前言：大腸激躁症是一種慢性持續性或反覆性胃腸疾病，其特徵為經常性的腹痛、腹脹、腸胃功能紊亂。病因目前尚未十分清楚，主要與腸胃的蠕動及感覺神經不協調有關。大腸激躁症的盛行率據美澳的統計約為10-20%，雖然大腸激躁症沒有致命的危險性，但大於40%的病人症狀可能嚴重到無法工作、參與社交活動、不敢長途旅行甚至不敢出門，大大的影響生活品質。目前西醫對大腸激躁症的治療僅止於症狀治療，沒有單一可靠的治療方式。
中醫藥治療腸胃道功能性疾病具全方位考量的優點，臨床上療效肯定，故以本試驗來評估驗證中藥驗方的療效，以期改善病人的生活品質，減少醫療資源的過度不當使用。本研究目的在於評估加味逍遙散對大腸激躁症的療效及安全性。
方法：本研究篩選符合Rome II大腸激躁症診斷標準，年齡介於20~60歲，男女不拘，受試者依隨機、對照、雙盲法則，分為實驗組與對照組，實驗組服用加味逍遙散9克/天，分三次服用。對照組服用安慰劑（低劑量加味逍遙散）0.9克/天，分三次服用。受試者於服藥前接受理學檢查、腸道症狀量表評分(GastrointestinalSymptomRatingScale-IrritableBowelSyndrome GSRS-IBS)、總體改善計分(世界衛生組織生活品質問卷台灣簡明版 WHOQOL-BREF,Taiwan version)、大腸激躁症生活品質評量表(Irritable Bowel Syndrome-Quality Of Life IBS-QOL )評估，之後開始服藥，共計服藥8週，每4周回診一次。以腸道症狀量表評分、總體改善計分、大腸激躁症生活品質評量表評分為療效判斷標準，以肝腎功能生化檢查及ADR來評估藥物的安全性。
結果：本研究共篩選67位患者，有54位符合收案標準進入隨機分組，36位回診三次完成試驗。比較實驗組和對照組兩組療效雖未達統計差異，但數據分析顯示實驗組改善之趨勢較對照組明顯，實驗組患者經藥物治療四周後，其GSRS-IBS及IBS-QOL分數即有明顯降低達統計差異（P<0.05），之後，於治療八周（第八周）及停藥四周（第十二周）之分數亦持續明顯的降低。
結論：實驗組GSRS-IBS及IBS-QOL分數明顯改善，且數據分析顯示實驗組改善之趨勢較對照組明顯，此改善之趨勢於停藥後四周的追蹤還是明顯持續，基於療效、副作用，及安全性結果之分析發現，本方應值得進一步更大規模臨床研究，故此古方未來的研究宜再增加收案數，建議以多中心收案方式增加收案數，使受試者便利就近回診評估以減少退出（drop out）比率，並增加研究治療時間，或可改變對照組的實驗設計，減低安慰劑效應，或可於西方醫學的診斷標準下再加入中醫學的辨證理論為篩選受試者標準，以期能了解此方對於大腸激燥症之真正療效。
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.
