Milk Thistle in Trichotillomania in Children and Adults
Condition: Trichotillomania; Hair Pulling Disorder
MeSH terms: Trichotillomania
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of the proposed study is to evaluate the efficacy and safety of silymarin (milk
      thistle) in children and adults with trichotillomania. The hypothesis to be tested is that
      silymarin will be more effective and well tolerated in children and adults with
      trichotillomania compared to placebo. The proposed study will provide needed data on the
      treatment of a disabling disorder that currently lacks a clearly effective treatment.
    

Detailed description: 
      Pathological hair-pulling, trichotillomania, has been defined as repetitive, intentionally
      performed pulling that causes noticeable hair loss and results in clinically significant
      distress or functional impairment. Trichotillomania appears relatively common with an
      estimated prevalence between 1-3%. Data on the pharmacological treatment of trichotillomania
      is limited to case reports and conflicting double-blind studies of serotonin reuptake
      inhibitors. One positive double-blind study of N-acetyl cysteine in adults was not successful
      when examined for children and adolescents. Available data on the treatment of
      trichotillomania in children are therefore limited.

      Silymarin, a flavonoid and a member of the Asteraceae family, is extracted from the seeds of
      milk thistle (Silybum marianum) and is known to have antioxidative and anti-apoptotic
      properties. Furthermore, it has been demonstrated that its anti-oxidative activity is related
      to the scavenging of free radicals and activation of anti-oxidative defenses: increases in
      cellular glutathione content and superoxide dismutase activity. Milk thistle has been used
      for a range of psychiatric disorders including methamphetamine abuse and obsessive compulsive
      disorder. The flavonoid complex silymarin in preclinical studies has been found to increase
      serotonin and dopamine levels in the cortex. In the frontal cortex one of the functions of
      dopamine is to increase the signal to noise ratio, increased dopamine correlating with
      increased frontal performance. Studies have shown that the higher cortical dopamine levels
      are associated with improved frontal cortical cognitive performance. Cortical inhibition is
      felt to be the basis for top-down control of motivated behaviors. A recent randomized
      controlled study with milk thistle was conducted in Iran Thirty five participants with
      moderate OCD were randomly assigned to 200 mg of milk thistle leaf extract or 10 mg of
      fluoxetine three times daily for eight weeks. Results revealed no significant difference in
      treatment effects between milk thistle and fluoxetine from baseline to endpoint as both
      interventions provided a highly significant reduction in symptoms. Silymarin or Milk Thistle
      may therefore offer promise for the treatment of individuals with trichotillomania.

      The current pilot study examines the tolerability and efficacy of milk thistle in the
      treatment of trichotillomania in children and adults. The investigators hypothesize that milk
      thistle will reduce the severity of symptoms related to trichotillomania and improve
      patients' overall functioning.
    

Intervention name(s): Milk Thistle; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Silymarin; Sugar Pill
Intervention MeSH terms: Silymarin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment