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Randomized Controlled Trial
隨機對照試驗
. 2009 Aug 27:339:b3154.
doi: 10.1136/bmj.b3154.

Soluble or insoluble fibre in irritable bowel syndrome in primary care? Randomised placebo controlled trial
原文:在初級保健中,患過敏性腸症候群的可溶性或不可溶性纖維?隨機安慰劑對照試驗 Translated Text: 在初級保健中,患過敏性腸症候群的可溶性或不可溶性纖維?隨機安慰劑對照試驗

Affiliations  聯繫
Randomized Controlled Trial

Soluble or insoluble fibre in irritable bowel syndrome in primary care? Randomised placebo controlled trial
原文:在初級保健中,患過敏性腸症候群的可溶性或不可溶性纖維?隨機安慰劑對照試驗 Translated Text: 在初級保健中,患過敏性腸症候群的可溶性或不可溶性纖維?隨機安慰劑對照試驗

C J Bijkerk et al. BMJ. .

Abstract  摘要

Objective: To determine the effectiveness of increasing the dietary content of soluble fibre (psyllium) or insoluble fibre (bran) in patients with irritable bowel syndrome.
目標: 確定增加可溶性纖維(洋車前子)或不溶性纖維(麩皮)在患有過敏性腸症候群的患者中的效果。

Design: Randomised controlled trial.
設計: 隨機對照試驗.

Setting: General practice.
設定: 一般實踐。

Participants: 275 patients aged 18-65 years with irritable bowel syndrome.
參與者: 275 名 18-65 歲患有過敏性腸症候群的患者。

Interventions: 12 weeks of treatment with 10 g psyllium (n=85), 10 g bran (n=97), or 10 g placebo (rice flour) (n=93).
干預: 12 週的治療,使用 10 克洋車前子(n=85)、10 克麩(n=97)或 10 克安慰劑(米粉)(n=93)。

Main outcome measures: The primary end point was adequate symptom relief during at least two weeks in the previous month, analysed after one, two, and three months of treatment to assess both short term and sustained effectiveness. Secondary end points included irritable bowel syndrome symptom severity score, severity of abdominal pain, and irritable bowel syndrome quality of life scale.
主要結果指標: 主要終點是在前一個月至少兩週期間達到足夠的症狀緩解,在治療後一個月、兩個月和三個月進行分析,以評估短期和持續有效性。次要終點包括過敏性腸症狀嚴重程度評分、腹痛嚴重程度和過敏性腸症狀生活品質量表。

Results: The proportion of responders was significantly greater in the psyllium group than in the placebo group during the first month (57% v 35%; relative risk 1.60, 95% confidence interval 1.13 to 2.26) and the second month of treatment (59% v 41%; 1.44, 1.02 to 2.06). Bran was more effective than placebo during the third month of treatment only (57% v 32%; 1.70, 1.12 to 2.57), but this was not statistically significant in the worst case analysis (1.45, 0.97 to 2.16). After three months of treatment, symptom severity in the psyllium group was reduced by 90 points, compared with 49 points in the placebo group (P=0.03) and 58 points in the bran group (P=0.61 versus placebo). No differences were found with respect to quality of life. Fifty four (64%) of the patients allocated to psyllium, 54 (56%) in the bran group, and 56 (60%) in the placebo group completed the three month treatment period. Early dropout was most common in the bran group; the main reason was that the symptoms of irritable bowel syndrome worsened.
結果: 在治療的第一個月(57%對 35%;相對風險 1.60,95%置信區間 1.13 至 2.26)和第二個月期間,應答者的比例在洋車菊組中明顯高於安慰劑組(59%對 41%;1.44,1.02 至 2.06)。在治療的第三個月中,麥麩僅比安慰劑更有效(57%對 32%;1.70,1.12 至 2.57),但在最壞情況分析中這在統計上並不顯著(1.45,0.97 至 2.16)。治療三個月後,洋車菊組的症狀嚴重程度減少了 90 分,而安慰劑組減少了 49 分(P=0.03),麥麩組減少了 58 分(P=0.61 與安慰劑相比)。就生活品質而言,沒有發現差異。分別有 54 名(64%)派給洋車菊組的患者,54 名(56%)麥麩組的患者,以及 56 名(60%)安慰劑組的患者完成了三個月的治療期。早期退出在麥麩組中最常見;主要原因是過敏性腸症狀惡化。

Conclusions: Psyllium offers benefits in patients with irritable bowel syndrome in primary care.
結論: 車前子對於初級保健中的過敏性腸症候群患者有益。

Trial registration: Clinical trials NCT00189033.
試驗註冊: 臨床試驗 NCT00189033.

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Conflict of interest statement
利益衝突聲明

Competing interests: None declared.
競爭利益:未宣布。

Figures  數字

None
Fig 1 Flow chart of trial. No patients assigned to psyllium, bran, or placebo received different treatment. EMF=electronic medical file; IBS=irritable bowel syndrome. *Number exceeds 724 because more than one reason could be given
None
Fig 2 Proportion of patients with adequate relief of symptoms each week (intention to treat analysis). *P<0.05

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