Vol 10, Issue 12, 2017 Online - 2455-3891 Print - 0974-2441 EFFECTIVITY ANALYSIS OF NEUROPROTECTOR (VITAMIN B COMPLEX AND MECOBALAMIN) AS NEUROPATHIC PAIN SUPPORTIVE THERAPY IN ELDERLY WITH TYPE 2 DIABETES MELLITUS MADE KRISNA ADI JAYA*, NI MADE OKA DWICANDRA Department of Clinical Pharmacy, Health Sciences Institute Medika Persada Bali, Denpasar, Bali, Indonesia. Email: krisnaadijaya598@gmail.com Received: 09 August 2017, Revised and Accepted: 12 September 2017 ABSTRACT Objective: Neuroprotector (Vitamin B complex or mecobalamin)is often used as a supportive neuropathic pain therapy. The effectiveness of this drug remains controversial, especially in geriatrics with Type 2 diabetic neuropathy pains. The aim of this study was to compare the diabetes neuropathic pain reduction in elderly with and without neuroprotective supplementation. Method: The study was conducted by prospective cohort design. 132 agings were observed during 4 weeks at Neurology Polyclinic, Sanglah Public Hospital, Denpasar, Bali-Indonesia. Individuals undergoing the first-line neuropathic pain therapy who received neuroprotector supplementation were included in the exposure group (66 individuals), while those not receiving neuroprotective supplementations were included in the nonexposure group (66 individuals). The pain scores were measured by numeric rating scales instruments. The measured outcome was a decrease in diabetic neuropathic pain scores. Result: Both groups showed reduce on pain scores statistically different compared to baseline pain score (p<0.05). The comparison head-to-head on neuroprotector supplementation group showed significantly greater to reduce the pain score compared to nonexposure group (p<0.05). The relative risk of pain score reduction more than 2 units was 1.37 (confidence interval [CI]95%: 1.05-1.80)and the number need to treat was 5 (CI 95%: 3-28) compared to nonexposure group. Conclusion: Individuals who are undergoing the first-line neuropathic pain therapy and getting Vitamin B complex or mecobalamin supplementation had decreased pain intensity better than without supplementation therapy. Keywords: Effectivity, Vitamin B complex, Mecobalamin, Neuropathic pain, Elderly. INTRODUCTION Diabetes mellitus (DM)is part of the chronic metabolic diseases that cause major neuropathy in the sufferer [1-3]. Neuropathy in DM is a disorder that occurs in the peripheral nervous system, due to DM. According to the Rochester study, the incidence of diabetic polyneuropathy in patients >60 years is greater than in other age groups (52%), so geriatrics need special attention [4-6]. Management of neuropathic pain and anther neuropathy problem, commonly utilized tricyclic antidepressant such as amitriptyline and gamma-aminobutyric acid analog such as gabapentin and pregabalin as the first-line therapy [7,8]. Phenomenon in health facilities often found clinicians add supportive therapy in the form of neuroprotectors such as Vitamin B complex (contain Vitamin B1, B6, and B12)or mecobalamin (Vitamin B12). Based on preliminary studies conducted at Sanglah Denpasar General Hospital, 70-85% of geriatric patients with diabetic neuropathy pain get supplementation of Vitamin B complex or mecobalamin. The use of neuroprotectors as a therapy supporting the pain of diabetic neuropathy is still controversial. A review by Jayabalan and Low, 2016, showed no evidence that the use of Vitamin B12 supplementation was associated with the improvement of clinical symptoms of diabetic neuropathy [9]. A randomize control trial study, in diabetic neuropathy patients, addition of methylcobalamin and alpha-lipoic acid showed significant improvement in the outcome of pain interference and sleep interference compared without the addition of methylcobalamin and alpha-lipoic acid [10,11]. There are no data related to the effectiveness of neuroprotectors in the local area. Based on the background of the problem, further research is needed to relate the effective analysis of neuroprotector (Vitamin B complex and mecobalamin)as supportive therapy in the treatment of neuropathic pain in geriatric patients with Type 2 DM. The results of this study are expected to be used as evidence-based medicine for clinicians, to determine the best therapy for treating diabetic neuropathic pain patients, especially in the elderly patient group in Indonesia. The novelty of this study was to directly compare the effects of neural supplementation and comparison of head-to-head Vitamin B complex and mecobalamin in geriatric patients with diabetic neuropathic pain. METHODS Subject The population in this study was geriatrics, diagnosed with diabetic neuropathy, and had an initial numeric rating scales (NRS)pain score of at least 2 units. The data were taken at the outpatient neurology polyclinic of the Central Hospital of Sanglah in Denpasar-Bali. The inclusion criteria were defined as men and women aged ≥60 years, patients with DM Type 2 with controlled blood sugar levels, patients with a diagnosis of painful diabetic neuropathy, and patients on therapy with the first-line neuropathic pain medicine with and without neuroprotector admission. The exclusion criteria were defined as patients who were not willing to participate in the study, patients with a history of heart disease, kidney failure, and impaired liver function. Sampling was carried out after obtaining the approval of a Sanglah Hospital research ethics committee with ethical clearance number 185/UN.14.2/R&D/2015 as well as informed consent from the patients. Patients will be included in the study if they are willing to be part of the © 2017 The Authors. Published by Innovare Academic Sciences Pvt Ltd. This is an open access article under the CC BY license (http://creativecommons. org/licenses/by/4. 0/) DOI: http://dx.doi.org/10.22159/ajpcr.2017.v10i12.21845 Research Article