Monthly Archives: April 2021
The new NICE draft guideline on acupuncture for chronic pain has been published several months ago, and we discussed it here. Now the final document entitled ‘Chronic pain (primary and secondary) in over 16s: assessment of all chronic pain and management of chronic primary pain‘ has been published on 7/4/2021. Like the draft, it includes quite a bit about acupuncture. Let me just quote three essential sections:
Recommendations: Acupuncture for chronic primary pain
Consider a single 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 (equivalent or lower) healthcare professional with appropriate training 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) or
- is delivered by another healthcare professional with appropriate training and/or in another setting for equivalent or lower cost.
_____________________________
Many studies (27 in total) showed that acupuncture reduced pain and improved quality of life in the short term (up to 3 months) compared with usual care or sham acupuncture. There was not enough evidence to determine longer-term benefits. The committee acknowledged the difficulty in blinding for sham procedures, but agreed that the benefit compared with a sham procedure indicated a specific treatment effect of acupuncture. There was a wide variation among the studies in the type and intensity of the intervention used, and the studies were from many different countries. The committee agreed that the type of acupuncture or dry needling should depend on the individual needs of the person with pain.
Two economic evaluations (1 in the UK) showed that acupuncture offered a good balance of benefits and costs for people with chronic neck pain. However, both studies had limitations; a notable limitation being that the costs of acupuncture seemed low. Threshold analysis based on these studies indicated the maximum number of hours of a band 6 and 7 healthcare professional’s time that would make the intervention cost effective.
An original economic model was developed for this guideline, which compared acupuncture with no acupuncture. The model used data from studies with usual care comparisons, not comparisons with sham acupuncture, because the committee agreed that a usual care comparison in an economic model better reflects the real world benefit of the intervention. The model showed that acupuncture was likely to be cost effective. The committee considered the results to be robust, and agreed that the studies used in the model were representative of the whole evidence review. Acupuncture remained cost effective when the assumed benefits and costs were varied (sensitivity analysis).
Overall, the committee agreed that there was a large evidence base showing acupuncture to be clinically effective in the short term (3 months); the original economic modelling also showed it is likely to be cost effective. However, they were uncertain whether the beneficial effects would be sustained long term and were aware of the high resource impact of implementation. Taking these factors into account, the committee made a recommendation to consider acupuncture or dry needling for chronic primary pain, caveated by the factors likely to make the intervention cost effective. These were: only if delivered in the community, and with a maximum of 5 treatment hours (based on the average resource use in the trials in the model and on the threshold analysis), and from a band 7 (equivalent cost or lower) healthcare professional (based on the threshold analysis). It was agreed there may be different ways of delivering the service that enable acupuncture to be delivered for the same costs, which would equally be appropriate. The committee agreed that discontinuing before this total amount of course time would be an option if the person finds that the first few sessions are not effective.
_______________________________
Acupuncture versus sham acupuncture
Pain reduction
Very low quality evidence from 13 studies with 1230 participants showed a clinically important benefit of acupuncture compared to sham acupuncture at ≤3 months. Low quality evidence from 2 studies with 159 participants showed a clinically important benefit of acupuncture compared to sham acupuncture at ≤3 months.
Low quality evidence from 4 studies with 376 participants showed no clinically important difference between acupuncture and sham acupuncture at >3 months. Moderate quality evidence from 2 studies with 159 participants showed a clinically important benefit of acupuncture compared to sham acupuncture at >3 months. Low quality evidence from 1 study with 61 participants showed no clinically important difference between acupuncture
and sham acupuncture at >3 months.
______________END OF QUOTES____________
I will leave this here without a comment for the moment and look forward to reading what you think about this.
The use of so-called alternative medicine (SCAM) is common among breast cancer patients, but less is known about whether SCAM influences breast cancer survival. The primary aim of this recent study from Tunesia was to determine the impact of self-use of herbs on the overall survival of women with breast cancer.
The researchers conducted a prospective study including 110 patients with breast cancer. All patients were questioned about their usage of herbal remedies. The demographic data and the overall survival of the patients were then analyzed.
The average age was 51 years (30-80 years old). In total, 37 had metastatic disease (33.6%), and 48 patients had taken plant-based treatments (43.6%). Of those women, 19 patients consumed Graviola (39.6%) and 29 Alenda (60.4%). Overall survival rates at 3 years and at 5 years were 96.2% and 82.4% in the absence of herbal medicine usage versus 78.5% and 78.5% in the presence of herbal medicine use (p = 0.015).
The authors concluded that self-medication with Graviola or Alenda may be associated with an increase of death risk in patients with breast cancer. Further studies are needed to confirm these results.
This is only a small and not very rigorous case-control study. In itself, it would be far from conclusive. What renders it relevant, however, is the fact that its findings do by no means stand alone. We have seen several times on this blog that SCAM use can shorten the life of cancer patients, e.g.:
- More evidence that SCAM-use is associated with shorter survival of cancer patients
- Patients who received CM were more likely to refuse additional CCT, and had a higher risk of death. The results suggest that mortality risk associated with CM was mediated by the refusal of CCT.
- The use of CAM had significantly associated with delay in presentation and resolution of diagnosis.
- CAM did not provide any definite survival benefit, CAM users reported clinically significant worse health-related quality of life.
So, perhaps it is true? Perhaps using SCAM is not such a good idea, if you are suffering from cancer!
The mechanisms of such detrimental effects are not difficult to imagine. They might include direct effects on the cancer, interactions with prescribed drugs, delay of cancer diagnosis, or less strict adherence to the anti-cancer treatments.
Osteopathic manipulative treatment (OMT) is frequently recommended by osteopaths for improving breastfeeding. But does it work?
This double-blind randomised clinical trial tested whether OMT was effective for facilitating breastfeeding. Breastfed term infants were eligible if one of the following criteria was met:
- suboptimal breastfeeding behaviour,
- maternal cracked nipples,
- maternal pain.
The infants were randomly assigned to the intervention or the control group. The intervention consisted of two sessions of early OMT, while in the control group, the manipulations were performed on a doll behind a screen. The primary outcome was the exclusive breastfeeding rate at 1 month, which was assessed in an intention-to-treat analysis. Randomisation was computer generated and only accessible to the osteopath practitioner. The parents, research assistants and paediatricians were masked to group assignment.
One hundred twenty-eight mother-infant dyads were randomised, with 64 assigned to each group. In each group, five infants were lost to follow-up. In the intervention group, 31 of 59 (53%) of infants were still exclusively breastfed at 1 month vs 39 of 59 (66%) in the control group. After adjustment for suboptimal breastfeeding behaviour, caesarean section, use of supplements and breast shields, the adjusted OR was 0.44. No adverse effects were reported in either group.
The authors concluded dryly that OMT did not improve exclusive breastfeeding at 1 month.
This is a rigorous trial with clear and expected results. It was conducted in cooperation with a group of 7 French osteopaths, and the study was sponsored by the ‘Société Européenne de Recherche en Osthéopathie Périnatale et Pédiatrique’, the ‘Fonds pour la Recherche en Ostéopathie’ and ‘Formation et Recherche Ostéopathie et Prévention’. The researchers need to be congratulated on publishing this trial and expressing the results so clearly despite the fact that the findings were not what the osteopaths had hoped for.
Three questions come to my mind:
- Is any of the many therapeutic recommendations of osteopaths valid?
- Why was it ever assumed that OMT would be effective?
- Do we really have to test every weird assumption before we can dismiss it?
The authors of this study claim that, in the aging brain, reduction in the pulsation of cerebral vasculature and fluid circulation causes impairment in the fluid exchange between different compartments and lays a foundation for the neuroinflammation that results in Alzheimer disease (AD). The knowledge that lymphatic vessels in the central nervous system play a role in the clearance of brain-derived metabolic waste products opens an unprecedented capability to increase the clearance of macromolecules such as amyloid β proteins. However, currently, there is no pharmacologic mechanism available to increase fluid circulation in the aging brain.
Based on these considerations, the authors conducted a study to demonstrate the influence of an osteopathic cranial manipulative medicine (OCMM) technique, specifically, compression of the fourth ventricle, on spatial memory and changes in substrates associated with mechanisms of metabolic waste clearance in the central nervous system using the naturally aged rat model of AD.
The rats in the OCMM group received the CV4 technique every day for 7 days for 4 to 7 minutes at each session. Rats were anesthetized with 1.5% to 3% isoflurane throughout the procedure. Rats in the UT group were also anesthetized to nullify any influence of isoflurane in spatial learning. During the CV4 procedure, the operator applied mechanical pressure over the rat’s occiput, medial to the junction of the occiput and temporal bone and inferior to the lambdoid suture to place tension on the dural membrane around the fourth ventricle. This gentle pressure was applied to resist cranial flexion with the aim of improving symmetry in the cranial rhythmic impulse (CRI), initiating a rhythmic fluctuation of the CSF, and improving mobility of the cranial bones and dural membranes. This rhythmic fluctuation is thought to be primarily due to flexion and extension that takes place at the synchondrosis between the sphenoid and basiocciput. The treatment end point was achieved when the operator identified that the tissues relaxed, a still point was reached, and improved symmetry or fullness of the CRI was felt. Currently, there is no quantitative measure for the pressure used in this treatment.
The results showed a significant improvement in spatial memory in 6 rats after 7 days of OCMM sessions. Live animal positron emission tomographic imaging and immunoassays revealed that OCMM reduced amyloid β levels, activated astrocytes, and improved neurotransmission in the aged rat brains.
The authors concluded that these findings demonstrate the molecular mechanism of OCMM in aged rats. This study and further investigations will help physicians promote OCMM as an evidence-based adjunctive treatment for patients with AD.
If there ever was an adventurous, over-optimistic extrapolation, this must be it!
Even assuming that all of the findings can be confirmed and replicated, they would be a very far shot from rendering OCMM an evidence-based treatment for AD:
- Rats are not humans.
- Aged rats do not have AD.
- OCMM is not a plausible treatment.
- An animal study is not a clinical trial.
I am at a complete loss to see how the findings of this bizarre animal experiment might help physicians promote OCMM as an evidence-based adjunctive treatment for patients with AD.
After yesterday’s post entitled ‘What does a holistic doctor do that a traditional doctor doesn’t?‘, I thought it would only be fair to turn the question around and ask: What does a proper doctor do that a holistic healer doesn’t? The answers will upset a lot of practitioners of alternative medicine (SCAM), but so be it.
So, what does a proper doctor do that a holistic healer doesn’t?
I suggest several answers and hope that the readers of this blog will contribute to further points. Many of them center around safeguarding the public:
- Proper doctors avoid confusing or misleading the public with titles they do not have.
- They do have rigorous education and training.
- They avoid making false therapeutic claims.
- They adhere to the ethical standards of their profession.
- They resist the temptation to advertise their services to the consumer.
- They do their best to identify the cause of their patient’s symptoms.
- They treat the causes of disease whenever possible.
- They avoid pretending that they always have all the answers.
- They abide by the rules of evidence-based medicine.
- They are aware that almost any effective treatment comes with adverse effects.
- They try to keep abreast with the rapid advances in medicine.
- They know that a patient is more than a diagnostic label.
- They try to treat patients holistically.
At this stage, I can hear some readers shout in anger:
- Ahh, but that is rubbish!
- I know doctors who are not at all like that!
- You are idealizing your profession!
- This is little more than wishful thinking!
Yes, I know that many patients are disappointed and have had a bad experience with conventional medicine. That is one of the reasons many try SCAM. I know that many doctors occasionally fail to live up to the ideal that I depicted above. And I fear that some do so more often than just occasionally.
This is regrettable and occasionally it is unacceptable. Medicine is populated not by perfect people; it is run by humans like you and me. Humans are fallible. Doctors have bad days just like you and me. If that happens regularly, we need to address the problems that may the cause of the deficit. If necessary, the case has to go before a disciplinary hearing. There are thousands of experts who are dedicated to improving healthcare in the hope of generating progress.
The point I was trying to make is that there is such a thing as an ideal physician. It relies on:
- rigorous training,
- ethical codes,
- post-graduate education,
- supervision,
- governance,
- swift disciplinary procedures,
- advances brought about through colossal research efforts,
- etc., etc.
Do ‘holistic healers’ offer all of these safeguards?
The sad answer is no.
For those who disagree, let’s briefly look at a recent example.
John Lawler died in 2017 after being treated by a chiropractor (as discussed on this blog before).
- Mr. Lawler died because of a tear and dislocation of the C4/C5 intervertebral disc caused by a considerable external force.
- The pathologist’s report also showed 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’ that applies only little and well-controlled force. However, she also employed a ‘drop table’ which applies a larger and not well-controlled force.
As far as I can see, most of the safeguards and standards that apply to conventional medicine were not in place to safeguard Mr. Lawler. And that includes a timely disciplinary hearing of the case. Mr. Lawler died in 2017! The CCG has been dragging its feet ever since, and, as far as I know, the chiropractor was meanwhile allowed to practise. The HEARING BEFORE THE PROFESSIONAL CONDUCT COMMITTEE OF THE GENERAL CHIROPRACTIC COUNCIL has now been scheduled to commence on 19 April 2021.
I know, it’s just an example. But it should make us think.
Holistic medicine is based on several core values:
- good health is a combination of physical, emotional, mental, spiritual, and social wellness
- prevention first, treatment second
- disease is caused by a problem with the whole body, rather than a single event or body part
- the goal of treatment is to fix the underlying cause of disease, instead of just improving the symptoms
- treatment involves a wide range of options, including education, self-care, CAM, and traditional medicine
- a person is not defined by their condition
- the relationship between a doctor and the person being treated determines the treatment outcome
Generally, traditional doctors treat symptoms. They provide medical solutions to alleviate a disease.
A holistic doctor treats the body as one. They aim to find the cause behind the disease, instead of just fixing the symptoms. This could require multiple therapies.
For example, if you have eczema, a medical doctor may give you a prescription cream. But a holistic doctor may suggest dietary and lifestyle changes. The holistic doctor might also recommend using the cream, plus natural home remedies like oatmeal baths.
So, now we know!
This could, of course, be just laughable if it were not perpetuating such common misconceptions. And as this sort of BS is so common, I feel obliged to carry on exposing it. Let me, therefore, correct the main errors in the short paragraph:
- ‘Traditional doctors’ are just doctors, proper doctors; holistic healers often give themselves the title ‘doctor’ but, unless they have been to medical school, they are not doctors.
- ‘Doctors treat symptoms’; yes, they do. But whenever possible, they treat the cause too. Therefore they do what is possible to identify the cause. And during the last 150 years or so, they have become reasonably good at this task.
- ‘A holistic doctor treats the body as one.’ That’s what they claim. But in reality, they are often not trained to do so. The body is mighty complex, and many holistic practitioners are simply not trained for coping with this complexity.
- ‘They aim to find the cause behind the disease’. They might well aim at that, but if they are not fully trained doctors, this is an impossible aim, and they merely end up finding what they have been taught about the cause of disease. An imbalance of Yin and Yang is the imagined cause of disease in TCM, and for many chiropractors, a subluxation is the cause of disease. But such assumptions are not facts; it is merely wishful thinking which get in the way of finding true causes of disease.
- Eczema happens to be a superb example (thank you ‘helpline’). The oatmeal bath of the holistic practitioner is at best a symptomatic treatment. This is why a proper doctor aims to find the cause of eczema which could be an allergy, for instance. Having identified it, the doctor would then advise how to avoid the allergen. If that is possible, further treatment might not be even necessary.
When practitioners are elaborating on their concept of holism, one often only needs to read on to find that those who pride themselves on holism are, in fact, the victims of multiple errors (or perhaps they use the holism gimmick only as a sales strategy, because consumers fall easily for this ‘bait and switch’). And those doctors who are accused of lacking holism are, in fact, more likely to be holistic than the so-called holists.
The authors offer the following conclusions:
After 45 years of study, scientific evidence of the value of TT as a complementary intervention in the management of any condition still remains immature and inconclusive:
- Given the mixed result, lack of replication, overall research quality, and significant issues of bias identified, there currently exists no good-quality evidence that supports the implementation of TT as an evidence‐based clinical intervention in any context.
- Research over the past decade exhibits the same issues as earlier work, with highly diverse poor quality unreplicated studies mainly published in alternative health media.
- As the nature of human biofield energy remains undemonstrated, and that no quality scientific work has established any clinically significant effect, more plausible explanations of the reported benefits are from wishful thinking and use of an elaborate theatrical placebo.
These are clear and much-needed words addressed at nurses (the paper was published in a nursing journal). Nurses have been oddly fond of TT. Therefore, it seems important to send evidence-based information in their direction. In my recent book, I arrived at similar conclusions about TT:
- The assumptions that form the basis for TT are not biologically plausible.
- Several trials and reviews of TT have emerged. However, many of them are by ardent proponents of TT, seriously flawed, and thus less than reliable. e.g.[1],[2]
- One rigorous pre-clinical study, co-designed by a 9-year-old girl, found that experienced TT practitioners were unable to detect the investigator’s “energy field.” Their failure to substantiate TT’s most fundamental claim is unrefuted evidence that the claims of TT are groundless and that further professional use is unjustified. [3]
- There are no reasons to assume that TT causes direct harm. One could, however, argue that, like all forms of paranormal healing, it undermines rational thinking.
[1] https://www.ncbi.nlm.nih.gov/pubmed/19299529
[2] https://www.ncbi.nlm.nih.gov/pubmed/27194823
[3] https://www.ncbi.nlm.nih.gov/pubmed/?term=rosa+e%2C+therapeutic+touch%2C+jama
