Edzard Ernst

MD, PhD, FMedSci, FSB, FRCP, FRCPEd

DOCTOR Jeffrey Collins, a chiropractor from the Chicago area, just sent me an email which, I think, is remarkable and hilarious - so much so that I want to share it with my readers. Here it is in its full length and beauty:

If you really think you can resolve all back pain syndromes with a pill then you are dumber than you look. I’ve been a chiropractor for 37 years and the primary difference between seeing me vs. an orthopedic surgeon for back pain is simple. When you have ANY fixation in the facet joint, the motor untitled is compromised. These are the load bearing joints in the spine and only an idiot would not realize they are the primary source of pain. The idea of giving facet blocks under fluoroscopy is so dark ages. Maybe you could return to blood letting. The fact that you attack chiropractors as being dangerous when EVERY DAY medical doctors kill people but that’s OK in the name of science. Remember Vioxx? Oh yeah that drug killed over 80,000 patients that they could find. It was likely double that. Oddly I have treated over 10,000 in my career and nobody died. Not one. I guess I was just lucky. I went to Palmer in Iowa. The best chiropractors come out of there. I should qualify that. The ones that have a skill adjusting the spine. 

I will leave you with this as a simple analogy most patients get. Anyone who has ever “cracked their knuckles” will tell you that they got immediate relief and joint function was restored instanter. That’s chiropractic in a nutshell. Not complicated and any chiropractor worth his salt can do that for 37 years without one adverse incident. A monkey could hand out pain pills and you know it. Only in America do you have to get a script to get to a drugstore so everybody gets a cut. What a joke. Somehow mitigating pain makes you feel better about yourselves when you are the real sham. Funny how chiropractors pay the LOWEST malpractice rates in the country. That must be luck as well. Where’s your science now? I would love to debate a guy like you face to face. If you ever come to Chicago email me and let’s meet. Then again guys like you never seem to like confrontation. 

I’ve enjoyed this and glad I found your site. Nobody reads the crap that you write and I found this by mistake. Keep the public in the dark as long as you can. It’s only a matter of time before it’s proven DRUGS ARE WORTHLESS.

I am pleased that DOCTOR Collins had fun. Now let me try to have some merriment as well.

This comment is a classic in several ways, for instance, it

  • starts with a frightfully primitive insult,
  • boasts of the author’s authority (37 years of experience) without mentioning anything that remotely resembles real evidence,
  • provides pseudoscientific explanations for quackery,
  • returns to insults (only an idiot return to blood letting),
  • uses classical fallacies (…medical doctors kill people),
  • returns to more boasting about authority (I went to Palmer in Iowa. The best chiropractors come out of there…),
  • injects a little conspiracy theory (…everybody gets a cut),
  • returns to insults (…you are the real sham… guys like you never seem to like confrontation.) 
  • and ends with an apocalyptic finish: It’s only a matter of time before it’s proven DRUGS ARE WORTHLESS.

I should not mock DOCTOR Collins, though; I should be thankful to him for at least two reasons. Firstly, he confirmed my theory that “Ad hominem attacks are signs of victories of reason over unreason“. Secondly, he made a major contribution to my enjoyment of this otherwise somewhat dreary bank holiday, and I hope the same goes for my readers.

Twenty years ago, when I started my Exeter job as a full-time researcher of complementary/alternative medicine (CAM), I defined the aim of my unit as applying science to CAM. At the time, this intention upset quite a few CAM-enthusiasts. One of the most prevalent arguments of CAM-proponents against my plan was that the study of CAM with rigorous science was quite simply an impossibility. They claimed that CAM included mind and body practices, holistic therapies, and other complex interventions which cannot not be put into the ‘straight jacket’ of conventional research, e. g. a controlled clinical trial. I spent the next few years showing that this notion was wrong. Gradually and hesitantly CAM researchers seemed to agree with my view – not all, of course, but first a few and then slowly, often reluctantly the majority of them.

What followed was a period during which several research groups started conducting rigorous tests of the hypotheses underlying CAM. All too often, the results turned out to be disappointing, to say the least: not only did most of the therapies in question fail to show efficacy, they were also by no means free of risks. Worst of all, perhaps, much of CAM was disclosed as being biologically implausible. The realization that rigorous scientific scrutiny often generated findings which were not what proponents had hoped for led to a sharp decline in the willingness of CAM-proponents to conduct rigorous tests of their hypotheses. Consequently, many asked whether science was such a good idea after all.

But that, in turn, created a new problem: once they had (at least nominally) committed themselves to science, how could they turn against it? The answer to this dilemma was easier that anticipated: the solution was to appear dedicated to science but, at the same time, to argue that, because CAM is subtle, holistic, complex etc., a different scientific approach was required. At this stage, I felt we had gone ‘full circle’ and had essentially arrived back where we were 20 years ago - except that CAM-proponents no longer rejected the scientific method outright but merely demanded different tools.

A recent article may serve as an example of this new and revised stance of CAM-proponents on science. Here proponents of alternative medicine argue that a challenge for research methodology in CAM/ICH* is the growing recognition that CAM/IHC practice often involves complex combination of novel interventions that include mind and body practices, holistic therapies, and others. Critics argue that the reductionist placebo controlled randomized control trial (RCT) model that works effectively for determining efficacy for most pharmaceutical or placebo trial RCTs may not be the most appropriate for determining effectiveness in clinical practice for either CAM/IHC or many of the interventions used in primary care, including health promotion practices. Therefore the reductionist methodology inherent in efficacy studies, and in particular in RCTs, may not be appropriate to study the outcomes for much of CAM/IHC, such as Traditional Korean Medicine (TKM) or other complex non-CAM/IHC interventions—especially those addressing comorbidities. In fact it can be argued that reductionist methodology may disrupt the very phenomenon, the whole system, that the research is attempting to capture and evaluate (i.e., the whole system in its naturalistic environment). Key issues that surround selection of the most appropriate methodology to evaluate complex interventions are well described in the Kings Fund report on IHC and also in the UK Medical Research Council (MRC) guidelines for evaluating complex interventions—guidelines which have been largely applied to the complexity of conventional primary care and care for patients with substantial comorbidity. These reports offer several potential solutions to the challenges inherent in studying CAM/IHC. [* IHC = integrated health care]

Let’s be clear and disclose what all of this actually means. The sequence of events, as I see it, can be summarized as follows:

  • We are foremost ALTERNATIVE! Our treatments are far too unique to be subjected to reductionist research; we therefore reject science and insist on an ALTERNATIVE.
  • We (well, some of us) have reconsidered our opposition and are prepared to test our hypotheses scientifically (NOT LEAST BECAUSE WE NEED THE RECOGNITION THAT THIS MIGHT BRING).
  • We are dismayed to see that the results are mostly negative; science, it turns out, works against our interests.
  • We need to reconsider our position.
  • We find it inconceivable that our treatments do not work; all the negative scientific results must therefore be wrong.
  • We always said that our treatments are unique; now we realize that they are far too holistic and complex to be submitted to reductionist scientific methods.
  • We still believe in science (or at least want people to believe that we do) - but we need a different type of science.
  • We insist that RCTs (and all other scientific methods that fail to demonstrate the value of CAM) are not adequate tools for testing complex interventions such as CAM.
  • We have determined that reductionist research methods disturb our subtle treatments.
  • We need pragmatic trials and similarly ‘soft’ methods that capture ‘real life’ situations, do justice to CAM and rarely produce a negative result.

What all of this really means is that, whenever the findings of research fail to disappoint CAM-proponents, the results are by definition false-negative. The obvious solution to this problem is to employ different (weaker) research methods, preferably those that cannot possibly generate a negative finding. Or, to put it bluntly: in CAM, science is acceptable only as long as it produces the desired results.

Linus Carl Pauling (1901 – 1994), the American scientist, peace activist, author, and educator who won two Nobel prizes, was one of the most influential chemists in history and ranks among the most important scientists of the 20th century. Linus Pauling’s work on vitamin C, however, generated considerable controversy. Pauling wrote many papers and a popular book, Cancer and Vitamin C. Vitamin C, we know today, protects cells from oxidative DNA damage and might thereby block carcinogenesis. Pauling popularised the regular intake of vitamin C; eventually he published two studies of end-stage cancer patients; their results apparently showed that vitamin C quadrupled survival times. A re-evaluation, however, found that the vitamin C groups were less sick on entry to the study. Later clinical trials concluded that there was no benefit to high-dose vitamin C. Since then, the established opinion is that the best evidence does not support a role for high dose vitamin C in the treatment of cancer. Despite all this, high dose IV vitamin C is in unexpectedly wide use by CAM practitioners.

Yesterday, new evidence has been published in the highly respected journal ‘Nature’; does it vindicate Pauling and his followers?

Chinese oncologists conducted a meta-analysis to assess the association between vitamin C intake and the risk to acquire lung cancer. Pertinent studies were identified by a searches of several electronic databases through December of 2013. Random-effect model was used to combine the data for analysis. Publication bias was estimated using Begg’s funnel plot and Egger’s regression asymmetry test.

Eighteen articles reporting 21 studies involving 8938 lung cancer cases were included in this meta-analysis. Pooled results suggested that highest vitamin C intake level versus lowest level was significantly associated with the risk of lung cancer. The effect was largest in investigations from the United States and in prospective studies. A linear dose-response relationship was found, with the risk of lung cancer decreasing by 7% for every 100 mg/day increase in the intake of vitamin C . No publication bias was found.

The authors conclude that their analysis suggested that the higher intake of vitamin C might have a protective effect against lung cancer, especially in the United States, although this conclusion needs to be confirmed.

Does this finding vindicate Pauling’s theory? Not really.

Even though the above-quoted conclusions seem to suggest a causal link, we are, in fact, far from having established one. The meta-analysis pooled mainly epidemiological data from various studies. Such investigations are doubtlessly valuable but they are fraught with uncertainties and cannot prove causality. For instance, there could be dozens of factors that have confounded these data in such a way that they produce a misleading result. The simplest explanation of the meta-analytic results might be that people who have a very high vitamin C intake tend to have generally healthier life-styles than those who take less vitamin C. When conducting a meta-analysis, one does, of course, try to account for such factors; but in many cases the necessary information to do that is not available, and therefore uncertainty persists.

In other words, the authors were certainly correct when stating that their findings needed to be confirmed. Pauling’s theory cannot be vindicated by such reports – in fact, the authors do not even mention Pauling with one word.

Dodgy science abounds in alternative medicine; this is perhaps particularly true for homeopathy. A brand-new trial seems to confirm this view.

The aim of this study was to test the hypothesis that homeopathy (H) enhances the effects of scaling and root planing (SRP) in patients with chronic periodontitis (CP).

The researchers, dentists from Brazil, randomised 50 patients with CP to one of two treatment groups: SRP (C-G) or SRP + H (H-G). Assessments were made at baseline and after 3 and 12 months of treatment. The local and systemic responses to the treatments were evaluated after one year of follow-up. The results showed that both groups displayed significant improvements, however, the H-G group performed significantly better than C-G group.

The authors concluded that homeopathic medicines, as an adjunctive to SRP, can provide significant local and systemic improvements for CP patients.

Really? I am afraid, I disagree!

Homeopathic medicines might have nothing whatsoever to do with this result. Much more likely is the possibility that the findings are caused by other factors such as:

  • placebo-effects,
  • patients’ expectations,
  • improved compliance with other health-related measures,
  • the researchers’ expectations,
  • the extra attention given to the patients in the H-G group,
  • disappointment of the C-G patients for not receiving the additional care,
  • a mixture of all or some of the above.

I should stress that it would not have been difficult to plan the study in such a way that these factors were eliminated as sources of bias or confounding. But this study was conducted according to the A+B versus B design which we have discussed repeatedly on this blog. In such trials, A is the experimental treatment (homeopathy) and B is the standard care (scaling and root planning). Unless A is an overtly harmful therapy, it is simply not conceivable that A+B does not generate better results than B alone. The simplest way to comprehend this argument is to imagine A and B are two different amounts of money: it is impossible that A+B is not more that B!

It is unclear to me what relevant research question such a study design actually does answer (if anyone knows, please tell me). It seems obvious, however, that it cannot test the hypothesis that homeopathy (H) enhances the effects of scaling and root planing (SRP). This does not necessarily mean that the design is necessarily useless.  But at the very minimum, one would need an adequate research question (one that matches this design) and adequate conclusions based on the findings.

The fact that the conclusions drawn from a dodgy trial are inadequate and misleading could be seen as merely a mild irritation. The facts that, in homeopathy, such poor science and misleading conclusions emerge all too regularly, and that journals continue to publish such rubbish are not just mildly irritating; they are annoying and worrying – annoying because such pseudo-science constitutes an unethical waste of scarce resources; worrying because it almost inevitably leads to wrong decisions in health care.

An article with this title was published recently by a team from Israel; essentially, it reports two interesting case histories:

Case 1

A 59-year-old male underwent a course of acupuncture for chronic low back pain, by a acupuncturist. During the therapy, the patient noted swelling at the point of puncture, but his therapist dismissed the claim. The region continued to swell, and three days later his family doctor diagnosed cellulitis and prescribed oral amoxicillin with clavulanic acid. The following day the patient’s condition worsened—he started to suffer from chills and more intense pain, so he went to the emergency room. At that stage, the patient had a fever of 37.9°C, a pulse of 119, and a blood pressure of 199/87. Edema was noted over the patient’s entire right flank (Figure 1A). Laboratory results were notable for a level of glucose of 298 mg/dL, sodium of 128 mmol/L, and white blood count (WBC) of 26,500 cells/μL with left shift. An emergency CT revealed an abscess of the abdominal wall involving the muscles, but no intra-abdominal pathology (Figure 1B).

Figure 1.
Figure 1.The patient received broad-spectrum antibiotics and was taken to the operating room for debridement. Upon incision there was subcutaneous edema with no puss, gangrene of the entire external oblique muscle, and an abscess between the external and internal oblique muscles. The muscles were debrided back to healthy, bleeding tissue and the wound copiously irrigated with saline. The wound was left open, with gauze and iodine as a cover. Gram stains and cultures returned group B streptococcus (GBS) sensitive to penicillin, and antibiotic coverage was adjusted accordingly. The patient returned to the operating room for serial debridement until the wound developed healthy granulation tissue. The patient received four units of blood and required 13 days of hospitalization. To date, he suffers from a disfiguring wound of his abdominal wall.

Considering the fact that group B streptococci live primarily in the female vagina, and that the acupuncturist was a young female, it is possible to assume that the cause for this grave illness was due to improper hygiene while treating our patient with acupuncture. Although rare, this tragic consequence of acupuncture has been seen previously by other researchers.

Case 2

A 27-year-old male with chronic cervical and back pain without any previous medical treatment or imaging was referred to a tertiary medical facility. To manage his pain, the patient used the services of a chiropractor who used cervical manipulation. Immediately after such a manipulation, the patient felt a severe cervical pain; 30 minutes after manipulation the patient started feeling paresthesia in his hands and legs. The patient was admitted to an emergency room with symptoms of progressive weakness in all four extremities and weakness. No additional symptoms were seen. Immediate MRI demonstrated an epidural hematoma at the C3-4 level (Figure 2).

Figure 2.
Figure 2.

The patient underwent immediate surgery to evacuate the hematoma via an anterior approach and C3-4 cage placement. The day after surgery the patient showed a remission of symptoms. At 6 months follow-up his remission was complete.

The literature includes several reports of SSPE immediately following a chiropractic manipulation that was considered the cause of this event. The authors of this case report concluded that chiropractic procedures can be dangerous when performed by practitioners who might be only partially trained, who might tend to perform an insufficient patient examination before the procedure, and thus endanger their patients.

On this blog, I have repeatedly warned that not all alternative treatments are free of risks. These two cases are impressive reminders of this undeniable fact.

I am sure that most proponents of alternative medicine will try to claim that

  • such complications are true rarities,
  • I am alarmist to keep alerting my readers to such events,
  • conventional medicine is dimensions more harmful,
  • the above cases are caused by poor practice.

However, I feel compelled to stress that there are no adequate post-marketing surveillance systems in alternative medicine and that the true frequencies of such events are therefore unknown. It seems therefore imperative (and not alarmist) to publicize such risks as widely as possible – in the hope that alternative practitioners, one day, might do the ethically and morally correct thing and implement proper surveillance of their practices.

“If ever there was a permanent cure for migraine, homeopathic medicines are the only one that can do this miracle. It may sound like an overstatement and quite quackerish, but it’s true. Long term treatment with homeopathy has an excellent cure for migraine headaches.” Statements like this can be found by the thousands on the internet, not just in relation to migraine but also about osteoarthritis. Both migraine and osteoarthritis are important domains for homeopathy, and most homeopaths would not doubt for a second that they can treat these conditions effectively. This is why it is so important to highlight the few sources which are not misleading consumers into making the wrong therapeutic decisions.

‘Healthcare Improvement Scotland’ (HCIS) have just published advice for patients suffering from migraine and osteoarthritis (the full document with all the evidence can be found here). I think it is worth having a close look and I therefore cite it in full:

Homeopathic remedies are prepared by repeated dilution and vigorous shaking of substances in water. Remedies are prepared from substances that in healthy people cause the signs and symptoms of the condition being treated. The more dilute the remedy is the more potent it becomes so that the most potent remedies are unlikely to contain any of the original substance.

People in Scotland have access to homeopathy through some GPs or a referral to homeopaths in the private sector, regional NHS clinics or the Centre for Integrative Care (CIC) (formerly Glasgow Homeopathic Hospital). Not all NHSScotland health boards provide funding for homeopathy; investment varies widely among those that do, and individual boards have begun to review funding for homeopathy services.

Clinical effectiveness

  • Evidence of clinical effectiveness was reviewed from systematic reviews of four placebo controlled randomised trials of homeopathy for migraine published between 1991 and 1997; and systematic reviews of four active treatment controlled randomised trials of homeopathy for osteoarthritis published between 1983 and 2000. The quality of the evidence was low to moderate.
  • Homeopathy for migraine has not been compared with active treatment in randomised controlled trials (RCTs). Of four RCTs comparing homeopathy with placebo, only one found homeopathy to be superior.
  • Three RCTs in osteoarthritis comparing homeopathy with medicines for pain relief found either no difference between the interventions, or that analgesic treatment had a better effect than homeopathy. A further RCT comparing intra-articular injection of a homeopathic remedy with hyaluronic acid injections showed similar pain reduction in both groups.

Safety

  • Published systematic reviews of homeopathy for migraine and osteoarthritis contain insufficient information to inform conclusions about safety.

Cost effectiveness

  • No evidence on the cost effectiveness of homeopathy for migraine was identified; and the evidence from a single cost-minimisation analysis of one homeopathic preparation for osteoarthritis is not generalisable to the UK.

Context/conclusion

  • Homeopathy for migraine has not been compared with standard care in RCTs and no evidence of cost effectiveness has been identified..
  • There is insufficient evidence to determine whether or not homeopathic treatment for osteoarthritis is clinically effective compared with standard care, and no relevant evidence of cost effectiveness has been identified.
  • The evidence does not support treating migraine or osteoarthritis with homeopathy.

Before the fans of homeopathy start shouting “THIS IS ALL RUBBISH AND DISREGARDS IMPORTANT EVIDENCE!!!”, I should mention that the top experts in homeopathy were asked to contribute their evidence and were unable to find any convincing data that would have changed this negative verdict. And it is important to point out that HCIS is a respected, independent organisation that issues statements based on thorough, unbiased reviews of the evidence.

As I reported a while ago, the Australian ‘NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL’ has assessed the effectiveness of homeopathy. The evaluation looks like the most comprehensive and most independent in the history of homeopathy. Its draft report  concluded that “the evidence from research in humans does not show that homeopathy is effective for treating the range of health conditions considered.”

So, the HCIS is in excellent company and I have no doubt whatsoever that this new statement is correct – but I also have little doubt that homeopaths will dispute it.

 

For every condition which is not curable by conventional medicine there are dozens of alternative treatments that offer a cure or at least symptomatic relief. Multiple sclerosis (MS) is such a disease. It is hard to find an alternative therapy that is not being promoted for MS.

Acupuncture is, of course, no exception. It is widely promoted for treating MS symptoms and many MS patients spend lots of money hoping that it does. The US ‘National MS Society’, For instance claim that acupuncture may provide relief for some MS-related symptoms, including pain, spasticity, numbness and tingling, bladder problems, and depression. There is no evidence, however, that acupuncture can reduce the frequency of MS exacerbations or slow the progression of disability. And the ‘British Acupuncture Council’ state that acupuncture may provide relief for some MS-related symptoms, including pain, spasticity, numbness and tingling, bladder problems, and depression.

Such claims seem a little over-optimistic; let’s have a look what the evidence really tells us.

The purpose of this brand-new review was to assess the literature on the effectiveness of acupuncture for treating MS. A literature search resulted in 12 peer-reviewed articles on the subject that examined the use of acupuncture to treat MS related quality of life, fatigue, spasticity, and pain. The majority of the studies were poorly designed-without control, randomization, or blinding. Description of the subjects, interventions, and outcome measures as well as statistical analysis were often lacking or minimal.

The authors concluded that although many of the studies suggested that acupuncture was successful in improving MS related symptoms, lack of statistical rigor and poor study design make it difficult to draw any conclusions about the true effectiveness of this intervention in the MS population. Further studies with more rigorous designs and analysis are needed before accurate claims can be made as to the effectiveness of acupuncture in this population.

And what about other alternative therapies? Our own systematic review of the subject included 12 randomized controlled trials: nutritional therapy (4), massage (1), Feldenkrais bodywork (1), reflexology (1), magnetic field therapy (2), neural therapy (1) and psychological counselling (2). But the evidence was not compelling for any of these therapies, with many trials suffering from significant methodological flaws. There is evidence to suggest some benefit of nutritional therapy for the physical symptoms of MS. Magnetic field therapy and neural therapy appear to have a short-term beneficial effect on the physical symptoms of MS. Massage/bodywork and psychological counselling seem to improve depression, anxiety and self-esteem.

That was some time ago,  and it is therefore reasonable to ask: has the evidence changed? Thankfully, the ‘American Academy of Neurology’ has just published the following guidelines entitles complementary and alternative medicine in multiple sclerosis:

Clinicians might offer oral cannabis extract for spasticity symptoms and pain (excluding central neuropathic pain) (Level A). Clinicians might offer tetrahydrocannabinol for spasticity symptoms and pain (excluding central neuropathic pain) (Level B). Clinicians should counsel patients that these agents are probably ineffective for objective spasticity (short-term)/tremor (Level B) and possibly effective for spasticity and pain (long-term) (Level C). Clinicians might offer Sativex oromucosal cannabinoid spray (nabiximols) for spasticity symptoms, pain, and urinary frequency (Level B). Clinicians should counsel patients that these agents are probably ineffective for objective spasticity/urinary incontinence (Level B). Clinicians might choose not to offer these agents for tremor (Level C). Clinicians might counsel patients that magnetic therapy is probably effective for fatigue and probably ineffective for depression (Level B); fish oil is probably ineffective for relapses, disability, fatigue, MRI lesions, and quality of life (QOL) (Level B); ginkgo biloba is ineffective for cognition (Level A) and possibly effective for fatigue (Level C); reflexology is possibly effective for paresthesia (Level C); Cari Loder regimen is possibly ineffective for disability, symptoms, depression, and fatigue (Level C); and bee sting therapy is possibly ineffective for relapses, disability, fatigue, lesion burden/volume, and health-related QOL (Level C). Cannabinoids may cause adverse effects. Clinicians should exercise caution regarding standardized vs nonstandardized cannabis extracts and overall CAM quality control/nonregulation. Safety/efficacy of other CAM/CAM interaction with MS disease-modifying therapies is unknown.

Interestingly, on yesterday it was announced that the NHS in Wales has just made available a cannabis-based spray for MS-sufferers (I should mention that most cannabis-based preparations are not full plant extracts and thus by definition not herbal but conventional medicines).

It would be wonderful, if other alternative therapies were of proven benefit to MS-sufferers. But sadly, this does not seem to be the case. I think it is better to be truthful about this than to raise false hopes of desperate patients.

Readers of this blog will know that few alternative treatments are more controversial and less plausible than homeopathy. Therefore they might be interested to read about the latest attempt of homeopathy-enthusiasts to convince the public that, despite all the clinical evidence to the contrary, homeopathy does work.

The new article was published in German by Swiss urologist and is a case-report describing a patient suffering from paralytic ileus. This condition is a typical complication of ileocystoplasty of the bladder, the operation the patient had undergone. The patient had also been suffering from a spinal cord injury which, due to a pre-existing neurogenic bowel dysfunction, increases the risk of paralytic ileus.

The paraplegic patient developed a massive paralytic ileus after ileocystoplasty and surgical revision. Conventional stimulation of bowel function was unsuccessful. But after adjunctive homeopathic treatment normalization of bowel function was achieved.

The authors conclude that adjunctive homeopathic therapy is a promising treatment option in patients with complex bowel dysfunction after abdominal surgery who do not adequately respond to conventional treatment.

YES, you did read correctly: homeopathic therapy is a promising treatment

In case anyone doubts that this is more than a trifle too optimistic, let me suggest three much more plausible reasons why the patient’s bowel function finally normalised:

  • It could have been a spontaneous recovery (in most cases, even severe ones, this is what happens).
  • It could have been all the conventional treatments aimed at stimulating bowel function.
  • It could have been a mixture of the two.

The article made me curious, and I checked whether the authors had previously published other material on homeopathy. Thus I found two further articles in a very similar vein:

Article No 2 (dated 2014):

We present the clinical course of a patient with an epididymal abscess caused by multiresistant bacteria. As the patient declined surgical intervention, a conservative approach was induced with intravenous antibiotic treatment. As the clinical findings did not ameliorate, adjunctive homeopathic treatment was used. Under combined treatment, laboratory parameters returned to normal, and the epididymal abscess was rapidly shrinking. After 1 week, merely a subcutaneous liquid structure was detected. Fine-needle aspiration revealed sterile purulent liquid, which was confirmed by microbiological testing when the subcutaneous abscess was drained. Postoperative course was uneventful.

As the risk for recurrent epididymitis is high in persons with spinal cord injury, an organ-preserving approach is justified even in severe cases. Homeopathic treatment was a valuable adjunctive treatment in the above-mentioned case. Therefore, prospective studies are needed to further elucidate the future opportunities and limitations of classical homeopathy in the treatment of urinary tract infections.

Article No 3 (dated 2012):

Recurrent urinary tract infections (UTI) in patients with spinal cord injury are a frequent clinical problem. Often, preventive measures are not successful. We present the case reports of five patients with recurrent UTI who received additional homeopathic treatment. Of these patients, three remained free of UTI, whereas UTI frequency was reduced in two patients. Our initial experience with homeopathic prevention of UTI is encouraging. For an evidence-based evaluation of this concept, prospective studies are required.

It seems clear that all of the three more plausible explanations for the patients’ recovery listed above also apply to these two cases.

One might not be far off speculating that J Pannek, the first author of all these three articles, is a fan of homeopathy (this suspicion is confirmed by a link between him and the HOMEOPATHY RESEARCH INSTITUE: Prof Jürgen Pannek on the use of homeopathy for prophylaxis of UTI’s in patients with neurogenic bladder dysfunction). If that is so, I wonder why he does not conduct a controlled trial, rather than publishing case-report after case-report of apparently successful homeopathic treatments. Does he perhaps fear that his effects might dissolve into thin air under controlled conditions?

Case-reports of this nature can, of course, be interesting and some might even deserve to be published. But it would be imperative to draw the correct conclusions. Looking at the three articles above, I get the impression that, as time goes by, the conclusions of Prof Pannek et al (no, I know nobody from this group of authors personally) are growing more and more firm on less and less safe ground.

In my view, responsible authors should have concluded much more cautiously and reasonably. In the case of the paralytic ileus, for instance, they should not have gone further than stating something like this: adjunctive homeopathic therapy might turn out to be a promising treatment option for such patients. Despite the implausibility of homeopathy, this case-report might deserve to be followed up with a controlled clinical trial. Without such evidence, firm conclusions are clearly not possible.

If you believe herbalists, the Daily Mail or similarly reliable sources, you come to the conclusion that herbal medicines are entirely safe – after all they are natural, and everything that is natural must be safe. However, there is plenty of evidence that these assumptions are not necessarily correct. In fact, herbal medicines can cause harm in diverse ways, e. g. because:

  • one or more ingredients of a plant are toxic,
  • they interact with prescribed drugs,
  • they are contaminated, for instance, with heavy metals,
  • they are adulterated with prescription drugs.

There is no shortage of evidence for any of these 4 scenarios. Here are some very recent and relevant publications:

German authors reviewed recent case reports and case series that provided evidence for herbal hepatotoxicity caused by Chinese herbal mixtures. The implicated remedies were the TCM products Ban Tu Wan, Chai Hu, Du Huo, Huang Qin, Jia Wei Xia Yao San, Jiguja, Kamishoyosan, Long Dan Xie Gan Tang, Lu Cha, Polygonum multiflorum products, Shan Chi, ‘White flood’ containing the herbal TCM Wu Zhu Yu and Qian Ceng Ta, and Xiao Chai Hu Tang. the authors concluded that stringent evaluation of the risk/benefit ratio is essential to protect traditional Chinese medicines users from health hazards including liver injury.

A recent review of Nigerian anti-diabetic herbal remedies suggested hypoglycemic effect of over 100 plants. One-third of them have been studied for their mechanism of action, while isolation of the bioactive constituent(s) has been accomplished for 23 plants. Several plants showed specific organ toxicity, mostly nephrotoxic or hepatotoxic, with direct effects on the levels of some liver function enzymes. Twenty-eight plants have been identified as in vitro modulators of P-glycoprotein and/or one or more of the cytochrome P450 enzymes, while eleven plants altered the levels of phase 2 metabolic enzymes, chiefly glutathione, with the potential to alter the pharmacokinetics of co-administered drugs

US authors published a case of a 44-year-old female who developed subacute liver injury demonstrated on a CT scan and liver biopsy within a month of using black cohosh to resolve her hot flashes. Since the patient was not taking any other drugs, they concluded that the acute liver injury was caused by the use of black cohosh. The authors concluded: we agree with the United States Pharmacopeia recommendations that a cautionary warning about hepatotoxicity should be labeled on the drug package.

Hong Kong toxicologists recently reported five cases of poisoning occurring as a result of inappropriate use of herbs in recipes or general herbal formulae acquired from books. Aconite poisoning due to overdose or inadequate processing accounted for three cases. The other two cases involved the use of herbs containing Strychnos alkaloids and Sophora alkaloids. These cases demonstrated that inappropriate use of Chinese medicine can result in major morbidity, and herbal formulae and recipes containing herbs available in general publications are not always safe.

Finally, Australian emergency doctors just published this case-report: A woman aged 34 years presented to hospital with a history of progressive shortness of breath, palpitations, decreased exercise tolerance and generalised arthralgia over the previous month. A full blood count revealed normochromic normocytic anaemia and a haemoglobin level of 66 g/L. The blood film showed basophilic stippling, prompting measurement of lead levels. Her blood lead level (BLL) was 105 µg/dL. Mercury and arsenic levels were also detected at very low levels. On further questioning, the patient reported that in the past 6 months she had ingested multiple herbal preparations supplied by an overseas Ayurvedic practitioner for enhancement of fertility. She was taking up to 12 different tablets and various pastes and powders daily. Her case was reported to public health authorities and the herbal preparations were sent for analytical testing. Analysis confirmed high levels of lead (4% w/w), mercury (12% w/w), arsenic and chromium. The lead levels were 4000 times the maximum allowable lead level in medications sold or produced in Australia. Following cessation of the herbal preparations, the patient was commenced on oral chelation therapy, iron supplementation and contraception. A 3-week course of oral DMSA (2,3-dimercaptosuccinic acid) was well tolerated; BLL was reduced to 13 µg/dL and haemoglobin increased to 99 g/L. Her symptoms improved over the subsequent 3 months and she remains hopeful about becoming pregnant.

So, how safe are herbal medicines? Unfortunately, the question is unanswerable. Some herbal medicines are quite safe, others are not. But always remember: whenever you administer a treatment you should ask yourself one absolutely crucial question: do the documented benefits outweigh the risks? There are several thousand different herbal medicines, and for less than a dozen of them can the honest answer to this question be YES.

Blinding patients in clinical trials is a key methodological procedure for minimizing bias and thus making sure that the results are reliable. In alternative medicine, blinding is not always straight forward, and many studies are therefore not patient-blinded. We all know that this can introduce bias into a trial, but how large is its effect on study outcomes?

This was the research question addressed by a recent systematic review of randomized clinical trials with one sub-study (i.e. experimental vs control) involving blinded patients and another, otherwise identical, sub-study involving non-blinded patients. Within each trial, the researchers compared the difference in effect sizes (i.e. standardized mean differences) between the two sub-studies. A difference <0 indicates that non-blinded patients generated a more optimistic effect estimate. The researchers then pooled the differences with random-effects inverse variance meta-analysis, and explored reasons for heterogeneity.

The main analysis included 12 trials with a total of 3869 patients. Ten of these RCTs were studies of acupuncture. The average difference in effect size for patient-reported outcomes was -0.56 (95% confidence interval -0.71 to -0.41), (I(2 )= 60%, P = 0.004), indicating that non-blinded patients exaggerated the effect size by an average of 0.56 standard deviation, but with considerable variation. Two of the 12 trials also used observer-reported outcomes, showing no indication of exaggerated effects due lack of patient blinding.

There was an even larger effect size difference in the 10 acupuncture trials [-0.63 (-0.77 to -0.49)], than in the two non-acupuncture trials [-0.17 (-0.41 to 0.07)]. Lack of patient blinding was also associated with increased attrition rates and the use of co-interventions: ratio of control group attrition risk 1.79 (1.18 to 2.70), and ratio of control group co-intervention risk 1.55 (0.99 to 2.43).

The authors conclude that this study provides empirical evidence of pronounced bias due to lack of patient blinding in complementary/alternative randomized clinical trials with patient-reported outcomes.

This is a timely, rigorous and important analysis. In alternative medicine, we currently see a proliferation of trials that are not patient-blinded. We always suspected that they are at a high risk of generating false-positive results – now we know that this is, in fact, the case.

What should we do with this insight? In my view, the following steps would be wise:

  1. Take the findings from the existing trials that are devoid of patient-blinding with more than just a pinch of salt.
  2. Discourage the funding of future studies that fail to include patient-blinding.
  3. If patient-blinding is truly and demonstrably impossible – which is not often the case – make sure that the trialists at least include blinding of the assessors of the primary outcome measures.

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