-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).
Muscle Fatigability with tenderness, twitching and spasms
Circulatory Impairment encompassing cold extremities, sensitivity to climatic change and excessive sweating
Cerebral dysfunction, including deterioration in memory and concentration, cognitive difficulties, sleep disturbance and mood change
The current NHS ‘symptoms’ are less succinct but essentially similar. (Appendix 1). It is clear that the Royal Free Outbreak and the symptoms currently listed by the NHS are referring to the same illness thus adding credence to the views of those who fought for its recognition as far back as 1955.
Other authors remain as bemused as to the exact origin of the condition. Mostert (1999:72) states that there are no tests to confirm or refute a diagnosis of CFS. However, recently, an osteopathic doctor, Raymond Perrin has developed a technique for diagnosing CFS, based on the theory that ‘different stress factors whether physical, allergies, emotional or infections lead to an overstrain of the sympathetic nervous system.’ He goes on to suggest that a build up of toxins in the fluid around the brain and spinal cord are the result of a nervous system overload. He has discovered definite physical signs common to all CFS sufferers and has developed a physical examination with a definite diagnosis at the end, based on what is found. (Perrin, 2007). It would appear that this could be revolutionary as regards treatment of the condition, but the discovery will take time to be absorbed and accepted by the medical community as a whole. In the meantime, diagnostic criteria has been set out by various bodies including Centre of Disease Control (CDC, Appendix 2), and the Oxford Criteria for CFS (Appendix 3) but as Wessely et al (1999) have discovered, the ‘current classification for CFS stands inadequate and unresolved.’
Much research has been conducted in terms of conventional medical treatment for CFS. Drug therapies have included anti depressants, hormones, corticosteroids, antiviral medications as well as immunologically targeted drug treatments. (Afari & Buchwald, 2003:229). Research has concluded that these approaches have not been significantly effective: ‘There is no pharmacological treatment or cure for CFS/ME’ (National Institute for Health and Clinical Excellence)
Homeopathic Research and the requirement for Evidence Based Medicine (EBM) in relation to the credibility of the Randomised Control Trial
Significantly, much of the recent specific homeopathic information available on CFS highlights an RCT carried out by Dr Elaine Weatherley-Jones at the University of Sheffield. She used a triple blind design (patient and homeopath blind to group assignment and data analyst blind to group until after initial analyses to reduce the possibility of bias due to data analyst) in a trial where patients were randomly assigned to homeopathic medicines or placebo. One hundred and three patients meeting the Oxford criteria for CFS were recruited to two specialist hospital outpatient departments in the UK and attended monthly consultations with professional homeopaths. Outcomes were assessed at six months using the Multidimensional Fatigue Inventory (MFI), Fatigue Impact Scale and the Functional Limitations Profile (FLP). Ninety two patients completed the trial (47 simillimum treatment and 45 placebo). The results showed that 47% of the patients in the treatment group showed significant improvement compared to only 28% of the placebo group. (Weatherley-Jones, 2004)
The trial was published in of the Journal Psychosomatic Research (2004) concluding that ‘There is weak but equivocal evidence that the effects of homeopathic medicine are superior to placebo’. In response to the same study, the British Medical Journal’s Clinical Evidence (2007) interprets the research differently, concluding as a clinical guide ‘That there is insufficient evidence to recommend homeopathy as a treatment in chronic fatigue syndrome’. Here the different paradigms of allopathic and homeopathic medicine are clearly indicated, with the difficulty in performing homeopathic research trials under the same ‘conditions’ as allopathic trials, where the methods of prescribing and case analysis are so clearly different. Another author appraised this trial concluding;
The study certainly hasn’t conclusively answered the question of whether the effects are purely due to placebo or if there is a specific homeopathic component in homeopathic remedies. (Walach, 2004:211).
Similar problems presented with the analysis of a trial undertaken by Awdry (1996). Awdry’s trial was a randomized double blind trial involving 64 participants each of whom attended at least 12 clinic visits over a 12 month period. Awdry considered the results to be encouraging. The study had two outcome measures: a daily wellness graph and a self-assessment chart to be completed at the end of the trial – his results are summarised overleaf. In conducting a statistical analysis of the data collected in the study, Wessely, Hotopf and Sharpe (1999:387) were sceptical in their opinions even though the study data suggested a 33% improvement in the group taking homeopathic medicines as opposed to a 3% improvement in the placebo group. They stated that the internal validity was ‘questionable and insufficient to render reliable results’. Afari and Buchwald (2003:228) concurred, considering Awdry’s study to be of poor quality and stated the outcome as ‘inconclusive’ This once more demonstrates the difficulty in measuring homeopathic ‘success rates’ by conventional, limited methods, not suited to the homeopathic paradigm. Disraeli (1804-1881) was aware of the dangers of basing judgement on pure statistics : ‘There are three kinds of lies: lies, damned lies and statistics.’ (Disraeli, cited by Rutten et al, 2006)
Clearly, the results of these trials are sufficient proof to homeopaths of the success of the research given that ‘more people in the homeopathic group showed clinical improvement on all primary outcomes’. (Awdry, 1996) An article in The BMJ, states that evidence based medicine is ‘about integrating individual clinical expertise and the best external evidence’ Sackett et al (1996). Sir Ian Chalmers, Director of the UK Cochrane Centre, suggests that conventional Medicine is biased against Complementary and Alternative Medicine (CAM), requiring lower standards of proof for conventional medical treatments than they do for CAM. (cited in House of Lords report on CAM 2000). Many researchers a priori see homeopathy as scientifically implausible, creating an immediate bias before any research is undertaken. Some of the theories put forward to explain the ‘mechanisms’ of homeopathy can indeed be confusing to both the homeopath and allopath. Central to homeopathy is Hahnemann’s idea of The Vital Force, which the researcher sees as a spirit like essence animating an undefined energy which is capable of fuelling a living organism; something that is inherent in all living things. When this energy is disrupted by illness ‘The Vital force is unable to feel, act, or maintain itself’ (Hahnemann 2003:15), Aphorism 10, and ‘It is only the pathological untuned vital force that causes disease’ (Hahnemann, 2003:19), Aphorism 12. Kent refers to Vital force as ‘simple substance’ ‘energy is not energy per se, but it is a powerful substance, and is endowed with intelligence that is of itself a substance’ (Kent, 1990:61). Vithoulkas in the Science of Homeopathy (1980) looks at the Vital Force in more scientific terms and suggests that it can be viewed in terms of the electromagnetic energy. The advent of Kirlian photography where the electrodynamic field surrounding all objects, living or not has added great weight to his ideas, although this is still somewhat controversial. He goes on to discuss that should the vital force be synonymous with the electrodynamic field in the body, then it would conform to known principles in physics.
Homeopathic views such as these may be difficult in concept to grasp, but this does not mean that the therapy is not effective, even though a clear understanding or exact hypothesis as to its mechanism (or that which is adapted to the scientific paradigm) still eludes us. A similar example is the action of aspirin, which took many years to understand, though was still used and its effectiveness applauded. (Walach, 2001).
The House of Lords report on Complementary and Alternative Medicine (2000) states that there are several types of evidence that is required, before a therapy is to be advocated.
- Evidence that the therapy is efficacious above and beyond the placebo effect
- Evidence that the therapy is safe
- Evidence that the therapy is cost effective
- Evidence concerning the mechanism and action of the therapy
The researcher must affirm that contrary to popular belief, patients with CFS have a lower rate of response to placebo than many other illnesses. Cho, Hotopf and Wessely, (2005) in a recent review and meta-analysis showed that 19.6 % of CFS patients improved from placebo, compared to the widely accepted figure of about 30% for other illnesses. This could be explained by the already low expectations of the patient due to disappointing treatment outcomes in the past.
The following quotation is encouraging to the homeopath;
“The finding of significant differences between the effects of placebo is consistent with a recent meta-analysis of placebo controlled clinical trials in homeopathy in which the authors concluded that their results were incompatible with the hypotheses that clinical effects of homeopathy are completely due to placebo.” (Linde, 1997).
Linde, here, even though he is allowing allopathic testing to set the criteria for homeopathy (albeit incompatible), is clearly stating that even under these circumstances, homeopathy is more than just the placebo effect.
Given that the’ Power of the Placebo’ is constantly being used as a measure against homeopathic remedies and in homeopathic RCT’s, accurate definition and research into this concept is warranted. The word placebo originates from the Latin ‘I Will Please’. It was originally seen in Latin text in the bible ‘Placebo Domino in Regione Vivorum’ (Psalm114: 1-9). Jerome, the translator, translates this as ‘I will please the Lord in the land of the living.’ Hrobjatsson and Gozsche (2001) state: ‘Placebo is difficult to define satisfactorily. In clinical trials placebos are generally control treatments with a similar appearance to the study treatments but without their specific activity. We therefore defined placebo practically as an intervention labelled as such in the report of a clinical trial’
Hrobjartsson and Gozsche conducted studies in 2001 and 2004 which analysed clinical trials ‘comparing placebo with no treatment’. Two meta-analyses were undertaken involving all 156 clinical trials in which an experimental drug or treatment was compared to a placebo/untreated group. It was found that in studies with a binary outcome (ie: improved or not improved) ‘placebo had no significant effect regardless of whether these outcomes were subjective or objective’. There was a small beneficial effect in the treatment of pain however, but the conclusion of these reviews clearly stated that ‘we found little evidence that placebo had powerful clinical effects’. Criticism of their meta-analysis following this conclusion ensued on the basis that their control group covered a highly mixed group of conditions. For instance, Meissner et al, 2007, stated that the placebo effect does work in ‘peripheral disease processes such as asthma, hypertension etc’ but not for processes reflecting physical diseases such as Crohns, urinary tract infections and heart disease. Similarly Barford (2005) concurs, stating that the placebo effect can be demonstrated under appropriate conditions.
It is clear that RCT’s will continue to be used in both homeopathic and allopathic trials, at least in the near future. As discussed in the introduction to this study, this method of assessing evidence has huge limitations. One of the most significant recent developments regarding the thinking as ‘to what is evidence’ was delivered by Sir Michael Rawlins, chairman of NICE ‘On the Evidence for Decisions about the use of Therapeutic Interventions’. Known as one of the lectures for ‘The Harvein Oration’, this speech was delivered before the fellows of The Royal College of Physicians (Rawlins, 2008). It is ground breaking and thought provoking in its delivery, passionate and erudite in its content. Rawlings cited Jadad 2007 stating that ‘Hierarchies place RCT’s on an undeserved pedestal, although the technique has advantages it also has significant disadvantages, similarly observational studies have defects but they also have merits.’ This is the fundamental essence of the speech which clearly has implications for any physician, allopathic or homeopathic and for this reason the key points of his speech are summarized in order to contribute to the understanding of trials in relation to research, an integral part of this study.
Sir Michael outlined the limitations of RCTs in several key areas, stating that they are:
Table 1. Limitations of RCT’s. (according to Sir Michael Rawlins)
Impossible in treatments for very rare diseases where the number of patients is too limited
Unnecessary when a treatment produces a dramatic benefit
Often stopped early, which leads to misinterpretation of the results. Interim analyses of trials to assess whether the treatment is showing benefit are now common, but the possibility that an interim analysis is a ‘random high’ may be difficult to avoid, especially as there is no consensus among statisticians as to how best to handle this problem
Expensive in terms of money, time and energy. A recent study of 153 trials completed in 2005 and 2006 showed a median cost of over £3 million with one trial costing £95 million
Often carried out on specific types of patients for a relatively short period of time, whereas in clinical practice the treatment will be used on a much greater variety of patients and for much longer.
Lionel Milgrom (2009) in alluding to Rawlins’ speech, became the ‘collective voice’ of the homeopath, when he stated:
No doubt Sir Michaels’ words will be music to the ears of those in homeopathy and CAM struggling to get their healing message heard against the cacophony of sceptical ‘heavy metal’ being pumped out by a largely hostile media.
It was clear that Rawlins highly-rated observational studies, particularly historical controlled trials and case-control studies, but other forms of observational data can also reveal important issues. ‘Contrary to a recent claim, only observational studies can realistically offer the evidence required for assessing less common or latency harms’ (Rawlins, 2008:33). It is clear that what he is purporting is highly significant to the homeopath, with much of the ‘success’ of the therapy being evident through case studies and observation. He begins his address noting that both Rene Descartes (1596-1650) and Thomas Hobbes (1588-1679) regarded observation to be the most appropriate approach, and ends it stating that Charles Darwin (1809-82) ‘conceived the theory of evolution as a result of close observation.’ The essence of this speech is summarized in the following quotation:
For investigators to continue to develop and improve their methodologies, for decision makers to avoid adopting entrenched positions about the nature of evidence and for both to accept that the interpretation of evidence requires judgment. (Rawlins 2008)
Homeopathy and the RCT
Given that for now at least, the RCT will continue to be used, despite the shortcomings outlined above, it is clear that on analysing the literature surrounding RCT’s, there appears to be methodological problems in their application to homeopathy (Kaptchuk 1998, Smallwood 2005, Kaptchuk 2002). The problems of methodology are complex, as even if the clinical effect is positive as in the Weatherley-Jones et al (2004) trial, the interpretation of ‘actual proof’ is questionable. RCT’s are the gold standard of medical research, yet as Rawlins (2008) states ‘the technique has important limitations and imperfections’. They are designed to test those medications which target specific areas in the body, therefore having a specific effect. Because homeopathy stimulates the body’s healing mechanisms, the focus of the ‘cure’ does not lie in one specific organ. Thus its way of achieving efficacy is non-specific. (Tyler, 2006, Mason et al 2002). Homeopathically, a remedy’s action is evident in a more holistic way, with improvement seen in mental and emotional symptoms and in many secondary physical symptoms. (See Figure 2. Lilley). There is often no way of measuring this in an RCT, so would be generally attributed to the placebo effect (Kaptchuk, 1998). Despite the incompatibility of homeopathy to this method of testing, some RCT’s have nonetheless shown that ‘homeopathy can be efficacious, if only the mechanism of action were more plausible’ (Kleijneet et al 1991). Essentially, research must focus on whether a patient’s symptoms can be controlled by homeopathy, the exact mechanism of action could be considered irrelevant. Many researchers concur that we must ‘redirect our energies to whole systems healthcare’ (Long et al, 2008). Jenkins 1989 concurs, stating ‘No particular line of treatment seems to be consistently effective so a broad-based holistic and multi-disciplinary approach would at present seem appropriate.’
The Multifactored Perspective and the Homeopathic Link: Psychoneuroimmunology as Scientific Evidence.
Jay Goldstein, MD, Director of the Chronic Fatigue Institute in Beverley Hills, California states that there is an increasing consensus that the illness (CFS) is ‘a virally induced, cytokine-mediated psychoneuroimmunologic disorder’ that occurs in genetically predisposed individuals.’ (Goldstein: 1991) It is significant from an allopathic perspective that there is a ‘shift’ from a ‘single-cause approach, such as a virus, to a multicausal approach. Goldstein refers to CFS as ‘neurosomatic disorder.’ (Goldstein 1996:2). He cites over 50 conditions that belong to this same ‘group of diseases’, Fibromyalgia, Irritable Bowel Syndrome and Premenstrual Syndrome to name but a few. He sees four ‘influences’ which are responsible for the development of neurosomatic illness.
Genetic susceptibility and ‘Expression of the trait’
Developmental issues in childhood
Viral encephalopathy and genetic susceptibility
An increased susceptibility to environmental stressors.
The summation of the first three points results in impaired flexibility of the brain relating to the concept of ‘allostatic load` described as `The price the body pays for containing the effects of arousing stimuli and expectation of negative consequences` (Goldstein 1996:75). The multi-causal perspective represents a `historic shift in how the medical world thinks about what determines health and illness.’ (Engel, G.L:1997).
Goldstein’s treatment protocol (see fig 3) is shocking to a homeopath: ‘I administer multiple medications sequentially in the same office visit until one has time to exert its effect before trying the next’. Homeopathically, allopathic drugs are seen as suppressors of The Vital Force. Hahnemann states in Aphorism 37 that: ‘If the disease is treated with violent allopathic drugs, other graver, more life threatening ailments are created in its place.’ (Hahnemann S, 2003:34). He calls this method of prescribing ‘contraria contrariis’ (Aphorism 57), the opposite of treating ‘like with like.’ The fact that ‘using this protocol most patients are dramatically improved in 1-2 office visits’ (Goldstein 1996:17) makes one wonder how long this ‘cure’ lasts; one is clearly sceptical from a homeopathic perspective. Goldstein’s results are inevitably disputed – for Wessely, Hotopf and Sharpe, (1999:399) disagree stating that: ‘No pharmacological agent has yet been shown to be convincingly helpful for CFS.’ Con’t..
A Typical Neurosomatic New Patient Treatment Protocol (Goldstein, 1996)
Agents, tried sequentially
Onset of action
Duration of action
Naphazoline HCL 0.1 % gtt T OU
Nitroglycerin 0.04 mg sublingual
2 – 3 minutes
Nimodipine 30 mg po
Gabapentin 100-300 mg
Badofen 10 mg
Oxytocin 5 -10 UIM QD or BID
or Synlocinon 1 – 2 pufls TID
15 minutes to 72 hours
Pyridostigmine 30 – 60mgpo
Hydralazine 10-25 mg po
Mexiletine 150 mgpo
Tacrine 10 mg
Risperidone 0.25 – 0.5 mg
8 – 12 hours
Pindolol 5 mg BID
15 minutes to 7 days
Lamotrigine 25 – 50 mg QD
Sumatriptan 3 – 6 mg SQ
Ranitidine 150 mg BID
1 hour – 1 week 1
Doxepin HCL elixir 2 – 20 mg HS
Sertraline 25 – 50 mg QAM
or Paroxetine 10 – 20 mg QAM
1 hour- 8 weeks
1- 2 days
30 minutes – 8 weeks
8 24 hours
Nefazodone 100 – 300 mg BID
Venlafaxine 37.5 – 75 mg BID
Glycine powder 0.4 Gm/Kg/day in juice
or Cycloserine 15 – 50 mg QD
Felbamate 400 mg
6 – 8 hours
Lidocaine 200 – 300 mg in 500 ml normal saline infused over 2 hours
2hours – 2 weeks
Based on Goldstein’s publications, there seems to be a meeting of minds amongst the homeopaths and allopaths regarding the psychoneuroimmunological basis of CFS. But how far can this convergence be seen to comply within the confines of EBM?
Psychoneuroimmunology is described by Rober Ader (2007) as a ‘convergence of disciplines, namely the behavioural sciences, the neurosciences, endocrinology and immunology.’ (Ader 2007). The concept has effectively grown from the realization that the immune system does not operate autonomously and research in this field in recent years has proved that the brain and immune system represent a single, integrated system of defence. ‘Indeed numerous studies conducted over the past 30 or so years have demonstrated that a wide variety of stressors can alter many aspects of the immune response’ (Maier et al, 1994). Watkins A (2007) and Ader et al (1995) concur, stating that there is biochemical, anatomical and physiological evidence that the body’s systems as outlined, engage in an interactive dialogue, to effectively attempt to create homeostatis. Dr David Felton, who heads up the Department of Neurobiology and Anatomy at the University of Rochester Medical Centre in New York, has been awarded several prestigious grants for his growing work in the field of psychoneuroimmunology (PNI). Similarly, Dr Herbert Benson, a cardiologist and associate professor of The Harvard Medical School and Director Emeritus of The Benson Henry Institute for Mind Body Medicine at Massachusetts General Hospital, received the prestigious Mani Bhaumik award, in March 2009, as a pioneer in Mind Body Medicine. As both are highly trained in orthodox medicine, this once more demonstrates a shift in allopathic thinking to a more integrated approach
Thus, the evidence suggests that those ideas central to homeopathic philosophy, ‘the totality of symptoms, the outer image expressing the inner essence of the disease, ie: of the disturbed vital force’ (Hahnemann S, 2003:12) Aphorism 7, are those which need to be explored in order to treat a patient successfully. This is irrefutable and is clearly demonstrated above.
Many of the diseases Vithoulkas refers to as ‘new diseases’ (1991) are ironically seen by Goldstein to be part of neurosomatic group which would benefit from his ‘treatment protocols`. Hahnemann clearly states in Aphorism 74 that ‘Among chronic disease we must unfortunately include all those widespread illnesses artificially created by allopathic treatments.'(Hahnemann, 2003:73)
Vithoulkas groups CFS together with Cancer, Asthma, MS etc as ‘new diseases, their cause unknown, puzzling and elusive. ‘How responsible for this phenomenon were the chemical drugs we were using? Is it possible that there is a connection between the practice of drug overuse and the inability of our immune system to prevent the appearance of these alarming new diseases?’ (Vithoulkas 1991:4). Herein lies the ultimate dilemma. Are the so-called medications used to ‘cure’ disease by the likes of Goldstein actually causing them?
PNEI Axis as Evidence
Given that one has established that CFS is a multi-systemic disease, it important as part of this study to discuss the way in which the homeopath can treat the condition based on the philosophy of those such as Sankaran (1997), Ullman D. (1991), Reichenberg-Ullman (1995), Chappell (1997). In homeopathy, the totality of symptoms deems that the mind state is at the top of the hierarchy ‘and the deepest core of an individual’s health’ (Ullman D., 1991:16). In treating the underlying cause of illness, the homeopath ‘will often find that the root of illness, even if the symptoms are physical, begins with a mental or emotional trauma. The homeopath then searches for ‘the state’ of each individual that allows the person to be susceptible to particular symptoms’ (Ullman, Reichenberg-Ullman, 1995:16-17). Sankaran sees multi-systemic disease on a psycho-neuro-endocrine-immunological axis, he refers to as PNEI (Sankaran 1999:52). In short, the mind acts on the body through three systems, the nervous, endocrine and the immunological system. A remedy will act on the Vital Force through this axis, targeting the ‘central disturbance’ which could appear anywhere on this axis, depending on susceptibility. ‘A delusion is a false perception of a reality, and disease too is a false perception of the present. The whole mental state of a person is an expression of this false perception.’ (Sankaran 2005:10). Sankaran considers this state to be ‘maladaptive’ (1999:11-15) and refers to it as ‘delusion’. Essentially the PNEI axis is like an energy grid, allowing flow of energy between each of the systems. It is kept in homeostasis by the Vital Force. Sankaran maintains his belief in this system but has subsequently extended the ‘delusion’ idea, inferring that there is a deeper underlying state which also manifests on the physical sphere. He calls this ‘The Vital Sensation’ which can be brought out of the patient through in- depth case taking, essentially a sensation connecting mind and body. Given that CFS is multi-systemic, Sankarans’ theories sit very well in unfurling the ‘central disturbance’ which is often elusive.
Both Vithoulkas (1991) and Scholten (1993) and Chappell’s (1997) views are in accordance with those of Sankaran in that the ‘mind state’ is dominant and intrinsically linked with the other systems in the body. ‘Each of these three planes – the mental, emotional and physical – though complex in nature, constitute distinct and separate entities that differ essentially in their vibrational frequencies and informational patterns. These three planes interact with extreme intelligence and react to any stimulus in a concerted manner that is always consistent with their own idiosyncrasies’ (Vithoulkas 1991:59). Where Sankaran looks as CFS as a multi-systemic disease on PNEI axis, Vithoulkas has essentially created a model which recognises the uniqueness of the individual and their particular susceptibility. Although Vithoulkas is one of the most classical homeopaths and Sankaran of a newer breed, it is interesting to observe that fundamentally they agree on the interaction of all systems in the body. Although vastly different in their approach to treatment, (as previously shown) this correlates with Jay Goldstein’s (1996) thinking of CFS as ‘psychoneuroimmunologic disorder ‘the study of how emotional and other psychological responses influence the biochemistry of the brain, hormone production, and the immune response’
Hahnemann and Chronic Disease
With reference to CFS, it is fundamentally essential to consider how Hahnemann views chronic diseases. His original and unique work on Chronic Disease ‘Die Chronischen Krankheiten,’ was first published in four volumes (1828-1830) the second edition of five volumes (1830-1835). Dimitriadis (2005) analyses this work and explains that Hahnemann in referring to Chronic Disease is relating to every disease which is neither acute, epidemic, sporadic nor chronic venereal disease. These include ‘neurasthenia, hysteria, hypochondria, mania, melancholia, idiocy, madness, epilepsy and all kinds of fits, softening of the bones….deficiency of the senses and every type of pain’. (Hahnemann 2003:78), Aphorism 80. He states also in this Aphorism that psora is the true underlying cause. He goes on to say that ‘the homeopathic physician must still piece together the perceptible symptoms and peculiarities of the chronic (psoric) disease being treated just as carefully as before to form an indicative picture, because no true cure of a psoric disease can take place without the strict individualization of every case.’
According to de Schepper (2004), both Boger and Boennninghausen base their repertories on Aphorism 95, which states: ‘patients become so accustomed to prolonged suffering that they no longer pay much if any attention to the many smaller, concomitant symptoms.’ (Hahnemann 2003:91), Aphorism 95. Sankaran’s views of ‘modalities reflecting the central disturbance’ is reflected here also, stating that if the specific mental state is discovered, it cannot be prescribed upon unless there is a ‘concomitant from another sphere’ (Sankaran, 1999:68). He states that this is the basis of Boenninghausen’s doctrine of concomitance and ‘the concomitant is to the totality what modality is to the symptom: it is the differentiating factor’. This reflects Hahnemann’s fundamental belief and the challenge that CFS presents to the homeopath, as so many common symptoms are presented with CFS and one is searching for those symptoms which are ‘striking, strange, unusual or peculiar’ (Hahnemann, S. 2003:125), Aphorism 153.
An evaluation of the evidence of homeopathic treatment as seen in two RCT’S (Weatherley Jones, 2002, Awdry 1996), published case studies and homeopathic literature including commonality in remedies, methodologies and philosophy.
Through the analysis of published cases and trials, it is essential to discover which methodologies were used in prescribing, and which had the most success in treatment in relation to CFS. Clearly, there are different approaches as discussed to measuring the ‘success of treatment’, each of which will be explored. Specific methodologies will be highlighted and critically analysed as to effectiveness in practice, the success measured in recovery, with a view to suggesting the optimum approach to a case. This helps to further understand that if homeopathy is successful in the treatment of CFS, (with reference to the research question), what makes it so, and what is the optimum method of administration? It is hoped that a consistency of approach can be determined in those cases that have been successful, to enable future prescribing and case management to be more effective.
The Weatherley-Jones et al trial (2002) and that of Awdry in 1996 are similar in that the approach to their cases was essentially classical or Kentian `taking the whole person into account as far as this is possible and treating the person simultaneously on all levels, physical, mental and emotional` (Watson, 2004:12). Mental and Emotional symptoms (including delusions) are given priority, followed by Physical General Symptoms and disease symptoms or Physical Particulars (Kramer, 2006). The homeopath, in using this method of prescribing is searching for the ‘simillimum’. It is based on the premise of ‘like cures like’ (Similia Similibus curanter,). This principle was first introduced by Paracelcus (1493-1541) and is outlined in Aphorism 27 in The Organon ‘The curative virtue of medicine thus depends on their symptoms being similar to the disease but stronger. It follows that a particular case of disease can be destroyed and removed most surely, thoroughly, swiftly and permanently only by a medicine that can make a human feel the totality of symptoms most completely similar to it but stronger.’ (Hahnemann 2003: 28), Aphorism 27.
It is important to note that even if the constitutional method of prescribing is not used, it is still ‘the simillimum’ that is sought, regardless of methodology used; this should still be the focus of the homeopathic enquiry. Both Weatherley-Jones (2002) and Awdry (1996) did not, however, use the constitutional method exclusively in their trials. As with other homeopaths, the constititutional approach was supported by part patient or miasmatic prescribing in conjunction with lifestyle changes. De Schepper (2004) concurs stating that ‘although often the problem cannot be rectified by a single medication, it can be controlled by a total approach.’ Other constitutional prescribers are Allen (1993) Hoover (1998) Klein (1998), Scholten 1998
In the Weatherley-Jones trial, mainly single remedies were prescribed but where remedies were prescribed sequentially, more than one was given. ‘This method is a variation on the aetiological method, where there is evidence of a sequence of causative factors (traumas that have systematically contributed to the patient’s current state of disease’ (Kramer 2005:58). Case management predicted when the remedy should be changed and the most common potency prescribed (to avoid aggravation) was Lms. 17% of the cases required an aetiological prescription of carcinosin as ‘a specific antidote to glandular fever’, similarly where viruses and vaccinations were seen as ‘the cause’; the appropriate antidoting remedy was given. These together with bowel nosodes added up to 8% of cases. The remaining 75% of cases were prescribed polychrest remedies, taking in the totality of symptoms and applying the constitutional method.
Dimitriadis (1991), in contrast who has worked with many cases of CFS, emphasises that ‘some cases are not suitable for polychrests’. Similarly, Klein (1998) finds that polychrest prescriptions particularly for CFS, are like trying ‘to fit a square peg in a round hole with mediocre results’ and often ‘chooses remedies on materia medica knowledge.’ In the case he is discussing, he prescribes ‘scutellaria’ which is very specific to the patient’s symptoms, but probably not a remedy that would have appeared on a repertorisation sheet. Hoover (1998), steers clear of the polychrests, and reaches a constitutional prescription of onosmodium ‘a small remedy rarely prescribed by means of ‘careful repertorisation and materia medica work.’
Awdry (1996b) states that overwork is a strong aetiology, seeing the virus infection as ‘merely the final straw which serves to dismantle an already shaky status quo.’ De Schepper (2004) mirrors this theory stating: ‘In every CFS patient that I have seen in my practice, stress was the ultimate triggering factor, the straw that broke the camel’s back. And most often, it is the single cause of relapse.’ In contrast, Harthoorn (1997) sees viruses as being a main aetiology and in a trial of 219 case histories, most responded well to viral therapy. This approach, refined by Harthoorn was initially used in relation to a number of hepatitis cases which responded well to the following protocol:
The virus in question (in this case hepatits A or B) was administered in high homeopathic potency.
Organ therapy (the liver was treated in these cases) to induce regeneration of the tissues and function
Immune system boosters given
Constitutional remedies given in addition to remedies for hepatitis.
Such was the success of this trial in relation to hepatitis, it has been used with other viruses such as herpes zoster and herpes progenitalis amongst others. Blood tests show the three most commonly implicated viruses in CFS/ME to be: Coxsackie, Epstein Barr and Cytomegalo, often seen in combination. The above protocol, applied as above and ‘complete recovery occurred in 81.74% of cases treated’. This trial was undertaken in Africa and it was not possible to conduct double-blind procedures in the environment of practice. Yet again, the results are based on observation and ‘cure’ with comments such as ‘I had been dead for 10 years and now I am alive again,’ being muted by grateful patients. (Harthoorn, 1997)
Dowson (1993) states: ‘The use of generalized homeopathic anti-virals may be beneficial, but if the exact virus present can be identified-by orthodox or complementary methods-high potency preparations of that virus may be more successful’. Allen (1992) concurs stating: ‘It is thought that viruses alter our immune systems, causing our bodies to react to stress, bacteria toxins, chemicals and the like’.
A different approach to aetiological prescribing is taken by Rudolph Verspoor in his book Homeopathy Renewed (1995). He suggests an effective approach to chronic complex cases (like CFS) that traditional homeopathic methods have failed to cure, often because the picture was confused by drugs, vaccinations and chronic stress. The method is sequential therapy and is outlined below by Ian Watson:
It involves taking a detailed case history and determining the nature and exact sequence of all shocks and traumas that have occurred in a person’s life, including the gestation period. Remedies are then given in reverse order which are known clinically to be capable of neutralising the effects of each. I am unsure how much time is allowed to elapse between each prescription, but my impression is that it ranges from as little as a day or two up to a month or longer, depending on the severity of the shock being treated, and on the potencies being used. (Watson, 1995).
Organ support, Isopathy, Tautopathy
Dowson (1993) discusses that patients with CFS complain of ‘altered bowel action, abdominal discomfort and excess flatulence’ as part of their condition and he strongly advocates support of the gastro-intestinal system, particularly remedies aimed at supporting the liver and kidneys. Organ support ‘involves identifying weakened organs in the system and prescribing remedies that are known to have an affinity for those organs in order to bring about improved function’ (Kramer 2006: 64). Like Awdry (1996), he suggests an anti-candida diet, anti-fungal medication. He also recommends ‘specific nosodes, particularly in bacterial infection, combined with homeopathic drainage and renal stimulation’. Weatherley-Jones (2004) also employed the use of bowel nosodes ‘prepared remedies from non lactose fermenting bacilli from the intestinal tract’ (Kramer 2006:68) in eight percent of her cases in the trial. Dr Julie Allen (1993) uses Isopathy ‘desensitising her patient suffering from intolerance to wheat’. Similarly, Jenkins recommends this approach. Watson defines this as ‘prescribing a remedy made from the supposed causative agents or products of a disease to a patient suffering from that same disease’ (Watson 2004:34). Harthoorn (1997) uses organ therapy, nosodes and tautopathy in his trial, the differentiating factor from isopathy being that it focuses on a drug or toxin taken by the patient that appears to have caused the symptoms (Kramer, 2006). Due to the high number of antibiotics given to many suffering from ME, candida is thought to be a causative factor by several authors. (Balch 1993, Chaitow, 1991).
The rationale behind Peter Chappell’s CFS trial
Sankaran alludes to ‘central disturbance’ and the connection between mind and body and how one ‘vital sensation’ expresses the fundamental state. (Sankaran, 2002). This is mirrored by other homeopaths (Vithoulkas 2004, Scholten1993, Verspoor 1995). Chappell (1997) refers to a state of ‘stuckness’ which has ‘feeling and physical components acting together synchronously’. Chappell is a controversial figure who went to Ethiopia in 2001 to help find a homeopathic solution to AIDS. Realising the normal homeopathic approach was not viable due to ‘lack of information in the homeopathic information set’, he developed a method of reverse engineering a remedy ‘from the totality and essence of the pathology’. His remedy for AIDS was known as PC1 and he generalized the approach to other epidemic diseases (malaria, dengue fever, diphtheria and gonorrhoea), referring to the remedies as ‘the second simillimum’. He extended his thinking to chronic diseases, which he sees as ‘slow running epidemics based on bacteria and viruses’. These became known as ‘Genus chronicus’, CFS being accompanied by remedies for Parkinson’s, Alzheimer’s and MS amongst others.
Chappell is controversial as he does not reveal the content of his remedies: ‘I am very reluctant to explain something fully which would leave the whole situation open to ridicule, because it is ahead of the science and because the terms aren’t there to explain it within the science’. (Chappell, Aug 07). Chappell refers to his remedies as ‘resonances’ to distinguish them from being ‘exactly homeopathic’, which are made by imprinting specific information into water, which has the ability to memorize and store information, as is the case for all homeopathic remedies diluted beyond Avogrado’s number. Ullman clarifies the idea of resonance with an analogy to music: ‘It is commonly known that when one plays a ‘C’ on the piano, other ‘C’ notes reverberate. Even on a piano at the other end of the room, ‘C’ notes still have a hypersensitivity to the ‘C’ resonance. In music theory (and physics), there is a basic principle that two things resonate if and only ‘if’ they are similar’. (Ullman D., 1991:13).
The rationale behind Chappell’s trial was clearly to find a cure for CFS, where so many other methods, (including homeopathic) had failed. It was another variation away from constitutional prescribing, another ‘protocol’ to try and get to the root of the condition, similar to those discussed already by the researcher. Like other approaches (Weatherley-Jones 2002, Awdry, 1996), the trial although small, did have a level of success. Much research was done before by the homeopaths involved, who looked at over 50 cases treated constitutionally, the results discussed with Chappell to formulate ‘the identity of the disease’. The remedy was designed as discussed with an emphasis on the pathology, a granule of PC CFS (the remedy name) dissolved in water and to be taken daily after vigorously shaking. All the patients suffered immediate aggravations and were advised to discontinue the remedy until their next consultation. Most of the aggravations faded away and were followed by an amelioration. Individual treatment ensued with some patients after 6 months ‘ameliorating dramatically, better with the PC remedy than with any other treatment they had had before’ (Vervarcke 2005.) This concurs with Rawlings theory that case studies and observations should be given weight as evidence of cure. Too often homeopaths such as Chappell, who have had real successes in terms of ‘cure’, are denigrated due to lack of understanding as to the method. After one year, half the group showed ‘remarkable improvements’ and the final conclusion for 50% was that they were able to be prescribed a constitutional remedy because the picture had been cleared. Sadly, a small number of the participants either had no reaction or had an aggravation to the remedy ‘without subsequent improvement’. On balance however ‘PC CFS could offer a solution in many cases. It could bridge the state of ‘no reaction’ on homeopathic remedies and fill the gap in our therapeutic approach. In this sense PC CFS remedy is a solution and success.’ (Vervarcke 2005.)
CONCLUSIONS AND RECOMMENDATIONS
It is clear from the research involved in this study, that current methods of ascertaining the efficacy of homeopathy are inadequate. The RCT has obvious limitations as demonstrated by Sir Michael Rawlins (2008) who has been Chairman of NICE for the last ten years. Simply, that the hierarchy of evidence as is now stands for all methods of assessing the evidence is inappropriate. Most of the cases analysed in this study have positive outcomes, based on observation. The results of the trials (Weatherley-Jones 2002, Awdry, 1996) as demonstrated were open to interpretation, depending on who was critiquing them. However, they were an unbiased cross-section of the available evidence because not every case was cured, and there were those highlighted that seemed, so far, resistant to any cure. Homeopathy is complex and cannot be assessed in a simplistic way. Researchers at Sheffield University are currently developing new and rigorous research models that will better fit the homeopathic paradigm in all its aspects. Dr Elaine Weatherley-Jones, in her paper ‘Placebo Control Trials in CAM’ (2004) concludes that it is time to redirect our energies into a ‘whole systems healthcare’ and ‘design more relevant pragmatic studies of comparative effectiveness’. This appears to echo the opinion of Rawlins and other experts in the field of research.
Thus, based on the findings of this study, the researcher would like to see in practice that which Rawlins (2008) proposes: ‘that hierarchies of evidence should be replaced by accepting, indeed embracing a diversity of approaches.’ He is convinced from experience that that it is wrong to replace judgement with ‘more robust approaches’ such as the RCT.
As regards research into CFS specifically, it is hoped that more trials are undertaken in the form suggested by Dr Elaine Weatherley-Jones (2004). These will be more suited to the homeopathic paradigm, thus delivering a fair assessment of the evidence, based on a multidimensional, holistic approach. ‘Our mechanistic society tends to overestimate the value of apparatus, but epidemiology teaches us this is not correct in medicine’. (Rutten et al, 2006).
To conclude, this study has comprehensively demonstrated that observation and judgment must consistently take precedence over statistical analysis alone.
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