Effectiveness of silymarin with lifestyle intervention in NAFLD and metabolic syndrome: a prospective single-arm study.

内容摘要

Non-alcoholic fatty liver disease (NAFLD) has now become a major global health concern. Lifestyle modifications are the first line of treatment; however, their effectiveness is often limited. Silymarin extracted from Silybum marianum is effective and well tolerated in patients with liver disorders. This study aimed to assess the effect of administration of silymarin along with lifestyle changes on lowering liver enzymes in patients with NAFLD and metabolic syndrome in a real-world setting. Patients enrolled in this observational study were prescribed standard of care (diet and physical exercise) and one capsule of 140 mg of silymarin thrice daily for 6 months. Laboratory tests, non-invasive tests, ultrasonography, quality of life questionnaire, lifestyle changes and safety were assessed at 3-month and 6-month visits. Of 360 patients enrolled in the study, 315 (88%) completed the study. At baseline, aspartate transaminase (AST), alanine transaminase (ALT) and gamma-glutamyl transferase (GGT) levels were elevated in 45%, 90% and 47% of patients, respectively. By end of study, 45% (148/328) of patients achieved normalization in at least one enzyme (AST: 42%, ALT: 34%, GGT: 28%), and overall, 78% of patients showed reduction in levels for at least one liver enzyme. Enzyme levels including AST, ALT, and GGT, underwent a clinically relevant decrease (>30%) in 42%, 40%, and 34% of patients, respectively. Silymarin was well tolerated with no serious side-effects. Silymarin combined with lifestyle modifications is a safe and effective treatment option for reducing and normalizing liver enzyme levels in patients with NAFLD and associated metabolic syndrome. ClinicalTrials.gov Identifier: NCT05051527. Many people today live with fat building up in their livers, a condition called NAFLD. It often shows up along with metabolic syndrome (MetS), which means having health problems such as high blood pressure, high blood sugar or extra body weight. People who have both NAFLD and MetS are at a higher risk of developing diabetes, heart issues or liver damage later in life.Doctors usually advise people to exercise more and follow a healthier diet. These changes help, but many people find them hard to maintain, or they may not see enough improvement.Silymarin, a natural extract from the milk thistle plant, has been known for its liver-protecting effects. It may calm inflammation and protect liver cells. Researchers wanted to see what would happen if people with NAFLD and MetS used silymarin alongside healthier habits. A group of 360 adults from Thailand, Malaysia and the Philippines joined the study. Everyone had NAFLD and MetS. Each person was asked to try and follow a healthier diet and add regular exercise to their routine. On top of that, they took silymarin (Legalon®) three times a day for 6 months.Every few months, doctors checked their liver enzyme levels, blood sugar, cholesterol and liver fat and how the participants felt overall. High liver enzymes usually mean the liver is irritated or under strain. When the numbers fall, it is often a sign that the liver is healing or working more smoothly. Most people started out with liver enzymes that were higher than normal. In 6 months, many of them saw improvements. In almost half the group, at least one liver enzyme went back to normal levels. About 78% saw their enzyme levels drop. AST levels improved in 42 out of 100 people, ALT levels improved in 40 out of 100 and GGT levels improved in 34 out of 100.There were also small but positive changes in blood sugar and liver tests that look at fat buildup and stiffness. Many people said they simply felt better physically and emotionally. The treatment was generally safe, and only a few side effects were reported, with everyone recovering. The number of people with NAFLD and MetS is increasing in many regions of the world. This study suggests that adding silymarin to everyday healthy habits might give the liver some extra support. It is not meant to replace diet or exercise, but it may offer a small boost, especially for people who feel their progress has slowed down. Lower liver enzyme levels are a good sign, and they often mean less inflammation and less stress on the liver. The results from this study are promising, but we still need more research to understand how silymarin might affect long-term heart health and overall metabolic health.