Original ResearchClinical—Alimentary TractEfficacy of Thalidomide for Refractory Gastrointestinal Bleeding From Vascular Malformation
Section snippets
Study Population
Consecutive patients who were diagnosed with GIVM at the Department of Gastroenterology, Renji Hospital, from November 2003 to November 2007 were eligible for the screening for the study.
Patients must have met the following inclusion criteria to enter the study: (1) patients were between 40 and 85 years old; (2) female patients were postmenopausal, with post-tubal ligation, or females with childbearing potential using some form of birth control (eg, contraceptive ring or latex condoms); (3)
Demographical and Clinical Characteristics
A total of 80 patients confirmed as having GIVM were screened and 2 patients who did not complete the 1-year observation were excluded from the study. Thus, 78 patients were enrolled and completed the 1-year observation, during which 19 patients had <6 bleeding episodes and 59 had ≥6 bleeding episodes. Of these 59 patients eligible for randomization, 2 developed severe concomitant diseases and had to be withdrawn and another 2 patients refused to continue. Fifty-five patients were finally
Discussion
This exploratory study showed that thalidomide is an effective and relatively safe therapy preventing recurrent bleeding as defined by positive iFOBT test due to GIVM, with an effective response rate of 71.4% (20 of 28), whereas the rate was 3.7% (1 of 27) in the iron-controlled group (intention-to-treat; P < .001) within 1-year follow-up. The rate of bleeding cessation was significantly higher in the thalidomide group than in the iron-controlled group (46.4% vs 0%; P < .001) during the whole
Conclusions
Thalidomide is effective and relatively safe for refractory bleeding from GIVM. Mechanisms of thalidomide activity might involve VEGF.
Acknowledgments
Drs Zhi-Zheng Ge and Hui-Min Chen contributed equally to this paper.
All procedures were in accordance with the Declaration of Helsinki. Informed consent was taken from all patients and the Institute Ethics Committee approved the study protocol. The full trial protocol can be accessed from Dr. Zhi-Zheng Ge via email to [email protected].
The name of trial registry is “Long-term Effects of Thalidomide for Recurrent Gastrointestinal Bleeding Due to Vascular Malformation.” The Registration
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Conflicts of interest The authors disclose no conflicts.
Funding The study was not supported by any pharmaceutical funding. The study medications were provided by the Pharmacy Department of Renji Hospital. All data and analyses were conducted at Renji Hospital.