Health care systems around the world are being pressured to “do more and spend less”, to make healthcare more cost effective. Owing to aging populations and the growing cost of providing health services, there’s more scrutiny than ever on the value of different health treatments, with the goal of reducing the use of treatments that don’t help. The Choosing Wisely initiative was establishing expressly for this purpose. Regrettably, while well-intentioned, Choosing Wisely hasn’t had as much of an effect as you might expect. Medicine can be slow to change, as David Gorski discussed in a post over at Science-Based Medicine. Unless we ruthlessly scrutinize what we do for effectiveness, and are willing to act on what we learn, self-driven change is unlikely. One way that governments (and insurers) can dramatically reduce the use of a health service or treatment is to simply stop offering it, or paying for it. Yet stopping funding is something that is relatively uncommon in health care. It seems to be much more difficult to stop a practice, possibly owing to inertia, a reluctance to change, and the sometimes-vociferous protests that can emerge from patients or physicians that may feel that their preferred therapy is effective. The formidable challenge of stopping health care funding, once it has started, is one reason why this blog has been very critical of the expanding scope of practice being granted to alternative medicine purveyors – the legislative alchemy that is the first step towards insurance coverage. Because once that’s in place, it will be far more difficult to stop it. So it’s essential to understand the evidence.
Yet sometimes, which the evidence is so stark, insurers and governments face facts and start cutting benefits. Economic circumstances can strengthen that resolve. The most politically-acceptable approach, not surprisingly, is to conduct ruthlessly rigorous scientific reviews. When done effectively, these reviews can lead to solid, science-based decision making. Consider the slow death we are witnessing of homeopathy on the UK’s National Health Service (NHS). The NHS is a comprehensive public insurance system that maintains a “blacklist” of services that won’t be reimbursed if prescribed by a physician. It would seem self-evident that sugar pills should fall into this category, and that’s exactly what we may soon see.
Australia is another country with a fairly comprehensive public healthcare system that is also facing economic challenges and the desire to use its resources more efficiently. It also has a complex system in which the public insurance program (Medicare) is supplemented by private insurance which covers the cost of treatments and service that are not publicly funded. The risk to good care (and choosing wisely) is that there are often fewer incentives to reduce inappropriate costs from private plans, because those costs can be passed right back to the insured, typically in the form of higher premiums.
The Australian government recently undertook a review of natural products covered by private health insurance. It did this for two main reasons: The first was to ensure that private insurance plans were paying for “clinically proven” treatment. The second was based on concerns about tax dollars being used to subsidize ineffective treatments. The government provides a rebate on private insurance, and questions were raised about the extent to which the government was effectively subsidizing “natural” therapies that were not supported by good evidence yet were still being paid for through insurance. So in 2012 the government announced a review of natural treatments to determine if these therapies were effective, safe, and provided good value for money. Perhaps not surprisingly, the report has concluded:
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 of the Australian Government Rebate on Natural Therapies for Private Health Insurance
The reality with many “natural” remedies is that there is often a lack of good evidence with which to evaluate them. Consequently, we’re often left with an “absence of evidence” rather than evidence that points clearly in one direction or another. (This gets to the distinction of evidence-based medicine from science-based medicine). In this review, the authors did not consider plausibility (a problem I will come back to), but looked only for direct evidence, drawing a very strict definition:
- The data set was limited to systematic reviews (i.e., reviews of trials) published in the last 5 years. However, the authors noted that most reviews searched for all potentially relevant primary studies, without date limitations. They also considered literature submitted by stakeholders. Upon examination, both were felt to be low-quality evidence.
- Searches were limited to the English language (which might limit the evidence base for some therapies).
The major problem with this approach was summarized by the authors as part of the quality assessment, and they noted the following:
- A lack of randomized controlled trials. Even trials reported as RCTs didn’t contain enough information to demonstrate that they were truly randomized.
- Poor comparators. Often trials were designed to make the assessment of a particular “natural therapy” impossible.
- Lack of power. Studies were underpowered and not designed to actually answer the question being asked.
- Lack of blinding. With most trials measuring subjective effects, blinding the investigator and the patient was critical. This was rarely observed. It was also observed that some therapies are very difficult, if not impossible, to truly blind (e.g., massage).
What was reviewed?
In three cases, the review had to modify its approach. Multi-modality therapies, like herbalism or naturopathy, needed to be studied differently. One topic, Ayurveda (natural medicine with Indian roots) was dropped owing to the diversity of the treatments and the requirement to translate data. Four others (hypnotherapy, biochemistry, nutrition and psychotherapy) were also dropped as it wasn’t clear which aspects of these therapies were “natural therapies”.
I’ve been blogging for years, but some of these therapies were new to me:
Alexander technique is a type of physical therapy that aims to improve movement and correct posture, with the goal of improving health and reducing pain. Invented by Frederick Matthias Alexander, the process seems to encompass elements of mindfulness in the practice. Nine systematic reviews were identified, but the overall evidence base was poor. The reviewers concluded that the Alexander technique may be effective in improving pain and disability of low back pain in the short term (up to 3 months) but the long-term effectiveness of Alexander technique was unclear. There was insufficient evidence for other conditions to draw any conclusions.
Aromatherapy uses essential oils with the intent of delivering a medicinal effect. It’s used as part of massage therapy, but also on its own. The main uses are to treat stress and anxiety, but the oils are also thought to help reduce pain and nausea. Proponents make very wild claims about the effectiveness of aromatherapy of essential oils, but the actual evidence is lacking. There was limited, low-quality evidence to suggest aromatherapy may be effective in reducing anxiety and agitation in patients with dementia, and possibly in reducing generalised anxiety in some other situations, such as before health-care procedures. However, this observation emerged from data that was judged to be of poor quality. The overall effectiveness and relevance of aromatherapy for these uses felt to be unclear. The effect of aromatherapy on health outcomes with other conditions remains uncertain.
Bowen therapy is a form of physical manipulation/massage/bodywork that is described as a soft-tissue remedial therapy or a form of bodywork that primarily focuses on the myofascia. Therapists use their fingers and thumbs to apply gentle rolling movements over muscles, tendons, and connective tissues. Invented by Australian Thomas Ambrose Bowen which he described as a “gift from god”, you can learn to offer Bowen therapy over a weekend. When the limited data were considered, it was concluded that there was insufficient evidence to make any conclusions about the safety or efficacy of Bowen therapy.
Buteyko (the Buteyko method) is a breathing technique developed in Russia for the treatment of asthma. It involves shallow breathing, through the nose, with breath-holding at the end of the exhalation. It is promoted as a treatment for respiratory disorders. It was invented by Konstantin Buteyko in a moment of inspiration when he was dazzled by a bright light (I’m starting to see a pattern here). The quality of the evidence for Buteyko is low. None of the evidence reviewed demonstrated that the Buteyko breathing technique improves pulmonary function, asthma symptoms or quality of life in adults. There is weak evidence that it may decrease bronchodilator use compared with inactive controls, however.
The Feldenkrais method was invented by Moshe Feldenkrais. It is a gentle form physical therapy that focuses on breath, posture, and movement. What the Feldenkrais technique promises is vague and seems to revolve around nonspecific “wellness” rather than any objective effects. While several systematic reviews were found, few contained any RCTs. Data quality, again, was poor. Overall, the effectiveness of Feldenkrais for the improvement of health outcomes in people with any clinical condition was felt to be uncertain.
Herbalism was the basis of modern pharmacology and involves the use of plants and plant-derived substances as medicine. The report identified three main types of herbalism: Chinese, Ayurvedic and “western”. Herbals treatments can be administered in many ways – not just orally. This review looked at the overall effectiveness of herbalism – not just herbal remedies, as the question facing the review was the funding of herbalists as an insured service. Chinese and Ayurvedic medicine were excluded from the review as they were determined to be out of scope. No systematic reviews were found. While there is considerable research on individual plants and products, there was no data on the overall effects of herbalism, and the process of “individualized” treatments as provided by herbalists. Given herbalism is effectively the provision of impure drugs and chemical combinations, the authors noted the significant potential for adverse events with herbalism, particularly when herbal remedies are combined with drug products.
Homeopathy is an elaborate system of placebos where most homeopathic “remedies” contain no active ingredients at all, invented 200 years ago by German physician Samuel Hahnemann. Based on the idea that “like cures like” (which is a form of sympathetic magic) and the belief that sequentially diluting a substance will increase its effect (because the water has a “memory” of the substance), most remedies are inert. The authors looked at the National Health and Medical Research Council report as part of this review. They noted that there is little high-quality evidence, the available evidence is not compelling, and overall fails to demonstrate that homeopathy is an effective treatment for any condition.
Iridology is an alternative health practice that is based on the belief that medical conditions manifest in the iris. Examining the iris is thought to bring insights about overall health as well as specific organs and body functions. Iridology is prescientific pseudoscience, yet is used by iridologists, naturopaths and homeopaths for diagnostic purposes. No systematic reviews were identified that have studied iridology, signaling there is a lack of evidence to demonstrate any effectiveness for the practice.
Kinesiology is the study of body movement that identifies factors that block the body’s “natural healing process”. It is more commonly referred to as “applied kinesiology (AK) or specialized kinesiology, which should be distinguished from the science-based use of the term kinesiology, which refers to studies of mechanics and anatomy. (This portion of the review was poorly done and confusing to parse, as it did not distinguish clearly between the different practices that may be called kinesiology.) AK was invented by chiropractor George Goodheart and is a combination of chiropractic, acupuncture and western biomechanics. Applied kinesiology is pure pseudoscience. Dysfunctions found in AK are addressed by focusing on acupressure points and other specific body movements. The literature search found only a single systematic review on the topic of applied or specialised kinesiology. Not surprisingly, it was observed that there is a lack of evidence showing AK is effective for any condition.
The term massage therapy or myotherapy encompasses a number of different manual therapies, and this review included remedial massage, sports therapy massage, deep tissue massage, myofascial release, therapeutic massage, myotherapy, lymphatic drainage, traditional Thai massage and Swedish massage. Systematic reviews were sought for any form of massage therapy. This was an extensive review and the data search results for each type of massage therapy are outlined in detail. Overall, the data was found to be of low quality. It’s important to acknowledge that like other manual therapies, blinding for providers and patients is difficult, as is data collection, as most outcomes are patient-reported, subjective measures.
The reviewers noted that there is a lack of good-quality evidence that examines the effectiveness of massage therapy for many conditions, and is actually inconclusive/uncertain for 29 clinical conditions it assessed. There is mixed but promising evidence for low back pain, and for reducing the length of stay in pre-term infants. There were some specific recommendations made about future research which I think are worth noting, as they point to the number of variables that may affect the effectiveness of massage therapy, and our ability to assess it:
In practice, massage therapists often combine various treatment modalities or techniques within a single session, and may also treat patients over longer periods of time than those assessed in an RCT. To allow for more firm and conclusive statements about the effectiveness of massage therapy for a particular clinical condition, more rigorous, multicentre, and well-designed clinical studies assessing the effectiveness of massage therapy for a particular patient population are required. RCTs need to combine treatment approaches so as to properly reflect the way that massage therapy is applied in practice. Also, there is little data about what constitutes an effective massage therapy session. Further research is required regarding optimal treatment parameters such as number of sessions or duration of sessions required, combined with longer-term follow-up of patients to assess the long-term effectiveness of massage therapy. Similarly, further high-quality research is required that reflects the way that myotherapists use various touch and equipment-based interventions in practice, to enable the effectiveness of this therapy to be assessed.
As has been noted many times on this blog, naturopathy is an alternative medicine practice that encompasses a variety of modalities including homeopathy, herbal medicine, and Traditional Chinese Medicine. “Vitalism” is the belief that living beings have a “life force” not found in inanimate objects; as a concept vitalism was disproved by Wöhler in 1828. Despite this, the idea remains the central dogma of naturopathy and informs much of its practice. Naturopathic treatment ideas are all grounded in the idea of restoring this “energy”, rather than being based on objective science. Naturopaths can use conventional medicine as part of their practice, but this tends to occur only when its use aligns with the naturopathic belief system. This review focused on the overall effectiveness of naturopathy and naturopathic practitioners, rather than individual remedies or treatments, some of which are covered separately in the report (e.g., homeopathy, which is a “clinical science” in naturopathy). The reviewers found a single systematic review as an unpublished abstract. Conditions studied included cardiovascular disease, multiple sclerosis, anxiety and various types of musculoskeletal pain. There was no data on acute conditions. The overall quality of the evidence was rated as low. It wasn’t clear if this data was generalizable, as the studies were North American, where many states (and Canadian provinces) licence naturopaths. Naturopathy is unregulated in Australia. While the reviewers concluded that there is some evidence to suggest that naturopathy as a service is effective in improving patient health for a range of chronic conditions, there were numerous limitations noted with that data. And as regular readers to the blog will know, the evidence demonstrating that naturopathy is effective is lacking.
Pilates is an exercise practice that is said to benefit health through improvements in strength, coordination, balance, flexibility, proprioception, range of motion, body definition, and muscle symmetry. It focuses on the body’s core muscles, as well as posture. Invented by Joe Pilates, there are over 500 exercises that may be done on the floor or using specialized equipment. Despite the popularity of Pilates, there is little published evidence that examines its efficacy. A search found 10 systematic reviews that included 18 unique RCTs. Conditions studied included obesity, breast cancer, strength/balance and falls prevention, low back pain, and stress urinary incontinence. Overall the data was quite limited, even for the conditions studied. The authors concluded that the effectiveness of Pilates for the conditions studied was uncertain. The most favourable interpretation was that Pilates may offer some benefit for low back pain, but even this tentative conclusion was limited by poor data quality.
Reflexology is the practice of applying pressure to the feet in the belief that points on the soles correspond to different organs and locations in the body overall. This type of massage is believed to release “blockages” and stimulate healing. Reflexology is another alternative medicine practice that is pure pseudoscience. Like iridology above, reflexology is a homonculus, or mapping-based system. Not surprisingly, this review found a lack of data and concluded that the effectiveness of reflexology was uncertain for all conditions that were assessed.
Rolfing is another form of manual therapy (sometimes referred to as structural integration) that is used to treat different health conditions, both musculoskeletal and non-musculoskeletal in nature. It seems to have elements of massage, yet focuses on the fascia and seems to veer more into beliefs about “energy medicine”. Rolfing was invented in the 1950s by Ida Pauline Rolf who claimed to identify a correlation between muscular tension and emotions. While anecdotal claims of effectiveness exist, there is a lack of published evidence that has critically examined Rolfing. The review concluded that there is a lack of evidence effectiveness of Rolfing for any clinical condition. Consequently, the safety, quality and/or cost-effectiveness of Rolfing could not be determined.
Shiatsu is a form of massage therapy that incorporates acupressure, with origins in Japan. Shiatsu is considered a gentle massage (unlike Rolfing) where pressure is applied to over 150 pressure points on the body. Its aim is to restore and “balance” “energy flows” in the body. Practitioners may also use other treatments, such as moxibustion, cupping, food as medicine and judo therapy/tai chi/qi gong. The researchers found no systematic reviews for shiatsu for any condition, so were unable to draw any conclusions about its effectiveness or safety. They noted that the lack of evidence makes it difficult for consumers and others to make informed assessments of this therapy.
Tai chi, taiji or taijiquan is a mind/body exercise that involves slow, flowing movements. It has origins in China as a martial art and is based on Confucian and Buddhist philosophies. It is thought that tai chi can balance the body’s yin and yang and the overall “life force” or “qi”. While there are several variants of tai chi, all use slow movements and focused breathing techniques. There is a substantial evidence base for tai chi: The authors found 37 systematic reviews that included 117 unique RCTs, and almost 9,000 participants across 16 clinical conditions. Overall, the quality of the evidence was not good however. The reviewers concluded that there was low-quality evidence to suggest that tai chi may have some beneficial health effects compared to control for some conditions. However, owing to the dearth of good data, the magnitude of any benefit was not clear. Tai chi is well tolerated, and the reviewers concluded it could be considered a safe treatment in the populations studied.
Yoga is a traditional Indian mind and body practice that involves a combination of physical postures, breathing techniques and meditation or relaxation. Depending on the form of yoga, there may be elements of stretching, strengthening and mediation. While spiritual elements are important components of traditional yoga, it is more popular as a form of exercise that ignores many of these elements. The reviewers found 67 reviews, 59 of which contained a total of 111 unique RCTs of yoga. The evidence base is limited by small, poor-quality studies that were poorly reported, making interpretation difficult. Consequently, the reviewers could only identify that there is weak evidence that yoga improves symptoms in people with depression compared with control. There was insufficient information available for other conditions.
Conclusion: Absence of evidence and plausibility
A comprehensive Australian review has found that there is a uniform lack of good quality clinical evidence to support the use of 17 different “natural” treatments. While absence of evidence is not the same as evidence of absence, the lack of good data to demonstrate efficacy suggests that these practices cannot be considered evidence-based. While this report gives a comprehensive summary of the current evidence, it is not without its problems. These therapies vary widely in their plausibility. On one end, iridology and homeopathy are pure pseudoscience. Pilates, yoga, and tai chi, however, are physical exercise which are admittedly difficult to evaluate in RCTs, yet are much more likely to have the potential to be beneficial. It’s here that a more clear science-based medicine filter would have been useful, something that the authors seem to acknowledge in their comments on the report, where plausibility is mentioned as a potential guide for future research. Given the very rigorous evidence bar it established, it is likely that insurance subsidies for these 17 treatments may end as a consequence of this review.
This is a cross-post from Science-Based Medicine. Comments are open there.
Photo via flickr user James Deacon used under a CC licence.