drugset / Trial / NCT00942097
Homeopathic Medication and Nutritional Oriented Diet to Treat Overweight Pregnant Women With Mental Disorder
Phase 2/3
Completed
134 enrolled
Edgard Costa de Vilhena
Amparo Maternal Maternidade Social · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to evaluate the efficacy of homeopathic treatment in pregnant women with overweight and class I obesity with suspicion of a mental disorder.
Timeline
- Start
- 2009-08
- Primary completion
- 2012-12
- Completion
- 2012-12
Publications
- Background Keppel KG, Taffel SM. Pregnancy-related weight gain and retention: implications of the 1990 Institute of Medicine guidelines. Am J Public Health. 1993 Aug;83(8):1100-3. doi: 10.2105/ajph.83.8.1100.
- Background Horton R. The neglected epidemic of chronic disease. Lancet. 2005 Oct 29-Nov 4;366(9496):1514. doi: 10.1016/S0140-6736(05)67454-5. No abstract available.
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- Background Monteiro CA, Conde WL, Popkin BM. Is obesity replacing or adding to undernutrition? Evidence from different social classes in Brazil. Public Health Nutr. 2002 Feb;5(1A):105-12. doi: 10.1079/PHN2001281.
- Background Yang D, Fontaine KR, Wang C, Allison DB. Weight loss causes increased mortality: cons. Obes Rev. 2003 Feb;4(1):9-16. doi: 10.1046/j.1467-789x.2003.00092.x.
- Background Hubert HB, Feinleib M, McNamara PM, Castelli WP. Obesity as an independent risk factor for cardiovascular disease: a 26-year follow-up of participants in the Framingham Heart Study. Circulation. 1983 May;67(5):968-77. doi: 10.1161/01.cir.67.5.968.
- Background Frankel PH. Obesity and cancer. N Engl J Med. 2003 Jul 31;349(5):502-4; author reply 502-4. No abstract available.
- Background Allison DB, Saunders SE. Obesity in North America. An overview. Med Clin North Am. 2000 Mar;84(2):305-32, v. doi: 10.1016/s0025-7125(05)70223-6.
- Background Allison DB, Fontaine KR, Manson JE, Stevens J, VanItallie TB. Annual deaths attributable to obesity in the United States. JAMA. 1999 Oct 27;282(16):1530-8. doi: 10.1001/jama.282.16.1530.
- Background Harris T, Cook EF, Garrison R, Higgins M, Kannel W, Goldman L. Body mass index and mortality among nonsmoking older persons. The Framingham Heart Study. JAMA. 1988 Mar 11;259(10):1520-4.
- Background Chu SY, Callaghan WM, Kim SY, Schmid CH, Lau J, England LJ, Dietz PM. Maternal obesity and risk of gestational diabetes mellitus. Diabetes Care. 2007 Aug;30(8):2070-6. doi: 10.2337/dc06-2559a. Epub 2007 Apr 6.
- Background Ohlin A, Rossner S. Maternal body weight development after pregnancy. Int J Obes. 1990 Feb;14(2):159-73.
- Background Greene GW, Smiciklas-Wright H, Scholl TO, Karp RJ. Postpartum weight change: how much of the weight gained in pregnancy will be lost after delivery? Obstet Gynecol. 1988 May;71(5):701-7.
- Background Linne Y, Barkeling B, Rossner S. Long-term weight development after pregnancy. Obes Rev. 2002 May;3(2):75-83. doi: 10.1046/j.1467-789x.2002.00061.x.
- Background Gore SA, Brown DM, West DS. The role of postpartum weight retention in obesity among women: a review of the evidence. Ann Behav Med. 2003 Oct;26(2):149-59. doi: 10.1207/S15324796ABM2602_07.
- Background Lederman SA. Pregnancy weight gain and postpartum loss: avoiding obesity while optimizing the growth and development of the fetus. J Am Med Womens Assoc (1972). 2001 Spring;56(2):53-8.
- Background Boardley DJ, Sargent RG, Coker AL, Hussey JR, Sharpe PA. The relationship between diet, activity, and other factors, and postpartum weight change by race. Obstet Gynecol. 1995 Nov;86(5):834-8. doi: 10.1016/0029-7844(95)00283-W.
- Background Parker JD, Abrams B. Differences in postpartum weight retention between black and white mothers. Obstet Gynecol. 1993 May;81(5 ( Pt 1)):768-74.
- Background Potter S, Hannum S, McFarlin B, Essex-Sorlie D, Campbell E, Trupin S. Does infant feeding method influence maternal postpartum weight loss? J Am Diet Assoc. 1991 Apr;91(4):441-6.
- Background Scholl TO, Hediger ML, Schall JI, Ances IG, Smith WK. Gestational weight gain, pregnancy outcome, and postpartum weight retention. Obstet Gynecol. 1995 Sep;86(3):423-7. doi: 10.1016/0029-7844(95)00190-3.
- Background Bradley PJ. Conditions recalled to have been associated with weight gain in adulthood. Appetite. 1985 Sep;6(3):235-41.
- Background Hill JO, Peters JC. Environmental contributions to the obesity epidemic. Science. 1998 May 29;280(5368):1371-4. doi: 10.1126/science.280.5368.1371.
- Background Maddi SR, Khoshaba DM, Persico M, Bleecker F, VanArsdall G. Psychosocial correlates of psychopathology in a national sample of the morbidly obese. Obes Surg. 1997 Oct;7(5):397-404. doi: 10.1381/096089297765555377.
- Background Lundberg U, Frankenhaeuser M. Pituitary-adrenal and sympathetic-adrenal correlates of distress and effort. J Psychosom Res. 1980;24(3-4):125-30. doi: 10.1016/0022-3999(80)90033-1. No abstract available.
- Background Pop-Jordanova N. Psychological characteristics and biofeedback mitigation in preadolescents with eating disorders. Pediatr Int. 2000 Feb;42(1):76-81. doi: 10.1046/j.1442-200x.2000.01176.x.
- Background Coggon D, Martyn C, Palmer KT, Evanoff B. Assessing case definitions in the absence of a diagnostic gold standard. Int J Epidemiol. 2005 Aug;34(4):949-52. doi: 10.1093/ije/dyi012.
- Background Botega NJ, Bio MR, Zomignani MA, Garcia C Jr, Pereira WA. [Mood disorders among inpatients in ambulatory and validation of the anxiety and depression scale HAD]. Rev Saude Publica. 1995 Oct;29(5):355-63. doi: 10.1590/s0034-89101995000500004. Portuguese.
- Background Kessler RC, Molnar BE, Feurer ID, Appelbaum M. Patterns and mental health predictors of domestic violence in the United States: results from the National Comorbidity Survey. Int J Law Psychiatry. 2001 Jul-Oct;24(4-5):487-508. doi: 10.1016/s0160-2527(01)00080-2. No abstract available.
- Background Kendler KS, Neale MC, Kessler RC, Heath AC, Eaves LJ. Major depression and generalized anxiety disorder. Same genes, (partly) different environments? Arch Gen Psychiatry. 1992 Sep;49(9):716-22. doi: 10.1001/archpsyc.1992.01820090044008.
- Background Pine DS, Cohen P, Gurley D, Brook J, Ma Y. The risk for early-adulthood anxiety and depressive disorders in adolescents with anxiety and depressive disorders. Arch Gen Psychiatry. 1998 Jan;55(1):56-64. doi: 10.1001/archpsyc.55.1.56.
- Background Wittchen HU, Stein MB, Kessler RC. Social fears and social phobia in a community sample of adolescents and young adults: prevalence, risk factors and co-morbidity. Psychol Med. 1999 Mar;29(2):309-23. doi: 10.1017/s0033291798008174.
- Background McCarter-Spaulding DE. Medications in pregnancy and lactation. MCN Am J Matern Child Nurs. 2005 Jan-Feb;30(1):10-7; quiz 18-9.
- Background Fisher P, Ward A. Complementary medicine in Europe. BMJ. 1994 Jul 9;309(6947):107-11. doi: 10.1136/bmj.309.6947.107.
- Background Endler PC, Pongratz W, Smith CW, Schulte J. Non-molecular information transfer from thyroxine to frogs with regard to homeopathic toxicology. Vet Hum Toxicol. 1995 Jun;37(3):259-60. No abstract available.
- Background Dugoua JJ, Mills E, Perri D, Koren G. Safety and efficacy of St. John's wort (hypericum) during pregnancy and lactation. Can J Clin Pharmacol. 2006 Fall;13(3):e268-76. Epub 2006 Nov 3.
- Background McKenna L, McIntyre M. What over-the-counter preparations are pregnant women taking? A literature review. J Adv Nurs. 2006 Dec;56(6):636-45. doi: 10.1111/j.1365-2648.2006.04037.x.
- Background Field T. Pregnancy and labor alternative therapy research. Altern Ther Health Med. 2008 Sep-Oct;14(5):28-34.
- Background Dayan J, Yoshida K. [Psychological and pharmacological treatments of mood and anxiety disorders during pregnancy and postpartum. Review and synthesis]. J Gynecol Obstet Biol Reprod (Paris). 2007 Oct;36(6):530-48. doi: 10.1016/j.jgyn.2007.06.004. Epub 2007 Jul 5. French.
- Background Charlton RA, Cunnington MC, de Vries CS, Weil JG. Data resources for investigating drug exposure during pregnancy and associated outcomes: the General Practice Research Database (GPRD) as an alternative to pregnancy registries. Drug Saf. 2008;31(1):39-51. doi: 10.2165/00002018-200831010-00004.
- Background Kyle PM. Drugs and the fetus. Curr Opin Obstet Gynecol. 2006 Apr;18(2):93-9. doi: 10.1097/01.gco.0000192974.61729.4c.
- Background Guelinckx I, Devlieger R, Beckers K, Vansant G. Maternal obesity: pregnancy complications, gestational weight gain and nutrition. Obes Rev. 2008 Mar;9(2):140-50. doi: 10.1111/j.1467-789X.2007.00464.x. Epub 2008 Jan 21.
- Background Polley BA, Wing RR, Sims CJ. Randomized controlled trial to prevent excessive weight gain in pregnant women. Int J Obes Relat Metab Disord. 2002 Nov;26(11):1494-502. doi: 10.1038/sj.ijo.0802130.
- Background Pearlstein T. Perinatal depression: treatment options and dilemmas. J Psychiatry Neurosci. 2008 Jul;33(4):302-18.
- Background Bonari L, Pinto N, Ahn E, Einarson A, Steiner M, Koren G. Perinatal risks of untreated depression during pregnancy. Can J Psychiatry. 2004 Nov;49(11):726-35. doi: 10.1177/070674370404901103.
- Background Epstein LH, Wing RR, Penner BC, Kress MJ. Effect of diet and controlled exercise on weight loss in obese children. J Pediatr. 1985 Sep;107(3):358-61. doi: 10.1016/s0022-3476(85)80506-0.
- Background Harding TW, de Arango MV, Baltazar J, Climent CE, Ibrahim HH, Ladrido-Ignacio L, Murthy RS, Wig NN. Mental disorders in primary health care: a study of their frequency and diagnosis in four developing countries. Psychol Med. 1980 May;10(2):231-41. doi: 10.1017/s0033291700043993.
- Background Mari JJ, Williams P. A comparison of the validity of two psychiatric screening questionnaires (GHQ-12 and SRQ-20) in Brazil, using Relative Operating Characteristic (ROC) analysis. Psychol Med. 1985 Aug;15(3):651-9. doi: 10.1017/s0033291700031500.
- Background Mari JJ, Williams P. A validity study of a psychiatric screening questionnaire (SRQ-20) in primary care in the city of Sao Paulo. Br J Psychiatry. 1986 Jan;148:23-6. doi: 10.1192/bjp.148.1.23.
- Background Milgrom LR. Vitalism, complexity and the concept of spin. Homeopathy. 2002 Jan;91(1):26-31. doi: 10.1054/homp.2001.0013.
- Background Milgrom LR. Patient-practitioner-remedy (PPR) entanglement. Part 3. Refining the quantum metaphor for homeopathy. Homeopathy. 2003 Jul;92(3):152-60. doi: 10.1016/s1475-4916(03)00038-9.
- Background Teixeira MZ. Homeopathic use of modern medicines: utilisation of the curative rebound effect. Med Hypotheses. 2003 Feb;60(2):276-83. doi: 10.1016/s0306-9877(02)00386-9.
- Background Weingartner O. What is the therapeutically active ingredient of homeopathic potencies? Homeopathy. 2003 Jul;92(3):145-51. doi: 10.1016/s1475-4916(03)00037-7.
- Background Linde K, Clausius N, Ramirez G, Melchart D, Eitel F, Hedges LV, Jonas WB. Are the clinical effects of homeopathy placebo effects? A meta-analysis of placebo-controlled trials. Lancet. 1997 Sep 20;350(9081):834-43. doi: 10.1016/s0140-6736(97)02293-9.
- Background Shang A, Huwiler-Muntener K, Nartey L, Juni P, Dorig S, Sterne JA, Pewsner D, Egger M. Are the clinical effects of homoeopathy placebo effects? Comparative study of placebo-controlled trials of homoeopathy and allopathy. Lancet. 2005 Aug 27-Sep 2;366(9487):726-32. doi: 10.1016/S0140-6736(05)67177-2.
- Background Oberbaum M, Singer SR, Frass M. Homeopathic research after the Lancet meta analysis--a moment for introspection. Complement Ther Med. 2005 Dec;13(4):303-5. doi: 10.1016/j.ctim.2005.10.006. Epub 2005 Nov 17. No abstract available.
- Background Mathie RT. The research evidence base for homeopathy: a fresh assessment of the literature. Homeopathy. 2003 Apr;92(2):84-91. doi: 10.1016/s1475-4916(03)00006-7.
- Background Jonas WB, Kaptchuk TJ, Linde K. A critical overview of homeopathy. Ann Intern Med. 2003 Mar 4;138(5):393-9. doi: 10.7326/0003-4819-138-5-200303040-00009.
- Background White A, Slade P, Hunt C, Hart A, Ernst E. Individualised homeopathy as an adjunct in the treatment of childhood asthma: a randomised placebo controlled trial. Thorax. 2003 Apr;58(4):317-21. doi: 10.1136/thorax.58.4.317.
- Background Jacobs J, Springer DA, Crothers D. Homeopathic treatment of acute otitis media in children: a preliminary randomized placebo-controlled trial. Pediatr Infect Dis J. 2001 Feb;20(2):177-83. doi: 10.1097/00006454-200102000-00012.
- Background Frei H, Thurneysen A. Homeopathy in acute otitis media in children: treatment effect or spontaneous resolution? Br Homeopath J. 2001 Oct;90(4):180-2. doi: 10.1054/homp.1999.0505.
- Background Taylor MA, Reilly D, Llewellyn-Jones RH, McSharry C, Aitchison TC. Randomised controlled trial of homoeopathy versus placebo in perennial allergic rhinitis with overview of four trial series. BMJ. 2000 Aug 19-26;321(7259):471-6. doi: 10.1136/bmj.321.7259.471.
- Background Jacobs J, Jonas WB, Jimenez-Perez M, Crothers D. Homeopathy for childhood diarrhea: combined results and metaanalysis from three randomized, controlled clinical trials. Pediatr Infect Dis J. 2003 Mar;22(3):229-34. doi: 10.1097/01.inf.0000055096.25724.48.
- Background Frass M, Linkesch M, Banyai S, Resch G, Dielacher C, Lobl T, Endler C, Haidvogl M, Muchitsch I, Schuster E. Adjunctive homeopathic treatment in patients with severe sepsis: a randomized, double-blind, placebo-controlled trial in an intensive care unit. Homeopathy. 2005 Apr;94(2):75-80. doi: 10.1016/j.homp.2005.01.002.
- Background Olson CM. Achieving a healthy weight gain during pregnancy. Annu Rev Nutr. 2008;28:411-23. doi: 10.1146/annurev.nutr.28.061807.155322.
- Background Kiel DW, Dodson EA, Artal R, Boehmer TK, Leet TL. Gestational weight gain and pregnancy outcomes in obese women: how much is enough? Obstet Gynecol. 2007 Oct;110(4):752-8. doi: 10.1097/01.AOG.0000278819.17190.87.
- Background Idler EL, Benyamini Y. Self-rated health and mortality: a review of twenty-seven community studies. J Health Soc Behav. 1997 Mar;38(1):21-37.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Con | Traditional medicine (herbal / TCM) | — | — |
| Comparator | Lyc | Traditional medicine (herbal / TCM) | — | — |
| Comparator | Nux v | Traditional medicine (herbal / TCM) | — | — |
| Comparator | Phos | Traditional medicine (herbal / TCM) | — | — |
| Comparator | Puls | Traditional medicine (herbal / TCM) | — | — |
| Comparator | Sep | Traditional medicine (herbal / TCM) | — | — |
| Comparator | Sulfur | Small molecule | — | — |
| Comparator | Sulph | Traditional medicine (herbal / TCM) | — | — |