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Neurophysiological Evaluation of Short-Term Outcome of Pharmacological Page 722 VOJNOSANITETSKI PREGLED Vojnosanit Pregl 2017; 74(8): 722–727. UDC: 615.03::[616.8-009.-02:616.379-008.64 ORIGINAL ARTICLE https://doi.org/10.2298/VSP151209261C Neurophysiological evaluation of short-term outcome of pharmacological treatment of diabetic neuropathy Neurofiziološka procena kratkoročnog ishoda farmakološkog lečenja dijabetesne neuropatije Milan Cvijanović*†, Svetlana Simić*†, Aleksandar Kopitović*†, Ranko Raičevi懧 Clinical Center of Vojvodina, *Neurology Clinic, Novi Sad, Serbia; University of Novi Sad, †Faculty of Medicine, Novi Sad, Serbia; Military Medical Academy, ‡Neurology Clinic, Belgrade, Serbia; University of Defence, §Faculty of Medicine of the Military Medical Academy, Belgrade, Serbia Abstract Apstrakt Background/Aim. Diabetic polyneuropathy (DPN) is a very Uvod/Cilj. Dijabetesna polineuropatija (DPN) je veoma česta, frequent and progressive disease that severely impairs the overall progredijentna bolest koja dovodi do grubog urušavanja kvaliteta quality of life, accompanied by a high rate of disability. For these života praćenog visokom stopom invalidnosti. Iz tih razloga reasons, the testing of therapeutic agents for this disease is in- ispitivanje terapijskih sredstava za ovu bolest je u zamahu. creasing. Methods. We tested the most frequently used drugs Metode. Ispitivani su najčešće korišćeni lekovi za dijabetesnu for diabetic neuropathy in our area, along with electrophysiologi- neuropatiju u našem podneblju, uz elektrofiziološko praćenje da cal monitoring in order to avoid subjectivity and the "placebo ef- bi se izbegla subjektivnost i „placebo efekat“. Kod ukupno 120 fect". A total of 120 patients were divided into four groups: three bolesnika podeljenih u četiri grupe ispitivana je alfa lipoinska groups who received alpha-lipoic acid, benfotiamine or gabapen- kiselina, benfotiamin i gabapentin, s tim što je elektrofiziološki tin respectively, and the control group who did not receive any praćena i grupa bolesnika koji u posmatranom periodu nisu treatment. In all the patients we analyzed motor conduction ve- dobijali terapiju. Analizirali smo motornu brzinu provođenja, locity, distal latency, sensory conduction velocity, F wave and F distalnu latencu, senzitivnu brzinu provođenja, F talas i wave chronodispersion before and after treatment with each hronodisperziju F talasa, pre i posle terapije za svako drug. Results. It is evident that some drugs had a favorable im- pojedinačno terapijsko sredstvo. Rezultati. Evidentno je da su pact on the condition of the peripheral nerves. Alpha-lipoic acid neki lekovi imali povoljan uticaj na stanje perifernog nerva. Alfa and benfotiamine had an impact on the recovery of the nerve, i.e. lipoinska kiselina i benfotiamini su imali uticaja na oporavak pathophysiological processes, whereas gabapentin had no impact nerva odnosno patofiziološke procese, gabapentin je bio bez on the recovery, similarly to the control group without any uticaja na oporavak, a slično je bilo i kod kontrolne grupe koja je treatment. Electrophysiological indicators had different sensitiv- bila bez bilo kakve terapije. Elektrofiziološki pokazatelji su imali ity to detect conditions of the peripheral neurons. The best ef- različitu osetljivost na detekciju stanja perifernog neurona. fect, in terms of increased sensory conduction velocity, had the Najbolji efekat koji se ogleda u povećanju senzitivne brzine patients treated with alpha-lipoic acid. Conclusion. The effect of provođenja imali su bolesnici koji su tretirani alfalipoičnom alpha-lipoic acid and benfotiamine on the condition of peripheral kiselinom. Zaključak. Uticaj alfa lipoinske kiselina i nerve was evident. The failure of recovery, i.e. deterioration of benfotiamina na stanje perifernog nerva je evidentno. Odsustvo electrophysiological parameters in patients who did not receive oporavka, odnosno pogoršanje elektrofizioloških pokazatelja kod neuroprotective therapy suggests the need of permanent medica- ispitanika koji nisu dobijali neuroprotektivnu terapiju, ukazuje na tion and periodic electrophysiological monitoring of patients potrebu permanentne medikacije i periodičnog elektrofiziološkog with diabetic polyneuropathy. praćenja bolesnika sa dijabetesnom polineuropatijom. Keywords: Ključne reči: diabetic neuropathies; electromyography; drug therapy; dijabetesne neuropatije; elektromiografija; lečenje thioctic acid; thiamine monophosphate; gabapentin; lekovima; tioktinska kiselina; tiamin monofosfat; treatment outcome. gabapentin; lečenje, ishod. Correspondence to: Milan Cvijanović, Clinical Center of Vojvodina, Neurology Clinic, 21 000 Novi Sad, Serbia. E-mail: [email protected] Vol. 74, No 8 VOJNOSANITETSKI PREGLED Page 723 Introduction examined in several studies 8 and are approved for use by the Food and Drug Administration (FDA) and the European Me- Diabetic neuropathy is a complex group of clinical dical Agency. There is data that pregabalin has a more pre- syndromes that damage the different regions of the nervous dictable and consistent pharmacokinetic profile and could be system, either individually or in combination 1. It is the most titrated faster and easier to use in comparison to gabapentin 9. common and the most unpleasant complication of diabetes, Benfotiamine (BENTO) the thiamine monophosphate leading to high morbidity and mortality, which results in lar- synthetic analogue, has improved bioavailability compared ge economic costs 2. with thiamine 10. It also has a preventive effect on microvas- Assessment of the frequency of this damage in patients cular complications in rats, without affecting the glycemic with diabetes is not simple and a wide range of various as- control 11. Some short-term studies, lasting 8–12 weeks, have sessments are available depending on the applied criteria and suggested its favorable impact on polyneuropathy 12, and methods for defining neuropathy. However, it can be said along with its widespread use, we chose it for our research. that diabetic neuropathy is the most common form of However, probably the longest used and most thoroughly neuropathy, which is responsible for more hospitalizations studied drug for diabetic neuropathy (Study 1 Sydney, than all other diabetic complications together. It should not Sydney 2, etc.), as confirmed by recent research, is alpha- be underestimated, because this "late" complication of diabe- lipoic acid (ALA) 13, 14, which has been shown to have a sig- tes can lead to foot ulcers and gangrene, lower leg and foot nificant impact on the improvement of diabetic amputations, or even sudden death of a patient, presumably polyneuropathy. due to cardiovascular autonomic neuropathy 3. The aim of this study was to study the effects of alpha- The most common type of diabetic neuropathy, accoun- lipoic acid, benfotiamine and gabapentin on ting for around 80% of all diabetic neuropathies, is a distal electrophysiological parameters of the state of peripheral symmetric neuropathy, or otherwise called diabetic sensori- nerves in diabetic polyneuropathy, with a control group of motor polyneuropathy 4, with initial symptoms in the feet, patients without any treatment. In addition, we aimed to de- spreading upwards. Hyperglycemia is the most important termine the differences among the applied treatments and to modifiable risk factor for its emergence, as well as for other estimate changes in individual electrophysiological parame- complications of diabetes, so a maximum control of glucose ters caused by the applied treatment. levels is the primary goal in diabetic patients 5. The question then arises as to why additional remedies Methods for neuropathy are continuously searched for, considering that a reliable control of blood glucose levels is possible. The study was designed as an observational analytical First, because despite considerable effort, the desired level of study, with the purpose to determine whether the drugs used metabolic control is often not achieved 6, and second, despite in the study have an effect in the treatment of peripheral ner- the ideal glucoregulation, a significant number of patients ve disorders in diabetic patients, which of them are more ef- with diabetes still experience neuropathic damage. A recent fective in the treatment of peripheral nerve injury, and to as- meta-analysis suggests that a constant glucose control pre- sess the needs for treatment in the controls in relation to the vents the development of clinical neuropathy only in type 1 results of repeated electrophysiological findings. diabetes, whereas in type 2 no reduction in incidence is fo- Our study monitored the neurophysiological state in pati- und 7. The quality of life of these patients is often very poor. ents with diabetic polyneuropathy, who were referred to This indicates a problem of early diagnosis and a successful electromyoneurographic examination to the Electromyography treatment action, which should be individualized. Unit of the Neurology Clinic of the Clinical Center of Vojvodi- In the clinical practice, a large number of drugs and the- na by primary care physicians. Since the first control, the pati- rapeutic procedures exist, which do not always lead to im- ents were subsequently recommended symptomatic treatment provements. Drugs are divided into two groups: symptomatic (gabapentin) or causally-related therapy (benfotiamine or alpha- treatment, or coanalgesics, and a therapy that presumably lipoic acid), depending on the clinical picture, and acts on the pathogenesis of diabetic polyneuropathy. Our ob- electrophysiological
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