MD, PhD, MAE, FMedSci, FRSB, FRCP, FRCPEd.

Monthly Archives: October 2016

The placebo response might be important in clinical practice, but it is certainly difficult to study and the findings of such investigations can be confusing. This seems to be exemplified by two new trials.

The first study examined the possibility of using theatrical performance tools, including stage directions and scripting, to reproducibly manipulate the style and content of a simulated doctor-patient encounter and influence the placebo response (defined as improvement of clinical outcome in individuals receiving inactive treatment) in experimental pain.

A total of 122 healthy volunteers were exposed to experimental pain using the cold pressor test and assessed for pain threshold and tolerance before and after receiving a placebo cream from a “doctor” impersonated by a trained actor. The actor alternated between two distinct scripts and stage directions. One script emulated a standard doctor-patient encounter (scenario A), while the other emphasized elements present in ritual healing such as attentiveness and strong suggestion (scenario B).

The placebo response size was calculated as the % difference in pain threshold and tolerance after exposure relative to baseline. Subjects demonstrating a ≥30% increase in pain threshold or tolerance relative to baseline were defined as responders. Each encounter was videotaped in its entirety.

Inspection of the videotapes confirmed the reproducibility and consistency of the distinct scenarios enacted by the “doctor”-performer. Furthermore, scenario B resulted in a significant increase in pain threshold relative to scenario A. This increase derived from the placebo responder subgroup; as shown by two-way analysis of variance (performance style, F = 4.30; p = 0.040; η(2) = 0.035; style × responder status interaction term, F = 5.21; p = 0.024) followed by post hoc analysis showing a ∼60% increase in pain threshold in responders exposed to scenario B (p = 0.020).

fpsyg-07-00874-g003

Performance style and response size in placebo responders and non-responders. Bars represent mean ± SE of % change in CPT threshold of 60 subjects in scenario A: 53 non-responders vs. 7 responders and 62 subjects in scenario B: 51 non-responders and 11 responders. Two-way ANOVA by performance style and responsiveness revealed significant effects of doctor’s performance (F = 4.30; p = 0.040; η2 = 0.035) and responsiveness (F = 134.71; p < 0.001) as well as a significant interaction term (F = 5.21; p = 0.024). p = 0.020, Fisher’s least significant difference post hoc test.

The authors concluded that these results support the hypothesis that structured manipulation of physician’s verbal and non-verbal performance, designed to build rapport and increase faith in treatment, is feasible and may have a significant beneficial effect on the size of the response to placebo analgesia. They also demonstrate that subjects, who are not susceptible to placebo, are also not susceptible to performance style.

In the second study, the authors investigated if an implicit priming procedure, where participants were unaware of the intended priming influence, affected placebo analgesia.

In a double-blind experiment, healthy participants (n = 36) were randomized to different implicit priming types; one aimed at increasing positive expectations and one neutral control condition. First, pain calibration (thermal) and a credibility demonstration of the placebo analgesic device were performed. In a second step, an independent experimenter administered the priming task; Scrambled Sentence Test. Then, pain sensitivity was assessed while telling participants that the analgesic device was either turned on (placebo) or turned off (baseline). Pain responses were recorded on a 0-100 Numeric Response Scale.

Overall, there was a significant placebo effect (p < 0.001), however, the priming conditions (positive/neutral) did not lead to differences in placebo outcome. Prior experience of pain relief (during initial pain testing) correlated significantly with placebo analgesia (p < 0.001) and explained 34% of placebo variance. Trait neuroticism correlated positively with placebo analgesia (p < 0.05) and explained 21% of placebo variance.

The authors concluded that priming is one of many ways to influence behaviour, and non-conscious activation of positive expectations could theoretically affect placebo analgesia. Yet, we found no SST priming effect on placebo analgesia. Instead, our data point to the significance of prior experience of pain relief, trait neuroticism and social interaction with the treating clinician.

The two studies are similar but generate somewhat contradictory results. In the discussion section, the authors of the first paper stress that “replication of our findings in clinical populations; employing professional physicians of both sexes, are necessary in order to establish their generality and possible application in medical training, with the aim of improving patient outcome across diseases and treatment modalities.” This is certainly true. They continue by stating that  “future studies using performance tools in clinical trial settings could demonstrate the potential of borrowing performance principles and techniques from traditional healing and applying them to physician–patient encounters in Western medicine, following certain necessary modifications. Performance tools could thus eventually be incorporated into the systematic training of physicians and medical students, possibly to complement programs in Narrative Medicine and Relational Medicine.”

These ideas are not dissimilar to what we have been discussing on this blog repeatedly. For instance, I have previously tried to explain that “the science and the art of medicine are essential elements of good medicine. In other words, if one is missing, medicine is by definition  not optimal. In vast areas of alternative medicine, the science-element is woefully neglected or even totally absent. It follows, that these areas cannot be good medicine. In some areas of conventional medicine, the art-element is weak or neglected. It follows that, in these areas, medicine is not good either.”

The fact that the two studies above show contradictory findings is not easy to interpret. Possibly, this shows how fragile the placebo response can be. It can be influenced by a multitude of factors related to an experiment or the clinical setting. If that is so, and placebo effects are truly unreliable, it would be yet another argument for not relying on them in clinical routine. In my view, clinicians should try to maximize them where they can. Yet placebo effects are not normally a justification for employing placebo therapies in clinical practice. In other words, the fact that a bogus treatment can generate a placebo response is not a good reason for using it on patients who need help.

Good clinicians have probably always been good ‘performers’. Alternative practitioners tend to be excellent ‘performers’, and I am sure their success is mainly due to this ability. I see little reason why conventional practitioners should not (re-)learn the skills that once upon a time were called ‘good bed-side manners’. Maximizing the placebo effect in this way might maximize the benefit patients experience – and for that we do not require the placebo-therapies of alternative medicine.

A few weeks ago, John Benneth – I am sure you know John, he is one of the few homeopathy-fans who make Dana Ullman look sane – published this note:

I am overwhelmed . . I am being shipped to Paris next week with bioengineer Bronson Ayala assisting to receive from the Conte Foundation homeopathy’s highest award, the Yves Lasne Price, for my research into the homeopathic mechanism, and deliver my thesis, “Physic of the Infinitesimal.”
Wish us luck . .
Au revoir!

John

Knowing the utter nonsense this man tends to publish on youtube (see for instance here) or elsewhere, I did not assume that there was any truth to it (see also here).

I was wrong!!!

Today I found this on Twitter:

29/09/2016 Paris Prix Yves Lasne décerné à John Benneth l’un des grands chercheurs & journalistes de la recherche fondamentale Homéopathie

The award does actually exist – here is the website.

AND THERE EVEN IS A PHOTO FOR THOSE WHO DOUBT IT

benneth

Unfortunately I did not find any press release or similar announcement of the prize. Therefore, I have to go by the short note on Twitter. It names John Benneth as one of the great scientist of basic research into homeopathy. That was new to me. So, I quickly did a search on PubMed to retrieve some of his work.

Guess how many papers I found?

ZERO!

The inevitable conclusion is that in homeopathy things are, as we all know, upside down; therefore to receive homeopathy’s highest award, one has to prove that one has never published any research into the subject.

It’s all quite logical, if you think of it.

Stable angina is a symptom of coronary heart disease which, in turn, is amongst the most frequent causes of death in developed countries. It is an alarm bell to any responsible clinician and requires causal, often life-saving treatments of which we today have several options. The last thing a patient needs in this condition is ACUPUNCTURE, I would say.

Yet acupuncture is precisely the therapy such patients might be tempted to employ.

Why?

Because irresponsible or criminally naïve acupuncturists advertise it!

Take this website, for instance; it informs us that a meta-analysis of eight clinical trials conducted between 2000 and 2014 demonstrates the efficacy of acupuncture for the treatment of stable angina. In all eight clinical trials, patients treated with acupuncture experienced a greater rate of angina relief than those in the control group treated with conventional drug therapies (90.1% vs 75.7%)….

I imagine that this sounds very convincing to patients and I fear that many might opt for acupuncture instead of potentially invasive/unpleasant but life-saving intervention. The original meta-analysis to which the above promotion referred to is equally optimistic. Here is its abstract:

Angina pectoris is a common symptom imperiling patients’ life quality. The aim of this study is to evaluate the efficacy and safety of acupuncture for stable angina pectoris. Clinical randomized-controlled trials (RCTs) comparing the efficacy of acupuncture to conventional drugs in patients with stable angina pectoris were searched using the following database of PubMed, Medline, Wanfang and CNKI. Overall odds ratio (ORs) and weighted mean difference (MD) with their 95% confidence intervals (CI) were calculated by using fixed- or random-effect models depending on the heterogeneity of the included trials. Total 8 RCTs, including 640 angina pectoris cases with 372 patients received acupuncture therapy and 268 patients received conventional drugs, were included. Overall, our result showed that acupuncture significantly increased the clinical curative effects in the relief of angina symptoms (OR=2.89, 95% CI=1.87-4.47, P<0.00001) and improved the electrocardiography (OR=1.83, 95% CI=1.23-2.71, P=0.003), indicating that acupuncture therapy was superior to conventional drugs. Although there was no significant difference in overall effective rate relating reduction of nitroglycerin between two groups (OR=2.13, 95% CI=0.90-5.07, P=0.09), a significant reduction on nitroglycerin consumption in acupuncture group was found (MD=-0.44, 95% CI=-0.64, -0.24, P<0.0001). Furthermore, the time to onset of angina relief was longer for acupuncture therapy than for traditional medicines (MD=2.44, 95% CI=1.64-3.24, P<0.00001, min). No adverse effects associated with acupuncture therapy were found. Acupuncture may be an effective therapy for stable angina pectoris. More clinical trials are needed to systematically assess the role of acupuncture in angina pectoris.

In the discussion section of the full paper, the authors explain that their analysis has several weaknesses:

Several limitations were presented in this meta-analysis. Firstly, conventional drugs in control group were different, this may bring some deviation. Secondly, for outcome of the time to onset of angina relief with acupuncture, only one trial included. Thirdly, the result of some outcomes presented in different expression method such as nitroglycerin consumption. Fourthly, acupuncture combined with traditional medicines or other factors may play a role in angina pectoris.

However, this does not deter them to conclude on a positive note:

In conclusion, we found that acupuncture therapy was superior to the conventional drugs in increasing the clinical curative effects of angina relief, improving the electrocardiography, and reducing the nitroglycerin consumption, indicating that acupuncture therapy may be effective and safe for treating stable angina pectoris. However, further clinical trials are needed to systematically and comprehensively evaluate acupuncture therapy in angina pectoris.

So, why do I find this irresponsibly and dangerously misleading?

Here a just a few reasons why this meta-analysis should not be trusted:

  • There was no systematic attempt to evaluate the methodological rigor of the primary studies; any meta-analysis MUST include such an assessment, or else it is not worth the paper it was printed on.
  • The primary studies all look extremely weak; this means they are likely to be false-positive.
  • They often assessed not acupuncture alone but in combination with other treatments; consequently the findings cannot be attributed to acupuncture.
  • All the primary studies originate from China; we have seen previously (see here and here) that Chinese acupuncture trials deliver nothing but positive results which means that their results cannot be trusted: they are false-positive.

My conclusion: the authors, editors and reviewers responsible for this article should be ashamed; they committed or allowed scientific misconduct, mislead the public and endangered patients’ lives.

Hard to believe, but today it is 4 years that I wrote the first post on this blog. Quite honestly, I never expected that this would turn out to be such a fascinating past-time. These 4 years have been busy, entertaining and informative in equal measure:

  • I wrote more than 800 articles,
  • you published more than 22 000 comments,
  • the blog attracted over 1.6 million views,
  • one particular post was read > 600 000 times,
  • I got insulted hundreds of times,
  • we all learnt a lot (I hope),
  • I had to ban just a handful of individuals from commenting,
  • the blog got noticed and cited by people and institutions of influence from across the globe,
  • I never seem to run out of material.

In my very first post of 14/10/2012, I wrote: “…my blog is not going to provide just another critique of alternative medicine; it is going to be different, I hope. The reasons for this are fairly obvious: I have researched alternative medicine for two decades. My team and I have conducted about 40 clinical trials and published more than 100 systematic reviews of alternative medicine. We were by far the most productive research unit in this area. For 14 years, we hosted an annual international conference for researchers in this field. I know many of the leading investigators personally, and I understand their way of thinking. I have rehearsed every possible argument for or against alternative medicine dozens of times. In a nutshell, I am not someone who judges alternative medicine from the outside; I come from within the field. Arguably, I am the only researcher in this area who is willing [or capable?] to state publicly what is wrong with alternative medicine. This is perhaps one of the advantages of being an emeritus professor!”

Today, I still feel that this is probably true.

What is unquestionably true, however, is that I have fun doing this blog – and that is the main reason for continuing dedicating plenty of time to it. On this 4th anniversary, let me once again thank all of you for your contributions and for making this blog such an exciting experience.

 

 

When sceptics claim that no positive trials of homeopathy exist, they are clearly mistaken. The truth is that there are plenty of them! But many, if not most are of such poor quality that it is safe to suspect they are false-positives. Here is a recent example of this type of scenario.

This new study investigated the clinical effectiveness of a homeopathic add-on therapy in children with upper respiratory tract infections (URTI). It was designed as a randomized, controlled, multi-national clinical trial. Patients received either on-demand symptomatic standard treatment (ST-group) or the same ST plus a homeopathic medication (Influcid; IFC-group) for 7 days. IFC tablets contain a fixed combination of 6 homeopathic single substances (Aconitum D3, Bryonia D2, Eupatorium perfoliatum D1, Gelsemium D3, Ipecacuanha D3, and Phosphorus D5). IFC was administered according to the following schedule: 8 tablets/day during the first 72 hours, 3 tablets/day during the following 96 hours. Outcome assessment was based on symptom and fever resolution and the Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21).

A total of 261 paediatric (<12 years) patients (130 IFC-group; 131 ST-group) were recruited in Germany and the Ukraine. The IFC-group used less symptomatic medication, their symptoms resolved significantly earlier, they had higher proportions of fever-free children from day 3 onwards, and the WURSS-assessed global disease severity was significantly less during the entire URTI episode.

10-1177_2333794x16654851-fig2

Days until symptom resolution (WURSS-21 item 1) in both treatment groups.

The light grey (IFC-group) and dark grey (ST-group) lines are polynomial fit curves. The dashed line estimates the between-group difference in the number of days after which 50% of patients had symptom resolution.

10-1177_2333794x16654851-fig3

Between-group differences (IFC − ST) with 95% confidence intervals in the proportion of patients without fever during the observational period.

A difference (%) greater than zero indicates a higher proportion without fever in the IFC-group. Day 1 = Baseline.

The authors concluded that IFC as add-on treatment in pediatric URTI reduced global disease severity, shortened symptom resolution, and was safe in use.

On the one hand, this study has many features of a rigorous trial. I am sure that homeopaths will praise its quality, sample size, clever statistical analyses, etc. etc. The trial will therefore be cited by enthusiasts as a poof for homeopathy’s effectiveness and for homeopaths’ laudable research efforts.

On the other hand, one only needs to apply a minimum of critical thinking to find that it has been designed such that it cannot possibly generate a negative result. In fact, the paper turns out to be much more of a marketing exercise than a research effort.

The homeopathic remedy was given as an add-on therapy according to a fairly tedious ritual. It is safe to assume that this ritual created expectations on the parents’ side. These expectations alone suffice to account for the small group differences which seemingly favour homeopathy. The study follows the infamous ‘A+B versus B’ design which (as we have discussed ad nauseam on this blog) is extremely likely to generate false positive findings.

Why do researchers nevertheless plan, conduct and publish such studies (in the case of the paper discussed here, they even published their findings twice! Their previous paper included a larger group of patients of all ages and concluded that the homeopathic treatment shortened URTI duration, reduced the use of symptomatic medication, and was well tolerated.)? The answer can be found, I think, in the small print at the end of the paper:

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Robert van Haselen has received a consultancy fee from the Deutsche Homöopathie-Union. Manuela Thinesse-Mallwitz received a fee from the Deutsche Homöopathie-Union for coordinating the study. Vitaliy Maidannyk received a fee from the Deutsche Homöopathie-Union for coordinating the study. Stephen L. Buskin is a member of the Advisory Board of the Deutsche Homöopathie-Union. Stephan Weber received a fee from the Deutsche Homöopathie-Union for contributing to the study. Thomas Keller received a fee from the Deutsche Homöopathie-Union for contributing to the study. Julia Burkart is an employee of the Deutsche Homöopathie-Union, the study sponsor and manufacturer of Influcid. Petra Klement is an employee of the Deutsche Homöopathie-Union, the study sponsor and manufacturer of Influcid.

Funding: The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The study was funded by Deutsche Homöopathie-Union, Karlsruhe, Germany. Deutsche Homöopathie-Union manufactures the homeopathic medicinal product used in this study and provided the publication fee.

I REST MY CASE

Antrodia cinnamomea (AC) is a fungus which is used in Taiwan as a remedy for cancer, hypertension, hangover and other conditions. There are several commercial AC products and the annual market is worth over $100 million in Taiwan alone.

Several studies have suggested anti-cancer properties in vitro but few clinical trials have been reported. Now Taiwanese researchers published a double-blind, randomized clinical study to investigate whether AC had acceptable safety and efficacy in advanced cancer patients receiving chemotherapy.

Patients with advanced and/or metastatic adenocarcinoma, performance status (PS) 0-2, and adequate organ function who had previously been treated with standard chemotherapy were randomly assigned to receive routine chemotherapy regimens with AC (20 ml twice daily) orally for 30 days or placebo. The primary endpoint was 6-month overall survival (OS); the secondary endpoints were disease control rate (DCR), quality of life (QoL), adverse event (AE), and biochemical features within 30 days of treatment.

A total of 37 subjects with gastric, lung, liver, breast, and colorectal cancer (17 in the AC group, 20 in the placebo group) were enrolled in the study. Disease progression was the primary cause of death in 4 (33.3 %) AC and 8 (66.7 %) placebo recipients. Mean OSs were 5.4 months for the AC group and 5.0 months for the placebo group (p = 0.340), and the DCRs were 41.2 and 55 %, respectively (p = 0.33). Most hematologic, liver, or kidney functions did not differ significantly between the two groups, but platelet counts were lower in the AC group than in the placebo group (p = 0.02). QoL assessments were similar in the two groups, except that the AC group showed significant improvements in quality of sleep (p = 0.04).

12906_2016_1312_fig2_html

The above figure shows the survival curves for both groups.

The authors concluded as follows: Although we found a lower mortality rate and longer mean OS in the AC group than in the control group, AC combined with chemotherapy was not shown to improve the outcome of advanced cancer patients, possibly due to the small sample size. In fact, the combination may present a potential risk of lowered platelet counts. Adequately powered clinical trials will be necessary to address this question.

I agree, the survival curve looks promising. But we must not get carried away: this was a tiny sample size and a relatively short treatment period. Thus the difference could be a coincidence or an artefact.

The investigators are sufficiently cautious in the interpretation of their findings, and most of us would probably agree that it is necessary to submit such traditional remedies to proper scientific tests. Yet, I feel a sense of unease when I read such articles.

On the one hand, it is possible that such investigations meaningfully contribute to progress. On the other hand, I wonder whether they merely end up providing a significant boost to the trade of bogus remedies sold at high prices to desperate patients. Do the benefits really out-weigh the risks? We will probably never know.

But to minimize the risk, the authors should now swiftly conduct a more definitive trial and create some clarity about the value or otherwise of this traditional cancer remedy.

A new study tested the efficacy of chiropractic spinal manipulative therapy (CSMT) for migraine. It was designed as a three-armed, single-blinded, placebo -controlled RCT of 17 months duration including 104 migraineurs with at least one migraine attack per month. Active treatment consisted of CSMT (group 1) and the placebo was a sham push manoeuvre of the lateral edge of the scapula and/or the gluteal region (group 2). The control group continued their usual pharmacological management (group 3).

The RCT began with a one-month run-in followed by three months intervention. The outcome measures were quantified at the end of the intervention and at 3, 6 and 12 months of follow-up. The primary end-point was the number of migraine days per month. Secondary end-points were migraine duration, migraine intensity and headache index, and medicine consumption.

The results show that migraine days were significantly reduced within all three groups from baseline to post-treatment (P < 0.001). The effect continued in the CSMT and placebo groups at all follow-up time points (groups 1 and 2), whereas the control group (group 3) returned to baseline. The reduction in migraine days was not significantly different between the groups. Migraine duration and headache index were reduced significantly more in the CSMT than in group 3 towards the end of follow-up. Adverse events were few, mild and transient. Blinding was strongly sustained throughout the RCT.

The authors concluded that it is possible to conduct a manual-therapy RCT with concealed placebo. The effect of CSMT observed in our study is probably due to a placebo response.

Chiropractors often cite clinical trials which suggest that CSMT might be effective. The effects sizes are rarely impressive, and it is tempting to suspect that the outcomes are mostly due to bias. Chiropractors, of course, deny such an explanation. Yet, to me, it seems fairly obvious: trials of CSMT are not blind, and therefore the expectation of the patient is likely to have major influence on the outcome.

Because of this phenomenon (and several others, of course), sceptics are usually unconvinced of the value of chiropractic. Chiropractors often respond by claiming that blind studies of physical intervention such as CSMT are not possible. This, however, is clearly not true; there have been several trials that employed sham treatments which adequately mimic CSMT. As these frequently fail to show what chiropractors had hoped, the methodology is intensely disliked by chiropractors.

The above study is yet another trial that adequately controls for patients’ expectation, and it shows that the apparent efficacy of CSMT disappears when this source of bias is properly accounted for. To me, such findings make a lot of sense, and I suspect that most, if not all the ‘positive’ studies of CSMT would turn out to be false positive, once such residual bias is eliminated.

I am so sorry we all missed this conference on ‘HOMEOPROPHYLAXIS’ ![Link disabled by Admin because of suspected malware]

The three-day meeting has ended yesterday.

It could have been a real eye-opener.

This is how it has been advertised:

This is THE conference for medical professionals, parents, and natural-minded healthcare providers to learn more about the evidence supporting the 200 year old practice of Homeoprophylaxis (HP), an immune boosting method that is safe and natural.

Homeoprophylaxis is internationally popular and proven method of protection against infectious disease.  It is safe, natural, and does no harm. There are no toxins, preservatives, chemicals, or pathological particles. It works by naturally educating your child’s immune system to recognize and combat disease.  Learn from our international panelists of doctors and researchers from across many field and schools of medicine at the upcoming HP Conference.  Internationally recognized, our speakers have conducted research across the globe on HP immunization, and will be providing you with answers on their safety, effectiveness, and proven success.

You have to admit that this is eye-opening. If anyone ever doubted that (some) homeopaths were deluded to the point of being dangerous, they now have to see that they were mistaken.

  • HP does not convey ‘natural immunity’.
  • HP does not boost anything.
  • HP is not safe; in fact it has the potential to kill millions through non-immunisation.
  • HP is not natural.
  • HP is luckily not popular; it is pursued merely by some extreme loons.
  • HP is not proven.
  • HP does not protect from infectious diseases.
  • HP goes absolutely nothing to the immune system or any other organ function.
  • HP does not combat disease.
  • HP is certainly not ‘internationally recognised’ for anything but a criminally dangerous replacement of proper immunisation.
  • HP is not of ‘proven success’.

All that HP truly provides is an indication as to how recklessly unethical and dangerously misleading homeopaths can be. As I wrote previously on this blog: I cannot think of anything in the realm of homeopathy that is more irresponsible than the promotion of HP.

This new study is amazing in several respects. It was conducted in Spain by otolaryngologists, and one of its authors is an employee of Boiron, the world’s biggest manufacturer of homeopathic products. It was designed as a double blind, placebo-controlled RCT. Patients aged 2 months to 12 years suffering from otitis media with effusion (OME), as diagnosed by pneumatic otoscopy (PNO) and tympanometry, were randomized into two groups. Both groups received aerosol therapy (mucolytics and corticosteroids). In addition, the experimental group received a homeopathic remedy of Agraphis nutans 5CH, Thuya Occidentalis 5CH, Kalium muriaticum 9CH and Arsenicum iodatum. The placebo group received placebos instead. Both of the treatments were continued for 3 months. Patients were evaluated by PNO examination and tympanometry at baseline, at 45 and 90 days.

A total of 97 patients were enrolled in this study. In the homeopathy group, 61.9% of individuals were cured according to PNO results by the 3rd visit compared with 56.8% of patients treated with placebo. 4.8% of patients in the homeopathy group suffered a recurrence (positive PNO in the 2nd visit changed to negative in the 3rd visit), while 11.4% did in the placebo group. These inter-group differences were not statistically significant. Adverse events were distributed similarly, except in the case of upper respiratory tract infections, which were less frequent in homeopathic group.

The authors of this new RCT concluded that the homeopathic scheme used as adjuvant treatment cannot be claimed to be an effective treatment in children with OME.

No surprises then – we already know that homeopathic remedies are placebos!

Sure, but at least two amazing features need to be pointed out:

  • I am delighted that the authors did not try to spin the results such that they appear to be positive. Some investigators might have emphasised the fact that there was a (non-significant) trend in favour of homeopathy, and that, for a secondary outcome measure (upper respiratory infections), it even reached the level of statistical significance.
  • Considering that this study was obviously Boiron-sponsored and its list of authors included an employee of this firm, such honesty can’t have been easy to maintain.
  • The design of this RCT is also worth a mention: most alt med proponents seem to think that ‘adjunctive’ use of alt med needs to be tested via the infamous ‘A+B vs B’ design which fails to control for placebo effects and therefore invariably produces false positive findings. The authors of this trial did the right thing by randomising their patients into usual care + homeopathy vs usual care + placebo. This is very simple and has the advantage to actually provide a meaningful result.

In view of all this, I raise my hat to the Spanish researchers: very well done!!!

If all trials of homeopathy were conducted and reported in this honourable fashion, the collective evidence would be in a much better state and far less confusing.

cufimrfweaarb0r

I found this on Twitter; fascinating isn’t it?

So much so, that I decided to run a quick ‘reality check’: are any of these claims based on anything resembling sound evidence?

Here we go:

IT HELPS BRING ABOUT RECOVERY

This is the sort of woolly language that quacks of any type seem to adore. Recovery of what? Perhaps recovery from delusion? No evidence for that, I am sure.

IT CAN REDUCE YOUR BLOOD PRESSURE

Yes, there are some studies on this topic. There is even a systematic review of the relevant trials; it was published by chiros in a chiro journal and it nevertheless concluded that there is currently a lack of low bias evidence to support the use of Spinal Manipulative Therapy as a therapy for the treatment of hypertension. Future investigations may clarify if SMT is effective for treating hypertension, either by itself or as an adjunctive therapy, and by which physiologic mechanism this occurs.

IT IMPROVES THE NERVOUS SYSTEM

Another woolly claim, if there ever was one. What does it mean? Nothing! Consequently, there also is no evidence to back it up.

BETTER POSTURE AND FLEXIBILITY

Chiros will probably claim that the exercises they sometimes recommend might lead to improvements in posture and flexibility of the musculoskeletal system. Even though there is not much good evidence for this, it might still be true. But chiropractic manipulations are unlikely to achieve these aims.

STRONG IMMUNE SYSTEM

There are some studies to imply that spinal manipulations stimulate the immune system. This is what I wrote about them previously: If we look at the actual research that might support such strange claims, we find that that it is scarce, flimsy and unconvincing. To the best of my knowledge, nobody has yet shown that people who receive regular chiropractic care are protected from conditions mediated via the immune system. Unless such a phenomenon can be demonstrated beyond reasonable doubt, we should be highly sceptical of the claim that chiropractic care stimulates the immune system and thus generates better health. In my view, regular chiropractic adjustments stimulate only one thing: the cash flow of the therapist.

LESS NEED FOR MEDICATIONS

This is one of the favourite claims of chiros. It is  supported by evidence showing that patients who see a chiropractor use less drugs than those who don’t. But that is due to chiros traditionally being anti-drug; they thus advise their patients not to take any drugs. Very different from claiming their patients need less medications, I’d say. In fact, it seems to me like saying people who regularly go to church pray more than those who don’t.

Why is any of this important?

Some might think that all of this is trivial, irrelevant and boring. I beg to differ.

It matters, I think, because such promotion and bogus claims are what consumers are constantly exposed to. Eventually, many will believe this nonsense, even if it is overtly wrong or stupid. What is being trumpeted loudly a thousand times might eventually be believed.

In other words, such advertisements are relevant because they shape the minds of the public. As responsible healthcare professionals, we ought to be aware of these campaigns and do what we can to correct the false impressions they generate.

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