Академический Документы
Профессиональный Документы
Культура Документы
Abstract
Background: Many cancer patients seek homeopathy as a complementary therapy. It has rarely been studied
systematically, whether homeopathic care is of benefit for cancer patients.
Methods: We conducted a prospective observational study with cancer patients in two differently treated cohorts:
one cohort with patients under complementary homeopathic treatment (HG; n = 259), and one cohort with
conventionally treated cancer patients (CG; n = 380). For a direct comparison, matched pairs with patients of the
same tumour entity and comparable prognosis were to be formed.
Main outcome parameter: change of quality of life (FACT-G, FACIT-Sp) after 3 months.
Secondary outcome parameters: change of quality of life (FACT-G, FACIT-Sp) after a year, as well as impairment by
fatigue (MFI) and by anxiety and depression (HADS).
Results: HG: FACT-G, or FACIT-Sp, respectively improved statistically significantly in the first three months, from
75.6 (SD 14.6) to 81.1 (SD 16.9), or from 32.1 (SD 8.2) to 34.9 (SD 8.32), respectively. After 12 months, a further
increase to 84.1 (SD 15.5) or 35.2 (SD 8.6) was found. Fatigue (MFI) decreased; anxiety and depression (HADS) did
not change.
CG: FACT-G remained constant in the first three months: 75.3 (SD 17.3) at t0, and 76.6 (SD 16.6) at t1. After 12
months, there was a slight increase to 78.9 (SD 18.1). FACIT-Sp scores improved significantly from t0 (31.0 - SD 8.9)
to t1 (32.1 - SD 8.9) and declined again after a year (31.6 - SD 9.4). For fatigue, anxiety, and depression, no relevant
changes were found.
120 patients of HG and 206 patients of CG met our criteria for matched-pairs selection. Due to large differences
between the two patient populations, however, only 11 matched pairs could be formed. This is not sufficient for a
comparative study.
Conclusion: In our prospective study, we observed an improvement of quality of life as well as a tendency of
fatigue symptoms to decrease in cancer patients under complementary homeopathic treatment. It would take
considerably larger samples to find matched pairs suitable for comparison in order to establish a definite causal
relation between these effects and homeopathic treatment.
and whether it is clinically effective is currently a matter QoL from homeopathic care. Therefore we conducted
of heated debate. While some reviews and meta-analyses an observational study with two natural cohorts to
find it potentially efficacious (e.g. [4], [5]), a recent ana- monitor the developing of QoL under homeopathic and
lysis finds it no better than placebo [6]. However, the under conventional care. For a direct comparison we
latter analysis has been heavily criticised and recently planned to form matched pairs out of patients with
shown to be extremely dependent on decisions as to matchable case histories from both cohorts as a nested
which trials to select for analysis [7]. Hence the debate feasibility study.
is unresolved.
In cancer patients homeopathy has rarely been studied Methods
systematically. A Cochrane Review of homeopathic medi- Over a period of 30 months all new patients who chose
cines for adverse effects of cancer treatments found eight treatment either in two clinics specialising in homeo-
randomised controlled studies with mixed results [8]. pathic care (Clinica Santa Croce, Orselina, Switzerland,
A second systematic review concluded that the “evidence and Homeopathic Centre Oberland-Klinik, Weilheim,
is encouraging but not convincing” [9]. The effects of Germany) or in two conventional specialised oncological
homeopathy on quality of life in cancer patients has been outpatient clinics with cancer care according to state of
studied very rarely. Only two randomised trials used it as the art (Clinic for Interdisciplinary Oncology and Hema-
a secondary outcome, one with and one without positive tology, Freiburg, Germany, and Clinic for Oncology and
results [10], [11]. A retrospective hypotheses generating Hematology, Offenburg, Germany) were approached and
study in a clinic specialising in the homeopathic care of included in a prospective observational study, once they
cancer patients found that the majority of patients indi- had given informed consent. All patients received the
cated that they had improved in QoL due to their normal standard of care offered in each place without
homeopathic treatment, as well as in fatigue symptoms any experimental intervention or interference with the
and psychological well-being (Rostock M, Hinrichs I, treatment plan. The homeopathic clinics offered a consti-
Walach H.: Homeopathic treatment of cancer patients: a tutional homeopathic treatment according to the princi-
retrospective analysis, submitted). ples of classical homeopathy accompanying or following
Most trials of homeopathy have not studied classical conventional cancer treatment. This consisted in an inpa-
homeopathy that individualises treatments for patients, tient stay of approximately one to two weeks for the
but used either fixed combinations for certain symptom purpose of finding the correct remedy and phone consul-
clusters, or isopathy, i.e. the same substance that triggers tations after patients had gone back home. Details of the
an allergic response, or simplified versions of homeop- treatment have been published elsewhere [12,13].
athy. In those cases it is comparatively easy to conduct Our protocol stipulated that patients from both the
randomised, placebo controlled studies. We wanted to conventional and homeopathic cohort were to be com-
study the clinical effects of classical homeopathy. This pared based on the matching criteria of demographic
entails complex interviews, selection of important symp- data, clinical data of tumour disease, staging and pre-
toms with multiple cycles of adjustments according to vious treatment. This entailed that for this direct com-
feedback, and long term observations [12,13]. Blinding parison only patients in a palliative stage could be
such procedures, although performed sometimes [14], is selected, while in the observational study part all cancer
only possible for a short period, and there are grave patients - in adjuvant and in palliative stages - who gave
doubts as to the validity of the results achieved by it. their informed consent were included.
Patients with cancer or other serious chronic diseases Thus, there were three parts to the whole project:
who seek out complementary care normally have very
clear preferences [15]. They are mostly unwilling to 1. A cross-sectional study comparing patient charac-
enter an experiment and submit to randomisation teristics of the two cohorts at the time of study
[16-20]. In the spirit of a staged evaluation approach it entry [22].
is mandatory to study the effects of treatments for 2. A longitudinal observation of two cohorts over 12
patients who have actively chosen them, since free months, one of homeopathic care, one of conven-
choice is part and parcel of a potentially important ther- tional care with the questions:
apeutic step [21]. We therefore set out to study classical a. Is there any difference between the cohorts
homeopathic care for cancer patients, as chosen by concerning their conventional or complementary
patients, including all elements of case taking, setting, treatment over the course of the year?
social support and the dispensation of homeopathic b. Are there any changes under the course of the
remedies, and compare it with a conventional setting. treatment in each cohort related to Qol, psycho-
We wanted to see whether patients benefit, overall, in logical wellbeing, fatigue and patient satisfaction?
Rostock et al. BMC Cancer 2011, 11:19 Page 3 of 8
http://www.biomedcentral.com/1471-2407/11/19
Table 2 Conventional Treatment treatment at a later stage than their conventional counter-
HOMEOPATHY CONVENTIONAL parts. While conventional patients accessed treatment on
N (%) CARE N(%) average 3 months after first diagnosis or after diagnosis of
Therapies t0-t1 tumour progress, patients in homeopathic care only
Surgery 11 (4,3%) 14 (3,7%) started treatment 10 months after first diagnosis in an
Chemotherapy 53 (20,5%) 244 (64,2%) adjuvant situation resp. 7 months after a progress had
Radiation 21 (8,1%) 38 (10,0%) been diagnosed. This explains the higher rate of patients
Hormone therapy 34 (13,2%) 48 (12,6%) pre-treated with chemotherapy or radiotherapy in homeo-
Other therapies (kinase 25 (9,7%) 52 (13,7%) pathic care.
inhibitors, etc.) While most patients used homeopathic care comple-
mentary to an appropriate oncological treatment, 10%
Therapies t1-t4 refused to have such a treatment for various reasons
Surgery 14 (5,4%) 19 (5,0%) and seek homeopathic treatment as an alternative. It is
Chemotherapy 1st line 56 (21,7%) 199 (52,4%) important to emphasise at this point that this patient
Chemotherapy 2nd line 20 (7,8%) 64 (16,8%) decision was neither encouraged nor discouraged by the
Chemotherapy 3rd line 10 (3,9%) 26 (6,8%) homeopathic physicians and has for the most part been
Chemotherapy 4th line 5 (1,9%) 3 (0,8%) taken before patients came to the clinic. All patients had
Radiation 22 (8,5%) 57 (15,0%) been informed about the fact that the decision as to
Hormone therapy 40 (15,5%) 71 (18,7%) which therapy to have or not to have falls within their
Other therapies (kinase 31 (12%) 44 (11,5%) and their doctors’ joint responsibility, as there was no
inhibitors, etc.)
experimental treatment within this observational study.
Despite the considerable difference in disease status of
months as well as after one year, but only for mental the two cohorts it is remarkable that their initial scores
fatigue, physical activity and physical fatigue did the in virtually all self-reported measures in quality of life,
change amount to half a standard deviation. No changes fatigue, anxiety and depression at baseline are quite
were seen in both cohorts regarding the HADS. comparable. Compared with norm data [27] and oncolo-
The data for the sub-cohorts of patients in progressed gical cohorts [26,28] our patients have a more severely
tumour stages who were eligible for matching were very reduced QoL, more anxiety and depression and compar-
similar. Here we show only the data for the primary able fatigue.
outcome parameter (Table 4). There were no differences During homeopathic care we saw a significant and
between HG and CG in patient satisfaction regarding stable improvement in QoL which, as measured by the
doctors as well as treatment results (data not shown). FACT G, is sizeable at more than half a standard devia-
tion. We do not see a comparable increase in QoL in
Matched Pairs the conventionally treated cohort. Such an effect size of
120 patients of HG and 206 patients of CG met our cri- more than half a standard deviation is by all standards a
teria for the matched-pairs selection. Due to the large clinically relevant improvement [29,30]. Some authors
differences between the two patient populations, how- consider an improvement of 3 to 7 points on the
ever, only 11 matched pairs could be formed, including FACT-G as the minimally important difference (MID)
2 pairs each with breast cancer, ovarian cancer, NSCLC, [31,32], which is achieved by our homeopathy cohort
pancreatic- and colon cancer and one pair with glioblas- who experienced an improvement by 5.5 points after 3
toma. This is not a sufficient number for a reliable months and by 8.5 points after 12 months. While
comparison. Data described in detail will be submitted depression and anxiety did not change much, as mea-
separately. sured by the HADS, fatigue improved significantly
across all scales. Homeopathic care patients experienced
Discussion an improvement of at least half a standard deviation
This is, to our knowledge, the first longitudinal study of after 12 months for mental fatigue, and both mental and
cancer patients under homeopathic care in a parallel physical fatigue improved to a degree that according to
group design with conventional care and the attempt for new norm data can be deemed a minimal clinically
a nested matched pairs comparison. Our primary aim important difference [28].
was to see whether cancer patients under homeopathic In the conventionally treated group improvements
care experience a benefit in their quality of life, psycho- were much smaller, failing half a standard deviation
logical well-being and fatigue. change by a wide margin. The MID is marginally
At study entry homeopathic patients were, roughly reached with an improvement of 3.6 on the FACT-G
speaking, more severely affected and initiated homeopathic after 12 months of treatment. Nevertheless, patients of
Rostock et al. BMC Cancer 2011, 11:19 Page 6 of 8
http://www.biomedcentral.com/1471-2407/11/19
both groups were satisfied with their treatment and their Since the cohorts were quite different, as expected from
doctors. the outset, we refrained from any formal testing of the
One possible explanation for the lack of improvement between group differences for the whole cohorts. For that
in QoL in the CG is that considerably more patients of reason we had anticipated a matched-pairs analysis. Since
this cohort got chemo- or radiotherapy with possible recruitment in the conventional centres fell considerably
acute side effects. This accounts for differences in the below the anticipated numbers we could not obtain the 40
first three months, but after a time period of twelve matched pairs anticipated. Also, the complex matching
months these differences should have washed out, espe- process devised, with 3 oncologists having to agree on a
cially because there were even more patients in a pallia- comparatively large set of initial data, led to the fact that
tive treatment situation in the HG, and one important only very few potentially matchable pairs could be found.
aim of the antitumour therapy is an improvement in One might consider a randomised study whereby studying
QoL in the long run. homeopathy as a complementary add-on an alternative.
effect of homeopathic remedies, but of homeopathic Received: 11 September 2010 Accepted: 17 January 2011
care. This comprises the whole setting of case taking, Published: 17 January 2011
individualisation, finding the right remedy and following
up on the perceived effects in multiple cycles of feed- References
1. Molassiotis A, Fernadez-Ortega P, Pud D, et al: Use of complementary and
back and adjustment. It goes without saying that this is alternative medicine in cancer patients: a European survey. Ann Oncol
an intensive communicative, interactive process that 2005, 16:655-663.
operates via many different pathways, some of which are 2. Frenkel M: Homeopathy in cancer care. Altern Ther Health Med
16:12-16.
likely to be psychological and very general in the sense 3. Walach H, Jonas WB, Ives J, et al: Research on homeopathy: state of the
of a meaning response [34], some of which might be art. J Altern Complement Med 2005, 11:813-829.
specific to homeopathic therapy and its usage of the 4. Jonas WB, Kaptchuk TJ, Linde K: A critical overview of homeopathy. Ann
Intern Med 2003, 138:393-399.
remedies. It is also a likely scenario that homeopathic 5. Linde K, Clausius N, Ramirez G, et al: Are the clinical effects of
remedies are only active in an unbroken therapeutic homeopathy placebo effects? A meta-analysis of placebo-controlled
context and that, at least for practical therapeutic rea- trials. Lancet 1997, 350:834-843.
6. Shang A, Huwiler-Müntener K, Nartey L, et al: Are the clinical effects of
sons, the question whether homeopathic remedies are homeopathy placebo effects? Comparative study of placebo-controlled
placebo or not, is irrelevant. trials of homeopathy and allopathy. Lancet 2005, 366:726-732.
Rostock et al. BMC Cancer 2011, 11:19 Page 8 of 8
http://www.biomedcentral.com/1471-2407/11/19
7. Ludtke R, Rutten AL: The conclusions on the effectiveness of 30. King MT, Fayers PM: Making quality-of-life results more meaningful for
homeopathy highly depend on the set of analyzed trials. J Clin Epidemiol clinicians. Lancet 2008, 371:709-710.
2008, 61:1197-1204. 31. Webster K, Cella D, Yost K: The Functional Assessment of Chronic Illness
8. Kassab S, Cummings M, Berkovitz S, et al: Homeopathic medicines for Therapy (FACIT) Measurement System: properties, applications, and
adverse effects of cancer treatments. Cochrane Database Syst Rev 2009, interpretation. Health Qual Life Outcomes 2003, 1:79.
CD004845. 32. Yost KJ, Eton DT: Combining distribution- and anchor-based approaches
9. Milazzo S, Russell N, Ernst E: Efficacy of homeopathic therapy in cancer to determine minimally important differences: the FACIT experience.
treatment. Eur J Cancer 2006, 42:282-289. Eval Health Prof 2005, 28:172-191.
10. Jacobs J, Herman P, Heron K, et al: Homeopathy for menopausal 33. Aickin M: Randomization, balance, and the validity and efficiency of
symptoms in breast cancer survivors: a preliminary randomized design-adaptive allocation methods. Journal of Statistical Planning and
controlled trial. J Altern Complement Med 2005, 11:21-27. Inference 2001, 94:97-119.
11. Thompson EA, Montgomery A, Douglas D, Reilly D: A pilot randomized, 34. Moerman DE, Jonas WB: Deconstructing the placebo effect and finding
double-blinded, placebo-controlled trial of individualized homeopathy the meaning response. Ann Intern Med 2002, 136:471-476.
for symptoms of estrogen withdrawal in breast-cancer survivors. J Altern
Complement Med 2005, 11:13-20. Pre-publication history
12. Spinedi D: Die Krebsbehandlung in der Homöopathie Kempten: Cheiron The pre-publication history for this paper can be accessed here:
Verlag; 1999, In Edition. http://www.biomedcentral.com/1471-2407/11/19/prepub
13. Takacs M: Erfahrungen bei der Krebsbehandlung in der Clinica Santa
Croce (Orselina, Schweiz). Allgemeine Homöopathische Zeitung 2004, doi:10.1186/1471-2407-11-19
249:232-239. Cite this article as: Rostock et al.: Classical homeopathy in the treatment
14. Walach H, Haeusler W, Lowes T, et al: Classical homeopathic treatment of of cancer patients - a prospective observational study of two
chronic headaches. Cephalalgia 1997, 17:119-126, discussion 101. independent cohorts. BMC Cancer 2011 11:19.
15. Mitzdorf U, Beck K, Horton-Hausknecht J, et al: Why do patients seek
treatment in hospitals of complementary medicine? J Altern Complement
Med 1999, 5:463-473.
16. Rostock M, Huber R: Randomized and double-blind studies–demands and
reality as demonstrated by two examples of mistletoe research. Forsch
Komplementarmed Klass Naturheilkd 2004, 11(Suppl 1):18-22.
17. Katz T, Fisher P, Katz A, et al: The feasibility of a randomised, placebo-
controlled clinical trial of homeopathic treatment of depression in
general practice. Homeopathy 2005, 94:145-152.
18. Lüdtke R, Schmück M, Gerhard I: Methodische Überlegungen zum
Wirksamkeitsnachweis der homöopathischen Einzelmittelbehandlung
von Zyklusstörungen. Forschende Komplementärmedizin 1997, 4:28-32.
19. von Rohr E, Pampallona S, van Wegberg B, et al: Experiences in the
realisation of a research project on anthroposophical medicine in
patients with advanced cancer. Schweiz Med Wochenschr 2000,
130:1173-1184.
20. Gerhard I, Abel U, Loewe-Mesch A, et al: Problems of randomized studies
in complementary medicine demonstrated in a study on mistletoe
treatment of patients with breast cancer. Forsch Komplementarmed Klass
Naturheilkd 2004, 11:150-157.
21. Walach H, Falkenberg T, Fonnebo V, et al: Circular instead of hierarchical:
methodological principles for the evaluation of complex interventions.
BMC Med Res Methodol 2006, 6:29.
22. Guethlin C, Walach H, Naumann J, et al: Characteristics of cancer patients
using homeopathy compared with those in conventional care: a cross-
sectional study. Ann Oncol 2010, 21:1094-1099.
23. Cella DF, Tulsky DS, Gray G, et al: The Functional Assessment of Cancer
Therapy scale: development and validation of the general measure. J
Clin Oncol 1993, 11:570-579.
24. Peterman AH, Fitchett G, Brady MJ, et al: Measuring spiritual well-being in
people with cancer: the functional assessment of chronic illness
therapy–Spiritual Well-being Scale (FACIT-Sp). Ann Behav Med 2002,
24:49-58.
25. Smets EM, Garssen B, Bonke B, De Haes JC: The Multidimensional Fatigue
Inventory (MFI) psychometric qualities of an instrument to assess
fatigue. J Psychosom Res 1995, 39:315-325.
26. Zigmond AS, Snaith RP: The hospital anxiety and depression scale. Acta Submit your next manuscript to BioMed Central
Psychiatr Scand 1983, 67:361-370. and take full advantage of:
27. Cella D, Hahn EA, Dineen K: Meaningful change in cancer-specific quality
of life scores: differences between improvement and worsening. Qual
• Convenient online submission
Life Res 2002, 11:207-221.
28. Purcell A, Fleming J, Bennett S, et al: Determining the minimal clinically • Thorough peer review
important difference criteria for the Multidimensional Fatigue Inventory • No space constraints or color figure charges
in a radiotherapy population. Support Care Cancer 18:307-315.
29. Cella D, Eton DT, Lai JS, et al: Combining anchor and distribution-based • Immediate publication on acceptance
methods to derive minimal clinically important differences on the • Inclusion in PubMed, CAS, Scopus and Google Scholar
Functional Assessment of Cancer Therapy (FACT) anemia and fatigue
• Research which is freely available for redistribution
scales. J Pain Symptom Manage 2002, 24:547-561.