Effectiveness of individualized homoeopathic treatment add on to lifestyle modifications in cases of Non-Alcoholic Fatty Liver Disease (NAFLD): A double-blind randomized placebo-controlled trial

Non-alcoholic fatty liver disease is a clinic-histopathological condition characterized by a spectrum of conditions characterized histologically by macrovesicular hepatic steatosis in those who do not consume alcohol in amounts generally considered harmful to the liver. The global prevalence of the disease is approximately 25% of the population and the prevalence of disease in India is approximately 9 – 35%. Obesity, type 2 (non-insulin-dependent) diabetes mellitus, and hyperlipidaemia are coexisting conditions frequently associated with NAFLD. The condition can be found in any age group including in childhood but the highest prevalence has been observed between 40 – 50 years of age. Most of the cases of NAFLD do not produce any signs of liver disease at the time of diagnosis, although symptoms of fatigue or malaise and sensation of discomfort or fulness over the right upper part of the abdomen may be present. An incidental rise in transaminases and fatty liver during ultrasonography conducted during routine check-ups may be the only demonstrable sign of the disease. Ultrasonography has a specificity and sensitivity of 85% in the detection of hepatic steatosis. Biochemical tests usually show mildly elevated AST and ALT, with the latter often higher.  Fibroscan (transient elastography) is another non-invasive procedure that determines the extension of fibrosis within the liver tissue and directly does not relate to the fat content within the liver. Pharmacological interventions for the condition did not offer much conclusive evidence till now as most of the reviews and clinical practice guidelines suggested. The availability of the evidence suggests a very low quality of evidence with a high risk of bias. Certain herbal medicines also demonstrated some positive evidence but again such studies suffered a significantly high risk of bias. No studies have been conducted in Homoeopathy on this condition to date. Moreover, Homoeopathy has also been criticized to be a causative factor behind the development of severe hepatitis due to the vehicle of alcohol being used in Homoeopathic medicines. Therefore a double blind placebo controlled study as an add on to lifestyle modification is being conducted to generate the necessary evidence for the condition. The study shall include patients aged 18 to 75 years of all gender with evidences of fatty changes in liver and shall be prospectively studied to observe changes in the laboratory and imaging parameters to elicit changes in relation to intervention and placebo along with lifestyle modifications.  The study is of 3 years duration, after which the the data shall be subjected to statistical analysis and the findings shall be disseminated to the scientific community for further researches and implementations.