affron®, a standardised extract from saffron (Crocus sativus L.) for the treatment of youth anxiety and depressive symptoms: A randomised, double-blind, placebo-controlled study

Abstract

Esta es la versión de autor del artículo publicado en: This is an author produced version of a paper published in:Journal of Affective Disorders 232 (2018) However, this is the first study examining its mood-related effects in teenagers. MethodsIn this 8-week, randomised, double-blind, placebo-controlled study, youth aged 12 to 16 years, with mild-to-moderate anxiety or depressive symptoms were given tablets containing placebo or a saffron extract (affron ® , 14mg b.i. d). The youth and parent versions of the Revised ChildAnxiety and Depression Scale (RCADS) were used as outcome measures.Results 80 participants were enrolled and 68 completed the study. Based on youth self-reports, affron ® was associated with greater improvements in overall internalising symptoms (p = .049), separation anxiety (p = .003), social phobia (p = .023), and depression (p = .016). Total internalising scores decreased by an average of 33% compared to 17% in the placebo group (p=.029). However, parental reports of improvements were inconsistent as mean improvements in RCADS scores were greater in the saffron group (40% vs 26%) (p=.026), although no other significant differences were identified. affron ® was well-tolerated and there was a trend of reduced headaches in participants on the active treatment.Limitations: The use of a self-report instrument, limited study duration, single treatment dose, and non-clinical sample used in this study limit the generalisability of study findings. ConclusionThe administration of a standardised saffron extract (affron ® ) for 8 weeks improved anxiety and depressive symptoms in youth with mild-to-moderate symptoms, at least from the perspective of the adolescent. However, these beneficial effects were inconsistently corroborated by parents.

Effect of saffron supplementation on symptoms of depression and anxiety: a systematic review and meta-analysis

“…Effects of saffron on depressive symptoms. Randomeffects meta-analysis found a significant and large positive effect size for saffron reducing symptoms of depression in comparison with placebo (g ¼ 0.99, 95%CI ¼ 0.61-1.37, n ¼ 14 studies, n ¼ 716 participants, P < 0.001; Figure 2 [22][23][24][25][26][27][29][30][31][33][34][35][36][37][38][39][40]42,44 ). An additional study that could not be entered into the metaanalysis due to insufficient available data also found that saffron significantly improved depressive symptoms compared with placebo (P < 0.0001).…”

“…Most studies were conducted in Iran (n ¼ 21/23), with 2 studies conducted in Australia. 34,35 Thirteen studies were conducted by the same research group. Risk of bias across most studies was low, with 20 studies receiving a score of 4 or 5 (out of 5) on the Jadad Scale (see Appendix S2 in the Supporting Information online).…”

Bioaccessibility and Pharmacokinetics of a Commercial Saffron (Crocus sativus L.) Extract

“…e fast presence of crocetin in blood plasma after the administration of the saffron extract contributes to better explain saffron beneficial effects in animal models [48]. e commercial standardised saffron extract affron ® used in this study is related to beneficial effects in depression and mood disorders by several clinical trials at the dosage used in the present work [13,14,16] and in the reduction of inflammatory damage in the retina in an animal model of glaucoma [20]. e obtained results in this study increase the interest of saffron extract use as a new preventive therapy that requires a fast-active countereffect, for instance, as "fast-track" carotenoid in the Aged-Related Eye Disease Study (AREDS-2) formula.…”

“…e saffron (Crocus sativus L.) stigmas were extracted in the factory of Pharmactive Biotech Products S. L. in Madrid (Spain) to produce the commercial saffron extract, branded as affron ® , and dosed in tablets as preferred galenic form for the in vitro digestion and the clinical trial. Each tablet contained 14 mg of dried affron ® standardised to ≥3.5% lepticrosalides ® , defined as the content of bioactive compounds including safranal and crocin by HPLC [12,13], together with the following excipients: microcrystalline cellulose, calcium hydrogen phosphate, povidone, croscarmellose sodium, colloidal anhydrous silica, and magnesium stearate as excipients and coated with hypromellose (HPMC), macrogol (PEG) 8000, and carnauba wax.…”

“…Nowadays, the clinical evidences of saffron extracts have been accumulated and has been postulated as a complementary therapy in several medical conditions. In particular, to delay the occurrence of the symptoms and effects of degenerative ocular diseases [8] and to prevent and treat mood disorders and mild-to-severe depression without side-effects, even in people with unremitted depression treated with antidepressant medication [12][13][14][15][16]. In depression, different mechanisms of actions have been proposed to explain the functional properties of saffron such as reuptake inhibitors of monoamines, N-methyl-Daspartate receptor (NMDA) antagonism, and gamma-aminobutyric acid (GABA) agonism [17,18].…”