A Critical Examination of the Evidence for the Use of Individualized Homeopathic Treatment in Rheumatoid Arthritis

November 15, 2009 by Jacqueline Dodding  

Filed under Homeopathy Scientific Research | Hpathy Ezine, November, 2009
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Introduction

This article will examine the evidence for the use of homeopathy in the treatment of Rheumatoid Arthritis (RA). The successful treatment of RA using homeopathy has been recently highlighted by two published papers.  Spence et al. (2005) undertook a six year university hospital outpatient observational study in which patients received homeopathic treatment for various ailments.  Amongst the many health problems monitored, 10% of the participants constituted rheumatology department referrals.  Outcome scores were assessed during the consultations.  Of these, 70% of the RA patients benefited from adjunctive homeopathic treatment, with 30% recording that they felt ‘better’ and 19% recording that they felt ‘much better’ according to the outcome scale measurement.  During a pilot study, using MYMOP 2  (Paterson, 1998) as a primary outcome measure,  6.9% of 482 patients surveyed, reported joint and mobility problems as the primary problem for which they had visited a homeopath (Relton et al., 2007).  These two papers provide evidence that homeopaths have treated patients suffering from RA, and therefore it is a valid area in which to review the available literature.

RA is a chronic inflammatory condition which can be progressive and incapacitating.  As the disorder is systemic by nature, it can affect extensive tissues (Gascoigne, 2001).  Further health problems which may occur as a result of progressive RA are ankylosis and bone deformity (Weller, 2001). Onset of the condition usually occurs between the ages of 30 – 40, and it affects three times more women than men.  Aetiology of the complaint is unknown, although an autoimmune process is recognised as being a significant factor.  Occasionally a theory emerges that the onset of RA is caused by an infective factor, although this has not been corroborated (Gascoigne, 2001). Conventional treatment of RA concentrates on symptom suppression, consisting primarily of non-steroidal anti-inflammatory drugs (NSAIDs), disease modifying drugs (DMARDs) or slow-acting anti-rheumatic drugs (SAARDs) (National Rheumatoid Arthritis Society (NRAS), 2007). These therapies may produce side-effects such as indigestion, poor appetite, nausea, vomiting, blood disorders and kidney and liver damage (Smith, 2005).

The seriousness and the progressive nature of the disorder together with the lack of effective treatment and potential side-effects implies that complementary therapies may offer an alternative  to controlling pain, the acute inflammatory response and the possible subsequent destruction of joints (Kenyon, 1994).   Homeopathy provides treatment for patients without the side-effects associated with conventional drug therapy, therefore offering a safe, effective solution if the correct remedy is prescribed (Swayne, 1998).  Classical homeopathy concentrates on prescribing for a patient’s individual symptoms.  Analysis of the case concentrates on what is unique to the individual patient, and therefore a variety of remedies may be prescribed for a conventionally diagnosed condition (Roy, 1999). Having identified these aspects of ‘classical homeopathy’ it seems crucial to evaluate the potential of individualised homeopathic prescriptions for RA, and critically analyse the evidence already available.

This article will concentrate on three trials (Gibson, Gibson, MacNeill & Watson Buchanon, 1980; Andrade, Ferraz, Atra, Castro & Silva, 1991; Fisher & Scott, 2001) which have been conducted in order to assess the effectiveness of individualised homeopathy in the treatment of RA.  All three trials are randomised controlled trials (RCTS) which are deemed the ‘gold standard’ for evaluating treatment efficacy in health research (Kane, 2004), but all three use individually prescribed homeopathic remedies, which resembles the true classical homeopathy scenario.

Critical Examination of selected studies on this topic

The three papers will be examined in date order starting with the Gibson et al. paper (1980).

Homeopathic Therapy in Rheumatoid Arthritis: Evaluation by Double-Blind Clinical Therapeutic Trial

Gibson, R.G., Gibson, S.L.M., MacNeill, A.D. & Watson Buchanan, W. (1980)

This trial was set at the Glasgow Homeopathic Hospital, Centre for Rheumatic Diseases.  It was undertaken in response to the 1978 trial and subsequent paper entitled ‘Salicylates and Homeopathy in Rheumatoid Arthritis: Preliminary Observations’ (Gibson et al., 1978).  Gibson et al. highlighted that the initial trial was methodologically flawed for the following reasons:-

In order to evaluate the importance of the methodological flaws, the 1980 trial was more rigidly controlled to limit potential variables which may have influenced the outcome. A randomised patient control group design was supervised by a third independent physician to determine reliability.  Inclusion criteria are detailed in the table below:

Patient progress was measured using the outcomes detailed below:

Gibson et al. (1980) recognised that homeopathic prescriptions are very individual to the patient.  Homeopathic principles dictate that patient prescriptions should be established on a holistic individual basis. Although some symptoms are highly regarded in the analysis of the consultation, the homeopath prescribes on the whole symptom picture, not merely on certain characteristics (Wheeler, 1982).  Although high internal validity is maintained by the division of patients into two groups, with ‘good’ prescribing symptoms (‘R’ group) or ‘poor’ prescribing symptoms (‘U’ group) (Appendix 1), ensuring precise distribution between placebo and active treatment groups, this evaluative practice is not reflective of homeopathic practice (Roberts, 1982).

As further variables were limited by the equal division between two physicians of patients using the same drug therapy and the maintenance of an unchanged dosage of anti-inflammatory agents, the quality of evidence produced is much improved from Gibson et al. (1978).  However, this trial lasted only six months compared to the previous study of twelve months.  The latter would be considered a more realistic timescale for the treatment of a chronic condition, potentially revealing statistically improved results in favour of homeopathy.  In spite of this, and the small sample size (46), the enhanced response to homeopathy suggests that it may be a useful addition for the treatment of RA.

Ethics have been considered on two occasions.  As some participants were prescribed placebo, conventional medication was not withdrawn.  Therefore, the principle of non-maleficence has been observed.  Those patients who had previously taken placebo were treated for a further three months with individualised homeopathy, observing the ethical principle of beneficence (Beauchamp and Childress, 2001).

Another factor considered important was the potential for improved response to homeopathic treatment due to the synergistic effects of the homeopathic consultation (Lewis, Jonas and Walach, 2002).  It has been suggested that the whole experience of homeopathy including the homeopathic consultation, affects the response of the patient.  The mere fact that a patient is at the centre of the homeopathic intervention may lead to improvements beyond the expectations of ingesting the remedy.  However, this assumption was found to be inaccurate as the placebo groups for both physicians were not statistically improved.

A Randomised Controlled Trial to Evaluate the Effectiveness of Homeopathy in Rheumatoid Arthritis

Andrade, L.E.C., Ferraz, M.B., Atra, E., Castro, A. and Silva, M.S.M. (1991)

This trial was undertaken in 1991 at the Escola Paulista de Medicine in Sao Paulo.  The authors claim that RCTs evaluating homeopathy are rare and often present conflicting results and believe that the application of appropriate scientific methodology will establish the RCT as a valuable tool for assessing the validity of homeopathy.  However, analysis of the methodology of the six month, double blind trial demonstrated flaws and potential variables which may have seriously affected the outcome.

Patients were consecutively chosen from the rheumatic disease outpatient clinic where the trial occurred and met at least three specific inclusion criteria for classical RA:

A number of medical tests for RA indicators were undertaken at baseline, three and six months, in order to establish whether the condition had worsened, stabilised or improved during the trial (Appendix 2).  These tests concluded that there was not any statistical change from the baseline results in either group. Monthly follow ups continued and the remedy was maintained or changed according to patient response.  Physical therapy was not undertaken during the trial.  Outcomes were measured using the same criteria as the Gibson et al. (1980) trial.

Although remedy prescriptions were individualised according to patient requirements, the potencies used were limited to 5 – 30C.  This is not reflective of homeopathic practice, as many factors are accounted for when choosing potency and dosage such as ‘energy’ of the patients, whether conventional medication is used regularly, and the length of duration of the chronic condition (Vithoulkas, 1980).  The specific measurement of the homeopathic intervention is compromised by the fact that a range of potencies is available.  It is unclear in the report whether patients received a constitutional and a therapeutic (local) remedy concurrently.  The criteria for using this method are not detailed and its inclusion would have allowed for a better understanding of the philosophy behind it.

Although the results for the active treatment group demonstrated that homeopathy may be useful in the treatment of RA, there was no statistical evidence that it was superior to placebo therapy.  However, this result may be due to a number of methodological flaws within the trial.  Again the study sample was small (44).  Unlike the Gibson et al. (1980) trial, care was not taken in dividing the sample evenly, thus possibly skewing the results (Appendix 3).  Furthermore, patients were authorised to continue with, or alter dosage of NSAIDs and steroidal drugs at the physician’s discretion, thereby not eliminating this variable.  Although dose reduction was higher in the placebo group, patients within this group suffered more serious symptoms statistically than the active treatment group. Some patients received alternate homeopathic remedies on a daily basis, thereby not reflecting classical homeopathic philosophy.  It is also unclear whether all patients received alternate remedies, or merely those whose symptoms were not precise enough to warrant a single remedy prescription.

A Randomised Controlled Trial of Homeopathy in Rheumatoid Arthritis

Fisher, P. & Scott, D.L. (2001)

Fisher and Scott undertook this trial to test the hypothesis that homeopathy is effective in reducing the symptoms of joint inflammation in RA using a six-month randomised, cross-over, double-blind, placebo-controlled study design.  Ethical approval was granted by Saint Bartholomew’s and the Homerton Ethical Committee.  All participants, recruited from a single rheumatology clinic, had classic symptoms of RA according to the ARA criteria (Appendix 4).  Other trial inclusion and exclusion criteria are detailed below:

The main outcome measures for analysis were visual analogue scale pain scores, Ritchie articular index, duration of morning stiffness and ESR.  Although the initial recruitment of participants was higher in number (112) compared to the previous trials analysed, there was a high attrition rate of 48.2%.  It is unclear, however, whether intention to treat data was analysed.  If it was not, although mean pain scores were significantly lower after three month’s placebo therapy, results could have been biased if the whole group was not analysed. Randomisation was stratified in order to ensure full representation in each group by participants in the trial (Kane, 2004).  Remedy prescriptions were individualised and could be adapted according to disease progression, although potency used was low, either 6cH or 30cH. Although this design limits variables, it is once again unreflective of daily homeopathic practice.

A crossover trial design was utilised, and at the three month interval participants changed over to placebo or active therapy.  This type of design is less common as there is a possibility of a residual effect of therapy which may continue during the next period of treatment, thereby potentially skewing results (Lewith et al., 2002).  This may be true, as remedies prescribed may affect a person’s health levels for some time after the final dose (Gibson et al., 1980).  Fisher and Scott (2001) debate the reasons that the placebo group showed significant improvement in pain scores.  Although they offer the suggestion that this may be due to an aggravation in the initial stages of the treatment, which may occasionally occur, they do not seem to have considered the residual effect of active homeopathic treatment.

Finally Fisher and Scott conclude that a new investigational approach is required which will try to discover whether homeopaths can genuinely control patient symptoms rather than continuing to compare homeopathy to a placebo response.

Jacqueline Dodding