Jul 172016
 
Natural remedies are popular. But are they an appropriate substitute for medication?

Natural remedies are popular. But are they an appropriate substitute for medication?

The idea of taking medication can be frightening. And as consumers and patients that want to make our own informed health decisions, it’s understandable and even appropriate to question our physicians when they recommend drug treatments. We need to understand the rationale for any medication that’s recommended or prescribed, the benefits of therapy, the side effects, and if there are any other approaches that might be more appropriate. Dietary supplements and natural health products are widely marketed as being safe and effective, and are occupying more and more shelf space in pharmacies, usually right beside the pharmacy counter. Many of my patient encounters in the pharmacy have included a discussion on the merits of drug therapy, versus the supplements that may have flashy packaging and impressive claims of effectiveness.

One encounter from my time working at a local pharmacy still sticks with me. I met a new patient who was anxious and eager to get my advice. He’d been cautioned by his family doctor that he was on the borderline of being diagnosed with diabetes. He had come to the pharmacy seeking a supplement that could help him avoid diabetes and medication. Rather than recommend any supplement, I suggested that the best approach he could probably take would be to lose some weight and get some exercise – it could be more effective than any supplement or drug, and would definitely help his health. He agreed, and then asked me what supplement he could take that could help him with some weight loss.

This type of discussion occurs all the time, and seems more common when there’s a lack of trust in the physician, or when the goals of treatment aren’t understood. The patient, reluctant to accept the physician’s recommendation, heads to the pharmacy for what they believe is a second opinion. In some cases, the patient may question the physician’s advice: “All my physician wants to do is prescribe drugs,” is a statement I’ve heard more than once. In those that are reluctant to accept medical treatment, there’s often a willingness to consider anything that’s available without a prescription – particularly if it’s perceived as “natural.” Natural products and dietary supplements are thought to be gentle, safe, and effective, while medicine may be felt to be unnatural, harsh, and potentially dangerous. Yet when I explain to patients that there’s actually little evidence to suggest most supplements offer any meaningful health benefits, I am sometimes met with puzzled or dismissive looks. The supplement industry’s marketing has been remarkably effective, glossing over the fact that the research done on dietary supplements is overall unconvincing and largely negative when it comes to having anything useful to offer for health.

Given I want to ensure patients are making informed health decisions based on good scientific evidence, I was eager to read a post that naturopath Reuben Dinsmore recently posted on the website of the British Columbia Naturopaths Association (BCNA). Entitled “The Top Five Medications You Shouldn’t Take Without Trying a Natural Alternative First,” Dinsmore states that supplements can offer all the benefits yet none of the side effects of prescription drugs:

Natural supplements, or nutraceuticals, have been given a bad rap lately—which, in some cases, has been absolutely warranted. But natural formulas that actually contain what they claim on the label, and that are formulated to have maximal efficacy, can be equal to their pharmaceutical counterparts. Better yet, they can be just as effective without the laundry list of side effects.

I approached the article with curiosity. Are supplements an appropriate therapy before medication? I have no bias against supplements, but I do have a bias against unsubstantiated claims. I want to know what works, supplement, drug or otherwise. I looked at each recommendation as if it was given to me by a patient in the pharmacy, and evaluate it against the scientific evidence.

Understanding the naturopathic approach

I’ve written multiple posts in the past about treatment claims by naturopaths, and how they stack up against the scientific evidence. Naturopaths offer an array of unconventional health practices like homeopathy, acupuncture and herbalism that are linked philosophically by a belief in vitalism – the prescientific idea we have a “life force”. From this philosophy can sometimes emerge sensible health advice, but it can also be illogical and even potentially harmful. In past posts I’ve looked at the naturopathic perspectives on fake diseases, infertility, autism, prenatal vitamins, vaccinations, allergies, and even scientific facts themselves. As long as a treatment is viewed as being congruent with the naturopathic belief system, it’s acceptably “naturopathic” – no matter what the scientific evidence says. Despite this obvious disconnect from science-based medicine, naturopaths present themselves as primary care providers, just like medical doctors. The BCNA’s own marketing campaign describes naturopaths as “medically trained”:

NatMedWeek-Banner-1030x515

Britt Hermes is a former naturopath and has written extensively about naturopathy, and her perspective is clear: There are no naturopathic standards of care and naturopathic training is very different than what naturopaths claim. She argues is that naturopathy has too much quackery and that what actually makes naturopathy unique is its embrace of pseudoscience.

So let’s examine the five categories of drugs that Dinsmore says have equally effective natural remedies. He lists statins, antacids, SSRIs (selective serotonin reuptake inhibitors), antihypertensives, and benzodiazepines.

Statins for high cholesterol

Why do we treat it?

High cholesterol has no symptoms. We treat high cholesterol to lower the risk of heart disease: heart attacks, strokes, and death. One’s risk of heart disease goes up with the LDL cholesterol level, along with the total number of heart disease risk factors.

When is drug treatment appropriate?

High cholesterol doesn’t mean that drug treatment is mandatory. An assessment will include age, family history, and other health conditions such as diabetes, heart disease, or a prior heart attack or stroke. Lifestyle changes are important: A healthy diet, an appropriate weight, regular physical exercise, and quitting smoking can also reduce your risk of heart disease. In those at low risk, drug therapy many not be necessary. “Statins” are a class of drugs that reduce LDL cholesterol. In those with a prior heart attack or stroke, the benefits of treatment with drugs like statins are well documented.

What benefits have drugs been shown to offer?

There’s two general uses for statin therapy: primary prevention (avoiding a first heart attack or stroke), and secondary prevention (using a statin in someone that has already had a heart attack or stroke) to reduce the risk of another cardiovascular event. There is good evidence that statins reduce the risk of heart attacks and strokes, when used for both primary and secondary prevention. Much of the debate on the usefulness of statins has focused on the net benefit when used in lower-risk groups. This is a fair question, and one that I’ve discussed at length previously. But what is not in question is that statins have been proven to reduce the risk of heart attacks, stroke, and death.

What does naturopathy suggest?

As per Dinsmore:

High cholesterol is blamed for heart attacks and strokes via formation of arterial plaques. But the real culprit is inflammation, without which the plaques wouldn’t form in the first place. Bottom line: You can lower cholesterol all you want, but as long as there is inflammation present, plaques can still form.

Some common side effects of statins include muscle pain, cognitive impairment, sexual dysfunction, and increased risk of cancer and diabetes.

Nutraceuticals are an alternative to statins. These include: Omega-3 fatty acids (best sourced from wild-caught fish oils) and curcumin (the active component in turmeric). Both are excellent supplements to lower inflammation. Garlic extracts have been proven to improve cholesterol levels as well. Another option I discuss with patients is red rice yeast extract, which is the natural compound statins were derived from in the first place, and works in a similar manner. This product may have side effects; I find that it can be beneficial for some patients, but not all, something I deal with on a patient by patient basis.

What evidence supports the use of naturopathic treatments?

The reason we use drug therapy to treat high cholesterol is to lower the risk of heart attacks, stroke, and death. Consequently, that’s the benefit we want to see when we consider taking any treatment – naturopathic or drug. Statins are proven effective, so that’s the effectiveness we should be looking for if we’re going to use supplements as an alternative. There is no published evidence to demonstrate that garlic extracts or curcurmin supplements can prevent heart attacks and stroke, or reduce the risk of death. The data are a bit more encouraging with omega-3 fatty acids (which, incidentally, exist as both a drug and a supplement with different regulatory standards for each), but whether or not these products actually produce a real survival advantage is not clear. There is a Cochrane review on dietary modifications for the treatment of high cholesterol, in which the authors conclude:

No conclusions can be made about the effectiveness of a cholesterol-lowering diet, or any of the other dietary interventions suggested for familial hypercholesterolaemia, for the primary outcomes: evidence and incidence of ischaemic heart disease, number of deaths and age at death, due to the lack of data on these. Large, parallel, randomised controlled trials are needed to investigate the effectiveness of a cholesterol-lowering diet and the addition of omega-3 fatty acids, plant sterols or stanols, soya protein, dietary fibers to a cholesterol-lowering diet.

Red rice yeast extract is effectively a natural but crude source of the statin drug lovastatin (the active molecules are identical). There are questions about its safety that are exclusive to red yeast rice, but not present with prescription drugs. Why red rice yeast extract would be preferred over a drug product is unclear, unless one puts a priority on something “natural” over something that’s standardized, predictable, and demonstrated to be effective.

What approach has the best evidence?

Statins provide proven benefits, reducing heart attacks, strokes, and the risk of death. Even if a supplement reduces cholesterol levels, real benefits haven’t been established. There’s no obvious reason to use supplements for high cholesterol.

“Antacids” (anti-ulcer medications for gastro-esophageal reflux)

Why do we treat it?

The reflux of stomach contents, often called “heartburn” requires medical attention when there is damage to the esophagus, or there are unpleasant symptoms. The objective of treatment is to repair any tissue damage and/or to reduce the symptoms of heartburn.

When is drug treatment appropriate?

So called “lifestyle” modifications are usually recommended first, and they aren’t always effective. Weight loss (if appropriate) can provide relief, as can elevating the head of the bed for those with heartburn at night. Minimizing specific foods or “triggers” is usually not necessary, but some find this approach helpful. Drug treatment with medications like proton pump inhibitors (PPIs), which suppress stomach acid production, are usually appropriate when symptoms are severe, or where there’s esophageal damage.

What benefits have drugs been shown to offer?

PPIs are among the most effective drugs to treat heartburn and heal esophagitis. PPIs are well tolerated over the short term. When acid production is suppressed for long-term periods (months to years), there are concerns this may predispose people to infections and malabsorption conditions. Whether or not PPIs raise the risk of osteoporosis or hip fractures isn’t clear. Many people find these medications highly effective, but some stay on therapy far longer than necessary. Current guidance suggests the lowest dose should be used for the shortest duration possible to minimize these risks.

What does naturopathy suggest?

As per Dinsmore:

It’s said that five million Canadians suffer from heartburn symptoms weekly. Prescriptions for the acid-blocking drugs PPIs (proton pump inhibitors) accounted for $24 million in BC alone in 2013. Risks of taking these mostly involve nutrient deficiencies from poor absorption DUE TO LOW STOMACH ACID (see the problem here?). Examples include bone fractures from poor calcium absorption or anemia from decreased levels of vitamin B12 or iron. B12 deficiency can also cause dementia and neurological damage. There has also been a correlation shown between PPI use and C. difficile infection, which causes life-threatening diarrhea.

Nutraceuticals: Long story short, most people don’t have too much stomach acid. The problem is the acid they have is getting into the wrong place (the lower esophagus) where it burns. This can be from the muscle between the esophagus and the stomach not closing properly, either from poor tone or insufficient stomach acid, which is the signal for the sphincter to close. Limonene (an extract from citrus peel) helps strengthen this muscle and promotes movement of food downward to the stomach. DGL (an extract from licorice root) stimulates mucus production in the stomach, which acts to coat and protect the sensitive lining of the esophagus.

What evidence supports the use of naturopathic treatments?

Limonene is an ingredient in citrus oils, and is considered “possibly safe” as a supplement by the Natural Medicines database. I could locate no published evidence in PubMed it has been studied for heartburn or GERD. I did find a reference to clinical trials in Alternative Medicine Review, but there’s not a lot of information to review: one trial had 19 adults and had no control group. The other had just 13 participants but was randomized and blinded, noting improvements in heartburn symptoms with limonene. There’s not much safety information on limonene, and it appears to have multiple interactions with drugs. How limonene might work isn’t clear. Long-term effects haven’t been reported.

Deglycyrrhizinated licorice (DGL) is licorice processed to remove the glycyrrhizic acid, which can cause steroid-like side effects when consumed in excess. Short term use of licorice as a supplement is considered “possibly safe” and long-term use is considered “possibly unsafe”. Some branded supplements combining licorice with other herbal ingredients have been studied for the treatment of acid reflux, stomach pain and cramping. How DGL might work isn’t clear. There’s a lack of evidence to suggest DGL is effective.

What approach has the best evidence?

There’s good evidence to show PPIs work, and they work quickly. There are some concerns when used for long-term purposes. The effectiveness of the remedies suggested by Dinsmore is unclear, as is their long-term safety. Given the lack of good evidence showing they work, I wouldn’t recommend the products, but if someone wanted to try them for mild heartburn, they appear to be low risk when used for short-term use.

SSRIs (selective serotonin reuptake inhibitors) for depression

Why do we treat it?

Depression is the most common psychiatric disorder and a major public health issue. It is associated with functional disability and greater risk of death. It frequently recurs.

When is drug treatment appropriate?

We treat depression to put symptoms into remission and to restore baseline (pre-depression) levels of function. The usual initial treatment of depression can include drug therapy or psychotherapy. Psychotherapy alone appears to be just as effective as drug therapy alone. There’s some evidence the combination may be more effective than either approach alone.

What benefits have drugs been shown to offer?

Antidepressants can help with depression, but the magnitude of that benefit has been questioned. The overall advantage of antidepressants over placebo can be modest for mild-to-moderate depression. Selective publication of trials may have led to an overestimate of the efficacy of antidepressants. SSRI’s or selective serotonin reuptake inhibitors are a popular class of antidepressant medications. No particular SSRI is dramatically and consistently superior to any other antidepressant drug in terms of effectiveness, but the side effects can vary. In severe cases of depression, drug therapy is combined with psychotherapy.

What does naturopathy suggest?

As per Dinsmore:

SSRIs (selective serotonin reuptake inhibitors) are the most common class of anti-depressant drugs. One in twelve Canadians will experience major depression in their lifetime, but it’s still one of the most misunderstood conditions. Standard treatment protocols typically target neurotransmitter activity (most commonly serotonin). However, new research indicates the underlying cause may actually be inflammation. Either way, natural medicine has you covered.

Some nutraceuticals to consider are 5-HTP, which is used to make serotonin, with the help of vitamin B6. The herb St. John’s Wort has been studied extensively and appears to work in the same way as SSRIs. Both 5-HTP and St. John’s wort have shown similar efficacy to SSRIs when given for mild to moderate depression. And as I mentioned earlier, omega-3 fatty acids and curcumin decrease inflammation throughout the body, including the brain.

Side effects of SSRIs include sexual dysfunction, weight gain, and worsened/chronic depression. St. John’s wort also has a side effect which should be considered if taking other medications—it impacts liver function, which can result in either higher or lower blood medication levels.

What evidence supports the use of naturopathic treatments?

5-HTP is considered “possibly effective” for the treatment of depression by the Natural Medicines database. It notes:

Overall, despite the preliminary beneficial effects shown in clinical research, the trials to date are generally small and have methodological problems or a lack of generalizability to mixed populations of depressed people. More higher-quality studies in larger patient populations are needed to confirm these result.

St. John’s Wort is considered to be “likely effective” for the treatment of depression by the Natural Medicines database. It’s an interesting natural product that is used widely for antidepressant effects. Trials have many limitations, but the data suggest that SJW may be as effective as SSRIs, but the evidence is less consistent. However, it’s not recommended in most treatment guidelines for many of the reasons discussed before at this blog: preparations of the product are often not standardized, supplement manufacturing quality is not clear, and the dosing may consequently not be predictable. Moreover, St. John’s Wort causes a wide array of drug interactions with other medications, making it difficult to use safely.

What approach has the best evidence?

Overall, there’s better evidence with the SSRIs compared to 5-HTP and St. John’s Wort. However, a decision to use St. John’s Wort is effectively a decision to use medicine, so unsupervised, unmonitored use, when treating depression, should be avoided.

Anti-hypertensives for the treatment of high blood pressure

Why do we treat it?

Untreated high blood pressure, or hypertension, can increase your risk of heart attack, stroke, heart failure, and kidney disease. We treat hypertension to reduce these risks.

When is drug treatment appropriate?

Non-drug treatments are usually considered before drug therapy, and can reduce the need for medication. Weight reduction (when necessary), quitting smoking, avoiding excessive alcohol, a healthy, reduced-salt diet, and regular exercise are all low-risk strategies that can be beneficial. Drug therapy can have side effects. People are usually unwilling to tolerate side effects for a symptomless condition, unless there is a good reason to take medication. There is good evidence that drug therapy provides real benefits to those with hypertension that can’t be controlled by lifestyle changes.

What benefits have drugs been shown to offer?

When drug treatment is considered appropriate (usually when blood pressure exceeds 140/90), there are multiple treatment options that may be appropriate. From Up-to-Date:

In large-scale randomized trials, antihypertensive therapy produces a nearly 50 percent relative risk reduction in the incidence of heart failure, a 30 to 40 percent relative risk reduction in stroke, and a 20 to 25 percent relative risk reduction in myocardial infarction.

The absolute benefit is less impressive, but still real: There’s an approximate 2% reduction in heart attacks and strokes. The benefits of medical treatment are not as clear in those with mild hypertension, those with few risk factors, or the frail elderly.

What does naturopathy suggest?

As per Dinsmore:

Hypertension (i.e., high blood pressure) affects 6 million Canadians, and is responsible for approximately 13 per cent of all deaths. Various classes of anti-hypertensives include diuretics, ACE inhibitors, angiotensin II receptor blockers (ARBs). Diuretics increase urine output, which can negatively affect sodium and potassium levels, which can cause muscle cramps. ACEIs and ARBs may both cause a chronic dry cough. All anti-hypertensives can cause dizziness, headache and low blood pressure.

Again, there are many nutraceutical options for patients to consider, such as CoQ10, magnesium, garlic extracts, omega-3 fatty acids, L-arginine and vitamin C. All of these have all been shown to lower high blood pressure by various means. Dandelion leaf is an effective diuretic that doesn’t lower potassium levels.

What evidence supports the use of naturopathic treatments?

I could find no published evidence that coenzyme-q10, magnesium, garlic, omega-3 fatty acids, l-arginine, or vitamin C supplements reduce the risk of heart attacks, stroke, heart failure, or kidney disease. There is some evidence to show that eating fatty fish (a source of omega-3 fatty acids) can reduce the risk of heart disease or stroke. Omega-3 supplements (also discussed above for hypercholesterolemia) may modestly reduce blood pressure. None of the products listed are considered both safe and effective for treatment of hypertension by the Natural Medicines database. I could find no published evidence that demonstrates dandelion leaf is an effective hypertension treatment.

What approach has the best evidence?

The only reason to treat hypertension with a drug or supplement is to reduce the risk of a future catastrophic event. If medicine is necessary, there’s little reason to choose a “natural” remedy first, as the real-world benefits of supplements have not been proven.

Benzodiazepines for anxiety and insomnia

Why do we treat it?

The term “anxiety” describes worries and fears that are difficult to control and can cause debilitating effects. Insomnia describes difficulty falling asleep or staying asleep. We treat both to reduce the consequences of these conditions, and to restore normal functioning.

When is drug treatment appropriate?

After a workup for underlying causes of anxiety or insomnia, drug therapy might be considered after options like lifestyle changes and cognitive behavioral therapy have been attempted. Benzodiazepines are a class of drugs that can be useful treatments for anxiety and insomnia, though they are usually not the first choice for either condition. There are justified concerns about dependence and tolerance with benzodiazepines, reinforcing the importance of using these medications cautiously and when the benefits are expected to outweigh the risks.

What benefits have drugs been shown to offer?

Benzodiazepines can work quickly and can be effective in anxiety where there’s a poor response to other medications. They are also effective insomnia treatments, with some taking effect within minutes.

What does naturopathy suggest?

As per Dinsmore:

Benzodiazepines are a class of drugs most often prescribed for anxiety disorders and insomnia. They work by binding to receptors for GABA, a neurotransmitter in the brain that calms activity of the nervous system. Interestingly, this is the same mechanism by which alcohol acts in the brain. One obvious effect of benzodiazepines is sedation—great when the treatment target is insomnia. Not so great when you just want to decrease your anxiety but still function. Other side effects include dizziness, loss of balance, and even cognitive impairment at higher doses. They also have a significant risk of developing physical or psychological dependence and rebound anxiety when discontinued.

This is an area where you should have a thorough workup with your naturopathic doctor and consider the options that are right for you. You can take GABA as an alternative (but there’s mixed evidence on whether or not it actually gets into the brain), or herbs such as passionflower (which has the same mechanism of action as benzodiazepines). Other herbs include valerian, chamomile, kava, and many others.

What evidence supports the use of naturopathic treatments?

Up-to-Date has a nice summary:

A variety of herbal products are purported to be useful for insomnia. There is little evidence from randomized controlled trials about the efficacy of many herbals, however, and for those that have been well studied (eg, valerian), there is little evidence of benefit. A meta-analysis that included 14 randomized trials in over 1600 patients found no significant difference between any herbal medicine and placebo on any of 13 clinical efficacy measures of insomnia [94]. The majority of the trials (11 out of 14) studied valerian; chamomile, kava, and wuling were studied in one trial each. Unlike the other herbals studied, valerian was associated with a greater number of adverse events per person compared with placebo. Valerian may also produce hepatotoxic effects [1]. Contamination with undesirable substances poses a problem for many such natural remedies.

And for natural treatments of anxiety, Up-to-Date notes:

None of the herbal remedies described here been shown in clinical trials to be clearly effective or ineffective for anxiety symptoms or disorders. Trials suggest that kava and chamomile may reduce anxiety in some people with generalized anxiety disorder (GAD). Findings from trials of valerian, passion flower, and St. John’s wort are either mixed or negative. Patients may wrongly equate “herbal” with terms such as “good,” “weak,” or “healthy” in evaluating these remedies. These perspectives underestimate their potential risks; some herbs can be potent, poisonous, or addictive. Potentially serious adverse effects of herbal remedies discussed here include hepatotoxicity with kava and anticoagulation with chamomile. It is not known if these remedies are safe or unsafe during pregnancy.

What approach has the best evidence?

It’s understandable to want to avoid benzodiazepines, but they can provide real and demonstrated benefit in select circumstances with close monitoring from a physician. There’s a lack of evidence to demonstrate the efficacy and safety of any of the herbal remedies recommended for the treatment of anxiety or insomnia.

Conclusion: The evidence simply doesn’t support these natural treatments

Naturopaths claim that they can effectively manage medical conditions with “natural” approaches, but the evidence supporting these recommendations has been consistently shown to be absent or weak. It may be that the treatment goals are not understood, which may explain why therapies without any demonstrated benefit are being recommended before proven therapies. In some cases, avoiding drug therapy and using natural remedies may be harmful. In light of the recommendations above, it seems prudent to discuss any naturopathic advice with a health professional like a pharmacist or physician before making any decision to delay medically-recommended drug therapy, or substitute a natural remedy or dietary supplement.

This is a cross-post from Science-Based Medicine. Comments are open there.

Photo from flickr user Ryan Somma used under a CC licence.

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Dec 192015
 
Reiki is as science-based as The Force

Reiki is as science-based as The Force

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:

The evidence

Alexander technique

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

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

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

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.

Feldenkrais

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/western herbalism

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

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

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

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.

Massage therapy

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.

Naturopathy

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

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

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

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

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

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

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.

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