and sertraline. It is hypothesized that the more consistent evidence of antidepressant activity that was observed early in treatment in the citalopram group was related to more pronounced antianxiety effects and better tolerability upon initiation of therapy. Previous research from the United Kingdom has shown hypnotherapy to be effective in the treatment of irritable bowel syndrome (IBS). The current study provides a systematic replication of this work in the United States. Six matched pairs of IBS patients were randomly assigned to either a gut-directed hypnotherapy (n = 6) or to a symptom monitoring wait-list control condition (n = 6) in a multiple baseline across subjects design. Those assigned to the control condition were later crossed over to the treatment condition. Subjects were matched on concurrent psychiatric diagnoses, susceptibility to hypnosis, and various demographic features. On a composite measure of primary IBS symptoms, treatment was superior (p = .016) to symptom monitoring. Results from the entire treated sample (n = 11; one subject was removed from analysis) indicate that the individual symptoms of abdominal pain, constipation, and flatulence improved significantly. State and trait anxiety scores were also seen to decrease significantly. Results at the 2-month follow-up point indicated good maintenance of treatment gains. No significant correlation was found between initial susceptibility to hypnosis and treatment gain. A positive relationship was found between the incidence of psychiatric diagnosis and overall level of improvement. 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.
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.