-with particular reference to the reliability of the randomised controlled trial as a method of measuring its efficacy in practice –
The aim of this study is to evaluate whether or not homeopathy is an effective treatment for Chronic Fatigue Syndrome (CFS). Highly complex in its nature, CFS is a challenge to physicians of every discipline, thus guidelines as to the efficacy of treatment are warranted. ‘Chronic Fatigue Syndrome is a symptom-defined condition in which physical and mental fatigue, usually made worse by activity, are the core symptoms’ (Sharpe 2004)
A literature search on the subject of Chronic fatigue/ME was undertaken, both on-line and through the Glasgow Homeopathic Library. An investigation into the allopathic treatment of the condition has been undertaken, documented and critically reviewed. Randomised Control Trials, the function of ‘the placebo effect’ and what constitutes Evidence Based Medicine were discussed to put the research into context. Homeopathic treatment and approaches were then evaluated by referring to published case studies, whilst analysing the different methodologies of individual homeopaths. In addition, different concepts and individual schools of thought were studied to highlight any particular successes or failures in approaches to their cases. Two RCT’s have been analysed (Awdry 1996, Weatherley-Jones 2002) and other treatment protocols namely, Peter Chappell’s CFS trial in Leuven (2004) and Harthoorne’s in South Africa (1997).
There is a positive response to homeopathic treatment in most trials and cases based on observation and outcome. Howeverthis study concludes that the focus on current methods of measuring the efficacy of homeopathy, namely randomised control trials, is not an appropriate or balanced assessment of the evidence. Other methods of measuring the efficacy of homeopathy such as observational studies (Rawlins, 2008) are more suited to adapting to the homeopathic paradigm.
This study suggests that there are many aetiologies for CFS and it is evident from the literature that the cure is often dependant on these facts. Treatment is individualised and ongoing to match ‘the state’ of the patient. It is recommended in this study that research into CFS should continue to refine the optimum approach. While statistical analysis may have some value, it is clear that professional judgement reinforced by longitudinal observation is a much stronger approach for correctly evaluating the success of treatment.
It is the intention of this study to give an in-depth insight into the homeopathic treatment of Chronic Fatigue Syndrome (CFS), through the analytical and critical research of published cases and trials. Because the efficacy of homeopathy is judged largely on the rigours of the Randomised Controlled Trials (RCT), a large section of the research in this study concentrates on the viability of the RCT, which according to Professor Sir Michael Rawlins, the Chairman of National Institute for Health and Clinical Excellence (NICE), does not deserve its elevated place in the hierarchy of evidence (Rawlins, 2008). In the Harveian Oration of 2008, ‘De Testimonio’ he cites Hill, the ‘architect’ of the RCT in stating ‘Any belief that the controlled trial is the only way to go would mean not that the pendulum had swung too far, but that it had come right off the hook’. He goes on to say: ‘Hierarchies attempt to replace judgment with an over simplistic, pseudo-quantitative, assessment of the quality of available evidence.’
Most trials alluded to in this study are ‘double or triple blind against placebo’. For this reason the placebo concept will be similarly analysed and placed in appropriate context. What constitutes ‘Evidence Based Medicine’ (EBM) is highly significant to the credibility of this study, so this too will be discussed. ‘It’s about integrating individual clinical expertise and the best external evidence’ (Sackett et al, 1996). The researcher is therefore using the study of the homeopathic treatment of CFS as a framework to explore these wider issues, whilst endeavouring to present the optimum approach to the condition.
To complete this study, a concise allopathic literature review will link into the homeopathic perspective on CFS, where homeopathic philosophy will be seen to relate to some allopathic concepts including psychoneuroimmunology. An in-depth analysis of the homeopathic treatment of CFS, including the rationale behind various trials and protocols, methodologies and philosophy will be discussed, appraised and criticised by the researcher, the purpose being to inform the reader at the highest level.
History of Chronic Fatigue Syndrome (CFS) to the present day
Descriptions of a disease not dissimilar to CFS were found on a piece of Egyptian papyrus dating back to 1900 B.C. From very early studies, clear aetiologies for this condition were evident and will be discussed at length in this study. Beard, (1869), a psychiatrist, referred to the condition as ‘neurasthenia’, after treating several young women for an illness with many similarities to CFS. He defined this as ‘a condition of nervous exhaustion, characterised by undue fatigue on the slightest exertion, both physical and mental …. the chief symptoms are headache, gastro-intestinal disturbances and subjective sensations of all kinds.’ He also referred to fatigue as ‘The Central Africa of Medicine, an unexplored territory where few men enter.’ Deale and Adams, (1894) concurred with Beard, also describing the condition as neurasthenia, with ‘enfeeblement of the nervous force, which may have all degrees of severity’. Almost one hundred years later, Jay Goldstein MD, a specialist in CFS, describes it as a ‘neurosomatic disorder, problems caused by a biochemical neural network dysfunction’ which is a ‘novel paradigm, confounding researchers and physicians alike’. (Goldstein,1996:2). Clearly, time has not offered the gift of great insight or cure which is ‘the gold standard in our research that has to be validated’ (Rutten et al, 2006), except that what is required is a ‘multidimensional approach’ (Wessely, Hotopf and Sharpe 1999:19)
An outbreak of an apparent disease at the The Royal Free Hospital 1955 was the defining situation for the beginning of acceptance of CFS. In this, sufferers presented symptoms such as problems with brain function, headaches, blurred vision and unusual skin sensations. The Central nervous system had been affected in 74% of cases (Parish, 1978, Shepherd, 1999). Some of these patients never recovered. (Chief Medical Officer’s Working Group report on CFS/ME, Feb 2002:4). Dr Melvin Ramsay who was the consultant physician at the infectious diseases unit at the time was compelled to publish a report in the Lancet (1956) describing the disease as ‘A New Clinical Entity.’ He subsequently suggested it should be called ‘Benign Encephalomyelitis.’ Two psychiatrists however, described the situation in the British Medical Journal in 1970 as ‘being caused by mass hysteria’ (McEvedy and Beard, 1970). Sadly, this had a profound effect on the medical community, who in large, remained cynical. It was only in 1998 that the Chief Medical Officer finally recognised the illness, after years of controversy and debate. Some remain cynical however, and views such as those of Shorter (1995) are still frequently voiced:
In every community there will be at least one physician willing to play up to his patients’ need for organicity. Thus do the caregivers themselves contribute to their patients’ somatic fixations, plunging youthful and productive individuals into careers of disability.
What is Chronic Fatigue Syndrome?
Chronic Fatigue Syndrome (CFS) is a disorder that presents with profound, debilitating fatigue which accompanies normal activities and is not relieved by bed rest and cannot be explained by another medical condition. (Afari and Buchwald, 2003:221.) It is also sometimes referred to as ME (Myalgic Encephalomyelitis), Post Viral Fatigue Syndrome and Immune Dysfunction Syndrome. It often comes on suddenly with no obvious cause. It is a syndrome that affects twice as many women than men and can last for months or years and it is envisaged that even more people will present with it in the years to come. It is thus an area of study that will be useful in practice. Dr Lucinda Bateman who serves on the board of CFIDS Association of America opened a fatigue consultation clinic in 2000 and has since had to evaluate more than 1000 patients: ‘In my clinical experience, I have found that CFS is among the most difficult conditions to improve at all, with either physical or psychological interventions.’ (Bateman, 2003).
According to Shepherd, (1999), it is generally acknowledged that CFS is a three stage illness which encompasses:
Predisposing factors which result in people becoming more susceptible
Events which subsequently stress the immune system and thus prompt the onset
Factors that contribute to perpetuating the symptoms and consequent disability
Young women (average age 32) are 3 times more likely to get CFS than men (Dowsett, 1990). The reason for this is multifaceted and Shepherd (1999) suggests that this is likely to occur for the following reasons:
Possibly a hormonal link with CFS (Harlow et al. 1996). Shepherd again states that during pregnancy women with CFS often see an improvement in their symptoms
Mothers and women of young children may be more exposed to infection
It is harder for mothers and women with domestic and family commitments to take time off when they should be resting
Women are more knowledgeable about CFS thus more likely to get a diagnosis
Allopathic Criteria for diagnosing CFS
The following diagnostic criteria are from Dr Melvin Ramsay who was The Royal Free Hospital’s infectious diseases specialist during the outbreak in 1955. There have been numerous other definitions since then (NICE guidelines run to over 50 pages) but ‘Dr Ramsey’s original work remains the best clinical description to date’ (Shepherd:1999: 7).