Affron® improved mood on menopausal women. A new, randomized, double-blind, placebo-controlled study showed that perimenopausal women taking affron® for 12 weeks experienced a reduction of 32-33% in low mood and occasional stress, without undesirable estrogenic effects.
Menopause can be accompanied by some very undesirable symptoms. Women usually begin perimenopause in their mid-forties, approximately four years before menopause sets in, which is the cessation of menstrual periods, specifically when a woman has not had her period for 12 consecutive months. These symptoms include occasional sleep disturbances, low and decreased mood and vasomotor symptoms such as hot flushes and sweating and result from changes to the levels of the ovarian hormones estrogen and progesterone in the body. Understandably, this can be a difficult transition for women to make.
- 38% of menopausal women suffer from sleep problems1
- 41% of women experience low mood during menopause2
- It is estimated that as many as 85 % of postmenopausal women have experienced a menopause-related symptom in their lifetime3
- It is estimated that 1.2 billion women worldwide will be menopausal or postmenopausal by the year 20304
Therapies with which to treat menopausal symptoms are often hormone-based. However, hormone therapy (HT) is contraindicated for those with a history of breast cancer, estrogen-sensitive malignant conditions, undiagnosed genital bleeding, untreated endometrial hyperplasia, any venous or arterial thromboembolic event, untreated hypertension, liver disease, and hypersensitivity to the active ingredients in HT5. Moreover, HT can be accompanied by unwanted side-effects that decrease patient compliance and therefore the success of HT treatment. Unwanted side-effects of HT include bloating, breast tenderness or swelling, nausea, leg cramps, headaches, indigestion, and vaginal bleeding6.
Fortunately, there is all-natural, non-hormonal support for women who want alleviation of menopausal symptoms.
Affron® is the botanical support for menopausal psychological symptoms that is not based on the problematic estrogenic replacement approach. It is a premium saffron (Crocus sativus L.) ingredient standardized to 3.5% Lepticrosalides®, which are the complex of bioactive compounds responsible for the beneficial properties of affron®.
Results of a double-blind, placebo-controlled, randomized, dose-response study published in the Journal of Menopausal Medicine show the tolerability and efficacy of affron® in helping menopausal mood-relatedsymptoms7.
The study was designed as a parallel-group, double-blind, randomized controlled trial with the objective of examining the tolerability and efficacy of affron® on menopausal complaints in women experiencing perimenopause. The participants were 86 healthy perimenopausal women* experiencing the most typical menopausal complaints. For twelve weeks participants took either affron® 28mg/day or a placebo. The three outcome measures used were the Greene Climacteric Scale (GCS), the Positive and Negative Affect Scale (PANAS), and the Short Form-36 (SF-36).
Based on data collected from the participants, affron® was associated with greater improvements in mood and psychological symptoms when compared to the placebo.
Results from the GCS revealed a significant reduction in the GCS psychological score (p<.001), characterised by a 33% reduction in tension and alertness, and a 32% reduction in low mood and negative thoughts scores from baseline to week 12. In addition to the significant decrease of these undesirable symptoms, there was a between-group significance compared to the placebo group (p<.032). Affron® also showed a strong tendency to improve vasomotor symptoms (hot flushes and sweating).
The study also demonstrated a significant reduction of 21.95% in the PANAS negative aspects score (ratings associated with descriptors such as stressed, upset, guilty, scared, hostile, irritable, ashamed, nervous, jittery, and afraid) (p=.043). Beyond reducing the negative aspects score, affron® showed a strong tendency to improve positive aspects in participants (ratings associated with descriptions such as strong, attentive, interested, enthusiastic, proud, and alert).
Affron® was very well-tolerated by participants and there were no adverse events or estrogenic effects reported. These results are in line with the seven additional human clinical trials conducted with this patented saffron extract.
These findings are empowering for women needing support during menopause, who are reluctant, for whatever reason, to take HT. Affron® offers these women a natural supplement. As a licensed pharmacist, I support the science behind affron®. I am also a woman (of a certain age) who takes the product and experiences its positive effects daily.
Benefits of affron® beyond “women’s health”
In addition to and independently of the disturbing symptoms associated with menopause, women are at the same time often faced with other life changes and challenges, the effects of which can impact their health. At the age of perimenopause, this “sandwich generation” of women often faces a tremendous mental load, managing their work, relationships, a family, and a household, often still taking care of children while also taking care of their parents and working both inside and outside of the home. Making it even more valuable that the health benefits of affron® extend beyond helping reduce symptoms of menopause.
Eight human clinical studies, conducted with the highest scientific rigour and published in peer-reviewed journals, support the role of affron® in maintaining a healthy mood, improving the quality and quantity of sleep, and alleviating occasional stress and tension while supporting the brain’s vital neurotransmitter network. Saffron is also a potent antioxidant. A property contributed to its bioactive compounds such as safranal and crocin scavenging and neutralizing free radicals and lowering the number of pro-inflammatory cytokines8. This antioxidant effect acts against excessive oxidative stress produced during occasional stress, tension or nervouness .
Affron® has won many international awards, including the recently bestowed NutraIngredients Europe Award 2022 “Ingredient of the Year: Healthy Ageing”, NutraIngredients-U.S.A Award 2020 for Ingredient of the Year: Cognitive Function. Its success results from its scientifically proven effects on mental balance and emotional wellness. This patented saffron extract offers a natural aid for women, men and adolescents to cope with daily life and stressful situations, supporting their health and wellbeing.
* INCLUSION CRITERIA • Female participants aged between 40 to 60 years with reports of changes in their menstrual cycle for at least 3 months • Total score of greater than 16 on the GCS • Body mass index (BMI) between 18 and 35 kg/m2 • Medication-free for at least 3 months • Non-smokers.
1. Sleep disorders during menopause, Sociedad Iberoamericana de Información Científica, 2004 Sept
2. La depresión afecta a siete de cada 10 mujeres durante la menopausia, Redacción Medica, 2020 Jul
3. Sussman, M., Trocio, J., Best, C., Mirkin, S., Bushmakin, A. G., Yood, R., Friedman, M., Menzin, J., & Louie, M. (2015). Prevalence of menopausal symptoms among mid-life women: findings from electronic medical records. BMC women’s health, 15, 58. https://doi.org/10.1186/s12905-015-0217-y
5. Sussman, M., Trocio, J., Best, C., Mirkin, S., Bushmakin, A. G., Yood, R., Friedman, M., Menzin, J., & Louie, M. (2015). Prevalence of menopausal symptoms among mid-life women: findings from electronic medical records. BMC women’s health, 15, 58. https://doi.org/10.1186/s12905-015-0217-y
7. Lopresti, A. L., & Smith, S. J. (2021). The Effects of a Saffron Extract (affron®) on Menopausal Symptoms in Women during Perimenopause: A Randomised, Double-Blind, Placebo-Controlled Study. Journal of menopausal medicine, 27(2), 66–78. https://doi.org/10.6118/jmm.21002
8. Mashmoul, M., Azlan, A., Khaza’ai, H., Yusof, B. N., & Noor, S. M. (2013). Saffron: A Natural Potent Antioxidant as a Promising Anti-Obesity Drug. Antioxidants (Basel, Switzerland), 2(4), 293–308. https://doi.org/10.3390/antiox2040293
Dr. Natalie Vladi, MRPharmS.
Scientific Advisor Pharmactive Biotech Products, S.L.
Managing Director Fountain House GmbH, home to the premium food supplements brand Foondiert®