Levosulpiride and cisapride in the treatment of dysmotility-like functional dyspepsia: A randomized, double-masked trial

Clinical Gastroenterology and Hepatology

Volumn 2, Issue 4, 2004, Pages 301-308

  Mearin, Fermín ^a   Rodrigo, Luis ^b   Pérez Mota, Arturo ^c   Balboa, Agustín ^a   Jiménez, Isabel ^d   Sebastián, Juan José ^e   Patón, Caro ^f  

^a CENTRO MÉDICO TEKNON   (Spain)

^b HOSPITAL UNIVERSITARIO CENTRAL DE ASTURIAS   (Spain)

^c HOSPITAL UNIVERSITARIO INFANTA LEONOR   (Spain)

^d HOSPITAL UNIVERSITARIO DE LA PRINCESA   (Spain)

^e HOSPITAL UNIVERSITARIO MIGUEL SERVET   (Spain)

^f HOSPITAL UNIVERSITARIO RÍO HORTEGA   (Spain)

Author keywords

Health related quality of life; HRQoL; Intention to treat; ITT; NHP; Nottingham Health Profile; Per protocol; PP; STAI; State Trait Anxiety Inventory

Indexed keywords

CISAPRIDE; DOPAMINE 2 RECEPTOR BLOCKING AGENT; SULPIRIDE;

ABDOMINAL PAIN; ADULT; ALLERGY; AMENORRHEA; ANXIETY; ARTICLE; BREAST TENDERNESS; CLINICAL FEATURE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DYSMOTILITY LIKE FUNCTIONAL DYSPEPSIA; DYSPEPSIA; FEMALE; GALACTORRHEA; HEADACHE; HUMAN; ILLNESS BEHAVIOR; INSOMNIA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; NERVOUSNESS; PAIN; PILOT STUDY; QUALITY OF LIFE; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL; SATIETY; SCORING SYSTEM; SIDE EFFECT; SOMNOLENCE; STATISTICAL SIGNIFICANCE; SWEATING; SYMPTOM; TACHYCARDIA; TREATMENT WITHDRAWAL; VOMITING;

ADMINISTRATION, ORAL; ADOLESCENT; ADULT; AGED; CISAPRIDE; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; DYSPEPSIA; ESOPHAGEAL MOTILITY DISORDERS; ESOPHAGOSCOPY; FEMALE; FOLLOW-UP STUDIES; HUMANS; MALE; MIDDLE AGED; PILOT PROJECTS; PROBABILITY; REFERENCE VALUES; RISK ASSESSMENT; SEVERITY OF ILLNESS INDEX; STATISTICS, NONPARAMETRIC; SULPIRIDE; TREATMENT OUTCOME;

EID: 1842427520     PISSN: 15423565     EISSN: None     Source Type: Journal    
DOI: 10.1016/S1542-3565(04)00059-X     Document Type: Article

References (36)

1. Talley N.J., Stanghellini V., Heading R.C., Koch K.L., Malagelada J.-R., Tytgat G.N. Functional gastroduodenal disorders. Gut. 45:(suppl II):1999;S37-S42.
2. Talley N.J., Silverstein M.D., Agréus L., Nyren O., Sonnenberg A., Holtmann G. AGA technical review evaluation of dyspepsia. Gastroenterology. 11:1998;582-595.
3. Mearin F., Cucala M., Azpiroz F., Malagelada J.R. The origin of symptoms on the brain-gut axis in functional dyspepsia. Gastroenterology. 101:1991;999-1006.
4. Bennet E.J., Beaurepaire J., Langeluddecke P., Kellow J., Tennant C. Life stress and non-ulcer dyspepsia a case control study. J Psychosom Res. 35:1991;579-590.
5. Bennet E.J., Piesse C., Palmer K., Badcock C.A., Tennant C.C., Kellow J.E. Functional gastrointestinal disorders psychological, social, and somatic features. Gut. 42:1998;414-420.
6. Tack J., Caenepeel P., Fischler B., Piessevaux H., Janssens J. Hypersensitivity to gastric distention is associated with symptoms in functional dyspepsia. Gastroenterology. 121:2001;526-535.
7. Stanghellini V., Tosetti C., Paternico A., Barbara G., Morselli-Labate A.M., Monetti N., Marengo M., Corinaldesi R. Risk indicators of delayed gastric emptying of solids in patients with functional dyspepsia. Gastroenterology. 110:1996;1036-1042.
8. Talley N.J., Meineche-Schmidt V., Pare P., Duckworth M., Raisanen P., Pap A., Kordecki H., Schmid V. Efficacy of omeprazol in functional dyspepsia double-blind, randomised, placebo-controlled trials (the Bond and Opera studies). Aliment Pharmacol Ther. 12:1998;1055-1065.
9. 2 Receptor antagonists and prokinetics in dyspepsia a critical review. Gut. 50:(suppl IV):2002;S58-S62.
10. Allescher H.D., Böckenhoff A., Knapp G., Wienbeck M., Hartung J. Treatment of non-ulcer dyspepsia a meta-analysis of placebo-controlled prospective studies. Scand J Gastroenterol. 36:2001;934-941.
11. Moayyedi P., Soo S., Deeks J., Delaney B., Innes M., Forman D. Pharmacological interventions for non-ulcer dyspepsia. Cochrane Database Syst Rev. 1:2003;. [CD ROM].
12. Finney J.S., Kinnersley N., Hughes M., O′Bryan-Tear C.G., Lothian J. Meta-analysis of antisecretory and gastrokinetic compounds in functional dyspepsia. J Clin Gastroenterol. 36:1998;312-320.
13. Veldhuyzen van Zanten S.J.O., Jones M.J., Verlinden M., Talley N.J. Efficacy of cisapride and domperidone in functional (nonulcer) dyspepsia a meta-analysis. Am J Gastroenterol. 96:2001;689-696.
14. Talley N.J. Therapeutic options in nonulcer dyspepsia. J Clin Gastroenterol. 32:2001;286-293.
15. US Food and Drug Administration. FDA talk paper. Janssen Pharmaceutica stops marketing cisapride in the US. 2000;. Available at: http://www.fda.gov. bbs.topics/ANSWER/ANSO1007.html. Accessed June 7.
16. Gheunens J. Dear healthcare provider. 2000;. [letter] Available at: http://www.fda.gov/medwatch/safety/2000/popul1.htm. Accessed June 7.
17. Richter J.E. Cisapride limited access and alternatives. Cleve Clin J Med. 67:2000;471-472.
18. Rossi F., Forgione A. Pharmatoxicological aspects of levosulpiride. Pharmacol Res. 31:1995;81-94.
19. Tonini M., Spelta V., De Giorgio R., Fiori E., Di Nucci A., Balestra B., De Ponti F. A re-assessment of the pharmacodynamics of levosulpiride in the guinea pig gastrointestinal tract. Gastroenterology. 116:1999;1093A. [abstr].
20. Sabbatini F., Petrelli G., La Manna S., Russo T., Lobello R., Maz-zacca G. The effect of L-sulpiride on lower esophageal sphincter pressure and esophageal peristaltic activity in healthy subjects. Curr Ther Res. 46:1989;445-451.
21. Passaretti S., Tosi T., Titoobello A. Effect of levosulpiride on gastric emptying in healthy volunteers. J Soc Clin Trials. 27:1990;100-102.
22. Arienti V., Corazza G.R., Sorge M., Boriani L., Ugenti F., Biagi F., Maconi G., Sottili S., Van Thiel D.H., Gasbarrini G. The effect of levosulpiride on gastric and gall-bladder emptying in functional dyspepsia. Aliment Pharmacol Ther. 8:1994;631-638.
23. Mansi C., Borro P., Giacomini M., Biagini R., Mele M.R., Pandolfo N., Savarino V. Comparative effects of levosulpiride and cisapride on gastric emptying and symptoms in patients with functional dyspepsia and gastroparesis. Aliment Pharmacol Ther. 14:2000;561-569.
24. Mansi C., Savarino V., Vigneri S., Perilli D., Melga P., Sciaba L., De Martini D., Mela G.S. Gastrokinetic effect of levosulpiride in dyspeptic patients with diabetic gastroparesis. Am J Gastroenterol. 90:1995;1989-1993.
25. Melga P., Mansi C., Cruchi E., Giusti R., Sciaba L., Prando R. Chronic administration of levosulpiride and glycemic control in IDDM patients with gastroparesis. Diabetes Care. 20:1997;55-58.
26. Distrutti E., Fiorucci S., Hauer S.K., Pensi M.O., Vanasia M., Morelli A. Effect of acute and chronic levosulpiride administration on gastric tone and perception in functional dyspepsia. Aliment Pharmacol Ther. 16:2002;613-622.
27. Zanoboni A., Forgione A., Zanussi C. Antiemetic efficacy and safety of L-sulpiride in patients with digestive and other disorders. Curr Ther Res. 41:1987;903-1014.
28. Mearin F., Cucala M., Balboa A., Zárate N., Malagelada J.-R. Placebo in functional dyspepsia symptomatic, gastrointestinal motor and gastric sensorial responses. Am J Gastroenterol. 94:1999;116-125.
29. Alonso J., Prieto L., Antó J.M. The Spanish version of the Nottingham Health Profile a review of adaptation and instrument characteristics. Qual Life Res. 3:1994;385-393.
30. Spielberger C.D., Gorsuch R.L., Lushene R.E. Cuestionario de Ansiedad Estado-Rasgo. 2nd ed:1986;TEA, Madrid, Spain.
31. Peselow E.D., Stanley M., Parry H. Clinical trials of benzamides in psychiatry. Rotrosen J., Stanley M. The benzamides: pharmacology, neurobiology and clinical aspects. Advances in biochemical psychopharmacology. Volume 35:1982;163-164 Raven, New York.
32. Kato R., Sato Y., Shimomura K. Studies on the mechanism of action of sulpiride. J Pharmacol. 5:(suppl 2):1974;S4-S49.
33. Zanoboni A., Forgione A., Opizzi G. Effectiveness of levosulpiride in chemotherapy induced emesis. Chemioterapia. 2:1983;311-316.
34. Corazza G.R., Biagi F., Albano O., Porro G.B., Cheli R., Mazzacca G., Miglio F., Naccarato R., Quaglino D., Surrenti C., Verme G., Gasbarrini G. Levosulpiride in functional dyspepsia a multicentric, double-blind, controlled trial. Ital J Gastroenterol. 28:1996;317-323.
35. Bocchetta A., Bernardi F., Burrai C., Pedditzi M., Del Zompo M. A double blind study of L-sulpiride versus amitriptyline in lithium-maintained bipolar depressives. Acta Psychiatr Scand. 88:1993;434-439.
36. McMurdo M.E., Howie P.W., Lewis M., Marnie M., McEwen J., McNeilly A.S. Prolactine response to low dose sulpiride. Br J Clin Pharmacol. 24:1987;133-136.