Many alternative therapy approaches are biologically implausible so why are they still used? Examples based on acupuncture and cranial osteopathy

Many alternative therapies are based on pre-scientific ideas that, over recent years, have been shown to have no plausible mechanism of action. When faced with this problem, providers of these therapies have often chosen to try and “reinvent” them by looking for a new mechanism of action that seems more plausible. It would be more logical to simply stop using them. Fortunately this problem occurs much less in conventional medicine, otherwise we would still be making widespread use of bloodletting and other unsuitable historic treatments. This willingness to reject unsuitable treatment approaches is one of the key things that sets conventional medicine apart from alternative therapies. Let us look at a couple of examples of this problem: acupuncture and cranial osteopathy.

Acupuncture

Acupuncture was originally based on the ideas of a flow of vital energy “qi” (or chi) that was thought to run through meridians. Thanks to modern science and medicine, we know that qi and meridians do not exist. Acupuncture lacks evidence of effectiveness and even in chronic pain there is no good evidence that it is effective. Supporters of acupuncture have tried to come up with new mechanisms of action such as suggesting that it may stimulate the release of natural pain-killing chemicals or relax tight muscles. Whilst these ideas are more plausible than qi and meridians, they are still speculative and do not change the fact that acupuncture has not actually been shown to work reliably for any health condition. Given the lack of a plausible basis for acupuncture and no good evidence of effectiveness, it would seem to make much more sense to just cease using it than to try to come up with new hypothetical explanations for it.

Cranial osteopathy

A more recent example is cranial osteopathy. Cranial osteopathy was proposed in the 1930s by William Sutherland, who believed that osteopaths could treat health conditions by manipulating the “cranial rhythm”. Since that time, we have learned a lot more in this area and it is quite clear that Sutherland’s ideas do not make any sense. Cranial osteopathy is a fanciful concept based on something that doesn’t exist. In addition, it has never been found effective for any health condition. Unfortunately, some osteopaths will just not let cranial osteopathy go and have tried to come up with new ideas for how it might work. In fact, the University College of Osteopathy have recently run a course “Osteopathy in the cranial field reloaded”. This is based on the ideas presented in a paper by a couple of osteopaths from 2014. The trouble is that these are just ideas. There is no research that shows they actually work or that any osteopathic treatment of the head provides any benefit whatsoever. Yet, osteopaths are continuing to learn these approaches and apply them with their patients. Cranial osteopathy is even less plausible than acupuncture and has not been found effective for any health condition. If osteopaths want to be seen as viable healthcare practitioners they really need to remove all use of cranial osteopathy from their profession.

Why do these unsuitable alternative therapies persist?

When faced with such obvious evidence that they are not viable, why do supporters of these (and other) alternative approaches continue to try to use them? There are probably numerous reasons but I would suggest that a key one is “belief”. The people using and researching these approaches believe that they work and therefore keep trying to look for a new way to show that they do. They are so invested in these alternative techniques that they are unable to step back and objectively assess the reality of the situation. It is fortunate that we do not see this in conventional medicine, or at least it is less frequent, otherwise the advances made over the past few decades would simply not have happened.

Shortcomings in trial design can result in the “wrong” outcome: An example based on acupuncture

I have recently written about the problems with the decision by the National Institute for Health and Care Excellence (NICE) to include acupuncture in their draft guidelines on chronic pain. Here, I’m going to look at one of the studies they used as a basis for that decision in more detail. It includes a number of serious issues that means the results are unlikely to be accurate.

Study Overview

The study in question is “German Randomized Acupuncture Trial for chronic shoulder pain (GRASP) – a pragmatic, controlled, patient-blinded, multi-centre trial in an outpatient care environment”. The hypothesis for the study was “There is a significant difference for the responder rate in the verum group compared to that of sham and of COT. The patients with a pain reduction of at least 50% compared to baseline were classified as responders.” (Note that “verum” in this case refers to the acupuncture treatment group and COT is short for conservative orthopaedic treatment). Patient self-assessment of pain levels on a visual analogue scale (VAS) was used as the measurement. This primary endpoint was assessed 3 months after the completion of the 6 weeks of treatment.

The study claimed: “The trial indicates that Chinese acupuncture is an effective alternative to conventional orthopaedic treatment for CSP”. Due to the many flaws in this study, this trial doesn’t actually show this at all.

Main Flaws in the Study

Here are some of the main issues with this study:

• Use of traditional acupuncture points. The study states that the following points were used: “ventral – Lung 1, 2; ventrolateral – Large Intestine 4, 11, 14, 15; lateral – Sanjiao 5, 13, 14; dorsal – Small Intestine 3, 9”. Traditional Chinese acupuncture is based on Qi and meridians, which are ideas that conflict with modern science. These traditional acupuncture points don’t actually exist.
• Delay in publication. Patients were recruited between 1997 and 1999 but the paper was only submitted for publication in March 2009, a full ten years later. There may have been valid reasons for this but it is certainly unusual and raises concerns. Even if there were genuine reasons for such an extended delay, it seems reasonable to expect that the paper authors would struggle to remember full details of the trial after such an extended period.
• Drop-outs and how these were handled in the analysis. Drop-outs were high, particularly in the sham arm. Only 74 out of 135 (just 55%) in the sham arm reached the primary endpoint. In the treatment arm 128 out of 154 (83%) reached this point, along with 106 out of 135 (79%) in the conservative orthopaedic treatment (COT) arm. In all cases the drop-outs were “treated as non responders”. The problem with this is the very high drop-out rate in the sham arm. Treating the people who have dropped out from the sham arm as “non responders” is likely to underestimate the improvement in this arm. Because the drop-out rate in the treatment arm was much lower this will make the treatment appear more effective than the sham. It is a mistake from the authors to not consider this issue in their analysis. They don’t even mention it. One possible solution they could have used is to assume that drop-outs in the sham arm are “responders” (https://www.sciencedirect.com/science/article/pii/B9780128042175000084 ). This is the most cautious way of assessing the results but is a way of minimising the impact of the very high drop-out in the sham arm.
• Adverse events. Adverse event reporting is very important for any trial of a treatment. This is what the authors say: “Although we did not observe any serious adverse events (SAEs), it cannot be excluded that this is due to an underreporting by centres not being experienced in reporting SAEs.” Were the centres not given a clear protocol for how and when to report adverse events? Inadequate reporting of SAEs raises safety concerns about the trial.
• Contextual effects and blinding. The sham acupuncture points used in this trial were located on the leg. Yet, this was a treatment for shoulder pain. The authors provide this explanation “the further away sham points were located from verum points, the greater the observed difference between verum and sham treatment”. I would suggest that there is a very obvious explanation for this. When sham points are chosen that are nowhere near the area of the body needing treatment, this makes the sham less believable. It seems likely that many patients will realise that they are receiving the sham treatment when they need treatment for their shoulder and acupuncture needles are placed in their leg! This means the patients are effectively unblinded at this point, resulting in less contextual effects and invalidating the comparison between treatment and sham.

Professor Edzard Ernst also raised concerns about this paper after it was published, particularly focusing on the potential for the observed benefits to be down to contextual effects rather than the treatment itself.

Conclusion

There are many serious issues with this trial including with the treatment approach, inadequate blinding, analysis issues and safety concerns. The results from this study therefore shouldn’t really be used to inform treatment choices and it definitely isn’t evidence of the effectiveness of acupuncture. It’s disappointing that NICE have used such poor quality studies as a basis for their recommendations in their draft guideline on chronic pain.

Why have NICE included acupuncture in their guidelines for chronic pain?

Earlier this month the National Institute for Health and Care Excellence (NICE) released a draft of their new guideline on chronic pain and one of the treatment recommendations was acupuncture. Although acupuncture is commonly used to treat pain, recent research found that the evidence is conflicting and inconclusive. NICE usually takes a rigorous approach to developing guidelines, so how did they end up recommending a treatment that does not have good evidence of effectiveness? This is a complex issue that deserves further investigation.

Summary of conclusions:

1. The evidence in favour of acupuncture for chronic pain is weak and in many cases conflicting.

2. Traditional Chinese acupuncture is based on entirely false beliefs in qi, meridians and other pre-scientific concepts. It shouldn’t be included in any health guidelines.

3. NICE seem to have made a mistake in recommending acupuncture in their draft guidelines for chronic pain. Hopefully they will correct this mistake in the final guidelines.

What is acupuncture?

There are many different types of acupuncture, with all of them being based in some way on placing needles in various parts of the body. There are two main ideas that underpin acupuncture: (i) Traditional Chinese acupuncture based on qi (or chi) and meridians and (ii) Modern acupuncture based on a neurophysiological model (that acupuncture needles stimulate nerve endings and alter brain function). Qi and meridians are based on pre-scientific beliefs and should have no place in modern healthcare.

What do the NICE guidelines for chronic pain say about acupuncture?

The NICE guidelines state:

Consider a course of acupuncture or dry needling, within a traditional Chinese or Western acupuncture system, for people aged 16 years and over to manage chronic primary pain, but only if the course:

• is delivered in a community setting, and
• is delivered by a band 7 (or lower) healthcare professional, and
• is made up of no more than 5 hours of healthcare professional time (the number and length of sessions can be adapted within these boundaries).

Besides the recommendation for acupuncture itself, it’s concerning that NICE refer to “a traditional Chinese or Western acupuncture system” (emphasis mine). As previously stated, traditional Chinese acupuncture is based on Qi and meridians. These are concepts that conflict with modern science and have never been shown to actually exist.

Looking in the more detailed Evidence review for acupuncture, things get even worse. In that section, NICE refer directly to the concept of Qi and talk about this as if it’s a real thing. Here is what they say:

“Therapists trained in traditional Chinese medicine operate under the assumption of optimising the flow of the vital energy “Qi” in the body.”

Now there is no such thing as “vital energy” but, for some reason that I’m struggling to understand, NICE appears not to know this. They also go on to say:

“protagonists of traditional Chinese medicine (TCM) choose distant points in their attempts to harmonise the perceived misbalance of body functions and emotions.”

This is complete nonsense, yet here is the organisation that is responsible for producing evidence-based health and social care guidance in the UK taking about it in their guideline for chronic pain.

I have written previously on this blog about other guidelines produced by NICE such as this post about acupuncture for low back pain. Their approach to developing guidelines is usually extremely rigorous. I have also personally worked with them on other topics and seen the same thorough approach there too. I am staggered, and I don’t use this word lightly, that an organisation that is usually so careful and thorough is referring to traditional Chinese acupuncture, Qi and related concepts in the evidence used to develop their guideline on chronic pain.

What does the actual evidence say?

Within NICE’s Evidence review for acupuncture they include a series of “Clinical evidence statements”. For acupuncture versus sham acupuncture they have a large number of these statements. In almost all cases the evidence is labelled as low or very low quality. Is evidence of such low quality sufficient to make a recommendation in favour of a treatment? I would argue that it is not. When you take into account that several of the papers used to prepare these evidence statements are based on traditional Chinese acupuncture, I would suggest that the argument in favour of acupuncture looks even more dubious.

I have looked more closely at some of the papers that NICE refer to in their Evidence review for acupuncture. I have focused on those papers that a) compare acupuncture to sham and b) have a reasonably large sample size. A detailed explanation of why I have done this is beyond the scope of this article but in short: a) comparison with sham is important to control for non-specific treatment effects such as placebo and b) studies with larger sample sizes are more likely to provide accurate results than those with smaller sample sizes. Overall the quality of papers is poor with numerous methodological flaws in most of them, ranging from problems with blinding to issues with the statistical analysis. Even where these poor quality papers found a benefit the improvement was actually pretty small and unlikely to be clinically significant. Importantly, several of the studies are also based on the use of traditional Chinese acupuncture. Here is an example quote from one of the papers:

“The most frequently diagnosed TCM syndromes were Liver Qi stagnation (44.4%), followed by Spleen and Kidney Yang deficiency (21%) and Yin deficiency (13.6%).”

None of these things is recognised or accepted as a medical diagnosis and they are based on an outdated and incorrect approach to carrying out such a diagnosis. Taking all of this into account, it is hard to understand why NICE think acupuncture is a viable treatment for chronic pain.

Why did NICE include acupuncture as a recommendation for chronic pain?

The evidence for acupuncture as a treatment for chronic pain is pretty thin on the ground and in a recent review has been described as conflicting and inconclusive. The traditional Chinese medicine approach to acupuncture is based on things that do not exist and makes no logical sense. Why then did NICE include it as a recommendation in their guidelines for chronic pain? I had given this significant thought and not come up with a good answer. I did wonder if they were just short of interventions to include as a treatment for chronic pain and had concluded that acupuncture is the best of a bad bunch. However, I think that on balance there are two better explanations:

• As described in the post from Steve Novella on Science Based Medicine, NICE have failed to consider Science Based Medicine altogether. This is a serious failing for an organisation that has such an important role in creating guidelines for health and social care.
• One of the members of the NICE committee is Jens Foell, a GP who makes use of acupuncture in his practice and has even authored papers supporting acupuncture. In the Declaration of Interests register for the committee members he declares “I have been a member of the council of BMAS, the British Medical Acupuncture Society and member of the editorial board of “Acupuncture in Medicine” in the 12 months preceding joining the advisory I stood down from these posts in the last weeks”. This is someone who is clearly a strong supporter of acupuncture and provides a potential explanation for the inclusion of acupuncture within the guideline. The DoI was handled by having him “Declare and withdraw from drafting recommendations on acupuncture.” However, it also states that “The committee member will remain in the room for presentation of the evidence and may be asked to respond to specific questions from the committee regarding this topic.” Is having a fellow member of the committee who could speak confidently and strongly in favour of acupuncture likely to influence the committee’s decision? Absolutely! My thanks to David Colquhoun for highlighting this issue.

The other important point raised in the Science Based Medicine post is the risk of legitimising acupuncture and the potential for acupuncturists to use this NICE recommendation to market acupuncture for other conditions. Quoting from the SBM article “By recommending acupuncture for pain, based upon very weak evidence of a clinically tiny effect in the face of a lack of a plausible mechanism, you are throwing patients to the wolves.”

To conclude, it is a serious concern that NICE has failed to apply any sort of science-based approach when selecting treatments to include in their guideline. This has resulted in them recommending a treatment based on Qi, meridians and other nonsensical concepts. Even putting the lack of plausible scientific basis to one side, the evidence supporting acupuncture as a treatment for chronic pain is very weak. I am not the only one to have these concerns. Besides the article by Steve Novella on SBM, Edzard Ernst has also written about this and reaches similar conclusions. I think that NICE have made a serious mistake here and hope that they correct this error when they produce the final version of the guideline.

Further reading – other reviews of the guidelines

• New NICE guidelines on chronic pain fall woefully short – and not just because of the acupuncture. An excellent article by Alice Howarth that highlights a number of problems with the guidelines.
• Doctors raise concerns about NICE guidelines on chronic primary pain. An article in the BMJ where doctors in pain management say that the guidelines do not reflect clinical practice or current evidence.
• FPM concerns regarding new NICE Chronic Pain Guidelines. The Faculty of Pain Medicine raises a number of concerns including: (i) risk of decommissioning of Pain Management Programmes (PMP), (ii) risk of secondary pain services being decommissioned, (iii) potential withdrawal of useful medications from patients by GPs and (iv) recommendation of treatment modalities such as acupuncture.
• Stakeholder feedback from the Cochrane Pain, Palliative and Supportive Care (PaPaS) Review Group on the National Institute of Health and Care Excellence (NICE) draft clinical guideline GID-NG10069 Chronic pain: assessment and management. A detailed review that raises some serious concerns such as the way that research was excluded for areas for which there is already NICE guidance (e.g. low back pain) even though the evidence is likely to be highly relevant for this guideline.

Last updated 12/04/21

Osteopathic practice makes misleading claims about acupuncture helping the immune and respiratory systems

During the current COVID-19 pandemic there is understandably a big focus on the immune and respiratory systems. Unfortunately, some practitioners are exploiting this pandemic for their own benefit by making unsubstantiated claims about their treatments helping these systems. One such example is Lymm Osteopathic Practice, which claimed that acupuncture can benefit the immune and respiratory systems and that this may be helpful during the COVID-19 pandemic. There is simply no evidence to support these claims. The acupuncturist (Daniel Windridge) went on to claim that he uses this in his practice to treat Asthma, COPD and Lung Sarcoidosis. Daniel even claimed that “results can be immediate”. These can be serious conditions and an acupuncturist is not qualified to treat them. They should instead be treated by a doctor.

Acupuncture beliefs and (lack of) evidence

Acupuncturists believe that there are specific “acupuncture points” that influence particular organs or parts of the body. This isn’t supported by science or evidence. In this particular case, the promoted idea is that there are twelve “immune acupressure points” and that by applying pressure to these points there will be improvement in the immune and respiratory systems. According to the article, five of the acupressure points are located on the arms and seven on the legs. I do wonder, what on earth makes someone believe that they can influence the immune system by pressing on different parts of the arms and legs? There is simply no plausible biological mechanism by which this could possibly happen and no evidence to support these claims. These (and any other) special “acupuncture” points simply don’t exist. The ideas behind them are based on pre-scientific beliefs and should have no place in modern healthcare.

Tackling these misleading claims

I reported this to the Advertising Standards Authority (ASA) on 29^th May via their COVID-19 specific complaint form. Unfortunately, this didn’t result in a change and the misleading claims remained on the Lymm Osteopathic Practice website. The acupuncturist also continued to promote this misleading information via his twitter account with regular tweets about the “immune acupressure points”. Given the seriousness of these claims I decided to make a further complaint to the ASA on 18^th July using their normal complaint form. This time around the ASA took action and contacted Lymm Osteopathic Practice to inform them that they had broken advertising rules and to provide guidance on the changes needed. The page has now been removed from the Lymm Osteopathic Practice website, which is good news.

If you would like to know more about the original claims, here is a screenshot of the first part of the article. (I also have further screenshots of the rest of it):

Although these particular misleading claims have been removed from the Lymm Osteopathic Practice website, many more misleading claims remain. For instance, look at this post about the treatment of a baby: https://www.lymmosteopathicpractice.co.uk/case-study-the-baby-with-sinus-problems/ It is worrying that any parent would think that they should take a baby with the following symptoms to an osteopath: “skin a strange shade of pink, with a bluey purple tinge, he also was subdued, lethargic and very floppy”. Osteopaths in the UK are complementary and alternative therapists, not doctors. According to the article, “There are several techniques that Osteopaths can employ to unblock sinuses”. This is nonsense. There are no osteopathic techniques that have been shown to be effective for unblocking sinuses. In this particular case, things turned out okay. However, it’s likely that this was just down to good luck rather than the actions of the osteopath. The outcome could have been very much worse and the baby should have been treated by a doctor straight away. The osteopath is now using this story to try and persuade other parents to take their babies in for treatment. This is potentially dangerous as maybe the outcome won’t be so good next time around. There are no infant health conditions for which osteopathy has been shown to be effective and no good reason to take any baby to an osteopath.

Conclusions

Osteopaths are regulated healthcare professionals and should not be misleading members of the public with unsubstantiated treatment claims. This includes claims made about their own treatments as well as by other therapists who work at their practices. Unfortunately, that is exactly what has happened here. Misleading claims like this are by no means an isolated incident within the osteopathic profession. I have previously reported on osteopaths and chiropractors making misleading claims about their treatments “boosting the immune system”. I have also written about many other misleading claims from the osteopathic profession such as giving the impression that they are doctors (they aren’t) and the leading UK osteopathic education institution training osteopaths to treat respiratory conditions in children. Not all UK osteopaths make these sorts of misleading claims but it is a problem that is far more widespread than should be expected from a regulated healthcare profession.

Acupuncture treatments won’t help the immune and respiratory systems. Not only is there no evidence to support these claims but there is no plausible biological mechanism by which this could possibly happen. In fact, there is little evidence to support the use of acupuncture for any health condition. Even in pain, the evidence on acupuncture is conflicting and inconclusive. It’s also important to be aware that acupuncturists are not doctors and any serious health conditions ought to be treated by a doctor.

During the COVID-19 pandemic, it is natural for people to look for ways to protect themselves by undertaking treatments that they hope will prevent and / or treat COVID-19. Unfortunately, this has led to the promotion of a wide range of “treatments” that do not actually help at all. If you find an acupuncturist, osteopath or chiropractor who claims that they can help you prevent or treat COVID-19 or that their treatments can benefit the immune system then please steer well clear.

The use of complementary medicine by cancer patients raises serious concerns

I came across an article that looked at complementary medicine use in people receiving palliative cancer treatment in Lyon, France. It found that the vast majority (90%) of this patient group used complementary medicine. This raises a number of serious concerns that I’d like to explore further.

Effectiveness

To start with, let’s make something really clear: There are no alternative or complementary approaches that are effective for the treatment of cancer itself. None. What about when these alternative approaches are used as complementary to (along with) conventional treatments? Even in this situation, there is still very little evidence that they provide any benefit whether that be for the symptoms of cancer or to help manage side effects of conventional treatments. For instance, acupuncture is sometimes used to help with cancer-related pain but a recent review concluded that “there are insufficient high-quality RCTs to judge the efficacy of acupuncture for cancer-related pain”. Put more simply, acupuncture hasn’t been shown to be effective for cancer pain. There is a reason why these alternative or complementary treatments haven’t been accepted by mainstream medicine even though they have been tried for a long time: they don’t work.

Safety

Use of complementary treatments by people undergoing palliative cancer care raises a number of risks. Firstly, there is the risk from the treatments themselves. No treatment is without risk, in spite of what some practitioners may claim. Probably more importantly, there are also a number of indirect risks. For instance, the complementary treatment may interact with mainstream treatments reducing their effectiveness or increasing side effects. What’s particularly concerning is the number of people who use complementary treatments without telling their doctor. In this study half of respondents had not disclosed their use of complementary medicine to their oncologist. This is concerning as it doesn’t allow the doctor to have a complete picture all of the treatments being used. When someone is experiencing particular symptoms is this due to the cancer itself, the conventional treatment or side effects from the complementary treatment that the doctor doesn’t know about? It’s very important that if you use complementary treatments you tell your doctor, regardless of how “safe” or innocuous these treatments may appear.

Cost

Within this study, about a third of patients said that it was difficult to manage financially some of the time, all of the time or that it was impossible. Yet, 90% of the people studied are spending money on complementary treatments. Some people are therefore spending money on completely ineffective complementary treatments when they are facing financial hardship. If they realised how ineffective these treatments are, would they still spend the money or would they put the money towards the costs of daily living instead?

Deception

Cancer patients use complementary treatments for a variety of reasons. However, according to the paper, some people say that they are using these treatments for “assisting in stimulating the body’s ability to fight the cancer” and “trying to do everything that can help their treatment or recovery”. None of the complementary treatments being used can help with these things and this raises the question of why members of the public end up believing that they could. Whilst there will be a range of reasons it seems probable that the original source of this misinformation is the complementary medicine practitioners themselves. Indeed this particular paper, as well as several of those that it references, paints the benefits of complementary treatments in an unjustifiably positive light. For instance, it suggests that aromatherapy “is considered a popular form of alternative medicine to treat various conditions, both internally and externally”. Popular it may well be, effective it certainly isn’t. Unfortunately, the paper authors forgot to mention the latter. They further make the unsubstantiated claim that osteopathy is beneficial for a range of cancer-related complaints. The “evidence” they provide to support this? A study of just 16 patients where the patients were asked what they thought osteopathy had helped with. No actual objective evidence at all. Members of the public are therefore being deceived into using complementary treatments based on unsubstantiated claims.

Potential for rejection of conventional treatments

There are a number of issues with a cancer patient using alternative approaches as complementary to their mainstream treatment but what happens if they are persuaded to use an alternative approach instead of their mainstream treatment? That’s when things get really bad. A study from 2017 found that the death rate from cancer was significantly higher when cancer patients chose to use only alternative treatments.

Conclusions

Many people who are diagnosed with cancer use some form of alternative or complementary treatments. There are a number of serious issues with using these treatments including lack of effectiveness, safety concerns, cost and the potential for rejection of conventional treatments. If somebody with cancer wants to go for a complementary therapy because they find it relaxing and enjoyable then provided they are fully informed of any risks this doesn’t present any particular concerns. What does need to stop is the promotion of these therapies as any form of “treatment” with any specific health benefit. They don’t provide that and it is high time that measures were put in place to protect members of the public from being deceived into believing that they do.