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Nicergoline in Balance Alterations in Adult and Elderly Patients

A Double-Blind, Placebo-Controlled Study

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Abstract

Objective

To evaluate the efficacy and safety of nicergoline in the treatment of balance disorders of central origin in adult and elderly patients.

Design and setting

Prospective, double-blind, placebo-controlled, parallel-group, randomised trial of nicergoline 30mg twice daily and placebo administered for 3 months. After baseline evaluation, patients were assessed monthly for efficacy and safety. The study was carried out in outpatients in five centres in Italy.

Patients

Eighty-nine adult and elderly outpatients (mean age 67.1 years) with balance disorders of central origin.

Interventions

At baseline, a complete clinical and instrumental otoneurological examination was carried out and the Vertigo-Dizziness Differential Diagnosis Score was calculated. Efficacy was assessed by the Dizziness Assessment Rating Scale (DARS), Dizziness Handicap Inventory (DHI) and static posturography. The safety evaluation included monitoring of adverse events, vital signs, haematology and blood chemistry.

Main outcome measures and results

The DARS total score was significantly reduced by both treatments; however, score change from baseline was significantly greater in the nicergoline group compared with the placebo group from the first month of treatment (p = 0.002). The between-treatment difference further increased (p < 0.001) in the following 2 months of treatment up to the end of the study. The DHI score change from baseline was also significantly greater in the nicergoline group compared with placebo (p < 0.001) at all timepoints, both for the total score and for all domains (functional, emotional and physical). A strong correlation was observed between DARS and DHI total score change from baseline. Static posturography measurements indicated an improvement for almost all considered variables in the nicergoline group, although no statistically significant difference was observed compared with placebo; however, significant changes from baseline were observed only in the nicergoline group. Adverse events were observed in 4.5% of the nicergoline and 4.4% of the placebo patients.

Conclusions

Nicergoline is an effective and well tolerated treatment for the clinical symptoms related to central vertigo and improves the quality of life of patients with dizziness.

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Notes

  1. 1Use of tradenames is for product identification only and does not imply endorsement.

References

  1. Tinetti ME, Williams CS, Gill TM. Dizziness among older adults: a possible geriatric syndrome. Ann Intern Med 2000; 132(5): 337–44

    PubMed  CAS  Google Scholar 

  2. Aggarwal NT, Bennett DA, Bienias JL, et al. The prevalence of dizziness and its association with functional disability in a biracial community population. J Gerontol A Biol Sci Med Sci 2000 May; 55(5): M288–92

    Article  PubMed  CAS  Google Scholar 

  3. Anderson DC, Yolton RL, Reinke AR, et al. The dizzy patient: a review of etiology, differential diagnosis, and management. J Am Optom Assoc 1995; 66(9): 545–58

    PubMed  CAS  Google Scholar 

  4. Sloane PD, Coeytaux RR, Beck RS, et al. Dizziness: state of the science. Ann Intern Med 2001; 134 (9 Pt 2): 823–32

    PubMed  CAS  Google Scholar 

  5. Tinetti ME, Williams CS, Gill TM. Health, functional, and psychological outcomes among older persons with chronic dizziness. J Am Geriatr Soc 2000; 48(4): 417–21

    PubMed  CAS  Google Scholar 

  6. Belal Jr A, Glorig A. Dysequilibrium of ageing (presbyastasis). J Laryngol Otol 1986; 100(9): 1037–41

    Article  PubMed  Google Scholar 

  7. Morawiec-Bajda A, Gryczynski M. Function of sensorimotor equilibrium function in elderly patients on the basis of vestibular evoked myogenic potentials (m.p.p.w) Otolaryngol Pol 2000; 54(6): 685–9

    PubMed  CAS  Google Scholar 

  8. Smith PF, Curthoys IS. Mechanisms of recovery following unilateral labyrinthectomy: a review. Brain Res Brain Res Rev. 1989; 14(2): 155–80

    Article  PubMed  CAS  Google Scholar 

  9. Lüneburg U, Flohr H. Effect of melanocortins on vestibular compensation. Prog Brain Res 1988; 76: 421–9

    Article  PubMed  Google Scholar 

  10. Flohr H, Lüneburg U. Effects of ACTH4-10 on vestibular compensation. Brain Res 1992; 248: 169–3

    Article  Google Scholar 

  11. Gilchrist PD, Smith PF, Darlington CL. ACTH (4–10) accelerates ocular motor recovery in the guinea pig following vestibular deafferentation. Neurosci Lett 1990; 118: 14–6

    Article  PubMed  CAS  Google Scholar 

  12. Gilchrist PD, Darlington CL, Smith PF. A dose-response analysis of the beneficial effects of the ACTH (4–9) analogue, Org 2766, on behavioural recovery following unilateral labyrinthectomy in guinea pig. Br J Pharmacol 1994; 111: 358–3

    Article  PubMed  CAS  Google Scholar 

  13. Gilchrist DP, Darlington CL, Smith PF. Evidence that short ACTH fragments enhance vestibular compensation via direct action on the ipsilateral vestibular nucleus. Neuroreport 1996; 7: 1489–92

    Article  PubMed  CAS  Google Scholar 

  14. Smith PF, Darlington CL. The contribution of N-methyl-D-aspartate receptors to lesion-induced plasticity in the vestibular nucleus. Prog Neurobiol 1997; 53(5): 517–31

    Article  PubMed  CAS  Google Scholar 

  15. Herrmann WM, Stephan K, Gaede K, et al. Multicenter randomized double-blind study on the efficacy and safety of nicergoline in patients with multi-infarct dementia. Dement Geriatr Cogn Disord 1997; 8(1): 9–17

    Article  PubMed  CAS  Google Scholar 

  16. Saletu B, Paulus E, Linzmayer L, et al. Nicergoline in senile dementia of Alzheimer type and multi-infarct dementia: a double-blind, placebo-controlled, clinical and EEG/ERP mapping study. Psychopharmacology (Berl) 1995; 117(4): 385–95

    Article  CAS  Google Scholar 

  17. Nappi G, Bono G, Merlo G, et al. Long-term nicergoline treatment of mild to moderate senile dementia. Clin Drug Invest 1997; 13: 308–16

    Article  CAS  Google Scholar 

  18. Winblad B, Bonura ML, Rossini BM, et al. Nicergoline in the treatment of mild-to-moderate Alzheimer’s disease: a European multicentre trial. Clin Drug Invest 2001; 21(9): 621–32

    Article  CAS  Google Scholar 

  19. Winblad B, Carfagna N, Bonura L, et al. Nicergoline in dementia: a review of its pharmacological properties and therapeutic potential. CNS Drugs 2000; 14(4): 267–87

    Article  CAS  Google Scholar 

  20. Giardino L, Zanni M, Fernandez M, et al. Plasticity of GABA(a) system during ageing: focus on vestibular compensation and possible pharmacological intervention. Brain Res 2002; 929(1): 76–86

    Article  PubMed  CAS  Google Scholar 

  21. Sacristan M, Alvarez-Vicent JJ, et al. (editors). Proceedings of the XIV World Congress of Otorhinolaryngology, Head Neck Surgery, Madrid 1989. Kugler & Ghedini Publisher: Amsterdam, Berkley, Milano 1990: 887–8.

    Google Scholar 

  22. Felisati G, Novellini R, Battaglia A, Valzelli S. Proposta per la valutazione diagnostica e quantitativa delle vertigini di origine centrale. Atti 78° Congresso Nazionale SIO, Rimini, Italy; 1991 May 21–25

  23. Felisati G, Brambilla D, Battaglia A, et al. Risultati di uno studio multicentico Italiano con nicergolina in pazienti anziani affetti da vertigine centrale. Monduzzi Ed. “Eu.F.O.S.” 1992: 405-409

  24. Spanio M, Annoni K, Battaglia A, et al. Instrumental evaluation of central dizziness by a multicentric open study on nicergoline effects [abstract]. 15th World ENT Congress; 1993, Istanbul, Turkey: 182

  25. Mira E, Manfrin M, Pignataro O, et al. Valutazione clinica e strumentale degli effetti di un derivato ergolinico sulle vertigini centrali [abstract]. In: 82° Congresso Nazionale della Società O.R.L; 1995 May 25–27; Viterbo.

  26. Jacobson GP, Newman CW, Hunter L, et al. Balance function test correlates of the Dizziness Handicap Inventory. J Am Acad Audiol 1991; 2(4): 253–60

    PubMed  CAS  Google Scholar 

  27. Gagey P, Gentaz R, Guillamon J, et al. 1988. Normes 85. Association Francaise de Posturologie, Paris.

    Google Scholar 

  28. Lacour M, Barthelemy J, Borel L, et al. Sensory strategies in human postural control before and after unilateral vestibular neurotomy. Exp Brain Res 1997; 115: 300–10

    Article  PubMed  CAS  Google Scholar 

  29. Guidetti G. La stabilometria statica. In: Guidetti G, editor. Diagnosi e terapia dei disturbi dell’equilibrio. Roma: Marrapese, 1996: 363–80

    Google Scholar 

  30. Freedman LS. Tables of the number of patients required in clinical trials using the logrank test. Stat Med 1982; 1: 121

    Article  PubMed  CAS  Google Scholar 

  31. Rampello L, Drago F. Nicergoline facilitates vestibular compensation in aged male rats with unilateral labyrinthectomy. Neurosci Lett 1999; 267(2): 93–6

    Article  PubMed  CAS  Google Scholar 

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Acknowledgements

The authors wish to thank the contract research organisations GIAEL and OPIS for their efforts in the management of the study and for statistical analysis. The study was supported by a grant from Pharmacia, Italy.

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Authors and Affiliations

  1. ENT Department, San Paolo Hospital, Milan University Medical School, Milan, Italy

    Giovanni Felisati

  2. Medical Department, Pharmacia Italia, Market Company Italy, via R. Koch 1.2, 20152, Milan, Italy

    Angelo Battaglia, Maria Grazia Papini & Bianca Maria Rossini

  3. 2nd ENT Department, Milan University Medical School, Milan, Italy

    Oreste Pignataro

Authors
  1. Giovanni Felisati
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  2. Angelo Battaglia
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  3. Maria Grazia Papini
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  4. Bianca Maria Rossini
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  5. Oreste Pignataro
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Consortia

Nicergoline Dizziness Study Group

Corresponding author

Correspondence to Angelo Battaglia.

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Felisati, G., Battaglia, A., Papini, M.G. et al. Nicergoline in Balance Alterations in Adult and Elderly Patients. Clin. Drug Investig. 22, 731–740 (2002). https://doi.org/10.2165/00044011-200222110-00002

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