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

symptom-relief

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Neurolinguistic programming (NLP) was developed in the mid-seventies. It is a so-called alternative therapy (SCAM) that is not easy to define. Those who started it and those involved in it use such vague language that NLP means different things to different people. One metaphor keeps recurring: NLP claims to help people change by teaching them to program their brains. We were given brains, we are told, without an instruction manual, and NLP offers a user-manual for the brain. Consciously or unconsciously, NLP is based on the assumptions that:

  • the unconscious mind constantly influences our conscious thoughts and actions;
  • Freud’s theories are correct;
  • hypnotherapy is effective.

Wikipedia is more outspoken about it: Neuro-linguistic programming (NLP) is a pseudoscientific approach to communication, personal development, and psychotherapy…

Despite the fact that NLP is unproven (to say the least), the COLLEGE OF MEDICINE AND INTEGRATED HEALTH (COMAIH) is sufficiently impressed by NLP to offer a course for GPs and SCAM practitioners. Here is their announcement:

Neurolinguistic Healthcare in association with the College of Medicine brings you a 2-day Introduction to Hypnosis, Neurolinguistic Programming (NLP) and Neurolinguistic Healthcare (NLH). Dr Wong and Dr Akhtar who lead the course are Trainers in NLP and Hypnosis and GPs who apply their skills in daily practice within the 10-minute consultation. The course is suitable for both medical professionals and complementary therapists. This is a limited training event offered by them to share their years of knowledge and skills with you.

You will learn:

    1. A basic overview of NLP and the most useful aspects to use it to begin making effective changes in how you and the people you treat think and behave
    2. An understanding of the NLH model of the mind so that you understand the concepts of therapy using this mixed hypnosis/ NLP approach in relation to health.
    3. The ability to Hypnotise effectively in a very short period of time with practical experience – the ability to go through all the stages of hypnosis – the induction, deepening, therapy, and emergence, including rapid hypnosis techniques. (Hypnosis courses which are less practical often charge in excess of £2000 for this)
    4. Learn at least 3 therapeutic techniques, including the NLP therapeutic techniques which work much better in trance, so using and applying the skills you will learn in hypnosis
    5. Access to an online mentorship programme with Dr Akhtar or Dr Wong for 6 months and who will provide 3x30mins group webinar meetings after the course to ensure any remaining questions get answered and that you are actually going forth to apply these skills. (worth another £600 in value)
    6. Access to an online learning membership site with educational videos and other content like pain relief techniques, papers with therapeutic scripts, etc

This is an opportunity to learn a different way of helping people from doctors who target the 10-minute consultation with fast, effective formal hypnosis techniques and sleight-of-mouth. It is possible to make change happen in 10-minutes.

Note that attending this course will not make you a certified hypnotherapist, but confer you the skills you will learn to use personally and in the context of guided meditations and relaxations that are commonplace now.

And what evidence do I have for stating that NLP is unproven?

Is there an up-to-date and sound systematic review of NLP?

The answer is yes.

This systematic review of NLP included 10 experimental studies. Five studies were RCTs and five were uncontrolled pre-post studies. Targeted health conditions were anxiety disorders, weight maintenance, morning sickness, substance misuse, and claustrophobia during MRI scanning. NLP interventions were mainly delivered across 4-20 sessions although three were single session. Eighteen outcomes were reported and the RCT sample sizes ranged from 22 to 106. Four RCTs reported no significant between group differences with the fifth finding in favour of NLP. Three RCTs and five pre-post studies reported within group improvements. Risk of bias across all studies was high or uncertain.

The authors concluded that there is little evidence that NLP interventions improve health-related outcomes. This conclusion reflects the limited quantity and quality of NLP research, rather than robust evidence of no effect. There is currently insufficient evidence to support the allocation of NHS resources to NLP activities outside of research purposes.

Surprised?

I am not!

I did not expect the COMAIH to allow critical thinking to get in the way of quackery-promotion.

I have been sceptical about Craniosacral Therapy (CST) several times (see for instance here, here and here). Now, a new paper might change all this:

The systematic review assessed the evidence of Craniosacral Therapy (CST) for the treatment of chronic pain. Randomized clinical trials (RCTs) assessing the effects of CST in chronic pain patients were eligible. Pain intensity and functional disability were the primary outcomes. Risk of bias was assessed using the Cochrane tool.

Ten RCTs with a total of 681 patients suffering from neck and back pain, migraine, headache, fibromyalgia, epicondylitis, and pelvic girdle pain were included.

Compared to treatment as usual, CST showed greater post intervention effects on:

  • pain intensity (SMD=-0.32, 95%CI=[−0.61,-0.02])
  • disability (SMD=-0.58, 95%CI=[−0.92,-0.24]).

Compared to manual/non-manual sham, CST showed greater post intervention effects on:

  • pain intensity (SMD=-0.63, 95%CI=[−0.90,-0.37])
  • disability (SMD=-0.54, 95%CI=[−0.81,-0.28]) ;

Compared to active manual treatments, CST showed greater post intervention effects on:

  • pain intensity (SMD=-0.53, 95%CI=[−0.89,-0.16])
  • disability (SMD=-0.58, 95%CI=[−0.95,-0.21]) .

At six months, CST showed greater effects on pain intensity (SMD=-0.59, 95%CI=[−0.99,-0.19]) and disability (SMD=-0.53, 95%CI=[−0.87,-0.19]) versus sham. Secondary outcomes were all significantly more improved in CST patients than in other groups, except for six-month mental quality of life versus sham. Sensitivity analyses revealed robust effects of CST against most risk of bias domains. Five of the 10 RCTs reported safety data. No serious adverse events occurred. Minor adverse events were equally distributed between the groups.

The authors concluded that, in patients with chronic pain, this meta-analysis suggests significant and robust effects of CST on pain and function lasting up to six months. More RCTs strictly following CONSORT are needed to further corroborate the effects and safety of CST on chronic pain.

Robust effects! This looks almost convincing, particularly to an uncritical proponent of so-called alternative medicine (SCAM). However, a bit of critical thinking quickly discloses numerous problems, not with this (technically well-made) review, but with the interpretation of its results and the conclusions. Let me mention a few that spring into my mind:

  1. The literature searches were concluded in August 2018; why publish the paper only in 2020? Meanwhile, there might have been further studies which would render the review outdated even on the day it was published. (I know that there are many reasons for such a delay, but a responsible journal editor must insist on an update of the searches before publication.)
  2. Comparisons to ‘treatment as usual’ do not control for the potentially important placebo effects of CST and thus tell us nothing about the effectiveness of CST per se.
  3. The same applies to comparisons to ‘active’ manual treatments and ‘non-manual’ sham (the purpose of a sham is to blind patients; a non-manual sham defies this purpose).
  4. This leaves us with exactly two trials employing a sham that might have been sufficiently credible to be able to fool patients into believing that they were receiving the verum.
  5. One of these trials (ref 44) is far too flimsy to be taken seriously: it was tiny (n=23), did not adequately blind patients, and failed to mention adverse effects (thus violating research ethics [I cannot take such trials seriously]).
  6. The other trial (ref 41) is by the same research group as the review, and the authors award themselves a higher quality score than any other of the primary studies (perhaps even correctly, because the other trials are even worse). Yet, their study has considerable weaknesses which they fail to discuss: it was small (n=54), there was no check to see whether patient-blinding was successful, and – as with all the CST studies – the therapist was, of course, no blind. The latter point is crucial, I think, because patients can easily be influenced by the therapists via verbal or non-verbal communication to report the findings favoured by the therapist. This means that the small effects seen in such studies are likely to be due to this residual bias and thus have nothing to do with the intervention per se.
  7. Despite the fact that the review findings depend critically on their own primary study, the authors of the review declared that they have no conflict of interest.

Considering all this plus the rather important fact that CST completely lacks biological plausibility, I do not think that the conclusions of the review are warranted. I much prefer the ones from my own systematic review of 2012. It included 6 RCTs (all of which were burdened with a high risk of bias) and concluded that the notion that CST is associated with more than non‐specific effects is not based on evidence from rigorous RCTs.

So, why do the review authors first go to the trouble of conducting a technically sound systematic review and meta-analysis and then fail utterly to interpret its findings critically? I might have an answer to this question. Back in 2016, I included the head of this research group, Gustav Dobos, into my ‘hall of fame’ because he is one of the many SCAM researchers who never seem to publish a negative result. This is what I then wrote about him:

Dobos seems to be an ‘all-rounder’ whose research tackles a wide range of alternative treatments. That is perhaps unremarkable – but what I do find remarkable is the impression that, whatever he researches, the results turn out to be pretty positive. This might imply one of two things, in my view:

I let my readers chose which possibility they deem to be more likely.

The aim of this review is to synthesise systematic reviews (SRs) of randomised clinical trials (RCTs) evaluating the efficacy of acupuncture to alleviate chronic pain. A total of 177 reviews of acupuncture from 1989 to 2019 met the eligibility criteria. The majority of SRs found that RCTs of acupuncture had methodological shortcomings, including inadequate statistical power with a high risk of bias. Heterogeneity between RCTs was such that meta-analysis was often inappropriate.

Having (co-) authored 13 of these SRs myself, I am impressed with the amount of work that went into this synthesis. The authors should be congratulated for doing it – and for doing it well! The paper itself differentiates the findings according to various types of pain. Here I reproduce the authors’ conclusion regarding different pain entities:

  • Evidence from SRs suggests that there are insufficient high‐quality RCTs to judge the efficacy of acupuncture for chronic pain associated with various medical conditions. There is no specific NICE guidance about the use of acupuncture for chronic pain conditions irrespective of aetiology or pathophysiology, although some guidance exists for specific pain conditions (see respective sections below). Guidance by NICE on chronic pain assessment and management is currently being developed (GIDNG10069) with publication expected in August 2020.
  • Evidence from the SRs suggests that acupuncture prevents episodic or chronic tension‐type headaches and episodic migraine, although long‐term studies and studies comparing acupuncture with other treatment options are still required. The current NICE guidance (clinical guideline CG150) is that a course of up to 10 sessions of acupuncture over 5–8 weeks is recommended for tension‐type headache and migraine.
  • The most recent evidence from a Cochrane review of 16 RCTs suggests that acupuncture is not superior to sham acupuncture for OA of the hip, although in contrast, evidence from nonCochrane reviews suggests that there is moderate‐quality evidence that acupuncture may be effective in the symptomatic relief of pain from OA of the knee. Why there should be a difference in evidence between the knee and the hip is not known. Interestingly, guidance from NICE (CG177) states: “Do not offer acupuncture for the management of osteoarthritis”.
  • Evidence suggests that there are insufficient high‐quality RCTs to judge the efficacy of acupuncture for low back pain. In 2009, NICE published guidance for the management of nonspecific low back pain that recommended a course of acupuncture as part of first line treatment. This guidance produced much debate. Subsequently, NICE have updated guidance for the management of low back pain and sciatica in people over 16 (NG59) and currently recommend in Section 1.2.8 “Do not offer acupuncture for managing low back pain with or without sciatica”, even though the evidence had not significantly changed.
  • Evidence from SRs suggests that dry needling acupuncture might be effective in alleviating pain associated with myofascial trigger points, at least in the short‐term, although there are insufficient high‐quality RCTs to judge the efficacy with any degree of certainty. There is no guidance from NICE on the management of myofascial pain syndrome.
  • Evidence from the SRs suggests that there are insufficient high‐quality RCTs to judge the efficacy of acupuncture for cancer‐related pain and more high‐quality, appropriately designed and adequately powered studies are needed. The most recent guidance from NICE (CSG4) recognises that patients who are receiving palliative care often seek complementary therapies, but it does not specifically recommend acupuncture. It recognises that “Many studies have a considerable number of methodological limitations, making it difficult to draw definitive conclusions”.
  • Evidence from SRs suggests that there are insufficient high‐quality RCTs to judge the efficacy of acupuncture for fibromyalgia pain. There is no NICE guidance on the treatment of fibromyalgia.
  • Evidence from the SRs suggests that there are insufficient high‐quality RCTs to judge the efficacy of acupuncture for primary dysmenorrhea or chronic pelvic pain. There is NICE guidance on endometriosis (NG73) [200] but this does not recommend any form of Chinese medicine for this type of pelvic pain, although acupuncture is not specifically mentioned.
  • Evidence from the SRs suggests that there are insufficient high‐quality RCTs to judge the efficacy of acupuncture for pain in inflammatory arthritis. There is a NICE guideline (NG100) [201] for the treatment of rheumatoid arthritis but this does not recommend acupuncture.
  • Evidence from the SRs suggests that there are insufficient high‐quality RCTs to judge the efficacy of acupuncture for neuropathic pain or neuralgia. There is NICE guidance (CG173) on the management of neuropathic pain, but acupuncture is not included in the list of recommended/not recommended treatments.
  • Evidence from SRs suggests that there are insufficient high‐quality RCTs to judge the efficacy of acupuncture for a variety of other painful conditions, including lateral elbow pain, shoulder pain and labour pain. There is no guidance available from NICE on the treatment of any of these conditions.

So, what should we make of all this?

Maybe I just point out two things:

  1. This is a most valuable addition to the literature about acupuncture. It can serve as a reference for all who are interested in an honest account of the (lack of) value of acupuncture in the management of chronic pain.
  2. If a therapy has been tested in hundreds of (sadly often flawed) trials and the conclusions fail to come out clearly in favour of it, it is most likely not a very effective treatment.

Until we have data to the contrary, acupuncture should not be considered to be an effective therapy for chronic pain management.

The current Cochrane review of clinical trials testing the effectiveness of manipulation/mobilisation for neck pain concluded as follows:

Although support can be found for use of thoracic manipulation versus control for neck pain, function and QoL, results for cervical manipulation and mobilisation versus control are few and diverse. Publication bias cannot be ruled out. Research designed to protect against various biases is needed. Findings suggest that manipulation and mobilisation present similar results for every outcome at immediate/short/intermediate-term follow-up. Multiple cervical manipulation sessions may provide better pain relief and functional improvement than certain medications at immediate/intermediate/long-term follow-up. Since the risk of rare but serious adverse events for manipulation exists, further high-quality research focusing on mobilisation and comparing mobilisation or manipulation versus other treatment options is needed to guide clinicians in their optimal treatment choices.

Such a critical assessment must be tough for chiropractors who gain a substantial part of their income from treating such patients. What is the solution? Simple, convene a panel of chiros and issue recommendations that are more prone to stimulate their cash flow!

Exactly that seems to have just happened.

The purpose of the researchers was to develop best-practice recommendations for chiropractic management of adults with neck pain.

A steering committee of experts in chiropractic practice, education, and research drafted a set of recommendations based on the most current relevant clinical practice guidelines. Additional supportive literature was identified through targeted searches conducted by a health sciences librarian. A national panel of chiropractors representing expertise in practice, research, and teaching rated the recommendations using a modified Delphi process. The consensus process was conducted from August to November 2018. Fifty-six panelists rated the 50 statements and concepts and reached consensus on all statements within 3 rounds.

The statements and concepts covered aspects of the clinical encounter, ranging from informed consent through diagnosis, assessment, treatment planning and implementation, and concurrent management and referral for patients presenting with neck pain.

The authors concluded that these best-practice recommendations for chiropractic management of adults with neck pain are based on the best available scientific evidence. For uncomplicated neck pain, including neck pain with headache or radicular symptoms, chiropractic manipulation and multimodal care are recommended.

Let’s be clear what this amounts to: a panel of highly selected chiropractors (sponsored by a chiropractic organisation) has reached a consensus (and published it in a chiropractic) which allows them to continue to treat patients with neck pain.

Isn’t that just great?

Now let’s think ahead – what next?

I suggest the following:

  1. A panel of homeopaths recommending homeopathy.
  2. A panel of faith healers recommending faith healing.
  3. A panel of crystal healers recommending crystal healing.
  4. A panel of colon therapists recommending colonic irrigation.
  5. A panel of supplement manufacturers recommending to buy supplements.

I am sure you get the gist.

 

 

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?

Recently, we discussed the findings of a meta-analysis which concluded that walking, which is easy to perform and highly accessible, can be recommended in the management of chronic LBP to reduce pain and disability.

At the time, I commented that

this will hardly please the legions of therapists who earn their daily bread with pretending their therapy is the best for LBP. But healthcare is clearly not about the welfare of the therapists, it is/should be about patients. And patients should surely welcome this evidence. I know, walking is not always easy for people with severe LBP, but it seems effective and it is safe, free and available to everyone.

My advice to patients is therefore to walk (slowly and cautiously) to the office of their preferred therapist, have a little rest there (say hello to the staff perhaps) and then walk straight back home.

Now, there is new evidence that seems to confirm what I wrote. An international team of researchers requested individual participant data (IPD) from high-quality randomised clinical trials of patients suffering from persistent low back pain. They conducted descriptive analyses and one-stage IPD meta-analysis. They received IPD for 27 trials with a total of 3514 participants.

For studies included in this analysis, compared with no treatment/usual care, exercise therapy on average reduced pain (mean effect/100 (95% CI) -10.7 (-14.1 to -7.4)), a result compatible with a clinically important 20% smallest worthwhile effect. Exercise therapy reduced functional limitations with a clinically important 23% improvement (mean effect/100 (95% CI) -10.2 (-13.2 to -7.3)) at short-term follow-up.

Not having heavy physical demands at work and medication use for low back pain were potential treatment effect modifiers-these were associated with superior exercise outcomes relative to non-exercise comparisons. Lower body mass index was also associated with better outcomes in exercise compared with no treatment/usual care.

But you cannot dismiss so-called alternative medicine (SCAM), just like that, I hear my chiropractic and other manipulating friends exclaim – at the very minimum, we need direct comparisons of the two approaches!!!

Alright, you convinced me; here you go:

The purpose of this systematic review was to determine the effectiveness of spinal manipulation vs prescribed exercise for patients diagnosed with chronic low back pain (CLBP). Only RCTs that compared head-to-head spinal manipulation to an exercise group were included in this review. Only three RCTs met the inclusion criteria. The outcomes used in these studies included Disability Indexes, Pain Scales and function improvement scales. One RCT found spinal manipulation to be more effective than exercise, and the results of another RCT indicated the reverse. The third RCT found both interventions offering equal effects in the long term. The author concluded that there is no conclusive evidence that clearly favours spinal manipulation or exercise as more effective in treatment of CLBP. More studies are needed to further explore which intervention is more effective.

Convinced?

No?

But I am!

Exercise is preferable to chiropractic and other manipulating SCAMs because:

  1. It is cheaper.
  2. It is safer.
  3. It is readily available to anyone.
  4. And you don’t have to listen to the bizarre and often dangerous advice many chiros offer their clients.

Tiger Balm (TB) ointments are Chinese topical remedies, often used for pain relief available as over-the-counter medications. TB is clearly popular, but does it work? The aim of this systematic review was to find out by assessing the efficacy, safety and tolerability of TB ointments.

A total of 12 studies were included (five on TB ointments efficacy, whereas seven on their safety and tolerability). Two cases of dermatitis and one of cheilitis likely ascribable to the use of TB ointments have been reported. Based on available studies, it might be estimated that around 4% [95% CI, 3%-5%] of patients with history of contact skin allergy could be positive if patch tested with TB ointments, therefore caution is recommended in the use of TB among these subjects.

The authors concluded that, according to retrieved evidence, TB ointments might be useful for the management of pain due to tension headache, and they seem capable of increasing leg blood flow if combined with massage. Considering available evidence on topical products with camphor, TB ointments shouldn’t be used in children, as well as in pregnant or lactating women. Chronic use, large amounts of balm, and the application on damaged skin must be avoided too. Further studies are recommended.

I had to laugh out loud when reading these conclusions:

  1.  That TB MIGHT be useful is hardly worth writing home about. A systematic review should tell us whether there is any good evidence THAT it is useful.
  2.  That TB seems capable of increasing leg blood flow is also nonsense. Firstly, anything increases blood flow IF COMBINED WITH MASSAGE. Secondly, why would anyone want to increase leg blood flow? Ahh of course: if you have leg ischaemia, e. g. in intermittent claudication. But then increasing blood flow of the skin of the leg is likely to be counter-productive, as this would shunt blood away from the already oxygen-starved muscles.

So, what evidence is there that TB might be effective? It turns out that there is all of ONE small randomised clinical trial that is over 20 years old which delivers a positive result. In view of this, I find it hard to resist re-writing the conclusions as follows:

TB IS A CHINESE REMEDY THAT CAN CAUSE ADVERSE EFFECTS AND FOR WHICH THERE IS NO GOOD EVIDENCE OF EFFICACY. ITS RISK/BENEFIT BALANCE IS THEREFORE NOT DEMONSTRABLY POSITIVE.

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.

I have often discussed the fact that many proponents of so-called alternative medicine (SCAM) have in recent years adopted the following argument: even if our SCAM were just a placebo, it would still be useful. After all, placebo effects are real and increasingly backed by sound science. The argument is deeply flawed, yet it convinces many lay people.

A recent article by Fabrizio Benedetti, the leading researcher in the area of placebo, is addressing exactly this issue. I feel that it is sufficiently important to quote it extensively here:

… a number of biochemical pathways, such as endogenous opioids and cannabinoids,5,6 and brain regions, like the prefrontal cortex, have been found to be involved in placebo analgesia. Likewise, dopamine and the basal ganglia circuitry have been found to mediate placebo responses in Parkinson’s disease. Although this is wonderful news for science, this may not be the case for society. The number of nonmedical organizations and healers that rely on this hard science, and actually justify their odd and bizarre procedures, has increased over the past few years. The main claim is that any procedure boosting patients’ expectations, which represent the main mediator of placebo effects, is acceptable because it can activate the same biochemical pathways and neural networks that have been made credible by hard science…

The crucial point here is that when hard science started investigating placebo effects, it unconsciously produced a shift in quackery thinking. In fact, charlatans are becoming more and more aware that their bizarre interventions could work through a placebo effect. Indeed, whereas hard science has so far denied any scientific basis for nonconventional therapies, now the very same hard science certifies that the placebo effect has scientific grounds. Therefore, quacks are no longer interested in showing that their pseudo-interventions work; rather, they justify their use on the basis of the possibility that these bizarre interventions may induce strong placebo effects…

… A first point that should be emphasized is that placebos do not cure, but rather, they may sometimes improve quality of life. There is plenty of confusion on this point, and unfortunately, many claim that they can cure virtually all illnesses with placebos. Hard science tells us that placebos can reduce symptoms such as pain and muscle rigidity in Parkinson’s disease, yet the progression of the disease is not affected; for example, in Parkinson’s disease, neurons keep degenerating even though some symptoms can be reduced for a short time.4 The second point is related to the first. The type of disease is crucial, and we need to make people understand that pain is different from cancer and that anxiety differs from infectious diseases. The psychological component of some illnesses can indeed be modulated by placebos, but placebos cannot stop cancer growth, nor can they kill the bacteria of pneumonia. The third point is related to the difference between real placebo effects and spontaneous remissions. So far, hard science has studied the placebo effect within a time span of hours/days, thereby limiting our knowledge to short-lasting effects. Consequently, long-lasting effects can be often attributed to spontaneous remissions.

In addition to these three important points, we should also make patients understand that a diagnosis is required before any sort of therapy. An apparently trivial pain may conceal a danger; thus, it must never be treated unless a diagnosis has been made before, and this can be made only by physicians. Moreover, not only should we discuss and consider the positive effects of placebos and the impact they may have in clinical trials and medical practice, but we should also pay much of our attention to the negative counterpart, that is, the misuse and abuse by quacks, charlatans, shamans, and nonmedical organizations. Thus, we need to inform the whole society that the benefits following a nonconventional healing procedure are attributable to a placebo effect in most of the cases. Last but not least, we need to be more honest on the real efficacy of many pharmacological and nonpharmacological treatments, acknowledging that some of them are useful whereas some others are not: This will boost patients’ trust and confidence in medicine further, which I believe are the best foes of quackery…

…Unfortunately, quackery has today one more weapon on its side, which is paradoxically represented by the hard science–supported placebo mechanisms. This new “scientific quackery” can do a lot of damage; thus, we must be very cautious and vigilant as to how the findings of hard science are exploited. The study of the biology of these vulnerable aspects of mankind may unravel new mechanisms of how our brain works, but it may have a profound negative impact on our society as well. We cannot accept a world where expectations can be enhanced with any means and by anybody. This is a perspective that would surely be worrisome and dangerous. I believe that some reflections are necessary in order to avoid a regression of medicine to past times, in which quackery and shamanism were dominant. Unfortunately, the new knowledge about placebos by hard science is now backfiring on it. What we need to do is to stop for a while and reflect on what we are doing and how we want to move forward. A crucial question to answer is, Does placebo research boost pseudoscience?

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I am immensely thankful to Prof Benedetti to make such clear and long-overdue statements. They will be most helpful in refuting the myth that homeopathy, para-normal healing, reflexology, acupuncture, chiropractic, etc., etc. are legitimate and uselful therapies, even if they are not better than a placebo. Using placebo therapies in routine care is not in the best interest of either the patient or progress.

It is hard to deny that many practitioners of so-called alternative medicine (SCAM) advise their patients to avoid ‘dangerous chemicals’. By this they usually mean prescription drugs. If you doubt how strong this sentiment often is, you have not followed the recent posts and the comments that regularly followed. Frequently, SCAM practitioners will suggest to their patients to not take this or that drug and predict that patients would then see for themselves how much better they feel (usually, they also administer their SCAM at this point).

Lo and behold, many patients do indeed feel better after discontinuing their ‘chemical’ medicines. Of course, this experience is subsequently interpreted as a proof that the drugs were dangerous: “I told you so, you are much better off not taking synthetic medicines; best to use the natural treatments I am offering.”

But is this always interpretation correct?

I seriously doubt it.

Let’s look at a common scenario: a middle-aged man on several medications for reducing his cardiovascular risk (no, it’s not me). He has been diagnosed to have multiple cardiovascular risk factors. Initially, his GP told him to change his life-style, nutrition and physical activity – to which he was only moderately compliant. Despite the patient feeling perfectly healthy, his blood pressure and lipids remained elevated. His doctor now strongly recommends drug treatment and our chap soon finds himself on statins, beta-blockers plus ACE-inhibitors.

Our previously healthy man has thus been turned into a patient with all sorts of symptoms. His persistent cough prompts his GP to change the ACE-inhibitor to a Ca-channel blocker. Now the patients cough is gone, but he notices ankle oedema and does not feel in top form. His GP said that this is nothing to worry about and asks him to grin and bear it. But the fact is that a previously healthy man has been turned into a patient with reduced quality of life (QoL).

This fact takes our man to a homeopath in the hope to restore his QoL (you see, it certainly isn’t me). The homeopath proceeds as outlined above: he explains that drugs are dangerous chemicals and should therefore best be dropped. The homeopath also prescribes homeopathics and is confident that they will control the blood pressure adequately. Our man complies. After just a few days, he feels miles better, his QoL is back, and even his sex-life improves. The homeopath is triumphant: “I told you so, homeopathy works and those drugs were really nasty stuff.”

When I was a junior doctor working in a homeopathic hospital, my boss explained to me that much of the often considerable success of our treatments was to get rid of most, if not all prescription drugs that our patients were taking (the full story can be found here). At the time, and for many years to come, this made a profound impression on me and my clinical practice. As a scientist, however, I have to critically evaluate this strategy and ask: is it the correct one?

The answer is YES and NO.

YES, many (bad) doctors over-prescribe. And there is not a shadow of a doubt that unnecessary drugs must be scrapped. But what is unnecessary? Is it every drug that makes a patient less well than he was before?

NO, treatments that are needed should not be scrapped, even if this would make the patient feel better. Where possible, they might be altered such that side-effects disappear or become minimal. Patients’ QoL is important, but it is not the only factor of importance. I am sure this must sound ridiculous to lay people who, at this stage of the discussion, would often quote the ethical imperative of FIRST DO NO HARM.

So, let me use an extreme example to explain this a bit better. Imagine a cancer patient on chemo. She is quite ill with it and QoL is a thing of the past. Her homeopath tells her to scrap the chemo and promises she will almost instantly feel fine again. With some side-effect-free homeopathy see will beat the cancer just as well (please, don’t tell me they don’t do that, because they do!). She follows the advice, feels much improved for several months. Alas, her condition then deteriorates, and a year later she is dead.

I know, this is an extreme example; therefore, let’s return to our cardiovascular patient from above. He too followed the advice of his homeopath and is happy like a lark for several years … until, 5 years after discontinuing the ‘nasty chemicals’, he drops dead with a massive myocardial infarction at the age of 62.

I hope I made my message clear: those SCAM providers who advise discontinuing prescribed drugs are often impressively successful in improving QoL and their patients love them for it. But many of these practitioners haven’t got a clue about real medicine, and are merely playing dirty tricks on their patients. The advise to stop a prescribed drug can be a very wise move. But frequently, it improves the quality, while reducing the quantity of life!

The lesson is simple: find a rational doctor who knows the difference between over-prescribing and evidence-based medicine. And make sure you start running when a SCAM provider tries to meddle with necessary prescribed drugs.

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