Homeopathy 2002; 91(04): 197-206
DOI: 10.1054/homp.2002.0049
Original Paper
Copyright ©The Faculty of Homeopathy 2002

Does a homeopathic ultramolecular dilution of Thyroidinum 30cH affect the rate of body weight reduction in fasting patients? A randomised placebo-controlled double-blind clinical trial

JM Schmidt
1   Krankenhaus für Naturheilweisen, Munich, Germany
2   Faculty of Medicine, Ludwig-Maximilians-University of Munich, Germany
,
B Ostermayr
1   Krankenhaus für Naturheilweisen, Munich, Germany
› Author Affiliations

Subject Editor:
Further Information

Publication History

revised21 February 2002

accepted22 July 2002

Publication Date:
04 January 2018 (online)

Abstract

Objective: To test whether an ultramolecular dilution of homeopathic Thyroidinum has an effect over placebo on weight reduction of fasting patients in so-called ‘fasting crisis’.

Design: Randomised, placebo-controlled, double-blind, parallel group, monocentre study.

Setting/location: Hospital for internal and complementary medicine in Munich, Germany.

Subjects: Two hundred and eight fasting patients encountering a stagnation or increase of weight after a weight reduction of at least 100 g/day in the preceding 3 days.

Intervention: One oral dose ofThyroidinum 30cH (preparation of thyroid gland) or placebo.

Outcome Measures: Main outcome measure was reduction of body weight 2 days after treatment. Secondary outcome measures were weight reduction on days 1 and 3, 15 complaints on days 1–3, and 34 laboratory findings on days 1–2 after treatment.

Results: Weight reduction on the second day after medication in the Thyroidinum group was less than in the placebo group (mean difference 92 g, 95% confidence interval 7–176 g, P=0.034). Adjustment for baseline differences in body weight and rate of weight reduction before medication, however, weakened the result to a non-significant level (P=0.094). There were no differences between groups in the secondary outcome measures.

Conclusions: Patients receiving Thyroidinum had less weight reduction on day 2 after treatment than those receiving placebo. Yet, since no significant differences were found in other outcomes and since adjustment for baseline differences rendered the difference for the main outcome measure non-significant, this result must be interpreted with caution. Post hoc evaluation of the data, however, suggests that by predefining the primary outcome measure in a different way, an augmented reduction of weight on day 1 after treatment with Thyroidinum may be demonstrated. Both results would be compatible with homeopathic doctrine (primary and secondary effect) as well as with findings from animal research.

 
  • References

  • 1 Kleijnen J, Knipschild P, ter Riet G. Clinical trials of homoeopathy. BMJ 1991; 302: 316-323.
  • 2 Linde KL, Clausius N, Ramirez G. et al. Are the clinical effects of homoeopathy placebo effects? A meta-analysis of placebo-controlled trials. Lancet 1997; 350: 834-843.
  • 3 Walach H, Gaus W, Haeusler W. et al. Classical homoeopathic treatment of chronic headaches. A double-blind, randomized, placebo-controlled study. Cephalgia 1997; 17: 119-126.
  • 4 Beer SF, Bircham PM, Bloom SR. et al. The effect of a 72-h fast on plasma levels of pituitary, adrenal, thyroid, pancreatic and gastrointestinal hormones in healthy men and women. J Endocrinol 1989; 120: 337-350.
  • 5 Romijn JA, Adriaanse R, Brabant G, Prank K, Endert E, Wiersinga WM. Pulsatile secretion of thyrotropin during fasting: a decrease of thyrotropin pulse amplitude. J Clin Endocrinol Metab 1990; 70: 1631-1636.
  • 6 Marine N, Hershman JM, Maxwell MH, Dornfeld LP, Schroth P. Dietary restriction on serum thyroid hormone levels. Am J Med Sci 1991; 301: 310-313.
  • 7 Gardner DF, Kaplan MM, Stanley CA, Utiger RD. Effect of tri-iodothyronine replacement on the metabolic and pituitary responses to starvation. N Engl J Med 1979; 300: 579-584.
  • 8 Koppeschaar HP, Meinders AE, Schwarz F. Metabolic responses during modified fasting and refeeding: the role of sympathetic nervous system activity and thyroid hormones. Hum Nutr Clin Nutr 1985; 39: 17-28.
  • 9 Everts ME, de Jong M, Lim CF. et al. Different regulation of thyroid hormone transport in liver and pituitary: its possible role in the maintenance of low T3 production during nonthyroidal illness and fasting in man. Thyroid 1996; 6: 359-368.
  • 10 Carter WJ, Shakir KM, Hodges S, Faas FH, Wynn JO. Effect of thyroid hormone on metabolic adaptation to fasting. Metabolism 1975; 24: 1177-1183.
  • 11 Burman KD, Wartofsky L, Dinterman RE, Kesler P, Wannemacher Jr RW. The effect of T3 and reverse T3 administration on muscle protein catabolism during fasting as measured by 3-methylhistidine excretion. Metabolism 1979; 28: 805-813.
  • 12 Byerley LO, Heber D. Metabolic effects of triiodothyronine replacement during fasting in obese subjects. J Clin Endocrinol Metab 1996; 81: 968-976.
  • 13 Fleming TR, Harrington DP, O'Brien PC. Designs for group sequential tests. Controlled Clin Trials 1984; 5: 348-361.
  • 14 Geller NL, Pocock SJ. Interim analyses in randomized clinical trials: ramifications and guidlines for practitioners. Biometrics 1987; 43: 213-223.
  • 15 Lan K KG, Simon R, Halperin M. Stochastically curtailed tests in long-term clinical trials. Commun Statist 1982; I: 207-219.
  • 16 Endler PC, Pongratz W, Van Wijk R, Kastberger G, Haidvogl M. Effects of highly diluted succussed thyroxine on metamorphosis of highland frogs. Berlin J Res Homoeopathy 1991; 1: 151-160.
  • 17 Endler PC, Pongratz W, Kastberger G, Weigant FA, Haidvogl M. Climbing activity in frogs and the effect of highly diluted successed thyroxine. Br Hom J 1991; 80: 194-200.
  • 18 Endler PC, Pongratz W, Smith CW, Schulte J. Controversies in toxicology: non-molecular information transfer from thyroxine to frogs with regard to homeopathic toxicology. Vet Hum Toxicol 1995; 37: 259-260.
  • 19 Carlston M, Shoultz DA, Jacobs J. Homeopathic diarrhea trial. Pediatrics 1995; 95: 159-161.
  • 20 De Lange de Klerk E SM, Blommers J, Kuik DJ, Bezemer D, Feenstra L. Effect of homoeopathic medicines on daily burden of symptoms in children with recurrent upper respiratory tract infections. BMJ 1994; 309: 1329-1332.
  • 21 Jacobs J, Jiménez LM, Gloyd SS, Gale JL, Crothers D. Treatment of acute childhood diarrhea with homeopathic medicine: a randomized clinical trial in Nicaragua. Pediatrics 1994; 93: 719-725.
  • 22 Jacobs J, Jiménez LM, Malthouse S. et al. Homeopathic treatment of acute childhood diarrhea: results from a clinical trial in Nepal. J Altern Complement Med 2000; 6: 131-139.
  • 23 Jonas WB. The homeopathy debate. J Altern Complement Med 2000; 6: 213-215.
  • 24 Kahn MF, Seed P, Paterson C, Vallance AK, Ernst E, Koch A, Benveniste J. Correspondence: meta-analysis of homoeopathic trials. Lancet 1998; 351: 365-368.
  • 25 Langmann M JS. Homoeopathy trials: reason for good ones but are they warrented?. Lancet 1997; 350: 825.
  • 26 Lökken P, Straumsheim PA, Tveiten D, Skjelbred P, Borchgrevink CF. Effect of homoeopathy on pain and other events after acute trauma: placebo controlled trial with bilateral oral surgery. BMJ 1995; 310: 1439-1442.
  • 27 Miller B, Lipworth BJ, Dean ME, Windeler J, Brown HM, Taylor MA. Homoeopathy versus placebo in perennial allergic rhinitis. BMJ 2001; 322: 169-171.
  • 28 Reilly DT, Taylor MA, McSharry C, Aitchison T. Is homoeopathy a placebo response? Controlled trial of homoeopathic potency, with pollen in hayfever as model. Lancet 1986; II: 881-886.
  • 29 Reilly D, Taylor MA, Beattie NGM. et al. Is evidence for homoeopathy reproducible?. Lancet 1994; 344: 1601-1606.
  • 30 Rothwell PM, Aulas JJ, Kahn MF, Gagnon R, van Duijn P, Happle R. Letters to the editor: is the evidence for homoeopathy reproducible?. Lancet 1995; 345: 251-253.
  • 31 Sampson W, London W. Analysis of homeopathic treatment of childhood diarrhea. Pediatrics 1995; 96: 961-964.
  • 32 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; 321: 471-476.
  • 33 Vallance AK. Can biological activity be maintained at ultrahigh dilution? An overview of homeopathy, evidence, and Bayesian philosophy. J Altern Complement Med 1998; 4: 49-76.
  • 34 Vandenbroucke JP. Homoeopathy trials: going nowhere. Lancet 1997; 350: 824.
  • 35 Vickers AJ, Fisher P, Smith C, Wyllie SE, Rees R. Homeopathic Arnica 30x is ineffective for muscle soreness after long-distance running: a randomized, double-blind, placebo-controlled trial. Clin J Pain 1998; 14: 227-231.
  • 36 Vickers AJ. Clinical trials of homeopathy and placebo: analysis of a scientific debate. J Altern Complement Med 2000; 6: 49-56.
  • 37 Schmidt JM, Ostermayr B. Does a single dose of a homoeopathic ultramolecular dilution of thyroidinum 30cH affect the decrease of body weight of fasting patients after stagnation of weight loss? A randomised placebo-controlled double-blind GCP-conforming clinical trial. FACT 2001; 6: 91.
  • 38 Altman DG, Doré CJ. Randomisation and baseline comparisons in clinical trials. Lancet 1990; 335: 149-153.
  • 39 Altman DG. Better reporting of randomised controlled trials: the CONSORT statement. BMJ 1996; 313: 570-571.
  • 40 Assmann SF, Pocock SJ, Enos LE, Kasten LE. Subgroup analysis and other (mis)uses of baseline data in clinical trials. Lancet 2000; 355: 1064-1069.
  • 41 Bailar JC, Mosteller F. Guidlines for statistical reporting in articles for medical journals. Ann Intern Med 1988; 108: 266-273.
  • 42 Begg C, Cho M, Eastwood S. et al. Improving the quality of reporting of randomized controlled trials: the CONSORT statement. JAMA 1996; 276: 637-639.
  • 43 Frison L, Pocock SJ. Repeated measures in clinical trials: analysis using mean summary statistics and its implications for design. Stat Med 1992; 11: 1685-1704.
  • 44 Gardner MJ, Altman DG. Confidence intervals rather than P values: estimation rather than hypothesis testing. BMJ 1986; 292: 746-750.
  • 45 Haynes RB, Mulrow CD, Huth EJ, Altman DG, Gardner MJ. More informative abstracts revisited. Ann Intern Med 1990; 113: 6976.
  • 46 Morrison B, Lilford RJ, Ernst E. Methodological rigour and results of clinical trials of homoeopathic remedies. Perfusion 2000; 13: 132-138.
  • 47 Perneger TV. What's wrong with Bonferroni adjustment. BMJ 1998; 316: 1236-1238.
  • 48 Pocock SJ, Hughes MD, Lee RJ. Statistical problems in the reporting of clinical trials. N Engl J Med 1987; 317: 426-432.
  • 49 Yusuf S, Wittes J, Probstfield J, Tyroler HA. Analysis and interpretation of treatment effects in subgroups of patients in randomized clinical trials. JAMA 1991; 266: 93-98.