Complementary Medicine Research Projects on Homeopathy

Homeopathic remedies as a treatment for rheumatoid arthritis:  is it the medication or the homeopathic process that benefits patients?

Investigators:  Sarah Brien/Laurie Lachance/George Lewith

Funded by:  Samueli Institute USA ($150,000); Southampton Complementary Medical Research Trust (£13,000). Personal Award Scheme Researcher Development Award, for Complementary and Alternative Medicine, from the National Institute of Health Research (for Sarah Brien and project funding).

Status:  One publication published, expected end of data completion March 2008.

Brien SB, Lachance L and Lewith GT. Are the effects of homeopathy attributed to the consultation, the homeopathic remedy or both? A protocol for a future exploratory feasibility trial in patients with rheumatoid arthritis. JACM 2004; 10(3); 499-502.

Abstract:  Systematic reviews suggest that homeopathy has a greater effect than placebo, however the mechanisms of its action are unknown. The clinical effects of homeopathy could be attributed to the specific effects of the remedy and/or to the contextual effects of the consultation process; these factors have not been critically evaluated. We have developed a model that will attempt to separate the consultation effects from the specific effects due to the remedy. We propose to investigate this design in a chronic condition, rheumatoid arthritis, where previous research has evaluated both classical and complex homeopathic interventions. The following protocol describes the study design. The aims of this exploratory trial are to assess the feasibility of the study design, identify effect sizes of the consultation, the complex treatment, and the individualised remedy, as well as possibly efficacy, for the two types of homeopathic treatment and the homeopathic consultation.


To investigate the therapeutic relationship in CAM

Investigators: Sarah Brien

Funded by:  National Institute of Health Research (£207,149)

Status:  Data collection in progress. Completion expected August 2008

Abstract:  None

Studies to include:

  1. Homeopathy, the process or specific clinical effects, a randomised controlled trial in RA;
    Investigators: Sarah Brien, Laurie Lachance and George Lewith
  2. A qualitative investigation of patient’s perspectives of communication within the homeopathic consultation, with emphasis on discussion of emotional and spiritual issues in CAM;
    Investigators: Sarah Brien
  3. What do practitioners perceive to be an effective consultation? A PhD programme
    Investigators: Caroline Eyles (supervised by Sarah Brien and Jan Walker)
  4. Development of a reporting tool to report healing and adverse responses to patients taking part in homeopathic clinical trials.
    Investigators: Sarah Brien, Clare McDermott, Hugh Harrison and June Daniels

Completed projects (3)

Understanding homeopathic decision-making: a qualitative study

Investigators: Burch A, Dibb B, Brien S

Status: Study completed, 1 paper published

Burch A, Dibb B, Brien S. Understanding homeopathic decision-making: a qualitative study.  Forschende Komplementarmed. 2008; 15: 218-225.

Abstract: Background: Understanding how homeopaths make clinical decisions is important in terms of optimising patient care, yet currently little is understood about this process. Most current literature investigating decision-making has focussed on conventional medicine; to date only two studies, both quantitative, have explored this area, with both studies investigating this in homeopathy. The aim of this qualitative study was to explore how homeopaths make prescribing decisions primarily during their first consultation with a patient.
Method: In-depth, semistructured, face to face interviews were carried out with 14 private homeopaths working in private practice. Interpretative phenomenological analysis (IPA) was carried out on the data by 3 researchers.
Findings: Cognitive processes that homeopaths used in decision-making emerged from the analysis included the use of pattern recognition (P), hypothetico-deductive reasoning (H) and intuition (I), which led to a precise remedy match (R-M). Four themes emerged from the data: three related to the process of making a decision; one theme to those factors that influence this process. These themes fitted into a decision-making model, which we describe: the P.H.I.RM decision-making model. Two further themes emerged, which contributed to the model: the practitioners’ awareness of avoiding major bias and the role of the patient practitioner relationship in influencing decision-making.
Conclusion: The P.H.I.R-M decision-making model describes how homeopathic practitioners’ used an evidence-based process to make decisions. This study also contributes more weight to the accumulating evidence that intuition is a valuable component of decision making for homeopathic practitioners.


IIPCOS-II. A study to evaluate the clinical effects and adverse reactions to homeopathy prescribed in general practice for upper respiratory tract and ear  infections.

Investigators:  George Lewith/Sarah Brien

Funded by:  Deutsche Homoopathie Union (£50,000)

Status: Study completed, paper published.-

Haidvogl M, Riley DS, Heger M, Brien S, Jong M, Fischer M, Lewith GT, Jansen G, Thurneysen A.  Homeopathic and conventional treatment for acute respiratory and ear complaints: a comparative study on outcome in a primary care setting. BMC Complementary and Alternative Medicine. 2007; 7:7 doi: 10.1186/1472-6882-7-7.

Abstract: This study was a multi-centred, international study; our unit was responsible for 3 centres within the United Kingdom.
Objectives To evaluate the effectiveness of homeopathy compared to conventional treatment in acute respiratory and ear complaints in a primary care setting.
Design International, multicenter, prospective outcome study.
Setting: Patients, presenting themselves with at least one chief complaint: acute (£ 7 days) runny nose, sore throat, ear pain, sinus pain or cough, were recruited at 57 primary care practices in Austria (8), Germany (8), the Netherlands (7), Russia (6), Spain (6), Ukraine (4), United Kingdom (10) and the USA (8) and given either homeopathic or conventional treatment.
Primary outcome criterion Response rate, defined as ‘complete recovery’ or ‘major improvement’ after 14 days of treatment according to the patients’ assessments.
Results A total of 1,577 patients could be evaluated of which 857 received homeopathic (H) and 720 conventional (C) treatment. The most frequent chief complaints were cough in children and sore throat in adults. The majority of patients in both groups reported their outcome after 14 days of treatment as complete recovered or major improved with no significant differences in children (H: 88.5%; C: 84.5%) and adults (H: 85.6%; C: 86.6%). The unadjusted odds ratio (OR) of this primary outcome criterion was 1.40 (0.89-2.22) for children and 0.92 (0.63-1.34) for adults. Adjustments for demographic differences at baseline did not significantly alter the OR. Other outcome criteria after 7 and 28 days also showed no significant difference in response rates between both treatment groups. However, onset of improvement within the first 7 days after treatment occurred significantly faster in both children (p=0.0488) and adults (p=0.0001) receiving homeopathic treatment compared to conventional treatment. Adverse drug reactions occurred more frequently in adults receiving conventional treatment compared to the homeopathy group (C: 7.6%; H: 3.1%, p=0.0032).
Conclusion In primary care, the outcome of homeopathic treatment for acute respiratory and ear complaints appears to be equal to that of conventional treatment.


A double-blind, randomised, controlled clinical trial of ultramolecular potencies of house dust mite in house dust mite allergic asthmatic patients.

Investigators:  George Lewith/Alan Watkins/Jackie Broomfield/Gina Dolan.

Funded by:  Smith’s Charity (£100,000); Boiron Ltd (£20,000); South & West Region (£38,000).

Status:  3 Papers published –

(1) Lewith GT, Watkins AD, Hyland M, Shaw S, Broomfield J, Dolan G, Holgate ST.  Use of ultramolecular potencies of allergen to treat asthmatic people to house dust mite: double blind randomised controlled clinical trial.   BMJ. 2002; 324: 520-523.

Abstract: ObjectiveTo evaluate the efficacy of homoeopathic immunotherapy on lung function and respiratory symptoms in asthmatic people allergic to house dust mite.
Design Double blind randomised controlled trial.
Setting 38 general practices in Hampshire and Dorset.
Participants 242 people with asthma and positive results to skin prick test for house dust mite; 202 completed clinic based assessments, and 186 completed diary based assessments. Intervention After a four week baseline assessment, participants were randomised to receive oral homoeopathic immunotherapy or placebo and then assessed over 16 weeks with three clinic visits and diary assessments every other week.
Outcome measure Clinic based assessments forced expiratory volume in one second (FEV1), quality of life, and mood. Diary based assessments: morning and evening peak expiratory flow, visual analogue scale of severity of asthma, quality of life, and daily mood. Results There was no difference in most outcomes between placebo and homoeopathic immunotherapy. There was a different pattern of change over the trial for three of the diary assessments: morning peak expiratory flow (P=0.025), visual analogue scale (P=0.017), and mood (P=0.035). At week three there was significant deterioration for visual analogue scale (P=0.047) and mood (P=0.013) in the homoeopathic immunotherapy group compared with the placebo group. Any improvement in participants’ asthma was independent of belief in complementary medicine.
Conclusion Homoeopathic immunotherapy is not effective in the treatment of patients with asthma. The different patterns of change between homoeopathic immunotherapy and placebo over the course of the study are unexplained.


(2) Lewith GT, Hyland M, Shaw S.  Do attitudes toward and beliefs about  complementary medicine affect treatment outcomes?  American Journal of Public Health.  2002; 92 (10): 1604-1606.

Abstract: Many patients seek help from practitioners of complementary and alternative medicine (CAM). Patients’ prior knowledge of CAM and desire for egalitarian relationships with medical practitioners have been shown to increase CAM use, as have higher scores on the Absorption scale (a measure of anxiety and “self-absorption”). Other personality scales do not predict CAM use.
Although users of CAM might not agree, a common view among scientists is that CAM outcomes are mediated through a placebo effect; that is, patients improve because they expect to do so. Our aims in the study described here were to assess the validity of the Attitudes toward Alternative Medicine Scale (AAMS) and to determine whether asthmatic patients who had positive attitudes toward and beliefs about CAM showed greater positive changes in outcomes.


(3)Lewith GT, Hyland ME.  Oscillatory effects in a homeopathic clinical trial: an explanation using complexity theory, and implications for clinical practice. British Homeopathic Journal. 2002; 91: 145-149.

Abstract: Four double-blind, randomized, placebo-controlled clinical trials of asthma or rhinitis treated with homeopathic immunotherapy (HIT) at a 30C potency have been published. The most recent study, involving house dust mite allergic asthmatics, failed to confirm a therapeutic improvement at the end of the study, but did provide preliminary evidence for an oscillation in outcome (both physiological and subjective) in with verum treatment to placebo. In this paper we show how such an oscillation is consistent with a complexity theory interpretation of how the body functions as a whole and speculate on why different studies have produced different results. If the complexity theory interpretation is correct, then this will have a significant impact on the design of clinical trials in homeopathy and possibly, other complementary medical interventions.


A randomised, double-blind, placebo-controlled trial to evaluate the effects of low dose homeopathy using the proving of Belladonna 30C as a model.

Investigators:  Sarah Brien/George Lewith

Funded by:  Wellcome Trust (£56,600)

Status:Study completed. 5 publications as follows:

(1) Brien SB, Lewith G, Bryant, T. Does ultramolecular homoeopathy have any clinical effects? A randomised double blind placebo controlled using the homoeopathic pathogenetic trial of Belladonna C30 as a model. British Journal of Clinical Pharmacology 2003; 56 (5): 562-568


(2) Brien SB, Lewith G.  Assessing homeopathic proving using questionnaire methodology. Consideration and implications for future studies.  Forsch Komplementarmed Klass Naturheilkd. 2005; 12: 152-158.


(3) Lewith GT, Brien S, Hyland ME.Presentiment or entanglement? An alternative explanation for apparent entanglement in provings. Homeopathy 2005: 94(2): 92-95


(4) Brien SB,  Prescott P,  Owen D, and Lewith, G.  How do homeopaths make decisions? An exploratory study of inter-rater reliability and intuition in the decision making process. Homeopathy 2004; 93 (3); 125-131.


(5) Brien SB Attitudes about complementary and alternative medicine did not predict outcome in a homeopathic proving trial.  JACM 2004; 10(3); 503-505.

 

References

Homeopathy has clinical benefits in rheumatoid arthritis patients that are attributable to the consultation process but not the homeopathic remedy: a randomized controlled …

S Brien, L Lachance, P Prescott, C McDermott, G Lewith
Rheumatology 50 (6), 1070-1082

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