The expectation was that
The Department would review ‘natural therapies’ to identify services that are not underpinned by a robust evidence base and for which the private health insurance rebate should be withdrawn.
The purpose of the Review was to ensure that natural therapies are underpinned by a credible evidence base that demonstrates their clinical efficacy, cost-effectiveness and safety and quality. The Rebate will be paid for insurance products that cover natural therapy services as described in the previous Government’s media release: "The Private Health Insurance Rebate will be paid for insurance products that cover natural therapy services only where the Chief Medical Officer finds there is clear evidence they are clinically effective".
Such clear evidence has not been found.The review examined the evidence of clinical efficacy, cost effectiveness, safety and quality of natural therapies 'in scope', ie those
- covered under private health insurance between December 2012 to January 2013 (as compiled from information provided by private health insurers);
- not subsidised directly under Medicare; and
- not provided by a health professional accredited under the Australian Health Practitioner Regulation Agency.
The Department received 46 submissions in relation to the Review. The report states
For a few modalities (Alexander technique, Buteyko, massage therapy, tai chi, yoga), there was evidence, which was graded as low to moderate quality, that these natural therapies may improve certain health outcomes for a limited number of clinical conditions. However, in most cases the quality of the overall body of evidence was not sufficient to enable definite conclusions to be drawn about the clinical effectiveness of the therapies. Very little literature exists in the area of health service delivery for most of the health-care disciplines evaluated in this report and this particularly affected consideration of herbalism, naturopathy and myotherapy. Overall, there was not reliable, high-quality evidence available to allow assessment of the clinical effectiveness of any of the natural therapies for any health conditions. Component treatment modalities in herbalism (see page 64) and naturopathy (see page 102) were not considered.
The absence of evidence does not in itself mean that the therapies evaluated do or do not work. Natural therapies emerged in an environment where there was not a premium on rigorous evidence base. Where there is limited evidence in some modalities, there is value in conducting more research.In considering homeopathy the report states "The available evidence failed to demonstrate that homeopathy is an effective treatment for any of the clinical conditions for which it has been examined". It comments -
Homeopathy overview report
Objective The objective of this overview is to summarise the evidence from SRs regarding the effectiveness of homeopathy as a treatment for any clinical condition. In considering the effectiveness of homeopathy for this review, the HWC determined the following uses are also within scope: (i) homeopathy used to treat the side effects of another treatment/intervention; and (ii) homeopathy used in conjunction with another treatment/intervention, where the design of the study does not confound the results (that is, where the specific effect of homeopathy can be determined). For example, studies that examined ‘homeopathy plus other intervention’ versus ‘other intervention’ were included. The use of homeopathy as a preventative/prophylactic intervention was considered out of scope. In addition, the report did not include studies that exclusively examined safety or homeopathic aggravations, defined as a temporary worsening of existing symptoms following the administration of a homeopathic remedy (Grabia and Ernst, 2003); however, safety results reported in otherwise included studies were presented in the report.
Background
NHMRC were tasked with examining the available evidence on effectiveness (and where available, the safety, quality and cost-effectiveness) of a selection of in-scope and prioritised natural therapies. Independently of the Department’s Natural Therapies Review, NHMRC had begun its own review of the evidence for the effectiveness of homeopathy. To avoid duplication, it was agreed that NHMRC would provide the Department with a copy of its homeopathy evidence review, to inform the Natural Therapies Review. At the start of the Review, the Department invited public submissions from stakeholder groups and members of the public. The purpose of this report is to review and evaluate any extra literature submitted to the Department that has not already been considered during NHMRC’s homeopathy review process.It goes on to state
Prior to the Department’s request that NHMRC examine the effectiveness of the in-scope natural therapies, which included homeopathy, the NHMRC had independently begun a review of the scientific evidence for the effectiveness of homeopathy. The purpose of the NHMRC’s homeopathy review was to inform development of an information paper and position statement to help Australians make informed health-care choices as a part of NHMRC’s activities under its Strategic Plan. Due to the requirements of the National Health and Medical Research Council Act 1992 (the NHMRC Act), this review had a different process and purpose, and differed from the approach to the other natural therapies in the following respects:
- A Homeopathy Working Committee (HWC) comprised of experts in evidence-based medicine and complementary and alternative medicine was set up by the NHMRC to oversee the review.
- For the information paper to be useful to the public, it needed to provide an NHMRC position on the effectiveness of homeopathy, based on the evidence as well as the HWC’s expert judgment. As the underlying principles of homeopathy lack scientific plausibility, the review used the null hypothesis that homeopathy has no effect as a treatment for a condition, unless there was sufficient reliable evidence to demonstrate otherwise. Evidence for each clinical condition was summarised and evidence statements were formulated after consultation and agreement with the HWC. In contrast, the evidence statements for the other in-scope natural therapies in this report state that the evidence is uncertain, unless there was sufficient evidence to demonstrate otherwise.
- The external reviewers for the homeopathy overview appraised all SRs published between January 1997 and 3 January 2013, whereas the other natural therapies overviews included all SRs done since 2008. In addition, the homeopathy overview included any prospectively designed and controlled studies included within SRs; that is, level III evidence, whereas for the other therapies, studies assessed as level III evidence or below were excluded.
What were the results? The report states
- In line with NHMRC’s requirements under the NHMRC Act, the draft information paper was open for public consultation from 9 April to 2 June 2014. Submissions received during public consultation, along with comments received from independent experts in evidence-based medicine and/or complementary medicine, are being considered by the HWC in finalising the information paper.
Results of the Review
There is a paucity of good-quality studies of sufficient size that examine the effectiveness of homeopathy as a treatment for any clinical condition. The available evidence is not compelling and fails to demonstrate that homeopathy is an effective treatment for any of the reported clinical conditions.
Plain language summary
The paucity of good-quality primary studies, the preponderance of studies with small sample size and insufficient power, and the lack of replication of results in multiple studies made the interpretation of apparent ‘significant’ differences in favour of homeopathy over placebo difficult. Many studies also failed to use (or report) appropriate comparators, blinding, or randomisation, all of which would be necessary to permit a high level of confidence in the outcomes reported. Accordingly, in rating the body of evidence, the overall shortcomings of the primary evidence limited the ability of the evidence review team to draw conclusions about the efficacy of homeopathy for many of the clinical conditions included in this overview.
Research gaps
A major challenge in assessing the evidence and interpreting the results for this overview has been the paucity of good-quality primary studies that are of sufficient size to demonstrate the effectiveness of homeopathy for specific clinical conditions. If further primary research is conducted, investigators should try to:
- recruit substantially larger samples of patients and include statistical tests to demonstrate the significance of results
- utilise blinding/double blinding methodology and randomised assignment of subjects to treatment groups
- improve trial reporting and follow-up (for example, reporting of drop outs)
- improve reporting of conflicts of interest
- provide more detailed descriptions of interventions (including doses, dilutions), better descriptions of outcomes and how they were measured, and better discussion of potential confounders or bias
- justify the use of active comparators and comment on the effectiveness of those comparators compared to placebo
- use a methodological approach that can differentiate between the effect of homeopathic medicines and treatment by a homeopath (that is, interaction at a consultation).
In addition, systematic reviewers should:
- justify the pooling of results in meta-analyses and provide a detailed discussion of heterogeneity between the primary studies
- adequately and accurately report study details including treatment regimens, length of follow-up, outcomes studied and the clinical and statistical significance of results.