We have repeatedly discussed the risks of chiropractic spinal manipulation (see, for instance here, here and here). Some chiropractors seem to believe that using a hand-held manipulator, called ‘activator’, better controls the forces used on the spine and therefore is safer. This recent paper raises doubts on this hypothesis.
A neurosurgeon from Florida published the case-report of a 75-year-old active woman who presented to a local hospital emergency room with a 3-day history of the acute onset of severe left temporal headache, initially self-treated with non-steroidals, to which they were resistant. Additional complaints included some vague right eye blurring of vision and a mild speech disturbance. Her primary-care physician had ordered an outpatient MRI, which was interpreted as showing a small sub-acute left posterior temporal lobe haemorrhage. He then referred her to the emergency room where she was categorized as a “stroke alert” and evaluated according to the hospital “stroke-alert” protocol.
There was no prior history of migraine, but some mild treated hypertension. The patient subsequently gave a history of chronic neck and back pain, but no headache, for which she had intermittently received chiropractic adjustments. Her current problem started after an activator treatment to the base of the left side at the junction of the skull with the upper cervical spine. She became concerned enough a few days later, because of the persistence of unremitting headache, to contact her primary-care physician. The patient was not taking any anticoagulants or antiplatelet agents and had a relatively unremarkable past medical and surgical history. Although she did not have a formal visual field examination or an ophthalmology consultation, she was found to have an incomplete right homonymous hemi-anopsia on clinical exam by the neurologist.
Based on MRI characteristics, the haemorrhage was determined to be primarily subarachnoid and displacing but not involving any brain parenchyma, and without any extra-axial component. After a 4-day hospitalization for evaluation and observation, the patient was discharged, neurologically improved in terms of visual and speech symptoms as well as headache complaints, to outpatient follow-up. She has remained well with resolution of imaging abnormalities and no reoccurrence of symptoms.
The authors explain how difficult it is to prove specific causation in such cases. It is frequently inferred by epidemiological reasoning or evidence. While there are other potential causes of the haemorrhage that occurred in this case, none is as or more likely than the activator stimulus. In support of the activator as the cause of the haemorrhage, the symptoms began almost immediately after the activator treatment (a temporal relationship), the area to which the activator was applied is almost directly superficial to the area of haemorrhage (a spatial relationship), the anatomic location of this haemorrhage is statistically unusual for any underlying and/or preexisting conditions, including stroke. The MRI confirmed that there was no infarction underlying the area of haemorrhage. The MRA disclosed no dissections or vascular lesions present. The only mechanisms left are trauma or cryptic vascular lesion that ruptured, obliterated itself, and occurred coincident to the activator stimulus. Although Activator stimulus is not high energy, it nonetheless was targeted to the cervico-occipital junction, an area where neural tissue is among the most vulnerable and least protected and closest to the skin (as opposed to the lower cervical or any of the thoracic or lumbar spine). There are many articles that make reference to minor or trivial head injury as a likely cause of intracranial haemorrhage.
The author concluded that he was unable to find a single documented case in which a brain hemorrhage in any location was reported from activator treatment. As such, this case appears to represent the first well-documented and reported brain hemorrhage plausibly a consequence of activator treatment. In the absence of any relevant information in the chiropractic or medical literature regarding cerebral hemorrhage as a consequence of activator treatment, this case should be instructive to the clinician who is faced with a diagnostic dilemma and should not forget to inquire about activator treatment as a potential cause of this complication. Our case had a benign course, but we do not rule out a more serious or potentially dangerous clinical course or adverse outcome. This is of heightened concern in the elderly and/or those with treatment-induced coagulopathy or platelet inhibition.
In light of all of the difficulties inherent in linking chiropractic treatments, including activator treatments, with serious neurological events, it is very possible that intracranial hemorrhage is far more frequent than reported. Several articles comment on the likelihood that complications of this type are almost certainly underreported. Most of the incidents mentioned in case series or surveys had never been previously reported. Neurologists, neurosurgeons, and chiropractors should be more vigilant both in the application and evaluation of these methods in all patients who report new neurologic-type symptoms following a manipulation (including an activator application) to the occiput or the cranio-cervical junction.
I think that case-report speaks for itself.
Chiropractors will, of course, argue (yet again) that:
- conventional treatments cause much more harm,
- spinal manipulation is highly effective,
- such complications are extreme rarities,
- the risk/benefit profile of spinal manipulation is positive,
- some studies have failed to show a risk of spinal manipulation,
- case-reports cannot establish causality.
We have rehearsed these arguments ad nauseam on this blog. The bottom line is well-expressed in the above conclusions: it is very possible that intracranial hemorrhage is far more frequent than reported. And that obviously applies to all other types of complications after chiropractic treatments.
Acupuncture is often recommended as a treatment for shoulder pain, but its effectiveness is far from proven. A new study has just been published; but does it change this uncertainty?
A total of 227 patients with subacromial pain syndrome were recruited to this RCT. The patients were allocated to three groups who received either A) group exercise, B) group exercise plus acupuncture or C) group exercise plus electro-acupuncture. The primary outcome measure was the Oxford Shoulder Score. Follow-up was post treatment, and at 6 and 12 months. Data were analysed on intention-to-treat principles with imputation of missing values.
Treatment groups were similar at baseline. All treatment groups demonstrated improvements over time. Between-group estimates were, however, small and non-significant.
The authors concluded that neither acupuncture nor electro-acupuncture were found to be more beneficial than exercise alone in the treatment of subacromial pain syndrome.
Well, that was to be expected!… I hear the rationalists amongst us exclaim.
Actually, I am not so sure.
One could easily have expected that the acupuncture groups (B and C) show a significant advantage over group A.
Because acupuncture is a ‘theatrical placebo’, a ritual that impresses patients and thus impacts on results, particularly on subjective outcomes like pain. If the results had shown a benefit for acupuncture + exercise (groups B and C) versus exercise alone (group A), what would we have made of it? Acupuncture fans would surely have claimed that it is evidence confirming acupuncture’s effectiveness. Sceptics, on the other hand, would have rightly insisted that it demonstrates nothing of the sort – it merely confirms that placebo effects can affect clinical outcomes such as pain.
As it turned out, however, this trial results happened to indicate that these placebo-effects can be so small that they fail to reach the level of statistical significance.
I think there is one noteworthy message here: RCTs with such a design (no adequate control for placebo effects) can easily generate false-positive results (in this case, this did not happen, but it was nevertheless a possible outcome). Such studies are popular but utterly useless: they don’t advance our knowledge one single iota. If that is so, we should not waste our resources on them because, in the final analysis, this is not ethical. In other words, we must stop funding research that has little or no chance of advancing our knowledge.
This new RCT was embargoed until today; so, I had to wait until I was able to publish my comments. Here are the essentials of the study:
The Swedish investigators compared the effect of two types of acupuncture versus no acupuncture in infants with colic in public child health centres (CHCs). The study was designed as a multicentre, randomised controlled, single-blind, three-armed trial (ACU-COL) comparing two styles of acupuncture with no acupuncture, as an adjunct to standard care. Among 426 infants whose parents sought help for colic and registered their child’s fussing/crying in a diary, 157 fulfilled the criteria for colic and 147 started the intervention.
Parallel to usual care, study participants visited the study CHC twice a week for 2 weeks. Thus, all infants received usual care plus 4 extra visits to a CHC, during which parents met a nurse for 20–30 min and were able to discuss their infant’s symptoms. Together these were considered to represent gold standard care. The nurse listened, and gave evidence-based advice and calming reassurance. Breastfeeding mothers were encouraged to continue breastfeeding. At each visit, the study nurse carried the infant to a separate treatment room where they were left alone with the acupuncturist for 5 min.
The acupuncturist treated the baby according to group allocation and recorded the treatment procedures and any adverse events. Disposable stainless steel 0.20×13 mm Vinco needles (Helio, Jiangsu Province, China) were used. Infants allocated to group A received standardised MA at LI4. One needle was inserted to a depth of approximately 3 mm unilaterally for 2–5 s and then withdrawn without stimulation. Infants allocated to group B received semi-standardised individualised acupuncture, mimicking clinical TCM practice. Following a manual, the acupuncturists were able to choose one point, or any combination of Sifeng, LI4 and ST36, depending on the infant’s symptoms, as reported in the diary. A maximum of five insertions were allowed per treatment. Needling at Sifeng consisted of 4 insertions, each to a depth of approximately 1 mm for 1 s. At LI4 and ST36, needles were inserted to a depth of approximately 3 mm, uni- or bilaterally. Needles could be retained for 30 seconds. De qi was not sought, therefore stimulation was similarly minimal in groups A and B. Infants in group C spent 5 min alone with the acupuncturist without receiving acupuncture.
The effect of the two types of acupuncture was similar and both were superior to gold standard care alone. Relative to baseline, there was a greater relative reduction in time spent crying and colicky crying by the second intervention week (p=0.050) and follow-up period (p=0.031), respectively, in infants receiving either type of acupuncture. More infants receiving acupuncture cried <3 hours/day, and thereby no longer fulfilled criteria for colic, in the first (p=0.040) and second (p=0.006) intervention weeks. No serious adverse events were reported.
The authors concluded that acupuncture appears to reduce crying in infants with colic safely.
Notice that the investigators are cautious and state in the abstract that “acupuncture appears to reduce crying…” Their conclusions from the actual article are, however, quite different; here they state the following:
Among those initially experiencing excessive infant crying, the majority of parents reported normal values once the infant’s crying had been evaluated in a diary and a diet free of cow’s milk had been introduced. Therefore, objective measurement of crying and exclusion of cow’s milk protein are recommended as first steps, to avoid unnecessary treatment. For those infants that continue to cry >3 hours/day, acupuncture may be an effective treatment option. The two styles of MA tested in ACU-COL had similar effects; both reduced crying in infants with colic and had no serious side effects. However, there is a need for further research to find the optimal needling locations, stimulation and treatment intervals.
Such phraseology is much more assertive and seems to assume acupuncture caused specific therapeutic effects. Yet, I think, this assumption is not warranted.
In fact, I believe, the study shows almost the opposite of what the authors conclude. Both minimal and TCM acupuncture seemed to reduce the symptoms of colic compared to no acupuncture at all. I think, this confirms previous research showing that acupuncture is a ‘theatrical placebo’. The study was designed without an adequate placebo group. It would have been easy to use some form of sham acupuncture in the control group. Why did the authors not do that? Heaven knows, but one might speculate that they were aiming for a positive result – and what better way to ensure it than with a ‘no treatment’ control group?
There are, of course, numerous other flaws. For instance, Prof David Colquhoun FRS, Professor of Pharmacology at University College London, criticised the study because of its lousy statistics:
START OF QUOTE
“It is truly astonishing that, in the 21st century, the BMJ still publishes a journal devoted to a form of pre-scientific medicine which after more than 3000 trials has still not been able to produce convincing evidence of efficacy1. Like most forms of alternative medicine, acupuncture has been advocated for a vast range of problems, and there is little evidence that it works for any of them. Colic has not been prominent in these claims. What parent would think that sticking needles into their baby would stop it crying? The idea sounds bizarre. It is. This paper certainly doesn’t show that it works.
“The statistical analysis in the paper is incompetent. This should have been detected by the referees, but wasn’t. For a start, the opening statement, ‘A two-sided P value ≤0.05 was considered statistically significant’ is simply unacceptable in the light of all recent work about reproducibility. Still worse, Table 1 uses the description ‘statistical tendency towards significance (p=0.051–0.1)’.
“Worst of all, Table 1 reports 24 different P values, of which three are (just) below 0.05. Yet no correction has been used for multiple comparisons. This is very bad practice. It’s highly unlikely that, if the proper correction had been done, any of the results would have given a type 1 error rate below 5%.
“Even were it not for this, most of the ‘significant’ P values are marginal (only slightly less than 0.05). It is now well known that the type 1 error rate gives an optimistic view. What matters is the false positive rate – the chance that a ‘significant’ result is a false positive. A p-value close to 0.05 implies that there is at least a 30% chance that they are false positives. If one thought, a priori, that the chance of colic being cured by sticking needles into a baby was less than 50%, the false positive rate could easily be greater than 80%2. It is now recognised that this misinterpretation of p-values is a major contributor to the crisis of reproducibility.
“Other problems concern the power calculation. A priori calculations of power are well-known to be overoptimistic, because small trials usually overestimate the effect size. In this case the initial estimated sample size was not attained, and a rather mysterious recalculation of power was used.
“Another small problem: the discussion points out that ‘the majority of infants in this cohort did not have colic’.
“The nature of the control group is not very clear. An appropriate control might have been to cuddle the baby – this was used in a study in which another implausible treatment, chiropractic, was shown not to work. This appears not to have been done.
“Lastly, p-values are reported in the text without mention of effect sizes. This is contrary to all statistical advice.
“In conclusion, the design of the trial is reasonable (apart from the control group) but the statistical analysis is appalling. It’s very likely that there aren’t any real effects of acupuncture at all. This paper serves more to muddy the waters than to add useful information. It’s a model for the sort of mistakes that have led to the crisis in reproducibility. The BMJ should not be publishing this sort of stuff, and the referees seem to have no understanding of statistics.”
END OF QUOTE
Despite these rather obvious – some would say fatal – flaws, the editor of ACUPUNCTURE IN MEDICINE (AIM) thought this trial to be so impressively rigorous that he issued a press-release about it. This, I think, is particularly telling, perhaps even humorous: it shows what kind of a journal AIM is, and also provides an insight into the state of acupuncture research in general.
The long and short of it is that conclusions about specific therapeutic effects of acupuncture are not permissible. We know that colicky babies respond even to minimal attention, and this trial confirms that even a little additional TLC in the form of acupuncture will generate an effect. The observed outcome is most likely unrelated to acupuncture.
Homeopaths have, since about 200 years, insisted that their remedies are efficacious treatments for infectious diseases. As evidence for this notion, they often produce epidemiological data showing that a group of infected patients treated homeopathically had better results than another group treated conventionally. While potentially interesting, such findings never constitute proof, because the two groups might not have been comparable and many other factors could have determined the observed outcome. In fact, these stories are prime examples for the need of rigorously controlled trials when testing the efficacy of medical treatments.
Homeopaths are invariably unable to provide more compelling evidence for their claims. Instead, they repeat, since 200 years, their assumptions over and over again. Are they not aware, I ask myself, that the repetition of a lie does not create a truth?
What their repetition of lies sometimes does create, unfortunately, is some impact on a political level. This website explains it fairly well:
The Public Health Ministry (of Thailand) is thinking of implementing alternative therapy homeopathy in all districts of Sing Buri this year, after a report that it could boost the human’s body immunity to fight dengue fever, an inspector-general at the ministry said.
Homeopathic medicines had been given to Sing Buri volunteer students from kindergarten to lower-secondary level in a 2012-13 trial and it yielded satisfactory results, said Dr Jakkriss Bhumisawasdi, director of the Inspector-General Region for Bureau of Inspection and Evaluation.
The number of dengue fever cases in Sing Buri have gone down, taking its rankings from No 67 in the country (with one death) in 2011 to No 76 in 2012. As there was a nationwide dengue fever outbreak in 2013, Sing Buri reported the country’s lowest prevalence at 44.95 per 100,000 population.
Jakkriss said “homeopathy” was safe and low-cost and had been used in various countries including the United Kingdom, France, Italy, Switzerland, Belgium, the United States, Australia, India and Malaysia.
Next, the system of medicine would be implemented in Region 4 Bureau’s seven other provinces: Nakhon Nayok, Nonthaburi, Pathum Thani, Ayutthaya, Lop Buri, Sara Buri and Ang Thong. If this one district per province pilot project went well, they would consider implementing it across the country, he said.
Sing Buri Hospital paediatrician Dr Wali Suwatthika said the preparation involved dissolving Eupatorium herbal pills in drinking water. Each child would be given 3cc of this tasteless water every three months. The trial, which began in July 2012, covered 4,250 children in Muang district and only four of them developed mild dengue fever in one year, while seven out of the district’s 2,856 remaining kids who didn’t get the medicine had dengue fever, in a more severe condition.
Thailand reported 150,934 dengue fever patients last year, double the previous year’s number, and 133 deaths. As there is no vaccine for dengue fever, the Public Health Ministry used a combination of several measures, including the eradication of mosquito larva incubation grounds and a campaign for people to install mosquito nets.
END OF QUOTE
So, where is the evidence that homeopathy does anything at all for Dengue patients? The 2012-13 trial referred to above has, as far as I can see, not been published. This probably means that it was not a publishable study at all. The only study available on Medline is this one:
A double-blind, placebo-controlled randomized trial of a homeopathic combination medication for dengue fever was carried out in municipal health clinics in Honduras. Sixty patients who met the case definition of dengue (fever plus two ancillary symptoms) were randomized to receive the homeopathic medication or placebo for 1 week, along with standard conventional analgesic treatment for dengue. The results showed no difference in outcomes between the two groups, including the number of days of fever and pain as well as analgesic use and complication rates. Only three subjects had laboratory confirmed dengue. An interesting sinusoidal curve in reported pain scores was seen in the verum group that might suggest a homeopathic aggravation or a proving. The small sample size makes conclusions difficult, but the results of this study do not suggest that this combination homeopathic remedy is effective for the symptoms that are characteristic of dengue fever.
END OF QUOTE
The bottom line is simple and depressing: the totality of the best available evidence fails to show that homeopathy is efficacious for Dengue fever (or any other infectious disease). It is irresponsible to claim otherwise.
If you want to scientifically investigate this question, it might be a good idea NOT to start with the following sentence: “Auricular acupuncture (AA) is effective in the treatment of preoperative anxiety”. Yet, this is exactly what the authors did in their recent publication.
The aim of this new study was to investigate whether AA can reduce exam anxiety as compared to placebo and no intervention. Forty-four medical students were randomized to receive AA, placebo, or no intervention in a crossover manner. Subsequently they completed three comparable oral anatomy exams with an interval of one month between the exams/interventions.
A licensed acupuncturist with more than five years of experience with this technique applied AA at the acupuncture points MA-IC1 (Lung), MA-TF1 (ear Shenmen), MA-SC (Kidney), MA-AT1 (Subcortex) and MA-TG (Adrenal gland) bilaterally. Indwelling fixed ‘New Pyonex’ needles embedded in a skin-coloured adhesive tape were used for AA. The participants were instructed by the acupuncturist to stimulate the auricular needles for 3–5 minutes, if they felt anxious. For the placebo procedure, ‘New Pyonex’ placebo needles were attached to five sites on the helix of the auricle bilaterally. ‘New Pyonex’ placebo needles have the same appearance as AA needles but consist of self-adhesive tape only. In order to avoid potential physiologic effects of acupressure, the participants were not instructed to stimulate the attached ‘New Pyonex’ placebo needles. AA and placebo needles were left in situ until the next day and were removed out of sight of the participants after the exam by the investigator, who was not involved in acupuncture procedure
Levels of anxiety were measured using a visual analogue scale before and after each intervention as well as before each exam. Additional measures included the State-Trait-Anxiety Inventory, duration of sleep at night, blood pressure, heart rate and the extent of participant blinding.
All included participants finished the study. Anxiety levels were reduced after AA and placebo intervention compared to baseline and the no intervention condition (p < 0.003). Moreover, AA was also better at reducing anxiety than placebo in the evening before the exam (p = 0.018). Participants were able to distinguish between AA and placebo intervention.
The authors concluded that both auricular acupuncture and placebo procedure were shown to be effective in reducing levels of exam anxiety in medical students. The superiority of verum AA over placebo AA and no intervention is considered to be due to stimulation of cranial nerves, but may have been increased in effect by insufficient participant blinding.
Here are just three of the major concerns I have about this study:
- The trial design seems odd: a crossover study can only work well, if there is a stable baseline. This may not be the case with three consecutive exams; the anxiety experienced by students is bound to get less as time goes by. I think anyone who has passed a series of exams will confirm that there is a large degree of habituation.
- It seems inadequate to employ just one acupuncturist; it means that the trial might end up testing not acupuncture per se but the skills of the therapist.
- The placebo used for this study cannot possibly have fooled anyone into believing that it was real AA; volunteers were not even instructed to ‘stimulate’ the placebo devices. The difference to the ‘real thing’ must have been very clear to all involved. This means that the control for placebo-effects was woefully incomplete. In turn, this means that the observed outcomes are most likely due to residual bias.
In view of these concerns, allow me to re-phrase the authors’ conclusions:
THE RESULTS OF THIS POORLY-DESIGNED STUDY ARE DIFFICULT TO INTERPRET. MOST LIKELY THEY SHOW THAT ACUPUNCTURE IS NOT EFFECTIVE BUT MERELY WORKS THROUGH A PLACEBO-RESPONSE.
This meta-analysis was performed “to ascertain the effectiveness of oral aloe vera consumption on the reduction of fasting blood glucose (FBG) and hemoglobin A1c (HbA1c).”
PubMed, CINAHL, Natural Medicines Comprehensive Database, and Natural Standard databases were searched. The searches were limited to clinical trials or observational studies conducted in humans and published in English. Studies of aloe vera’s effect on FBG, HbA1c, homeostasis model assessment-estimated insulin resistance (HOMA-IR), fasting serum insulin, fructosamine, and oral glucose tolerance test (OGTT) in prediabetic and diabetic populations were examined.
Nine studies were included in the FBG parameter (n = 283); 5 of these studies included HbA1c data (n = 89). Aloe vera decreased FBG by 46.6 mg/dL (p < 0.0001) and HbA1c by 1.05% (p = 0.004). Significant reductions of both endpoints were maintained in all subgroup analyses. Additionally, the data suggested that patients with an FBG ≥200 mg/dL may see a greater benefit. A mean FBG reduction of 109.9 mg/dL was observed in this population (p ≤ 0.0001). There was evidence of publication bias with FBG but not with HbA1c.
The authors concluded that the results of this meta-analysis support the use of oral aloe vera for significantly reducing both FBG (46.6 mg/dL) and HbA1c (1.05%) in prediabetic and diabetic patients. However, given the current overall quality and relative scarcity of data, further clinical studies that are more robust and better controlled are warranted to confirm and further explore these findings.
Oh no, the results do not support the use of aloe vera at all!!
Because this ‘meta-analysis’ is of unacceptably poor quality. Here are just some of the flaws that render it totally useless, particularly for issuing advice such as above:
- The authors included uncontrolled observational studies which make no attempt to control for non-specific effects.
- In several studies, the use of concomitant anti-diabetic medications was allowed; therefore it is not possible to establish cause and effect by aloe vera.
- The search strategy was woefully inadequate; for instance non-English publications were not considered.
- There was no assessment of the scientific rigor of the included studies; this totally invalidates the reliably of the conclusions.
- The included studies used preparations of widely different aloe vera preparations, and there is no way of knowing the does of the active ingredients.
Diabetes is a serious condition that affects millions worldwide. If some of these patients are sufficiently gullible to follow the conclusions of this paper, they might be dead within a matter of days. This makes this article one of the most dangerous papers that I have seen in the ‘peer-reviewed’ literature of alternative medicine.
Who publishes such utter and irresponsible rubbish?
You may well ask.
The journal has been discussed on this blog before for the junk that regularly appears in its pages, and so has its editor in chief. The authors (and the reviewers) are not known to me, but one thing is for sure: they don’t know the first thing about conducting a decent systematic review/meta-analysis.
The common cold is one of the indications for which homeopathy is deemed to be effective… by homeopaths that is! Non-homeopaths are understandably critical about this claim, not least because there is no good evidence for it. But, hold on, there is a new study which might change all this.
This study was recently published in COMPLEMENTARY THERAPIES IN MEDICINE which is supposed to be one of the better journals in this area. According to its authors, it was conducted “to determine if a homeopathic syrup was effective in treating cold symptoms in preschool children.” Children diagnosed with an upper respiratory tract infection were randomized to receive a commercial homeopathic cold syrup containing allium cepa 6X, hepar sulf calc 12X, natrum muriaticum 6X, phosphorous 12X, pulsatilla 6X, sulphur 12X, and hydrastasis 6X or placebo. Parents administered the study medication as needed for 3 days. The primary outcome was change in symptoms one hour after each dose. Parents also assessed the severity of each of the symptoms of runny nose, cough, congestion and sneezing at baseline and twice daily for 3 days, using a 4-point rating scale. A composite cold score was calculated by combining the values for each of the four symptoms. Among 261 eligible participants, data on 957 doses of study medication in 154 children were analyzed. There was no significant difference in improvement one hour after the dose for any symptom between the two groups. Analysis of twice daily data on the severity of cold symptoms compared to baseline values found that improvements in sneezing, cough and the composite cold score were significantly greater at both the first and second assessments among those receiving the cold syrup compared to placebo recipients.
The authors concluded that the homeopathic syrup appeared to be effective in reducing the severity of cold symptoms in the first day after beginning treatment.
Where to start? There are so many problems with this study that I find it difficult to chose the most crucial ones:
- The study had a clearly defined primary endpoint; it was not affected by the homeopathic treatment which doubtlessly makes the study a negative trial. The only correct conclusion therefore is that THE HOMEOPATHIC SYRUP FAILED TO AFFECT THE PRIMARY OUTCOME MEASURE OF THIS STUDY. THEREFORE THE TRIAL DID NOT PRODUCE ANY EVIDENCE TO ASSUME THAT THE EXPERIMENTAL TREATMENT WAS EFFICACIOUS.
- I don’t think that many of the primary or secondary outcome measures are validated or reliable.
- All the positive results reported in the abstract and the article relate to secondary endpoints which are purely explanatory by nature. They should, in my view, not be mentioned in the conclusions at all.
- The fact that some results turned out to be positive can be explained by the fact that the investigators ran dozens of tests for statistical significance which means that, by simple chance, some will turn out to produce a positive result.
- A further explanation for the seemingly positive results might be the fact disclosed in the text of the article that the children in the homeopathy group received more conventional drugs than those in the placebo group.
- Whatever the reason for these positive results, they certainly had nothing to do with the homeopathic syrup.
- The study was funded by the company producing the syrup and for which one of the authors was employed as a consultant. This might be an explanation for the abominably poor science. In other words, this paper is not an exercise in testing a hypothesis but one in marketing.
While I might forgive the company for trying to maximise their sales figures, I do find it harder to forgive the authors, reviewers and editors for publishing such overtly false conclusions. In my view, they are all guilty of scientific misconduct.
Meniscus-injuries are common and there is no consensus as to how best treat them. Physiotherapists tend to advocate exercise, while surgeons tend to advise surgery.
Of course, exercise is not a typical alternative therapy but, as many alternative practitioners might disagree with this statement because they regularly recommend it to their patients, it makes sense to cover it on this blog. So, is exercise better than surgery for meniscus-problems?
The aim of this recent Norwegian study aimed to shed some light on this question. Specifically wanted to determine whether exercise therapy is superior to arthroscopic partial meniscectomy for knee function in patients with degenerative meniscal tears.
A total of 140 adults with degenerative medial meniscal tear verified by magnetic resonance imaging were randomised to either receiving 12 week supervised exercise therapy alone, or arthroscopic partial meniscectomy alone. Intention to treat analysis of between group difference in change in knee injury and osteoarthritis outcome score (KOOS4), defined a priori as the mean score for four of five KOOS subscale scores (pain, other symptoms, function in sport and recreation, and knee related quality of life) from baseline to two-year follow-up and change in thigh muscle strength from baseline to three months.
The results showed no clinically relevant difference between the two groups in change in KOOS4 at two years (0.9 points, 95% confidence interval −4.3 to 6.1; P=0.72). At three months, muscle strength had improved in the exercise group (P≤0.004). No serious adverse events occurred in either group during the two-year follow-up. 19% of the participants allocated to exercise therapy crossed over to surgery during the two-year follow-up, with no additional benefit.
The authors concluded that the observed difference in treatment effect was minute after two years of follow-up, and the trial’s inferential uncertainty was sufficiently small to exclude clinically relevant differences. Exercise therapy showed positive effects over surgery in improving thigh muscle strength, at least in the short-term. Our results should encourage clinicians and middle-aged patients with degenerative meniscal tear and no definitive radiographic evidence of osteoarthritis to consider supervised exercise therapy as a treatment option.
As I stated above, I mention this trial because exercise might be considered by some as an alternative therapy. The main reason for including it is, however, that it is in many ways an exemplary good study from which researchers in alternative medicine could learn.
Like so many alternative therapies, exercise is a treatment for which placebo-controlled studies are difficult, if not impossible. But that does not mean that rigorous tests of its value are impossible. The present study shows the way how it can be done.
Meaningful clinical research is no rocket science; it merely needs well-trained scientists who are willing to test the (rather than promote) their hypotheses. Sadly such individuals are as rare as gold dust in the realm of alternative medicine.
WHAT DOCTORS DON’T TELL YOU (WDDTY) is probably the most vile publication I know. It systematically misleads its readers by alarming news about this or that conventional treatment, while relentlessly promoting pseudoscientific non-sense. This article , entitled “MMR can cause skin problems and ulcers if your immune system is compromised” is a good example (one of a multitude):
The MMR vaccine can cause serious adverse reactions, researchers have admitted this week. The rubella (German measles) component of the jab increases the risk of infection from the rubella virus itself, and can cause serious skin inflammation and ulcers in anyone whose immune system is compromised.
The risk is highest among people with primary immunodeficiency diseases (PIDD), chronic genetic disorders that cause the immune system to malfunction.
Although the risk for people with compromised immune systems has been known, and is even included in the package inserts supplied with the vaccine, it was theoretical, say researchers from the Children’s Hospital of Philadelphia, who say they have uncovered “genuine evidence of harm.”
The researchers analysed the health profile of 14 people—four adults and 10 children—who suffered some form of a PIDD. Seven of them still had the rubella virus in their tissues, suggesting that their immune systems were too weak to get rid of the virus in the vaccine. The virus can damage skin cells and cause ulcers, and makes the person more susceptible to the actual rubella virus, the researchers say.
People with a poor immune system already have compromised T-cells—which are responsible for clearing viral infections—and the MMR makes the problem worse.
END OF QUOTE
And what is wrong with this article?
The answer is quite a lot:
- The research seems to be about a very specific and rare condition, yet WDDTY seem to want to draw much more general conclusions.
- The research itself is not described in a way that it would be possible to evaluate.
- The sample size of what seems to have been a case-control study was tiny.
- The study is not properly cited for the reader to verify and check; for all we know, it might not even exist.
- I was not able to find the publication on Medline, based on the information given.
Collectively, these points render the article not just useless, in my view, but make it a prime example of unethical, unhelpful and irresponsible scaremongering.
Acupuncture for hot flushes?
I know, to rational thinkers this sounds bizarre – but, actually, there are quite a few studies on the subject. Enough evidence for me to have published not one but four different systematic reviews on the subject.
The first (2009) concluded that “the evidence is not convincing to suggest acupuncture is an effective treatment of hot flash in patients with breast cancer. Further research is required to investigate whether there are specific effects of acupuncture for treating hot flash in patients with breast cancer.”
The second (also 2009) concluded that “sham-controlled RCTs fail to show specific effects of acupuncture for control of menopausal hot flushes. More rigorous research seems warranted.”
The third (again 2009) concluded that “the evidence is not convincing to suggest acupuncture is an effective treatment for hot flush in patients with prostate cancer. Further research is required to investigate whether acupuncture has hot-flush-specific effects.”
The fourth (2013), a Cochrane review, “found insufficient evidence to determine whether acupuncture is effective for controlling menopausal vasomotor symptoms. When we compared acupuncture with sham acupuncture, there was no evidence of a significant difference in their effect on menopausal vasomotor symptoms. When we compared acupuncture with no treatment there appeared to be a benefit from acupuncture, but acupuncture appeared to be less effective than HT. These findings should be treated with great caution as the evidence was low or very low quality and the studies comparing acupuncture versus no treatment or HT were not controlled with sham acupuncture or placebo HT. Data on adverse effects were lacking.”
And now, there is a new systematic review; its aim was to evaluate the effectiveness of acupuncture for treatment of hot flash in women with breast cancer. The searches identified 12 relevant articles for inclusion. The meta-analysis without any subgroup or moderator failed to show favorable effects of acupuncture on reducing the frequency of hot flashes after intervention (n = 680, SMD = − 0.478, 95 % CI −0.397 to 0.241, P = 0.632) but exhibited marked heterogeneity of the results (Q value = 83.200, P = 0.000, I^2 = 83.17, τ^2 = 0.310). The authors concluded that “the meta-analysis used had contradictory results and yielded no convincing evidence to suggest that acupuncture was an effective treatment of hot flash in patients with breast cancer. Multi-central studies including large sample size are required to investigate the efficiency of acupuncture for treating hot flash in patients with breast cancer.”
What follows from all this?
- The collective evidence does NOT seem to suggest that acupuncture is a promising treatment for hot flushes of any aetiology.
- The new paper is unimpressive, in my view. I don’t see the necessity for it, particularly as it fails to include a formal assessment of the methodological quality of the primary studies (contrary to what the authors state in the abstract) and because it merely includes articles published in English (with a therapy like acupuncture, such a strategy seems ridiculous, in my view).
- I predict that future studies will suggest an effect – as long as they are designed such that they are open to bias.
- Rigorous trials are likely to show an effect beyond placebo.
- My own reviews typically state that MORE RESEARCH IS NEEDED. I regret such statements and would today no longer issue them.