A randomized placebo-compared study on the efficacy of classical ayurvedic pharmaceutical form versus aqueous alcoholic extracts of Phyllanthus niruri Linn. Plus Sida cordifolia Linn. In patients of diabetic sensory polyneuropathy

BACKGROUND: In routine, Ayurveda practitioners prefer classical pharmaceutical form of herbal medicines in compare to modern extracts. OBJECTIVE: To explore the difference of efficiency between whole drug powder of Phyllanthus niruri plus root decoction of Sida cordifolia and modern extracts of the same in compared to placebo in patients of diabetic poly-neuropathy. MATERIAL AND METHODS: A randomized, partly-double-blinded, placebo-controlled trial evaluated the efficacy of two different pharmaceutical forms of herbal medicines over placebo in 90 patients (30 in each group) of diabetic sensory polyneuropathy for first three weeks period. After three weeks, active herbal medication groups were continued with their assigned medicaments for next 5 weeks period and all placebo-patients were randomized again into 2 groups of active medication and treated for next 8 weeks. Patients were assessed with Neuropathy Total Symptom Score 6 and sensation thresholds. RESULTS: Significant effect of both form of herbal medicines over placebo was found in aching pain [F (2, 49) = 6.79, p = 0.002], allodynia [F (2, 59) = 6.74, p = 0.002], burning pain [F (2, 82) = 14.66, p < 0.0001], numbness [F (2, 77) = 16.37, p < 0.0001] and pricking pain [F (2, 50) = 14.23, p < 0.0001]. After the 8 weeks period, no significant difference was identified between the effect of both the herbal treatment on aching pain (U = 220, p = 0.03), allodynia (U = 421.5, p = 0.29), burning pain (U = 881.5, p = 0.846), numbness (U = 778, p = 0.92) and pricking pain (U = 260, p = 0.15). CONCLUSION: Both herbal groups have significant effect to reduce NTSS-6 score in compare to placebo. No significant difference found between the effect of two different pharmaceutical forms of Phyllanthus niruri and S. cordifolia.