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

causation

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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.

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. 

Personally, I like sauna bathing. It makes me feel fine. But is it healthy? More specifically, is it good for the cardiovascular system?

Finnish researchers had already shown in a large cohort study with 20 years of follow-up that increased frequency of sauna bathing is associated with a reduced risk of sudden cardiac death (SCD), fatal coronary heart disease (CHD), fatal cardiovascular disease (CVD), and all-cause mortality. Now the same group of researchers report more encouraging news for sauna-fans.

The aim of their new study was to investigate the relationship between sauna habits and CVD mortality in men and women, and whether adding information on sauna habits to conventional cardiovascular risk factors is associated with improvement in prediction of CVD mortality risk.

Sauna bathing habits were assessed at baseline in a sample of 1688 participants (mean age 63; range 53-74 years), of whom 51.4% were women. Multivariable-adjusted hazard ratios (HRs) were calculated to investigate the relationships of frequency and duration of sauna use with CVD mortality.

A total of 181 fatal CVD events occurred during a median follow-up of 15.0 years (interquartile range, 14.1-15.9). The risk of CVD mortality decreased linearly with increasing sauna sessions per week with no threshold effect. In age- and sex-adjusted analysis, compared with participants who had one sauna bathing session per week, HRs (95% CIs) for CVD mortality were 0.71 (0.52 to 0.98) and 0.30 (0.14 to 0.64) for participants with two to three and four to seven sauna sessions per week, respectively. After adjustment for established CVD risk factors, potential confounders including physical activity, socioeconomic status, and incident coronary heart disease, the corresponding HRs (95% CIs) were 0.75 (0.52 to 1.08) and 0.23 (0.08 to 0.65), respectively. The duration of sauna use (minutes per week) was inversely associated with CVD mortality in a continuous manner. Addition of information on sauna bathing frequency to a CVD mortality risk prediction model containing established risk factors was associated with a C-index change (0.0091; P = 0.010), difference in - 2 log likelihood (P = 0.019), and categorical net reclassification improvement (4.14%; P = 0.004).

(Hazard ratios for cardiovascular mortality by quartiles of the duration of sauna bathing. a Adjusted for age and gender. b Adjusted for age, gender, body mass index, smoking, systolic blood pressure, serum low-density lipoprotein cholesterol, alcohol consumption, previous myocardial infarction, and type 2 diabetes. CI, confidence interval.)

The authors concluded that higher frequency and duration of sauna bathing are each strongly, inversely, and independently associated with fatal CVD events in middle-aged to elderly males and females. The frequency of sauna bathing improves the prediction of the long-term risk for CVD mortality.

These results are impressive. What could be the underlying mechanisms? The authors offer plenty of explanations: Dry and hot sauna baths have been shown to increase the demands of cardiovascular function. Sauna bathing causes an increase in heart rate which is a reaction to the body heat load. Heart rate may be elevated up to 120–150 beats per minute during sauna bathing, corresponding to low- to moderate-intensity physical exercise training for the circulatory system without active muscle work. Acute sauna exposure has been shown to produce blood pressure lowering effects, decrease peripheral vascular resistance and arterial stiffness, and improve arterial compliance. Short-term sauna exposure also activates the sympathetic nervous and the renin-angiotensin-aldosterone systems and the hypothalamus-pituitary-adrenal hormonal axis, and short-term increases in levels of their associated hormones have been reported. Repeated sauna exposure improves endothelial function, suggesting a beneficial role of thermal therapy on vascular function. Long-term sauna bathing habit may be beneficial in the reduction of high systemic blood pressure, which is in line with previous evidence showing that blood pressure may be lower among those who are living in warm conditions with higher ambient temperature. Regular sauna bathing is associated with a lowered risk of future hypertension. Typical hot and dry Finnish sauna increases body temperature which causes more efficient skin blood flow, leading to a higher cardiac output, whereas blood flow to internal organs decreases. Sweat is typically secreted at a rate which corresponds to an average total secretion of 0.5 kg during a sauna bathing session. Increased sweating is accompanied by a reduction in blood pressure and higher heart rate, while cardiac stroke volume is largely maintained, although a part of blood volume is diverted from the internal organs to body peripheral parts with decreasing venous return which is not facilitated by active skeletal muscle work. However, it has been proposed that muscle blood flow may increase to at least some extent in response to heat stress, although sauna therapy-induced myocardial metabolic adaptations are largely unexplored. There is also evidence that regular long-term sauna bathing (average of two sessions per week) increases left ventricular ejection fraction. Heat therapy may improve left ventricular function with decreased cardiac pre- and afterload, thereby maintaining appropriate stroke volume despite large reductions in ventricular filling pressures. Additionally, previous studies have demonstrated a positive alteration of the autonomic nervous system and reduced levels of natriuretic peptides, oxidative stress, inflammation, and norepinephrine due to regular sauna therapy.

It is possible that the results are influenced by confounding factors that the researchers were unable to account for. It is also possible that people who are already ill avoid sauna bathing and that this contributed to the findings. However, the authors did their best to explore such phenomena in sub-group analysis and found that a causal relationship between sauna and CVD risk is still very likely. As a sauna-fan, I am inclined to believe them and the sceptic in me tends to agree.

Alternative medicine is an odd term (but it is probably as good or bad as any other term for it). It describes a wide range of treatments (and diagnostic techniques which I exclude from this discussion) that have hardly anything in common.

Hardly anything!

And that means there are a few common denominators. Here are 7 of them:

  1. The treatments have a long history and have thus stood the ‘test of time’.
  2. The treatments enjoy a lot of support.
  3. The treatments are natural and therefore safe.
  4. The treatments are holistic.
  5. The treatments tackle the root causes of the problem.
  6. The treatments are being suppressed by the establishment.
  7. The treatments are inexpensive and therefore value for money.

One only has to scratch the surface to discover that these common denominators of alternative medicine turn out to be unmitigated nonsense.

Let me explain:

The treatments have a long history and have thus stood the ‘test of time’.

It is true that most alternative therapies have a long history; but what does that really mean? In my view, it signals but one thing: when these therapies were invented, people had no idea how our body functions; they mostly had speculations, superstitions and myths. It follows, I think, that the treatments in question are built on speculations, superstitions and myths.

This might be a bit too harsh, I admit. But one thing is absolutely sure: a long history of usage is no proof of efficacy.

The treatments enjoy a lot of support.

Again, this is true. Alternative treatments are supported by many patients who swear by them, by thousands of clinicians who employ them as well as by royalty and other celebrities who make the headlines with them.

Such support is usually based on experience or belief. Neither are evidence; quite the opposite, remember: the three most dangerous words in medicine are ‘IN MY EXPERIENCE’. To be clear, experience and belief can fool us profoundly, and science is a tool to prevent us being misled by them.

The treatments are natural and therefore safe.

Here we have two fallacies moulded into one. Firstly, not all alternative therapies are natural; secondly, none is entirely safe.

There is nothing natural about diluting the Berlin Wall and selling it as a homeopathic remedy. There is nothing natural about forcing a spinal joint beyond its physiological range of motion and calling it spinal manipulation. There is nothing natural about sticking needles into the skin and claiming this re-balances our vital energies.

Acupuncture, chiropractic, herbal medicine, etc. are burdened with their fair share of adverse effects. But the real danger of alternative medicine is the harm done by neglecting effective therapies. Anyone who decides to forfeit conventional treatments for a serious condition, and uses alternative therapies instead, runs the risk of shortening their lives.

The treatments are holistic.

Alternative therapists try very hard to sell their treatments as holistic. This sounds good and must be an excellent marketing gimmick. Alas, it is not true.

There is nothing less holistic than seeing subluxations, yin/yang imbalances, auto-intoxications, energy blockages, etc. as the cause of all illness. Holism is at the heart of all good healthcare; the attempt by alternative practitioners to hijack it is merely a transparent attempt to boost their business.

The treatments tackle the root causes of the problem.

Alternative therapists claim that they can identify the root causes of all conditions and thus treat them more effectively than conventional clinicians who merely treat their symptoms. Nothing could be further from the truth. Conventional medicine has been so spectacularly successful not least because we always aim at identifying the cause that underlie a symptom and, whenever possible, treat that cause (often in addition to treating symptoms). Alternative practitioners may well delude themselves that energy imbalances, subluxations, chi-blockages etc. are root causes, but there simply is no evidence to support their deluded claims.

The treatments are being suppressed by the establishment.

The feeling of paranoia seems endemic in alternative medicine. Many practitioners are so affected by it that they believe everyone who doubts their implausible notions and misconceptions is out to get them. Big Pharma’ or whoever else they feel prosecuted by are more likely to smile at such wild conspiracy theories than to fear for their profit margins. And whenever ‘Big Pharma’ does smell a fast buck, they do not hesitate to jump on the alternative band-waggon joining them in ripping off the public by flogging dubious supplements, homeopathics, essential oils, vitamins, flower remedies, detox-remedies, etc.

The treatments are inexpensive and therefore value for money.

It is probably true that the average cost of a homeopathic remedy, an acupuncture treatment or an aromatherapy session costs less than the average conventional treatment. However, to conclude from it that alternative therapies are value for money is wrong. To be of real value, a treatment needs to generate more good than harm; but very few alternative treatments fulfil this criterion. To use a blunt analogy, if someone offers you a used car, it may well be inexpensive – if, however, it does not run and is beyond repair, it cannot be value for money.

As I already stated: alternative medicine is so diverse that its various branches are almost entirely unrelated, and the few common denominators of alternative medicine that do exist are unmitigated nonsense.

Back pain is a huge problem: it affects many people, causes much suffering and leads to extraordinary high cost for all of us. Considering these facts, it would be excellent to identify a treatment that truly works. However, at present, we do not have found the ideal therapy; instead we have dozens of different approaches that are similarly effective/ineffective. Two of these therapies are massage and acupuncture.

Is one better than the other?

This study compared the efficacy of classical massage (KMT, n = 66) with acupuncture therapy (AKU, n = 66) in patients with chronic back pain. The primary endpoint was the non-inferiority of classical massage compared with the acupuncture treatment in respect of the impairment in everyday life, with the help of the Hannover function questionnaire (HFAQ) and the reduction in pain (“Von Korff”-Questionnaire) at the follow-up after one month.

In the per-protocol analysis during the period between enrollment in the study and follow-up, the responder rate of the KMT was 56.5% and thus tended to be inferior to the responder rate of the AKU with 62.5% (Δ = - 6%; KIΔ: - 23.5 to + 11.4%).

The authors concluded that classical massage therapy is not significantly inferior to acupuncture therapy in the period from admission to follow-up. Thus, the non-inferiority of the KMT to the AKU cannot be proven in the context of the defined irrelevance area.

I find such studies oddly useless.

To conduct a controlled trial, one needs an experimental treatment (the therapy that is not understood) and compare it with an intervention that is understood (such as a placebo that has no specific effects, or a treatment that has been shown to work). In comparative studies like the one above, one compares one unknown with another unknown. I do not see how such a comparison can ever produce a meaningful result.

In a way, it is like an equation with two unknowns: x + 5 = y. It is simply not possible to define either x nor y, and the equation is unsolvable.

For comparative studies of two back-pain treatments to make sense, we would need one of which the effect size is well-established. I do not think that we currently have identified such a therapy. Certainly, we cannot say that we know it for massage or acupuncture.

In other words, comparative studies like the one above are a waste of resources that cannot possibly make a meaningful contribution to our knowledge.

To put it even more bluntly: we ought to stop such pseudo-research.

Acupuncture is a branch of alternative medicine where pseudo-science abounds. Here is yet another example of this deplorable phenomenon.

This study was conducted to evaluate the efficacy of acupuncture in the management of primary dysmenorrhea.

Sixty females aged 17-23 years were randomly assigned to either a study group or a control group.

  • The study group received acupuncture for the duration of 20 minutes/day, for 15 days/month, for the period of 90 days.
  • The control group did not receive acupuncture for the same period.

Both groups were assessed on day 1; day 30 and day 60; and day 90. The results showed a significant reduction in all the variables such as the visual analogue scale score for pain, menstrual cramps, headache, dizziness, diarrhoea, faint, mood changes, tiredness, nausea, and vomiting in the study group compared with those in the control group.

The authors concluded that acupuncture could be considered as an effective treatment modality for the management of primary dysmenorrhea.

These findings contradict those of a recent Cochrane review (authored by known acupuncture-proponents) which included 42 RCTs and concluded that there is insufficient evidence to demonstrate whether or not acupuncture or acupressure are effective in treating primary dysmenorrhoea, and for most comparisons no data were available on adverse events. The quality of the evidence was low or very low for all comparisons. The main limitations were risk of bias, poor reporting, inconsistency and risk of publication bias.

The question that I ask myself is this: why do researchers bother to conduct studies that contribute NOTHING to our knowledge and progress? The new study had a no-treatment control group which means it cannot control for the effects of placebo, the extra attention, social desirability etc. In view of the fact that already 42 poor quality trials exist, it is not just useless to add a 43rd but, in my view, it is scandalous! A 43rd useless trial:

  • tells us nothing of value;
  • misleads the public;
  • pollutes the medical literature;
  • is a waste of resources;
  • undermines the trust in clinical research;
  • is deeply unethical.

It is high time to stop such redundant, foolish, wasteful and unethical pseudo-science.

 

The researcher who proves that highly diluted homeopathics work beyond placebo might be in for a Nobel Prize. The scientist who finds a cure for addictions probably also deserves one. The investigator who does both might get two Nobels. The question is, do these Brazilian homeopaths fulfil these criteria?

Their study investigated the effectiveness and tolerability of homeopathic Q-potencies of opium and E. coca in the integrative treatment of cocaine craving in a community-based psychosocial rehabilitation setting. A randomized, double-blind, placebo-controlled, parallel-group, eight-week pilot trial was performed at the Psychosocial Attention Center for Alcohol and Other Drugs (CAPS-AD), Sao Carlos/SP, Brazil. Eligible subjects included CAPS-AD patients between 18 and 65 years of age, with an International Classification of Diseases-10 diagnosis of cocaine dependence. The patients were randomly assigned to two treatment groups: psychosocial rehabilitation plus homeopathic Q-potencies of opium and E. coca (homeopathy group), and psychosocial rehabilitation plus indistinguishable placebo (placebo group). The main outcome measure was the percentage of cocaine-using days. Secondary measures were the Minnesota Cocaine Craving Scale and 12-Item Short-Form Health Survey scores. Adverse events were recorded in both groups.

The study population comprised 54 patients who attended at least one post-baseline assessment, out of the 104 subjects initially enrolled. The mean percentage of cocaine-using days in the homeopathy group was 18.1% compared to 29.8% in the placebo group (P < 0.01). Analysis of the Minnesota Cocaine Craving Scale scores showed no between-group differences in the intensity of cravings, but results significantly favored homeopathy over placebo in the proportion of weeks without craving episodes and the patients’ appraisal of treatment efficacy for reduction of cravings. Analysis of 12-Item Short-Form Health Survey scores found no significant differences. Few adverse events were reported: 0.57 adverse events/patient in the homeopathy group compared to 0.69 adverse events/patient in the placebo group.

The authors concluded that a psychosocial rehabilitation setting improved recruitment but was not sufficient to decrease dropout frequency among Brazilian cocaine treatment seekers. Psychosocial rehabilitation plus homeopathic Q-potencies of opium and E. coca were more effective than psychosocial rehabilitation alone in reducing cocaine cravings. Due to high dropout rate and risk of bias, further research is required to confirm our findings, with specific focus on strategies to increase patient retention.

I am glad that the authors mention the high dropout rate which clearly is a serious limitation of this fascinating trial. Had they analysed the data according to an intention to treat analysis – which, I think, would have been a better statistical approach – the results would almost certainly have been negative.

But there are other puzzling issues about this study:

  • The authors say they used homeopathic remedies. I think, however, that this is not the case. Homeopathy is defined as a therapy that follows the ‘like cures like’ principle. If the remedy is based on the causative agent, as in the case of the present study, it follows a different principle (identical cures identical) and is not called homeopathy but isopathy (here an explanation from my book: “Isopathy is the use of potentised remedies which are derived from the causative agent of the disease that is being treated. It thus does not follow the supreme law of homeopathy; instead of ‘like cures like’, instead it postulates that identical cures identical. An example of isopathy is the use of potentised grass pollen to treat patients suffering from hay fever. Some of the methodologically best trials that generated a positive result were done using isopathy; they therefore did not test homeopathy and its principal assumption, the ‘like cures like’ theory. They are nevertheless regularly used by proponents of homeopathy to argue that homeopathy is effective”). This means that the above trial does, in fact, NOT test the defining principle of homeopathy.
  • Moreover, I fail to understand why the authors called their trial a PILOT study. It does not explore the feasibility of a more definitive trial, but tests the effectiveness of the intervention. It is thus NOT a pilot study.
  • I cannot help being suspicious of authors who, based on an extremely implausible, such as homeopathy, publish one paper after the next with positive or encouraging results.
  • I am also puzzled by the fact that, in 2012 and 2013, the authors have published two previous studies along the same lines that produced encouraging results. Surely 6/5 years are a long enough period for INDEPENDENT replications to be carried out and published. And surely, a finding like this would have been replicated several times by now.
  • I furthermore find it odd that the authors chose to publish their findings in the JOURNAL OF INTEGRATIVE MEDICINE. This is a 3rd class journal read only by those who promote alternative therapies. The notion that a treatment of addiction has finally be found should appear in journals like SCIENCE, NATURE, NEJM, etc.
  • Considering the extremely low prior probability of their hypothesis, the authors should perhaps have not used the conventional 5% probability threshold, but one two dimensions lower.
  • I have not found a statement regarding informed consent of the study participants.

So, are these Brazilian homeopaths likely to be on the next list of Nobel laureates?

I have my doubts.

What do you think?

The authors of this paper wanted to establish and compare the effectiveness of Healing Touch (HT) and Oncology Massage (OM) therapies on cancer patients’ pain. They conducted pre-test/post-test, observational, retrospective study. A total of 572 outpatient oncology were recruited and asked to report pain before and after receiving a single session of either HT or OM from a certified practitioner.

Both HT and OM significantly reduced pain. Unadjusted rates of clinically significant pain improvement (defined as ≥2-point reduction in pain score) were 0.68 HT and 0.71 OM. Adjusted for pre-therapy pain, OM was associated with increased odds of pain improvement. For patients with severe pre-therapy pain, OM was not more effective in yielding clinically significant pain reduction when adjusting for pre-therapy pain score.

The authors concluded that both HT and OM provided immediate pain relief. Future research should explore the duration of pain relief, patient attitudes about HT compared with OM, and how this may differ among patients with varied pretherapy pain levels.

This paper made me laugh out loud; no, not because of the ‘certified’ practitioners (in the UK, we use this term to indicate that someone is not quite sane), but because of the admission that the authors aimed at establishing the effectiveness of their therapies. Most researchers of alternative medicine have exactly this motivation, but few make the mistake to write it into the abstract of their papers. Little do they know that this admission discloses a fatal amount of bias. Science is supposed to test hypotheses, and researchers who aim at establishing the effectiveness of their pet-therapy oust themselves as pseudo-researchers.

It comes therefore as no surprise that the study turns out to be a pseudo-study. As there was no adequate control group, these outcomes cannot be attributed to the interventions administered. The results could therefore be due to:

  • the time that has passed;
  • regression to the mean;
  • the attention provided by the therapists;
  • the expectation of the patient;
  • social desirability;
  • all of the above.

It follows that – just as with the study discussed in the previous post – the conclusion is wholly misleading. In fact, the data are consistent with the hypothesis that HT and OM both aggravated the pain (the results might have been better without HT and OM). The devils advocate concludes that both HT and OM provided an immediate increase in pain.

This study was aimed at evaluating group-level and individual-level change in health-related quality of life among persons with chronic low back pain or neck pain receiving chiropractic care in the United States.

A 3-month longitudinal study was conducted of 2,024 patients with chronic low back pain or neck pain receiving care from 125 chiropractic clinics at 6 locations throughout the US. Ninety-one percent of the sample completed the baseline and 3-month follow-up survey (n = 1,835). Average age was 49, 74% females, and most of the sample had a college degree, were non-Hispanic White, worked full-time, and had an annual income of $60,000 or more. Group-level and individual-level changes on the Patient-Reported Outcomes Measurement Information System (PROMIS) v2.0 profile measure were evaluated: 6 multi-item scales (physical functioning, pain, fatigue, sleep disturbance, social health, emotional distress) and physical and mental health summary scores.

Within group t-tests indicated significant group-level change for all scores except for emotional distress, and these changes represented small improvements in health. From 13% (physical functioning) to 30% (PROMIS-29 Mental Health Summary Score) got better from baseline to 3 months later.

The authors concluded that chiropractic care was associated with significant group-level improvement in health-related quality of life over time, especially in pain. But only a minority of the individuals in the sample got significantly better (“responders”). This study suggests some benefits of chiropractic on functioning and well-being of patients with low back pain or neck pain.

These conclusions are worded carefully to avoid any statement of cause and effect. But I nevertheless feel that the authors strongly imply that chiropractic caused the observed outcomes. This is perhaps most obvious when they state that this study suggests some benefits of chiropractic on functioning and well-being of patients with low back pain or neck pain.

To me, it is obvious that this is wrong. The data are just as consistent with the opposite conclusion. There was no control group. It is therefore conceivable that the patients would have improved more and/or faster, if they had never consulted a chiropractor. The devil’s advocate therefore concludes this: the results of this study suggest that chiropractic has significant detrimental effects on functioning and well-being of patients with low back pain or neck pain.

Try to prove me wrong!

PS

I am concerned that a leading journal (Spine) publishes such rubbish.

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