Neuropathic pain is a common disorder characterized by negative and positive subjective signs and symptoms ranging from numbness to crippling pain. Type 2 diabetes mellitus (T2DM) is the primary cause of neuropathy and neuropathic pain. Diabetic neuropathic pain (DPN) is one of the most common diabetes mellitus complications. The study was aimed to analyze the efficacy and safety of Pregabalin, Duloxetine, and their combination with Epalrestat in T2DM neuropathic patients. The study was conducted on 200 subjects. The patients were divided into 4 groups each comprising of 50 patients. Group I(P) was subjected to Pregabalin (150 mg O.D), Group II (D) to Duloxetine (60 mg O.D), Group III (P + E) to Pregabalin + Epalrestat (150 mg + 100 mg (O.D), and Group IV (D + E) to Duloxetine +Epalrestat (60 mg + 100 mg (O.D) and) for a period of 6 months. Various clinical parameters like vibration perception threshold, gycated haemoglobin level, visual analog scale, DPNdiabetic diagnostic questionnaire, advance glycated end products, thiobarbituric acid reactive substances, C-reactive proteins, SF12 score, and cost-effectiveness were assessed at baseline and 3 and 6 months. Results demonstrated that Pregabalin and Epalrestat therapy has a better effect on neuropathic pain reduction than Duloxetine and Epalrestat with strict glycemic control and favorably contributes to the health effective benefits by inhibiting disease progression and fulfills the alternate goals of management of DPN. It has been suggested that Pregabalin and Epalrestat therapy is more efficacious and armamentarium for patients with DPN. It has been suggested that Group III therapy is more efficacious, cost-effective, and armamentarium for patients with DPN.

Introduction: Immunoassay technology is subject to matrix interferences that can produce inaccurate results and incorrect conclusions when using samples not previously validated. While many commercially available research grade (RG) immunoassay kits are available, caution should be applied when using RG kits for thyroid health assessments, particularly on samples from pregnant individuals whose blood chemistry is unique to non-pregnant individuals. Question: Do RG immunoassay kits reliably provide precise and accurate measurements of thyroid health biomarkers in serum Standard Reference Materials (SRMs) from pregnant and non-pregnant donors? Methods: T4, T3, rT3, Tg and TSH measurements were conducted on SRMs 971, Hormones in Frozen Human Serum, and SRM 1949, Frozen Prenatal Serum, using RG immunoassay kits. When available, performance was assessed against validated FDA approved immunoassays or mass spectrometric (MS) methods. Results: RG kits were variable, inaccurate, or imprecise for four of the six biomarkers assessed. RG kit total thyroid hormone measurements overall performed comparably to MS methods, except rT3 measurements, which were twofold greater than mass spectrometric measurements (971M RG mean = 0.51 ng/mL, MS mean = 0.20 ng/mL, p < 0.0001; 971F RG = 0.48 ng/mL, MS = 0.18 ng/mL, p < 0.0001) and had CVs over 30 %. RG kit Tg measurements varied sometimes by as much as tenfold (971M means of 6.50 ng/mL up to 63.3 ng/mL, p < 0.0001; 971F means of 0.350 ng/mL up to 14.5 mg/mL, p < 0.0001). TSH values differed by RG kit manufacturer (971M means of 1.27 µIU/mL up to 1.82 µIU/mL, p < 0.0001; 971F means of 1.36 µIU/mL up to 2.27 µIU/mL, p < 0.0001) and by dilution scheme using the same manufacturer with one case indicating a diagnosis of hypothyroid versus normal TSH levels (1949 non-pregnant undiluted mean = 2325 pg/mL, half dilution mean = 1631 pg/mL, p < 0.0001). Conclusions: RG immunoassays are often used for research projects because they do not require expensive equipment and are simple to conducted. However, we demonstrate here that not all kits are accurate for all patient samples. By utilizing a matrix matched SRM with well-defined quantities of thyroid health biomarkers, one can assess method accuracy, making measurements from different methods comparable. Thereby, data can be harmonized to contribute reliable data on thyroid biomarkers to advance the field of thyroid health.