Efficacy of a Homeopathic Medicine of Capsicum frutescens L. (Solanaceae) in the Treatment of Hot Flashes in Menopausal Women: A Phase-2 Randomized Controlled Trial

Abstract

Background Hot flashes are common in women during menopause, and are an important cause of discomfort, increasing the number of medical appointments. Hormone replacement therapy is an effective treatment, but it can bring undesirable consequences. Alternative treatments exist but they are not universally accepted or effective. The ingestion of malagueta peppers (popular name for fruits of Capsicum frutescens L., Solanaceae) causes sensations similar to those experienced by women during hot flashes. Using the homeopathic law of similars (let like be cured by like), we hypothesized that a homeopathic remedy made of malagueta peppers can be effective in alleviating menopausal hot flashes. We named this remedy Malagueta.

Methods This randomized, placebo-controlled, double-blind, phase-2 clinical trial was designed to test the hypothesis that, in menopausal women, the homeopathic medicine Malagueta (30 CH), compared with placebo, will significantly reduce the intensity of hot flashes, after 4 weeks of treatment. The primary outcome was the intensity of hot flashes, measured by the Measure Yourself Medical Outcome Profile (MYMOP) instrument. A total of 40 women were enrolled in the study, 20 in each group.

Results The effect of Malagueta on the primary outcome, the intensity of hot flashes, assessed by MYMOP, was superior to that of placebo over the 4 weeks of treatment, with worsening in both groups after treatment was interrupted (after week 4, p < 0.001 in ordinal logistic regression). The odds ratio for treatment response (reduction of at least three MYMOP categories) was 2.78 (95% confidence interval, 0.77 to 10.05). Treatment with Malagueta, compared with placebo, also reduced the intensity of the secondary symptoms (p = 0.001) and improved level of activity (p = 0.025) and well-being (p = 0.008).

Conclusion The homeopathic medicine of Capsicum frutescens (Malagueta) was superior to placebo in reducing the intensity of hot flashes in menopausal women after 4 weeks of treatment.

Keywords

menopause - hot flashes - pepper - Solanaceae - homeopathy

• References

• 1 Kronenberg F. Menopausal hot flashes: a review of physiology and biosociocultural perspective on methods of assessment. J Nutr 2010; 140: 1380S-1385S
• 2 Sclowitz IK, Santos IS, Silveira MF. Prevalence and factors associated with hot flashes in climacteric and post-climacteric women [article in Portuguese]. Cad Saude Publica 2005; 21: 469-481
• 3 Thompson EA. Alternative and complementary therapies for the menopause: a homeopathic approach. Maturitas 2010; 66: 350-354
• 4 Rada G, Capurro D, Pantoja T. , et al. Non-hormonal interventions for hot flushes in women with a history of breast cancer. Cochrane Database Syst Rev 2010; CD004923
• 5 Tropicos [Internet]. Capsicum frutescens L. Available at: http://www.tropicos.org/Name/29602638 2018 . Accessed April 18, 2018
• 6 Reifschneider FJB. Capsicum: Hot and Bell Peppers in Brazil [Portuguese]. Brasília: Embrapa Hortaliças; 2000
• 7 Schulz KF, Altman DG, Moher D. ; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med 2010; 152: 726-732
• 8 Dean ME, Coulter MK, Fisher P, Jobst K, Walach H. Reporting data on homeopathic treatments (RedHot): a supplement to CONSORT. Homeopathy 2007; 96: 42-45
• 9 Harlow SD, Gass M, Hall JE. , et al; STRAW 10 Collaborative Group. Executive summary of the Stages of Reproductive Aging Workshop + 10: addressing the unfinished agenda of staging reproductive aging. Menopause 2012; 19: 387-395
• 10 BRAZIL. Brazilian Homeopathic Pharmacopea [Portuguese]. 3rd ed. Brazilian Health Regulatory Agency (ANVISA); Brasilia; 2011
• 11 Ratka A, Miller V, Brown K. , et al. Menopausal Vasomotor Symptoms (MVS) survey for assessment of hot flashes. J Womens Health (Larchmt) 2006; 15: 77-89
• 12 Paterson C, Britten N. In pursuit of patient-centred outcomes: a qualitative evaluation of the ‘Measure Yourself Medical Outcome Profile’. J Health Serv Res Policy 2000; 5: 27-36
• 13 Paterson C. Measuring outcomes in primary care: a patient generated measure, MYMOP, compared with the SF-36 health survey. BMJ 1996; 312: 1016-1020
• 14 Thompson EA, Montgomery A, Douglas D, Reilly D. A pilot, randomized, double-blinded, placebo-controlled trial of individualized homeopathy for symptoms of estrogen withdrawal in breast-cancer survivors. J Altern Complement Med 2005; 11: 13-20
• 15 Jacobs J, Herman P, Heron K, Olsen S, Vaughters L. Homeopathy for menopausal symptoms in breast cancer survivors: a preliminary randomized controlled trial. J Altern Complement Med 2005; 11: 21-27
• 16 Newall CA, Anderson LA, Phillipson JD. Herbal Medicines: A Guide for Health-Care Professionals. London: The Pharmaceutical Press; 1996
• 17 Willoughby MJ, Mills SY. British Herbal Pharmacopoeia. London: British Herbal Medicine Association; 1996
• 18 Blumenthal M. The Complete German Commission E Monographs: Therapeutic Guide to Herbal Medicines. 1st ed. Massachusetts: American Botanical Council; 1998