Over a period of 30 months all new patients who chose treatment either in two clinics specialising in homeopathic care (Clinica Santa Croce, Orselina, Switzerland, and Homeopathic Centre Oberland-Klinik, Weilheim, Germany) or in two conventional specialised oncological outpatient clinics with cancer care according to state of the art (Clinic for Interdisciplinary Oncology and Hematology, Freiburg, Germany, and Clinic for Oncology and Hematology, Offenburg, Germany) were approached and included in a prospective observational study, once they had given informed consent. All patients received the normal standard of care offered in each place without any experimental intervention or interference with the treatment plan. The homeopathic clinics offered a constitutional homeopathic treatment according to the principles of classical homeopathy accompanying or following conventional cancer treatment. This consisted in an inpatient stay of approximately one to two weeks for the purpose of finding the correct remedy and phone consultations after patients had gone back home. Details of the treatment have been published elsewhere [12
Our protocol stipulated that patients from both the conventional and homeopathic cohort were to be compared based on the matching criteria of demographic data, clinical data of tumour disease, staging and previous treatment. This entailed that for this direct comparison only patients in a palliative stage could be selected, while in the observational study part all cancer patients - in adjuvant and in palliative stages - who gave their informed consent were included.
Thus, there were three parts to the whole project:
1. A cross-sectional study comparing patient characteristics of the two cohorts at the time of study entry [22
2. A longitudinal observation of two cohorts over 12 months, one of homeopathic care, one of conventional care with the questions:
a. Is there any difference between the cohorts concerning their conventional or complementary treatment over the course of the year?
b. Are there any changes under the course of the treatment in each cohort related to Qol, psychological wellbeing, fatigue and patient satisfaction?
3. An integrated nested matched pairs comparison between comparable patients in both cohorts regarding their QoL as a feasibility study.
This paper reports on the second part of the project and summarizes the results of the first and the third part.
Measures were patient self-reports, taken at study entry and every 3 months over the course of one year, filled in by patients at intake and sent by post and directly back to the study centre thereafter. Medical records were taken by the treating physicians using case report forms (CRF). Patient records (CRFs) were checked for completeness and information regarding previous treatments and diagnostic information verified at study entry and completion by a monitor. All measures were used in the appropriate and validated German language versions.
Our primary outcome was change in QoL, as measured by the Functional Assessment of Cancer Therapy - General (FACT-G) [23
] in conjunction with the Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-Sp) [24
]. We defined change scores after 3 months and after 12 months as the points of interest to document short and mid-term effects.
Secondary parameters were:
- Change of fatigue, measured by the Multidimensional Fatigue Inventory, MFI [25
- Change of psychological wellbeing, measured by the Hospital Anxiety and Depression Scale, HADS [26
- Patient satisfaction measured by three single items.
Case Report forms documented the sociodemographic parameters, diagnostic information (tumour entity, status, histology, staging, time since diagnosis, progression, metastases), previous treatment (surgery, radiation, chemotherapy, hormone therapy, other treatments), current treatment and survival status.
We included all patients older than 18 years who suffered from a verified tumour disease and who gave informed consent to participation. Since we wanted these data to be as representative as possible we did not apply any exclusion criteria.
Patients who fulfilled the following criteria were included in the matched pairs analysis:
- Histological evidence of malignity
- Evidence for a progressed malignity that is uncurable
- Likely life expectancy of 3 months or more
For each prospective matched-pairs patient all potential matching criteria (see Table ) were entered in a database and a case vignette was constructed with all relevant data. These were presented to three oncologists otherwise not involved in the treatment of the patients at any time and blind against outcome and further development. Each oncologist decided which patients could be paired. In a final conference they had to find a consensus.
Data Treatment and Statistics
All case report forms were monitored and information verified against documentation and patient records. Patient self-report data were entered using a scanning system. Data are presented descriptively, with t-tests for dependent data for significant changes within the groups. Effect sizes are expressed as mean differences, using pooled standard deviations in the denominator.
A previous retrospective pilot-study had shown that we can expect a good patient participation in the homeopathic clinic with roughly 200 patients in two years. However, we had no indication of a prospective effect size to go by and hence opted for a feasible number of 200 homeopathy patients recruited over a two year period. We aimed at a core of at least 40 matched pairs and hence at a recruitment of 800 to 1000 patients from the conventional clinics, a figure mentioned as realistic by the participating recruitment centres in several planning meetings. The study was conducted according to Good Clinical Practice (GCP) and the declaration of Helsinki. It was approved by the ethics committee of the University Hospital Freiburg, Germany and the respective local committees of Bellinzona, Switzerland and Stuttgart, Germany.