Homeopathy 2017; 106(01): 3-10
DOI: 10.1016/j.homp.2016.11.002
Original Paper
Copyright © The Faculty of Homeopathy 2016

Is metabolic dysregulation associated with antidepressant response in depressed women in climacteric treated with individualized homeopathic medicines or fluoxetine? The HOMDEP-MENOP Study

Emma del Carmen Macías-Cortés
1   Consulta Externa de Homeopatía, Hospital Juárez de México, Secretaría de Salud, Ave. Instituto Politécnico Nacional 5160, Col. Magdalena de las Salinas, CP 7760, Ciudad de México, Mexico
2   Jefatura de Enseñanza e Investigación, Hospital Nacional Homeopático, Secretaría de Salud, Ave Chimalpopoca 135, Col. Obrera, CP 06800, Ciudad de México, Mexico
,
Lidia Llanes-González
3   Unidad de Salud Mental, Hospital Juárez de México, Secretaría de Salud, Ave. Instituto Politécnico Nacional 5160, Col. Magdalena de las Salinas, CP 7760, Ciudad de México, Mexico
,
Leopoldo Aguilar-Faisal
4   División de Posgrado, Escuela Superior de Medicina, Instituto Politécnico Nacional, Ave. Plan de San Luis y Salvador Díaz Mirón, Casco de Santo Tomás, CP 11340, Ciudad de México, Mexico
,
Juan Asbun-Bojalil
4   División de Posgrado, Escuela Superior de Medicina, Instituto Politécnico Nacional, Ave. Plan de San Luis y Salvador Díaz Mirón, Casco de Santo Tomás, CP 11340, Ciudad de México, Mexico
› Author Affiliations
Further Information

Publication History

Received 06 May 2016
revised 30 November 2016

accepted 30 November 2016

Publication Date:
28 December 2017 (online)

Background: Climacteric is associated with both depression and metabolic dysregulation. Scarce evidence suggests that metabolic dysregulation may predict poor response to conventional antidepressants. Response to depression treatment has not been studied in homeopathic medicine. The aim of this study was to investigate the prevalence of metabolic disorders in depressed climacteric women treated with homeopathic medicines, fluoxetine or placebo, and if these alterations have any association with response to depression treatment.

Methods: One hundred and thirty-three Mexican women (40–65 years) with depression, enrolled in the HOMDEP-MENOP study, a randomized, placebo-controlled, double-blind, double-dummy, three-arm trial with a 6 week follow-up, underwent a complete medical history and clinical examination. Metabolic parameters were assessed at baseline. Association between baseline metabolic parameters and response to depression treatment was analyzed with bivariate analysis in the three groups. Odds ratios (OR) with their 95% confidence interval (95% CI) were calculated. Metabolic parameters were considered for inclusion in the logistic regression model if they had a statistically significant relationship with response rate on bivariate analysis at p < 0.05 or if they were clinically relevant.

Results: Overall combined prevalence (obesity and overweight) was 86.5%; 52.3% had hypertriglyceridemia; 44.7% hypercholesterolemia; 46.7% insulin resistance; and 16% subclinical hypothyroidism. There was no statistically significant association between dyslipidemia, overweight, or insulin resistance and non-response in the homeopathy group [OR (95% CI) 1.57 (0.46–5.32), p = 0.467; 0.37 (0.003–1.11), p = 0.059; 0.67 (0.16–2.7), p = 0.579, respectively].

Conclusion: Metabolic dysregulation was not significantly associated with response to depression treatment in depressed climacteric women treated with individualized homeopathic treatment (IHT), fluoxetine or placebo. Due to the high prevalence of metabolic disorders and its relationship with depression in the climacteric, further investigation should be focused on whether individualized prescriptions based on classical homeopathy for depressed climacteric women have an effect on metabolic parameters, and/or if treating the metabolic disorders at the same time could lead to higher response rates.

ClinicalTrials.gov Identifier: NCT01635218

URL: http://clinicaltrials.gov/ct2/show/NCT01635218?term=depression+homeopathy&rank=1

 
  • References

  • 1 Soules M.R., Sherman S., Parrott T. Executive summary: stages of reproductive aging workshop (STRAW). Fertil Steril 2001; 76: 874-878.
  • 2 Jansen I., Powell L.H., Crawford S., Lasley B., Sutton-Tyrrell K. Menopause and metabolic syndrome. Arch Intern Med 2008; 168 (14) 1568-1575.
  • 3 Do K.A., Green A., Guthrie J.R., Dudley E.C., Burger H.G., Dennerstein L. Longitudinal study of risk factors for coronary heart disease across the menopausal transition. Am J Epidemiol 2000; 151 (06) 584-593.
  • 4 Guthrie J.R., Taffe J.R., Lehert P., Burger H.G., Dennerstein L. Association between hormonal changes at menopause and the risk of a coronary event: a longitudinal study. Menopause 2004; 11 (03) 315-322.
  • 5 Lakka H.M., Laaksonen D.E., Lakka T.A. et al. The metabolic syndrome and total and cardiovascular disease mortality in middle-aged men. JAMA 2002; 288: 2709-2716.
  • 6 Carr M.C. The emergence of the metabolic syndrome with menopause. J Clin Endocrinol Metab 2003; 88 (06) 2404-2411.
  • 7 The National Cholesterol Education Program. Executive summary of the third report of the National Cholesterol Education Program (NCEP) expert pannel on detection, evaluation and treatment of high blood cholesterol in adults (adult treatment panel III). JAMA 2001; 285: 2486-2497.
  • 8 Avis N.E., Brambilla D., McKinlay S.M. et al. A longitudinal analysis of the association between menopause and depression: results from the Massachusetts Women's Health Study. Ann Epidemiol 1994; 4: 214-220.
  • 9 Goldbacher E.M., Bromberger J., Matthews K.A. Lifetime history of major depression predicts the development of the metabolic syndrome in middle-aged women. Psychosom Med 2009; 7 (03) 266-272.
  • 10 Pan A., Keum N., Okereke O.I. et al. Bidirectional association between depression and metabolic syndrome. Diabetes Care 2012; 35: 1171-1180.
  • 11 Mansur R.B., Brietzke E., McIntyre R. Is there a “metabolic-mood syndrome”? A review of the relationship between obesity and mood disorders. Neurosci Biobehav Rev 2015; 52: 89-104.
  • 12 Preskorn ShH. Prediction of individual response to antidepressants and antipsychotics: an integrated concept. Dialogues Clin Neurosci 2014; 16: 545-554.
  • 13 Vogelzangs N., Beekman A.T.F., van Reedt Dortland A.K.B. et al. inflammatory and metabolic dysregulation and the 2-year course of depressive disorders in antidepressant users. Psychopharmacology 2014; 39: 1624-1634.
  • 14 Sutherland J.P., McKinley B., Eckel R.H. The metabolic syndrome and inflammation. Metab Syndr Relat Disord 2004; 2: 82-104.
  • 15 Lanquillon S., Krieg J.C., Bening-Abu-Sach U., Vedder H. Cytokine production and treatment response in major depressive disorder. Neuropsychopharmaology 2000; 22: 370-379.
  • 16 Cattaneo A., Gennarelli M., Uher R. et al. Candidate genes expression profile associated with antidepressants response in the GENDEP study: differentiating between baseline ‘predictors’ and longitudinal ‘targets’. Neuropsychopharmacology 2013; 38: 377-385.
  • 17 Manoharan A., Rajkumar R.P., Shewade D.G., Sundaram R., Muthuramalingam A., Paul A. Evaluation of interleukin-6 and serotonin as biomarkers to predict response to fluoxetine. Hum Psychopharmacol Clin Exp 2016; 31: 178-184. 10.1002/hup.2525.
  • 18 Thompson E.A. Alternative and complementary therapies for the menopause: a homeopathic approach. Maturitas 2010; 66 (04) 350-354.
  • 19 Thompson E.A., Reilly D. The homeopathic approach to the treatment of symptoms of oestrogen withdrawal in breast cancer patients. A prospective observational study. Homeopathy 2003; 92 (03) 131-134.
  • 20 Nayak C., Singh V., Singh K. et al. Management of distress during climacteric years by homeopathic therapy. J Altern Complement Med 2011; 17 (11) 1037-1042.
  • 21 Sampath S., Narasimhan A., Chinta R. et al. Effect of homeopathic preparations of Syzygium jambolanum and Cephalandra indica on gastrocnemius muscle of high fat and high fructose-induced type-2 diabetic rats. Homeopathy 2013; 102 (03) Jul 160-171. 10.1016/j.homp.2013.05.002.
  • 22 Chagas V.T., França L.M., Malik S., Paes A.M.A. Syzygium cumini (L.) skeels: a prominent source of bioactive molecules against cardiometabolic diseases. Front Pharmacol 2015; 6: 259 10.3389/fphar.2015.00259.
  • 23 Macías-Cortés EdC., Llanes-González L., Aguilar-Faisal L., Asbun-Bojalil J. Individualized homeopathic treatment and fluoxetine for moderate to severe depression in peri- and postmenopausal women (HOMDEP-MENOP Study): a randomized, double-dummy, double-blind, placebo-controlled trial. PLoS ONE 2015; 10 (03) e0118440 10.1371/journal.pone.0118440.
  • 24 Pearce S.H.S., Brabant G., Duntas L.H. et al. ETA guideline: management of subclinical hypothyroidism. Eur Thyroid J 2013; 2013 (02) 215-228. 10.1159/000356507.
  • 25 Pramparo P., Schargrodsky H., Boissonet C. et al. Cardiovascular risk factors for heart disease and stroke in women by age and time since menopause, in seven Latin American cities: the CARMELA study. CVD Prev and Control 2008; 3: 181-189. 10.1016/j.cvdpc.2008.08.002.
  • 26 Escobedo de la Peña J., de Jesus-Pérez R., Schargrodsky H., Champagne B. Prevalencia de dislipidemias en la Ciudad de México y su asociación con otros factores de riesgo cardiovascular. Resultados del estudio CARMELA. Gac Med México 2014; 150: 128-136.
  • 27 Blümel J.E., Chedraui P., Aedo S., Fica J., Mezones-Holguin E. et al. Obesity and its relation to depressive symptoms and sedentary lifestyle in middle-aged women. Maturitas 2015; 80: 100-105.
  • 28 http://www.cenetec.salud.gob.mx/descargas/gpc/CatalogoMaestro/019_GPC_ClimatyMenop/SS_019_08_EyR.pdf.
  • 29 http://www.cenetec.salud.gob.mx/descargas/gpc/CatalogoMaestro/233_GPC_Dislipidemias/GER_Dislipidemia.pdf.
  • 30 Chakraborty D., Samadder A., Dutta S., Khuda-Bukhsh A.R. Antihyperglycemic potentials of a threatened plant, Helonias dioica: antioxidative stress responses and the signaling cascade. Exp Biol Med (Maywood) 2012; 237 (01) 64-76. 10.1258/ebm.2011.011161 Epub 2011 Dec 14.
  • 31 Kato M., Serretti A. Review and meta-analysis of antidepressant pharmacogenetic findings in major depressive disorder. Mol Psychiatry 2010; 15: 473-500.
  • 32 Mocking R.J.T., Verburg H.F., Westerink A.M. et al. Fatty acid metabolism and its longitudinal relationship with the hypothalamic—pituitary—adrenal axis in major depression: associations with prospective antidepressant response. Psychoneuroendocrinology 2015; 59: 1-13.
  • 33 Papakostas G.I., Öngür D., Iosifescu D.V., Mischoulon D., Fava M. Cholesterol in mood and anxiety disorders: review of the literature and new hypothesis. Eur Neuropsychopharmacol 2014; 14: 135-142.