A common misconception is that natural medicines are not scientifically proven. In fact, there is a huge bank of research and clinical trials validating natural medicines. Another misconception is that natural medicines are not regulated and make false claims.
In Australia via the TGA and in the USA via the FDA, all health claims need to be substantiated. There are quite strict guidelines and any claims made without scientific validation come with heavy fines and product delisting. Below are some of the scientific studies used in the formulation of Happy Hormones and the claims validation process.
Sage (Salvia officinalis)
1. An extract of Salvia (sage) with anticholinesterase properties improves memory and attention in healthy older volunteers.
Authors: Andrew B. Scholey, Nicola T. J. Tildesley, Clive G. Ballard, Keith A. Wesnes Andrea Tasker, Elaine K. Perry, David O. Kennedy
Publication: Psychopharmacology (Berl). 2008 May;198(1):127-39.
Pubmed Data: DOI 10.1007/s00213-008-1101-3. Epub 2008 Mar 19.
2. First-time proof of sage's tolerability and efficacy in menopausal women with hot flushes.
Authors: S. Bommer, P. Klein, A. Suter
Publication: Adv Ther. 2011 Jun;28(6):490-500.
Pubmed Data: DOI 10.1007/s12325-011-0027-z. Epub 2011 May 16.
Black Cohosh
3. Black cohosh with or without St. John's wort for symptom-specific climacteric treatment--results of a large-scale, controlled, observational study.
Authors: Briese V(1), Stammwitz U, Friede M, Henneicke-von Zepelin HH.
Publication: Maturitas. 2007 Aug 20;57(4):405-14.
Pubmed Data: Epub 2007 Jun 21.
4. Black cohosh improves objective sleep in postmenopausal women with sleep disturbance.
Authors: Jiang K(1), Jin Y, Huang L, Feng S, Hou X, Du B, Zheng J, Li L.
Publication: Climacteric. 2015;18(4):559-67.
Pubmed Data: DOI 10.3109/13697137.2015.1042450. Epub 2015 May 22.
5. Phyto-Female Complex for the relief of hot flushes, night sweats and quality of sleep: randomized, controlled, double-blind pilot study.
Authors: Rotem C(1), Kaplan B.
Publication: Gynecol Endocrinol. 2007 Feb;23(2):117-22.
Pubmed Data: DOI: 10.1080/09513590701200900
6. Menopause: a standardized isopropanolic black cohosh extract (remifemin) is found to be safe and effective for menopausal symptoms.
Authors: Ross SM(1).
Publication: Holist Nurs Pract. 2012 Jan-Feb;26(1):58-61.
Pubmed Data: DOI 10.1097/HNP.0b013e31823d1f67.
7. Efficacy and tolerability of a medicinal product containing an isopropanolic black cohosh extract in Chinese women with menopausal symptoms: a randomized, double blind, parallel-controlled study versus tibolone.
Authors: Bai W(1), Henneicke-von Zepelin HH, Wang S, Zheng S, Liu J, Zhang Z, Geng L, Hu L, Jiao C, Liske E.
Publication: Maturitas. 2007 Sep 20;58(1):31-41.
Pubmed Data: DOI 10.1016/j.maturitas.2007.04.009. Epub 2007 Jun 22.
8. Black cohosh and fluoxetine in the treatment of postmenopausal symptoms: a prospective, randomized trial.
Authors: Oktem M(1), Eroglu D, Karahan HB, Taskintuna N, Kuscu E, Zeyneloglu HB.
Publication: Advances in Therapy 2007 Mar-Apr;24(2):448-61.
Maca
9. Maca reduces blood pressure and depression, in a pilot study in postmenopausal women.
Authors: Stojanovska L(1), Law C, Lai B, Chung T, Nelson K, Day S, Apostolopoulos V, Haines C.
Publication: Climacteric. 2015 Feb;18(1):69-78.
Pubmed Data: DOI 10.3109/13697137.2014.929649. Epub 2014 Aug 7.
10. Beneficial effects of Lepidium meyenii (Maca) on psychological symptoms and measures of sexual dysfunction in postmenopausal women are not related to estrogen or androgen content.
Authors: Brooks NA(1), Wilcox G, Walker KZ, Ashton JF, Cox MB, Stojanovska L.
Publication: Menopause. 2008 Nov-Dec;15(6):1157-62.
Pubmed Data: DOI 10.1097/gme.0b013e3181732953.
11. Therapeutic Effects of Pre-Gelatinized Maca (Lepidium Peruvianum Chacon) used as a Non-Hormonal Alternative to HRT in Perimenopausal Women - Clinical Pilot Study.
Authors: Meissner HO(1), Reich-Bilinska H, Mscisz A, Kedzia B.
Publication: Int J Biomed Sci. 2006 Jun;2(2):143-59.
Gymnema Sylvestre
12. An open label study on the supplementation of Gymnema sylvestre in type 2 diabetics.
Authors: Kumar SN(1), Mani UV, Mani I.
Publication: J Diet Suppl. 2010 Sep;7(3):273-82.
Pubmed Data: DOI 10.3109/19390211.2010.505901.
Chaste Berry
13. Effects of a combination of Hypericum perforatum and Vitex agnus-castus on PMS-like symptoms in late-perimenopausal women: findings from a subpopulation analysis.
Authors: van Die MD(1), Bone KM, Burger HG, Reece JE, Teede HJ.
Publication: J Altern Complement Med. 2009 Sep;15(9):1045-8.
Pubmed Data: DOI 10.1089/acm.2008.0539.
14. Treatment of premenstrual syndrome with a phytopharmaceutical formulation containing Vitex agnus castus.
Authors: Loch EG(1), Selle H, Boblitz N.
Publication: J Womens Health Gend Based Med. 2000 Apr;9(3):315-20.
15. Phyto-Female Complex for the relief of hot flushes, night sweats and quality of sleep: randomized, controlled, double-blind pilot study.
Authors: Rotem C(1), Kaplan B.
Publication: Gynecol Endocrinol. 2007 Feb;23(2):117-22.
Pubmed Data: DOI: 10.1080/09513590701200900
Red Clover
16. Improvement of postmenopausal depressive and anxiety symptoms after treatment with isoflavones derived from red clover extracts.
Authors: Lipovac M(1), Chedraui P, Gruenhut C, Gocan A, Stammler M, Imhof M.
Publication: Maturitas. 2010 Mar;65(3):258-61.
Pubmed Data: DOI 10.1016/j.maturitas.2009.10.014. Epub 2009 Nov 30.
17. Effectiveness of Red Clover in alleviating menopausal symptoms: a 12-week randomized, controlled trial.
Authors: Shakeri F(1), Taavoni S, Goushegir A, Haghani H.
Publication: Climacteric. 2015;18(4):568-73.
Pubmed Data: DOI 10.3109/13697137.2014.999660. Epub 2015 Feb 24.
18. The effect of red clover isoflavone supplementation over vasomotor and menopausal symptoms in postmenopausal women.
Authors: Lipovac M(1), Chedraui P, Gruenhut C, Gocan A, Kurz C, Neuber B, Imhof M.
Publication: Gynecol Endocrinol. 2012 Mar;28(3):203-7.
Pubmed Data: DOI 10.3109/09513590.2011.593671. Epub 2011 Aug 26.
19. Influence of red clover-derived isoflavones on serum lipid profile in postmenopausal women.
Authors: Terzic MM(1), Dotlic J, Maricic S, Mihailovic T, Tosic-Race B.
Publication: J Obstet Gynaecol Res. 2009 Dec;35(6):1091-5.
Pubmed Data: DOI 10.1111/j.1447-0756.2009.001059.x.
20. Effect of Trifolium pratense-derived isoflavones on the lipid profile of postmenopausal women with increased body mass index.
Authors: Chedraui P(1), San Miguel G, Hidalgo L, Morocho N, Ross S.
Publication: Gynecol Endocrinol. 2008 Nov;24(11):620-4.
Pubmed Data: DOI 10.1080/09513590802288283.
Dandelion Root
21. The diuretic effect in human subjects of an extract of Taraxacum officinale folium over a single day.
Authors: Clare BA(1), Conroy RS, Spelman K.
Publication: J Altern Complement Med. 2009 Aug;15(8):929-34.
Pubmed Data: DOI 10.1089/acm.2008.0152.
Passiflora
22. Passiflora incarnata Linneaus as an anxiolytic before spinal anesthesia.
Authors: Aslanargun P(1), Cuvas O, Dikmen B, Aslan E, Yuksel MU.
Publication: J Anesth. 2012 Feb;26(1):39-44.
Pubmed Data: DOI 10.1007/s00540-011-1265-6. Epub 2011 Nov 3.
23. A double-blind, placebo-controlled investigation of the effects of Passiflora incarnata (passionflower) herbal tea on subjective sleep quality.
Authors: Ngan A(1), Conduit R.
Publication: Phytother Res. 2011 Aug;25(8):1153-9.
Pubmed Data: DOI 10.1002/ptr.3400. Epub 2011 Feb 3.
24. Preoperative oral Passiflora incarnata reduces anxiety in ambulatory surgery patients: a double-blind, placebo-controlled study.
Authors: Movafegh A(1), Alizadeh R, Hajimohamadi F, Esfehani F, Nejatfar M.
Publication: Anesth Analg. 2008 Jun;106(6):1728-32.
Pubmed Data: DOI 10.1213/ane.0b013e318172c3f9.
