Observational studies

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    [post_content] => Observational studies (such as case reports and clinical outcome studies) are designed to explore and describe what happens to patients under normal conditions, rather than during the artificial conditions of trials. These research methods most closely reflect real-life patient experiences, as investigators observe and record what happens to a group of people without influencing the course of events.

Case reports

Case reports detail observations about a single patient or ‘case’. The homeopathic literature includes thousands of individual case reports describing successful homeopathic treatment1. Articles in the media also present numerous patient accounts of how they feel their health has been improved by treatment from a homeopath2.

These anecdotal reports are important in documenting the collective experience of homeopathic practitioners and patients worldwide and demonstrate why homeopathy is such a long-established and well-used therapy.

However, in terms of the hierarchy of evidence, individual case reports have to be of exceptional quality to have much outward facing research significance. For this reason any documented individual clinical results and experiences need to be explored further using formalised, large-scale studies.

Clinical outcome studies

Clinical outcome studies are designed to establish patient outcomes after treatment under normal clinical conditions, rather than under artificially-controlled conditions, but on a larger scale than collected case reports. Controlled trials and investigations 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.

The real-world strength of the clinical outcome study is balanced by other design limitations such as being non-randomised (i.e. patients may be allowed to choose for themselves whether they receive homeopathic treatment, rather than being selected at random), there may be no comparator group to see whether patients might have got better anyway, and what treatment is given to each patient is not concealed.

Some researchers consider non-randomised or non-controlled clinical outcome studies to be near the bottom of the hierarchy of evidence but this research method can still make a useful contribution to homeopathy research3. 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.

The design and structure of clinical outcome studies restricts the number of questions that can be answered and their results should be viewed with these limitations in mind. However, this does not undermine the role that these clinical outcome studies play in providing an answer to the single question they were intended to answer, i.e. ‘What happens in normal clinical practice?’

The following are some key clinical outcome studies in the evidence base for homeopathy:

A service evaluation at Bristol Homeopathic Hospital which recorded the outcome of homeopathic treatment in over 6,500 consecutive patients over a six year period4. At follow-up, 70% of patients reported an improvement in their health, including 50% who reported ‘major improvement’.

A study involving 3,981 patients which looked at the long-term outcome for patients receiving homeopathic treatment in 103 German and Swiss primary care practices5. The results showed that treatment by a homeopath lead to marked and sustained improvements in disease severity and quality of life.

A 500-patient survey at the Royal London Homeopathic Hospital, which showed that many patients were able to reduce or stop conventional medication following homeopathic treatment6. 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.

A major study in France followed 8559 patients attending GP practices. Key findings of the EPI3 project were that patients with Upper respiratory tract infections (URTIs) treated by GPs trained in homeopathy did as well clinically as those treated with conventional medicine, but used fewer conventional drugs. 7 In the same study, patients with musculoskeletal disorders (MSDs) treated with homeopathy did as well clinically as those treated with conventional medicine, but used only half the amount of non-steroidal anti-inflammatory drugs (NSAIDs) and had fewer NSAID-related side effects. 8 Patients with sleep, anxiety and depressive disorders (SADD) treated by certified homeopathic physicians were less likely to be prescribed psychotropic drugs.9

References

    
 	
  1. Homeopathic text books and journals such as Homeopathic Links, Homeopathy and The Homeopath regularly include case studies.
    2. 
 	
  2. The alternative Holby City that treats 30,000 patients a year, by Caroline Bellamy, 02 August 2008 www.mailonsunday.co.uk/health/article-1040950
    3. 
 	
  3. White A, Ernst E. The case for uncontrolled clinical trials: a starting point for the evidence base for CAM. Complement Ther Med, 2001; 9: 111–5
    4. 
 	
  4. 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
    5. 
 	
  5. Witt CM, et al. Homeopathic medical practice: long-term results of a cohort study with 3,981 patients. BMC Public Health, 2005; 5: 115
    6. 
 	
  6. Sharples F, van Haselen R, Fisher P. NHS patients’ perspective on complementary medicine. Complementary Therapies in Medicine, 2003; 11: 243–8
    7. 
 	
  7. Grimaldi-Bensouda, L. et al.Management of upper respiratory tract infections by different medical practices, including homeopathy, and consumption of antibiotics in primary care: the EPI3 cohort study in France 2007-2008. PLoS One, 2014;9: e89990
    8. 
 	
  8. Rossignol, M. et al.Impact of physician preferences for homeopathic or conventional medicines on patients with musculoskeletal disorders: results from the EPI3-MSD cohort. Drug Saf.,2012; 21: 1093–1101 |
    9. 
 	
  9. Grimaldi-Bensouda, L. et al.Who seeks primary care for sleep, anxiety and depressive disorders from physicians prescribing homeopathic and other complementary medicine? Results from the EPI3 population survey. BMJ Open, 2012;2 | Full text
    10. 


 
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Observational studies (such as case reports and clinical outcome studies) are designed to explore and describe what happens to patients under normal conditions, rather than during the artificial conditions of trials. These research methods most closely reflect real-life patient experiences, as investigators observe and record what happens to a group of people without influencing the course of events.

Case reports

Case reports detail observations about a single patient or ‘case’. The homeopathic literature includes thousands of individual case reports describing successful homeopathic treatment1. Articles in the media also present numerous patient accounts of how they feel their health has been improved by treatment from a homeopath2.

These anecdotal reports are important in documenting the collective experience of homeopathic practitioners and patients worldwide and demonstrate why homeopathy is such a long-established and well-used therapy.

However, in terms of the hierarchy of evidence, individual case reports have to be of exceptional quality to have much outward facing research significance. For this reason any documented individual clinical results and experiences need to be explored further using formalised, large-scale studies.

Clinical outcome studies

Clinical outcome studies are designed to establish patient outcomes after treatment under normal clinical conditions, rather than under artificially-controlled conditions, but on a larger scale than collected case reports. Controlled trials and investigations 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.

The real-world strength of the clinical outcome study is balanced by other design limitations such as being non-randomised (i.e. patients may be allowed to choose for themselves whether they receive homeopathic treatment, rather than being selected at random), there may be no comparator group to see whether patients might have got better anyway, and what treatment is given to each patient is not concealed.

Some researchers consider non-randomised or non-controlled clinical outcome studies to be near the bottom of the hierarchy of evidence but this research method can still make a useful contribution to homeopathy research3. 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.

The design and structure of clinical outcome studies restricts the number of questions that can be answered and their results should be viewed with these limitations in mind. However, this does not undermine the role that these clinical outcome studies play in providing an answer to the single question they were intended to answer, i.e. ‘What happens in normal clinical practice?’

The following are some key clinical outcome studies in the evidence base for homeopathy:

A service evaluation at Bristol Homeopathic Hospital which recorded the outcome of homeopathic treatment in over 6,500 consecutive patients over a six year period4. At follow-up, 70% of patients reported an improvement in their health, including 50% who reported ‘major improvement’.

A study involving 3,981 patients which looked at the long-term outcome for patients receiving homeopathic treatment in 103 German and Swiss primary care practices5. The results showed that treatment by a homeopath lead to marked and sustained improvements in disease severity and quality of life.

A 500-patient survey at the Royal London Homeopathic Hospital, which showed that many patients were able to reduce or stop conventional medication following homeopathic treatment6. 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.

A major study in France followed 8559 patients attending GP practices. Key findings of the EPI3 project were that patients with Upper respiratory tract infections (URTIs) treated by GPs trained in homeopathy did as well clinically as those treated with conventional medicine, but used fewer conventional drugs. 7 In the same study, patients with musculoskeletal disorders (MSDs) treated with homeopathy did as well clinically as those treated with conventional medicine, but used only half the amount of non-steroidal anti-inflammatory drugs (NSAIDs) and had fewer NSAID-related side effects. 8 Patients with sleep, anxiety and depressive disorders (SADD) treated by certified homeopathic physicians were less likely to be prescribed psychotropic drugs.9

References

  1. Homeopathic text books and journals such as Homeopathic Links, Homeopathy and The Homeopath regularly include case studies.
  2. The alternative Holby City that treats 30,000 patients a year, by Caroline Bellamy, 02 August 2008 www.mailonsunday.co.uk/health/article-1040950
  3. White A, Ernst E. The case for uncontrolled clinical trials: a starting point for the evidence base for CAM. Complement Ther Med, 2001; 9: 111–5
  4. 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
  5. Witt CM, et al. Homeopathic medical practice: long-term results of a cohort study with 3,981 patients. BMC Public Health, 2005; 5: 115
  6. Sharples F, van Haselen R, Fisher P. NHS patients’ perspective on complementary medicine. Complementary Therapies in Medicine, 2003; 11: 243–8
  7. Grimaldi-Bensouda, L. et al.Management of upper respiratory tract infections by different medical practices, including homeopathy, and consumption of antibiotics in primary care: the EPI3 cohort study in France 2007-2008. PLoS One, 2014;9: e89990
  8. Rossignol, M. et al.Impact of physician preferences for homeopathic or conventional medicines on patients with musculoskeletal disorders: results from the EPI3-MSD cohort. Drug Saf.,2012; 21: 1093–1101 |
  9. Grimaldi-Bensouda, L. et al.Who seeks primary care for sleep, anxiety and depressive disorders from physicians prescribing homeopathic and other complementary medicine? Results from the EPI3 population survey. BMJ Open, 2012;2 | Full text

 

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