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, Volume 33, Supplement 2, pp 125–130 | Cite as

Clinical Experience with Cyclandelate in Insulin-Dependent Diabetic Patients with Neuropathy

  • I. H. De Leeuw
  • P. Van Rooy
  • M. Moeremans
  • M. Driessens
Section 2: Clinical Studies

Summary

Previous trials have demonstrated a clinical and electrophysiological improvement of diabetic peripheral polyneuropathy in diabetic patients treated with cyclandelate at a dosage of 1600 mg/day. Hence, a double- blind randomised trial was started in 16 insulin- dependent diabetic patients presenting with symptoms of neuropathy, an increased vibration perception threshold (VPT), disturbed tendon reflexes at lower limbs and an EMG showing a significantly decreased motor nerve conduction velocity (MCV) of the peroneal nerves.

The placebo-treated group and the cyclandelate-treated group were not significantly different regarding age, duration of diabetes and level of metabolic control (measured as total HbA1), which remained unchanged during the year of observation. In the cyclandelate- treated group, pathological sensation improved significantly in 7 of 8 patients. MCV, measured under standardised conditions, increased significantly during the first 6 months of treatment, while mean VPT did not change. In the placebo group 3 of 8 patients showed an improvement of sensation, 3 did not feel any change and 2 worsened. Neither mean MCV nor VPT changed significantly. No severe side effects were observed during the study period.

Keywords

Diabetic Neuropathy Peroneal Nerve Aldose Reductase Aldose Reductase Inhibitor Motor Nerve Conduction Velocity 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Résumé

Des études précédentes ont mis en évidence l’amélioration clinique et électrophysiologique des polyneuropathies diabétiques périphériques chez des patients traités par 1600 mg/jour de cyclandélate. Ces résultats ont justifié l’initiation d’une étude randomisée et en double insu incluant 16 patients atteints d’un diabète insulino-dépendant et présentant des symptômes de neuropathie, une augmentation du seuil de perception des vibrations (SPV), des altérations des réflexes tendineux des membres inférieurs et, à l’EMG, une diminution significative de la vitesse de conduction nerveuse motrice (VCM) des nerfs péroniers. Le groupe placebo et le groupe cyclandélate ne présentaient pas de différence significative relative à l’âge, l’ancienneté du diabète et la qualité du contrôle métabolique (mesuré par le dosage de l’HbA1), qui n’a pas varié au cours de la période d’observation de un an. Dans le groupe cyclandélate, les symptômes se sont améliorés de façon significative chez 7 patients sur 8. La mesure de la VCM dans des conditions de reproductibilité a révélé une augmentation significative de ce paramètre au cours des 6 premiers mois de traitement, sans modification du SPV moyen. Dans le groupe placebo, les symptômes se sont améliorés chez 3 patients sur 8, n’ont pas varié chez 3 et se sont aggravés chez 2. La VCM et le SPV n’ont pas été significativement modifiés. On n’a observé aucun effet secondaire sévère pendant la durée de l’étude.

Riassunto

Precedenti esperimenti avevano dimostrato un miglioramento clinico ed elettrofisiologico della polineuropatia diabetica periferica in pazienti diabetici trattati con 1600 mglgiorno di ciclandelato. Si iniziô una prova randomizzata a doppio cieco su 16 pazienti diabetici insulino-dipendenti, che presentavano sintomi di neuropatia, aumentata soglia della percezione delle vibrazioni (VPT), alterati riflessi tendinei degli arti inferiori e un EMG ehe mostrava una significativa diminuzione della velocità di conduzione delle componenti motorie (MCV) dei nervi peroneali. Il gruppo trattato con placebo e il gruppo trattato con ciclandelato non presentavano differenze significative rispetto all’età, alla durata del diabete e al livello del controllo metabolico (misurato come HbA1 totale). Questi valori rimasero inalterati durante Vanno di osservazione. Nel gruppo trattato con ciclandelato, in 7 pazienti su 8 si verified un miglioramento della sensazione patologica. L’MCV, misurato in condizioni standard, aumentò significativamente nei primi sei mesi di trattamento, mentre il VPT medio non cambio. Nel gruppo trattato con placebo, 3 pazienti su 8 mostrarono un miglioramento della sensazione, 3 non avvertirono alcun cambiamento e 2 peggiorarono. Né l’MCV medio né il VPT cambiarono in modo significativo. Nel corso della ricerca non furono riscontrati notevoli effetti collaterali.

Samenvatting

In vroegere onderzoekingen werd een klinische en elektrofysiologische verbetering waargenomen van diabetische perifere polyneuropathie bij diabetici die met een dagelijkse dosis van 1600 mg cyclandelaat werden behandeld. Daarom werd een dubbelblind, aselect onder-zoek opgezet bij 16 insuline afhankelijke diabetici. Naast Symptomen van neuropathie ver-toonden zij een verhoogde waarnemingsdrempel voor trillingen, peesreflexstoornissen in de onderste ledematen en — zoals uit het elektromyogram blijkt — een significant verminderde conductiesnelheid van de bewegingszenuw (MCV) in de peroneale zenuwen. Tussen de groep die placebo toegediend kreeg en de met cyclandelaat behandelde groep waren er geen significante verschillen in leeftijd, duur van de diabetes en metabolische-controlegraad (gemeten als het totale HbA1), die onveranderd bleef tijdens het jaar waarin de patiënten geob-serveerd werden. In de met cyclandelaat behandelde groep verbeterde pathologische perceptie significant bij 7 van de 8 patiënten. De MCV, die in gestandaardiseerde omstandigheden werd gemeten, nam significant toe tijdens de eerste 6 maanden van de behandeling, terwijl de gemiddelde waarnemingsdrempel voor trillingen niet veranderde. In de placebogroep verbeterde de toestand bij 3 van de 8 patiënten; 3 voelden geen verandering en 2 gingen achteruit. De gemiddelde waarden wat de conductiesnelheid en waarnemingsdrempel, betreft, veranderden niet significant. Tijdens de onderzoeksperiode werden geen ernstige bijwerkingen waargenomen.

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Copyright information

© ADIS Press Limited 1987

Authors and Affiliations

  • I. H. De Leeuw
    • 1
    • 2
  • P. Van Rooy
    • 1
    • 2
  • M. Moeremans
    • 1
    • 2
  • M. Driessens
    • 1
    • 2
  1. 1.Department of EndocrinologyUniversity Hospital Antwerp (UZA)AntwerpBelgium
  2. 2.Department of MedicineUniversity Hospital Antwerp (UZA)AntwerpBelgium

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