The efficacy of Silybum marianum (L.) Gaertn. (Silymarin) in the treatment of physiological neonatal jaundice ( a randomized, double-blind, placebo-controlled, clinical trial)

Abstract

Back ground and aim of work Unconjugated hyperbilirubinemia (UCB) is one of the most common conditions in neonates. Conventional treatments are phototherapy and exchange transfusion. Phototherapy is safe and effective, but it has several disadvantages, which indicates the need to develop alternative pharmacological treatment strategies. These alternative treatment strategies should be less invasive and at least as effective and safe as phototherapy. The present study was designed to investigate the effects of Silybum marianum (silymarin) on the duration of phototherapy, which is known to have antioxidant, anti-inflammatory, hepatic-protective, and regenerative properties, including enhancing glucuronidation activities. Patients and methods A randomized double-blind clinical trial was conducted on 170 full-term healthy neonates with UCB divided into two well-matched groups. Of the 170 neonates, 85 received 3.75 mg/kg of silymarin orally, twice daily, in addition to phototherapy, and 85 received placebo and phototherapy. Total serum bilirubin was measured every 24 h, and alanine aminotransferase (SGPT) and alanine transaminase (SGOT) levels were measured before and after therapy in both groups. Results The mean duration of phototherapy was found to be significantly reduced from 5.3±0.82 days in the control group to 4.2±0.76 days in the silymarin-treated group (P=0.001). SGPT and SGOT levels were significantly normalized (P=0.001). Conclusion Silymarin at a dose of 3.75 mg/kg twice daily along with phototherapy was more effective than phototherapy alone in treating full-term healthy neonates with UCB.