I think I must have mentioned this once or twice before: I am constantly on the look-out for new evidence which shows or suggests that some form of alternative medicine works. Today, it seems, I have been lucky.
In this randomised, double-blind, placebo-controlled clinical trial, 200 patients suffering from chronic obstructive pulmonary disease (COPD) were randomly allocated to receive oral therapy with 3 × 30 drops/day of an extract of Pelargonium sidoides (EPs 7630) or placebo. Both treatments were administered in addition to standardised COPD- therapies, and the treatment period lasted 24 weeks. The primary endpoint of this study was the time to the next exacerbation of COPD. Secondary endpoints were the number of such exacerbations, consumption of antibiotics, quality of life, patient satisfaction, inability to work, and the tolerability of the treatment.
The results show that the median time to exacerbation was significantly prolonged with the herbal treatment compared to placebo (57 versus 43 days). The superiority of EPs 7630 over placebo was also confirmed in secondary endpoints, e.g., fewer exacerbations, less patients with antibiotic use, improved quality of life, higher patient satisfaction, and less days of inability to work. The incidence of minor gastrointestinal adverse events was higher in the EPs 7630 group.
The authors of the study conclude that “the results demonstrate a statistically significant and clinically relevant superiority of add-on therapy with EPs 7630 over placebo and a good long-term tolerability in the treatment of moderate to severe COPD. EPs 7630 prolonged time to exacerbations and reduced exacerbation frequency and antibiotic use.”
Chronic obstructive pulmonary disease, is a progressive and serious condition linked to smoking which makes breathing increasingly difficult. The symptoms of COPD typically include a productive cough, wheezing, shortness of breath and chest tightness. Long-term exposure to other lung irritants—such as air pollution, chemical fumes, or dust may contribute to COPD. The condition is a major cause of disability, and currently it is the third leading cause of death, which means that millions of people suffer from COPD.
There is no cure for COPD; the damage to the airways and lungs is not reversible. Various symptomatic treatments exist, for instance, antibiotics, bronchio-dilators, steroids and physiotherapy. Lifestyle changes can further improve the situation, help patients to stay more active, and slow the progress of the disease.
It is clear that COPD is a very serious condition, that the burden of suffering for individual patients can be immense, that therapeutic options are limited and often associated with adverse-effects. In this situation, any new effective and safe therapy would be more than welcome. Pelargonium has previously shown promise in the treatment of asthma, acute bronchitis as well as other respiratory infections. It seems generally safe but is not totally devoid of adverse-effects.
This new study gives hope to COPD-sufferers as it suggests that Pelargonium sidoides might alleviate their symptoms. The trial seems rigorous but the benefit is not huge and the treatment is not a cure of COPD. Moreover, I should point out that any new finding of this nature requires independent confirmations. I do think that the trial is an important step in the right direction, yet I feel that it is too early for issuing general recommendations.
The developed world is in the middle of a major obesity epidemic. It is predicted to cause millions of premature deaths and billions of dollars, money that would be badly needed elsewhere. The well-known method of eating less and moving more is most efficacious but sadly not very effective, that is to say people do not easily adopt and adhere to it. This is why many experts are searching for a treatment that works and is acceptable to all or at least most patients.
Entrepreneurs of alternative medicine have long jumped on this band waggon. They have learnt that the regulations are lax or non-existent, that consumers are keen to believe anything they tell them and that the opportunities to make a fast buck are thus enormous. Today, they are offering an endless array of treatments which are cleverly marketed, for instance via the Internet.
Since many years, my research team are involved in a programme of assessing the alternative slimming aids mostly through systematic reviews and occasionally also through conducting our own clinical trials. Our published analyses include the following treatments:
Supplements containing conjugated linoleic acid
There are, of course, many more but, for most, no evidence exist at all. The treatments listed above have all been submitted to clinical trials. The results show invariably that the outcomes were not convincingly positive: either there were too few data, or there were too many flaws in the studies, or the weight reduction achieved was too small to be clinically relevant.
Our latest systematic review is a good example; its aim was to evaluate the evidence from randomized controlled trials (RCTs) involving the use of the African Bush Mango, Irvingia gabonensis, for body weight reduction in obese and overweight individuals. Three RCTs were identified, and all had major methodological flaws. All RCTs reported statistically significant reductions in body weight and waist circumference favoring I. gabonensis over placebo. They also suggested positive effects of I. gabonensis on blood lipids. Adverse events included headache and insomnia. Despite these apparently positive findings, our conclusions had to be cautious: “Due to the paucity and poor reporting quality of the RCTs, the effect of I. gabonensis on body weight and related parameters are unproven. Therefore, I. gabonensis cannot be recommended as a weight loss aid. Future research in this area should be more rigorous and better reported.”
People who want to loose weight are often extremely desperate and ready to try anything. They are thus easy victims of the irresponsible promises that are being made on the Internet and elsewhere. Despite the overwhelmingly evidence to the contrary, consumers are led to believe that alternative slimming aids are effective. What is more, they are also misled to assume they are risks-free. This latter assumption is false too: apart from the harm done to the patient’s bank account, many alternative slimming aids are associated with side-effects which, in some cases, are serious and can even include death.
The conclusion from all this is short and simple: alternative slimming aids are bogus.
There are at least two dramatically different kinds of herbal medicine, and the proper distinction of the two is crucially important. The first type is supported by some reasonably sound evidence and essentially uses well-tested herbal remedies against specific conditions; this approach has been called by some experts RATIONAL PHYTOTHERAPY. An example is the use of St John’s Wort for depression.
The second type of herbal medicine. It entails consulting a herbal practitioner who takes a history, makes a diagnosis (usually according to obsolete concepts) and prescribes a mixture of several herbal remedies tailor-made to the characteristics of his patient. Thus 10 patients with the identical diagnosis (say depression) might receive 10 different mixtures of herbs. This is true for individualized herbalism of all traditions, e.g. Chinese, Indian or European, and virtually every herbalist you might consult will employ this individualized, traditional approach.
Many consumers know that, in principle, there is some reasonably good evidence for herbal medicine. They fail to appreciate, however, that this does only apply to (sections of) rational phytotherapy. So, they consult herbal practitioners in the belief that they are about to receive an evidence-based therapy. Nothing could be further from the truth! The individualised approach is not evidence-based; even if the individual extracts employed were all supported by sound data (which they frequently are not) the mixutres applied are clearly not.
And this is where the danger of traditional herbalism lies; over the years, herbalists have fooled us all with this fundamental misunderstanding. In the UK, they might even achieve statutory regulation on the back of this self-serving misconception. When this happens, we would have a situation where a completely unproven practice has obtained the same status as doctors, nurses and physiotherapists. If this is not grossly misleading for the consumer, I do not know what is!!!
Some claim that individualized herbalism cannot be tested in clinical trials. This notion can very easily be shown to be wrong: several such studies testing individualized herbalism have been published. To the dismay of traditional herbalists, their results fail to confirm that such treatments are effective for any condition.
Now a further trial has become available that importantly contributes to this knowledge-base. Its authors (all enthusiasts of individualized herbalism) randomized 102 patients suffering from hip or knee-osteoarthritis into two groups. The experimental group received tailor-made mixtures of 7 to 10 Chinese herbs which were traditionally assumed to be helpful. The control group took a mixture of plants known to be ineffective but tasting similar. After 20 weeks of treatment, there were no differences between the groups in any of the outcome measures: pain, stiffness and function. These results thus confirm that this approach is not effective. Not only that, it also carries more risks.
As individualized herbalism employs a multitude of ingredients, the dangers of adverse-effects and herb-drug interactions, contamination, adulteration etc. are bigger that those with the use of single herbal extracts. It seems to follow therefore that the risks of individualized herbalism do not outweigh its benefit.
My recommendations are thus fairly straight forward: if we consider herbal medicine, it is vital to differentiate between the two types. Rational phytotherapy might be fine – of course, depending on the remedy and the condition we are aiming to treat. Individualised or traditional herbalism is not fine; it is not demonstrably effective and has considerable risks. This means consulting a herbalist is not a reasonable approach to treating any human ailment. It also means that regulating herbalists (as we are about to do in the UK) is a seriously bad idea: the regulation of non-sense will result in non-sense!
I don’t suppose that many readers of this blog believe all things natural to be entirely safe, but the general public seems to be hard-wired victims of this myth: Mother Nature is benign, and herbal remedies must be harmless!
There are, of course, several reasons why supposedly “natural” herbal treatments can be unsafe. Plants extracts can be toxic, they might interact with prescribed drugs or they can be contaminated or adulterated.
The latter two terms describe similar but not identical phenomena: contamination means the accidental addition of substances which should not be present in an herbal remedy; and adulteration signifies the deliberate addition of ingredients. If the substances in question are not pharmacologically inert, their presence in herbal remedies can cause adverse effects.
Both contamination and adulteration break laws and regulations; both are therefore illegal. Sadly, this does not mean that such things do not happen.
We have recently published an overview of the existing knowledge in this area. For this purpose, we summarised the evidence from 26 previously published reviews. Our findings were interesting but far from reassuring: the most commonly found contaminants were dust, pollen, insects, rodents, parasites, microbes, fungi, mould, pesticides, and heavy metals. The adulterants invariably were prescription drugs such as steroids, anti-diabetic medications etc.
These substances were implicated in a wide range of serious adverse effects in the unfortunate patients who took the remedies in question: agranulocytosis, meningitis, multi-organ failure, stroke, arsenic poisoning, mercury poisoning, lead poisoning, caner, encephalopathy, hepato-renal syndrome, kidney damage, rhabdomyolosis, metabolic acidosis, renal failure, liver failure, cerebral oedema, coma, and intra-cerebral bleeding. Several patients did not survive.
To avoid such disasters, consumers need to know which types of herbal remedies are most frequently implicated; our review showed that these were foremost Chinese and Indian remedies. While herbal medicines from the US or Europe ought to comply with certain rules and regulations regarding their quality and safety, Chinese and Indian herbal mixtures frequently enter our countries illegally or are bought from dubious sources, for instance, over the Internet. It is this type of herbal remedy that we should be concerned about.
We have to ask whether the risks outweigh the proven benefits of Chinese or Indian herbal mixtures. The short answer to this question is NO. There is very little compelling evidence to suggest that these treatments are efficacious. In the absence of proven benefit, even small or rare risks weigh heavily.
If the risk-benefit profile for any medical intervention fails to be positive, there can only be one reasonable conclusion regarding the use of this therapy – and that is: DON’T DO IT!
Guest post by Louise Lubetkin
A while ago this sardonic little vignette, titled Medicine Through the Ages, was doing the rounds on the Internet:
2000 B.C. – Here, eat this root.
1000 A.D. – That root is pagan. Here, say this prayer.
1750 A.D. – That prayer is superstition. Here, drink this potion.
1900 A.D. – That potion is snake oil. Here, swallow this pill.
1985 A.D. – That pill is ineffective. Here, take this antibiotic.
2000 A.D. – That antibiotic is unnatural. Here, eat this root.
We seem to have come full circle. The idea of health as a personal goal, something that can be achieved by taking nutritional supplements such as herbal preparations, vitamins and minerals, is a fundamental tenet of alternative medicine. Consequently the rise of alternative medicine has been accompanied by a parallel rise in the use of dietary supplements.
Most people assume that dietary supplements, like pharmaceuticals, are thoroughly tested before being allowed onto the market, and that in any case because they are “natural” they are ipso facto safe.
Neither assumption is correct.
First of all, it is a great mistake to assume that all “natural” substances are harmless and therefore fit for consumption. (Fugu anyone? Perhaps with some sautéed Amanita mushrooms?) Secondly, unlike pharmaceuticals, which must undergo protracted pre-market testing for safety and efficacy, dietary supplements need not undergo even rudimentary testing before being sold over the counter to the public.
Supplement usage is at an all-time high. Currently, almost 50 percent of us regularly take supplements. The older you are, the more likely you are to take them: usage climbs to 70 percent amongst people 70 years and older. Similarly, the more formal education you have had, and the higher your income level, the more likely you are to be a regular consumer of dietary supplements.
Our collective enthusiasm for taking supplements has undoubtedly done considerably more for the health of the supplement industry than it has for that of the public. There is mounting research evidence to suggest that taking dietary supplements may neither be as safe nor beneficial to health as has previously been assumed (more on this in another post). Nevertheless, physicians seem to be just as vulnerable as the rest of us to the blandishments of the supplement industry. According to one study published in the Journal of Nutrition, 75 percent of dermatologists, 73 percent of orthopedists and 57 percent of cardiologists reported personally using dietary supplements. An earlier study by the same research group found that a staggering 79 percent of physicians and 82 percent of nurses reported recommending dietary supplements to their patients. Of course the fact that supplements come with a personal recommendation by a physician only serves to reinforce the public’s ill-founded presumption of safety.
The manufacture and sale of supplements is a hugely profitable business, generating more than $25 billion in annual sales and contributing an estimated $60 billion to the US economy. While most other industries have languished during the current economic downturn, the supplement industry has grown steadily: overall, between 2008 and 2012, sales of supplements rose by 31.7 percent.
(Ironically, the huge popularity of these so-called “natural” health products has not escaped the notice of agribusiness and pharmaceutical giants such as Kellogg’s, Pfizer, Monsanto and others, all of which have now begun manufacturing and marketing nutritional supplements of their own.)
None of this would have been possible had it not been for the 1994 enactment by the US Congress of the Dietary Supplement Health and Education Act (DSHEA), an extraordinarily ill-conceived piece of legislation that drastically weakened the FDA’s regulatory control over vitamins, minerals, herbal, botanical and other “traditional” medical products. Prior to DSHEA, these products were classified as drugs and were therefore subject to FDA regulation. By reclassifying them as foods rather than drugs DSHEA effectively removed dietary supplements from FDA regulatory oversight. As a result, supplement manufacturers became exempt from any obligation to perform pre-market testing for purity, safety or effectiveness, and it became infinitely harder for the FDA to detect unsafe products and quickly remove them from the market.
While the FDA does have the authority to insist that manufacturers refrain from making unsubstantiated health claims, it no longer has the power to mandate removal of unsafe products from the market without first clearing the almost insurmountable legal hurdle of proving significant risk. In other words, DSHEA inverts the responsibility for ensuring safety. Before the FDA can act, consumers must first be harmed sufficiently seriously, and in sufficient numbers, to trigger an investigation.
In one fell legislative swoop, DSHEA dished up a profit bonanza to the supplement industry while simultaneously robbing the public of any meaningful protection. Thus disencumbered of all but token regulation, the dietary supplement industry quickly burgeoned. In 1994, when DSHEA was enacted, there were just 4,000 dietary supplements on the market. Today there are more than 75,000.
The brave new world spawned by DSHEA is well exemplified by the ephedra case. Herbal weight loss supplements containing the plant alkaloids ephedra and ephedrine were linked to a string of over 150 deaths and countless other serious adverse events. Metabolife, the manufacturer of the supplement, received 15,000 complaints of adverse events – including deaths – related to the product, yet was under no obligation to alert the FDA, and (not surprisingly) chose not to do so.
It took a full 10 years of intense legal fighting for the FDA to succeed in getting ephedra-containing supplements removed from the market. Undeterred, powerful industry lobbying groups and vociferous opponents of regulation mounted a successful appeal challenging the legality of the FDA ban, and ephedra supplements once again went on sale in several states. The ruling against FDA was eventually overturned on appeal and the ephedra ban was upheld, but the cost, difficulty and duration of the legal process of restricting access to this dangerous “natural” supplement was staggering. Yet even now, despite the FDA’s hard-won ban on ephedra, it is perfectly legal to buy ephedrine hydrochloride – an extract of ephedra – over the counter in the US, where it is marketed for sale without prescription as a bronchodilator and nasal decongestant. The only restriction on its sale is that it must be presented in pill form with dosage not exceeding 8mg, and the label cannot promote it as a weight loss aid – a restriction which can be sidestepped with the greatest of ease, as this website, with the in-your-face domain name ephedrinediet.org, vividly demonstrates.
Perhaps not surprisingly, the ephedra case is the only time the FDA has attempted to force the removal of a dangerous supplement from the market. Hamstrung by DSHEA, the FDA can do little more than exert its limited authority over the wording on supplement labels to ensure that manufacturers make no explicit claims that their products may be used prevent, cure or treat a specific disease. However, the lack of seriousness with which an increasingly confident supplement industry takes the FDA and its semantic policing powers is well illustrated by the following statement which appears in a recent report published by the Natural Products Foundation, an industry umbrella and lobbying group:
Healthy consumers use supplements to decrease their risk of heart disease, boost their immune systems, prevent vision loss, build strong bones, or prevent birth defects. Less healthy or ill consumers turn to supplements as an alternative to traditional medical treatments, to either complement prescription drugs they may be taking or substitute supplements for prescription drugs they either cannot afford or do not trust.
There are encouraging signs that concern about the dangers posed by an largely unregulated supplement industry may at last be growing, although industry and grass-roots opposition to attempts to repeal DSHEA have been well organized, well funded and vociferous. Even so, in 2007, largely as a result of public unease over the FDA’s protracted struggle to ban ephedra, DSHEA was amended to make reporting of serious adverse events such as death, life-threatening emergencies, inpatient hospitalizations or significant, persistent incapacities, mandatory. As a result of this amendment, in the first 9 months of 2008 alone, the FDA received almost 600 reports of serious adverse events arising from the use of dietary supplements. Moreover, the FDA believes that adverse events are being seriously under-reported, and that the annual number of supplement-related adverse events in the US is close to 50,000.
Perhaps it will take another ephedra disaster to make us rethink DSHEA, take the handcuffs off the FDA and begin looking more critically at the notion that dietary supplements are intrinsically beneficial and harmless.
In the meantime, here’s the 2013 addendum to Medicine Through the Ages:
2000 A.D. – That antibiotic is unnatural. Here, eat this root.
2013 A.D. – Has that root been assayed for adulterants, standardized for potency and purity? Has that root been approved by the FDA following clinical trials to establish dosage, efficacy and safety? Is the use of that root use evidence-based? Is it safe to take that root concurrently with other roots? Are there any contraindications? My diet already contains roots; will taking more be too much?
Whenever I lecture on the topic of alternative medicine for cancer, the first comment from the audience usually is “aren’t there any herbal treatments that are effective?” This is of course a most reasonable question; after all, many conventional cancer drugs originate from the plant kingdom – think of Taxol, for instance.
My answer often upsets believers in alternative cancer remedies. I tell them that, no, there is none and, even worse, there never will be one.
Did I just contradict myself? Did I not just state that many cancer drugs come from plants? Yes, but once the pure ingredient is isolated and synthetized, the drug ceases to be an herbal remedy which is defined as an extract of all the plant’s ingredients, not just one isolated constituent.
And why am I so depressingly pessimistic about there ever being an herbal cancer cure? Because of a simple fact: as soon as a natural substance shows the slightest promise, scientists will analyse and test it. If this process turns out to be successful, we will have a new cancer drug – but not an effective herbal remedy. Again, think of Taxol.
Since almost a decade, colleagues and I have been working on a relatively little-known project called CAM cancer. It started as an EU-funded activity and is now coordinated by Norwegian researchers. Our main aim is to provide unbiased and reliable information about all sorts of alternative treatments for cancer.
Our team is large, hard-working, highly motivated and independent – we do not accept sponsorship from anyone who might want to influence the results of what we are publishing. It is probably fair to say that most individuals who give their time working for CAM cancer are more optimistic than I regarding the value of alternative treatments. Therefore, our publications are certainly not biased against them; if anything, they are a bit on the generous side.
Much of our work consists in generating rigorously researched and fully referenced summaries of the evidence. Before these get published, they are thoroughly peer-reviewed and, whenever necessary, they also get updated to include the newest data. A good proportion of the reviews relates to herbal treatments.
Here are the crucial bits from our conclusions about those herbal cancer remedies which we have so far investigated:
Aloe vera: …studies are too preliminary to tell whether it is effective.
Artemisia annua: …there is no evidence from clinical trials…
Black cohosh: …In all but one trial black cohosh extracts were not superior to placebo.
Boswellia: …No certain conclusions can be drawn…
Cannabis: …The use of cannabinoids for anorexia-cachexia-syndrome in advanced cancer is not supported by the evidence…
Carctol: … is not supported by evidence…
Chinese herbal medicine for pancreatic cancer: …the potential benefit… is not strong enough to support their use…
Curcumin: There is currently insufficient documentation to support the effectiveness and efficacy of curcumin for cancer…
Echinacea: …there is currently insufficient evidence to support or refute the claims… in relation to cancer management.
Essiac: There is no evidence from clinical trials to indicate that it is effective…
Garlic: Only a few clinical trials exist and their results are inconclusive.
Green tea: …the findings… are still inconclusive.
Milk vetch: Poor design and low quality… prohibit any definite conclusions.
Mistletoe: …the evidence to support these claims is weak.
Noni: …evidence on the proposed benefits in cancer patients is lacking…
PC-Spes: …the… contamination issues render these results meaningless. An improved PC-Spes2 preparation was evaluated in an uncontrolled study which did not confirm the encouraging results…
St John’s wort: …there are no clinical studies to show that St. John’s wort would change the natural history of any type of cancer…
Ukrain: …several limitations in the studies prevent any conclusion.
As you can see, so far, we have not identified a single herbal cancer treatment that demonstrably alters the natural history of cancer in a positive direction. To me, this suggests that my rather bold statements above might be correct.
Of course, there will be some enthusiasts who point out that the list is not complete; and they, of course, are correct: there are probably hundreds of herbal remedies that we have not yet dealt with. And, of course, for some of those the evidence might be more convincing – but somehow I doubt it; after all, we did try to tackle the most promising herbal remedies first.
My claim therefore stands: there never will be a herbal (or other alternative) cancer cure. But, please, feel free to convince me otherwise.