Add-on effect of Ayurvedic treatment protocol for diabetic retinopathy: A randomized controlled clinical study

BACKGROUND: Diabetic retinopathy (DR), the leading cause of visual disability in diabetics, is a significant complication of diabetes mellitus. Currently available conventional treatments for DR have certain limitations, considering which Ayurvedic treatment protocol was designed. AIM: The aim of this study was to evaluate the clinical efficacy of the Ayurvedic treatment protocol for DR. MATERIALS AND METHODS: This was a randomized, controlled, black box design clinical study conducted from April 2016 to September 2017 by the department of Shalakya Tantra of a tertiary academic hospital in Western India. A hundred patients of DR in the age group 30–70 years were randomly divided into two groups by simple random sampling using computer-generated random number tables. In the trial group (n = 70), the preparatory phase included Dipana-Pachana (stomachic and digestant), Koshtha Shodhana (mild therapeutic purgation), and Shiro Virechana (eliminative nasal medication). The treatment phase included Marsha Nasya (nasal medication) and Pratimarsha Nasya (nasal medication of mild dose) with Durvadi Ghrita, Takra Dhara (pouring medicated buttermilk over the scalp) with Siddha Takra, and intake of Rasayana Yoga (treatment duration – 3 months). In the control group (n = 30), patients were kept under conservative treatment and observed during the trial period of 3 months. Patients of both groups continued with their treatment for diabetes and DR if any. Two follow-ups were done at an interval of 15 days. The primary outcomes were objective signs like best-corrected visual acuity (BCVA); ophthalmoscopic signs such as superficial hemorrhages, dot-blot hemorrhages, hard exudates, cotton wool spots, neovascularization disc, neovascularization elsewhere, and fibrovascular proliferation; subjective symptoms such as diminished vision, blurred vision, frequent changes in presbyopia glasses, perception of flashes of light, floaters, and problem for dark adaptation. The secondary outcomes were fasting blood sugar (FBS), postprandial blood sugar (PPBS), urine sugar, serum cholesterol, hemoglobin (Hb), glycosylated HbA1C, liver function test, and renal function test outcomes were assessed before and after the treatment. RESULTS: Ninety participants were included in the analysis of the primary outcome (62 in the trial and 28 in the control group). The trial group provided better results which were statistically significant on dot-blot hemorrhages, superficial hemorrhages, hard exudates, BCVA, FBS, and serum cholesterol. Both the groups provided almost similar effects in PPBS, Hb, HbA1C, and urine sugar which were statistically insignificant. Adverse effects were not reported in any of the patient among either groups. CONCLUSION: Ayurvedic treatment protocol is safe and effective in DR.