Efficacy of Folic Acid and Vitamin B12 Replacement Therapies in the Reduction of Adverse Effects of Isotretinoin: A Randomized Controlled Trial

Skinmed. 2018 Jul 1;16(4):239-245. eCollection 2018.

Abstract

Previous studies have reported elevated homocysteine levels and folic acid and/or vitamin B12 deficiencies after isotretinoin therapy, which increase the risk of cardiovascular and neuropsychiatric disorders. Homocysteine is metabolized in the liver, a process requiring folate and vitamin B12. We conducted a randomized controlled trial to investigate whether folate and vitamin B12 replacement therapy with isotretinoin would be useful for preventing hyperhomocysteinemia. A total of 66 patients with acne were randomized into two groups: group A took isotretinoin, folic acid, and vitamin B12, whereas group B took isotretinoin alone. Treatment was continued for 2 months. Blood homocysteine, folic acid, and vitamin B12 levels were measured before and after treatment. In group A, a significant decrease in homocysteine level was observed after treatment (P=.0004), although it was still within the normal range. Folic acid and vitamin B12 levels significantly increased (P=.0026 and P=.0002, respectively). In group B, no significant changes were observed in the levels of homocysteine and vitamin B12, but folic acid levels decreased significantly (P=.02). We concluded that folic acid and vitamin B12 supplementation during isotretinoin therapy could be useful for preventing folate deficiency and improving blood homocysteine levels; this might as a result reduce the risks for cardiovascular and neuropsychiatric disorders in patients taking isotretinoin.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Acne Vulgaris / drug therapy
  • Adolescent
  • Adult
  • Dermatologic Agents / adverse effects*
  • Female
  • Folic Acid / therapeutic use*
  • Humans
  • Hyperhomocysteinemia / chemically induced
  • Hyperhomocysteinemia / prevention & control*
  • Isotretinoin / adverse effects*
  • Male
  • Vitamin B 12 / therapeutic use*
  • Vitamin B Complex / therapeutic use*
  • Young Adult

Substances

  • Dermatologic Agents
  • Vitamin B Complex
  • Folic Acid
  • Isotretinoin
  • Vitamin B 12