MD, PhD, FMedSci, FSB, FRCP, FRCPEd

test of time

The ‘Deutsche Apotheker Zeitung’, a paper for German pharmacists, rarely is the most humorous of publications. However, recently they reported on a battle between the EU and the European producers of homeopathic remedies – a battle over mercury which has, I think, hints of Monty Python and the Flying Circus.

The EU already has strict regulations on the use of mercury, for obvious reasons, they apply particularly to medicines. The law in this area is now 8 years old and is about to be replaced by a new one which is even stricter. A draft has been recently published here.

The new law would prohibit all mercury in medicinal products, except for some used in dentistry. For the homeopathic and anthroposophic manufacturers, this is not good news because they have many remedies on the market that have the word ‘mercury’ on the label. Consequently, they fear that the sale of these products might be impeded or even become impossible in the EU.

„Quecksilber und Quecksilberverbindungen stellen für manche homöopathische und andere traditionelle Arzneimittel einen unverzichtbaren Bestandteil dar“ (Mercury and mercury compounds are an essential ingredient of some homeopathic and other traditional medicines) .. “Es steht keine Quecksilber-freie Alternative zur Verfügung, die als aktiver Bestandteil in der Therapie mit homöopathischen oder anderen traditionellen Arzneimitteln verwendet werden könnte“ (There is no mercury-free alternative that could be used in these medications”) wrote the Dachverband der Arzneimittelhersteller im Bereich der Selbstmedikation (AESGP) (a lobby group of the homeopathic manufacturers) in a comment adding that „Diese Produkte sind seit Dekaden auf dem europäischen Markt und gehören zum Arzneimittel-Werkzeugkoffer” (these products are on the market since decades and belong to the medical tool-kit)… and that these products contain merely tiny amounts of mercury – even the largest manufacturers of these remedies only require a few milligrams for their production.

The plea of the manufacturers therefore is for an exemption from the new law which would allow the trade of mercury-containing remedies in future. They even have the support of some health politicians; for instance Peter Liese CDU favours an exemption for homeopathic medicines. The next meeting of the EU committee on public health will vote on the matter.

Personally, I can imagine the following dialogue between the EU officials (EU) and the lobbyists of the homeopathic industry (LOHI):

EU: We are very sorry but, because of the toxicity of mercury, we will not allow any of it in medicines.

LOHI: But we have always used it and nobody has come to harm.

EU: We don’t know that, and we have to be strict.

LOHI: We appreciate your concern, but we use only very, very tiny amounts; they cannot cause harm.

EU: The law is the law!

LOHI: Actually, the vast majority of our products are so dilute that they do not contain a single molecule of the ingredient on the bottle.

EU: That’s interesting! In this case, they are not medicines and we will have to ban them.

LOHI: NO, no, no – you don’t understand. We potentise our medicines; this means that the ingredient that they no longer contain gets more and more powerful.

EU: Are you sure?

LOHI: Absolutely!

EU: In this case, we will ban not just your mercury products but all your phony remedies. Because either science is right and they are fraudulent, or you are correct and they are dangerous.

Dengue is a viral infection spread by mosquitoes; it is common in many parts of the world. The symptoms include fever, headache, muscle/joint pain and a red rash. The infection is usually mild and lasts about a week. In rare cases it can be more serious and even life threatening. There’s no specific treatment – except for homeopathy; at least this is what many homeopaths want us to believe.

And, of course, we don’t want to listen to just any odd homeopath, we want true experts to tell us the truth – for instance, experts like Dr. R.K. Manchanda, Deputy Director(Homoeopathy), Directorate of ISM & Homoeopathy, Govt. of NCT of Delhi and Dr. Surinder Verma, Assistant Director (Homoeopathy), Directorate of ISM & Homoeopathy, Govt. of NCT of Delhi. They authored an article which states the following:

There are about 25 homoeopathic drugs available for the treatment of dengue fever. These are Aconite., Arnica, Arsenic-alb., Arum-tri., Baptisia., Belladonna., Bryonia., Cantharis., China officinalis Colocynthis., Eupatorium perfoliatum., Ferrum metallicum., Gelsemium., Hamamelis., Ipecac., Lachesis, Merc-sol, Nux vomica., Podophyllum., Rhus toxicodendron., Rhus-venenata., Sanicula., Secale cornutum and Sul-acidum. These drugs had been successfully used by various homeopaths across the globe for its treatment and management. In 1996 during the epidemic of dengue in Delhi Eupatorium perfoliatum was found most effective.

Sadly, the article does not provide any evidence. A quick Medline search located one (!) single trial on the subject. Here is the abstract:

A double-blind, placebo-controlled randomized trial of a homeopathic combination medication for dengue fever was carried out in municipal health clinics in Honduras. Sixty patients who met the case definition of dengue (fever plus two ancillary symptoms) were randomized to receive the homeopathic medication or placebo for 1 week, along with standard conventional analgesic treatment for dengue. The results showed no difference in outcomes between the two groups, including the number of days of fever and pain as well as analgesic use and complication rates. Only three subjects had laboratory confirmed dengue. An interesting sinusoidal curve in reported pain scores was seen in the verum group that might suggest a homeopathic aggravation or a proving. The small sample size makes conclusions difficult, but the results of this study do not suggest that this combination homeopathic remedy is effective for the symptoms that are characteristic of dengue fever.

This is a 2007 study by a well-known US homeopath. Its results fail to confirm that homeopathy is effective for Dengue. So, surely the homeopathic community has since stopped claiming that homeopathy is an option for this infection!

No, you guessed correctly, they continue claiming that homeopathy works for Dengue. Currently, there are about half a million websites doing exactly that. An example is this article published YESTERDAY (!):

Alopathy is no more the only solution for Dengue these days. Especially in a place like Bengaluru where doctors and medicines are both expensive, residents have now turned to a cheaper and an effective alternative-Homeopathy to combat Dengue.People have been milling Homeopathy clinics and hospitals for an antidote. Dr Sudhir Babu of Javaji Advanced Homeopathy said, “People ask for some cure to keep the disease at bay. We do in fact have medicines to help build immunity against the ailment.”The dosage is for four or five days and is taken daily. Homeopathy has now become a trusted alternative in the field of medicine, especially because of its easy acceptibility among children and adults. According to a survey by IMRB, 100% people know about this form of medicine and 92% perceive it as a reputed form of treatment. The medicines that are administered depending on the symmptoms of Dengue Fever are Aconitum Napellus, Arsenicum Album, Belladonna, Bryonia Alba, Cantharis, Cinchona Officinalis, Eupatorium Perfoliatum, Gelsemium, Ipecacuanha, Nux Vomica, Rhus Toxicodendron and Rhus Venenata.

What I found particularly impressive here is the way popularity has been used to replace evidence. This, I think, begs several questions:

  • How long will homeopaths continue treating self-limiting conditions to claim success based no nothing but their natural history?
  • How long will they continue to lie to the public?
  • How long will they refuse to learn from the evidence?
  • How long will they ignore even the most fundamental rules of medical ethics?
  • How long will we let them get away with all this?

Moxibustion is an ancient variation of acupuncture using  moxa made from dried mugwort (Artemisia argyi). It has long played an important role in the traditional heath care systems of China and other Asian countries. More recently, it has become popular also in the West. Practitioners use moxa sticks indirectly to warm acupuncture needles, or burn it close to the patient’s skin. Essentially, moxibustion is a treatment where acupuncture points are stimulated mainly or exclusively by the heat of burning moxa.

Because of moxibustion’s long history of usage and the fact that it is employed in many countries for a very wide range of conditions, some might argue that it has stood the ‘test of time’ and should be considered to be a well-established therapy. More critical thinkers would, however, point out that this is not an argument but a classical fallacy.

My team at Exeter regularly had research fellows from Korea and other Asian countries, and we managed to develop a truly productive cooperation. It enabled us to conduct systematic reviews including the Asian literature – and this is how we got involved in an unusual amount of research into moxibustion which, after all, is a fairly exotic alternative therapy. In 2010, we began a series of systematic reviews of moxibustion.

One of the first such articles included 9 RCTs testing the effectiveness of this treatment for stroke rehabilitation. Three RCTs reported favorable effects of moxibustion plus standard care on motor function versus standard care alone Three randomized clinical trials compared the effects of moxibustion on activities of daily living alone but failed to show favorable effects of moxibustion.

Also in 2010, our systematic review of RCTs of moxibustion as a treatment of ulcerative colitis (UC) concluded that current evidence is insufficient to show that moxibustion is an effective treatment of UC. Most of included trials had high risk of bias. More rigorous studies seem warranted.

Our (2010) systematic review od RCTs of moxibustion as a therapy in cancer care found that the evidence was limited to suggest moxibustion is an effective supportive cancer care in nausea and vomiting. However, all studies had a high risk of bias so effectively there was not enough evidence to draw any conclusion.

Our (2010) systematic review of RCTs of moxibustion for treating hypertension concluded that there was insufficient evidence to suggest that moxibustion is an effective treatment for hypertension.

Our (2010) systematic review of RCTs of moxibustion for constipation concluded as follows: Given that the methodological quality of all RCTs was poor, the results from the present review are insufficient to suggest that moxibustion is an effective treatment for constipation. More rigorous studies are warranted.

Our (2010) systematic review found few RCTs were available that test the effectiveness of moxibustion in the management of pain, and most of the existing trials had a high risk of bias. Therefore, more rigorous studies are required before the effectiveness of moxibustion for the treatment of pain can be determined.

Our (2011) systematic review of 14 RCTs of moxibustion for rheumatic conditions failed to provide conclusive evidence for the effectiveness of moxibustion compared with drug therapy in rheumatic conditions.

The, so far, last article in this series has only just been published. The purpose of this systematic review was to assess the efficacy of moxibustion as a treatment of chemotherapy-induced leukopenia. Twelve databases were searched from their inception through June 2014, without a language restriction. Randomized clinical trials (RCTs) were included, if moxibustion was used as the sole treatment or as a part of a combination therapy with conventional drugs for leukopenia induced by chemotherapy. Cochrane criteria were used to assess the risk of bias.

Six RCTs with a total of 681 patients met our inclusion criteria. All of the included RCTs were associated with a high risk of bias. The trials included patients with various types of cancer receiving ongoing chemotherapy or after chemotherapy. The results of two RCTs suggested the effectiveness of moxibustion combined with chemotherapy vs. chemotherapy alone. In four RCTs, moxibustion was more effective than conventional drug therapy. Six RCTs showed that moxibustion was more effective than various types of control interventions in increasing white blood cell counts.

Our conclusion: there is low level of evidence based on these six trials that demonstrates the superiority of moxibustion over drug therapies in the treatment of chemotherapy-induced leukopenia. However, the number of trials, the total sample size, and the methodological quality are too low to draw firm conclusions. Future RCTs appear to be warranted.

Was all this research for nothing?

I know many people who would think so. However, I disagree. If nothing else, these articles demonstrated several facts quite clearly:

  • There is quite a bit of research even on the most exotic alternative therapy; sometimes one needs to look hard and include languages other than English.
  • Studies from China and other Asian counties very rarely report negative results; this fact casts a dark shadow on the credibility of such data.
  • The poor quality of trials in most areas of alternative medicine is lamentable and must be stimulus for researchers in this field to improve their act.
  • Authors of systematic reviews must resist the temptation to draw positive conclusions based on flawed primary data.
  • Moxibustion is a perfect example for demonstrating that the ‘test of time’ is no substitute for evidence.
  • As for moxibustion, it cannot currently be considered an evidence-based treatment for any condition.

We have probably all fallen into the trap of thinking that something which has stood the ‘test of time’, i.e. something that has been used for centuries with apparent success, must be ok. In alternative medicine, this belief is extremely wide-spread, and one could argue that the entire sector is built on it. Influential proponents of ‘traditional’ medicine like Prince Charles do their best to strengthen this assumption. Sadly, however, it is easily disclosed as a classical fallacy: things that have stood the ‘test of time’ might work, of course, but the ‘test of time’ is never a proof of anything.

A recent study brought this message home loud and clear. This trial tested the efficacy of Rhodiola crenulata (R. crenulata), a traditional remedy which has been used widely in the Himalayan areas and in Tibet to prevent acute mountain sickness . As no scientific studies of this traditional treatment existed, the researchers conducted a double-blind, placebo-controlled crossover RCT to test its efficacy in acute mountain sickness prevention.

Healthy adult volunteers were randomized to two treatment sequences, receiving either 800 mg R. crenulata extract or placebo daily for 7 days before ascent and two days during mountaineering. After a three-month wash-out period, they were crossed over to the alternate treatment. On each occasion, the participants ascended rapidly from 250 m to 3421 m. The primary outcome measure was the incidence of acute mountain sickness with headache and at least one of the symptoms of nausea or vomiting, fatigue, dizziness, or difficulty sleeping.

One hundred and two participants completed the trial. No significant differences in the incidence of acute mountain sickness were found between R. crenulata extract and placebo groups. If anything, the incidence of severe acute mountain sickness with Rhodiola extract was slightly higher compared to the one with placebo: 35.3% vs. 29.4%.

R. crenulata extract was not effective in reducing the incidence or severity of acute mountain sickness as compared to placebo.

Similar examples could be found by the dozen. They demonstrate very clearly that the notion of the ‘test of time’ is erroneous: a treatment which has a long history of usage is not necessarily effective (or safe) – not only that, it might be dangerous. The true value of a therapy cannot be judged by experience, to be sure, we need rigorous clinical trials. Acute mountain sickness is a potentially life-threatening condition for which there are reasonably effective treatments. If people relied on the ‘ancient wisdom’ instead of using a therapy that actually works, they might pay for their error with their lives. The sooner alternative medicine proponents realise that, the better.

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