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

pseudo-science

The Journal of Experimental Therapeutics and Oncology states that it is devoted to the rapid publication of innovative preclinical investigations on therapeutic agents against cancer and pertinent findings of experimental and clinical oncology. In the journal you will find review articles, original articles, and short communications on all areas of cancer research, including but not limited to preclinical experimental therapeutics; anticancer drug development; cancer biochemistry; biotechnology; carcinogenesis; cancer cytogenetics; clinical oncology; cytokine biology; epidemiology; molecular biology; pathology; pharmacology; tumor cell biology; and experimental oncology.

After reading an article entitled ‘How homeopathic medicine works in cancer treatment: deep insight from clinical to experimental studies’ in its latest issue, I doubt that the journal is devoted to anything.

Here is the abstract:

In the current scenario of medical sciences, homeopathy, the most popular system of therapy, is recognized as one of the components of complementary and alternative medicine (CAM) across the world. Despite, a long debate is continuing whether homeopathy is just a placebo or more than it, homeopathy has been considered to be safe and cost-effectiveness therapeutic modality. A number of human ailments ranging from common to serious have been treated with homeopathy. However, selection of appropriate medicines against a disease is cumbersome task as total spectrum of symptoms of a patient guides this process. Available data suggest that homeopathy has potency not only to treat various types of cancers but also to reduce the side effects caused by standard therapeutic modalities like chemotherapy, radiotherapy or surgery. Although homeopathy has been widely used for management of cancers, its efficacy is still under question. In the present review, the anti-cancer effect of various homeopathic drugs against different kinds of cancers has been discussed and future course of action has also been suggested.

I do wonder what possessed the reviewers of this paper and the editors of the journal to allow such dangerous (and badly written) rubbish to get published. Do they not know that:

  1. homeopathy is a placebo therapy,
  2. homeopathy can not cure any cancer,
  3. cancer patients are highly vulnerable to false hope,
  4. such an article endangers the lives of many cancer patients,
  5. they have an ethical, moral and possibly legal duty to prevent such mistakes?

What makes this paper even more upsetting is the fact that one of its authors is affiliated with the Department of Health Research, Ministry of Health and Family Welfare, Government of India.

Family welfare my foot!

This certainly is one of the worst violations of healthcare and publication ethic that I have come across for a long time.

 

If so-called alternative medicine (SCAM) ever were to enter the Guinness Book of Records, it would most certainly be because it generates more surveys than any other area of medical inquiry. I have long been rather sceptical about this survey-mania. Therefore, I greet any major new survey with some trepidation.

The aim of this new survey was to obtain up-to-date general population figures for practitioner-led SCAM use in England, and to discover people’s views and experiences regarding access. The researchers commissioned a face-to-face questionnaire survey of a nationally representative adult quota sample (aged ≥15 years). Ten questions were included within Ipsos MORI’s weekly population-based survey. The questions explored 12-month practitioner-led SCAM use, reasons for non-use, views on NHS-provided SCAM, and willingness to pay.

Of 4862 adults surveyed, 766 (16%) had seen a SCAM practitioner. People most commonly visited SCAM practitioners for manual therapies (massage, osteopathy, chiropractic) and acupuncture, as well as yoga, pilates, reflexology, and mindfulness or meditation. Women, people with higher socioeconomic status (SES) and those in south England were more likely to access SCAM. Musculoskeletal conditions (mainly back pain) accounted for 68% of use, and mental health 12%. Most was through self-referral (70%) and self-financing. GPs (17%) or NHS professionals (4%) referred and/or recommended SCAM to users. These SCAM users were more often unemployed, with lower income and social grade, and receiving NHS-funded SCAM. Responders were willing to pay varying amounts for SCAM; 22% would not pay anything. Almost two in five responders felt NHS funding and GP referral and/or endorsement would increase their SCAM use.

The authors concluded that SCAM is commonly used in England, particularly for musculoskeletal and mental health problems, and by affluent groups paying privately. However, less well-off people are also being GP-referred for NHS-funded treatments. For SCAM with evidence of effectiveness (and cost-effectiveness), those of lower SES may be unable to access potentially useful interventions, and access via GPs may be able to address this inequality. Researchers, patients, and commissioners should collaborate to research the effectiveness and cost-effectiveness of SCAM, and consider its availability on the NHS.

I feel that a few critical thoughts are in order:

  1. The authors call their survey an ‘up-date’. The survey ran between 25 September and 18 October 2015. That is more than three years ago. I would not exactly call this an up-date!
  2. Authors (several of whom are known SCAM-enthusiasts) also state that practitioner-led SCAM use was about 5% higher than previous national (UK and England) surveys. This may relate to the authors’ wider SCAM definition, which included 11 more therapies than Hunt et al (a survey from my team), or increased SCAM use since 2005. Despite this uncertainty, the authors write this: Figures from 2005 reported that 12% of the English population used practitioner-led CAM. This 2015 survey has found that 16% of the general population had used practitioner-led CAM in the previous 12 months. Thus, they imply that SCAM-use has been increasing.
  3. The main justification for running yet another survey presumably was to determine whether SCAM-use has increased, decreased or remained the same (virtually everything else found in the new survey had been shown many times before). To not answer this main question conclusively by asking the same questions as a previous survey is just daft, in my view. We have used the same survey methods at two points one decade apart and found little evidence for an increase, on the contrary: overall, GPs were less likely to endorse CAMs than previously shown (38% versus 19%).
  4. The main reason why I have long been critical about such surveys is the manner in which their data get interpreted. The present paper is no exception in this respect. Invariably the data show that SCAM is used by those who can afford it. This points to INEQUALITY that needs to be addressed by allowing much more SCAM on the public purse. In other words, such surveys are little more that very expensive and somewhat under-hand promotion of quackery.
  5. Yes, I know, the present authors are more clever than that; they want the funds limited to SCAM with evidence of effectiveness and cost-effectiveness. So, why do they not list those SCAMs together with the evidence for effectiveness and cost-effectiveness? This would enable us to check the validity of the claim that more public money should fund SCAM. I think I know why: such SCAMs do not exist or, at lest, they are extremely rare.

But otherwise the new survey was excellent.

 

The objective of this ‘real world’ study was to evaluate the effectiveness of integrative medicine (IM) on patients with coronary artery disease (CAD) and investigate the prognostic factors of CAD in a real-world setting.

A total of 1,087 hospitalized patients with CAD from 4 hospitals in Beijing, China were consecutively selected between August 2011 and February 2012. The patients were assigned to two groups:

  1. Chinese medicine (CM) plus conventional treatment, i.e., IM therapy (IM group). IM therapy meant that the patients accepted the conventional treatment of Western medicine and the treatment of Chinese herbal medicine including herbal-based injection and Chinese patent medicine as well as decoction for at least 7 days in the hospital or 3 months out of the hospital.
  2. Conventional treatment alone (CT group).

The endpoint was a major cardiac event [MCE; including cardiac death, myocardial infarction (MI), and the need for revascularization].

A total of 1,040 patients finished the 2-year follow-up. Of them, 49.4% received IM therapy. During the 2-year follow-up, the total incidence of MCE was 11.3%. Most of the events involved revascularization (9.3%). Cardiac death/MI occurred in 3.0% of cases. For revascularization, logistic stepwise regression analysis revealed that age ⩾ 65 years [odds ratio (OR), 2.224], MI (OR, 2.561), diabetes mellitus (OR, 1.650), multi-vessel lesions (OR, 2.554), baseline high sensitivity C-reactive protein level ⩾ 3 mg/L (OR, 1.678), and moderate or severe anxiety/depression (OR, 1.849) were negative predictors (P<0.05); while anti-platelet agents (OR, 0.422), β-blockers (OR, 0.626), statins (OR, 0.318), and IM therapy (OR, 0.583) were protective predictors (P<0.05). For cardiac death/MI, age ⩾ 65 years (OR, 6.389) and heart failure (OR, 7.969) were negative predictors (P<0.05), while statin use (OR, 0.323) was a protective predictor (P<0.05) and IM therapy showed a beneficial tendency (OR, 0.587), although the difference was not statistically significant (P=0.218).

The authors concluded that in a real-world setting, for patients with CAD, IM therapy was associated with a decreased incidence of revascularization and showed a potential benefit in reducing the incidence of cardiac death or MI.

What the authors call ‘real world setting’ seems to be a synonym of ‘lousy science’, I fear. I am not aware of good evidence to show that herbal injections and concoctions are effective treatments for CAD, and this study can unfortunately not change this. In the methods section of the paper, we read that the treatment decisions were made by the responsible physicians without restriction. That means the two groups were far from comparable. In their discussion section, the authors state; we found that IM therapy was efficacious in clinical practice. I think that this statement is incorrect. All they have shown is that two groups of patients with similar diagnoses can differ in numerous ways, including clinical outcomes.

The lessons here are simple:

  1. In clinical trials, lack of randomisation (the only method to create reliably comparable groups) often leads to false results.
  2. Flawed research is currently being used by many proponents of  SCAM (so-called alternative medicine) to mislead us about the value of SCAM.
  3. The integration of dubious treatments into routine care does not lead to better outcomes.
  4. Integrative medicine, as currently advocated by SCAM-proponents, is a nonsense.

Patients with rheumatoid arthritis (RA) have a higher risk of coronary heart disease (CHD). Despite good evidence for effectiveness, acupuncture is often advocated for RA, and it has not been reported to prevent CHD in patients with RA.

The authors of this analysis aimed to assess the risk of developing CHD in acupuncture-users and non-users of patients with RA. They identified 29,741 patients with newly diagnosed RA from January 1997 to December 2010 from the Registry of Catastrophic Illness Patients Database from the Taiwanese National Health Insurance Research Database. Among them, 10,199 patients received acupuncture (acupuncture users), and 19,542 patients did not receive acupuncture (no-acupuncture users). After performing 1:1 propensity score matching by sex, age, baseline comorbidity, conventional treatment, initial diagnostic year, and index year, there were 9932 patients in both the acupuncture and no-acupuncture cohorts. The main outcome was the diagnosis of CHD in patients with RA in the acupuncture and no-acupuncture cohorts.

Acupuncture users had a lower incidence of CHD than non-users (adjusted HR = 0.60, 95% CI = 0.55-0.65). The estimated cumulative incidence of CHD was significantly lower in the acupuncture cohort (log-rank test, p < .001). Subgroup analysis showed that patients receiving manual acupuncture of traditional Chinese medicine style, electroacupuncture, or combination of both all had a lower incidence of CHD than patients never receiving acupuncture treatment. The beneficial effect of acupuncture on preventing CHD was independent of age, sex, diabetes mellitus, hypertension, hyperlipidemia, and statins use.

The authors concluded that this is the first large-scale study to reveal that acupuncture might have beneficial effect on reducing the risk of CHD in patients with RA. This study may provide useful information for clinical utilization and future studies.

Pigs might fly, but – call me a sceptic – I somehow doubt it almost as much as I doubt that acupuncture might have beneficial effect on reducing the risk of CHD.

Why?

Because of two reasons mainly:

  1. For the life of me, I cannot see a mechanism by which acupuncture achieves this extraordinary feast (the authors allege an anti-inflammatory effect of acupuncture which I find wholly unconvincing).
  2. There is a much simpler explanation for the observed outcomes.

The propensity score used here did, of course, only match the groups for a hand-full of factors. Yet there are many more that could play a part which the authors could not consider because they did not have the data to do so. The one that foremost comes to my mind is a generally healthier life-style of the patients using acupuncture. I think it stands to reason that people who bother to have and pay for an additional treatment are higher motivated to adhere to a life-style (e. g. smoking-cessation, exercise, nutrition, stress) that reduces the CHD-risk. And the influence of this factor could be very significant indeed. As the devil’s advocate, I could therefore even postulate that acupuncture itself had a slightly detrimental effect which, however, was over-ridden by the massive effect of the healthier life-style.

And the lesson to learn from all this?

Before we conclude about ‘beneficial effects’ of acupuncture or any other therapy, we need RCTs that effectively eliminate these rather obvious confounders.

 

In 1995, Dabbs and Lauretti reviewed the risks of cervical manipulation and compared them to those of non-steroidal, anti-inflammatory drugs (NSAIDs). They concluded that the best evidence indicates that cervical manipulation for neck pain is much safer than the use of NSAIDs, by as much as a factor of several hundred times. This article must be amongst the most-quoted paper by chiropractors, and its conclusion has become somewhat of a chiropractic mantra which is being repeated ad nauseam. For instance, the American Chiropractic Association states that the risks associated with some of the most common treatments for musculoskeletal pain—over-the-counter or prescription nonsteroidal anti-inflammatory drugs (NSAIDS) and prescription painkillers—are significantly greater than those of chiropractic manipulation.

As far as I can see, no further comparative safety-analyses between cervical manipulation and NSAIDs have become available since this 1995 article. It would therefore be time, I think, to conduct new comparative safety and risk/benefit analyses aimed at updating our knowledge in this important area.

Meanwhile, I will attempt a quick assessment of the much-quoted paper by Dabbs and Lauretti with a view of checking how reliable its conclusions truly are.

The most obvious criticism of this article has already been mentioned: it is now 23 years old, and today we know much more about the risks and benefits of these two therapeutic approaches. This point alone should make responsible healthcare professionals think twice before promoting its conclusions.

Equally important is the fact that we still have no surveillance system to monitor the adverse events of spinal manipulation. Consequently, our data on this issue are woefully incomplete, and we have to rely mostly on case reports. Yet, most adverse events remain unpublished and under-reporting is therefore huge. We have shown that, in our UK survey, it amounted to exactly 100%.

To make matters worse, case reports were excluded from the analysis of Dabbs and Lauretti. In fact, they included only articles providing numerical estimates of risk (even reports that reported no adverse effects at all), the opinion of exerts, and a 1993 statistic from a malpractice insurer. None of these sources would lead to reliable incidence figures; they are thus no adequate basis for a comparative analysis.

In contrast, NSAIDs have long been subject to proper post-marketing surveillance systems generating realistic incidence figures of adverse effects which Dabbs and Lauretti were able to use. It is, however, important to note that the figures they did employ were not from patients using NSAIDs for neck pain. Instead they were from patients using NSAIDs for arthritis. Equally important is the fact that they refer to long-term use of NSAIDs, while cervical manipulation is rarely applied long-term. Therefore, the comparison of risks of these two approaches seems not valid.

Moreover, when comparing the risks between cervical manipulation and NSAIDs, Dabbs and Lauretti seemed to have used incidence per manipulation, while for NSAIDs the incidence figures were bases on events per patient using these drugs (the paper is not well-constructed and does not have a methods section; thus, it is often unclear what exactly the authors did investigate and how). Similarly, it remains unclear whether the NSAID-risk refers only to patients who had used the prescribed dose, or whether over-dosing (a phenomenon that surely is not uncommon with patients suffering from chronic arthritis pain) was included in the incidence figures.

It is worth mentioning that the article by Dabbs and Lauretti refers to neck pain only. Many chiropractors have in the past broadened its conclusions to mean that spinal manipulations or chiropractic care are safer than drugs. This is clearly not permissible without sound data to support such claims. As far as I can see, such data do not exist (if anyone knows of such evidence, I would be most thankful to let me see it).

To obtain a fair picture of the risks in a real life situation, one should perhaps also mention that chiropractors often fail to warn patients of the possibility of adverse effects. With NSAIDs, by contrast, patients have, at the very minimum, the drug information leaflets that do warn them of potential harm in full detail.

Finally, one could argue that the effectiveness and costs of the two therapies need careful consideration. The costs for most NSAIDs per day are certainly much lower than those for repeated sessions of manipulations. As to the effectiveness of the treatments, it is clear that NSAIDs do effectively alleviate pain, while the evidence seems far from being conclusively positive in the case of cervical manipulation.

In conclusion, the much-cited paper by Dabbs and Lauretti is out-dated, poor quality, and heavily biased. It provides no sound basis for an evidence-based judgement on the relative risks of cervical manipulation and NSAIDs. The notion that cervical manipulations are safer than NSAIDs is therefore not based on reliable data. Thus, it is misleading and irresponsible to repeat this claim.

 

Once again, I am indebted to the German homeopathy lobbyist, Jens Behnke (research officer at the Karl and Veronica Carstens-Foundation); this time for alerting me via a tweet to the existence of the ‘Institute for Scientific Homeopathy’ run by Dr K Lenger. Anyone who combines the terms ‘scientific’ and ‘homeopathy’ has my full attention.

The institution seems to be small (too small to have its own website); in fact, it seems to have just one member: Dr Karin Lenger. But size is not everything! Lenger has achieved something extraordinary: she has answered the questions that have puzzled many of us for a long time; she has found the ‘modus operandi’ of homeopathy by discovering that:

  • Homeopathy is a regulation therapy that acts (and reacts) as per the principle of resonance to deal hypo- and hyper-functions of pathological pathways.
  • As per resonance principle, the fundamental principles of homeopathy have the same frequencies so that the resonance principle can work.
  • Pathological pathways are cured by using their highly potentized substrates, inhibitors, and enzymes.
  • The efficacy of homeopathy now has a scientific base and is completely explained by applying biochemical and biophysical laws.

Progress at last!

If that is not noteworthy, what is?

But there is more!

This website, for instance, explains that Lenger Karin Dr.rer.nat., pursued Diploma in Biochem, studied Biochemistry at the Universities of Tubingen and Cologne. Her research topics revolved around enzymatic gene regulation, cancer research, enzymatic mechanisms of steroid hormones at the Medical University of Lubeck. In 1987 she became a Lecturer for Homeopathy at DHU ((Deutsche Homöopathie Union = German Homeopathy Union). Since 1995 she worked as a Homeopathic Practitioner and developed the “biochemical homeopathy” by using highly potentized substrates of pathological enzymes for her patients. She detected magnetic photons in high homeopathic potencies by two magnetic resonance methods and developed a model of physical and biochemical function of homeopathy.

Karin Lenger detected magnetic photons in highly diluted and potentized homeopathic remedies. Since the living body is an electromagnetic wavepackage (Einstein), the homeopathic law of Similars (Hahnemann 1755-1843) can be expressed as: the frequencies of the patient must match the frequencies of the remedies. Homeopathy is a regulation therapy curing hypo and hyperfunction of a pathological pathway by resonance: highly potentized substrates, inhibitors, enzymes, receptors of the distinct pathological pathways cure according to biochemical rules: A homeopathic symptom picture is obtained by poisoning a volunteer with a toxin. Simultaneously he develops psychological symptoms, the toxicological pathway and e.g. frequencies I-V. The highly potentized toxin has the frequencies I-V. The patient has symptoms as if he was poisoned by the toxin: during his illness he developed the toxicological pathway, frequencies I-V and psychological symptoms. The potentized toxin cures simultaneously the patient’s frequencies by resonance, his pathological pathway and the psychological symptoms. A stitch of honey bee, apis mellifica, causes a red oedema; a patient developing a red oedema at the finger-joint by rheumatism is cured by highly potentized Apis mellifica. Paralyses caused by a lack of the neurotransmitter acetylcholine bound to the acetylcholine-receptor at the post-synapsis can be healed by using these potentized remedies: the venom of cobra, Naja tripudians containing the receptor’s irreversible inhibitor cobrotoxin, the reversible inhibitor Atropine and Acetylcholine, daily applied. The availability of acetylcholine is maintained by glycolysis and fatty acid oxidation. This can be supported by giving these remedies: Lecithin, Lipasum, Glycerinum, Glucosum and Coenzyme A.

And in case, you are not yet fully convinced, a recent publication is bound to ball you over. Here is its abstract, if you need more, the link allows you to read the full paper as well:

Homeopathy, a holistic therapy, is believed to cure only acute symptoms of a beginning illness according to the Laws of Similars; but not deep, bleeding, septic wounds. The homeopaths refuse to heal according to special medical indications. Based on Lenger’s detection of magnetic photons in homeopathic remedies a biochemical and biophysical model of homeopathic healing was developed Biochemical, pathological pathways can be treated by their highly potentized substrates and inhibitors. Three groups of patients with moderate, severe and septic wounds had been successfully treated with the suitable remedies depending on the biochemical pathological state.

___________________________________________________________

Do I sense a Nobel Prize in the offing?

Surely!

Lenger’s clinical trial is baffling. But much more impressive are the ‘magnetic photons’ and the reference to Einstein. This is even more significant, if we consider what the genius (Einstein, not Lenger!) is reported to have said about homeopathy:  Einstein reflected for a little while and then said: “If one were to lock up 10 very clever people in a room and told them they were only allowed out once they had come up with the most stupid idea conceivable, they would soon come up with homeopathy.”

The ‘Dunning Kruger Effect‘ (DuKE) has been discussed here before. The DuKE means that, the less you know, the less able you are to recognize how little you know, and the less likely you are to recognize your limitations. Consequently, your confidence in yourself is inflated and you believe you are more competent than your opponent. Expressed differently:

  • Incompetence prevents the recognition of incompetence.
  • Too stupid to doubt.

A recent paper brilliantly shows the DuKE in action; here is its abstract

There is widespread agreement among scientists that genetically modified foods are safe to consume and have the potential to provide substantial benefits to humankind. However, many people still harbour concerns about them or oppose their use. In a nationally representative sample of US adults, we find that as extremity of opposition to and concern about genetically modified foods increases, objective knowledge about science and genetics decreases, but perceived understanding of genetically modified foods increases. Extreme opponents know the least, but think they know the most. Moreover, the relationship between self-assessed and objective knowledge shifts from positive to negative at high levels of opposition. Similar results were obtained in a parallel study with representative samples from the United States, France and Germany, and in a study testing attitudes about a medical application of genetic engineering technology (gene therapy). This pattern did not emerge, however, for attitudes and beliefs about climate change.

As I have stated before, I suspect the DuKE can explain much of what is going on in the realm of SCAM (so-called alternative medicine). So much so that I am tempted to re-write part of the above abstract as follows:

As extremity of belief in SCAM increases, objective knowledge about science and medicine decreases. In parallel, perceived understanding of science and medicine increases. Extreme believers in SCAM know the least, but think they know the most. Moreover, the relationship between self-assessed and objective knowledge shifts from positive to negative at high levels of SCAM-belief.

Yes, yes, I know. You are absolutely correct: this is little more than speculation! And I also realise, of course, that not everyone can have a full understanding of SCAM, medicine and science; however, if someone has a strong interest in (plus a strong opinion of) these matters, it would be advisable to read up about at least the most basic facts.

In case you disapprove, please do have a look at some of the recent comments on this blog or assess what some of the most famous proponents of SCAM tell the public, and I am confident that you will begin to suspect that my speculation might be not that far off the mark.

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.

I came across an embarrassingly poor and uncritical article that essentially seemed to promote a London-based clinic specialised in giving vitamins intravenously. Its website shows the full range of options on offer and it even lists the eye-watering prices they command. Reading this information, my amazement became considerable and I decided to share some of it with you.

Possibly the most remarkable of all the treatments on offer is this one (the following are quotes from the clinic’s website):

Stemcellation injections or placenta lucchini (sheep placenta) treatments are delivered intravenously (via IV), although intramuscular (IM) administration is also possible. Stem cells are reported to possess regenerative biological properties.

We offer two types of Stemcellation injections: a non-vegetarian option and a vegetarian-friendly option. Please enquire for further details.

Alongside placenta lucchini, Stemcellation injections at Vitamin Injections London contain a range of other potent active ingredients, including: physiologically active carbohydrate, nucleic acid, epithelial growth factor, amino acids, hydrolysed collagen, concentrated bioprotein and stem cells.

Please visit our Vitamin 101 section to learn more about the ingredients in Stemcellation sheep placenta injections.

Renowned for their powerful regenerating properties, Stemcellation injections can stimulate collagen production as well as:

  • Remedy cosmetic problems such as wrinkles, discolouration, pigmentation, eye bags and uneven skin tone;
  • Can be undertaken by those who are interested in maintaining their physical activity levels;
  • Can be undertaken alongside other IV/IM injections.

Vitamin Injections London is headed by skilled IV/IM Medical Aesthetician and Skin Specialist Bianca Estelle. Our skilled IV/IM practitioners will conduct a full review of your medical history and advise you regarding your suitability for Stemcellation injections.

END OF QUOTES

The only Medline-listed paper I was able to locate on the subject of placenta lucchini injections was from 1962 and did not substantiate any of the above claims. In my view, all of this begs many questions; here are just seven that spring into my mind:

  1. Is there any evidence at all that any of the intravenous injections/infusions offered at this clinic are effective for any condition other than acute vitamin deficiencies (which are, of course, extremely rare these days)?
  2. Would the staff be adequately trained to diagnose such cases?
  3. How do they justify the price tags for their treatments?
  4. What is a ‘medical aesthetician’ and a ‘skin specialist’?
  5. Is it at all legal for ‘medical aestheticians’ and ‘skin specialists’ (apparently without medical qualifications) to give intravenous injections and infusions?
  6. How many customers have suffered severe allergic reactions after placenta lucchini (or other) treatments?
  7. Is the clinic equipped and its staff adequately trained to deal with medical emergencies?

These are not rhetorical questions; I genuinely do not know the answers. Therefore, I would be obliged, if you could answer them for me, in case you know them.

 

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