Efficacy and Safety of Ya Sahatsathara on Diabetic Peripheral Neuropathy of Lower legs in Type 2 Diabetic Patients
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Abstract
Introduction and objectives: Complication of peripheral neuropathy in patients with type 2 diabetes mellitus (T2DM) continues its natural course with increasing pain and numbness, loss of sensation, ulcers, infections, amputations and even death. Ya Sahatsathara (SHT) is one of the herbal medicinal formulas on the National List of Essential Medicines. There is an indication of the use for relieving gastrointestinal gas (lom kong yap), muscle and joint pain, hand spasms and foot numbness. This study aimed to investigate the efficacy and safety of SHT on peripheral neuropathy of lower legs in T2DM patients, and to assess the correlation between SHT therapy and the quality of life of the patients.
Methods: This double-blinded, randomized controlled trial was undertaken in 62 T2DM patients with peripheral neuropathy, aged 45–75 years, who received treatment in the Diabetes Clinic of Khlong Luang Hospital and Khlong Nueng THPH. The patients were divided into two groups: group 1 receiving SHT and group 2 receiving placebo. Each patient took 500 mg (2 capsules) each time, 3 times a day before meals for 28 consecutive days. Both groups received a vitamin B1 supplement after meals. Screening for peripheral nervous system degeneration was performed using the Michigan Neuropathy Screening Instrument (MNSI). The drug efficacy was evaluated with the Short-Form McGill Pain Questionnaire and the Neuropathy Total Symptom Score-6 (NTSS-6); and the quality of life (QOL) was assessed with the Diabetes-39 Questionnaire.
Results The group received SHT found a change in the pain score of McGill, which decreased by -1.66 (95%CI: -2.23, -1.09). The total score of the six sensory symptoms decreased by -1.24 (95%CI: -1.83, -0.64). Aching pain decreased by -0.69 (95%CI: -0.85, -0.53), and numbness decreased by -0.62 (95%CI: -0.76, -0.48). The evaluation of the quality of life of diabetic patients with Diabetes-39 indicated a better quality of life in terms of energy and vitality, with the effect scores decreasing by -5.27 (95%CI: -6.81, -3.72).
Discussion The scores for pain and sensory symptoms, such as aching pain and numbness, as well as the quality of life in terms of energy and vitality. The group received SHT found change in scores decreased significant differences (p-value < 0.05) compare with placebo control group. In addition, liver and kidney function values were within normal limits. The adverse reactions listed in consist of abdominal pain, dry mouth, dry throat, dizziness and constipation were mild to moderate severity.
Conclusion: Ya Sahatsathara medication in T2DM patients with peripheral neuropathy, for 28 days consecutively, can reduce sensory symptoms, pain and numbness, but increase quality of life regarding energy and vitality. No severe adverse drug reactions were observed.
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