Abstract：
BACKGROUND: Dietary advice and medical treatments are recommended to patients with irritable bowel syndrome (IBS). Studies have not yet compared the efficacy of dietary treatment with pharmacological treatment targeting the predominant IBS symptom. We therefore aimed to compare the effects of two restrictive dietary treatment options versus optimised medical treatment in people with IBS.
METHODS: This single-centre, single-blind, randomised controlled trial was conducted in a specialised outpatient clinic at the Sahlgrenska University Hospital, Gothenburg, Sweden. Participants (aged ≥18 years) with moderate-to-severe IBS (Rome IV; IBS Severity Scoring System [IBS-SSS] ≥175) and no other serious diseases or food allergies were randomly assigned (1:1:1) by web-based randomisation to receive a diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) plus traditional IBS dietary advice recommended by the UK National Institute for Health and Care Excellence (hereafter the LFTD diet), a fibre-optimised diet low in total carbohydrates and high in protein and fat (hereafter the low-carbohydrate diet), or optimised medical treatment based on predominant IBS symptom. Participants were masked to the names of the diets, but the pharmacological treatment was open-label. The intervention lasted 4 weeks, after which time participants in the dietary interventions were unmasked to their diets and encouraged to continue during 6 months\' follow-up, participants in the LFTD group were instructed on how to reintroduce FODMAPs, and participants receiving pharmacological treatment were offered diet counselling and to continue with their medication. The primary endpoint was the proportion of participants who responded to the 4-week intervention, defined as a reduction of 50 or more in IBS-SSS relative to baseline, and was analysed per modified intention-to-treat (ie, all participants who started the intervention). Safety was analysed in the modified intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT02970591, and is complete.
RESULTS: Between Jan 24, 2017, and Sept 2, 2021, 1104 participants were assessed for eligibility and 304 were randomly assigned. Ten participants did not receive their intervention after randomisation and thus 294 participants were included in the modified intention-to-treat population (96 assigned to the LFTD diet, 97 to the low-carbohydrate diet, and 101 to optimised medical treatment). 241 (82%) of 294 participants were women and 53 (18%) were men and the mean age was 38 (SD 13). After 4 weeks, 73 (76%) of 96 participants in the LFTD diet group, 69 (71%) of 97 participants in the low-carbohydrate diet group, and 59 (58%) of 101 participants in the optimised medical treatment group had a reduction of 50 or more in IBS-SSS compared with baseline, with a significant difference between the groups (p=0·023). 91 (95%) of 96 participants completed 4 weeks in the LFTD group, 92 (95%) of 97 completed 4 weeks in the low-carbohydrate group, and 91 (90%) of 101 completed 4 weeks in the optimised medical treatment group. Two individuals in each of the intervention groups stated that adverse events were the reason for discontinuing the 4-week intervention. Five (5%) of 91 participants in the optimised medical treatment group stopped treatment prematurely due to side-effects. No serious adverse events or treatment-related deaths occurred.
CONCLUSIONS: Two 4-week dietary interventions and optimised medical treatment reduced the severity of IBS symptoms, with a larger effect size in the diet groups. Dietary interventions might be considered as an initial treatment for patients with IBS. Research is needed to enable personalised treatment strategies.
BACKGROUND: The Healthcare Board Region Västra Götaland, the Swedish Research Council, the Swedish Research Council for Health, Working Life and Welfare, AFA Insurance, grants from the Swedish state, the Wilhelm and Martina Lundgren Science Foundation, Skandia, the Dietary Science Foundation, and the Nanna Swartz Foundation.
METHODS: This single-centre, single-blind, randomised controlled trial was conducted in a specialised outpatient clinic at the Sahlgrenska University Hospital, Gothenburg, Sweden. Participants (aged ≥18 years) with moderate-to-severe IBS (Rome IV; IBS Severity Scoring System [IBS-SSS] ≥175) and no other serious diseases or food allergies were randomly assigned (1:1:1) by web-based randomisation to receive a diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) plus traditional IBS dietary advice recommended by the UK National Institute for Health and Care Excellence (hereafter the LFTD diet), a fibre-optimised diet low in total carbohydrates and high in protein and fat (hereafter the low-carbohydrate diet), or optimised medical treatment based on predominant IBS symptom. Participants were masked to the names of the diets, but the pharmacological treatment was open-label. The intervention lasted 4 weeks, after which time participants in the dietary interventions were unmasked to their diets and encouraged to continue during 6 months\' follow-up, participants in the LFTD group were instructed on how to reintroduce FODMAPs, and participants receiving pharmacological treatment were offered diet counselling and to continue with their medication. The primary endpoint was the proportion of participants who responded to the 4-week intervention, defined as a reduction of 50 or more in IBS-SSS relative to baseline, and was analysed per modified intention-to-treat (ie, all participants who started the intervention). Safety was analysed in the modified intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT02970591, and is complete.
RESULTS: Between Jan 24, 2017, and Sept 2, 2021, 1104 participants were assessed for eligibility and 304 were randomly assigned. Ten participants did not receive their intervention after randomisation and thus 294 participants were included in the modified intention-to-treat population (96 assigned to the LFTD diet, 97 to the low-carbohydrate diet, and 101 to optimised medical treatment). 241 (82%) of 294 participants were women and 53 (18%) were men and the mean age was 38 (SD 13). After 4 weeks, 73 (76%) of 96 participants in the LFTD diet group, 69 (71%) of 97 participants in the low-carbohydrate diet group, and 59 (58%) of 101 participants in the optimised medical treatment group had a reduction of 50 or more in IBS-SSS compared with baseline, with a significant difference between the groups (p=0·023). 91 (95%) of 96 participants completed 4 weeks in the LFTD group, 92 (95%) of 97 completed 4 weeks in the low-carbohydrate group, and 91 (90%) of 101 completed 4 weeks in the optimised medical treatment group. Two individuals in each of the intervention groups stated that adverse events were the reason for discontinuing the 4-week intervention. Five (5%) of 91 participants in the optimised medical treatment group stopped treatment prematurely due to side-effects. No serious adverse events or treatment-related deaths occurred.
CONCLUSIONS: Two 4-week dietary interventions and optimised medical treatment reduced the severity of IBS symptoms, with a larger effect size in the diet groups. Dietary interventions might be considered as an initial treatment for patients with IBS. Research is needed to enable personalised treatment strategies.
BACKGROUND: The Healthcare Board Region Västra Götaland, the Swedish Research Council, the Swedish Research Council for Health, Working Life and Welfare, AFA Insurance, grants from the Swedish state, the Wilhelm and Martina Lundgren Science Foundation, Skandia, the Dietary Science Foundation, and the Nanna Swartz Foundation.
摘要：
背景：对肠易激综合征（IBS）患者推荐饮食建议和药物治疗。研究尚未将饮食治疗与针对主要IBS症状的药物治疗的功效进行比较。因此，我们旨在比较IBS患者两种限制性饮食治疗方案与优化药物治疗方案的效果。
方法：这种单中心，单盲,随机对照试验在Sahlgrenska大学医院的专科门诊进行，哥德堡,瑞典。中度至重度IBS（罗马IV;IBS严重程度评分系统[IBS-SSS]≥175）且无其他严重疾病或食物过敏的参与者（年龄≥18岁）通过网络随机分配（1：1：1）接受低可发酵寡糖饮食，二糖，单糖，和多元醇（FODMAP）加上英国国家健康与护理卓越研究所推荐的传统IBS饮食建议（以下简称LFTD饮食），低碳水化合物和高蛋白质和脂肪的纤维优化饮食（以下简称低碳水化合物饮食），或基于主要IBS症状的优化药物治疗。参与者被掩盖了饮食的名称，但药物治疗是开放标签。干预持续了4周,之后，参与饮食干预的参与者被揭露他们的饮食，并被鼓励在6个月的随访期间继续进行，LFTD组的参与者被指导如何重新引入FODMAP，接受药物治疗的参与者接受了饮食咨询,并继续接受药物治疗.主要终点是对4周干预有反应的参与者比例，定义为IBS-SSS相对于基线减少50或更多，并按修改后的意向治疗进行分析(即，所有开始干预的参与者)。在改良的意向治疗人群中分析安全性。该试验已在ClinicalTrials.gov注册，NCT02970591，并且完成。
结果：在2017年1月24日至2021年9月2日之间，对1104名参与者进行了资格评估，对304名参与者进行了随机分配。10名参与者在随机分组后没有接受干预，因此294名参与者被纳入改良的意向治疗人群(96名参与者被分配到LFTD饮食，97到低碳水化合物饮食，和101以优化医疗)。294名参与者中有241名（82%）是女性，53名（18%）是男性，平均年龄为38岁（SD13）。4周后,LFTD饮食组的96名参与者中有73名（76％），低碳水化合物饮食组97名参与者中有69名（71%），与基线相比，优化药物治疗组101名参与者中有59名（58％）的IBS-SSS减少了50或更多，组间差异显著(p=0·023)。在LFTD组中，96名参与者中有91名（95％）完成了4周，在低碳水化合物组中，97人中有92人（95％）完成了4周，在优化的药物治疗组中，101人中有91人(90%)完成了4周的治疗。每个干预组中的两个个体表示不良事件是中断4周干预的原因。优化药物治疗组的91名参与者中有5名（5％）由于副作用而过早停止治疗。没有发生严重不良事件或治疗相关死亡。
结论：两个为期4周的饮食干预和优化的药物治疗降低了IBS症状的严重程度，在饮食组中具有更大的效果大小。饮食干预可能被认为是IBS患者的初始治疗方法。需要进行研究以实现个性化治疗策略。
背景：医疗保健委员会地区VästraGötaland，瑞典研究委员会,瑞典卫生研究委员会,工作生活和福利，AFA保险，来自瑞典国家的赠款，Wilhelm和MartinaLundgren科学基金会,Skandia,膳食科学基金会,和NannaSwartz基金会.
方法：这种单中心，单盲,随机对照试验在Sahlgrenska大学医院的专科门诊进行，哥德堡,瑞典。中度至重度IBS（罗马IV;IBS严重程度评分系统[IBS-SSS]≥175）且无其他严重疾病或食物过敏的参与者（年龄≥18岁）通过网络随机分配（1：1：1）接受低可发酵寡糖饮食，二糖，单糖，和多元醇（FODMAP）加上英国国家健康与护理卓越研究所推荐的传统IBS饮食建议（以下简称LFTD饮食），低碳水化合物和高蛋白质和脂肪的纤维优化饮食（以下简称低碳水化合物饮食），或基于主要IBS症状的优化药物治疗。参与者被掩盖了饮食的名称，但药物治疗是开放标签。干预持续了4周,之后，参与饮食干预的参与者被揭露他们的饮食，并被鼓励在6个月的随访期间继续进行，LFTD组的参与者被指导如何重新引入FODMAP，接受药物治疗的参与者接受了饮食咨询,并继续接受药物治疗.主要终点是对4周干预有反应的参与者比例，定义为IBS-SSS相对于基线减少50或更多，并按修改后的意向治疗进行分析(即，所有开始干预的参与者)。在改良的意向治疗人群中分析安全性。该试验已在ClinicalTrials.gov注册，NCT02970591，并且完成。
结果：在2017年1月24日至2021年9月2日之间，对1104名参与者进行了资格评估，对304名参与者进行了随机分配。10名参与者在随机分组后没有接受干预，因此294名参与者被纳入改良的意向治疗人群(96名参与者被分配到LFTD饮食，97到低碳水化合物饮食，和101以优化医疗)。294名参与者中有241名（82%）是女性，53名（18%）是男性，平均年龄为38岁（SD13）。4周后,LFTD饮食组的96名参与者中有73名（76％），低碳水化合物饮食组97名参与者中有69名（71%），与基线相比，优化药物治疗组101名参与者中有59名（58％）的IBS-SSS减少了50或更多，组间差异显著(p=0·023)。在LFTD组中，96名参与者中有91名（95％）完成了4周，在低碳水化合物组中，97人中有92人（95％）完成了4周，在优化的药物治疗组中，101人中有91人(90%)完成了4周的治疗。每个干预组中的两个个体表示不良事件是中断4周干预的原因。优化药物治疗组的91名参与者中有5名（5％）由于副作用而过早停止治疗。没有发生严重不良事件或治疗相关死亡。
结论：两个为期4周的饮食干预和优化的药物治疗降低了IBS症状的严重程度，在饮食组中具有更大的效果大小。饮食干预可能被认为是IBS患者的初始治疗方法。需要进行研究以实现个性化治疗策略。
背景：医疗保健委员会地区VästraGötaland，瑞典研究委员会,瑞典卫生研究委员会,工作生活和福利，AFA保险，来自瑞典国家的赠款，Wilhelm和MartinaLundgren科学基金会,Skandia,膳食科学基金会,和NannaSwartz基金会.
