MD, PhD, FMedSci, FSB, FRCP, FRCPEd

Monthly Archives: December 2014

As promised, I will try with this post to explain my reservations regarding the new meta-analysis suggesting that individualised homeopathic remedies are superior to placebos. Before I start, however, I want to thank all those who have commented on various issues; it is well worth reading the numerous and diverse comments.

To remind us of the actual meta-analysis, it might be useful to re-publish its abstract (the full article is also available online):

BACKGROUND:

A rigorous and focused systematic review and meta-analysis of randomised controlled trials (RCTs) of individualised homeopathic treatment has not previously been undertaken. We tested the hypothesis that the outcome of an individualised homeopathic treatment approach using homeopathic medicines is distinguishable from that of placebos.

METHODS:

The review’s methods, including literature search strategy, data extraction, assessment of risk of bias and statistical analysis, were strictly protocol-based. Judgment in seven assessment domains enabled a trial’s risk of bias to be designated as low, unclear or high. A trial was judged to comprise ‘reliable evidence’ if its risk of bias was low or was unclear in one specified domain. ‘Effect size’ was reported as odds ratio (OR), with arithmetic transformation for continuous data carried out as required; OR > 1 signified an effect favouring homeopathy.

RESULTS:

Thirty-two eligible RCTs studied 24 different medical conditions in total. Twelve trials were classed ‘uncertain risk of bias’, three of which displayed relatively minor uncertainty and were designated reliable evidence; 20 trials were classed ‘high risk of bias’. Twenty-two trials had extractable data and were subjected to meta-analysis; OR = 1.53 (95% confidence interval (CI) 1.22 to 1.91). For the three trials with reliable evidence, sensitivity analysis revealed OR = 1.98 (95% CI 1.16 to 3.38).

CONCLUSIONS:

Medicines prescribed in individualised homeopathy may have small, specific treatment effects. Findings are consistent with sub-group data available in a previous ‘global’ systematic review. The low or unclear overall quality of the evidence prompts caution in interpreting the findings. New high-quality RCT research is necessary to enable more decisive interpretation.

Since my team had published an RCTs of individualised homeopathy, it seems only natural that my interest focussed on why the study (even though identified by Mathie et al) had not been included in the meta-analysis. Our study had provided no evidence that adjunctive homeopathic remedies, as prescribed by experienced homeopathic practitioners, are superior to placebo in improving the quality of life of children with mild to moderate asthma in addition to conventional treatment in primary care.

I was convinced that this trial had been rigorous and thus puzzled why, despite receiving ‘full marks’ from the reviewers, they had not included it in their meta-analysis. I thus wrote to Mathie, the lead author of the meta-analysis, and he explained: For your trial (White et al. 2003), under domain V of assessment, we were unable to extract data for meta-analysis, and so it was attributed high risk of bias, as specified by the Cochrane judgmental criteria. Our designated main outcome was the CAQ, for which we needed to know (or could at least estimate) a mean and SD for both the baseline and the end-point of the study. Since your paper reported only the change from baseline in Table 3 or in the main text, it is not possible to derive the necessary end-point for analysis.

It took a while and several further emails until I understood: our study did report both the primary (Table 2 quality of life) and secondary outcome measure (Table 3 severity of symptoms). The primary outcome measure was reported in full detail such that a meta-analysis would have been possible. The secondary outcome measure was also reported but not in full detail, and the data provided by us would not lend themselves to meta-analyses. By electing not our primary but our secondary outcome measure for their meta-analysis, Mathie et al were able to claim that they were unable to use our study and reject it for their meta-analysis.

Why did they do that?

The answer is simple: in their methods section, they specify that they used outcome measures “based on a pre-specified hierarchical list in order of greatest to least importance, recommended by the WHO“. This, I would argue is deeply flawed: the most important outcome measure of a study is usually the one for which the study was designed, not the one that some guys at the WHO feel might be important (incidentally, the WHO list was never meant to be applied to meta-analyses in that way).

By following rigidly their published protocol, the authors of the meta-analysis managed to exclude our negative trial. Thus they did everything right – or did they?

Well, I think they committed several serious mistakes.

  • Firstly, they wrote the protocol, which forced them to exclude our study. Following a protocol is not a virtue in itself; if the protocol is nonsensical it even is the opposite. Had they proceeded as is normal in such cases and used our primary outcome measure in their meta-analyses, it is most likely that their overall results would not have been in favour of homeopathy.
  • Secondly, they awarded our study a malus point for the criterium ‘selective outcome reporting’. This is clearly a wrong decision: we did report the severity-outcome, albeit not in sufficient detail for their meta-analysis. Had they not committed this misjudgment, our RCT would have been the only one with an ‘A’ rating. This would have very clearly highlighted the nonsense of excluding the best-rated trial from meta-analysis.

There are several other oddities as well. For instance, Mathie et al judge our study to be NOT free of vested interest. I asked Mathie why they had done this and was told it is because we accepted free trial medication from a homeopathic pharmacy. I would argue that my team was far less plagued by vested interest than the authors of their three best (and of course positive) trials who, as I happen to know, are consultants for homeopathic manufacturers.

And all of this is just in relation to our own study. Norbert Aust has uncovered similar irregularities with other trials and I take the liberty of quoting his comments posted previously again here:

I have reason to believe that this review and metaanalysis in biased in favor of homeopathy. To check this, I compared two studies (1) Jacobs 1994 about the treatment of childhood diarrhea in Nicaragua, (2) Walach 1997 about homeopathic threatment of headaches. The Jacobs study is one of the three that provided ‘reliable evidence’, Walach’s study earned a poor C2.2 rating and was not included in the meta-analyses. Jacobs’ results were in favour of homeopathy, Walach’s not.

For the domains where the rating of Walach’s study was less than that of the Jacobs study, please find citations from the original studies or my short summaries for the point in question.

Domain I: Sequence generation:
Walach:
“The remedy selected was then mailed to a notary public who held a stock of placebos. The notary threw a dice and mailed either the homeopathic remedy or an appropriate placebo. The notary was provided with a blank randomisation list.”
Rating: UNCLEAR (Medium risk of bias)

Jacobs:
“For each of these medications, there was a box of tubes in sequentially numbered order which had been previously randomized into treatment or control medication using a random numbers table in blocks of four”
Rating: YES (Low risk of bias)

Domain IIIb: Blinding of outcome assessor
Walach:
“The notary was provided with a blank randomization list which was an absolutely unique document. It was only handed out after the biometrician (WG) had deposited all coded original data as a printout at the notary’s office. (…) Data entry was performed blindly by personnel not involved in the study. ”
Rating: UNCLEAR (Medium risk of bias)

Jacobs:
“All statistical analyses were done before breaking the randomisation code, using the program …”
Rating: YES (Low risk of bias)

Domain V: Selective outcome reporting

Walach:
Study protocol was published in 1991 prior to enrollment of participants, all primary outcome variables were reported with respect to all participants and the endpoints.
Rating: NO (high risk of bias)

Jacobs:
No prior publication of protocol, but a pilot study exists. However this was published in 1993 only after the trial was performed in 1991. Primary outcome defined (duration of diarrhea), reported but table and graph do not match, secondary outcome (number of unformed stools on day 3) seems defined post hoc, for this is the only one point in time, this outcome yielded a significant result.
Rating: YES (low risk of bias)

Domain VI: Other sources of bias:

Walach:
Rating: NO (high risk of bias), no details given

Jacobs:
Imbalance of group properties (size, weight and age of children), that might have some impact on course of disease, high impact of parallel therapy (rehydration) by far exceeding effect size of homeopathic treatment
Rating: YES (low risk of bias), no details given

In a nutshell: I fail to see the basis for the different ratings in the studies themselves. I assume bias of the authors of the review.

Conclusion

So, what about the question posed in the title of this article? The meta-analysis is clearly not a ‘proof of concept’. But is it proof for misconduct? I asked Mathie and he answered as follows: No, your statement does not reflect the situation at all. As for each and every paper, we selected the main outcome measure for your trial using the objective WHO classification approach (in which quality of life is clearly of lower rank than severity). This is all clearly described in our prospective protocol. Under no circumstances did we approach this matter retrospectively, in the way you are implying. 

Some nasty sceptics might have assumed that the handful of rigorous studies with negative results were well-known to most researchers of homeopathy. In this situation, it would have been hugely tempting to write the protocol such that these studies must be excluded. I am thrilled to be told that the authors of the current new meta-analysis (who declared all sorts of vested interests at the end of the article) resisted this temptation.

On this blog and elsewhere, I have repeatedly cast doubt on the efficacy of homeopathy – not because I have ‘an axe to grind’, as some seem to believe, but because

  1. the assumptions which underpin homeopathy fly in the face of science,
  2. the clinical evidence fails to show that it works beyond a placebo effect.

But was I correct?

A new systematic review and meta-analysis seems to indicate that I was mistaken. It tested the hypothesis that the outcome of an individualised homeopathic treatment (homeopaths would argue that this is the only true approach to homeopathy) is distinguishable from that with placebos.

The review’s methods, including literature search strategy, data extraction, assessment of risk of bias and statistical analysis, were strictly protocol-based. Judgment in seven assessment domains enabled a trial’s risk of bias to be designated as low, unclear or high. A trial was judged to comprise ‘reliable evidence’ if its risk of bias was low or was unclear in one specified domain. ‘Effect size’ was reported as odds ratio (OR), with arithmetic transformation for continuous data carried out as required; OR > 1 signified an effect favouring homeopathy.

Thirty-two eligible RCTs studied 24 different medical conditions in total. Twelve trials were classed ‘uncertain risk of bias’, three of which displayed relatively minor uncertainty and were designated reliable evidence; 20 trials were classed ‘high risk of bias’. Twenty-two trials had extractable data and were subjected to meta-analysis; OR = 1.53 (95% confidence interval (CI) 1.22 to 1.91). For the three trials with reliable evidence, sensitivity analysis revealed OR = 1.98 (95% CI 1.16 to 3.38).

The authors arrived at the following conclusion: medicines prescribed in individualised homeopathy may have small, specific treatment effects. Findings are consistent with sub-group data available in a previous ‘global’ systematic review. The low or unclear overall quality of the evidence prompts caution in interpreting the findings. New high-quality RCT research is necessary to enable more decisive interpretation.

One does not need to be a prophet to predict that the world of homeopathy will declare this article as the ultimate proof of homeopathy’s efficacy beyond placebo. Already the ‘British Homeopathic Association’ has issued the following press release:

Clinical evidence for homeopathy published

Research into the effectiveness of homeopathy as an individualised treatment has produced results that may surprise many from the worlds of science and medicine. The conclusions are reported cautiously, but the new publication is the first of its type to present evidence that medicines prescribed in individualised homeopathy may have specific effects.

The paper, published in the peer-reviewed journal Systematic Reviews,1 reports a rigorous systematic review and meta-analysis of 32 randomised controlled trials (RCTs) in which homeopathic medicines were prescribed on an individual basis to each participant, depending on their particular symptoms.

The overall quality of the RCT evidence was found to be low or unclear, preventing the researchers from reaching decisive conclusions. Three RCTs were identified as “reliable evidence”.

The study was led by Dr Robert Mathie, research development adviser for the British Homeopathic Association, in partnership with a number of collaborators, including colleagues at the Robertson Centre for Biostatistics, University of Glasgow, who independently verified the statistical methods and findings.

“What we found from the statistics,” says Dr Mathie, “is that the effect of individualised treatment using homeopathic medicines was significantly greater than placebos, and that this effect was retained when we included only the three trials with reliable evidence. This tentatively provides proof of concept that homeopathic medicines have clinical treatment effects.”

Surprised? I was stunned and thus studied the article in much detail (luckily the full text version is available online). Then I entered into an email exchange with the first author who I happen to know personally (to his credit, he responded regularly). In the end, this conversation helped me to better understand the review’s methodology; but it also resulted in me being very much underwhelmed by the reliability of the authors’ conclusion.

Normally I would now explain why. But, in this particular case, I thought it would be interesting and helpful to give others the opportunity to examine the article and come up with their own comments. Subsequently I will add my criticisms.

SO PLEASE TAKE SOME TIME TO STUDY THIS PAPER AND TELL US WHAT YOU THINK.

Well, not everywhere actually; if you go on Medline, for instance, and search for ‘detox’, you hardly find anything at all on detox as used in alternative medicine. This is because there is no science behind it (for the purpose of this post, ‘detox’ means the alternative detox that is supposed to rid us from environmental poisons and, more relevant to the Christmas season, of the effects of over-indulgence). Notwithstanding this lack of science and evidence, detox is currently being heavily promoted in magazines, newspapers and, of course, via the Internet.

Take the heir to our thrown, Prince Charles, for instance; he famously marketed his Duchy Originals ‘DETOX TINCTURE’. And he has competition from thousands who also exploit the gullible with similar placebos. One website even claimed that “2014 was the year of the cleanse diet. Celebrities swear by them and more and more people have been getting in on the action, whether it’s to detox diet, brighten skin, lose weight, or get a fresh start. And nowhere is that more evident than in Yahoo’s Year in Review, where different health cleanses consistently topped the site’s most popular stories lists. Here, the year’s top 10 most popular cleanses.”

The author then continues by promoting 10 different forms of detox:

1. A Colon Cleanse.

2. A Liver Cleanse.

3. The Master Cleanse.

4. The 10-Day Green Smoothie Cleanse.

5. A Juice Cleanse.

6. Detox Cleanse.

7. Slendera Garcinia and Natural Cleanse.

8. Dherbs Full Body Cleanse.

9. Blueprint Cleanse.

10. Isagenix Cleanse for Life.

These treatments seem diverse but they all have one thing in common: they do not work; they do not eliminate poisons from the body, they merely eliminate cash from your wallet.

But being so very negative is not the way forward, some might argue. Why does he not tell us which forms of detox do actually work?

Because it is Christmas, I will do just that and provide my readers with a full list of detox treatments that are effective. If you are looking for a specific type of detox and it is not on the list, it means you should spend your money on something else, stop over-indulging yourself and adopt a sensibly health lifestyle.

HERE WE GO – THIS IS MY COMPLETE LIST OF EFFECTIVE FORMS OF DETOX:

MERRY CHRISTMAS EVERYONE

Each year, during the Christmas period, we are bombarded with religious ideology, soapy sentimentality and delusive festive cheer. In case you are beginning to feel slightly nauseous about all this, it might be time to counter-balance this abundance with my (not entirely serious) version of the ’10 commandments of quackery’?

  1. You must not use therapies other than those recommended by your healer – certainly nothing that is evidence-based!
  2. You must never doubt what your healer tells you; (s)he embraces the wisdom of millennia combined with the deep insights of post-modernism – and is therefore beyond doubt.
  3. You must happily purchase all the books, gadgets, supplements etc. your healer offers for sale. For more merchandise, you must frequent your local health food shops. Money is no object!
  4. You must never read scientific literature; it is the writing of evil. The truth can only be found by studying the texts recommended by your healer.
  5. You must never enter into discussions with sceptics or other critical thinkers; they are wicked and want to destroy your well-being.
  6. You must do everything in your power to fight the establishment, Big Pharma, their dangerous drugs and vicious vaccines.
  7. You must support Steiner Schools, Prince Charles and other enlightened visionaries so that the next generation is guided towards the eternal light.
  8. You must detox regularly to eliminate the ubiquitous, malignant poisons of Satan.
  9. You must blindly, unreservedly and religiously believe in vitalism, quantum medicine, vibrational energy and all other concepts your healer relies upon.
  10. You must denounce, vilify, aggress and attack anyone who disagrees with the gospel of your healer.

The regular consumption of fish-oil has a potentially favourable role in inflammation, carcinogenesis inhibition and cancer outcomes. An analysis of the literature aimed to review the evidence for the roles of dietary-fish and fish-oil intake in prostate-cancer (PC) risk, aggressiveness and mortality.

A systematic-review, following PRISMA guidelines was conducted. PubMed, MEDLINE and Embase were searched to explore PC-risk, aggressiveness and mortality associated with dietary-fish and fish-oil intake. 37 studies were selected.

A total of 37-studies with 495,321 participants were analysed. They revealed various relationships regarding PC-risk (n = 31), aggressiveness (n = 8) and mortality (n = 3). Overall, 10 studies considering PC-risk found significant inverse trends with fish and fish-oil intake. One found a dose–response relationship whereas greater intake of long-chain-polyunsaturated fatty acids increased risk of PC when considering crude odds-ratios [OR: 1.36 (95% CI: 0.99–1.86); p = 0.014]. Three studies addressing aggressiveness identified significant positive relationships with reduced risk of aggressive cancer when considering the greatest intake of total fish [OR 0.56 (95% CI 0.37–0.86)], dark fish and shellfish-meat (p < 0.0001), EPA (p = 0.03) and DHA (p = 0.04). Three studies investigating fish consumption and PC-mortality identified a significantly reduced risk. Multivariate-OR (95% CI) were 0.9 (0.6–1.7), 0.12 (0.05–0.32) and 0.52 (0.30–0.91) at highest fish intakes.

The authors concluded that fish and fish-oil do not show consistent roles in reducing PC incidence, aggressiveness and mortality. Results suggest that the specific fish type and the fish-oil ratio must be considered. Findings suggest the need for large intervention randomised placebo-controlled trials.

Several other recent reviews have also generated encouraging evidence, e.g.:

Available evidence is suggestive, but currently inadequate, to support the hypothesis that n-3 PUFAs protect against skin malignancy.

…omega-3 fatty acids may exert their anticancer actions by influencing multiple targets implicated in various stages of cancer development, including cell proliferation, cell survival, angiogenesis, inflammation, metastasis and epigenetic abnormalities that are crucial to the onset and progression of cancer.

If I was aiming for a career as a cancer quack, I would now use this evidence to promote my very own cancer prevention and treatment diet. As I have no such ambitions, I should tell you that regular fish oil consumption is no way to treat cancer. It also is no way to prevent cancer. If anything, it might turn out to be a way of slightly reducing the risk of certain cancers. To be sure, we need a lot more research, and once we have it, fish oil will be entirely mainstream. Raising false hopes regarding ‘alternative cancer cures’ based on fairly preliminary evidence is counter-productive, unethical and irresponsible.

Few subjects make chiropractors more uneasy than a discussion of the safety of their spinal manipulations. Many chiropractors flatly deny that there are any risks at all. However, the evidence seems to tell a different story.

The purpose of a new review was to summarise the literature for cases of adverse events in infants and children treated by chiropractors or other manual therapists, identifying treatment type and if a preexisting pathology was present. English language, peer-reviewed journals and non-peer-reviewed case reports discussing adverse events (ranging from minor to serious) were systematically searched from inception of the relevant searchable bibliographic databases through March 2014. Articles not referring to infants or children were excluded.

Thirty-one articles met the selection criteria. A total of 12 articles reporting 15 serious adverse events were found. Three deaths occurred under the care of various providers (1 physical therapist, 1 unknown practitioner, and 1 craniosacral therapist) and 12 serious injuries were reported (7 chiropractors/doctors of chiropractic, 1 medical practitioner, 1 osteopath, 2 physical therapists, and 1 unknown practitioner). High-velocity, extension, and rotational spinal manipulation was reported in most cases, with 1 case involving forcibly applied craniosacral dural tension and another involving use of an adjusting instrument. Underlying preexisting pathology was identified in a majority of the cases.

The authors concluded that published cases of serious adverse events in infants and children receiving chiropractic, osteopathic, physiotherapy, or manual medical therapy are rare. The 3 deaths that have been reported were associated with various manual therapists; however, no deaths associated with chiropractic care were found in the literature to date. Because underlying preexisting pathology was associated in a majority of reported cases, performing a thorough history and examination to exclude anatomical or neurologic anomalies before applying any manual therapy may further reduce adverse events across all manual therapy professions.

This review is a valuable addition to our knowledge about the risks of spinal manipulations. My own review summarised 26 deaths after chiropractic manipulations. In several of these instances, the age of the patient had not been reported. Therefore the above conclusion (no deaths associated with chiropractic) seems a little odd.

The following text is a shortened version of the discussion of my review which, I think, addresses most of the pertinent issues.

 numerous deaths have been associated with chiropractic. Usually high-velocity, short-lever thrusts of the upper spine with rotation are implicated. They are believed to cause vertebral arterial dissection in predisposed individuals which, in turn, can lead to a chain of events including stroke and death. Many chiropractors claim that, because arterial dissection can also occur spontaneously, causality between the chiropractic intervention and arterial dissection is not proven. However, when carefully evaluating the known facts, one does arrive at the conclusion that causality is at least likely. Even if it were merely a remote possibility, the precautionary principle in healthcare would mean that neck manipulations should be considered unsafe until proven otherwise. Moreover, there is no good evidence for assuming that neck manipulation is an effective therapy for any medical condition. Thus, the risk-benefit balance for chiropractic neck manipulation fails to be positive.

Reliable estimates of the frequency of vascular accidents are prevented by the fact that underreporting is known to be substantial. In a survey of UK neurologists, for instance, under-reporting of serious complications was 100%. Those cases which are published often turn out to be incomplete. Of 40 case reports of serious adverse effects associated with spinal manipulation, nine failed to provide any information about the clinical outcome. Incomplete reporting of outcomes might therefore further increase the true number of fatalities.

This review is focussed on deaths after chiropractic, yet neck manipulations are, of course, used by other healthcare professionals as well. The reason for this focus is simple: chiropractors are more frequently associated with serious manipulation-related adverse effects than osteopaths, physiotherapists, doctors or other professionals. Of the 40 cases of serious adverse effects mentioned above, 28 can be traced back to a chiropractor and none to a osteopath. A review of complications after spinal manipulations by any type of healthcare professional included three deaths related to osteopaths, nine to medical practitioners, none to a physiotherapist, one to a naturopath and 17 to chiropractors. This article also summarised a total of 265 vascular accidents of which 142 were linked to chiropractors. Another review of complications after neck manipulations published by 1997 included 177 vascular accidents, 32 of which were fatal. The vast majority of these cases were associated with chiropractic and none with physiotherapy. The most obvious explanation for the dominance of chiropractic is that chiropractors routinely employ high-velocity, short-lever thrusts on the upper spine with a rotational element, while the other healthcare professionals use them much more sparingly.

[REFERENCES FOR THE ABOVE STATEMENTS CAN BE FOUND IN MY REVIEW]

How many times have we heard from practitioners of alternative medicine, particularly chiropractors, that their patients are more severely ill than those of conventional clinicians. The claim is usually that they have tried all that conventional medicine can offer and eventually, as a last resort, they turn to the alternatives.

But is this true? If so, it would explain why these patients do no better or even worse than those treated conventionally.

Here is a new article that goes some way in addressing these issues.

For this study, Danish chiropractors and general practitioners recruited adult patients seeking care for low back pain (LBP). Extensive baseline questionnaires were obtained and descriptive analyses were performed to define the differences between the two populations.

Questionnaires were returned from 934 patients in chiropractic practice and 319 patients from general practice. Four out of five patients had previous episodes, one-fourth were on sick leave, and the LBP considerably limited daily activities. The general practice patients were slightly older and less educated, more often female, and generally worse on all disease-related parameters than chiropractic patients. All the disease specific parameters showed a statistically significant difference between general and chiropractic practice. Patients in general practice were generally more severely affected. They had higher pain intensity (mainly for leg pain), longer pain duration, more previous episodes, more sick leave, more activity limitation on the disability scale, slightly higher level of depression, slightly more fear-avoidance beliefs, and a poorer self-reported general health. All these differences were statistically significant.

The authors concluded that LBP in primary care was recurrent, causing sick leave and activity limitations. There were clear differences between the chiropractic and general practice populations in this study.

I know, I know: these findings are from Denmark and therefore they cannot be generalised to other countries. However, the authors point out that similar findings have been reported from the US. Furthermore the observations relate to chiropractors and must not be applied to other alternative practitioners. Nevertheless they do show that, in this specific scenario, patients opting for the alternative are not more but less severely ill.

The next time an alternative practitioner claims ‘my patients have worse outcomes because they are sicker’, I will insist on seeing the evidence before I believe it.

Adverse events have been reported extensively following chiropractic.  About 50% of patients suffer side-effects after seeing a chiropractor. The majority of these events are mild, transitory and self-limiting. However, chiropractic spinal manipulations, particularly those of the upper spine, have also been associated with very serious complications; several hundred such cases have been reported in the medical literature and, as there is no monitoring system to record these instances, this figure is almost certainly just the tip of a much larger iceberg.

Despite these facts, little is known about patient filed compensation claims related to the chiropractic consultation process. The aim of a new study was to describe claims reported to the Danish Patient Compensation Association and the Norwegian System of Compensation to Patients related to chiropractic from 2004 to 2012.

All finalized compensation claims involving chiropractors reported to one of the two associations between 2004 and 2012 were assessed for age, gender, type of complaint, decisions and appeals. Descriptive statistics were used to describe the study population.

338 claims were registered in Denmark and Norway between 2004 and 2012 of which 300 were included in the analysis. 41 (13.7%) were approved for financial compensation. The most frequent complaints were worsening of symptoms following treatment (n = 91, 30.3%), alleged disk herniations (n = 57, 19%) and cases with delayed referral (n = 46, 15.3%). A total financial payment of €2,305,757 (median payment €7,730) were distributed among the forty-one cases with complaints relating to a few cases of cervical artery dissection (n = 11, 5.7%) accounting for 88.7% of the total amount.

The authors concluded that chiropractors in Denmark and Norway received approximately one compensation claim per 100.000 consultations. The approval rate was low across the majority of complaint categories and lower than the approval rates for general practitioners and physiotherapists. Many claims can probably be prevented if chiropractors would prioritize informing patients about the normal course of their complaint and normal benign reactions to treatment.

Despite its somewhat odd conclusion (it is not truly based on the data), this is a unique article; I am not aware that other studies of chiropractic compensation  claims exist in an European context. The authors should be applauded for their work. Clearly we need more of the same from other countries and from all professions doing manipulative therapies.

In the discussion section of their article, the authors point out that Norwegian  and Danish chiropractors both deliver approximately two million consultations annually. They receive on average 42 claims combined suggesting roughly one claim per 100.000 consultations. By comparison, Danish statistics show that in the period 2007–2012 chiropractors, GPs and physiotherapists (+ occupational therapists) received 1.76, 1.32 and 0.52 claims per 100.000 consultations, respectively with approval rates of 13%, 25% and 21%, respectively. During this period these three groups were reimbursed on average €58,000, €29,000 and €18,000 per approved claim, respectively.

These data are preliminary and their interpretation might be a matter of debate. However, one thing seems clear enough: contrary to what we frequently hear from apologists, chiropractors do receive a considerable amount of compensation claims which means many patients do get harmed.

As I have said on several occasions before: I am constantly on the lookout for new rigorous science that supports the claims of alternative medicine. Thus I was delighted to find a recent and potentially important article with some positive evidence.

Fish oil has been studied extensively in terms of its effects on health. We know that it has powerful anti-inflammatory properties and might thus benefit a wide range of conditions. However, the effects of FO in rheumatoid arthritis (RA) have not been examined in the context of contemporary treatment of early RA.

A new study has tried to fill this gap by examining the effects of high versus low dose FO in early RA employing a ‘treat-to-target’ protocol of combination disease-modifying anti-rheumatic drugs (DMARDs).

Patients with RA <12 months’ duration and who were DMARD-naïve were enrolled and randomised 2:1 to FO at a high dose or low dose (for masking). These groups, designated FO and control, were given 5.5 or 0.4 g/day, respectively, of the omega-3 fats, eicosapentaenoic acid + docosahexaenoic acid. All patients received methotrexate (MTX), sulphasalazine and hydroxychloroquine, and DMARD doses were adjusted according to an algorithm taking disease activity and toxicity into account. DAS28-erythrocyte sedimentation rate, modified Health Assessment Questionnaire (mHAQ) and remission were assessed three monthly. The primary outcome measure was failure of triple DMARD therapy.

In the FO group, failure of triple DMARD therapy was lower (HR=0.28 (95% CI 0.12 to 0.63; p=0.002) unadjusted and 0.24 (95% CI 0.10 to 0.54; p=0.0006) following adjustment for smoking history, shared epitope and baseline anti–cyclic citrullinated peptide. The rate of first American College of Rheumatology (ACR) remission was significantly greater in the FO compared with the control group (HRs=2.17 (95% CI 1.07 to 4.42; p=0.03) unadjusted and 2.09 (95% CI 1.02 to 4.30; p=0.04) adjusted). There were no differences between groups in MTX dose, DAS28 or mHAQ scores, or adverse events.

The authors concluded that FO was associated with benefits additional to those achieved by combination ‘treat-to-target’ DMARDs with similar MTX use. These included reduced triple DMARD failure and a higher rate of ACR remission.

So here we have a dietary supplement that actually might generate more good than harm! There is a mountain of data of good research on the subject. We understand the mechanism of action and we have encouraging clinical evidence. Some people might still say that we do not need to take supplements in order to benefit from the health effects of FO, consuming fatty fish regularly might have the same effects. This is true, of course, but the amount of fish that one would need to eat every day would probably be too large for most people’s taste.

The drawback (from the perspective of alternative medicine) in all this is, of course, that some experts might deny that FO has much to do with alternative medicine. Again: what do we call alternative medicine that works? We call it MEDICINE! And perhaps FO is an excellent example of exactly that.

Dietary supplements (DS) are heavily promoted usually with the claim that they have stood the test of time and that they are natural and hence harmless. Unsurprisingly, their use has become very wide-spread. A new study determined the use of DSs, factors associated with DS use, and reasons for use among U.S. college students.

College students (N = 1248) at 5 U.S. universities were surveyed. Survey questions included descriptive demographics, types and frequency of DS used, reasons for use and money spent on supplements. Supplements were classified using standard criteria. Logistic regression analyses examined relationships between demographic and lifestyle factors and DS use.

Sixty-six percent of college students surveyed used DS at least once a week, and 12% consumed 5 or more supplements a week. Forty-two percent used multivitamins/multiminerals, 18% vitamin C, 17% protein/amino acids and 13% calcium at least once a week. Factors associated with supplement use included dietary patterns, exercise, and tobacco use. Students used supplements to promote general health (73%), provide more energy (29%), increase muscle strength (20%), and enhance performance (19%).

The authors of this survey concluded that college students appear more likely to use DS than the general population and many use multiple types of supplements weekly. Habits established at a young age persist throughout life. Therefore, longitudinal research should be conducted to determine whether patterns of DS use established early in adulthood are maintained throughout life. Adequate scientific justification for widespread use of DS in healthy, young populations is lacking.

Another new study investigated the use of DSs in 334 dancers from 53 countries, who completed a digitally based 35-question survey detailing demographic information and the use of DSs. Supplement use was prevalent amongst this international cohort, with 48% reporting regular DSs use. Major motives for supplement use were to improve health, boost immunity, and reduce fatigue. Forty-five percent believed that dancing increased the need for supplementation, whilst 30% recognized that there were risks associated with DSs.

The most frequently consumed DSs were vitamin C (60%), multivitamins (67%), and caffeine (72%). A smaller group of participants declared the use of whey protein (21%) or creatine (14%). Supplements were mainly obtained from pharmacies, supermarkets, and health-food stores. Dancers recognized their lack of knowledge in DSs use and relied on peer recommendations instead of sound evidence-based advice from acknowledged nutrition or health care professionals.

The authors concluded that this study demonstrates that DSs use is internationally prevalent amongst dancers. Continued efforts are warranted with regard to information dissemination.

Finally, a third study investigated use of DSs in patients in Japan. This survey was completed by 2732 people, including 599 admitted patients, 1154 ambulatory patients, and 979 healthy subjects who attended a seminar about DSs. At the time of the questionnaire, 20.4% of admitted patients, 39.1% of ambulatory patients, and 30.7% of healthy subjects were using DSs, which including vitamin/mineral supplements, herbal extracts, its ingredients, or food for specified health uses.

The primary purpose for use in all groups was health maintenance, whereas 3.7% of healthy subjects, 10.0% of ambulatory patients, and 13.2% of admitted patients used DSs to treat diseases. In addition, 17.7% of admitted patients and 36.8% of ambulatory patients were using DSs concomitantly with their medications. However, among both admitted patients and ambulatory patients, almost 70% did not mention DSs use to their physicians. Overall, 3.3% of all subjects realized adverse effects associated with DSs.

The authors concluded that communication between patients and physicians is important to avoid health problems associated with the use of DSs.

There is little doubt, DSs are popular with all sorts of populations and have grown into a multi billion dollar industry. There is also no doubt that the use of only very few DSs are evidence-based (and if so, in only relatively rare situations). And there can be no doubt that many DSs can do harm. What follows is simple: for the vast majority of DSs the benefits do not demonstrably out-weigh the risks.

If that is true, we have to ask ourselves: Why are they so popular?

The answer, I think, is because of the very phenomenon I am constantly trying to fight on this blog – IRRESPONSIBLE CHARLATANS PULLING WOOL OVER CONSUMERS EYES.

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