Efficacy and tolerability of a fixed low-dose combination of cinnarizine and dimenhydrinate in the treatment of vertigo: A 4-week, randomized, double-blind, active- and placebo-controlled, parallel-group, outpatient study

Clinical Therapeutics

Volumn 29, Issue 1, 2007, Pages 84-98

  Pytel, Joseph ^a   Nagy, György ^a   Tóth, Agnes ^b   Spellenberg, Sándor ^c   Schwarz, Mario ^d   Répassy, Gabor ^e  

^a UNIVERSITY OF PÉCS   (Hungary)

^b UNIVERSITY OF DEBRECEN   (Hungary)

^c ST JOHN'S HOSPITAL   (Hungary)

^d Medical Department   (Germany)

^e SEMMELWEIS UNIVERSITY   (Hungary)

Author keywords

cinnarizine; dimenhydrinate; fixed combination; placebo; vertigo

Indexed keywords

CINNARIZINE; DIMENHYDRINATE; PLACEBO;

ABDOMINAL PAIN; ADULT; AGED; AMNESIA; ARTICLE; CARDIOGENIC SHOCK; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEPRESSION; DOUBLE BLIND PROCEDURE; DROWSINESS; DRUG EFFECT; DRUG EFFICACY; DRUG TOLERABILITY; EVALUATION; FATIGUE; FEMALE; HEADACHE; HUMAN; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; MULTICENTER STUDY; NAUSEA; OUTCOME ASSESSMENT; OUTPATIENT; PAIN; PRURITUS; PSEUDOANGINA; RANDOMIZED CONTROLLED TRIAL; RANK SUM TEST; SEDATION; SHOCK; SIDE EFFECT; SYMPTOM; TREMOR; URTICARIA; VERTIGO; VISUAL ANALOG SCALE;

ADULT; AGED; AGED, 80 AND OVER; CINNARIZINE; DIMENHYDRINATE; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG COMBINATIONS; FEMALE; HISTAMINE H1 ANTAGONISTS; HUMANS; LEAST-SQUARES ANALYSIS; MALE; MIDDLE AGED; NAUSEA; VERTIGO;

EID: 33947112957     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2007.01.010     Document Type: Article

References (38)

1. Brandt T. Vertigo. Its Multisensory Syndromes. 2nd ed. (1999), Springer Verlag, London, UK
2. Luxon L.M. Evaluation and management of the dizzy patient. J Neurol Neurosurg Psychiatry 75 Suppl 4 (2004) iv45-iv52
3. Schwarz D.W., and Tomlinson R.D. Physiology of the vestibular system. In: Jackler R.K., and Brackmann D.E. (Eds). Neurotology (1994), Mosby-Year Book, St Louis, Mo 59-98
4. Hamid M.A. Overview of clinical anatomy and physiology of the vestibular system. In: Arenberg I.K. (Ed). Dizziness and Balance Disorders (1993), Kugler Publications, Amsterdam, The Netherlands 41-43
5. Edmeads J. Understanding dizziness. How to decipher this nonspecific symptom. Postgrad Med 88 (1990) 255-268
6. [published correction appears in JAMA. 1998;279:584]?. Froehling D.A., Silverstein M.D., Mohr D.N., and Beatty C.W. The rational clinical examination. Does this dizzy patient have a serious form of vertigo. JAMA 271 (1994) 385-388
7. Honrubia V., Bell T.S., Harris M.R., et al. Quantitative evaluation of dizziness characteristics and impact on quality of life. Am J Otol 17 (1996) 595-602
8. Kveton J.F. Symptoms of vestibular disease. In: Jackler R.K., and Brackmann D.E. (Eds). Neurotology (1994), Mosby-Year Book, St Louis, Mo 145-151
9. Smith D.B. Dizziness: The history and physical examination. In: Arenberg I.K. (Ed). Dizziness and Balance Disorders (1993), Kugler Publications, Amsterdam, The Netherlands 3-10
10. Oosterveld W.J. Vertigo. Current concepts in management. Drugs 30 (1985) 275-283
11. Wackym P.A., Blackwell K.E., and Nyerges A.M. Pharmacotherapy of vestibular dysfunction. In: Jackler R.K., and Brackmann D.E. (Eds). Neurotology (1994), Mosby-Year Book, St Louis, Mo 543-553
12. Darlington C.L., and Smith P.F. Drug treatment for vertigo and dizziness. N Z Med J 111 (1998) 332-334
13. Hain T.C., and Uddin M. Pharmacological treatment of vertigo. CNS Drugs 17 (2003) 85-100
14. Fermin H., van Deinse J.B., and Hammelburg E. The effect of dimenhydrinate upon the labyrinth (an experimental study). Acta Otolaryngol 38 (1950) 543-549
15. Gutner L.B., Gould W.J., and Batterman R.C. Action of dimenhydrinate (dramamine) and other drugs on vestibular function. AMA Arch Otolaryngol 53 (1951) 308-315
16. Philipszoon A.J. Influence of cinnarizine on the labyrinth and on vertigo. Clin Pharmacol Ther 3 (1962) 184-190
17. Godfraind T., Towse G., and Van Nueten J.M. Cinnarizine: A selective calcium entry blocker. Drugs Today 18 (1982) 27-42
18. Towse G. Cinnarizine-a labyrinthine sedative. J Laryngol Otol 94 (1980) 1009-1015
19. Perin P., Soto E., Vega R., et al. Calcium channels functional roles in the frog semicircular canal. Neuroreport 11 (2000) 417-420
20. Arab S.F., Duwel P., Jungling E., et al. Inhibition of voltage-gated calcium currents in type II vestibular hair cells by cinnarizine. Naunyn Schmiedebergs Arch Pharmacol 369 (2004) 570-575
21. Duwel P., Haasler T., Jungling E., et al. Effects of cinnarizine on calcium and pressure-dependent potassium currents in guinea pig vestibular hair cells. Naunyn Schmiedebergs Arch Pharmacol 371 (2005) 441-448
22. Novotny M., Kostrica R., and Cirek Z. The efficacy of arlevert therapy for vertigo and tinnitus. Int Tinnitus J 5 (1999) 60-62
23. Schremmer D., Bognar-Steinberg I., Baumann W., and Pytel J. Efficacy and tolerability of a fixed combination of cinnarizine and dimenhydrinate in treatment of vertigo. Analysis of data from five randomised, doubleblind clinical studies. Clin Drug Invest 18 (1999) 355-368
24. Novotny M., and Kostrica R. Fixed combination of cinnarizine and dimenhydrinate versus betahistine dimesylate in the treatment of Meniere's disease: A randomized, double-blind, parallel group clinical study. Int Tinnitusl 8 (2002) 115-123
25. Scholtz A.W., Schwarz M., Baumann W., et al. Treatment of vertigo due to acute unilateral vestibular loss with a fixed combination of cinnarizine and dimenhydrinate: A doubleblind, randomized, parallel-group clinical study. Clin Ther 26 (2004) 866-877
26. Cirek Z., Schwarz M., Baumann W., and Novotny M. Efficacy and tolerability of a fixed combination of cinnarizine and dimenhydrinate versus betahistine in the treatment of otogenic vertigo: A double-blind, randomised clinical study. Clin Drug Invest 25 (2005) 377-389
27. Ben-David J., Podoshin L., and Fradis M. A comparative cranio-corpography study on the findings in the Romberg standing test versus the Unterberger/Fukuda stepping test in vertigo patients. Acta Otorhinolaryngol Belg 39 (1985) 924-932
28. Bojrab D.I., and Stockwell C.W. Electronystagmography and rotation tests. In: Jackler R.K., and Brackmann D.E. (Eds). Neurotology (1994), Mosby-Year Book, St Louis, Mo 219-228
29. Jongkees L.B. Which is the preferable method to perform the caloric test?. Arch Otolaryngol 49 (1949) 594-608
30. Novak M.A. Hearing loss in neurotologic diagnosis. In: Jackler R.K., and Brackmann D.E. (Eds). Neurotology (1994), Mosby-Year Book, St Louis, Mo 131-144
31. Colditz G.A., Miller J.N., and Mosteller F. Measuring gain in the evaluation of medical technology. The probability of a better outcome. Int J Technol Assess Health Care 4 (1988) 637-642
32. Bland J.I.M., and Altman D.G. Multiple significance tests: The Bonferroni method. BMJ 310 (1995) 170
33. Schneider D., Kiessling B., Wieczorek M., et al. Influence of 3 antivertiginous medications on the vigilance of healthy volunteers. Int J Clin Pharmacol Ther 41 (2003) 171-181
34. Philipova D., Tzenova B., Iwanowitsch A., and Bognar-Steinberg I. Influence of an antivertiginous combination prepara tion of cinnarizine and dimenhydrinate on event-related potentials, reaction time and psychomotor performance-a randomized, doubleblind, 3-way crossover study in healthy volunteers. Int J Clin Pharmacol Ther 42 (2004) 218-231
35. Oosterveld W.J. Cinnarizine in the vertiginous syndrome. In: Towse G. (Ed). Cinnarizine and the Vertiginous Syndrome. International Congress and Symposium Series No. 33 (1979), Royal Society of Medicine and Academic Press Inc, London, UK 29-37
36. Nilles R. Direct evidence of a protective effect of calcium antagonists in the innerear. Inhibition ofa toxic increase in the calcium level in hair cells of the guinea pig [in German]. HNO 43 (1995) 716-723
37. Jaju B.P., and Wang S.C. Effects of diphenhydramine and dimenhydrinate on vestibular neuronal activity of cat: A search for the locus of their antimotion sickness action. J Pharmacol Exp Ther 176 (1971) 718-724
38. Fujimoto S., Sasa M., Takaori S., and Matsuoka I. Selective effect of cinnarizine on the vestibular nucleus neurons. Arch Otorhinolaryngol 221 (1978) 37-45