Is saffron effective in treating anxiety in pediatric populations?

Saffron for Pediatric Anxiety

Saffron extract (affron®, 14 mg twice daily) can be considered as an alternative treatment option for mild-to-moderate anxiety symptoms in adolescents aged 12-16 years, but it should not replace guideline-recommended first-line treatments like cognitive-behavioral therapy (CBT) or SSRIs for clinically diagnosed anxiety disorders. 1

Guideline-Recommended First-Line Treatments

The American Academy of Child and Adolescent Psychiatry establishes clear treatment hierarchies that do not include saffron:

• CBT is the first-line treatment for mild-to-moderate anxiety in children and adolescents, delivered over 12-20 structured sessions targeting cognitive, behavioral, and physiologic dimensions of anxiety 2, 3
• SSRIs (particularly fluoxetine) are recommended as first-line pharmacotherapy for children 6-18 years with social anxiety, generalized anxiety, separation anxiety, or panic disorder when CBT is unavailable or for severe presentations 2, 3
• Benzodiazepines are explicitly not recommended for pediatric anxiety due to lack of efficacy data and dependence risk 2, 4

Evidence for Saffron in Pediatric Anxiety

The Single Pediatric Trial

One randomized, double-blind, placebo-controlled study examined saffron specifically in youth:

• Study population: 80 adolescents aged 12-16 years with mild-to-moderate anxiety or depressive symptoms (not formal anxiety disorder diagnoses) 1
• Dosing: affron® 14 mg twice daily for 8 weeks 1
• Youth-reported outcomes: Total internalizing symptoms decreased 33% vs 17% with placebo (p=0.029), with significant improvements in separation anxiety (p=0.003), social phobia (p=0.023), and depression (p=0.016) 1
• Parent-reported outcomes: Inconsistent findings—overall improvement was greater (40% vs 26%, p=0.026) but individual symptom domains showed no significant differences 1
• Safety: Well-tolerated with a trend toward reduced headaches 1

Critical Limitations

• Non-clinical sample: Participants had mild-to-moderate symptoms, not formal anxiety disorder diagnoses requiring treatment per guidelines 1
• Single dose studied: No dose-ranging or optimization data 1
• Short duration: Only 8 weeks of treatment 1
• Discrepancy between youth and parent reports raises questions about clinical meaningfulness 1

Adult Evidence (Not Directly Applicable)

While meta-analyses show large effect sizes for saffron in adult depression (g=0.99) and anxiety (g=0.95) compared to placebo, these findings cannot be extrapolated to children given developmental differences in neurobiology and medication response 5. Adult studies also show evidence of publication bias 5.

Clinical Algorithm for Pediatric Anxiety

For Mild-to-Moderate Anxiety:

1. Start with CBT as monotherapy (12-20 sessions with exposure therapy as the cornerstone) 2, 3
2. If CBT unavailable or ineffective: Consider SSRIs (fluoxetine 5-10 mg daily, titrated to 20-40 mg) 2
3. Saffron may be considered only for adolescents 12-16 years with mild symptoms who decline or cannot access standard treatments, using affron® 14 mg twice daily 1

For Severe Anxiety:

1. Combination of CBT plus SSRI is more effective than either alone 3
2. Saffron should not be used as monotherapy for severe presentations 1

Important Caveats

• Saffron is not FDA-approved for pediatric anxiety and is not mentioned in any major clinical practice guidelines 6, 2, 3, 4
• No data exist for children under age 12 with anxiety 1
• The single pediatric trial studied subclinical symptoms, not diagnosed anxiety disorders requiring treatment 1
• Close monitoring for suicidal ideation is mandatory if SSRIs are used (pooled absolute risk 1% vs 0.2% with placebo, number needed to harm = 143) 2, 4
• Untreated anxiety leads to significant long-term impairments in social, educational, and mental health outcomes, making evidence-based treatment critical 3, 4

When Saffron Might Be Reasonable

Saffron could be discussed as an option for:

• Adolescents 12-16 years with mild subclinical anxiety symptoms who are not candidates for formal treatment 1
• Families declining standard treatments while working to engage them in CBT 1
• Adjunctive use while waiting for CBT availability, though no data support this approach 1

Saffron should never delay or replace guideline-recommended CBT or SSRIs for clinically significant anxiety disorders in children and adolescents. 6, 2, 3