A randomised, controlled, triple-blind trial of the efficacy of homeopathic treatment for chronic fatigue syndrome

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Abstract

Objective: There is no management regime for chronic fatigue syndrome (CFS) that has been found to be universally beneficial and no treatment can be considered a “cure” [1]. Patients with CFS may use complementary and alternative medicine (CAM) [1]. Our aim was to evaluate homeopathic treatment in reducing subjective symptoms of CFS. Method: Using 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), we randomly assigned patients to homeopathic medicine or identical placebo. One hundred and three patients meeting the Oxford criteria for CFS were recruited from two specialist hospital out patient departments. Patients had monthly consultations with a professional homeopath for 6 months. Main outcome measures were scores on the subscales of the Multidimensional Fatigue Inventory (MFI) and proportions of each group attaining clinically significant improvements on each subscale. Secondary outcome measures were the Fatigue Impact Scale (FIS) and the Functional Limitations Profile (FLP). Ninety-two patients completed treatment in the trial (47 homeopathic treatment, 45 placebo). Eighty-six patients returned fully or partially completed posttreatment outcome measures (41 homeopathic treatment group who completed treatment, 2 homeopathic treatment group who did not complete treatment, 38 placebo group who completed treatment, and 5 placebo group who did not complete treatment). Results: Seventeen of 103 patients withdrew from treatment or were lost to follow-up. Patients in the homeopathic medicine group showed significantly more improvement on the MFI general fatigue subscale (one of the primary outcome measures) and the FLP physical subscale but not on other subscales. Although group differences were not statistically significant on four out of the five MFI subscales (the primary outcome measures), more people in the homeopathic medicine group showed clinically significant improvement. More people in the homeopathic medicine group showed clinical improvement on all primary outcomes (relative risk=2.75, P=.09). Conclusions: There is weak but equivocal evidence that the effects of homeopathic medicine are superior to placebo. Results also suggest that there may be nonspecific benefits from the homeopathic consultation. Further studies are needed to determine whether these differences hold in larger samples.

Introduction

The point prevalence of chronic fatigue syndrome (CFS), according to the Oxford criteria, is estimated to be 0.5% for a population aged 18–45 without comorbid psychological disorders [2]. CFS is characterised by abnormal mental and physical fatigue associated with distress and functional impairment and no evident physical or psychological disorder that sufficiently explains the symptoms. Symptoms are largely subjective with no definitive physical markers or pathognomic signs. The syndrome is diagnosed by exclusion of other explanatory disease.

CFS has only relatively recently been defined by consensus criteria. Diagnostic criteria commonly used in research and clinical practice are the Oxford criteria [3] and the Center for Disease Control (CDC) criteria [4]. Table 1 shows the Oxford and CDC case definitions for CFS.

At present, there is no universally effective treatment for CFS and few evidence-based treatments for CFS [5], [6]. There is evidence indicating that cognitive behavioural therapy (CBT), administered by skilled therapists in specialist centres, is more effective for adult outpatients with CFS than routine medical care or relaxation [7], [8], [9], [10]. CBT has been shown to be more effective than guided support groups in reducing fatigue severity and self-improved ratings [11]. Graded exercise has modest effects for CFS patients compared to standardised medical care [12], [13].

There are potentially high direct and indirect costs of CFS. In 1990, the economic impact of CFS was estimated at $59 million for the Australian population [14]. There are indications that patients seeking treatment for CFS may seek help from complementary and alternative medicines (CAM) [15]. There are no estimates of how many people use CAM specifically for CFS. It is estimated that there are 1.31 million annual visits to homeopaths in England [16].

A report of homeopathic treatment for CFS presented qualitative outcome data suggesting efficacy of treatment [17]. However, no quantitative analyses were presented. In a pilot study, without a control group, a multitherapeutic approach to the treatment of CFS was used, including homeopathic treatment of allergies and constitutional homeopathic treatment [18]. The therapeutic package had a positive impact on physical and psychological parameters. Given the multitherapeutic approach and the absence of an RCT design, it is not clear how much improvement can be attributed to the homeopathic treatment.

The current trial was designed to test the efficacy of homeopathic treatment for symptoms of CFS. A triple-blind, placebo-controlled RCT compared patients with CFS treated with homeopathic remedies in the context of a homeopathic consultation with patients treated with placebo in the context of a homeopathic consultation. Two research questions were posed:

  • Do patients treated with homeopathic remedies show more improvement in subjective symptoms of fatigue compared to patients treated with placebo?

  • Are changes in either group clinically significant?

The first question concerns the efficacy of homeopathic remedies; the second concerns the effectiveness of homeopathic treatment as a whole.

Section snippets

Patients

Patients over 18 years old were recruited from two hospital outpatient departments in the UK: The Fatigue Outpatient Clinic at the Seacroft Hospital (part of the Leeds Teaching Hospitals NHS Trust) in Leeds and the Infectious Diseases Outpatient Clinic at the Royal Hallamshire Hospital, Sheffield. Patients are usually referred to these clinics by their general practitioners with a provisional diagnosis of CFS. Consecutive new referrals to these two clinics were assessed for their eligibility

Results

Two hundred and fourteen patients were referred to the trial by hospital clinicians and 103 patients were randomised into the trial. A CONSORT diagram showing how patients entered the trial is shown in Fig. 1. Six patients in the homeopathic treatment arm and five patients in the placebo arm did not complete 6 months of homeopathic treatment. These patients all started treatment and had at least one appointment and treatment duration ranged from 1 week to 5 months. For all patients in the

Discussion

In 1997, the quality of trials in homeopathic medicine was described as methodologically poor in two thirds of those reviewed [34]. The same article encouraged rigorous and systematic research on homeopathy. The trial reported here used systematic and rigorous methods of investigation, analysis, and interpretation that are entirely replicable. The standards recommended in the CONSORT statement are met. Methodological standards exceeded those of some trials of conventional medicine, which

Conclusions

These results inform two questions: Is there is evidence that the effects of homeopathic medicine are more than placebo and is there evidence of efficacy of homeopathic treatment for patients with CFS? There is weak, probably unpersuasive, evidence that the effects of homeopathic medicine are other than placebo effects. The finding of significant differences between the effects of homeopathic remedies and placebo is consistent with a recent meta-analysis of placebo-controlled clinical trials in

Acknowledgements

The research was supported by a grant from the Linbury Trust. The authors would like to thank Mark Pickin, Medical Care Research Unit, for comments on the paper.

The Homeopathic Trials Group: Homeopaths—Gill de Boer, MBChB, MFHom, Maryjoan Foster, RSHom, Susanne Hartley, RSHom, Jane Howarth, BRCPHom, Pat Mayborne RSHom, Georgina Ramsayer RSHom, Clare Relton, RSHom, Pat Strong, MBBS, MFHom, Angela Zajac, BSc, RSHom, BRCPHom; Homeopathic pharmacists—John Morgan, RSHom, Roger Haddon, RSHom.

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