Homeopathy 2014; 103(04): 232-238
DOI: 10.1016/j.homp.2014.06.001
Original Paper
Copyright © The Faculty of Homeopathy 2014

Open-label uncontrolled pilot study to evaluate complementary therapy with Ruta graveolens 9c in patients with advanced cancer

Gilles Freyer
1   Université de Lyon, Hospices Civils de Lyon, Service d'Oncologie Médicale, CH Lyon-Sud, Pierre-Bénite, France
,
Benoit You
2   Centre d'Investigation des Therapeutiques en Onco-hématologie des HCL (CITOH – phase 1 – INCA), Unité de Coordination Onco-gériatrique de Lyon, Service d'Oncologie Médicale, CH Lyon-Sud, France
,
Stéphanie Villet
3   BOIRON, 2 avenue de l'ouest lyonnais, 69510 Messimy, France
,
Sophie Tartas
2   Centre d'Investigation des Therapeutiques en Onco-hématologie des HCL (CITOH – phase 1 – INCA), Unité de Coordination Onco-gériatrique de Lyon, Service d'Oncologie Médicale, CH Lyon-Sud, France
,
Cécile Fournel-Federico
2   Centre d'Investigation des Therapeutiques en Onco-hématologie des HCL (CITOH – phase 1 – INCA), Unité de Coordination Onco-gériatrique de Lyon, Service d'Oncologie Médicale, CH Lyon-Sud, France
,
Véronique Trillet-Lenoir
2   Centre d'Investigation des Therapeutiques en Onco-hématologie des HCL (CITOH – phase 1 – INCA), Unité de Coordination Onco-gériatrique de Lyon, Service d'Oncologie Médicale, CH Lyon-Sud, France
,
Salima Hamizi
2   Centre d'Investigation des Therapeutiques en Onco-hématologie des HCL (CITOH – phase 1 – INCA), Unité de Coordination Onco-gériatrique de Lyon, Service d'Oncologie Médicale, CH Lyon-Sud, France
,
Olivier Colomban
2   Centre d'Investigation des Therapeutiques en Onco-hématologie des HCL (CITOH – phase 1 – INCA), Unité de Coordination Onco-gériatrique de Lyon, Service d'Oncologie Médicale, CH Lyon-Sud, France
,
Nathalie Chavernoz
2   Centre d'Investigation des Therapeutiques en Onco-hématologie des HCL (CITOH – phase 1 – INCA), Unité de Coordination Onco-gériatrique de Lyon, Service d'Oncologie Médicale, CH Lyon-Sud, France
,
Claire Falandry
2   Centre d'Investigation des Therapeutiques en Onco-hématologie des HCL (CITOH – phase 1 – INCA), Unité de Coordination Onco-gériatrique de Lyon, Service d'Oncologie Médicale, CH Lyon-Sud, France
› Author Affiliations

Subject Editor:
Further Information

Publication History

Received10 February 2014
revised06 June 2014

accepted10 June 2014

Publication Date:
19 December 2017 (online)

Background: Patients with advanced metastatic disease are often treated aggressively with multiple lines of chemotherapy, even in the last month of life. The benefit of such an approach remains uncertain. The objective of the study was to investigate whether Ruta graveolens 9c homeopathic medicine can improve quality of life (QoL) and tumour progression in patients with advanced cancer.

Material and methods: This was a single-centre, open-label, uncontrolled, pilot study. Patients (>18-years, life-expectancy ≥3 months, performance status ≤2) with locally-advanced solid tumours or metastases, previously treated with all available standard anti-cancer treatments were recruited. Oral treatment consisted of two 1-mL ampoules of Ruta graveolens (9c dilution) given daily for a minimum of 8 weeks, or until tumour and/or clinical progression. Primary outcome was QoL measured using the EORTC QLQ-C30 questionnaire. Secondary outcome measures were anxiety/depression measured using the Hospital Anxiety and Depression Scale (HADS), WHO performance status (PS), tumour progression assessed using RECIST criteria and tumour markers, survival and tolerance.

Results: Thirty-one patients were included (mean age: 64.3 years). Mean duration of treatment was 3.3 months (median: 2.1). QoL global health status improved significantly between baseline and week 8 (P < 0.001) and week 16 (P = 0.035), but was at the limit of significance (P = 0.057) at the end of the study. There was no significant change in anxiety/depression or PS during treatment. Ruta graveolens 9c had no obvious effect on tumour progression. Median survival was 6.7 months [95%CI: 4.8–14.9]. Ruta graveolens 9c was well-tolerated.

Conclusion: Some patients treated with Ruta graveolens 9c had a transitory improvement in QoL, but the effectiveness of this treatment remains to be confirmed in further studies.

 
  • References

  • 1 Howlader N., Noone A.M., Krapcho M. et al. SEER cancer statistics review, 1975–2009 (vintage 2009 populations). Bethesda, MD: National Cancer Institute; 2009. http://seer.cancer.gov/csr/1975_2009_pops09/.
  • 2 Ferlay J., Parkin D.M., Steliarova-Foucher E. Estimates of cancer incidence and mortality in Europe in 2008. Eur J Cancer 2010; 46: 765-781.
  • 3 Coleman M.P., Forman D., Bryant H. et al. ICBP module 1 working group: cancer survival in Australia, Canada, Denmark, Norway, Sweden, and the UK, 1995–2007 (the International Cancer Benchmarking Partnership): an analysis of population-based cancer registry data. Lancet 2011; 377: 127-138.
  • 4 Earle C.C., Landrum M.B., Souza J.M. et al. Aggressiveness of cancer care near the end of life: is it a quality-of-care issue?. J Clin Oncol 2008; 26: 3860-3866.
  • 5 Dufresne A., Pivot X., Tournigand C. et al. Impact of chemotherapy beyond the first line in patients with metastatic breast cancer. Breast Cancer Res Treat 2008; 107: 275-279.
  • 6 Cardoso F., Di L.A., Lohrisch C. et al. Second and subsequent lines of chemotherapy for metastatic breast cancer: what did we learn in the last two decades?. Ann Oncol 2002; 13: 197-207.
  • 7 Molassiotis A., Fernadez-Ortega P., Pud D. et al. Use of complementary and alternative medicine in cancer patients: a European survey. Ann Oncol 2005; 16: 655-663.
  • 8 Scott J.A., Kearney N., Hummerston S., Molassiotis A. Use of complementary and alternative medicine in patients with cancer: a UK survey. Eur J Oncol Nurs 2005; 9: 131-137.
  • 9 Boon H.S., Olatunde F., Zick S.M. Trends in complementary/alternative medicine use by breast cancer survivors: comparing survey data from 1998 and 2005. BMC Women's Health 2007; 7: 4.
  • 10 Träger-Maury S., Tournigand C., Maindrault-Goebel F. et al. [Use of complementary medicine by cancer patients in a French oncology department]. [in French] Bull Cancer 2007; 94: 1017-1025.
  • 11 Simon L., Prebay D., Beretz A. et al. [Complementary and alternative medicines taken by cancer patients]. [in French] Bull Cancer 2007; 94: 483-488.
  • 12 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.
  • 13 Balzarini A., Felisi E., Martini A., De Conno F. Efficacy of homeopathic treatment of skin reactions during radiotherapy for breast cancer: a randomised, double-blind clinical trial. Br Homeopath J 2000; 89: 8-12.
  • 14 Pommier P., Gomez F., Sunyach M.P. et al. Phase III randomized trial of Calendula officinalis compared with trolamine for the prevention of acute dermatitis during irradiation for breast cancer. J Clin Oncol 2004; 22: 1447-1453.
  • 15 Genre D., Tarpin C., Braud A.C. et al. Double-blind study comparing homeopathy (Cocculine) with placebo in prevention of nausea/vomiting among patients receiving adjuvant chemotherapy for breast cancer. Breast Cancer Res Treat 82 suppl. 2003; 637.
  • 16 Oberbaum M., Yaniv I., Ben-Gal Y. et al. A randomized, controlled clinical trial of the homeopathic medication TRAUMEEL S in the treatment of chemotherapy-induced stomatitis in children undergoing stem cell transplantation. Cancer 2001; 92: 684-690.
  • 17 Thompson E.A., Reillly D. The homeopathic approach to symptom control in the cancer patient: a prospective observational study. Palliat Med 2002; 16: 227-233.
  • 18 Rostock M., Naumann J., Guethlin C. et al. Classical homeopathy in the treatment of cancer patients – a prospective observational study of two independent cohorts. BMC Cancer 2011; 11: 19.
  • 19 Preethi K.C., Kuttan G., Kuttan R. Anti-tumour activity of Ruta graveolens extract. Asian Pac J Cancer Prev 2006; 7: 439-443.
  • 20 Kumar K.B., Sunila E.S., Kuttan G. et al. Inhibition of chemically induced carcinogenesis by drugs used in homeopathic medicine. Asian Pac J Cancer Prev 2007; 8: 98-102.
  • 21 Sunila E.S., Kuttan R., Preethi K.C., Kuttan G. Dynamized preparations in cell culture. Evid Based Complement Alternat Med 2009; 6: 257-263.
  • 22 Pathak S., Multani A.S., Banerji P., Banerji P. Ruta 6 selectively induces cell death in brain cancer cells but proliferation in normal peripheral blood lymphocytes: A novel treatment for human brain cancer. Int J Oncol 2003; 23: 975-982.
  • 23 Fadlalla K., Watson A., Yehualaeshet T. et al. Ruta graveolens extract induces DNA damage pathways and blocks Akt activation to inhibit cancer cell proliferation and survival. Anticancer Res 2011; 31: 233-241.
  • 24 Eisenhauer E.A., Therasse P., Bogaerts J. et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 2009; 45: 228-247.
  • 25 Osoba D., Rodrigues G., Myles J. et al. Interpreting the significance of changes in health-related quality-of-life scores. J Clin Oncol 1998; 16: 139-144.
  • 26 Frenkel M. Homeopathy in cancer care. Altern Ther Health Med 2010; 16: 12-16.
  • 27 Koedoot C.G., de Haan R.J., Stiggelbout A.M. et al. Palliative chemotherapy or best supportive care? A prospective study explaining patients' treatment preference and choice. Br J Cancer 2003; 89: 2219-2226.
  • 28 Matsuyama R., Reddy S., Smith T.J. Why do patients choose chemotherapy near the end of life? A review of the perspective of those facing death from cancer. J Clin Oncol 2006; 24: 3490-3496.
  • 29 Slevin M.L., Stubbs L., Plant H.J. et al. Attitudes to chemotherapy: comparing views of patients with cancer with those of doctors, nurses, and general public. BMJ 1990; 300: 1458-1460.
  • 30 Silvestri G., Pritchard R., Welch H.G. Preferences for chemotherapy in patients with advanced non-small cell lung cancer: descriptive study based on scripted interviews. BMJ 1998; 317: 771-775.
  • 31 Chvetzoff G., Tannock I.F. Placebo effects in oncology. J Natl Cancer Inst 2003; 95: 19-29.
  • 32 Whitford H.S., Olver I.N. When expectations predict experience: the influence of psychological factors on chemotherapy toxicities. J Pain Symptom Manage 2012; 43: 1036-1050.
  • 33 Olver I.N., Taylor A.E., Whitford H.S. Relationships between patients' pre-treatment expectations of toxicities and post chemotherapy experiences. Psycho-oncology 2005; 14: 25-33.