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

causation

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Radiation-induced xerostomia (RIX) is a common, often debilitating, adverse effect of radiation therapy among patients with head and neck cancer. Quality of life can be severely affected, and current treatments have limited benefit. Acupuncture is often recommended, but does it work? This study was aimed at finding out whether acupuncture can prevent RIX in patients with head and neck cancer undergoing radiation therapy.

The 2-center, phase 3, randomized clinical trial compared a standard care control (SCC) with true acupuncture (TA) and sham acupuncture (SA) among patients with oropharyngeal or nasopharyngeal carcinoma who were undergoing radiation therapy in comprehensive cancer centres in the United States and China. Patients were enrolled between December 16, 2011, and July 7, 2015. Final follow-up was August 15, 2016. Analyses were conducted February 1 through 28, 2019. Either TA or SA using a validated acupuncture placebo device were performed 3 times per week during a 6- to 7-week course of radiation therapy. The primary end point was RIX, as determined by the Xerostomia Questionnaire in which a higher score indicates worse RIX, for combined institutions 1 year after radiation therapy ended. Secondary outcomes included incidence of clinically significant xerostomia (score >30), salivary flow, quality of life, salivary constituents, and role of baseline expectancy related to acupuncture on outcomes.

Of 399 patients randomized, 339 were included in the final analysis, including 112 patients in the TA group, 115 patients in the SA group, and 112 patients in the SCC group. For the primary aim, the adjusted least square mean (SD) xerostomia score in the TA group (26.6 [17.7]) was significantly lower than in the SCC group (34.8 [18.7]) (P = .001; effect size = -0.44) and marginally lower but not statistically significant different from the SA group (31.3 [18.6]) (P = .06; effect size = -0.26). Incidence of clinically significant xerostomia 1 year after radiation therapy ended followed a similar pattern, with 38 patients in the TA group (34.6%), 54 patients in the SA group (47.8%), and 60 patients in the SCC group (55.1%) experiencing clinically significant xerostomia (P = .009). Post hoc comparisons revealed a significant difference between the TA and SCC groups at both institutions, but TA was significantly different from SA only at Fudan University Cancer Center, Shanghai, China (estimated difference [SE]: TA vs SCC, -9.9 [2.5]; P < .001; SA vs SCC, -1.7 [2.5]; P = .50; TA vs SA, -8.2 [2.5]; P = .001), and SA was significantly different from SCC only at the University of Texas MD Anderson Cancer Center, Houston, Texas (estimated difference [SE]: TA vs SCC, -8.1 [3.4]; P = .016; SA vs SCC, -10.5 [3.3]; P = .002; TA vs SA, 2.4 [3.2]; P = .45).

The authors concluded that this randomized clinical trial found that TA resulted in significantly fewer and less severe RIX symptoms 1 year after treatment vs SCC. However, further studies are needed to confirm clinical relevance and generalizability of this finding and to evaluate inconsistencies in response to sham acupuncture between patients in the United States and China.

In essence this two-centre study shows that:

  • real acupuncture is better than usual care, but the effect size is small and of doubtful clinical relevance;
  • real acupuncture is not significantly better than sham acupuncture;
  • the findings differ remarkably between the US and the Chinese centre.

I find the last point the most interesting one. We know from previous research that acupuncture studies from China are notoriously unreliable; they never report a negative result and there is evidence that data fabrication is rife in China. The new findings seems to throw more light on this notion. In the US centre, real and sham acupuncture generated practically identical results. By contrast, in the Chinese centre, real acupuncture generated significantly better results than sham. The authors offer several hypotheses to explain this remarkable phenomenon. Yet, in my view, the most likely one is that Chinese researchers are determined to show that acupuncture is effective. Thus all sorts of unconscious or even conscious biases might get introduced into such studies.

In essence, trial therefore confirms that acupuncture is little more than a theatrical placebo, particularly if we consider the US data which, in my opinion, are more trustworthy.

Lorenzo Cohen, Professor of Palliative, Rehabilitation, and Integrative Medicine and director of the Integrative Medicine Program as well as senior author of the paper unsurprisingly disagrees. He was quoted saying: “The evidence is to a point where patients should incorporate acupuncture alongside radiation treatment as a way to prevent the severity of dry mouth symptoms. I think with this study we can add acupuncture to the list for the prevention and treatment of xerostomia, and the guidelines for the use of acupuncture in the oncology setting should be revised to include this important chronic condition.”

Who do you think is closer to the truth?

Maintenance Care is an approach whereby patients have chiropractic manipulations even when symptom-free. Thus, it is an ideal method to keep chiropractors in clover. Previous reviews concluded that evidence behind this strategy is lacking. Since then, more data have emerged. It was therefore timely to review the evidence.

Fourteen original research articles were included in the review. Maintenance Care was defined as a secondary or tertiary preventive approach, recommended to patients with previous pain episodes, who respond well to chiropractic care. Maintenance Care is applied to approximately 30% of Scandinavian chiropractic patients. Both chiropractors and patients believe in the efficacy of Maintenance Care. Four studies investigating the effect of chiropractic Maintenance Care were identified, with disparate results on pain and disability of neck and back pain. However, only one of these studies utilized all the existing evidence when selecting study subjects and found that Maintenance Care patients experienced fewer days with low back pain compared to patients invited to contact their chiropractor ‘when needed’. No studies were found on the cost-effectiveness of Maintenance Care.

The authors concluded that knowledge of chiropractic Maintenance Care has advanced. There is reasonable consensus among chiropractors on what Maintenance Care is, how it should be used, and its indications. Presently, Maintenance Care can be considered an evidence-based method to perform secondary or tertiary prevention in patients with previous episodes of low back pain, who report a good outcome from the initial treatments. However, these results should not be interpreted as an indication for Maintenance Care on all patients, who receive chiropractic treatment.

I have to admit, I have problems with these conclusions.

  1. Maintenance Care is not normally defined as secondary or tertitary prevention. It also includes primary prevention, which means that chiropractors recommend it for just about anyone.  By definition it is long term care, that is not therapeutically necessary, but performed at regular intervals to help prevent injury and enhance quality of life.  This form of care is provided after maximal therapeutic benefit is achieved, without a trial of treatment withdrawal, to prevent symptoms from returning or for those without symptoms to promote health or prevent future problems.
  2.  I am not convinced that the evidence would be positive, even if we confined it to secondary and tertiary prevention.

To explain my last point, let’s have a look at the 4 RCT and check whether they really warrant such a relatively positive conclusion.

FIRST STUDY For individuals with recurrent or persistent non-specific low back pain (LBP), exercise and exercise combined with education have been shown to be effective in preventing new episodes or in reducing the impact of the condition. Chiropractors have traditionally used Maintenance Care (MC), as secondary and tertiary prevention strategies. The aim of this trial was to investigate the effectiveness of MC on pain trajectories for patients with recurrent or persistent LBP.

This pragmatic, investigator-blinded, two arm randomized controlled trial included consecutive patients (18–65 years old) with non-specific LBP, who had an early favorable response to chiropractic care. After an initial course of treatment, eligible subjects were randomized to either MC or control (symptom-guided treatment). The primary outcome was total number of days with bothersome LBP during 52 weeks collected weekly with text-messages (SMS) and estimated by a GEE model.

Three hundred and twenty-eight subjects were randomly allocated to one of the two treatment groups. MC resulted in a reduction in the total number of days per week with bothersome LBP compared with symptom-guided treatment. During the 12 month study period, the MC group (n = 163, 3 dropouts) reported 12.8 (95% CI = 10.1, 15.5; p = <0.001) fewer days in total with bothersome LBP compared to the control group (n = 158, 4 dropouts) and received 1.7 (95% CI = 1.8, 2.1; p = <0.001) more treatments. Numbers presented are means. No serious adverse events were recorded.

MC was more effective than symptom-guided treatment in reducing the total number of days over 52 weeks with bothersome non-specific LBP but it resulted in a higher number of treatments. For selected patients with recurrent or persistent non-specific LBP who respond well to an initial course of chiropractic care, MC should be considered an option for tertiary prevention.

SECOND STUDY Back and neck pain are associated with disability and loss of independence in older adults. Whether long‐term management using commonly recommended treatments is superior to shorter‐term treatment is unknown. This randomized clinical trial compared short‐term treatment (12 weeks) versus long‐term management (36 weeks) of back‐ and neck‐related disability in older adults using spinal manipulative therapy (SMT) combined with supervised rehabilitative exercises (SRE).

Eligible participants were ages ≥65 years with back and neck disability for ≥12 weeks. Coprimary outcomes were changes in Oswestry Disability Index (ODI) and Neck Disability Index (NDI) scores after 36 weeks. An intent‐to‐treat approach used linear mixed‐model analysis to detect between‐group differences. Secondary analyses included other self‐reported outcomes, adverse events, and objective functional measures.

A total of 182 participants were randomized. The short‐term and long‐term groups demonstrated significant improvements in back disability (ODI score –3.9 [95% confidence interval (95% CI) –5.8, –2.0] versus ODI score –6.3 [95% CI –8.2, –4.4]) and neck disability (NDI score –7.3 [95% CI –9.1, –5.5] versus NDI score –9.0 [95% CI –10.8, –7.2]) after 36 weeks, with no difference between groups (back ODI score 2.4 [95% CI –0.3, 5.1]; neck NDI score 1.7 [95% CI 0.8, 4.2]). The long‐term management group experienced greater improvement in neck pain at week 36, in self‐efficacy at weeks 36 and 52, and in functional ability, and balance.For older adults with chronic back and neck disability, extending management with SMT and SRE from 12 to 36 weeks did not result in any additional important reduction in disability.

THIRD STUDY A prospective single blinded placebo controlled study was conducted. To assess the effectiveness of spinal manipulation therapy (SMT) for the management of chronic nonspecific low back pain (LBP) and to determine the effectiveness of maintenance SMT in long-term reduction of pain and disability levels associated with chronic low back conditions after an initial phase of treatments. SMT is a common treatment option for LBP. Numerous clinical trials have attempted to evaluate its effectiveness for different subgroups of acute and chronic LBP but the efficacy of maintenance SMT in chronic nonspecific LBP has not been studied. Sixty patients, with chronic, nonspecific LBP lasting at least 6 months, were randomized to receive either (1) 12 treatments of sham SMT over a 1-month period, (2) 12 treatments, consisting of SMT over a 1-month period, but no treatments for the subsequent 9 months, or (3) 12 treatments over a 1-month period, along with “maintenance spinal manipulation” every 2 weeks for the following 9 months. To determine any difference among therapies, we measured pain and disability scores, generic health status, and back-specific patient satisfaction at baseline and at 1-, 4-, 7-, and 10-month intervals. Patients in second and third groups experienced significantly lower pain and disability scores than first group at the end of 1-month period (P = 0.0027 and 0.0029, respectively). However, only the third group that was given spinal manipulations (SM) during the follow-up period showed more improvement in pain and disability scores at the 10-month evaluation. In the nonmaintained SMT group, however, the mean pain and disability scores returned back near to their pretreatment level.SMT is effective for the treatment of chronic nonspecific LBP. To obtain long-term benefit, this study suggests maintenance SM after the initial intensive manipulative therapy.

FORTH STUDY Evidence indicates that supervised home exercises, combined or not with manual therapy, can be beneficial for patients with non-specific chronic neck pain (NCNP). The objective of the study is to investigate the efficacy of preventive spinal manipulative therapy (SMT) compared to a no treatment group in NCNP patients. Another objective is to assess the efficacy of SMT with and without a home exercise program.Ninety-eight patients underwent a short symptomatic phase of treatment before being randomly allocated to either an attention-group (n = 29), a SMT group (n = 36) or a SMT + exercise group (n = 33). The preventive phase of treatment, which lasted for 10 months, consisted of meeting with a chiropractor every two months to evaluate and discuss symptoms (attention-control group), 1 monthly SMT session (SMT group) or 1 monthly SMT session combined with a home exercise program (SMT + exercise group). The primary and secondary outcome measures were represented by scores on a 10-cm visual analog scale (VAS), active cervical ranges of motion (cROM), the neck disability index (NDI) and the Bournemouth questionnaire (BQ). Exploratory outcome measures were scored on the Fear-avoidance Behaviour Questionnaire (FABQ) and the SF-12 Questionnaire. Our results show that, in the preventive phase of the trial, all 3 groups showed primary and secondary outcomes scores similar to those obtain following the non-randomised, symptomatic phase. No group difference was observed for the primary, secondary and exploratory variables. Significant improvements in FABQ scores were noted in all groups during the preventive phase of the trial. However, no significant change in health related quality of life (HRQL) was associated with the preventive phase. This study hypothesised that participants in the combined intervention group would have less pain and disability and better function than participants from the 2 other groups during the preventive phase of the trial. This hypothesis was not supported by the study results. Lack of a treatment specific effect is discussed in relation to the placebo and patient provider interactions in manual therapies. Further research is needed to delineate the specific and non-specific effects of treatment modalities to prevent unnecessary disability and to minimise morbidity related to NCNP. Additional investigation is also required to identify the best strategies for secondary and tertiary prevention of NCNP.

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I honestly do not think that the findings from these 4 small trials justify the far-reaching conclusion that Maintenance Care can be considered an evidence-based method… For that statement to be evidence-based, one would need to see more and better studies. Therefore, the honest conclusion, I think, is that maintenance care is not supported by sound evidence for effectiveness; as chiropractic manipulations are costly and not risk-free, its risk/benefit balance fails to be positive. Therefore, this approach cannot be recommended.

On 6 November the Guardian published an article in which acupuncture and its risks were briefly mentioned. It prompted a complaint by the British Acupuncture Council which, I think, is sufficiently interesting to merit a discussion. The British Acupuncture Council (BAcC) has a membership of around 3,000 professionally qualified acupuncturists. It is the UK’s largest professional/ self-regulatory body for the practice of traditional acupuncture. Here is their complaint in full:

Re: Guardian article ‘Doctors call for tighter regulation of traditional Chinese medicine’, published 6 November 2019. We wish to respond to the article referenced above, specifically with regards to the two sentences relating to the safety of acupuncture. We request you correct the misleading comments made in the article and publish this letter online.

1. ‘And acupuncture, they will say, “is not necessarily harmless.”’

Yes, of course it may not be harmless: it involves piercing the skin with a sharp object. Hence the need for proper training of acupuncturists, together with evidenced guidelines, a robust code of safe practice and regulatory teeth. These components are all in place for members of the British Acupuncture Council (BAcC). Acupuncture has not been taken into state control in the UK precisely because it has been found to be so safe; instead, the BAcC is entrusted with self-regulation and is an accredited member of the Professional Standards Authority. Statements about the safety of acupuncture commonly conclude: ‘Acupuncture seems, in skilled hands, one of the safer forms of medical intervention’ (White 2001).

2. ‘…A review in 2017 found many injuries, infections and adverse reactions.’
That first part of your acupuncture safety comment was a direct quote from the FEAM/EASAC statement, which was the focus of the article, but it then departs from the script to manufacture the colourful soundbite above. You refer to the same acupuncture safety overview paper (Chan et al 2017) that FEAM/EASAC drew on, but then substantially misrepresent its content and messages. It is neither a quote from the FEAM/EASAC statement, nor from the overview paper. In fact, the latter sums up the findings of the 17 included reviews thus:  ‘However, all the reviews have suggested that adverse events are rare and often minor.’ Your statement about many injuries, infections and adverse reactions gives a very different message to the paper’s authors.
The Guardian article appears to have been written with little understanding of the science involved in investigating medical adverse events. In particular, it is impossible to establish the significance of the numbers of adverse events reported without knowing how many treatments they came from. Chan et al (2017) noted that incidence rates could not be calculated ‘because many adverse events came from case reports and many of the reviews did not include full details about the number of participants in their included studies’. The 17 reviews between them covered literature from 1950 to 2014 and countries across the globe, so potentially millions and millions of treatments. No wonder they turned up plenty of incidents!
One of the ‘gold standard’ acupuncture safety reviews (Xu et al 2013), which was included in Chan’s overview, provides the following information on this issue:

‘Incidence rates for major AEs [adverse events] of acupuncture are best estimated from large prospective surveys of practitioners. Four recent surveys of acupuncture safety among regulated, qualified practitioners, two conducted in Germany (Melchart 2004; Witt 2009), and two in the United Kingdom (MacPherson 2001; White 2001), confirm that serious adverse events after acupuncture are uncommon. Indeed, of these surveys, covering more than 3 million acupuncture treatments all together, there were no deaths or permanent disabilities, and all those with AEs fully recovered (Witt 2011). Thus, it can be concluded that acupuncture has a very low rate of AEs, when conducted among licensed, qualified practitioners in the West.’

The overview authors also raised this concern: ‘A major limitation of the presented information was that no causality could be determined’. In other words there is often no evidence to link acupuncture to the reported event: it is implicated just because it was around at the time. Adverse events only become adverse reactions (your words) if there is a substantiated link.
Your article (and indeed the FEAM/EASAC statement) completely omits perhaps the most important consideration: how does acupuncture compare to other available treatment options? It is most often used by people for chronic pain. The evidence base for this is good (Vickers 2018) and supports acupuncture’s effectiveness compared to conventional treatments (Trinh 2019). The potential harms of opioids and non-steroidal anti-inflammatory drugs are well known and acupuncture is associated with fewer adverse events than medications in controlled trials across a wide range of conditions (Cao 2018; Xu 2018; Lu 2016).  It was estimated that one in 1,200 people taking NSAIDS for at least two months will die of gastrointestinal complications (Tramer 2000). Six percent of hospitalisations in developed countries are due to adverse drug reactions (Angamo 2016).

On safety grounds there is no comparison: no serious adverse events were reported in a survey covering 34,407 acupuncture treatments given by BAcC members (Macpherson 2001). Of the mild transient reactions reported, the most frequent were ‘feeling relaxed’, and ‘feeling energised’. This is not to downplay the potential harms, for they can be serious, but as with any medical intervention there should be a proper assessment of how likely this is, which the Guardian article signally failed to do.
Yours sincerely

Mark Bovey Research Manager British Acupuncture Council

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I had no involvement in the Guardian article; I nevertheless feel that several things need to be pointed out about this bizarre complaint:

  1. The quote attributed to White A is, in fact, by White, Hayhoe, Hart and Ernst (yes, petty point), and our investigation showed (not petty point) that there were 43 significant minor adverse events reported, a rate of 14 per 10,000, of which 13 (30%) interfered with daily activities. One patient suffered a seizure (probably reflex anoxic) during acupuncture, but no adverse event was classified as serious. Avoidable events included forgotten patients, needles left in patients, cellulitis and moxa burns. This, I think, entirely justifies the words -is not necessarily harmless – published by the Guardian.
  2. The complaint states that there is often no evidence to link acupuncture to the reported event: it is implicated just because it was around at the time. Adverse events only become adverse reactions (your words) if there is a substantiated link. What this seems to imply is this: the BAcC claim that causality of adverse effects remains speculative, while having failed to establish a surveillance system that could establish their causality more firmly. Perhaps the BAcC should file a complaint about themselves?
  3. The BAcC claim that the author of the Guardian article lacks understanding of the science of adverse effect reporting. However, I get the impression that the lack of understanding is embarrassingly evident on the side of the BAcC.
  4. The BAcC then highlight the most important consideration: how does acupuncture compare to other available treatment options? This is more than a little odd. Firstly, such comparisons hardly were the aim of the Guardian article. Secondly, such comparisons only make sense with options that have a comparable risk/benefit profile. As the benefits of acupuncture for most conditions are still debatable, and since its risks are finite, its risk/benefit balance might not be clearly positive. Therefore, such comparisons are of doubtful value and could easily turn out to generate unfavourable evidence against acupuncture.
  5. Comparisons to opioids or NSAIDS are evidently nonsensical for the reason just mentioned.
  6. The Guardian article’s comments on acupuncture risks were of a general nature and were unelated to any specific issues about BAcC members. There are many non-medically trained acupuncturists – both in the UK and abroad – who might represent a substantially higher risk. Therefore the Guardian should not be criticised but praised for publishing words of caution.

The BAcC state that this is not to downplay the potential harms, yet I fear that this is precisely what they are trying to do. Until there is a post-marketing surveillance system, it would be honest and ethical to admit that the risks of acupuncture are essentially not known.

In my view, the complaint has no reasonable basis, tells us more about the BAcC than the Guardian, and should not be acted upon by the Guardian.

 

We have discussed the tragic case of John Lawler before. Today, the Mail carries a long article about it. Here I merely want to summarise the sequence of events and highlight the role of the GCC.

  • In 2017, Mr Lawler, aged 79 at the time, has a history of back problems, including back surgery with metal implants and suffers from pain in his leg.
  • His GP recommends to consult a physiotherapist.
  • As waiting lists are too long, Mr Lawler sees a chiropractor shortly after his 80th birthday who calls herself ‘doctor’ and who he assumes to be a medic specialising in back pain.
  • The chiropractor uses a spinal manipulation of the neck with the drop table.
  • There is no evidence that this treatment is effective for pain in the leg.
  • No informed consent is obtained from the patient.
  • This is acutely painful and brakes the calcified ligaments of Mr Lawler’s upper spine.
  • Mr Lawler is immediately paraplegic.
  • The chiropractor who had no training in resuscitation is panicked tries mouth to mouth.
  • Bending the patient’s neck backwards the chiropractor further compresses his spinal cord.
  • When ambulance arrives, the chiropractor misleads the paramedics telling them nothing about a forceful neck manipulation with the drop and suspecting a stroke.
  • Thus the paramedics do not stabilise the patient’s neck which could have saved his life.
  • Mr Lawler dies the next day in hospital.
  • The chiropractor is arrested immediately by the police but then released on bail.
  • The expert advising the police is a prominent chiropractor.
  • One bail condition is not to practise, pending a hearing by the GCC.
  • The GCC decide not to take any action.
  • The police therefore release the bail conditions and she goes back to practising.
  • The interim suspension hearing of the GCC is being held in September 2017.
  • The deceased’s son wants to attend but is not allowed to be present at the hearing even though such events are normally public.
  • The coroner’s inquest starts in 2019.
  • In November 2019, a coroner rules that Mr Lawler died of respiratory depression.
  • The coroner also calls on the GCC to bring in pre-treatment imaging to protect vulnerable patients.
  • The GCC announce that they will now continue their inquiry to determine whether or not chiropractor will be struck off the register.

The son of the deceased is today quoted stating that the GCC “seems to be a little self-regulatory chiropractic bubble where chiropractors regulate chiropractors.”

I sympathise with this statement. On this blog, I have repeatedly voiced my concerns about the GCC – see here, for instance – which I therefore do not need to repeat. My opinion of the GCC is also coloured by a personal experience which I will quickly recount now:

A long time ago (I estimate 10 – 15 years), the GCC invited me to give a lecture and I accepted. I do not remember the exact subject they had given me, but I clearly recall elaborating on the risks of spinal manipulation. This was not too well received. When I had finished, a discussion ensued in which I was accused of not knowing my subject and aggressed for daring to ctiticise chiropractic. I had, of couse, given the lecture assuming they wanted to hear my criticism. In the end, I left with the impression that this assumption was wrong and that they really just wanted to lecture, humiliate and punish me for having been a long-term critic of their trade.

I therefore can fully understand of David Lawler’s opinion about the GCC. To me, they certainly behaved as though their aim was not to protect the public, but to defend chiropractors from criticism.

As reported, the Bavarian government has set aside almost half a million Euros for research to determine whether the over-use of antibiotics can be reduced by replacing them with homeopathic remedies. Homeopaths in and beyond Germany were delighted, of course, but many experts were bewildered (see also this or this, if you read German).

While the Bavarians are entering the planning stage of this research, I want to elaborate on the question what methodology might be employed for this task. As far as I can see, there are, depending on the precise research questions, various options.

IN VITRO TESTS OF HOMEOPATHICS

The most straight forward way to find out whether homeopathics are an alternative to antibiotics would be to screen them for antibiotic activity. For this, we would take all homeopathic remedies in several potencies that are commonly used, for instance D12 and C30, and add them to bacterial cultures. To cover even part of the range of homeopathic remedies, several thousand such tests would be required. The remedies that show activity in vitro would then be candidates for further clinical tests.

I doubt that this will generate meaningful findings. As homeopaths would probably point out quickly, they never claimed that their remedies have any antibiotic effects. Homeopathics work not via pharmacological mechanisms (there is none), they stimulate the vital force, the immune system, or whatever mystical force you fancy. Faced with the inevitably negative results of in vitro tests, homeopaths would merely shrug their shoulders and say: ‘we told you so’.

ANIMAL MODELS

Thus it might be more constructive to go directly into animal models. Such tests could take several shapes and forms. For instance, scientists could infect animals with a bacterium and subsequently treat one group with a high potency homeopathic remedy and the control group with a placebo. If the homeopathic animals survive, while the controls die, the homeopathic treatment was effective.

Such concepts would run into problems on at least two levels. Firstly, any ethics committee worth its name would refuse to pass such a protocol and argue that it is not ethical to infect and then treat animals with two different types of placebo. Secondly, the homeopathic fraternity would explain that homeopathy must be individualised which cannot be done properly in animals. Faced with the inevitably negative results of such animal studies, homeopaths would merely shrug their shoulders and say: ‘we told you so’.

CLINICAL TRIALS

Homeopathy may, according to some homeopaths, defy in vitro and animal tests, but it is most certainly amenable to being tested in clinical trials. The simplest version of a clinical study would entail randomising a group of patients with bacterial infections – say pneumonia – into receiving either individualised homeopathy or placebo. Possibly, one could add a third group of patients being treated with appropriate antibiotics.

The problem here would again be the ethics; no proper ethic committee would pass such a concept (see above). Another problem might be that even the homeopathic fraternity would oppose such a study. Why? Because all but the most deluded homeopaths know only too well that the result of such a trial would be devastatingly negative for homeopathy.

Therefore, homeopaths are likely to go for a different study design, for instance, one where patients suspected to have a bacterial infection are randomised to two groups of GPs. One group of ‘normal’ GPs would proceed as usual, while the other group are also trained in homeopathy and would be free to give whatever they feel is right for each individual patient. With a bit of luck, the ‘normal’ GPs would over-prescribe antibiotics (because that’s what they are apparently doing routinely), while the homeopathic GPs would often use homeopathics instead.

Such a study would indeed generate a result alleging that the use of homeopathy reduces the use of antibiotics. Of course, to be truly ‘positive’ it would need to exclude any clinical outcome such as time to recovery, because that might not be in favour of homeopathy.

The problem might again be the ethics committee. Assuming they are scientifically switched on, they will see through the futility of a trial designed to produce the desired result. They might also argue that science is not for testing one faulty approach (over-prescribing) against another (homeopathy) and insist that science is about finding the best treatment (which is neither of the two).

There are, of course, many other study designs that could be considered. Generally, they fall into two different categories: if they are rigorous tests of a hypothesis, they are sure to produce a result unfavourable to homeopathy. Such studies will therefore be opposed to by the powerful homeopathic fraternity. If, however, studies are flimsily designed to generate a positive finding, they might be liked by homeopaths, yet rejected by scientists and ethicists.

SURVEYS

A much easier solution to the question ‘does the use of homeopathy reduce the use of antibiotics’ might be to not do a trial at all, but to run a simple survey. For instance, one could retrospectively assess how many antibiotics 100 homeopathic GPs have prescribed during the last year and compare this to the figure of 100 over-prescribing, ‘normal’ GPs. This type of ‘research’ is a sure winner for the homeopaths. Therefore, I predict that they will advocate this or a similarly flawed concept.

Most politicians are scientifically illiterate to such a degree that they might actually agree to finance such a survey and then confuse correlation with causation by triumphantly stating that the use of homeopathy reduces over-prescribing of antibiotics. Few, I fear, will realise that there is only one method for reducing the over-prescribing of antibiotics: remind doctors what they all learnt in medical school, namely to prescribe antibiotics only in cases where they are indicated. And for that we evidently need no homeopathy or other SCAM.

I have reported previously about the tragic death of John Lawler. Now after the inquest into the events leading to it has concluded, I have the permission to publish the statement of Mr Lawler’s family:

We were devastated to lose John in such tragic and unforeseen circumstances two years ago. A much-loved husband, father and grandfather, he continues to be greatly missed by all of us. Having to re-live the circumstances of his death has been particularly difficult for us but we are grateful to have a clearer picture of the events that led to John’s death. We would like to take this opportunity to thank the coroner’s team, our legal representatives and our wider family and friends for their guidance, empathy and sensitivity throughout this process.

There were several events that went very wrong with John’s chiropractic treatment, before, during, and after the actual manipulation that broke his neck.

Firstly, John thought he was being treated by a medically qualified doctor, when he was not. Furthermore, he had not given informed consent to this treatment.

The chiropractor diagnosed so-called ‘vertebral subluxation complex’ which she aimed to treat by manipulating his neck. We heard this week from medical experts that John had ossified ligaments in his spine, where previously flexible ligaments had turned to bone and become rigid. This condition is not uncommon, and is present in about 10% of those over 50. It would have showed on an X-ray or other imaging technique. The chiropractor did not ask for any images before commencing treatment and was seemingly unaware of the risks of doing a manual manipulation on an elderly patient.

It has become clear that the chiropractor did the manipulation incorrectly, and broke these rigid ligaments during a so-called ‘drop table’ manipulation, causing discs in the cervical spine to rupture and the spinal cord to become crushed. Although these manipulations are done frequently by chiropractors, we have heard that the force applied to his neck by the chiropractor would have had to have been “significant”.

Immediately John reported loss of sensation and paralysis in his arms. At this stage the only safe and appropriate response was to leave him on the treatment bed and await the arrival of the paramedics, and provide an accurate history to the ambulance controller and paramedics. The chiropractor, in fact, manhandled John from the treatment bed into a chair; then tipped his head backwards and gave “mouth to mouth” breaths. She provided an inaccurate and misleading history to the paramedic and ambulance controller, causing the paramedic to treat the incident as “medical” not “traumatic” and to transport John downstairs to the ambulance without stabilising his neck. If the paramedics had been given the full and accurate story, they would have stabilised his neck in situ and transported him on a scoop stretcher – and he would have subsequently survived.

The General Chiropractic Council decided not to suspend the chiropractor from practicing in September 2017. They heard evidence from the chiropractor that she had “not touched the neck during the appointment” and from an expert chiropractor that it would be “physically impossible” for the treatment provided to cause the injury which followed. We have heard this week that this is incorrect. The family was not allowed to attend or give evidence at that hearing, and we are waiting – now 2 years further on – for the GCC to complete their investigations.

We hope that the publicity surrounding this event will highlight the dangers of chiropractic, especially in the elderly and those with already compromised spines. We would again urge the regulator to take immediate measures to ensure that the profession is properly controlled: that chiropractors are prevented from styling themselves as medical professionals; that patients are fully informed and consent to the risks involved; that imaging is done before certain procedures and on high risk clients; and that the limits of the benefits chiropractic can provide are fully explored.

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Before someone comments pointing out that this is merely a single case which does not amount to evidence, let me remind you of the review of cervical manipulation prepared for the Manitoba Health Professions Advisory Council. Here is the abstract:

Neck manipulation or adjustment is a manual treatment where a vertebral joint in the cervical spine—comprised of the 7 vertebrae C1 to C7—is moved by using high-velocity, low-amplitude (HVLA) thrusts that cannot be resisted by the patient. These HVLA thrusts are applied over an individual, restricted joint beyond its physiological limit of motion but within its anatomical limit. The goal of neck manipulation, referred to throughout this report as cervical spine manipulation (CSM), is to restore optimal motion, function, and/or reduce pain. CSM is occasionally utilized by physiotherapists, massage therapists, naturopaths, osteopaths, and physicians, and is the hallmark treatment of chiropractors; however the use of CSM is controversial. This paper aims to thoroughly synthesize evidence from the academic literature regarding the potential risks and benefits of cervical spine manipulation utilizing a rapid literature review method.

METHODS Individual peer-reviewed articles published between January 1990 and November 2016 concerning the safety and efficacy of cervical spine manipulation were identified through MEDLINE (PubMed), EMBASE, and the Cochrane Library.

KEY FINDINGS

  • A total of 159 references were identified and cited in this review: 86 case reports/ case series, 37 reviews of the literature, 9 randomized controlled trials, 6 surveys/qualitative studies, 5 case-control studies, 2 retrospective studies, 2 prospective studies and 12 others.
  • Serious adverse events following CSM seem to be rare, whereas minor adverse events occur frequently.
  • Minor adverse events can include transient neurological symptoms, increased neck pain or stiffness, headache, tiredness and fatigue, dizziness or imbalance, extremity weakness, ringing in the ears, depression or anxiety, nausea or vomiting, blurred or impaired vision, and confusion or disorientation.
  • Serious adverse events following CSM can include the following: cerebrovascular injury such as cervical artery dissection, ischemic stroke, or transient ischemic attacks; neurological injury such as damage to nerves or spinal cord (including the dura mater); and musculoskeletal injury including injury to cervical vertebral discs (including herniation, protrusion, or prolapse), vertebrae fracture or subluxation (dislocation), spinal edema, or issues with the paravertebral muscles.
  • Rates of incidence of all serious adverse events following CSM range from 1 in 10,000 to 1 in several million cervical spine manipulations, however the literature generally agrees that serious adverse events are likely underreported.
  • The best available estimate of incidence of vertebral artery dissection of occlusion attributable to CSM is approximately 1.3 cases for every 100,000 persons <45 years of age receiving CSM within 1 week of manipulative therapy. The current best incidence estimate for vertebral dissection-caused stroke associated with CSM is 0.97 residents per 100,000.
  • While CSM is used by manual therapists for a large variety of indications including neck, upper back, and shoulder/arm pain, as well as headaches, the evidence seems to support CSM as a treatment of headache and neck pain only. However, whether CSM provides more benefit than spinal mobilization is still contentious.
  • A number of factors may make certain types of patients at higher risk for experiencing an adverse cerebrovascular event after CSM, including vertebral artery abnormalities or insufficiency, atherosclerotic or other vascular disease, hypertension, connective tissue disorders, receiving multiple manipulations in the last 4 weeks, receiving a first CSM treatment, visiting a primary care physician, and younger age. Patients whom have experience prior cervical trauma or neck pain may be at particularly higher risk of experiencing an adverse cerebrovascular event after CSM.

CONCLUSION The current debate around CSM is notably polarized. Many authors stated that the risk of CSM does not outweigh the benefit, while others maintained that CSM is safe—especially in comparison to conventional treatments—and effective for treating certain conditions, particularly neck pain and headache. Because the current state of the literature may not yet be robust enough to inform definitive prohibitory or permissive policies around the application of CSM, an interim approach that balances both perspectives may involve the implementation of a harm-reduction strategy to mitigate potential harms of CSM until the evidence is more concrete. As noted by authors in the literature, approaches might include ensuring manual therapists are providing informed consent before treatment; that patients are provided with resources to aid in early recognition of a serious adverse event; and that regulatory bodies ensure the establishment of consistent definitions of adverse events for effective reporting and surveillance, institute rigorous protocol for identifying high-risk patients, and create detailed guidelines for appropriate application and contraindications of CSM. Most authors indicated that manipulation of the upper cervical spine should be reserved for carefully selected musculoskeletal conditions and that CSM should not be utilized in circumstances where there has not yet been sufficient evidence to establish benefit.

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Just three points which, in my view, sand out most in relation to Mr Lawler’s death:

  1. Mr Lawler had no proven indication (and at least one very important contra-indication)  for neck manipulation.
  2. He did not give infromed consent.
  3. The neck manipulation was not within the limits of the physiological range of motion.

An intercessory prayer (IP) is an intervention characterized by one or more individuals praying for the well-being or a positive outcome of another person. There have been several trials of IP, but the evidence is far from clear-cut. Perhaps this new study will bring clarity?

The goal of this double-blind RCT was to assess the effects of intercessory prayer on psychological, spiritual and biological scores of breast 31 cancer patients who were undergoing radiotherapy (RT). The experimental group was prayed for, while the controla group received no such treatment. The intercessory prayer was performed by a group of six Christians, who prayed daily during 1 h while participant where under RT. The prayers asked for calm, peace, harmony and recovery of health and spiritual well-being of all participants. Data collection was performed in three time points (T0, T1 and T2).

Significant changes were noted in the intra-group analysis, concerning the decrease in spiritual distress score; negative religious/spiritual coping prevailed, while the total religious/spiritual coping increased between the posttest T2 to T0.

The authors concluded that begging a higher being for health recovery is a common practice among people, regardless of their spirituality and religiosity. In this study, this practice was performed through intercessory prayer, which promoted positive health effects, since spiritual distress and negative spiritual coping have reduced. Also, spiritual coping has increased, which means that participants facing difficult situations developed strategies to better cope and solve the problems. Given the results related to the use of intercession prayer, as a complementary therapeutic intervention, holistic nursing care should integrate this intervention, which is included in the Nursing Interventions Classification. Additionally, further evidence and research is needed about the effect of this nursing spiritual intervention in other cultures, in different clinical settings and with larger samples.

The write-up of this study is very poor and most confusing – so much so that I find it hard to make sense of the data provided. If I understand it correctly, the positive findings relate to changes within the experimental group. As RCTs are about compating one group to another, these changes are irrelevant. Therefore (and for several other methodological flaws as well), the conclusion that IP generates positive effects is not warranted by these new findings.

Like all other forms of paranormal healing, IP is implausible and lacks support of clinical effectiveness.

The tragic case of John Lawler who died after being treated by a chiropractor has been discussed on this blog before. Naturally, it generated much discussion which, however, left many questions unanswered. Today, I am able to answer some of them.

  • Mr Lawler died because of a tear and dislocation of the C4/C5 intervertebral disc caused by considerable external force.
  • The pathologist’s report also shows that the deceased’s ligaments holding the vertebrae of the upper spine in place were ossified.
  • This is a common abnormality in elderly patients and limits the range of movement of the neck.
  • There was no adequately informed consent by Mr Lawler.
  • Mr Lawler seemed to have been under the impression that the chiropractor, who used the ‘Dr’ title, was a medical doctor.
  • There is no reason to assume that the treatment of Mr Lawler’s neck would be effective for his pain located in his leg.
  • The chiropractor used an ‘activator’ which applies only little and well-controlled force. However, she also employed a ‘drop table’ which applies a larger and not well-controlled force.

I have the permission to publish the submissions made to the coroner by the barrister representing the family of Mr Lawler. The barrister’s evidence shows that:

a. The treating chiropractor owed a duty of care to the Deceased, her patient;
b. That duty was breached in that:
i. After the Deceased reported loss of sensation and paralysis in his arms, the only safe and appropriate response was to:
1. Leave him in situ;
2. Await the arrival of the paramedic;
3. Provide an accurate history to the ambulance controller and attending paramedic;
ii. The treating chiropractor, in fact:
1. Manhandled the Deceased from the treatment bed into a sitting position on a chair;
2. Tipped his head backwards and gave “mouth to mouth” breaths;
3. Provided an inaccurate and misleading history to the paramedic and ambulance controller, causing the paramedic to treat the incident as “medical” not “traumatic” and to transport the Deceased downstairs to the ambulance without stabilising his neck.
c. The risk of death was a reasonably foreseeable consequence of the breach;
d. In the absence of the breach:
iii. The paramedic would have stabilised the neck, in situ, and transported the Deceased on a scoop stretcher;
iv. The deceased would have survived.
e. Having regard to the risk of death involved, the misconduct was grossly negligent so as to be condemned as the serious crime of manslaughter. The decision to intervene as she did, went beyond a very serious mistake or very serious error of judgment having regard to the fact that:
i. She held herself out as a provider of (quasi) medical treatment;
ii. She styled herself as “doctor”, (when she was not entitled to do so);
iii. She intervened without any understanding of the injury she had caused nor any training in how to intervene safely.
___________________________________________________________________________
To put it in blunt layman’s terms, the chiropractor broke Mr Lawler’s neck and, by then moving his head the way she did (she put him into the sitting position and bent his head backwards), may well have caused his death.
Here are five lessons we might learn from this tragic case:
  1. Chiropractors are not medical doctors and should make this perfectly clear to all of their patients.
  2. Elderly patients can have several contra-indications to spinal manipulations. They should therefore think twice before consulting a chiropractor.
  3. A limited range of spinal movement usually is the sign for a chiropractor to intervene. However, this may lead to dramatically bad consequences, if the patient’s para-vertebral ligaments are ossified which happens in about 10% of all elderly individuals.
  4. Chiropractors are by no means exempt from obtaining informed consent. (In the case of Mr Lawler, this would have had to include the information that the neck manipulation carries serious risks and has not shown to work for any type of pain in the leg and might have saved his life, as he then might have refused to accept the treatment.)
  5. Chiropractors are not trained to deal with medical emergencies and must leave that to those healthcare professionals who are fully trained.

On 11/11/2019, the York Press reported from coroner’s inquest regarding a chiropractor who allegedly killed a patient. John Lawler suffered a broken neck while being treated by a chiropractor for an aching leg, an inquest has been told. His widow told how her husband was on the treatment table when things started to go wrong. She said he started shouting at chiropractor Dr Arleen Scholten: “You are hurting me. You are hurting me.” Then he began moaning and then said: “I can’t feel my arms.”

Mrs Lawler said Scholten tried to turn him over and then manoeuvred him into a chair next to the treatment table but he had become unresponsive. “He was like a rag doll,” she said. “His lips looked a little bit blue but I knew he was breathing. “I said ‘Has he had a stroke?’ She put his head back and said ‘no, his features are symmetrical’.

When the paramedics arrived, they treated Mr Lawler and to hospital. He had an MRI scan and a doctor told Mrs Lawler that he had suffered a broken neck. She was then informed that her husband was a paraplegic and he could undergo a 14 hour operation which would be traumatic but even before that could happen he “faded away” and died.

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There are, as far as I can see, four issues of interest here:

  1. It could be that Mr Lawler had osteoporosis; we will no doubt hear about this in the course of the inquest. If so, normal force could have led to the fracture, and the chiropractor would claim that she is not to blame for the fracture and the subsequent death of her patient. The question then would be whether she was under an obligation to check whether, in a man of Mr Lawler’s age, his bone density was normal or whether she could just assume that it was. In my view, any clinician applying a potentially harmful therapy has the obligation to make sure there are no contra-indications to it. If that all is so, the chiropractor might have been both negligent and reckless.
  2. Has neck manipulation been shown to be effective for any type of pain in the leg? That’s an easy one: No!
  3. Has the chiropractor obtained informed consent from her patient before commencing the treatment? The inquest will no doubt verify this. As many chiropractors fail to do it, I would not be too surprised if, in the present case, this was also not done. Should that be so, the chiropractor would have been negligent.
  4. One might be surprised to hear that the chiropractor manipulated the neck of a patient who consulted her not because of neck pain but because of a condition seemingly unrelated to the neck. This is an issue that comes up regularly and which is therefore importan; some people might be aware that it is dangerous to see a chiropractor when suffering from neck pain because he/she is bound to manipulate the neck. By contrast, most people would probably think it is ok to consult a chiropractor when suffering from lower back pain, because manipulations in that region is far less risky. The truth, however, is that chiropractors have been taught that the spine is one organ and one entity. Thus they tend to check for subluxations (or whatever name they give to the non-existing condition they all aim to treat) in every region of the spine. If they find one in the neck – and they usually do – they would ‘adjust’ it, meaning they would apply one or more high-velocity, low-amplitude thrusts and manipulate the neck. This could well be, I think, how the chiropractor in the case that is before the court at present came to manipulate the neck of her patient. And this might be how poor Mr Lawler lost his life.

Is there a lesson to be learnt from this tragic case?

Yes, I think there is: if you want to make sure that a chiropractor does not break your neck, don’t go and consult one – whatever your health problem happens to be.

 

 

This review provides published data on so-called alternative medicine (SCAM)-related liver injuries (DILI) in Asia, with detail on incidences, lists of most frequently implicated herbal remedies, along with analysis of patient population and their clinical outcomes.

Its authors conclude that SCAM use is widely prevalent in Asia and is associated with, among other adverse effects, hepatotoxicity. Both proprietary as well as non-proprietary or traditional SCAMs have been implicated in hepatotoxicity. Acute hepatocellular pattern of liver injury is the most common type of liver injury seen, and the spectrum of liver-related adverse events range from simple elevation of liver enzymes to the very serious ALF and ACLF, which may, at times, require liver transplant.

SCAM-related liver injury is one among the major causes for hepatotoxicity, including ALF and ACLF worldwide, with high incidence among Asian countries. Patient outcomes associated with SCAM-DILI are generally poor, with very high mortality rates in those with chronic liver disease. Stringent regulations, at par with that of conventional modern medicine, are required, and may help improve safety of patients seeking SCAM for their health needs. Regional surveillance including post-marketing analysis from government agencies associated with drug regulation and control in tandem with national as well as regional level hepatology societies are important for understanding the true prevalence of DILI associated with SCAM. An integrated approach used by practitioners combining conventional and traditional medicine to identify safety and efficacy of SCAMs is an unmet need in most of the Asian countries. Endorsement of scientific methodology with good quality preclinical and clinical trials and abolishment of unhealthy publication practices is an area that needs immediate attention in SCAM practice. Such holistic standard science-based approaches could help ameliorate liver disease burden in the general and patient population.

I congratulate the authors to this excellent paper. It contains a wealth of information and is well worth reading in full. The review will serve me as a valuable source of data for many years to come.

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