N Kakushima1, K Hori2, H Ono3, T Horimatsu2, N Uedo4, K Ohata5, H Doyama6, K Kaneko7, I Oda8, T Hikichi9, Y Kawahara10, K Niimi11, Y Takaki12, M Mizuno13, S Yazumi14, A Hosokawa15, A Imagawa16, M Niimi2, K Yoshimura17, M Muto2. 1. Division of Endoscopy, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi, Suntougun, Shizuoka, 4118777, Japan. kakushin-tky@umin.ac.jp. 2. Kyoto University Graduate School of Medicine, Kyoto, Japan. 3. Division of Endoscopy, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi, Suntougun, Shizuoka, 4118777, Japan. 4. Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan. 5. NTT Medical Center Tokyo, Tokyo, Japan. 6. Ishikawa Prefectural Central Hospital, Kanazawa, Ishikawa, Japan. 7. National Cancer Center East, Chiba, Japan. 8. National Cancer Center, Tokyo, Japan. 9. Fukushima Medical University, Fukushima, Japan. 10. Okayama University Hospital, Okayama, Japan. 11. The University of Tokyo Graduate School of Medicine, Tokyo, Japan. 12. Fukuoka University Chikushi Hospital, Fukuoka, Japan. 13. Hiroshima City Hospital, Hiroshima, Japan. 14. Kitano General Hospital, Osaka, Japan. 15. Toyama University Hospital, Toyama, Japan. 16. Mitoyo General Hospital, Kanonji, Kagawa, Japan. 17. Kobe University School of Medicine, Kobe, Japan.
Abstract
BACKGROUND: Whether proton pump inhibitors (PPIs) relieve heartburn or precordial pain after endoscopic resection (ER) for esophageal squamous cell carcinoma (ESCC) remains unclear. The aim of this study was to investigate the efficacy of PPI therapy for these symptoms after ER for ESCC. METHODS: We conducted a multicenter prospective randomized controlled trial among 15 hospitals in Japan. In total, 229 patients with cT1a ESCC were randomly assigned to receive PPI therapy for 5 weeks after ER (the PPI group, n = 115) or follow-up without PPI therapy (the non-PPI group, n = 114). The primary end point was the incidence of gastroesophageal reflux disease (GERD)-like symptoms after ER from a self-reported questionnaire (Frequency Scale for Symptoms of GERD). Secondary end points were ulcer healing rate at 5 weeks, incidence of pain, improvement rate of symptoms in those who started PPI therapy because of GERD-like symptoms in the non-PPI group, and adverse events. RESULTS: No significant difference was observed in the incidence of GERD-like symptoms after ER between the non-PPI and PPI groups (30 % vs 34 %, respectively). No significant differences were observed in the ulcer healing rate at 5 weeks (84 % vs 85 %) and incidence of pain within 1 week (36 % vs 45 %). In nine of ten patients (90 %) who started PPI therapy because of GERD-like symptoms in the non-PPI group, PPI administration relieved GERD-like symptoms. No adverse events related to PPI administration were observed. CONCLUSION:PPI therapy is not efficacious in reducing symptoms and did not promote healing of ulcers in patients undergoing ER for ESCC.
RCT Entities:
BACKGROUND: Whether proton pump inhibitors (PPIs) relieve heartburn or precordial pain after endoscopic resection (ER) for esophageal squamous cell carcinoma (ESCC) remains unclear. The aim of this study was to investigate the efficacy of PPI therapy for these symptoms after ER for ESCC. METHODS: We conducted a multicenter prospective randomized controlled trial among 15 hospitals in Japan. In total, 229 patients with cT1a ESCC were randomly assigned to receive PPI therapy for 5 weeks after ER (the PPI group, n = 115) or follow-up without PPI therapy (the non-PPI group, n = 114). The primary end point was the incidence of gastroesophageal reflux disease (GERD)-like symptoms after ER from a self-reported questionnaire (Frequency Scale for Symptoms of GERD). Secondary end points were ulcer healing rate at 5 weeks, incidence of pain, improvement rate of symptoms in those who started PPI therapy because of GERD-like symptoms in the non-PPI group, and adverse events. RESULTS: No significant difference was observed in the incidence of GERD-like symptoms after ER between the non-PPI and PPI groups (30 % vs 34 %, respectively). No significant differences were observed in the ulcer healing rate at 5 weeks (84 % vs 85 %) and incidence of pain within 1 week (36 % vs 45 %). In nine of ten patients (90 %) who started PPI therapy because of GERD-like symptoms in the non-PPI group, PPI administration relieved GERD-like symptoms. No adverse events related to PPI administration were observed. CONCLUSION: PPI therapy is not efficacious in reducing symptoms and did not promote healing of ulcers in patients undergoing ER for ESCC.
Authors: D Armstrong; J R Bennett; A L Blum; J Dent; F T De Dombal; J P Galmiche; L Lundell; M Margulies; J E Richter; S J Spechler; G N Tytgat; L Wallin Journal: Gastroenterology Date: 1996-07 Impact factor: 22.682