A Critical Examination of the Homeopathic Treatment of Chronic Fatigue Syndrome

8/6/2019 A Critical Examination of the Homeopathic Treatment of Chronic Fatigue Syndrome

1/18

A Critical Examination of the

Homeopathic Treatment of Chronic

Fatigue Syndrome

April 7, 2011 by Gill Graham

-with particular reference to the reliability of the randomised controlled trial as amethod of measuring its efficacy in practice -

Abstract

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-lineand 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 RCTs have beenanalysed (Awdry 1996, Weatherley-Jones 2002) and other treatment protocols namely,

Peter Chappells CFS trial in Leuven (2004) and Harthoornes in South Africa (1997).

There is a positive response to homeopathic treatment in most trials and cases based onobservation and outcome. Howeverthis study concludes that the focus on current

methods of measuring the efficacy of homeopathy, namely randomised control trials, isnot 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 theliterature that the cure is often dependant on these facts. Treatment is individualised and


2/18

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 analysismay have some value, it is clear that professional judgement reinforced by longitudinal

observation is a much stronger approach for correctly evaluating the success oftreatment.

It is the intention of this study to give an in-depth insight into the homeopathictreatment of Chronic Fatigue Syndrome (CFS), through the analytical and criticalresearch 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 toProfessor Sir Michael Rawlins, the Chairman of National Institute for Health and

Clinical Excellence (NICE), does not deserve its elevated place in the hierarchy ofevidence (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 onlyway 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 anover 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. Its 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 bythe 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 ofnervous 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 hundredyears 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


3/18

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 standardin 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 presentedsymptoms such as problems with brain function, headaches, blurred vision and unusualskin sensations. The Central nervous system had been affected in 74% of cases (Parish,

1978, Shepherd, 1999). Some of these patients never recovered. (Chief Medical

Officers Working Group report on CFS/ME, Feb 2002:4). Dr Melvin Ramsay who wasthe 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 asbeing 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 onlyin 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 ofShorter (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 bedrest 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:

y1. Predisposing factors which result in people becoming more susceptible2. Events which subsequently stress the immune system and thus prompt

the onset


4/18

3. Factors that contribute to perpetuating the symptoms and consequentdisability

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:

y Possibly a hormonal link with CFS (Harlow et al. 1996). Shepherd again statesthat during pregnancy women with CFS often see an improvement in their

symptoms

y Mothers and women of young children may be more exposed to infectiony It is harder for mothers and women with domestic and family commitments to

take time off when they should be resting

y Women are more knowledgeable about CFS thus more likely to get a diagnosisAllopathic Criteria for diagnosing CFS

The following diagnostic criteria are from Dr Melvin Ramsay who was The Royal Free

Hospitals infectious diseases specialist during the outbreak in 1955. There have beennumerous other definitions since then (NICE guidelines run to over 50 pages) but Dr

Ramseys original work remains the best clinical description to date (Shepherd:1999:

7).

y Muscle Fatigability with tenderness, twitching and spasmsy Circulatory Impairment encompassing cold extremities, sensitivity to climatic

change and excessive sweating

y 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 definitephysical signs common to all CFS sufferers and has developed a physical examinationwith 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 thediscovery 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.


5/18

Much research has been conducted in terms of conventional medical treatment for CFS.

Drug therapies have included anti depressants, hormones, corticosteroids, antiviralmedications as well as immunologically targeted drug treatments. (Afari & Buchwald,

2003:229). Research has concluded that these approaches have not been significantlyeffective: 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 groupassignment 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 assignedto homeopathic medicines or placebo. One hundred and three patients meeting the

Oxford criteria for CFS were recruited to two specialist hospital outpatient departmentsin 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 Journals

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 hasnt 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).

Awdrys 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 graphand 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 homeopathicmedicines 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 andBuchwald (2003:228) concurred, considering Awdrys study to be of poor quality and

stated the outcome as inconclusive This once more demonstrates the difficulty in


6/18

measuring homeopathic success rates by conventional, limited methods, not suited to

the homeopathic paradigm. Disraeli (1804-1881) was aware of the dangers of basingjudgement 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 clinicalimprovement on all primary outcomes. (Awdry, 1996) An article in The BMJ, statesthat 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 Complementaryand Alternative Medicine (CAM), requiring lower standards of proof for conventional

medical treatments than they do for CAM. (cited in House of Lords report on CAM2000). Many researchers a priori see homeopathy as scientifically implausible, creating

an immediate bias before any research is undertaken. Some of the theories put forwardto explain the mechanisms of homeopathy can indeed be confusing to both the

homeopath and allopath. Central to homeopathy is Hahnemanns idea of The VitalForce, 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 livingthings. 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 notmean 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) stilleludes 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) statesthat there are several types of evidence that is required, before a therapy is to be

advocated.

y Evidence that the therapy is efficacious above and beyond the placebo effecty Evidence that the therapy is safey Evidence that the therapy is cost effectivey Evidence concerning the mechanism and action of the therapy


7/18

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 otherillnesses. 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 forhomeopathy (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 againsthomeopathic remedies and in homeopathic RCTs, 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 definesatisfactorily. In clinical trials placebos are generally control treatments with a similar

appearance to the study treatments but without their specific activity. We thereforedefined 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 clinicaltrials comparing placebo with no treatment. Two meta-analyses were undertaken

involving all 156 clinical trials in which an experimental drug or treatment wascompared 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 RCTs 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 recentdevelopments 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


8/18

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 RCTson 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 anyphysician, allopathic or homeopathic and for this reason the key points of his speech aresummarized 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 RCTs. ( 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 nowcommon, 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 howbest 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 andCAM 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 thehomeopath, 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


9/18

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 inthe 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

Homeopath

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 RCTs, 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. RCTs are the gold standard of medical

research, yet as Rawlins (2008) states the technique has important limitations andimperfections. They are designed to test those medications which target specific areas

in the body, therefore having a specific effect. Because homeopathy stimulates the

bodys 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 remedys action is evident in a more holistic way, withimprovement 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 RCTs have nonethelessshown 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

patients 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 ingenetically 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 ofdiseases, Fibromyalgia, Irritable Bowel Syndrome and Premenstrual Syndrome to

name but a few. He sees four influences which are responsible for the development ofneurosomatic illness.


10/18

y Genetic susceptibility and Expression of the traity Developmental issues in childhoody Viral encephalopathy and genetic susceptibilityy An increased susceptibility to environmental stressors.

(Goldstein 1996)

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).

Goldsteins 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 inits 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. Goldsteins 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. Cont..

Figure 3.

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 2-3 seconds 3-6 hours

Nitroglycerin 0.04 mg sublingual 2 - 3 minutes 3-6 hours

Nimodipine 30 mg po 20-40 minutes 4-8 hours

Gabapentin 100-300 mg 30 minutes 8 hours

Badofen 10 mg 30 minutes 8 hours

Oxytocin 5 -10 UIM QD or BID

or Synlocinon 1 2 pufls TID

15 minutes to 72

hours

12 -24hours


11/18

Base

d onGold

steins

publi

cations,there

seem

s to

be a

meet

ing

of

mind

s

amo

ngstthehom

eopaths

andallop

athsregar

dingthe

psyc

hone

uroi

mmu

nolo

gical

basis

of

CFS.

But

howfar

canthis

conv

erge

nce

be

seen

to

com

Pyridostigmine 30 60mgpo 30 minutes 4-6 hours

Hydralazine 10-25 mg po 30-60 minutes 6-12 hours

Mexiletine 150 mgpo 30-45 minutes 6-8 hours

Tacrine 10 mg 30 minutes 4-6 hours

Risperidone 0.25 0.5 mg 45-60 minutes 8 12 hours

Pindolol 5 mg BID 15 minutes to 7days

12 hours

Lamotrigine 25 50 mg QD 30-45 minutes 24 hours

Sumatriptan 3 6 mg SQ 15-30 minutes 16 hours

Ranitidine 150 mg BID 1 hour 1 week

1

12-24 hours

Doxepin HCL elixir 2 - 20 mg HS 1 hour variable

Sertraline 25 50 mg QAM

or Paroxetine 10 20 mg QAM

1 hour- 8 weeks 1- 2 days

Biipropion lOOmgTID 30 minutes 8

weeks

8 24 hours

Nefazodone 100 300 mg BID 2-8 weeks 24 hours

Venlafaxine 37.5 75 mg BID 1-4 weeks 24 hours

Glycine powder 0.4 Gm/Kg/day in

juice

or Cycloserine 15 50 mg QD

1 hour 24 hours

Felbamate 400 mg 30 minutes 6 8 hours

Lidocaine 200 300 mg in 500 ml normal saline

infused over 2 hours

2hours - 2 weeks


12/18

ply within the confines of EBM?

Psychoneuroimmunology is described by Rober Ader (2007) as a convergence of

disciplines, namely the behavioural sciences, the neurosciences, endocrinology andimmunology. (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 systemof defence. Indeed numerous studies conducted over the past 30 or so years havedemonstrated 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 bodyssystems as outlined, engage in an interactive dialogue, to effectively attempt to create

homeostatis. Dr David Felton, who heads up the Department of Neurobiology andAnatomy at the University of Rochester Medical Centre in New York, has been

awarded several prestigious grants for his growing work in the field ofpsychoneuroimmunology (PNI). Similarly, Dr Herbert Benson, a cardiologist and

associate professor of The Harvard Medical School and Director Emeritus of TheBenson Henry Institute for Mind Body Medicine at Massachusetts General Hospital,

received the prestigious Mani Bhaumik award, in March 2009, as a pioneer in MindBody 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 onthe philosophy of those such as Sankaran (1997), Ullmann (1991), Reichenberg-

Ullmann (1995), Chappell (1997). In homeopathy, the totality of symptoms deems thatthe mind state is at the top of the hierarchy and the deepest core of an individuals

health (Ullmann 1991:16). In treating the underlying cause of illness, the homeopath


13/18

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 eachindividual that allows the person to be susceptible to particular symptoms (Ullmann,

Reichenberg-Ullmann, 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, targetingthe central disturbance which could appear anywhere on this axis, depending onsusceptibility. 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 Chappells (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 thatfundamentally 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 JayGoldsteins (1996) thinking of CFS as psychoneuroimmunologic disorderthe study of

how emotional and other psychological responses influence the biochemistry of thebrain, 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 offive 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 offits, 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


14/18

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 everycase.

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. Sankarans views ofmodalities 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 basisof Boenninghausens doctrine of concomitance and the concomitant is to the totality

what modality is to the symptom: it is the differentiating factor. This reflectsHahnemanns 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 thosesymptoms 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 RCTS(Weatherley Jones, 2002, Awdry 1996), published case studies and homeopathic

literature including commonality in remedies, methodologies and philosophy.

Methodologies

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 inrelation to CFS. Clearly, there are different approaches as discussed to measuring the

success of treatment, each of which will be explored. Specific methodologies will behighlighted 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 tofurther 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.

Classical Method:

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 Emotionalsymptoms (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 principlewas 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 similarto 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


15/18

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, itis 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. Aswith other homeopaths, the constititutional approach was supported by part patient ormiasmatic 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 areAllen (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 avariation on the aetiological method, where there is evidence of a sequence of causative

factors (traumas that have systematically contributed to the patients current state ofdisease (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 patients symptoms, but probably not a remedy that would have appeared

on a repertorisation sheet. Hoover (1998), steers clear of the polychrests, and reaches aconstitutional prescription of onosmodium a small remedy rarely prescribed by means

of careful repertorisation and materia medica work.

Aetiological prescribing

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 camelsback. 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 followingprotocol:

y The virus in question (in this case hepatits A or B) was administered in highhomeopathic potency.


16/18

y Organ therapy (the liver was treated in these cases) to induce regeneration of thetissues and function

y Immune system boosters giveny 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 showthe three most commonly implicated viruses in CFS/ME to be: Coxsackie, Epstein Barrand 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 ofpractice. 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 gratefulpatients. (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 orcomplementary methods-high potency preparations of that virus may be more

successful. Allen (1992) concurs stating: It is thought that viruses alter our immunesystems, 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 sequenceof all shocks and traumas that have occurred in a persons life, including the gestation

period. Remedies are then given in reverse order which are known clinically to becapable 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 thoseorgans 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 ofbowel 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 JulieAllen (1993) uses Isopathy desensitising her patient suffering from intolerance to

wheat. Similarly, Jenkins recommends this approach. Watson defines this as


17/18

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) usesorgan 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 havecaused the symptoms (Kramer, 2006). Due to the high number of anti biotics 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 Chappells 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 whowent 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 thehomeopathic 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 asPC1 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 Parkinsons, Alzheimers 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 arent 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 Avogrados

number. Ullman clarifies the idea of resonance with an analogy to music: It iscommonly 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 tothe C resonance. In music theory (and physics), there is a basic principle that two

things resonate if and only if they are similar. (Ullmann 1991:13).

The rationale behind Chappells 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 casestreated 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 advisedto discontinue the remedy until their next consultation. Most of the aggravations faded

away and were followed by an amelioration. Individual treatment ensued with some


18/18

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 Rawlingstheory 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 beencleared. Sadly, a small number of the participants either had no reaction or had anaggravation 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 asdemonstrated 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 ofassessing 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 practicethat which Rawlins (2008) proposes: that hierarchies of evidence should be replaced by

accepting, indeed embracing a diversity of approaches. He is convinced fromexperience 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 thevalue 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 andjudgment must consistently take precedence over statistical analysis alone.

Documents

A Critical Examination of the Homeopathic Treatment of Chronic Fatigue Syndrome