THE STUDY OF SAFETY AND EFFICACY FOR THE COMBINATION OF AMITRIPTYLINE AND MECOBALAMIN IN NEUROPATHIC PAIN

Abstract

Objective: Study was done to evaluate the  efficacy  as  well  as  safety  for  the combination  of amitriptyline  and  mecobalamin.

Methods: Study was conducted at 72 centres all over India. The patients who met with the inclusion and  exclusion  criteria  were  enrolled  in  the  study  and  treated  with the combination of amitriptyline and mecobalamin, taken once a  day  at  night  before sleep. Patients were evaluated for the efficacy by visual analogue scale (VAS).  Safety was evaluated through the noted adverse events occurring during the clinical trial. Patients VAS score were noted  on  baseline,  visit  2  at  day  30  and  visit  3  at  day  45 and also asked for  any  adverse  events  and  accordingly  case  report  forms  were  filled by the investigators. Then from the collected data change in mean  VAS  score  and percent decrease in  pain  intensity  from  baseline  to  visit  2  and  visit  3  and  percentage of patients  achieving  ?50%  reduction  in pain  from the  baseline  were  collected.

Results: The mean VAS score at baseline was 7.39 decreased to 5.6 at visit 2 and further decreased to 3.99 at visit 3. The percent  decrease  in  mean  VAS  score  was found to be 24.22% at visit  2  and  46%  at  visit  3.  63.99% and 82.44% patients at visit 2 and visit 3 had ?50% reduction in neuropathic pain.  No serious side effects were observed.

Conclusion: The combination of amitriptyline  and  mecobalamin  was  found  to  be  safe and  efficacious  in  the treatment  of neuropathic  pain.

Keywords: AmNurite, Amitriptyline,  Methylcobalamin,  safety,  efficacy.