EVALUATION OF TREATMENT OUTCOME MEASURES IN IRRITABLE BOWEL SYNDROME CLINICAL TRIALS

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GHOLAMREZAEI A.; NEMATI K.; MINAKARI M.; DAGHAGHZADEH H.; TAVAKKOLI H.; EMAMI M.H.

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Journal: GOVARESH JOURNAL Year:2010 | Volume:14 | Issue:4 (69) Page(s): 219-225

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Title

EVALUATION OF TREATMENT OUTCOME MEASURES IN IRRITABLE BOWEL SYNDROME CLINICAL TRIALS

Author(s)

Keywords

IRRITABLE BOWEL SYNDROMEQ2

TREATMENT OUTCOME MEASUREQ3

END POINTQ3

CLINICAL TRIALQ3

SYMPTOM SEVERITYQ2

QUALITY OF LIFEQ2

Abstract

Background: In CLINICAL TRIALs of IRRITABLE BOWEL SYNDROME (IBS), evaluation of treatment efficacy is still mainly subjective. We compared three outcome measures in reflecting response to treatment in a CLINICAL TRIAL of IBS.Materials and Methods: Sixty three adult IBS patients participated in a placebo-controlled trial of 10-wk cognitive-behavioral therapy. Patients completed .the IBS-quality of Life questionnaire (IBS-QOL), IBS-symptom severity scale (IBS-SSS), extra-intestinal SYMPTOM SEVERITY scale (EISSS), and Hospital Anxiety and Depression Scale (HADS) before and after the intervention. After the intervention, patients responded to the IBS-Adequate Relied (IBS-AR) and IBS-Global Assessment of Improvement (IBS-GAI) instruments. Patients were categorized into responders and non-responders based on each of the IBS-AR, IBS-GAI, and IBS-SSS instruments. QUALITY OF LIFE, IBS and extra-intestinal symptoms severity, anxiety, and depression scores were compared-between the responders and non-responders.Results: Forty six patients (mean age 31.5±6.9 years, 82.6% female) completed the study. After the intervention, significant correlations were found between responder definitions results (r=0.385 to 0.689, P<0.001). Compared with IBS-AR and IBS-GAI, defining responders based on the IBS-SSS instrument was related to more reduction in severities of IBS and extra-intestinal symptoms, anxiety, and depression scores and to more increase in QUALITY OF LIFE scores.Conclusion: The IBS-SSS instrument is more comprehensive in reflecting changes in symptoms severity, QUALITY OF LIFE,-and psychological status compared with other outcome measures. IBS-AR is accepted as the current standard for evaluating the efficacy of IBS treatments, however, we recommend IBS-SSS to be applied as well.

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APA: Copy

GHOLAMREZAEI, A., NEMATI, K., MINAKARI, M., DAGHAGHZADEH, H., TAVAKKOLI, H., & EMAMI, M.H.. (2010). EVALUATION OF TREATMENT OUTCOME MEASURES IN IRRITABLE BOWEL SYNDROME CLINICAL TRIALS. GOVARESH JOURNAL, 14(4 (69)), 219-225. SID. https://sid.ir/paper/86287/en

Vancouver: Copy

GHOLAMREZAEI A., NEMATI K., MINAKARI M., DAGHAGHZADEH H., TAVAKKOLI H., EMAMI M.H.. EVALUATION OF TREATMENT OUTCOME MEASURES IN IRRITABLE BOWEL SYNDROME CLINICAL TRIALS. GOVARESH JOURNAL[Internet]. 2010;14(4 (69)):219-225. Available from: https://sid.ir/paper/86287/en

IEEE: Copy

A. GHOLAMREZAEI, K. NEMATI, M. MINAKARI, H. DAGHAGHZADEH, H. TAVAKKOLI, and M.H. EMAMI, “EVALUATION OF TREATMENT OUTCOME MEASURES IN IRRITABLE BOWEL SYNDROME CLINICAL TRIALS,” GOVARESH JOURNAL, vol. 14, no. 4 (69), pp. 219–225, 2010, [Online]. Available: https://sid.ir/paper/86287/en

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