There are many different types of research evidence used to assess medical treatments.
Observational studies (investigators observe and record what happens to a group of people without influencing the course of events, also called non-experimental study) such as case reports (report detailing observations about a single patient or ‘case’) and clinical outcome studies are designed to explore and describe what happens to patients under normal conditions, rather than during the artificial conditions of experimental trials. These research methods are the closest reflection of the real-life patient experience.
Topic covered on this page include:
- Case reports
- Clinical outcome studies
- Value of evidence from outcome studies
- Limitations of outcome studies
Homeopathic literature includes thousands of individual case reports describing successful homeopathic treatment. Articles in the media also present numerous patient accounts of how their health has been improved by treatment from a homeopath. These anecdotal reports are important in documenting the collective experience of practitioners and patients worldwide and demonstrate why homeopathy is such a long-established and well-used therapy. However in terms of formal evidence, individual case reports have to be of exceptional quality to have much significance. For this reason clinical results must also be explored using formalised, large-scale outcome studies.
Clinical outcome studies
A service evaluation at Bristol Homeopathic Hospital recorded the outcome of homeopathic treatment in over 6,500 consecutive patients over a 6 year period. At follow-up, 70% of patients reported an improvement in their health, including 50% who reported ‘major improvement’. Patients were referred by their GP or hospital specialist after conventional options had failed or because conventional treatment was contraindicated.
- The best clinical results were seen in the treatment of children with eczema and asthma, and adults with inflammatory bowel disease, irritable bowel syndrome, menopausal problems and migraine. Other conditions which improved after homeopathic treatment included arthritis, depression and chronic fatigue syndrome.
- Strengths of the study: The large sample size gives particular ‘weight’ to the findings.
- Spence D, Thompson E and Barron S. Homeopathic treatment for chronic disease: A 6-Year, university-hospital outpatient observational study. J Altern Complement Med 2005; 5: 793-8.
A study involving 3,981 patients looked at the long-term outcome for patients receiving homeopathic treatment in 103 German and Swiss primary care practices.4. Witt CM, et al. Homeopathic medical practice: long-term results of a cohort study with 3,981 patients. BMC Public Health, 2005; 5: 115 The results showed that treatment by a homeopath lead to marked and sustained improvements in disease severity and quality of life.
- Witt CM, et al. Homeopathic medical practice: long-term results of a cohort study with 3,981 patients. BMC Public Health, 2005; 5: 115 http://www.ncbi.nlm.nih.gov/pubmed?term=16266440
A 500-patient survey at the Royal London Homeopathic Hospital showed that many patients were able to reduce or stop conventional medication following homeopathic treatment.5. Sharples F, van Haselen R, Fisher P. NHS patients’ perspective on complementary medicine. Complementary Therapies in Medicine, 2003; 11: 243-8 The size of the effect varied between diagnoses, for example 72% of patients with skin complaints reported being able to stop or reduce their conventional medication; for cancer patients there was no reduction.
Value of evidence from outcome studies
210 primary care doctors were surveyed to find out what forms of evidence they would want before using or recommending an unorthodox therapy.6. Reilly D. The Evidence For Homeopathy, Article version 5.5 January 2003 They rated outcome studies as the highest form of evidence, whilst theoretical or laboratory evidence was considered to be least important.
Experiments are useful for answering certain questions, but finding out what happens in real life is essential for health care providers and patients alike, and this is done primarily through clinical outcome studies.
Limitations of outcome studies
Outcome studies are designed to establish outcomes under normal clinical conditions, rather than under artificially-controlled experimental conditions.
- patients may be allowed to choose for themselves whether they receive homeopathic treatment, rather than being selected at random (non-randomised study)
- depending on the purpose of the study, there may be no control group (control group = provides a basis for comparison within a trial) (non-controlled study) and
- which treatment is given to each patient is not concealed (open label study).
These design issues restrict the number of questions that can be answered by observational studies, and their results should be viewed with these limitations in mind, but they do not reduce the quality of the studies in terms of answering the single question they were intended to answer i.e. ‘What happens in normal clinical practice?’
Some researchers consider non-randomised or non-controlled outcome studies to be near the bottom of the ‘evidence hierarchy’ but they can make a useful contribution to homeopathy research. As well as being essential for investigating safety, cost-effectiveness and real life clinical results, outcome studies can suggest areas where homeopathic treatment is sufficiently effective to warrant further research using more rigorous (and expensive) methods in future.
1. Homeopathic text books and journals such as Homeopathic Links, Homeopathy and The Homeopath regularly include case studies
3. Spence D, Thompson E and Barron S. Homeopathic treatment for chronic disease: A 6-Year, university-hospital outpatient observational study. J Altern Complement Med 2005; 5: 793-8
4. Witt CM, et al. Homeopathic medical practice: long-term results of a cohort study with 3,981 patients. BMC Public Health, 2005; 5: 115
5. Sharples F, van Haselen R, Fisher P. NHS patients’ perspective on complementary medicine. Complementary Therapies in Medicine, 2003; 11: 243–8
6. Reilly D. The Evidence For Homeopathy, Article version 5.5 January 2003