Edzard Ernst

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

On their website, the UK ‘ROYAL COLLEGE OF CHIROPRACTORS (RCC) published a short statement regarding the safety of chiropractic. Here it is in full:

Experiencing mild or moderate adverse effects after manual therapy, such as soreness or stiffness, is relatively common, affecting up to 50% of patients. However, such ‘benign effects’ are a normal outcome and are not unique to chiropractic care.

Cases of serious adverse events, including spinal or neurological problems and strokes caused by damage to arteries in the neck, have been associated with spinal manipulation. Such events are rare with estimates ranging from 1 per 2 million manipulations to 13 per 10,000 patients; furthermore, due to the nature of the underlying evidence in relation to such events (case reports, retrospective surveys and case-control studies), it is very difficult to confirm causation (Swait and Finch, 2017).

For example, while an association between stroke caused by vertebral artery damage or ‘dissection’ (VAD) and chiropractor visits has been reported in a few case-control studies, the risk of stoke has been found to be similar after seeing a primary care physician (medical doctor). Because patients with VAD commonly present with neck pain, it is possible they seek therapy for this symptom from a range of practitioners, including chiropractors, and that the VAD has occurred spontaneously, or from some other cause, beforehand (Biller et al, 2014). This highlights the importance of ensuring careful screening for known neck artery stroke risk factors, or signs or symptoms that there is an ongoing problem, is performed prior to manual treatment of patients (Swait and Finch, 2017). Chiropractors are well trained to do this on a routine basis, and to urgently refer patients if necessary.

END OF QUOTE

The statement reads well but it might not be entirely free from conflicts of interest. Yet, in the name of accuracy, completeness and truthfulness, I take the liberty of making a few slight alterations. Here is my revised version:

Experiencing mild or moderate adverse effects after chiropractic spinal manipulations, such as pain or stiffness (usually lasting 1-3 days and strong enough to impair patients’ quality of life), is very common. In fact, it affects around 50% of all patients. 

Cases of serious adverse events, including spinal or neurological problems and strokes often caused by damage to arteries in the neck, have been reported after spinal manipulation. Such events are probably not frequent (several hundred are on record including about 100 fatalities).  But, as we have never established proper surveillance systems, nobody can tell how often they occur. Furthermore, due to our reluctance of introducing such surveillance, some of us are able to question causality.

An association between stroke caused by vertebral artery damage or ‘dissection’ (VAD) and chiropractic spinal manipulation has been reported in about 20 independent investigations. Yet one much-criticised case-control study found the risk of stoke to be similar after seeing a primary care physician (medical doctor). Because patients with VAD commonly have neck pain, it is possible they seek therapy for this symptom from chiropractors, and that the VAD has occurred spontaneously, or from some other cause, beforehand (Biller et al, 2014). Ensuring careful screening for known neck artery stroke risk factors, or signs that there is an ongoing problem would therefore be important (Swait and Finch, 2017). Sadly, no reliable screening tests exist, and neck pain (the symptom that might be indicative of VAD) continues to be one of the conditions most frequently treated by chiropractors.

I do not expect the RCC to adopt my improved version. In case I am wrong, let me state this: I am entirely free of conflicts of interest and will not charge a fee for my revision. In the interest of advancing public health, I herewith offer it for free.

According to the investigators, the primary objective this study (thanks again Dr Jens Behnke) was to evaluate the effectiveness of homoeopathic remedies in improving quality of life (QoL) of chronic urticaria (CU) patients.

The study population included patients attending the Outpatient Department of State Homoeopathic Dispensary, Ahmadpur, India. Quality of Life (QoL) questionnaire (CU-Q2oL) and average Urticaria Activity Score for 7 days (UAS7) questionnaires were filled at baseline and 3rd, 6th, 9th and 12th months. The study included both male and female patients diagnosed with CU. Eighteen homoeopathic remedies were used. The individualised prescriptions were based on the totality of each patient’s symptoms.

A total of 134 patients were screened and 70 were diagnosed with CU and enrolled in the study. The results were analysed under modified intention-to-treat approach. Significant difference was found in baseline and 12th month CU-Q2oL score. Apis mellifica (n = 10), Natrum muriaticum (n = 9), Rhus toxicodendron (n = 8) and Sulphur (n = 8) were the most frequently used remedies.

The authors concluded that homoeopathic medicines have potential to improve QoL of CU patients by reducing pruritus, intensity of wheals, swelling, nervousness, and improve sleep, mood and concentration. Further studies with more sample size are desirable.

The primary objective of this study was, I would argue, to promote the erroneous idea that homeopathy is an effective therapy. It cannot have been to evaluate its effectiveness, because for such an aim one would clearly have needed a control group. Without it, the findings are consistent with the following facts:

  1. Homeopathy is useless.
  2. CU responds to placebo treatments.
  3. CU gets better over time.
  4. Regression towards the mean has contributed to the outcome.
  5. Homeopaths often have no idea about clinical research.
  6. Further trials are not needed.
  7. If someone disagrees with my point 6, the sample size is less important than the inclusion of a control group.

An article alerted me to a new report on alternative medicine in the NHS. The report itself is so monumentally important that I cannot find it anywhere (if someone finds a link, please let us know). Behind it is our homeopathy-loving friend David Tredinnick MP, chair of the All-Party Parliamentary Group. I am sure you remember him; he is ‘perhaps the worst example of scientific illiteracy in government’. And what has David been up to now?

His new report by the All-Party Parliamentary Group for Integrated Healthcare is urging the NHS to embrace more medicine to ease the mounting burden on service provision. It claims that more patients suffer from two or more long-term health conditions than ever before, and that their number will amount to 18 million by 2025.

And the solution?

Isn’t it obvious?

David Tredinnick MP, chair of the All-Party Parliamentary Group, insists that the current approach being taken by the government is unsustainable for the long-term future of the country. “Despite positive signs that ministers are proving open to change, words must translate into reality. For some time our treasured NHS has faced threats to its financial sustainability and to common trust in the system. Multimorbidity is more apparent now in the UK than at any time in our recent history. As a trend it threatens to swamp a struggling NHS, but the good news is that many self-limiting conditions can be treated at home with the most minimal of expert intervention. Other European governments facing similar challenges have considered the benefits of exploring complementary, traditional and natural medicines. If we are to hand on our most invaluable institution to future generations, so should we.”

Hold on, this sounds familiar!

Wasn’t there something like it before?

Yes, of course, the ‘Smallwood Report‘, commissioned over a decade ago by Prince Charles. It also proclaimed that the NHS could save plenty of money, if it employed more bogus therapies. But it was so full of errors and wrong conclusions that its impact on the NHS was close to zero. At the time, I concluded that the ‘Smallwood report’ is one of the strangest examples of an attempt to review CAM that I have ever seen. One gets the impression that its conclusions were written before the authors had searched for evidence that might match them. Both Mr Smallwood and the ‘Freshminds’ team told me that they understand neither health care nor CAM. Mr Smallwood stressed that this is positive as it prevents him from being ‘accused of bias’. My response was that ‘severely flawed research methodology almost inevitably leads to bias’.

And which other European countries might the Tory Brexiter David refer to?

Not Spain?

Not France?

Not Austria?

Not Germany?

Sadly, I have not seen Tredinnick’s  new oeuvre and do not know its precise content. What I do know, however, that the evidence, for alternative medicine’s cost effectiveness has not improved; if anything, it has become more negative. From that, one can safely conclude that Tredinnick’s notions of NHS-savings through more use of alternative medicine are erroneous. Therefore, I suspect the new report will swiftly and deservedly go the same way as its predecessor, the ‘Smallwood Report’: straight into the bins of Westminster.

The most frequent of all potentially serious adverse events of acupuncture is pneumothorax. It happens when an acupuncture needle penetrates the lungs which subsequently deflate. The pulmonary collapse can be partial or complete as well as one or two sided. This new case-report shows just how serious a pneumothorax can be.

A 52-year-old man underwent acupuncture and cupping treatment at an illegal Chinese medicine clinic for neck and back discomfort. Multiple 0.25 mm × 75 mm needles were utilized and the acupuncture points were located in the middle and on both sides of the upper back and the middle of the lower back. He was admitted to hospital with severe dyspnoea about 30 hours later. On admission, the patient was lucid, was gasping, had apnoea and low respiratory murmur, accompanied by some wheeze in both sides of the lungs. Because of the respiratory difficulty, the patient could hardly speak. After primary physical examination, he was suspected of having a foreign body airway obstruction. Around 30 minutes after admission, the patient suddenly became unconscious and died despite attempts of cardiopulmonary resuscitation.

Whole-body post-mortem computed tomography of the victim revealed the collapse of the both lungs and mediastinal compression, which were also confirmed by autopsy. More than 20 pinprick injuries were found on the skin of the upper and lower back in which multiple pinpricks were located on the body surface projection of the lungs. The cause of death was determined as acute respiratory and circulatory failure due to acupuncture-induced bilateral tension pneumothorax.

The authors caution that acupuncture-induced tension pneumothorax is rare and should be recognized by forensic pathologists. Postmortem computed tomography can be used to detect and accurately evaluate the severity of pneumothorax before autopsy and can play a supporting role in determining the cause of death.

The authors mention that pneumothorax is the most frequent but by no means the only serious complication of acupuncture. Other adverse events include:

  • central nervous system injury,
  • infection,
  • epidural haematoma,
  • subarachnoid haemorrhage,
  • cardiac tamponade,
  • gallbladder perforation,
  • hepatitis.

No other possible lung diseases that may lead to bilateral spontaneous pneumothorax were found. The needles used in the case left tiny perforations in the victim’s lungs. A small amount of air continued to slowly enter the chest cavities over a long period. The victim possibly tolerated the mild discomfort and did not pay attention when early symptoms appeared. It took 30 hours to develop into symptoms of a severe pneumothorax, and then the victim was sent to the hospital. There he was misdiagnosed, not adequately treated and thus died. I applaud the authors for nevertheless publishing this case-report.

This case occurred in China. Acupuncturists might argue that such things would not happen in Western countries where acupuncturists are fully trained and aware of the danger. They would be mistaken – and alarmingly, there is no surveillance system that could tell us how often serious complications occur.

The Spanish Ministries of Health and Sciences have announced their ‘Health Protection Plan against Pseudotherapies’. Very wisely, they have included chiropractic under this umbrella. To a large degree, this is the result of Spanish sceptics pointing out that alternative therapies are a danger to public health, helped perhaps a tiny bit also by the publication of two of my books (see here and here) in Spanish. Unsurprisingly, such delelopments alarm Spanish chiropractors who fear for their livelihoods. A quickly-written statement of the AEQ (Spanish Chiropractic Association) is aimed at averting the blow. It makes the following 11 points (my comments are below):

1. The World Health Organization (WHO) defines chiropractic as a healthcare profession. It is independent of any other health profession and it is neither a therapy nor a pseudotherapy.

2. Chiropractic is statutorily recognised as a healthcare profession in many European countries including Portugal, France, Italy, Switzerland, Belgium, Denmark, Sweden, Norway and the United Kingdom10, as well as in the USA, Canada and Australia, to name a few.

3. Chiropractic members of the AEQ undergo university-level training of at least 5 years full-time (300 ECTS points). Chiropractic training is offered within prestigious institutions such as the Medical Colleges of the University of Zurich and the University of Southern Denmark.

4. Chiropractors are spinal health care experts. Chiropractors practice evidence-based, patient-centred conservative interventions, which include spinal manipulation, exercise prescription, patient education and lifestyle advice.

5. The use of these interventions for the treatment of spine-related disorders is consistent with guidelines and is supported by high quality scientific evidence, including multiple systematic reviews undertaken by the prestigious Cochrane collaboration15, 16, 17.

6. The Global Burden of Disease study shows that spinal disorders are the leading cause of years lived with disability worldwide, exceeding depression, breast cancer and diabetes.

7. Interventions used by chiropractors are recommended in the 2018 Low Back Pain series of articles published in The Lancet and clinical practice guidelines from Denmark, Canada, the European Spine Journal, American College of Physicians and the Global Spine Care Initiative.

8. The AEQ supports and promotes scientific research, providing funding and resources for the development of high quality research in collaboration with institutions of high repute, such as Fundación Jiménez Díaz and the University of Alcalá de Henares.

9. The AEQ strenuously promotes among its members the practice of evidence-based, patient-centred care, consistent with a biopsychosocial model of health.

10. The AEQ demands the highest standards of practice and professional ethics, by implementing among its members the Quality Standard UNE-EN 16224 “Healthcare provision by chiropractors”, issued by the European Committee of Normalisation and ratified by AENOR.

11. The AEQ urges the Spanish Government to regulate chiropractic as a healthcare profession. Without such legislation, citizens of Spain cannot be assured that they are protected from unqualified practitioners and will continue to face legal uncertainties and barriers to access an essential, high-quality, evidence-based healthcare service.

END OF QUOTE

I think that some comments might be in order (they follow the numbering of the AEQ):

  1. The WHO is the last organisation I would consult for information on alternative medicine; during recent years, they have published mainly nonsense on this subject. How about asking the inventor of chiropractic? D.D. Palmer defined it as “a science of healing without drugs.” Chiropractors nowadays prefer to be defined as a profession which has the advantage that one cannot easily pin them down for doing mainly spinal manipulation; if one does, they indignantly respond “but we also use many other interventions, like life-style advice, for instance, and nobody can claim this to be nonsense” (see also point 4 below).
  2. Perfect use of a classical fallacy: appeal to authority.
  3. Appeal to authority, plus ignorance of the fact that teaching nonsense even at the highest level must result in nonsense.
  4. This is an ingenious mix of misleading arguments and lies: most chiros pride themselves of treating also non-spinal conditions. Very few interventions used by chiros are evidence-based. Exercise prescription, patient education and lifestyle advice are hardy typical for chiros and can all be obtained more authoratively from other healthcare professionals.
  5. Plenty of porkies here too. For instance, the AEQ cite three Cochrane reviews. The first concluded that high-quality evidence suggests that there is no clinically relevant difference between SMT and other interventions for reducing pain and improving function in patients with chronic low-back pain. The second stated that combined chiropractic interventions slightly improved pain and disability in the short term and pain in the medium term for acute/subacute LBP. However, there is currently no evidence that supports or refutes that these interventions provide a clinically meaningful difference for pain or disability in people with LBP when compared to other interventions. And the third concluded that, although support can be found for use of thoracic manipulation versus control for neck pain, function and QoL, results for cervical manipulation and mobilisation versus control are few and diverse. Publication bias cannot be ruled out. Research designed to protect against various biases is needed. Findings suggest that manipulation and mobilisation present similar results for every outcome at immediate/short/intermediate-term follow-up. Multiple cervical manipulation sessions may provide better pain relief and functional improvement than certain medications at immediate/intermediate/long-term follow-up. Since the risk of rare but serious adverse events for manipulation exists, further high-quality research focusing on mobilisation and comparing mobilisation or manipulation versus other treatment options is needed to guide clinicians in their optimal treatment choices. Hardly the positive endorsement implied by the AEQ!
  6. Yes, but that is not an argument for chiropractic; in fact, it’s another fallacy.
  7. Did they forget the many guidelines, institutions and articles that do NOT recommend chiropractic?
  8. I believe the cigarette industry also sponsors research; should we therefore all start smoking?
  9. I truly doubt that the AEQ strenuously promotes among its members the practice of evidence-based healthcare; if they did, they would have to discourage spinal manipulation!
  10. The ‘highest standards of practice and professional ethics’ are clearly not compatible with chiropractors’ use of spinal manipulation. In our recent book, we explained in full detail why this is so.
  11. An essential, high-quality, evidence-based healthcare service? Chiropractic is certainly not essential, rarely high-quality, and clearly not evidence-based.

Nice try AEQ.

But not good enough, I am afraid.

Many chiropractors tell new mothers that their child needs chiropractic adjustments because the birth is in their view a trauma for the new-born that causes subluxations of the baby’s spine. Without expert chiropractic intervention, they claim, the poor child risks serious developmental disorders.

This article (one of hundreds) explains it well: Birth trauma is often overlooked by doctors as the cause of chronic problems, and over time, as the child grows, it becomes a thought less considered. But the truth is that birth trauma is real, and the impact it can have on a mother or child needs to be addressed. Psychological therapy, physical therapy, chiropractic care, acupuncture, and other healing techniques should all be considered following an extremely difficult birth.

And another article makes it quite clear what intervention is required: Caesarian section or a delivery that required forceps or vacuum extraction procedures, in-utero constraint, an unusual presentation of the baby, and many more can cause an individual segment of the spine or a region to shift from its normal healthy alignment. This ‘shift’ in the spine is called a Subluxation, and it can happen immediately before, during, or after birth.

Thousands of advertisements try to persuade mothers to take their new-born babies to a chiropractor to get the problem sorted which chiropractors often call KISS (kinetic imbalance due to suboccipital strain-syndrome), caused by intrauterine-constraint or the traumas of birth.

This abundance of advertisements and promotional articles is in sharp contrast with the paucity of scientific evidence.

A review of 1993 concluded that birth trauma remains an underpublicized and, therefore, an undertreated problem. There is a need for further documentation and especially more studies directed toward prevention. In the meantime, manual treatment of birth trauma injuries to the neuromusculoskeletal system could be beneficial to many patients not now receiving such treatment, and it is well within the means of current practice in chiropractic and manual medicine.

A more critical assessment of … concluded that, given the absence of evidence of beneficial effects of spinal manipulation in infants and in view of its potential risks, manual therapy, chiropractic and osteopathy should not be used in infants with the kinetic imbalance due to suboccipital strain-syndrome, except within the context of randomised double-blind controlled trials.

So, what follows from all this?

How about this?

Chiropractors’ assumption of an obligatory birth trauma that causes subluxation and requires spinal adjustments is nothing more than a ploy by charlatans for filling their pockets with the cash of gullible parents.

It is time, I think, to express my gratitude to Dr Jens Behnke, a German homeopath employed by the pro-homeopathy lobby group the ‘Carstens Stiftung’, who diligently tweets trials of homeopathy which he obviously believes prove the value of his convictions.

The primary objective of this new study was to evaluate the efficacy of homoeopathy for women suffering from polycystic ovary syndrome. This condition is characterised by:

  • irregular periods which means your ovaries don’t regularly release eggs,
  • abnormally high levels of male hormones in the body, which may cause physical signs such as excess facial or body hair,
  • polycystic ovaries – ovaries become enlarged and contain many fluid-filled sacs (follicles) which surround the eggs.

There’s no cure for PCOS, but the symptoms can usually be treated. As so often in such situations, homeopaths are happy to step into the fray.

This single-blind, randomised, placebo-controlled pilot study was conducted at two research centres in India. The cases fulfilling the eligibility criteria were enrolled (n = 60) and randomised to either the homoeopathic intervention (HI) (n = 30) or placebo (P) (n = 30) with uniform lifestyle modification (LSM) for 6 months.

The menstrual regularity with improvement in other signs/symptoms was observed in 60% of the cases (n = 18) in HI + LSM group and none (n = 0) in control group. Statistically significant difference was observed in the reduction of intermenstrual duration in HI + LSM in comparison to placebo + LSM group. Significant improvements were also observed in HI+LSM group in domains of weight, fertility, emotions and menstrual problems. No change was observed in respect of improvement in the ultrasound findings. Pulsatilla was the most frequently indicated homeopathic remedy.

The authors concluded that HI along with LSM has shown promising outcome; further comparative study with standard conventional treatment on adequate sample size is desirable.

This trial might convince believers (mostly because they do not even need convincing), but it cannot convince anybody capable of critical thinking. Here is why:

  • According to its authors, this trial was a pilot study; this means it should not report any results and merely focus on the feasibility of a definitive trial.
  • Researchers were not blinded, meaning that they might have influenced the outcome in more than one way.
  • The primary endpoint was subjective and could have been influenced by the non-blinded researchers.
  • 0% success rate in achieving the primary endpoint in the placebo group is not plausible.
  • Compliance to LSM was not checked; as the homeopathy group lost more weight, these patients seemed to have complied better (probably due to being better motivated by the non-blinded researchers).

So?

My conclusion is not very original but all the more true: POORLY DESIGNED STUDIES USUALLY GENERATE UNRELIABLE RESULTS. 

A pain in the neck is just that: A PAIN IN THE NECK! Unfortunately, this symptom is both common and often difficult to treat. Chiropractors pride themselves of treating neck pain effectively. Yet, the evidence is at best thin, the costs are high and, as often-discussed, the risks might be considerable. Thus, any inexpensive, effective and safe alternative would be welcome.

This RCT  tested two hypotheses:

1) that denneroll cervical traction (a very simple device for the rehabilitation of sagittal cervical alignment) will improve the sagittal alignment of the cervical spine.

2) that restoration of normal cervical sagittal alignment will improve both short and long-term outcomes in cervical myofascial pain syndrome patients.

The study included 120 (76 males) patients with chronic myofascial cervical pain syndrome (CMCPS) and defined cervical sagittal posture abnormalities. They were randomly assigned to the control or an intervention group. Both groups received the Integrated neuromuscular inhibition technique (INIT); additionally, the intervention group received the denneroll cervical traction device. Alignment outcomes included two measures of sagittal posture: cervical angle (CV), and shoulder angle (SH). Patient relevant outcome measures included: neck pain intensity (NRS), neck disability (NDI), pressure pain thresholds (PPT), cervical range of motion using the CROM. Measures were assessed at three intervals: baseline, 10 weeks, and 1 year after the 10 week follow up.

After 10 weeks of treatment, between group statistical analysis, showed equal improvements for both the intervention and control groups in NRS and NDI. However, at 10 weeks, there were significant differences between groups favouring the intervention group for PPT and all measures of CROM. Additionally, at 10 weeks the sagittal alignment variables showed significant differences favouring the intervention group for CV and SH indicating improved CSA. Importantly, at the 1-year follow-up, between group analysis identified a regression back to baseline values for the control group for the non-significant group differences (NRS and NDI) at the 10-week mark. Thus, all variables were significantly different between groups favouring the intervention group at 1-year follow up.

The authors concluded that the addition of the denneroll cervical orthotic to a multimodal program positively affected CMCPS outcomes at long term follow up. We speculate the improved sagittal cervical posture alignment outcomes contributed to our findings.

Yes, I know, this study is far from rigorous or conclusive. And the evidence for traction is largely negative. But the device has one huge advantage over chiropractic: it cannot cause much harm. The harm to the wallet is less than that of endless sessions chiropractors or other manual therapists (conceivably, a self-made cushion will have similar effects without any expense); and the chances that patients suffer a stroke are close to zero.

I have repeatedly discussed the risks of chiropractic manipulation. Sadly, when doing so, we have to rely mostly on case reports (there is no monitoring system that would record such events, reliable incidence figures are therefore not available). This means every new case report is of considerable importance.

Korean neurosurgeons recently reported the case of a patient who had an infarction of the posterior inferior cerebellar artery (PICA) after a chiropractic cervical manipulation. A 39-year-old man visited the emergency room with signs of cerebellar dysfunction, presenting with a 6-hour history of vertigo and imbalance. Two weeks before, he had been treated by a chiropractor for intermittent neck pain. At the time of admission, brain computed tomography, magnetic resonance imaging, and angiography revealed an acute infarction in the left PICA territory and occlusion of the extracranial vertebral artery (VA; V1/2 junction) as a result of a dissection of the VA. Angiography revealed complete occlusion of the left PICA and arterial dissection was shown in the extracranial portion of the VA. The patient was treated with antiplatelet therapy. Three weeks later, he was discharged without any sequelae.

The authors concluded that the possibility of VA dissection should be considered at least once in patients presenting with cerebellar dysfunctions with a recent history of chiropractic cervical manipulation.

In the discussion section, the authors leave little doubt about the question of causality: damage to the V3 portion is the most common injury that may occur after chiropractic manipulation related to anatomical structures. The VA is located horizontally in a groove in the upper side of the atlas’ posterior arch. During abruptly forced neck rotation and stretching, the gap between the atlas and the atlanto-occipital membrane, which the VA penetrates, can be stretched, resulting in dissection. In our case, it appeared that the V1/2 junction had been dissected due to excessive lateral bending of the neck, thought to be caused by an impact to the left transverse foramen of the sixth cervical spine, through which the left VA passes. It is presumed that there was a mechanical injury to the vessel wall at the time of the procedure, which caused dissection and then the thrombus generated, and two weeks after small emboli caused the occlusion of PICA. Low-speed, high-amplitude manipulations that consist of a series of smooth, repetitive movements are configured in certain areas of the neck, and this does not often cause damage. However, a sudden thrust or high-speed, low-amplitude manipulation is often considered the cause of VA dissection. In particular, this type of manipulation can be theorized to result in a sudden, symmetrical rotation of the extended cervical vertebrae, leading to damage to the high cervical and proximal parts of the carotid artery and VA.

It is high time, I think, that chiropractors take such events seriously. At the very minimum, we need a system of monitoring such cases, so that – eventually – we will be able to define their frequency. In this context, it is obviously important to remember that there is precious little evidence to suggest that neck manipulations are effective for any condition. What inescapably follows is clear: until we have reliable incidence data, it is wise to avoid chiropractic neck manipulations altogether.

For some researchers, the question whether homeopathy works beyond a placebo effect is not as relevant as the question whether it works as well as an established treatment. To answer it, they must conduct RCTs comparing homeopathy with a therapy that has been shown beyond reasonable doubt to be effective, i.e better than placebo. Such a drug is, for instance, Ibuprofen.

The purpose of this study was to compare the efficacy of Ibuprofen and homeopathic Belladonna for orthodontic pain. 51 females and 21 males, were included in this study. Cases with non-extraction treatment plan having proper contacts’ mesial and distal to permanent first molar and currently not taking any analgesics or antibiotics were included in the study. They were randomly divided into two groups; one group was assigned to ibuprofen 400 mg and second group took Belladonna 6C (that’s a dilution of 1: 1000000000000). Patients were given two doses of medication of their respective remedies one hour before placement of elastomeric separators (Ormco Separators, Ormco Corporation, CA, USA) and one dose 6 h after the placement. Pain scores were recorded on a visual analogue scale (VAS) 2 h after placement, 6 h after placement, bedtime, day 1 morning, day 2 morning, day 3 morning and day 5 morning.

The comparisons showed that there were no differences between the two groups at any time point.

(Mean visual analogue scale pain score at different time intervals after separator placement in Ibuprofen and Belladonna group)

The authors concluded that Ibuprofen and Belladonna 6C are effective and provide adequate analgesia with no statistically significant difference. Lack of adverse effects with Belladonna 6C makes it an effective and viable alternative.

FINALLY, THE PROOF HOMEOPATHS HAVE BEEN WAITING FOR: HOMEOPATHY DOES WORK AFTER ALL!

Not so fast – before we draw any conclusions, let’s have a closer look at this study. Here are a few of its limitations (apart from the fact that it was published in a journal that does not exactly belong to the ‘crème de la crème’ of medical publications):

  • Patients obviously knew which group they were assigned to; thus their expectations would have influenced the outcome.
  • The same applies to the researchers (the study could have been ‘blind’ using a ‘double dummy’ method, but the researchers did not use it).
  • The study was an equivalence trial (it did not test whether homeopathy is superior to placebo, but whether its effects are equivalent to Ibuprofen); such studies need sample sizes that are about one dimension larger than was the case here.

Therefore, all this trial does demonstrate that the sample was too small for an existing group difference in favour of Ibuprofen to show.

So sorry, my homeopathic friends!

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