| Summary: | 碩士 === 中國醫藥大學 === 中西醫結合研究所碩士班 === 98 === Background：
Irritable bowel syndrome (IBS) is a chronic continuous or remittent gastrointestinal illness characterized by frequent unexplained symptoms that include abdominal pain, bloating and bowel disturbance. There are no organic or structural lesion can be detected (using currently available diagnostic modalities) as present . It was stated by colonic motility and sensory nerve disharmony. The reported prevalence of patients in general population with symptoms consistent with IBS ranges from 10-20 %. Approximately 80 % of General physicians had no knowledge of diagnosing criteria . So the prevalence may be underestimating. More than 40 % of IBS patients suffer symptoms so frequent and severe that they have to take time off from work, curtail their social life, cancel appointments, stop traveling and even stay confined to their house for fear of embarrassment. So IBS should not be neglect. As present no single available treatment is reliable and effective for IBS . Therefore medical shopping occurred at this population.
Traditional Chinese medicine was reported to treat IBS in studies previously. But the study design was criticized.
Mehtods：
we created the study which is a prospective, randomized and double blinded placebo-controlled trial. Patients who fulfilled Rome II criteria without organic or structural abnormality after series examination were enrolled and were randomized to two groups (active treatment and control group).The active treatment group was prescribed GWESE01 9 grams per day. The control group was prescribed GWESE01 0.9 gram per day. We evaluated the efficacy and safety at week 4, week 8 and week 12 by using Gastrointestinal System Rating Scale-IBS(GSRS-IBS), global improvement score (WHOQOL-BREF, Taiwan version), Irritable Bowel Syndrome Quality of Life (IBS-QOL ) , hepatic and renal function by laboratory test. The results of the study were analyzed using the t- test.
Results：
There were 67 patients were screened totally . 54 patients which fulfilled the criteria of the study were recruited. 28 patients were randomized to active treatment group and 26 to control group. 18 patients in active treatment group and 18 patients in control group completed the study. Comparing GSRS-IBS and IBS-QOL’ scores of V1(week0)with V2(week4)、V3(week8) and V4(week12) in active treatment group , there is significant difference（P<0.05）.But there is no significant difference between active treatment group and control group .
Conclusion:
The improvement of GSRS-IBS and IBS-QOL scores in active treatment group is significant. The data revealed that improvement of active treatment group is more obvious than control group. Due to insufficient in case number, there is no significant difference between active treatment group and control group . For this reason, these researches need to get more case number and can be truly determined the efficacy of this formulation.
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