Division of Gastroenterology and Hepatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, Pennsylvania; Crohn's & Colitis Foundation Clinical Research Alliance, New York, New York.
Crohn's & Colitis Foundation Clinical Research Alliance, New York, New York; Division of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, North Carolina.
Gastroenterology. 2021 Sep;161(3):837-852.e9. doi: 10.1053/j.gastro.2021.05.047. Epub 2021 May 27.
BACKGROUND & AIMS: This study compared the effectiveness of the Specific Carbohydrate Diet (SCD) to the Mediterranean diet (MD) as treatment for Crohn's disease (CD) with mild to moderate symptoms.
Adult patients with CD and with mild-to-moderate symptoms were randomly assigned 1:1 to consume the MD or SCD for 12 weeks. For the first 6 weeks, participants received prepared meals and snacks according to their assigned diet. After 6 weeks, participants were instructed to follow the diet independently. The primary outcome was symptomatic remission at week 6. Key secondary outcomes at week 6 included fecal calprotectin (FC) response (FC <250 μg/g and reduction by >50% among those with baseline FC >250 μg/g) and C-reactive protein (CRP) response (high-sensitivity CRP <5 mg/L and >50% reduction from baseline among those with high-sensitivity CRP >5 mg/L).
The study randomized 194 patients, and 191 were included in the efficacy analyses. The percentage of participants who achieved symptomatic remission at week 6 was not superior with the SCD (SCD, 46.5%; MD, 43.5%; P = .77). FC response was achieved in 8 of 23 participants (34.8%) with the SCD and in 4 of 13 participants (30.8%) with the MD (P = .83). CRP response was achieved in 2 of 37 participants (5.4%) with the SCD and in 1 of 28 participants (3.6%) with the MD (P = .68).
The SCD was not superior to the MD to achieve symptomatic remission, FC response, and CRP response. CRP response was uncommon. Given these results, the greater ease of following the MD and other health benefits associated with the MD, the MD may be preferred to the SCD for most patients with CD with mild to moderate symptoms. ClinicalTrials.gov Identifier: NCT03058679.
本研究比较了特定碳水化合物饮食(SCD)与地中海饮食(MD)在治疗有轻到中度症状的克罗恩病(CD)方面的疗效。
患有 CD 且有轻到中度症状的成年患者被随机 1:1 分配到 SCD 或 MD 组,进行 12 周的治疗。在前 6 周,根据患者的饮食分配为他们提供准备好的餐食和零食。6 周后,患者需自行遵循饮食方案。主要终点是治疗第 6 周时的症状缓解。治疗第 6 周时的关键次要终点包括粪便钙卫蛋白(FC)应答(基线 FC>250μg/g 者 FC<250μg/g 和降低>50%)和 C 反应蛋白(CRP)应答(高敏 CRP>5mg/L 者 CRP<5mg/L 和降低>50%)。
本研究共纳入 194 例患者,其中 191 例患者被纳入疗效分析。治疗第 6 周时,达到症状缓解的患者比例在 SCD 组(46.5%)与 MD 组(43.5%)之间无显著差异(P=0.77)。SCD 组有 8 例(34.8%)患者达到 FC 应答,MD 组有 4 例(30.8%)患者达到 FC 应答(P=0.83)。SCD 组有 2 例(5.4%)患者达到 CRP 应答,MD 组有 1 例(3.6%)患者达到 CRP 应答(P=0.68)。
SCD 并未比 MD 更能达到症状缓解、FC 应答和 CRP 应答。CRP 应答很少见。鉴于这些结果,MD 更容易遵循,并且与 MD 相关的其他健康益处可能更适合大多数有轻到中度症状的 CD 患者,而不是 SCD。临床试验注册编号:NCT03058679。