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Thalidomide for Recurrent Bleeding Due to Small-Intestinal Angiodysplasia
Huimin Chen1, Shan Wu1, Mingyu Tang1
1From the Division of Gastroenterology and Hepatology, Shanghai Jiao-Tong University School of Medicine Renji Hospital, Shanghai Institute of Digestive Disease, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health (Shanghai Jiao-Tong University) (Huimin Chen, S.W., M.T., R.Z., Q.Z., Z.D., Y.G., X.L., H.L., H. Xiong, Y.S., Haiying Chen, S.G., H. Xue, Z.G.), the Department of Gastroenterology and Hepatology, Changhai Hospital, Naval Medical University (Z.L., Y.D.), the Department of Gastroenterology, Huashan Hospital (L.Z.), and the Department of Gastroenterology and Hepatology, Zhongshan Hospital (X.S.), Fudan University, the Department of Gastroenterology, Shanghai General Hospital, Shanghai Jiao-Tong University School of Medicine (L.L.), the Department of Gastroenterology, Xinhua Hospital, Shanghai Jiao-Tong University School of Medicine (L.X.), and the Department of Gastroenterology, Ruijin Hospital, Shanghai Jiao-Tong University School of Medicine (J.Z.), Shanghai, the Department of Gastroenterology, Xinqiao Hospital, Army Medical University, Chongqing (S.Y.), the Department of Gastroenterology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing (A.Y.), and the Department of Gastroenterology, Guangdong Provincial Key Laboratory of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou (S.L.) - all in China.
Thalidomide significantly reduced recurrent small intestinal bleeding (SIA) in patients. This study confirms thalidomide
Area of Science:
- Gastroenterology
- Clinical Pharmacology
Background:
- Recurrent small intestinal bleeding (SIA) is a significant clinical challenge, accounting for 5-10% of GI bleeding cases.
- Previous evaluations of thalidomide for SIA lacked confirmatory trial data.
Purpose of the Study:
- To investigate the efficacy and safety of thalidomide in treating recurrent bleeding due to small-intestinal angiodysplasia (SIA).
Main Methods:
- A multicenter, double-blind, randomized, placebo-controlled trial involving 150 patients with recurrent SIA.
- Patients received oral thalidomide (100 mg or 50 mg daily) or placebo for 4 months, followed by at least 1 year of observation.
- Primary endpoint was a ≥50% reduction in bleeding episodes post-treatment compared to pre-treatment.
Main Results:
- Effective response rates were significantly higher with thalidomide (68.6% for 100 mg, 51.0% for 50 mg) compared to placebo (16.0%) (P<0.001).
- Secondary endpoints, including cessation of bleeding and improved hemoglobin levels, also favored thalidomide treatment.
- Adverse events like constipation and somnolence were more frequent in thalidomide groups.
Conclusions:
- Thalidomide treatment effectively reduced recurrent bleeding in patients with small-intestinal angiodysplasia.
- The study provides robust evidence supporting thalidomide's therapeutic role in managing this challenging condition.
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