జర్నల్ ఆఫ్ క్లినికల్ ట్రయల్స్
అందరికి ప్రవేశం

నైరూప్య

Improvement of Quality of Life in Patients with Peripheral Neuropathy Treated with a Fixed Dose Combination of High-Dose Vitamin B1, B6 and B12: Results from a 12-week Prospective Non-interventional Study in Indonesia

Manfaluthy Hakim, Nani Kurniani, Rizaldy Pinzon, Dodik Tugasworo, Mudjiani Basuki, Hasnawi Haddani, Pagan Pambudi, Aida Fithrie and Audry Devisanty Wuysang

Objective: The 12-week prospective, non-interventional study conducted in Indonesia aimed to evaluate the effectiveness and safety of a fixed combination of high-dose vitamin B1, B6 and B12 in subjects with peripheral neuropathy (PN) of various etiology. As PN is known to significantly impair patients’ quality of life (QoL), special attention has been paid to this aspect and QoL data were collected as secondary outcome parameters over time. Methods: The study enrolled subjects aged 18–65 years with mild or moderate PN of various etiologies. PN symptoms were measured by Total Symptom Score (TSS) and Visual Analogue Scale (VAS) at visit 1 (baseline), visit 2 (day 14), visit 3 (day 30), visit 4 (day 60), and visit 5 (day 90). At visits 1, 3, 4, and 5, the subjects also reported QoL data as assessed by the Short Form 8 (SF-8) Health Survey Questionnaire. Changes from baseline to other follow-up visits were calculated by exploratory analysis for TSS, VAS, and QoL scores. Results: Data of 411 subjects with PN (104 diabetic, 44 carpal tunnel syndrome, 112 idiopathic, 25 other, and 126 with combinations of different causes) were available at baseline. Mean total TSS had improved by 62.9% at visit 5. Mean VAS reductions at visit 5 ranged from 57.8–89.6% for the evaluated symptoms numbness, burning, tingling, pain, and paresthesia. Symptom relief was associated with a significant improvement in QoL. This was evident in the total population by a significant increase of the physical component summary score (PCS) and the mental component summary score (MCS) at visit 5 compared to baseline (both p<0.0001). In addition, all etiologic subgroups showed a significant progressive QoL improvement over time. Study results related to effectiveness have been published previously; the focus of this publication is on QoL improvement, assessed by one of the secondary parameters. Conclusion: The study results suggest that the fixed dose combination of high-dose vitamin B1, B6 and B12 is effective to treat mild to moderate PN of various etiologies and is well tolerated. The improvements in PN positively affected the patients’ QoL as reflected by the SF-8 scores.