Homeopathy 2018; 107(03): 196-201
DOI: 10.1055/s-0038-1646775
Original Research Article
The Faculty of Homeopathy

An N-of-1 Feasibility Study of Homeopathic Treatment for Fatigue in Patients Receiving Chemotherapy

David Brulé
1   Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Canada
2   Riverdale Homeopathic Clinic, Toronto, Canada
Jeffrey Balon
3   Stittsville Integrative Medicine Centre, Toronto, Canada
Linlu Zhao
4   Ottawa Integrative Cancer Centre, Ottawa, Canada
Dugald Seely
4   Ottawa Integrative Cancer Centre, Ottawa, Canada
› Author Affiliations
Funding Funding for this study was provided by the Canadian CAM Research Fund (CCRF). CCRF had no involvement in the study design, in the collection, analysis and interpretation of data, in the writing of the report, or in the decision to submit the article for publication.
Further Information

Publication History

27 November 2017

23 March 2018

Publication Date:
07 May 2018 (online)


Background Cancer-related fatigue has been described as a subjective feeling of physical, emotional, and/or cognitive tiredness. Homeopathy has been widely used to treat side effects of chemotherapy. The n-of-1 design is a single-patient trial method to study a clinical condition that is either short lived and reversible or is chronic and stable. The n-of-1 design requires a washout/reset period. The feasibility of performing an n-of-1 study in homeopathy has not previously been tested.

Methods A feasibility n-of-1 trial of individualized homeopathic treatment for fatigue in a single adult undergoing chemotherapy administered periodically was performed. For each matched pair of treatments, the participant was randomly allocated either placebo or verum for the period between treatments. For the subsequent treatment period, the opposite allocation was given. Participant and practitioner were blinded to the allocation. Ongoing conventional treatments were permitted. The ability to recruit and retain was monitored and changes in fatigue and quality of life were measured using two validated outcome measures.

Results Sixty-eight patients were assessed between February 2014 and February 2015. Four patients were eligible for the study and one consented to participate. The participant enrolled in the study for six cycles of chemotherapy and completed all treatment and outcome measures. There was no improvement under homeopathic treatment compared to placebo. There were multiple confounding events such as conventional medication changes and an adverse event unrelated to therapy.

Conclusion Adequate recruitment was not feasible in this setting. The n-of-1 study design is feasible in this population from the perspective of the ability to complete the trial. No conclusion on the efficacy of homeopathy for this individual can be made. It is unclear as to whether multiple treatments of chemotherapy would be an appropriate clinical situation in which to apply the n-of-1 trial methodology. Future studies should pilot adaptations to this study design.


• This study is the first n-of-1 clinical trial conducted in homeopathy.

• The objective of this study was to determine whether an n-of-1 trial exploring individualized homeopathic treatment for fatigue in patients receiving chemotherapy is feasible.

• The n-of-1 study design was feasible in this setting from the perspective of the ability of the participant to complete the trial.

• Adequate participant recruitment under the specific parameters of this trial was not feasible.

• No conclusion on the efficacy of homeopathy for this individual could be made in this feasibility trial.

  • References

  • 1 Gibson F, Garnett M, Richardson A, Edwards J, Sepion B. Heavy to carry: a survey of parents' and healthcare professionals' perceptions of cancer-related fatigue in children and young people. Cancer Nurs 2005; 28: 27-35
  • 2 Minton O, Richardson A, Sharpe M, Hotopf M, Stone P. Drug therapy for the management of cancer-related fatigue. Cochrane Database Syst Rev 2010; CD006704
  • 3 Clerici CA, Veneroni L, Giacon B, Mariani L, Fossati-Bellani F. Complementary and alternative medical therapies used by children with cancer treated at an Italian pediatric oncology unit. Pediatr Blood Cancer 2009; 53: 599-604
  • 4 Längler A, Spix C, Edelhäuser F, Kameda G, Kaatsch P, Seifert G. Use of homeopathy in pediatric oncology in Germany. Evid Based Complement Alternat Med 2011; 2011: 867151
  • 5 Simon L, Prebay D, Beretz A. , et al. Complementary and alternative medicines taken by cancer patients [Article in French]. Bull Cancer 2007; 94: 483-488
  • 6 Hahnemann S. Organon of the Medical Art. Palo Alto: Birdcage Books; 1996
  • 7 Mathie RT, Lloyd SM, Legg LA. , et al. Randomised placebo-controlled trials of individualised homeopathic treatment: systematic review and meta-analysis. Syst Rev 2014; 3: 142
  • 8 Mathie RT, Ramparsad N, Legg LA. , et al. Randomised, double-blind, placebo-controlled trials of non-individualised homeopathic treatment: systematic review and meta-analysis. Syst Rev 2017; 6: 63
  • 9 Weatherley-Jones E, Nicholl JP, Thomas KJ. , et al. A randomised, controlled, triple-blind trial of the efficacy of homeopathic treatment for chronic fatigue syndrome. J Psychosom Res 2004; 56: 189-197
  • 10 Awdry R. Homeopathy may help ME. Int J Altern Complement Med 1996; 14: 12-16
  • 11 Thompson EA, Reilly D. The homeopathic approach to the treatment of symptoms of oestrogen withdrawal in breast cancer patients. A prospective observational study. Homeopathy 2003; 92: 131-134
  • 12 Relton C, Weatherley-Jones E. Homeopathy service in a National Health Service community menopause clinic: audit of clinical outcomes. J Br Menopause Soc 2005; 11: 72-73
  • 13 Thompson EA, Reillly D. The homeopathic approach to symptom control in the cancer patient: a prospective observational study. Palliat Med 2002; 16: 227-233
  • 14 Rostock M, Naumann J, Guethlin C, Guenther L, Bartsch HH, Walach H. Classical homeopathy in the treatment of cancer patients--a prospective observational study of two independent cohorts. BMC Cancer 2011; 11: 19
  • 15 Kassab S, Cummings M, Berkovitz S, van Haselen R, Fisher P. Homeopathic medicines for adverse effects of cancer treatments. Cochrane Database Syst Rev 2009; CD004845
  • 16 Brien S, Lachance L, Prescott P, McDermott C, Lewith G. Homeopathy has clinical benefits in rheumatoid arthritis patients that are attributable to the consultation process but not the homeopathic remedy: a randomized controlled clinical trial. Rheumatology (Oxford) 2011; 50: 1070-1082
  • 17 Frei H, Everts R, von Ammon K. , et al. Homeopathic treatment of children with attention deficit hyperactivity disorder: a randomised, double blind, placebo controlled crossover trial. Eur J Pediatr 2005; 164: 758-767
  • 18 Lillie EO, Patay B, Diamant J, Issell B, Topol EJ, Schork NJ. The n-of-1 clinical trial: the ultimate strategy for individualizing medicine?. Per Med 2011; 8: 161-173
  • 19 Ulbrich-Zürni S, Teut M, Roll S, Mathie RT. The N-of-1 clinical trial: a timely research opportunity in homeopathy. Homeopathy 2018; 107: 10-18
  • 20 Sung L, Feldman BM. N-of-1 trials: innovative methods to evaluate complementary and alternative medicines in pediatric cancer. J Pediatr Hematol Oncol 2006; 28: 263-266
  • 21 Sung L, Tomlinson GA, Greenberg ML. , et al. Serial controlled N-of-1 trials of topical vitamin E as prophylaxis for chemotherapy-induced oral mucositis in paediatric patients. Eur J Cancer 2007; 43: 1269-1275
  • 22 RADAR Homeopathic Software [Computer software]. (2014). Retrieved from http://archibel.com/radar.html . Accessed November 23, 2017.
  • 23 Schroyens F. Synthesis Repertorium Homeopathicum 9.1. London: Homeopathic Book Publishers; 2004
  • 24 Vermeulen F. Concordant Materia Medica, 3rd ed. Haarlem: Emryss Publishers; 2000
  • 25 Murphy R. Nature's Materia Medica. Blacksburg: Lotus Health Institute; 2006
  • 26 International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Guideline. Available at: http://www.ich.org/ . Accessed November 23, 2017