As we have discussed ad nauseam on this blog, spinal manipulation therapy (SMT) can cause serious adverse events, including spinal epidural hematoma (SEH), an emergency that can cause severe neurological dysfunction. Chinese surgeons have reported three cases of SEH after SMT.
- The first case was a 30-year-old woman who experienced neck pain and numbness in both upper limbs immediately after SMT. Her symptoms persisted after 3 d of conservative treatment, and she was admitted to our hospital. Magnetic resonance imaging (MRI) demonstrated an SEH, extending from C6 to C7.
- The second case was a 55-year-old man with sudden back pain 1 d after SMT, numbness in both lower limbs, an inability to stand or walk, and difficulty urinating. MRI revealed an SEH, extending from T1 to T3.
- The third case was a 28-year-old man who suddenly developed symptoms of numbness in both lower limbs 4 h after SMT. He was unable to stand or walk and experienced mild back pain. MRI revealed an SEH, extending from T1 to T2.
All three patients underwent surgery after failed conservative treatment. Blood clots were found during the operation in case 1 and case 2, and the postoperative pathology confirmed a hematoma. In case three, a vein ruptured during the operation, causing massive bleeding. The three patients recovered to ASIA grade E on day 5, 1 wk, and day 10 after surgery, respectively. All patients returned to normal after 3 mo of follow-up.
Imaging examinations of case 1. A: T1-weighted preoperative magnetic resonance imaging (MRI) image shows high signal intensity (orange arrow); B and C: Preoperative T2-weighted image shows low signal intensity, and an axial T2-weighted image demonstrates that the hematoma occurred in the posterior region (white arrow); D: Preoperative enhanced MRI suggests an enhanced hematoma signal (orange arrow); E: Intraoperative photograph shows that spinal cord compression has recovered; F: Postoperative pathology suggested a hematoma; G and H: X-ray at the 3-mo follow-up indicated intact internal fixation.
The authors concluded that before proceeding with SMT, each patient should be evaluated in detail and checked for risk factors. In cases where the physical condition changes rapidly, physicians should be alert to the danger and send the patient to the emergency department for a complete MRI examination. We recommend surgery if neurological symptoms appear.
In their paper, the authors also review 15 further cases of SEH that have been previously published. They stress several times in their article that this complication is rare. In my view, this begs the question: how do they know? As there is no post-marketing surveillance of chiropractors or other clinicians doing SMT, I would insist that nobody can be sure about the true incidence of SEH or any other complication after SMT.
I was asked by the ‘Science Media Centre’ (SMC) to provide a short comment on the following press release (which was embargoed until today):
Daily use of cannabidiol (‘CBD’) oil may be linked to lung cancer regression
… The report authors describe the case of a woman in her 80s, diagnosed with non-small cell lung cancer. She also had mild chronic obstructive pulmonary disease (COPD), osteoarthritis, and high blood pressure, for which she was taking various drugs.
She was a smoker, getting through around a pack plus of cigarettes every week (68 packs/year).
Her tumour was 41 mm in size at diagnosis, with no evidence of local or further spread, so was suitable for conventional treatment of surgery, chemotherapy, and radiotherapy. But the woman refused treatment, so was placed under ‘watch and wait’ monitoring, which included regular CT scans every 3-6 months.
These showed that the tumour was progressively shrinking, reducing in size from 41 mm in June 2018 to 10 mm by February 2021, equal to an overall 76% reduction in maximum diameter, averaging 2.4% a month, say the report authors.
When contacted in 2019 to discuss her progress, the woman revealed that she had been taking CBD oil as an alternative self-treatment for her lung cancer since August 2018, shortly after her original diagnosis.
She had done so on the advice of a relative, after witnessing her husband struggle with the side effects of radiotherapy. She said she consistently took 0.5 ml of the oil, usually three times a day, but sometimes twice.
The supplier had advised that the main active ingredients were Δ9-tetrahydrocannabinol (THC) at 19.5%, cannabidiol at around 20%, and tetrahydrocannabinolic acid (THCA) at around 24%.
The supplier also advised that hot food or drinks should be avoided when taking the oil as she might otherwise feel stoned. The woman said she had reduced appetite since taking the oil but had no other obvious ‘side effects’. There were no other changes to her prescribed meds, diet, or lifestyle. And she continued to smoke throughout.
This is just one case report, with only one other similar case reported, caution the authors. And it’s not clear which of the CBD oil ingredients might have been helpful.
“We are unable to confirm the full ingredients of the CBD oil that the patient was taking or to provide information on which of the ingredient(s) may be contributing to the observed tumour regression,” they point out.
And they emphasise: “Although there appears to be a relationship between the intake of CBD oil and the observed tumour regression, we are unable to conclusively confirm that the tumour regression is due to the patient taking CBD oil.”
Cannabis has a long ‘medicinal’ history in modern medicine, having been first introduced in 1842 for its analgesic, sedative, anti-inflammatory, antispasmodic and anticonvulsant effects. And it is widely believed that cannabinoids can help people with chronic pain, anxiety and sleep disorders; cannabinoids are also used in palliative care, the authors add.
“More research is needed to identify the actual mechanism of action, administration pathways, safe dosages, its effects on different types of cancer and any potential adverse side effects when using cannabinoids,” they conclude.
The SMC published three invited comments:
Prof David Nutt, The Edmond J Safra Chair in Neuropsychopharmacology, Imperial College London, said:
“This is one of many such promising single case reports of medical cannabis self-treatment for various cancers. Such case reports are biologically credible given the adaptogenic nature of the endocannabinoid system. A case report itself is not sufficient to give any form of proof that one thing caused the other – we need trials for that. There are some controlled trials already started and more are required to properly explore the potential of medical cannabis in a range of cancers.”
Prof Edzard Ernst, Emeritus Professor of Complementary Medicine, University of Exeter, said:
“Cannabinoids have been shown to reduce the size of prostate cancer tumours in animal models. Previous case reports have yielded encouraging findings also in human cancers. However, case reports cannot be considered to be reliable evidence, and there are currently no data from rigorous clinical trials to suggest that cannabis products will alter the natural history of any cancer.”
Dr Tom Freeman, Senior Lecturer and Director of the Addiction and Mental Health Group, University of Bath, said:
“These results are exciting and very encouraging for this patient. However as a single case study the quality of scientific evidence is low and should not be used to change clinical practice. People with lung cancer should always seek guidance from a healthcare professional when deciding on an appropriate treatment.
“The product used by this patient reportedly contained high levels of THC (the intoxicating component of cannabis), and was sourced from outside the UK. This type of product is very different to most CBD oils which predominantly contain CBD. Unlike prescribed medicines, CBD wellness products lack assurance of quality, safety or efficacy and should not be used for medicinal purposes.”
The original paper has now been published and can be found here.
Practitioners of so-called alternative medicine (SCAM) regularly claim with great pride that they treat the ROOT CAUSES of disease. The claim has at least 4 effects:
- It distracts from the true causes of disease which are often multifactorial.
- It attracts customers to SCAM.
- It implies that conventional medicine is at best symptomatic and thus far inferior to SCAM.
- It encourages the patients of SCAM practitioners to turn their backs on mainstream healthcare.
The notion that SCAM practitioners treat the root causes is based on the practitioners’ understanding of etiology:
- If a traditional acupuncturist, for instance, becomes convinced that all disease is the expression of an imbalance of life-forces, and that needling acupuncture points will re-balance these forces thus restoring health, he must automatically assume that he is treating the root causes of any condition.
- If a chiropractor believes that all diseases are due to ‘subluxations’ of the spine, it must seem logical to him that spinal ‘adjustment’ is synonymous with treating the root cause of whatever complaint his patient is suffering from.
- If a Bowen therapist is convinced that “the Bowen Technique aims to balance the whole person, not just the symptoms“, he is bound to be equally sure that the root cause of “practically any problem can potentially be addressed” by this intervention.
- If a homeopath is convinced that all illness stems from a weakness of the ‘vital force’ and that only homeopathic remedies can revitalize it, they are likely to believe that their remedies tackle the root cause of all diseases.
- Etc., etc.
So, are SCAM practitioners correct when they claim to treat the root causes of disease?
When a root cause has been eliminated, the disease has been eliminated by its root. Treating a root cause, therefore, means that the disease is permanently cured. The above question can therefore be re-phrased as follows:
Is there any SCAM that cures any disease permanently?
I think the answer is NO. (At least, I know none. I would, however, be most grateful if someone could name one together with the evidence)
Even demonstrably effective forms of SCAM are effective only in terms of alleviating the symptoms. The one with the best evidence is probably St John’s wort. It works fine for mild to moderate depression. Yet, it does not cure depression: if we discontinue the treatment, the depression is likely to return.
And what about conventional medicine? Does it offer any permanent cures?
I have been searching and have to admit that I cannot find many either. Here is my list so far of diseases that are potentially curable (meaning they are unlikely to come back once the treatment has stopped and excluding disease prevention) with conventional medicine – and again, I would be really grateful if readers could add to my preliminary list:
- Acute emergencies, like anaphylaxis, cardiac arrest, etc.
- Bacterial infections (well most of them)
- Cancer (some), like Hodgkin lymphoma
- Malnutrition like beriberi of iron-deficiency anemia
- Phobias (some)
- Fungal infections (some)
- Poisonings (some)
- Many surgical indications such as appendicitis, gall stones, carpal tunnel syndrome, etc.
Not a long list, I admit (but better than nothing!) – so, please help me to prolong it by adding diseases that I did not mention.
This shocking paper presents 5 cases of patients with moderate to severe COVID-19 infections, 2 of them hospitalized in the intensive care unit, who were successfully treated with homeopathy. All 5 patients responded to homeopathic treatment in an unexpectedly short time span (in fact, it took up to 8 days), improving both physically and mentally.
The authors concluded that the present case series emphasizes the rapidity of response among moderate to severely ill patients to homeopathic treatment, when conventional medical options have been unable to relieve or shorten the disease. The observations described should encourage use of homeopathy in treating patients with COVID-19 during the acute phase of the disease.
If I hear about patients suffering from a cold, or tennis elbow, or otitis, or back pain, or allergy who responded to homeopathic treatment in an unexpectedly short time span, I tend to giggle and usually consider it a waste of time to explain that the observed outcome most likely is not a RESPONSE to homeopathic treatment but a non-causally related by-product. Correlation is not causation! What caused the outcome was, in fact, the natural history of the condition which would have improved even without homeopathy. To make this even clearer, I sometimes ask the homeopath: HOW DO YOU KNOW THAT THE PATIENT WOULD NOT HAVE IMPROVED EVEN FASTER IF YOU HAD NOT GIVEN HIM THE HOMEOPATHIC REMEDY? This question sometimes (sadly not always) leads to the realization that homeopathy may not have caused the outcome.
But when, in the middle of a pandemic during which millions of people died and continue to die, someone writes in a medical journal that 5 COVID patients responded to homeopathic treatment in an unexpectedly short time span, I feel compelled to disclose the statement as pure, unethical, irresponsible, and dangerous quackery.
The 5 patients with COVID-19 were hospitalized at a tertiary medical center in Jerusalem for moderate to severe
COVID-19-related symptoms. Each of them requested homeopathic treatment in addition to conventional therapy from the hospital’s ‘Center for Integrative Complementary Medicine’. All 5 patients were over 18 years old and had confirmed COVID-19 infection at the time of admission. They received their homeopathic medications as small round pills (globules); no further information about the homeopathic treatment was provided. Similarly, we also do not learn whether some patients who did not receive homeopathy recovered just as quickly (I am sure that worldwide thousands did), or whether some patients who did get homeopathic remedies failed to recover.
To make matters worse, the authors of this paper state this:
Several conclusions are evident from the cases presented:
1 homeopathy’s effect may be expected within minutes or, at most, hours;
2 contrary to classical homeopathic consultations, which may extend over an hour, correct medications for patients with acute COVID-19 symptoms may be determined in minutes;
3 there were no observable adverse effects to homeopathic treatment of COVID-19;
4 therapy can be administered via telehealth services, increasing safety of treating patients with active infection;
5 patient satisfaction was high; scoring their experience of homeopathic therapy on a 7-point scale, ranging
from “It greatly improved my condition” to “It greatly aggravated my condition,” all 5 patients indicated it
had greatly improved their condition.
The possibility that the outcomes are not causally related to the homeopathic treatment seems to have escaped the authors. The harm that can be done by such an article seems obvious: fans of homeopathy might be misled into assuming that homeopathy is an effective therapy for COVID infections and other serious conditions. It is not hard to imagine that this error would cost many lives.
The authors state in their article that, to the best of their knowledge, this is the first time that a tertiary medical center has permitted homeopathic therapy of patients under treatment for COVID-19-related illness.
I sincerely hope that it is also the last time!
On 19-30 April 2021 & 1-2 September, 2021 the Professional Conduct Committee of the General Chiropractic Council considered the case of Arleen Scholten, the chiropractor who treated John Lawler, the patient who died after her treatment. Details of the case can be found in the following posts:
- Former chiropractor fined after death of MS patient receiving hyperbaric oxygen therapy
- Death by chiropractic: thoughts about the sad case of Mr Lawler
- The death of Mr Lawler highlights the scandals of chiropractic
- Death by chiropractic neck manipulation? More details on the Lawler case
The Committee considered there had been breaches of the Code, those breaches occurred as a result of Mrs. Scholten’s state of mind at the time and not as a result of a deliberate intention on her part to be inaccurate or misleading. In light of those circumstances, the Committee considered other members of the profession and fully informed members of the public would not consider her failings to be morally reprehensible or deplorable, but rather would consider them regrettable but understandable in the exceptional, albeit tragic, circumstances of this case. The Committee, therefore, agreed with the GCC’s expert witness Mr Brown and did not think Mrs Scholten’s conduct fell far short of the standard required of a registered chiropractor. The Committee was not satisfied, therefore, that her behaviour amounted to unacceptable professional conduct. Accordingly, the Committee found the allegation of UPC not to be well-founded.
How can this be right?
To remind us of the case, here is what I wrote about it previously:
The tragic case of John Lawler who died after being treated by a chiropractor has been discussed on this blog before. Naturally, it generated much discussion which, however, left many questions unanswered. Today, I am able to answer some of them.
- Mr Lawler died because of a tear and dislocation of the C4/C5 intervertebral disc caused by considerable external force.
- The pathologist’s report also shows that the deceased’s ligaments holding the vertebrae of the upper spine in place were ossified.
- This is a common abnormality in elderly patients and limits the range of movement of the neck.
- There was no adequately informed consent by Mr Lawler.
- Mr Lawler seemed to have been under the impression that the chiropractor, who used the ‘Dr’ title, was a medical doctor.
- There is no reason to assume that the treatment of Mr Lawler’s neck would be effective for his pain located in his leg.
- The chiropractor used an ‘activator’ which applies only little and well-controlled force. However, she also employed a ‘drop table’ which applies a larger and not well-controlled force.
I have the permission to publish the submissions made to the coroner by the barrister representing the family of Mr Lawler. The barrister’s evidence shows that:
The chiropractor, Mrs. Scholten, had been accused by the GCC of unacceptable professional conduct. The exact text of the GCC reads as follows :
1. Between 31 July 2017 and 11 August 2017, you provided chiropractic care and
treatment to Patient A at Chiropractic 1st, 68 The Mount, North Yorkshire, YO24 1AR,
2. On 11 August 2017 you provided treatment to Patient A which included:
a. a drop technique applied to the thoracic spine;
b. the use of an Activator applied to the thoracic spine;
c. the use of an Activator applied to the cervical spine.
3. Following the drop technique, Patient A indicated he was in discomfort and had lost sensation in his arms and you inappropriately continued treatment.
4. During the course of a subsequent 999 telephone call:
a. you told the call handler that Patient A had laid on the adjusting table and you had used the Activator on his midback;
b. you told the call handler that when you were using the Activator on Patient A’s midback he had said his hands had gone numb;
c. you told the call handler that as Patient A was elderly you had never used any manual adjustment on Patient A;
d. you omitted to tell the call handler that you had used a drop technique on Patient A;
e. you omitted to tell the call handler that Patient A had first expressed discomfort following the drop technique;
f. you omitted to tell the call handler that you had treated Patient A’s cervical spine.
5. When paramedics arrived at the Clinic:
a. you told them words to the effect that you had manipulated Patient A’s midback with the use of an Activator;
b. you told them words to the effect that Patient A had first complained of discomfort when you had been using the Activator on his midback;
c. you omitted to tell the paramedics you had used a drop technique on Patient A;
d. you omitted to tell the paramedics that Patient A had first expressed discomfort following the drop technique;
e. you omitted to tell the paramedics that you had treated Patient A’s cervical spine;
f. you demonstrated the force applied by an Activator on one of the paramedic’s arms.
6. In Patient A’s records for 11 August 2017:
a. you recorded that you had used the Activator on Patient A’s thoracic spine at T2/3 level;
b. you recorded that Patient A had directly said his arms felt numb;
c. you omitted to record that you had used a drop technique on Patient A;
d. you omitted to record that you had treated Patient A’s cervical spine.
7. Your comments and omissions as set out above at 4 and/or 5, and/or as recorded at 6 above, were;
c. dishonest in that you intended to mislead as to the precise details of the treatment you had provided Patient A
Mr Goldring, on behalf of Mrs Scholten, indicated that the following facts were admitted: Particulars 1, 2(a), 4(a), 4(b), 4(c), 4(d), 5(a), 5(b), 5(c), 5(f), 6(a), 6(b), 6(c) and 7(a) and (b), insofar as they related to the aforementioned admitted facts. The Chair therefore announced that those matters were found proved. Later in the proceedings Mr Goldring indicated that 7(a) and 7(b) were not in fact admitted in respect of 4(c) and 6(b), since it was Mrs Scholten’s case that she had not used any manual adjustment on Patient A, (Particular 4(c)) and the record that Patient A had directly said his arms felt numb was accurate, (Particular 6(b)). Accordingly, the Chair formally announced that position.
END OF QUOTES
I am totally baffled by this ruling.
- What about the fact that the chiropractor’s treatment was not even indicated?
- What about the fact that no informed consent was obtained?
- What about the fear that the chiropractor moved her patient after the injury had happened and made an attempt of ‘mouth to mouth’ resuscitation which seems to have aggravated the injury?
- What about the fact that she misled the paramedics which then caused them not to stabilise Mr. Lawlwer’s neck?
Is the GCC truly saying that, as long as a chiropractor panics, all these mistakes can be excused? I am at a complete loss trying to understand the GCC ruling and very much hope that someone can explain it to me.
Homeopaths believe that their remedies work for every condition imaginable and that naturally includes irritable bowel syndrome (IBS). But what does the evidence show?
The aim of this pilot study was to evaluate the efficacy of individualized homeopathic treatment in patients with IBS. The study was carried out at the National Homeopathic Hospital of the Secretary of Health, Mexico City, Mexico and included 41 patients: 3 men and 38 women, mean age 54 ± 14.89 years, diagnosed with IBS as defined by the Rome IV Diagnostic criteria. Single individualized homeopathics were prescribed for each patient, taking into account all presenting symptoms, clinical history, and personality via repertorization using RADAR Homeopathic Software. The homeopathic remedies were used at the fifty-millesimal (LM) potency per the Mexican Homeopathic Pharmacopoeia starting with 0/1 and increasing every month (0/2, 0/3, 0/6). Severity scales were applied at the beginning of treatment and every month for 4 months of treatment. The evaluation was based on comparing symptom severity scales during treatment.
The results demonstrated that 100% of patients showed some improvement and 63% showed major improvement or were cured. The study showed a significant decrease in the severity of symptom scores 3 months after the treatment, with the pain score showing a decrease already one month after treatment.
The authors state that the results highlight the importance of individualized medicine regimens using LM potency, although the early decrease in pain observed could also be due to the fact that Lycopodium clavatum and Nux vomica were the main homeopathic medicine prescribed, and these medicines contain many types of alkaloids, which have shown significant analgesic effects on pain caused by physical and chemical stimulation.
Where to begin?
Let me mention just a few rather obvious points:
- A pilot study is not for evaluating the efficacy, but for testing the feasibility of a definitive trial.
- The study has no control group, therefore the outcome cannot be attributed to the treatment but is most likely due to a mixture of placebo effects, regression towards the mean, and natural history of IBS.
- The conclusions are not warranted.
- The paper was published in the infamous Altern Ther Health Med.
Just to make sure that nobody is fooled into believing that homeopathy might nonetheless be effective for IBS. Here is what the Cochrane review on this subject tells us: no firm conclusions regarding the effectiveness and safety of homeopathy for the treatment of IBS can be drawn. Further high quality, adequately powered RCTs are required to assess the efficacy and safety of clinical and individualised homeopathy for IBS compared to placebo or usual care.
In my view, even the conclusion of the Cochrane review is odd and slightly misleading. The correct conclusion would have been something more to the point:
THE CURRENT TRIAL EVIDENCE FAILS TO INDICATE THAT HOMEOPATHY IS AN EFFECTIVE TREATMENT FOR IBS.
Acupuncture is usually promoted as a safe therapy. This may be good marketing but, sadly, it is not the truth. About 10% of all patients experience mild to moderate adverse effects such as pain or bleeding. In addition, there are well-documented complications, for instance:
However, there have been few reports of deaths due to pneumothorax after acupuncture treatment, especially focused on electroacupuncture.
Japanese authors recently reported an autopsy case of a man in his 60s who went into cardiopulmonary arrest and died immediately after receiving electroacupuncture. Postmortem computed tomography (PMCT) showed bilateral pneumothoraces, as well as the presence of numerous gold threads embedded subcutaneously. An autopsy revealed two ecchymoses in the right thoracic cavity and a pinhole injury on the lower lobe of the right lung, suggesting that the needles had penetrated the lung. There were marked emphysematous changes in the lung, suggesting that rupture of bullae might also have contributed to bilateral pneumothoraces and fatal outcomes. The acupuncture needles may have been drawn deeper into the body than at the time of insertion due to electrical pulses and muscle contraction, indicating the need for careful determination of treatment indications and technical safety measures, such as fail-safe mechanisms.
This is the first case report of fatal bilateral pneumothoraces after electroacupuncture reported in the English literature. This case sheds light on the safety of electroacupuncture and the need for special care when administering it to patients with pulmonary disease who may be at a higher risk of pneumothorax. This is also the first report of three-dimensional reconstructed PMCT images showing the whole-body distribution of embedded gold acupuncture threads, which is unusual.
One-sided pneumothoraxes are common events after acupuncture. Several hundred cases have been published and the vast majority of such incidents remain unpublished or even unnoticed. These events are not normally life-threatening. If ‘only’ one lung is punctured, the patient may experience breathing difficulties, but in many cases these are temporary and the patient soon recovers.
Yet a bilateral pneumothorax is an entirely different affair. If both lungs malfunction, the patient’s chances of survival are slim unless he/she is close to an intensive care unit.
You might think that it needs an especially ungifted acupuncturist to manage to puncture both lungs simultaneously. I might agree, but we need to consider that acupuncture needles are often inserted in a symmetrical fashion into the patient’s body. This means that, if the therapist puts a needle at one point of the thorax that is close to a lung, he is not unlikely to do the same on the other side.
And how does one prevent such disasters?
- train acupuncturists properly,
- avoid needles on the upper thorax,
- or refuse acupuncture altogether.
Research on glucosamine, one of the most popular dietary supplements, shows anti-inflammatory and anti-cancer benefits with minimal adverse effects. An international team of researchers aimed to explore the relationship between the use of glucosamine and the risk of lung cancer and lung cancer mortality based on data from the large-scale nationwide prospective UK Biobank cohort study.
Participants were enrolled between the years 2006 and 2010 and followed up to 2020. The Cox proportion hazards model was used to assess the relationship between glucosamine use and the risk of lung cancer and lung cancer mortality. Subgroup analyses and sensitivity analyses were performed to explore the potential effect modifications and the robustness of the main findings.
A total of 439,393 participants (mean age: 56 years; 53% females) with a mean follow-up of 11 years were included for analyses. There were 82,603 (18.80%) participants reporting regular use of glucosamine at baseline. During follow-up, there were 1,971 (0.45%) lung cancer events documented. Glucosamine use was significantly associated with a decreased risk of lung cancer (hazard ratio=0.84, 95% CI: 0.75-0.92, p<0.001) and lung cancer mortality (hazard ratio=0.88, 95% CI: 0.81-0.96, p=0.002) in fully adjusted models. A stronger association between glucosamine use and decreased lung cancer risk was observed in participants with a family history of lung cancer when compared to those without a family history.
The authors concluded that regular use of glucosamine was significantly related with decreased risk of lung cancer and lung cancer mortality, based on data from this nationwide prospective cohort study.
A previous analysis of the same data concluded that regular glucosamine supplementation was associated with lower mortality due to all causes, cancer, CVD, respiratory and digestive diseases. The new analysis shows a strong association with lung cancer.
This is certainly interesting, but does it prove a causal relationship?
The answer is no.
Correlation is not causation!
What would be helpful in testing whether we are dealing with a cause-effect relationship?
- We need data from other studies. Several other epidemiological investigations indicated that glucosamine use might play a role in the prevention of cancer.
- We require to know the strength of the association. The new analysis suggests that it is indeed strong.
- We need a mode of action. Might the anti-inflammatory action of glucosamine explain the effect?
- We should ask whether there is a dose-response relationship. As far as I know, this has not been addressed as yet.
- Ideally, we would require a randomized trial to test the hypothesis. But I fear that such a study might be too difficult to conduct and will thus not be forthcoming.
And what if glucosamine should one day be proven to reduce the cancer risk? Would it become the first ALTERNATIVE measure to prevent cancer?
It would automatically become a conventional method of cancer prevention. All the research into the subject has been entirely conventional and is unrelated to the alternative medicine movement. Or, to put it bluntly, alternative cancer prevention is a contradiction in terms. Either it works in which case it is conventional medicine, or it doesn’t in which case it is not even an alternative but at best so-called alternative medicine.
In their 2019 systematic review of spinal manipulative therapy (SMT) for chronic back pain, Rubinstein et al included 7 studies comparing the effect of SMT with sham SMT.
They defined SMT as any hands-on treatment of the spine, including both mobilization and manipulation. Mobilizations use low-grade velocity, small or large amplitude passive movement techniques within the patient’s range of motion and control. Manipulation uses a high-velocity impulse or thrust applied to a synovial joint over a short amplitude near or at the end of the passive or physiological range of motion. Even though there is overlap, it seems fair to say that mobilization is the domain of osteopaths, while manipulation is that of chiropractors.
The researchers found:
- low-quality evidence suggesting that SMT does not result in a statistically better effect than sham SMT at one month,
- very low-quality evidence suggesting that SMT does not result in a statistically better effect than sham SMT at six and 12 months.
- low-quality evidence suggesting that, in terms of function, SMT results in a moderate to strong statistically significant and clinically better effect than sham SMT at one month. Exclusion of an extreme outlier accounted for a large percentage of the statistical heterogeneity for this outcome at this time interval (SMD −0.27, 95% confidence interval −0.52 to −0.02; participants=698; studies=7; I2=39%), resulting in a small, clinically better effect in favor of SMT.
- very low-quality evidence suggesting that, in terms of function, SMT does not result in a statistically significant better effect than sham SMT at six and 12 months.
This means that SMT has effects that are very similar to placebo (the uncertain effects on function could be interpreted as the result of residual de-blinding due to a lack of an optimal placebo or sham intervention). In turn, this means that the effects patients experience are largely or completely due to a placebo response and that SMT has no or only a negligibly small specific effect on back pain. Considering the facts that SMT is by no means risk-free and that less risky treatments exist, the inescapable conclusion is that SMT cannot be recommended as a treatment of chronic back pain.
The objective of this systematic review was to assess the effects and reliability of sham procedures in manual therapy (MT) trials in the treatment of back pain (BP) in order to provide methodological guidance for clinical trial development. Different databases were screened up to 20 August 2020. Randomised clinical trials involving adults affected by BP (cervical and lumbar), acute or chronic, were included. Hand contact sham treatment (ST) was compared with different MT (physiotherapy, chiropractic, osteopathy, massage, kinesiology, and reflexology) and to no treatment. Primary outcomes were BP improvement, the success of blinding, and adverse effect (AE). Secondary outcomes were the number of drop-outs. Dichotomous outcomes were analysed using risk ratio (RR), continuous using mean difference (MD), 95% CIs. The minimal clinically important difference was 30 mm changes in pain score.
A total of 24 trials were included involving 2019 participants. Different manual treatments were provided:
- SM/chiropractic (7 studies, 567 participants).
- Osteopathy (5 trials, 645 participants).
- Kinesiology (1 trial, 58 participants).
- Articular mobilisations (6 trials, 445 participants).
- Muscular release (5 trials, 304 participants).
Very low evidence quality suggests clinically insignificant pain improvement in favour of MT compared with ST (MD 3.86, 95% CI 3.29 to 4.43) and no differences between ST and no treatment (MD -5.84, 95% CI -20.46 to 8.78).ST reliability shows a high percentage of correct detection by participants (ranged from 46.7% to 83.5%), spinal manipulation being the most recognised technique. Low quality of evidence suggests that AE and drop-out rates were similar between ST and MT (RR AE=0.84, 95% CI 0.55 to 1.28, RR drop-outs=0.98, 95% CI 0.77 to 1.25). A similar drop-out rate was reported for no treatment (RR=0.82, 95% 0.43 to 1.55).
Forest plot of comparison ST versus MT in back pain outcome at short term. MT, manual therapy; ST, sham treatment.
The authors concluded that MT does not seem to have clinically relevant effect compared with ST. Similar effects were found with no treatment. The heterogeneousness of sham MT studies and the very low quality of evidence render uncertain these review findings. Future trials should develop reliable kinds of ST, similar to active treatment, to ensure participant blinding and to guarantee a proper sample size for the reliable detection of clinically meaningful treatment effects.
Essentially these findings suggest that the effects patients experience after MT are not due to MT per see but to placebo effects. The review could be criticised because of the somewhat odd mix of MTs lumped together in one analysis. Yet, I think it is fair to point out that most of the studies were of chiropractic and osteopathy. Thus, this review implies that chiropractic and osteopathy are essentially placebo treatments.
The authors of the review also provide this further comment:
Similar findings were found in other reviews conducted on LBP. Ruddock et al included studies where SM was compared with what authors called ‘an effective ST’, namely a credible sham manipulation that physically mimics the SM. Pooled data from four trials showed a very small and not clinically meaningful effect in favour of MT.52
Rubinstein et al 53 compared SM and mobilisation techniques to recommended, non-recommended therapies and to ST. Their findings showed that 5/47 studies included attempted to blind patients to the assigned intervention by providing an ST. Of these five trials, two were judged at unclear risk of participants blinding. The authors also questioned the need for additional studies on this argument, as during the update of their review they found recent small pragmatic studies with high risk of bias. We agree with Rubinstein et al that recent studies included in this review did not show a higher quality of evidence. The development of RCT with similar characteristic will probably not add any proof of evidence on MT and ST effectiveness.53
If we agree that chiropractic and osteopathy are placebo therapies, we might ask whether they should have a place in the management of BP. Considering the considerable risks associated with them, I feel that the answer is obvious and simple: