Pneumatic Balloon Dilatation for Achalasia: A Systematic Review of Randomized Controlled Trials_Chinese Journal of Evidence-Based Medicine

Authors：

HE Jidong ¹ ,  WANG Yiping ²

1. Department of Gastroenterology, The second People’s Hospital of YaAn YaAn 625000, China2. Department of Gastroenterology, West China Hospital, Sichuan University, Chengdu 610041, China;

Corresponding author：

WANG Yiping, Email: wyiping2002@yahoo.com

Keywords：

Achalasia; Pneumatic ballon dilatation; Systematic review; Meta-analysis

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Objective 　To determine the effectiveness and safety of pneumatic balloon dilatation in patients with achalasia.
Methods 　We searched the Cochrane Central Register of Controlled Trials (CENTRAL, issue 1, 2007), MEDLINE or PUBMED (1978-2007), Embase (1978-2007), OVID Database (1978-2007), Chinese Biological Medicine Database (CBMDisc, 1978-2007), CNKI (1979-2007), Chinese VIP Database (1989-2007) and Wanfang Database (1978-2007). We also checked the reference lists of retrieved articles and relevant proceedings. We used the methods recommended by The Cochrane Collaboration to conduct this systematic review. 　
Results 　Twenty four trials involving 1045 patients were included. Meta-analyses showed that the short-term total effective rate was much higher with pneumatic dilatation than intrasphincteric botulinum toxin injection (P=0.0007). The long-term total effective rate was higher with pneumatic dilatation compared to intrasphincteric botulinum toxin injection (P=0.005). Intrasphincteric botulinum toxin injection was superior to pneumatic dilatation in terms of clinical relapse rate (P lt;0.0001). Our analyses of complications and adverse effects found that pneumatic dilatation was superior to intrasphincteric botulinum toxin injection (P=0.0008), and endoscopic sphincterotomy was superior to balloon dilatation (P=0.0006).
Conclusions 　The limited current evidence shows that: pneumatic dilatation is safe and effective for the short- or long-term treatment of achalasia.

Citation： HE Jidong,WANG Yiping. Pneumatic Balloon Dilatation for Achalasia: A Systematic Review of Randomized Controlled Trials. Chinese Journal of Evidence-Based Medicine, 2007, 07(7): 496-506. doi: Copy

1.	Qian F. Clinical study on intrasphincteric injection of botulinum toxin vs balloon dilation in the treatment of achalasia. Journal of Practical Diagnosis and therapy, 2006, 20(12): 908-909.
2.	Liu JY, Yang CM, Zhang AZ, et al. Clinical study on intrasphincteric injection of botulinum toxin and/or small balloon dilation in patients with esophageal achalasia. Chin J Dig Endosc, 2003, 20(3): 158-160.
3.	Jia DQ, Ouyang Q, Wang ZQ, et al. The value of pneumatic dilation in treament of esophageal achalasia. Chin J Dig Endosc, 2001, 18(6): 158-159.
4.	Yang ZW, Shao XY, Bu LX, et al. Clinical study on intrasphinctive injection of botulinum toxin A and balloon dilation in patients with esophageal achalasia. Chin J Dig Endosc, 2006, 12(7): 706-709.
5.	Cai FC, Liu QS, Guo RB, et al. The kinetic changes in esophageal achalasia treated by pneumatic dilation or intrasphincteric injection of botulinum toxin. Chin J Dig Endosc, 2003, 20(3): 161-163.
6.	Gui RH, Zheng XP, Leng JH, et al. Clinical study on intrasphinctive injection of botulinum toxin or small balloon dilation in patients with esophageal achalasia. Chinese Modern Medical and Clinical, 2006, 3(8): 31-32.
7.	Jin Y. The efficacy of patients with achalasia by intrasphincteric injection of botulinum toxin versus balloon dilation. Modern Medicine and Health, 2004, 20(17): 1728-1729.
8.	Yang CM, Liu JY, Liu QY, et al. Clinical study on intrasphincteric injection of botulinum toxin in the treatment of achalasia.ShanDong Medical Journal, 2002, 42(22): 1-2.
9.	Richter JE. Oesophageal motility disorders. Lancet, 2001, 358: 823-828.
10.	Streitz JM Jr, Ellis FH Jr, Gibb SP, et al. Achalasia and squamouscell carcinoma of the esophagus: analysis of 241 patients. Ann Thorac Surg, 1995, 59(6): 1604-1609.
11.	Meijssen MA, Tilanus HW, van Blankenstein M, et al. Achalasia complicated by oesophageal squamous cell carcinoma:a prospective study in 195 patients. Gut, 1992, 33(2): 155-158.
12.	Brucher BL, Stein HJ, Bartels H, et al. Achalasia and esophageal cancer: incidence, prevalence, and prognosis. World J Surg, 2001, 25(6): 745-749.
13.	Just-Viera JO, Haight C. Achalasia and carcinoma of the esophagus.Surg Gynecol Obstet, 1969, 128(5): 1081-1095.
14.	West RL, Hirsch DP, Bartelsman JF, et al. Long term results of pneumatic dilation in achalasia followed for more than 5 years. Am J Gastroenterol, 2002, 97(6): 1346-1351.
15.	Lehman MB, Clark SB, Ormsby AH, et al. Squamous mucosal alterations in esophagectomy specimens from patients with endstage achalasia. Am J Surg Pathol, 2001, 25(11): 1413-1418.
16.	Georgios Karamanolis, Spiros Sgouros, Georgios Karatzias, et al. Long-Term outcome of pneumatic dilation in the treatment of achalasia. Am J Gastroenterol, 2005, 100: 270-274.
17.	Society for Surgery of the Alimentary Tract (SSAT). Esophageal achalasia. Manchester (MA): Society for Surgery of the Alimentary Tract (SSAT); 2003. 3.
18.	Pasricha PJ, Ravich WJ, Hendrix TR, et al. Intrasphincteric botulinum toxin for the treatment of achalasia. N Engl J Med, 1995, 322: 774-778.
19.	Higgins JPT, Green S, editors. Cochrane Handbook for Systematic Reviews of Interventions 4.2.4 [updated March 2005]. In: The Cochrane Library, Issue 2, 2005.
20.	Annese V, Bassotti G, Coccia G, et al. A multicentre randomised study of intrasphincteric botulinum toxin in patients with oesophageal achalasia. Gastroenterology, 1996, 111: 1418-1424.
21.	Des Varannes SB, Lemiere S,, Guillemot JF, et al. Botulinum toxin versus pneumatic dilatation in achalasia: results of a multicentre controlled trial. Esophageal, Gastric, and Duodenal Disorders, A129.
22.	Mikaeli J, Fazel A, Montazeri G. Randomized controlled trial comparing botulinum toxin injection to pneumatic dilatation for the treatment of achalasia. Aliment Pharmacol Ther, 2001, 15(9): 1389-1396.
23.	Bansal R, Nostrant TT, Scheiman JM, et al. Intrasphincteric botulinum toxin versus pneumatic balloon dilation for treatment of primary achalasia. J Clin Gastroenterol, 2003, 36(3): 209-214.
24.	Vaezi MF, Richter JE, Wilcox CM, et al. Botulinum toxin versus pneumatic dilatation in the treatment of achalasia: a randomised trial. Gut, 1999, 44: 231-239.
25.	Ghoshal UC, Chaudhuri S, Pal BB, et al. Randomized controlled trial of intrasphincteric botulinum toxin A injection versus balloon dilatation in treatment of achalasia cardia. Dis Esophagus, 2001, 14: 227-231.
26.	Muehldorfer SM, Schneider TH, Hochberger J. Esophageal achalasia:intrasphincteric injection of botulinum toxin A versus balloon dilation. Endoscopy, 1999, 31(7): 517-521.
27.	蔡逢春, 刘庆森, 郭荣斌, 等. 气囊扩张和肉毒杆菌毒素注射治疗贲门失弛缓食管动力变化的比较. 中华消化内镜杂志, 2003, 20(3): 161-163.
28.	桂若虎, 郑新平, 冷建辉, 等. 经内镜球囊扩张与肉毒碱注射治疗贲门失弛缓症的临床研究. 中华现代医学与临床, 2006, 3(8): 31-32.
29.	金延. 内镜下肉毒碱注射及气囊扩张治疗贲门失弛缓症的疗效分析. 现代医药卫生, 2004, 20(17): 1728-1729.
30.	杨崇美, 刘吉勇, 刘清英, 等. 内镜下注射肉毒杆菌毒素治疗贲门失弛缓症的研究. 山东医药, 2002, 42(22): 1-2.
31.	钱峰. 气囊扩张与肉毒杆菌毒素注射治疗贲门失弛缓症的疗效分析. 实用诊断与治疗杂志, 2006, 20(12): 908-909.
32.	刘吉勇, 杨崇美, 张安忠, 等. 气囊扩张与肉毒杆菌毒素注射联合治疗贲门失弛缓症的临床研究. 中华消化内镜杂志, 2003, 20(3): 158-160.
33.	Csendes A, Braghetto I, Henriquez A, et al. Late results of a prospective randomised study comparing forceful dilatation and oesophagomyotomy in patients with achalasia. Gut, 1989, 30(3): 299-304.
34.	Csendes A, Velasco N, Braghetto I, et al. A prospective randomized study comparing forceful dilatation and esophagomyotomy in patients with achalasia of the esophagus. Gastroenterology, 1981, 80(4): 789-795.
35.	贾道全, 欧阳钦, 王志强, 等. 内镜下气囊扩张治疗贲门失弛缓症的价值. 中华消化内镜杂志, 2001, 18(6): 158-159.
36.	杨正武, 邵先玉, 卜令秀, 等. 气囊扩张与肉毒杆菌毒素注射序贯联合治疗贲门失弛缓症的临床研究. 中国内镜杂志, 2006, 12(7): 706-709.
37.	Gideon RM, Castell DO, Yarze J. Prospective randomized comparison of pneumatic dilatation technique in patients with Idiopathic achialasia. Digestive Diseases and Sciences, 1999, 44(9): 1853-1857.
38.	Alonso-Aguirre P, Aba-Garrote C, Estévez-Prieto E, et al. Treatment of achalasia with the Witzel dilator: a prospective randomized study of two methods. Endoscopy, 2003, 35(5): 379-382.
39.	F Mearin,, JR Armengol, L Chicharro, et al. Forceful dilatation under endoscopic control in the treatment of achalasia: a randomised trial of pneumatic versus metallic dilator. Gut, 1994, 35: 1360-1362.
40.	Muehldorfer SM, Hahn EG, Ell C. High- and low-compliance balloon dilators in patients with achalasia: a randomized prospective comparative trial. Gastrointest Endosc, 1996, 44(4): 398-403.
41.	Stark GA, Castell DO, Richter JE, et al. Prospective randomized comparison of Brown-McHardy and microvasive balloon dilators in treatment of achalasia. Am J Gastroenterol, 1990, 85(10): 1322-1326.
42.	Becker K, Biesenbach S, Erckenbrecht JF, et al. Effect of balloon compliance on symptomatic success of pneumatic dilation in achalasia patients. Z Gastroenterol, 2001, 39: 831-836.
43.	Khan AA, Shah SW, Alam A, et al. Pneumatic balloon dilation in achalasia: a prospective comparison of balloon distention time. Am J Gastroenterol, 1998, 93(7): 1064-1067.
44.	Vaezi MF, Richter JE. Current therapies for achalasia: Comparison and efficacy. J Clin Gastroenterol, 1998, 27: 21-35.

1. Qian F. Clinical study on intrasphincteric injection of botulinum toxin vs balloon dilation in the treatment of achalasia. Journal of Practical Diagnosis and therapy, 2006, 20(12): 908-909.
2. Liu JY, Yang CM, Zhang AZ, et al. Clinical study on intrasphincteric injection of botulinum toxin and/or small balloon dilation in patients with esophageal achalasia. Chin J Dig Endosc, 2003, 20(3): 158-160.
3. Jia DQ, Ouyang Q, Wang ZQ, et al. The value of pneumatic dilation in treament of esophageal achalasia. Chin J Dig Endosc, 2001, 18(6): 158-159.
4. Yang ZW, Shao XY, Bu LX, et al. Clinical study on intrasphinctive injection of botulinum toxin A and balloon dilation in patients with esophageal achalasia. Chin J Dig Endosc, 2006, 12(7): 706-709.
5. Cai FC, Liu QS, Guo RB, et al. The kinetic changes in esophageal achalasia treated by pneumatic dilation or intrasphincteric injection of botulinum toxin. Chin J Dig Endosc, 2003, 20(3): 161-163.
6. Gui RH, Zheng XP, Leng JH, et al. Clinical study on intrasphinctive injection of botulinum toxin or small balloon dilation in patients with esophageal achalasia. Chinese Modern Medical and Clinical, 2006, 3(8): 31-32.
7. Jin Y. The efficacy of patients with achalasia by intrasphincteric injection of botulinum toxin versus balloon dilation. Modern Medicine and Health, 2004, 20(17): 1728-1729.
8. Yang CM, Liu JY, Liu QY, et al. Clinical study on intrasphincteric injection of botulinum toxin in the treatment of achalasia.ShanDong Medical Journal, 2002, 42(22): 1-2.
9. Richter JE. Oesophageal motility disorders. Lancet, 2001, 358: 823-828.
10. Streitz JM Jr, Ellis FH Jr, Gibb SP, et al. Achalasia and squamouscell carcinoma of the esophagus: analysis of 241 patients. Ann Thorac Surg, 1995, 59(6): 1604-1609.
11. Meijssen MA, Tilanus HW, van Blankenstein M, et al. Achalasia complicated by oesophageal squamous cell carcinoma:a prospective study in 195 patients. Gut, 1992, 33(2): 155-158.
12. Brucher BL, Stein HJ, Bartels H, et al. Achalasia and esophageal cancer: incidence, prevalence, and prognosis. World J Surg, 2001, 25(6): 745-749.
13. Just-Viera JO, Haight C. Achalasia and carcinoma of the esophagus.Surg Gynecol Obstet, 1969, 128(5): 1081-1095.
14. West RL, Hirsch DP, Bartelsman JF, et al. Long term results of pneumatic dilation in achalasia followed for more than 5 years. Am J Gastroenterol, 2002, 97(6): 1346-1351.
15. Lehman MB, Clark SB, Ormsby AH, et al. Squamous mucosal alterations in esophagectomy specimens from patients with endstage achalasia. Am J Surg Pathol, 2001, 25(11): 1413-1418.
16. Georgios Karamanolis, Spiros Sgouros, Georgios Karatzias, et al. Long-Term outcome of pneumatic dilation in the treatment of achalasia. Am J Gastroenterol, 2005, 100: 270-274.
17. Society for Surgery of the Alimentary Tract (SSAT). Esophageal achalasia. Manchester (MA): Society for Surgery of the Alimentary Tract (SSAT); 2003. 3.
18. Pasricha PJ, Ravich WJ, Hendrix TR, et al. Intrasphincteric botulinum toxin for the treatment of achalasia. N Engl J Med, 1995, 322: 774-778.
19. Higgins JPT, Green S, editors. Cochrane Handbook for Systematic Reviews of Interventions 4.2.4 [updated March 2005]. In: The Cochrane Library, Issue 2, 2005.
20. Annese V, Bassotti G, Coccia G, et al. A multicentre randomised study of intrasphincteric botulinum toxin in patients with oesophageal achalasia. Gastroenterology, 1996, 111: 1418-1424.
21. Des Varannes SB, Lemiere S,, Guillemot JF, et al. Botulinum toxin versus pneumatic dilatation in achalasia: results of a multicentre controlled trial. Esophageal, Gastric, and Duodenal Disorders, A129.
22. Mikaeli J, Fazel A, Montazeri G. Randomized controlled trial comparing botulinum toxin injection to pneumatic dilatation for the treatment of achalasia. Aliment Pharmacol Ther, 2001, 15(9): 1389-1396.
23. Bansal R, Nostrant TT, Scheiman JM, et al. Intrasphincteric botulinum toxin versus pneumatic balloon dilation for treatment of primary achalasia. J Clin Gastroenterol, 2003, 36(3): 209-214.
24. Vaezi MF, Richter JE, Wilcox CM, et al. Botulinum toxin versus pneumatic dilatation in the treatment of achalasia: a randomised trial. Gut, 1999, 44: 231-239.
25. Ghoshal UC, Chaudhuri S, Pal BB, et al. Randomized controlled trial of intrasphincteric botulinum toxin A injection versus balloon dilatation in treatment of achalasia cardia. Dis Esophagus, 2001, 14: 227-231.
26. Muehldorfer SM, Schneider TH, Hochberger J. Esophageal achalasia:intrasphincteric injection of botulinum toxin A versus balloon dilation. Endoscopy, 1999, 31(7): 517-521.
27. 蔡逢春, 刘庆森, 郭荣斌, 等. 气囊扩张和肉毒杆菌毒素注射治疗贲门失弛缓食管动力变化的比较. 中华消化内镜杂志, 2003, 20(3): 161-163.
28. 桂若虎, 郑新平, 冷建辉, 等. 经内镜球囊扩张与肉毒碱注射治疗贲门失弛缓症的临床研究. 中华现代医学与临床, 2006, 3(8): 31-32.
29. 金延. 内镜下肉毒碱注射及气囊扩张治疗贲门失弛缓症的疗效分析. 现代医药卫生, 2004, 20(17): 1728-1729.
30. 杨崇美, 刘吉勇, 刘清英, 等. 内镜下注射肉毒杆菌毒素治疗贲门失弛缓症的研究. 山东医药, 2002, 42(22): 1-2.
31. 钱峰. 气囊扩张与肉毒杆菌毒素注射治疗贲门失弛缓症的疗效分析. 实用诊断与治疗杂志, 2006, 20(12): 908-909.
32. 刘吉勇, 杨崇美, 张安忠, 等. 气囊扩张与肉毒杆菌毒素注射联合治疗贲门失弛缓症的临床研究. 中华消化内镜杂志, 2003, 20(3): 158-160.
33. Csendes A, Braghetto I, Henriquez A, et al. Late results of a prospective randomised study comparing forceful dilatation and oesophagomyotomy in patients with achalasia. Gut, 1989, 30(3): 299-304.
34. Csendes A, Velasco N, Braghetto I, et al. A prospective randomized study comparing forceful dilatation and esophagomyotomy in patients with achalasia of the esophagus. Gastroenterology, 1981, 80(4): 789-795.
35. 贾道全, 欧阳钦, 王志强, 等. 内镜下气囊扩张治疗贲门失弛缓症的价值. 中华消化内镜杂志, 2001, 18(6): 158-159.
36. 杨正武, 邵先玉, 卜令秀, 等. 气囊扩张与肉毒杆菌毒素注射序贯联合治疗贲门失弛缓症的临床研究. 中国内镜杂志, 2006, 12(7): 706-709.
37. Gideon RM, Castell DO, Yarze J. Prospective randomized comparison of pneumatic dilatation technique in patients with Idiopathic achialasia. Digestive Diseases and Sciences, 1999, 44(9): 1853-1857.
38. Alonso-Aguirre P, Aba-Garrote C, Estévez-Prieto E, et al. Treatment of achalasia with the Witzel dilator: a prospective randomized study of two methods. Endoscopy, 2003, 35(5): 379-382.
39. F Mearin,, JR Armengol, L Chicharro, et al. Forceful dilatation under endoscopic control in the treatment of achalasia: a randomised trial of pneumatic versus metallic dilator. Gut, 1994, 35: 1360-1362.
40. Muehldorfer SM, Hahn EG, Ell C. High- and low-compliance balloon dilators in patients with achalasia: a randomized prospective comparative trial. Gastrointest Endosc, 1996, 44(4): 398-403.
41. Stark GA, Castell DO, Richter JE, et al. Prospective randomized comparison of Brown-McHardy and microvasive balloon dilators in treatment of achalasia. Am J Gastroenterol, 1990, 85(10): 1322-1326.
42. Becker K, Biesenbach S, Erckenbrecht JF, et al. Effect of balloon compliance on symptomatic success of pneumatic dilation in achalasia patients. Z Gastroenterol, 2001, 39: 831-836.
43. Khan AA, Shah SW, Alam A, et al. Pneumatic balloon dilation in achalasia: a prospective comparison of balloon distention time. Am J Gastroenterol, 1998, 93(7): 1064-1067.
44. Vaezi MF, Richter JE. Current therapies for achalasia: Comparison and efficacy. J Clin Gastroenterol, 1998, 27: 21-35.

Chinese Journal of Evidence-Based Medicine

Pneumatic Balloon Dilatation for Achalasia: A Systematic Review of Randomized Controlled Trials

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