Background: Peripheral neuropathy is a common condition which can have a significant impact on quality of life. It occurs as a component of several common and rare diseases or can be idiopathic and can present with various symptoms. Aims and Objectives: This study is aimed at evaluating the effectiveness and safety of the fixed dose combination of vitamin B1, B6 and B12 in mild to moderate peripheral neuropathy of various etiologies in the Indonesian population. Materials and Methods: This was a prospective, open label, multi-center, single arm observational study (Indonesian Clinical Trial Registry No: INA-KPA0DYA). A total of 411 subjects with mild to moderate peripheral neuropathy of various etiologies, who met the eligibility criteria, were included in the study. A subject was considered to have “completed” the study if the study procedures, up to Visit 3 (one month of treatment) were accomplished. Procedural results and 12-week clinical outcomes are reported. Results: Treatment with combination of vitamin B1, B6 and B12 in subjects with symptoms of PN showed significant improvement in overall Total Symptom Score (TSS), within 14 days. The treatment also successfully reduced individual components of TSS from baseline to Visit 5. A significant percentage reduction was also observed for all the Visual Analogue Scale (VAS) parameters at the end of 12 weeks, while the Quality of Life (QoL) scores increased from baseline to the end of treatment. Conclusions: The fixed dose combination of vitamin B1, B6 and B12 was effective and well tolerated in subjects with mild to moderate peripheral neuropathy, of various etiologies.
INTRODUCTION: Peripheral neuropathy (PN) is a clinical condition, wherein the peripheral nervous system is damaged.1 Symptoms of PN can be diverse, patients often experience prickling, tingling, numbness, a reduced ability to feel pain or changes in temperature, a burning pain, and allodynia.2-5 The common causes of PN include systemic diseases like diabetes, environmental toxins, vitamin and nutritional deficiency, drug-induced traumatic injury, excessive consumption or alcohol abuse, immune system diseases or viral infection, hypothyroidism, genetic and idiopathic.5-9 Although the exact incidence of PN is not well documented, there is data showing a prevalence of 8.1% in general population at the age of 40-49.9 Early diagnosis and treatment are crucial to maintaining the quality of life (QoL) and avoid further progression of the disease and development of severe symptoms. When symptoms are severe or irreversible, PN can lead to deterioration of QoL.10 Various treatment options are available for the management of neuropathy.11 Studies have shown effectiveness of Vitamin B, Alpha Lipoic Acid (ALA) and Acetyl L Carnitine in the management of mild to moderate PN9,12-16 and B Vitamins can also be used as co-treatment in advanced stages.17-19 Vitamin B (B1 , B6 , B12) deficiencies, may lead to an impaired nervous system.20 The three vitamins are complementary as they act via different modes of action.19 Thiamine diphosphate is the active form of vitamin B1 and serves as a cofactor for several enzymes involved primarily in carbohydrate catabolism21 and may prevent microvascular complications in diabetes.21 Vitamin B6 also is a coenzyme in many different metabolic reactions including transaminases and L-amino acid decarboxylases, which are crucial for the synthesis of neurotransmitters like dopamine, serotonin and γ aminobutyric-acid (GABA).22 Vitamin B12 may improve the nerve regeneration and restores nerve function, decreases neurotoxic cytokines, and improves myelin structure. 21 Fixed dose combination products of vitamin B1 , B6 and B12 were found to be effective, safe and well tolerated in the treatment of PN in earlier studies.13,14,23,24 The combination of vitamin B1 , B6 and B12 is commonly used in the clinical practice for decades to treat peripheral neuropathy, however, the level of published scientific evidence is not high but this treatment is seen as a well-established, experience-based treatment. Additionally, majority of the studies showing effectiveness of this combination, in treatment of PN, have been performed with diabetic patients not providing information on the effect in PN of any other etiology.25 The objective of the present noninterventional study was to evaluate the effectiveness and safety of commercially available fixed-dose combination of vitamin B1 (100 mg), B6 (100 mg) and B12 (5000 mcg) once daily, in routine clinical practice in mild to moderate PN of various etiologies in addition to diabetes, in the Indonesian population.
Hakim et al., J Clin Trials 2018, 8:2 management of peripheral neuropathy symptoms with a fixed dose combination of high – dose vitamin B1, B6 and B12: A 12 week prospective non – interventional study in Indonesia