I would warn every parent who thinks that taking their child to a chiropractor is a good idea. For this, I have three main reasons:
- Chiropractic has not been shown to be effective for any paediatric condition.
- Chiropractors often advise parents against vaccinating their children.
- Chiropractic spinal manipulations can cause harm to kids.
The latter point seems to be confirmed by a recent PhD thesis of which so far only one short report is available. Here are the relevant bits of information from it:
Katie Pohlman has successfully defended her PhD thesis, which focused on the assessment of safety in pediatric manual therapy. As a clinical research scientist at Parker University, Dallas, Texas, she identified a lack of prospective patient safety research within the chiropractic population in general and investigated this deficit in the paediatric population in particular.
Pohlman used a cross-sectional survey to assess the barriers and facilitators for participation in a patient safety reporting system. At the same time, she also conducted a randomized controlled trial comparing the quantity and quality of adverse event reports in children under 14 years receiving chiropractic care.
The RCT recruited 69 chiropractors and found adverse events reported in 8.8% and 0.1% of active and passive surveillance groups respectively. Of the adverse events reported, 56% were considered mild, 26% were moderate and 18% were severe. The frequency of adverse events was more common than previously thought.
This last sentence from the report is somewhat puzzling. Our systematic review of the risks of spinal manipulation showed that data from prospective studies suggest that minor, transient adverse events occur in approximately half of all patients receiving spinal manipulation. The most common serious adverse events are vertebrobasilar accidents, disk herniation, and cauda equina syndrome. Estimates of the incidence of serious complications range from 1 per 2 million manipulations to 1 per 400,000. Given the popularity of spinal manipulation, its safety requires rigorous investigation.
The 8.8% reported by Pohlman are therefore not even one fifth of the average incidence figure reported previously in all age groups.
What could be the explanation for this discrepancy?
There are, of course, several possibilities, including the fact that infants cannot tell the clinician when their pain has increased. However, the most likely one, in my view, lies in the fact that RCTs are wholly inadequate for investigating risks because they typically include far too few patients to generate reliable incidence figures about adverse events. More importantly, clinicians included in such studies are self-selected (and thus particularly responsible/cautious) and are bound to behave most carefully while being part of a clinical trial. Therefore it seems possible – I would speculate even likely – that the 8.8% reported by Pohlman is unrealistically low.
Having said that, I do feel that the research by Kathie Pohlman is a step in the right direction and I do applaud her initiative.
Lumbar spinal stenosis (LSS) is a common reason for spine surgery. Several non-surgical LSS treatment options are also available, but their effectiveness remains unproven. The objective of this study was to explore the comparative clinical effectiveness of three non-surgical interventions for patients with LSS:
- medical care,
- group exercise,
- individualised exercise plus manual therapy.
All interventions were delivered during 6 weeks with follow-up at 2 months and 6 months at an outpatient research clinic. Patients older than 60 years with LSS were recruited from the general public. Eligibility required anatomical evidence of central canal and/or lateral recess stenosis (magnetic resonance imaging/computed tomography) and clinical symptoms associated with LSS (neurogenic claudication; less symptoms with flexion). Analysis was intention to treat.
Medical care consisted of medications and/or epidural injections provided by a physiatrist. Group exercise classes were supervised by fitness instructors. Manual therapy/individualized exercise consisted of spinal mobilization, stretches, and strength training provided by chiropractors and physical therapists. The primary outcomes were between-group differences at 2 months in self-reported symptoms and physical function measured by the Swiss Spinal Stenosis questionnaire (score range, 12-55) and a measure of walking capacity using the self-paced walking test (meters walked for 0 to 30 minutes).
A total of 259 participants were allocated to medical care (n = 88), group exercise (n = 84), or manual therapy/individualized exercise (n = 87). Adjusted between-group analyses at 2 months showed manual therapy/individualized exercise had greater improvement of symptoms and physical function compared with medical care or group exercise. Manual therapy/individualized exercise had a greater proportion of responders (≥30% improvement) in symptoms and physical function (20%) and walking capacity (65.3%) at 2 months compared with medical care (7.6% and 48.7%, respectively) or group exercise (3.0% and 46.2%, respectively). At 6 months, there were no between-group differences in mean outcome scores or responder rates.
The authors concluded that a combination of manual therapy/individualized exercise provides greater short-term improvement in symptoms and physical function and walking capacity than medical care or group exercises, although all 3 interventions were associated with improvements in long-term walking capacity.
In many ways, this is a fairly rigorous study; in one important way, however, it is odd. One can easily see why one group received the usual standard care (except perhaps for the fact that standard medical care should also include exercise). I also understand why one group attended group exercise. Yet, I fail to see the logic in the third intervention, individualised exercise plus manual therapy.
Individualised exercise is likely to be superior to group exercise. If the researchers wanted to test this hypothesis, they should not have added the manual therapy. If they wanted to find out whether manual therapy is better that the other two treatments, they should not have added individualised exercise. As it stands, they cannot claim that either manual therapy or individualised exercise are effective (yet, I am sure that the chiropractic fraternity will claim that this study shows their treatment to be indicated for LSS [three of the authors are chiropractors and the 1st author seems to have a commercial interest in the matter!]).
Manual therapy procedures used in this trial included:
- lumbar distraction mobilization,
- hip joint mobilization,
- side posture lumbar/sacroiliac joint mobilization,
- and neural mobilization.
Is there any good reason to assume that these interventions work for LSS? I doubt it!
And this is what makes the new study odd, in my view. Assuming I am correct in speculating that individualised exercise is better than group exercise, the trial would have yielded a similarly positive result, if the researchers had offered, instead of the manual therapy, a packet of cigarettes, a cup of tea, a chocolate bar, or swinging a dead cat. In other words, if someone had wanted to make a useless therapy appear to be effective, they could not have chosen a better trial design.
And why do I find such studies objectionable?
Mainly because they deliberately mislead many of us. In the present case, many non-critical observers might conclude that manual therapy is effective for LSS. Yet, the truth could well be that it is useless or even harmful (assuming that the effect size of individualised exercise is large, adding a harmful therapy would still render the combination effective). To put it bluntly, such trials
- could harm patients,
- might waste money,
- and hinder progress.
Benign prostate hypertrophy (BPH) affects many men aged 50 and older. It is caused by an enlargement of the prostate resulting in difficulties to urinate and to fully empty the bladder. There are several conventional treatment options, including life-style changes that are effective. In addition, a myriad of alternative therapies are being promoted, most of which are of doubtful effectiveness. Recently, a homeopathy-promoter, Dr Jens Behnke, triumphantly tweeted a trial of homeopathy for BPH allegedly proving that homeopathy does work after all. There is no conceivable reason why homeopathic remedies should have any effect on this (or any other) condition. Therefore, I decided to have a closer look at this paper.
The objective of this 5-centre, three-armed, open, randomised study was to evaluate the effectiveness of Homoeopathic Constitutional remedy (HC) and Homoeopathic Constitutional + Organ remedy (HCOM) in comparison to Placebo (PL) in patients suffering from BPH using International Prostate Symptom Score (IPSS), ultrasonographic changes in prostate volume, post-void residual urine, uroflowmetry and in WHO Quality of Life (QOL)-BREF. Patients were randomised into three groups in 2:2:1 ratio and were followed up for 6 months. The statistical analysis was done with modified intention-to-treat principle (mITT).
Of 461 patients screened, 254 patients were enrolled in the study and 241 patients were analysed as per mITT. The mean changes in IPSS and QOL due to urinary symptoms from baseline to end of study showed a positive trend in all the three groups. However, in the HC group, the changes were more prominent as compared to the other two groups. There was no difference between HC and HCOM groups and they were equally effective in terms of managing lower urinary tract symptoms due to BPH. With regard to secondary outcome, there was no difference between the groups. The psychological, social and environmental domains of WHOQOL-BREF have shown positive trend, but there was no statistically significant difference in intervention groups.
The authors concluded that statistical significance was found in the IPSS in all the three groups but only in HC and not in any of the objective parameters.
The paper is so badly written that I struggle to make sense of it. However, the above graph seems clear enough. The changes are perhaps statistically significant (which I find odd and cannot quite understand) but they are certainly not clinically relevant. Most likely, they are due to the fact that this study was not blind, meaning that patients and investigators were aware of the group allocations. This suggests to me that this study
- is dubious in more than one way,
- tests a hypothesis that lacks plausibility,
- yields a result that is clinically irrelevant.
In other words, it does not amount to anything remotely resembling a proof of homeopathy’s efficacy.
You probably know what yoga is. But what is FODMAP? It stands for fermentable oligosaccharides, disaccharides, monosaccharides and polyols, more commonly known as carbohydrates. In essence, FODMAPs are carbohydrates found in a wide range of foods including onions, garlic, mushrooms, apples, lentils, rye and milk. These sugars are poorly absorbed, pass through the small intestine and enter the colon . There they are fermented by bacteria a process that produces gas which stretches the sensitive bowel causing bloating, wind and sometimes even pain. This can also cause water to move into and out of the colon, causing diarrhoea, constipation or a combination of both. Irritable bowel syndrome (IBS) makes people more susceptible to such problems.
During a low FODMAP diet these carbohydrates are eliminated usually for six to eight weeks. Subsequently, small amounts of FODMAP foods are gradually re-introduced to find a level of symptom-free tolerance. The question is, does the low FODMAP diet work?
This study examined the effect of a yoga-based intervention vs a low FODMAP diet on patients with irritable bowel syndrome. Fifty-nine patients with IBS undertook a randomised controlled trial involving yoga or a low FODMAP diet for 12 weeks. Patients in the yoga group received two sessions weekly, while patients in the low FODMAP group received a total of three sessions of nutritional counselling. The primary outcome was a change in gastrointestinal symptoms (IBS-SSS). Secondary outcomes explored changes in quality of life (IBS-QOL), health (SF-36), perceived stress (CPSS, PSQ), body awareness (BAQ), body responsiveness (BRS) and safety of the interventions. Outcomes were examined in weeks 12 and 24 by assessors “blinded” to patients’ group allocation.
No statistically significant difference was found between the intervention groups, with regard to IBS-SSS score, at either 12 or 24 weeks. Within-group comparisons showed statistically significant effects for yoga and low FODMAP diet at both 12 and 24 weeks. Comparable within-group effects occurred for the other outcomes. One patient in each intervention group experienced serious adverse events and another, also in each group, experienced nonserious adverse events.
The authors concluded that patients with irritable bowel syndrome might benefit from yoga and a low-FODMAP diet, as both groups showed a reduction in gastrointestinal symptoms. More research on the underlying mechanisms of both interventions is warranted, as well as exploration of potential benefits from their combined use.
Technically, this study is an equivalence study comparing two interventions. Such trials only make sense, if one of the two treatments have been proven to be effective. This is, however, not the case. Moreover, equivalence studies require much larger sample sizes than the 59 patients included here.
What follows is that this trial is pure pseudoscience and the positive conclusion of this study is not warranted. The authors have, in my view, demonstrated a remarkable level of ignorance regarding clinical research. None of this is all that unusual in the realm of alternative medicine; sadly, it seems more the rule than the exception.
What might make this lack of research know-how more noteworthy is something else: starting in January 2019, one of the lead authors of this piece of pseudo-research (Prof. Dr. med. Jost Langhorst) will be the director of the new Stiftungslehrstuhl “Integrative Medizin” am Klinikum Bamberg (clinic and chair of integrative medicine in Bamberg, Germany).
This does not bode well, does it?
Carpal tunnel syndrome (CTS) is caused by the tendons in the wrist getting too tight and thus putting pressure on the nerves that run beneath them. The symptoms can include:
- pain in fingers, hand or arm,
- numb hands,
- tingling or ‘pins and needles’,
- a weak thumb or difficulty gripping.
These symptoms often start slowly and they can come and go but often get worse over time. They are usually worse at night and may keep patients from having a good night’s sleep.
The treatments advocated for CTS include painkillers, splints and just about every alternative therapy one can think of, particularly acupuncture. Acupuncture may be popular, but does it work?
This new Cochrane review was aimed at assessing the evidence for acupuncture and similar treatments for CTS. It included 12 studies with 869 participants. Ten studies reported the primary outcome of overall clinical improvement at short‐term follow‐up (3 months or less) after randomisation. Most studies could not be combined in a meta‐analysis due to heterogeneity, and all had an unclear or high overall risk of bias. Only 7 studies provided information on adverse events.
The authors (two of them are from my former Exeter team) found that, in comparison with placebo or sham-treatments, acupuncture and laser acupuncture have little or no effect in the short term on symptoms of CTS. It is uncertain whether acupuncture and related interventions are more or less effective in relieving symptoms of CTS than corticosteroid nerve blocks, oral corticosteroids, vitamin B12, ibuprofen, splints, or when added to NSAIDs plus vitamins, as the certainty of any conclusions from the evidence is low or very low and most evidence is short term. The included studies covered diverse interventions, had diverse designs, limited ethnic diversity, and clinical heterogeneity.
The authors concluded that high‐quality randomised controlled trials (RCTs) are necessary to rigorously assess the effects of acupuncture and related interventions upon symptoms of CTS. Based on moderate to very‐low certainty evidence, acupuncture was associated with no serious adverse events, or reported discomfort, pain, local paraesthesia and temporary skin bruises, but not all studies provided adverse event data.
This last point is one that I made very often: most trials of acupuncture fail to report adverse effects. This is doubtlessly unethical (it gives a false-positive overall impression about acupuncture’s safety). And what can you do with studies that are unethical? My answer is simple: bin them!
Most of the trials were of poor or very poor quality. Such studies tend to generate false-positive results. And what can you do with studies that are flimsy and misleading? My answer is simple: bin them!
So, what can we do with acupuncture trials of CTS? … I let you decide.
But binning the evidence offers little help to patients who suffer from chronic, progressive CTS. What can those patients do? Go and see a surgeon! (S)he will cure you with a relatively simply and safe operation; in all likelihood, you will never look back at dubious treatments.
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:
- Homeopathy is useless.
- CU responds to placebo treatments.
- CU gets better over time.
- Regression towards the mean has contributed to the outcome.
- Homeopaths often have no idea about clinical research.
- Further trials are not needed.
- If someone disagrees with my point 6, the sample size is less important than the inclusion of a control group.
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).
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.
Acupressure is the stimulation of acu-points by using pressure instead of needles, as in acupuncture. The evidence for or against acupressure mirrors that of acupuncture, except there is far less of it. This is why this new trial might be important.
The aim of this RCT was to determine the effect of self-acupressure on fasting blood sugar (FBS) and insulin level in type 2 diabetes patients. A total of 60 diabetic patients were selected from diabetes clinic in Rafsanjan in Iran, and assigned to 2 groups, 30 in the acupressure and 30 in the control-group. The intervention group received acupressure at ST-36, LIV-3, KD-3 and SP-6 points bilaterally for 5 minutes at each point in 10 seconds pressure and 2 seconds rest periods. Subjects in the control group received no intervention. The FBS and insulin levels were measured before and after the intervention for both groups.
There were no significant differences between the acupressure and control group regarding age, sex and level of education. The insulin level significantly increased after treatment in the acupressure group (p=0.001). There were no significant differences between the levels of insulin in study or control groups. Serum FBS level decreased significantly after intervention in the acupressure group compared to the control group (p=0.02).
The authors concluded that self-acupressure as a complementary alternative medicine can be a helpful complementary method in reducing FBS and increasing insulin levels in type 2 diabetic patients.
I do not want to go into the methodological details of this study; suffice to say that it was less than rigorous and that its findings are therefore not trustworthy (never mind the fact that the results are biologically implausible). Even if that had not been the case, a single study would certainly not be sufficient reason to reach the conclusion that acupressure is helpful to control diabetes. For that, I am sure, we would need at least half a dozen independent replications.
Like most people, I have several non-medical friends who suffer from diabetes. They would love nothing better than having a simple, safe and effective method applying pressure to their skin in order to manage their disease. If they read this paper, some of them might conclude that acupressure is the answer to their problems and use it to control their condition. One does not need all that much imagination to see that this could seriously harm them, or even cost several lives.
Acupressure might be virtually free of risks, but with a bit of ill advice, even seemingly harmless treatments can kill.
In the latest issue of ‘Simile’ (the Faculty of Homeopathy‘s newsletter), the following short article with the above title has been published. I took the liberty of copying it for you:
Members of the Faculty of Homeopathy practising in the UK have the opportunity to take part in a trial of a new homeopathic remedy for treating infant colic. An American manufacturer of homeopathic remedies has made a registration application for the new remedy to the MHRA (Medicines and Healthcare products Regulatory Agency) under the UK “National Rules” scheme. As part of its application the manufacturer is seeking at least two homeopathic doctors who would be willing to trial the product for about a year, then write a short report about using the remedy and its clinical results. If you would like to take part in the trial, further details can be obtained from …
END OF QUOTE
A homeopathic remedy for infant colic?
The British Homeopathic Association and many similar ‘professional’ organisations recommend homeopathy for infant colic: Infantile colic is a common problem in babies, especially up to around sixteen weeks of age. It is characterised by incessant crying, often inconsolable, usually in the evenings and often through the night. Having excluded underlying pathology, the standard advice given by GPs and health visitors is winding technique, Infacol or Gripe Water. These measures are often ineffective but fortunately there are a number of homeopathic medicines that may be effective. In my experience Colocynth is the most successful; alternatives are Carbo Veg, Chamomilla and Nux vomica.
SO, IT MUST BE GOOD!
But hold on, I cannot find a single clinical trial to suggest that homeopathy is effective for infant colic.
Ahhhhhhhhhhhhhhhhhhh, I see, that’s why they now want to conduct a trial!
They want to do the right thing and do some science to see whether their claims are supported by evidence.
How very laudable!
After all, the members of the Faculty of Homeopathy are doctors; they have certain ethical standards!
After all, the Faculty of Homeopathy aims to provide a high level of service to members and members of the public at all times.
Judging from the short text about the ‘homeopathy for infant colic trial’, it will involve a few (at least two) homeopaths prescribing the homeopathic remedy to patients and then writing a report. These reports will unanimously state that, after the remedy had been administered, the symptoms improved considerably. (I know this because they always do improve – with or without treatment.)
These reports will then be put together – perhaps we should call this a meta-analysis? – and the overall finding will be nice, positive and helpful for the American company.
And now, we all understand what homeopaths, more precisely the Faculty of Homeopathy, consider to be evidence.