A New Pharmacologic Treatment of Functional Gastrointestinal Disorder: A Double-Blind Placebo-Controlled Study with Mianserin

Tanum, Lars; Malt, UF

doi:10.3109/00365529609006404

Cited by 83 publications

(66 citation statements)

References 19 publications

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“…However, because 7 of the 15 patients withdrew from the trial, the results must be interpreted with caution. According to an RCT involving patients with functional gastrointestinal disorders (IBS and non-ulcer dyspepsia), the administration of the tetracyclic antidepressant mianserin significantly improved abdominal symptoms and social dysfunction, compared with a placebo [123]. Although antidepressants are effective for IBS, they likely have various side effects.…”

Section: Commentmentioning

confidence: 99%

Evidence-based clinical practice guidelines for irritable bowel syndrome

et al. 2014

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New strategies for the care of irritable bowel syndrome (IBS) are developing and several novel treatments have been globally produced. New methods of care should be customized geographically because each country has a specific medical system, life style, eating habit, gut microbiota, genes and so on. Several clinical guidelines for IBS have been proposed and the Japanese Society of Gastroenterology (JSGE) subsequently developed evidence-based clinical practice guidelines for IBS. Sixty-two clinical questions (CQs) comprising 1 definition, 6 epidemiology, 6 pathophysiology, 10 diagnosis, 30 treatment, 4 prognosis, and 5 complications were proposed and statements were made to answer to CQs. A diagnosis algorithm and a three-step treatment was provided for patients with chronic abdominal pain or abdominal discomfort and/or abnormal bowel movement. If more than one alarm symptom/sign, risk factor and/or routine examination is positive, colonoscopy is indicated. If all of them, or the subsequent colonoscopy, are/is negative, Rome III or compatible criteria is applied. After IBS diagnosis, step 1 therapy consisting of diet therapy, behavioral modification and guttargeted pharmacotherapy is indicated for four weeks. Nonresponders to step 1 therapy proceed to the second step that includes psychopharmacological agents and simple psychotherapy for four weeks. In the third step, for patients nonresponsive to step 2 therapy, a combination of gut-targeted pharmacotherapy, psychopharmacological treatments and/or specific psychotherapy is/are indicated. Clinical guidelines and consensus for IBS treatment in Japan are well suited for Japanese IBS patients; as such, they may provide useful insight for IBS treatment in other countries around the world.

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Section: Commentmentioning

confidence: 99%

Evidence-based clinical practice guidelines for irritable bowel syndrome

et al. 2014

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“…As the precise etiology of functional dyspepsia is not known, empirical therapies such as antidepressant with uncertain efficacy are reserved for difficult cases as options (9,10). Although the clinical implications of the CYP2C19 mutations have not been clearly established, it may be anticipated that the PMs are more likely to develop adverse effects to antidepressants that are substrates of the enzyme if given at normal doses.…”

Section: Discussionmentioning

confidence: 99%

The prevalence of CYP2C19 mutations in Turkish patients with dyspepsia

Çelebi

Kocaman²,

Savlı³

et al. 2009

Turk J Gastroenterol

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“…Moreover, trials should include baseline assessment of symptoms, account for patient disposition (discontinuations, withdrawals, etc), provide sample size calculation and enroll an adequate number of patients, with the primary outcome being improvement of global IBS symptoms based on patient assessment and/or use of a validated scale to assess IBS symptoms [3] . To date, 10 randomized, controlled trials and two crossover studies have evaluated the effectiveness of TCAs in the treatment of IBS [10][11][12][13][14][15][16][17][18] . The largest and best study to date on TCAs was done by Drossman et al [19] , investigating the role of desipramine in patients with functional disorders.…”

Section: Discussionmentioning

confidence: 99%

“…The primary study endpoint was global symptom relief as assessed by the patient at the end of the 12-wk treatment. Secondary endpoints were symptom relief at week 16 and changes in quality of life (QoL) as measured using the short form SF-36 questionnaire. Figure 1 shows the general design of the study.…”

Section: Introductionmentioning

confidence: 99%

A randomized controlled trial of imipramine in patients with irritable bowel syndrome

Abdul‐Baki¹,

Hajj²,

El-Zahabi³

et al. 2009

WJG

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AIM:To study the efficacy of low-dose imipramine in relieving symptoms associated with the irritable bowel syndrome (IBS). METHODS:A randomized, double-blind trial of 25 mg imipramine vs matched placebo for 12 wk was performed. Doubling the dose was allowed once at week 2 in case of an unsatisfactory early response. Primary efficacy variables were subjective global symptom relief and quality of life (QoL) using SF-36 at week 12. RESULTS:One hundred and seven patients were enrolled by advertisement or referral by general practitioners and 56 (31 imipramine: 25 placebo) completed the 16-wk study. Baseline characteristics were comparable. A high overall dropout rate was noted in the imipramine and placebo arms (47.5% vs 47.9%, P > 0.05), a mean of 25.0 and 37.4 d from enrollment, respectively (P < 0.05). At the end of 12 wk, there was a significant difference in global symptom relief with imipramine over placebo (per-protocol: 80.6% vs 48.0%, P = 0.01) and a trend on intent-to-treat (ITT) analysis (42.4% vs 25.0%, P = 0.06). This improvement was evident early and persisted to week 16 (P = 0.024 and 0.053 by per-protocol and ITT analyses, respectively). Mean cumulative and componentspecific SF-36 scores improved in the imipramine group only (per-protocol, P < 0.01). Drug-related adverse events leading to patient dropout were more common in the imipramine group (25.4% vs 12.5%, P > 0.05). CONCLUSION:Imipramine may be effective in the treatment of IBS patients and is associated with improved QoL. Careful patient selection, initiation of a low dose with gradual escalation and monitoring for side effects may result in an improved therapeutic response.

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A New Pharmacologic Treatment of Functional Gastrointestinal Disorder: A Double-Blind Placebo-Controlled Study with Mianserin

Abstract: Mianserin may be an effective and well-tolerated pharmacologic short-term treatment for functional gastrointestinal disorders in patients with no clinical evidence of psychopathology.

Cited by 83 publications

References 19 publications

Evidence-based clinical practice guidelines for irritable bowel syndrome

Evidence-based clinical practice guidelines for irritable bowel syndrome

The prevalence of CYP2C19 mutations in Turkish patients with dyspepsia

A randomized controlled trial of imipramine in patients with irritable bowel syndrome

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