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

Monthly Archives: March 2019

Crohn’s disease (CD) is an inflammatory bowel disease characterized by recurring flares altered by periods of inactive disease and remission, affecting physical and psychological aspects and quality of life (QoL). The aim of this study was to determine the therapeutic benefits of soft non-manipulative osteopathic techniques in patients with CD.

A randomized controlled trial was performed. It included 30 individuals with CD who were divided into 2 groups: 16 in the experimental group (EG) and 14 in the control group (CG). The EG was treated with the 6 manual techniques depicted below. All patients were advised to continue their prescribed medications and diets. The intervention period lasted 30 days (1 session every 10 days). Pain, global quality of life (GQoL) and QoL specific for CD (QoLCD) were assessed before and after the intervention. Anxiety and depression levels were measured at the beginning of the study.

A significant effect was observed of the treatment in both the physical and task subscales of the GQoL and also in the QoLCD but not in pain score. When the intensity of pain was taken into consideration in the analysis of the EG, there was a significantly greater increment in the QoLCD after treatment in people without pain than in those with pain. The improvements in GQoL were independent from the disease status.

The authors concluded that soft, non-manipulative osteopathic treatment is effective in improving overall and physical-related QoL in CD patients, regardless of the phase of the disease. Pain is an important factor that inversely correlates with the improvements in QoL.

Where to begin?

Here are some of the most obvious flaws of this study:

  1. It was far too small for drawing any far-reaching conclusions.
  2. Because the sample size was so small, randomisation failed to create two comparable groups.
  3. Sub-group analyses are based on even smaller samples and thus even less meaningful.
  4. The authors call their trial a ‘single-blind’ study but, in fact, neither the patients nor the therapists (physiotherapists) were blind.
  5. The researchers were physiotherapists, their treatments were mostly physiotherapy. It is therefore puzzling why they repeatedly call them ‘osteopathic’.
  6. It also seems unclear why these and not some other soft tissue techniques were employed.
  7. The CG did not receive additional treatment at all; no attempt was thus made to control for placebo effects.
  8. The stated aim to determine the therapeutic benefits… seems to be a clue that this study was never aimed at rigorously testing the effectiveness of the treatments.

My conclusion therefore is (yet again) that poor science has the potential to mislead and thus harm us all.

Researchers tend to report only studies that are positive, while leaving negative trials unpublished. This publication bias can mislead us when looking at the totality of the published data. One solution to this problem is the p-curve. A significant p-value indicates that obtaining the result within the null distribution is improbable. The p-curve is the distribution of statistically significant p-values for a set of studies (ps < .05). Because only true effects are expected to generate right-skewed p-curves – containing more low (.01s) than high (.04s) significant p-values – only right-skewed p-curves are diagnostic of evidential value. By telling us whether we can rule out selective reporting as the sole explanation for a set of findings, p-curve offers a solution to the age-old inferential problems caused by file-drawers of failed studies and analyses.

The authors of this article tested the distributions of sets of statistically significant p-values from placebo-controlled studies of homeopathic ultramolecular dilutions. Such dilute mixtures are unlikely to contain a single molecule of an active substance. The researchers tested whether p-curve accurately rejects the evidential value of significant results obtained in placebo-controlled clinical trials of homeopathic ultramolecular dilutions.

Their inclusion criteria were as follows:

  1. Study is accessible to the authors.
  2. Study is a clinical trial comparing ultramolecular dilutions to placebo.
  3. Study is randomized, with randomization method specified.
  4. Study is double-blinded.
  5. Study design and methodology result in interpretable findings (e.g., an appropriate statistical test is used).
  6. Study reports a test statistic for the hypothesis of interest.
  7. Study reports a discrete p-value or a test statistic from which a p-value can be derived.
  8. Study reports a p-value independent of other p-values in p-curve.

The first 20 studies, in the order of search output, that met the inclusion criteria were used for analysis.

The researchers found that p-curve analysis accurately rejects the evidential value of statistically significant results from placebo-controlled, homeopathic ultramolecular dilution trials (1st graph below). This result indicates that replications of the trials are not expected to replicate a statistically significant result. A subsequent p-curve analysis was performed using the second significant p-value listed in the studies, if a second p-value was reported, to examine the robustness of initial results. P-curve rejects evidential value with greater statistical significance (2nd graph below). In essence, this seems to indicate that those studies of highly diluted homeopathics that reported positive findings, i. e. homeopathy is better than placebo, are false-positive results due to error, bias or fraud.

The authors’ conclusion: Our results suggest that p-curve can accurately detect when sets of statistically significant results lack evidential value.

True effects with significant non-central distributions would have a greater density of low p-values than high p-values resulting in a right-skewed p-curve (like the dotted green lines in the above graphs). The fact that such a shape is not observed for studies of homeopathy confirms the many analyses previously demonstrating that ULTRAMOLECULAR HOMEOPATHIC REMEDIES ARE PLACEBOS.

As you know, I have repeatedly written about integrative cancer therapy (ICT). Yet, to be honest, I was never entirely sure what it really is; it just did not make sense – not until I saw this announcement. It left little doubt about the nature of ICT.

As it is in German, allow me to translate it for you [the numbers added to the text refer to my comments below]:

ICT is a method of treatment that views humans holistically [1]. The approach is characterised by a synergistic application (integration) of all conventional [the actual term used is a derogatory term coined by Hahnemann to denounce the prevailing medicine of his time], immunological, biological and psychological insights [2]. In this spirit, also personal needs and subjective experiences of disease are accounted for [3]. The aim of this special approach is to offer cancer patients an individualised, interdisciplinary treatment [4].

Besides surgery, chemotherapy and radiotherapy, ICT also includes hormone therapy, hyperthermia, pain management, immunotherapy, normalisation of metabolism, stabilisation of the psyche, physical activity, dietary changes, as well as substitution of vital nutrients [5].

With ICT, the newest discoveries of cancer research are being offered [6], that support the aims of ICT. Therefore, the aims of the ICT doctor include continuous research of the world literature on oncology [7]…

Likewise, one has to start immediately with measures that help prevent metastases and tumour progression [8]. Both the maximization of survival and the optimisation of quality of life ought to be guaranteed [9]. Therefore, the alleviation of the side-effects of the aggressive therapies are one of the most important aims of ICT [10]…

HERE IS THE GERMAN ORIGINAL

Die integrative Krebstherapie ist eine Behandlungsmethode, die den Menschen in seiner Ganzheit sieht und sich dafür einsetzt. Ihre Behandlungsweise ist gekennzeichnet durch die synergetische Anwendung (Integration) aller sinnvollen schulmedizinischen, immunologischen, biologischen und psychologischen Erkenntnisse. In diesem Sinne werden auch die persönlichen Bedürfnisse und die subjektiven Krankheitserlebnisse berücksichtigt. Ziel dieser besonderen Therapie ist es, dass dem Krebspatienten eine individuell eingerichtete und interdisziplinär geplante Behandlung angeboten wird.

Zur integrativen Krebstherapie gehört neben der operativen Tumorbeseitigung, Chemotherapie und Strahlentherapie auch die Hormontherapie, Hyperthermie, Schmerzbeseitigung, Immuntherapie, Normalisierung des Stoffwechsels, Stabilisierung der Psyche, körperliche Aktivierung, Umstellung der Ernährung sowie die Ergänzung fehlender lebensnotwendiger Vitalstoffe.

Mit dieser Behandlungsmethode werden auch die neuesten Entdeckungen der Krebsforschung angeboten, die die Ziele der Integrativen Krebstherapie unterstützen. Deshalb sind die ständigen Recherchen der umfangreichen Ergebnisse der Onkologie-Forschung in der medizinischen Weltliteratur auch Aufgabe der Mediziner in der Integrativen Krebstherapie…

Ebenso sollte auch sofort mit den Maßnahmen begonnen werden, die helfen, dieMetastasen Bildung und Tumorprogredienz zu verhindern. Nicht nur die Maximierung des Überlebens, sondern auch die Optimierung der Lebensqualität sollen gewährleistet werden. Deshalb ist auch die Linderung der Nebenwirkungen der aggressiven Behandlungsmethoden eines der wichtigsten Ziele der Integrativen Krebstherapie….

MY COMMENTS

  1. Actually, this describes conventional oncology!
  2. Actually, this describes conventional oncology!
  3. Actually, this describes conventional oncology!
  4. Actually, this describes conventional oncology!
  5. Actually, this describes conventional oncology!
  6. Actually, this describes conventional oncology!
  7. Actually, this describes conventional oncology!
  8. Actually, this describes conventional oncology!
  9. Actually, this describes conventional oncology!
  10. Actually, this describes conventional oncology!

ICT might sound fine to many consumers. I can imagine that it gives confidence to some patients. But it really is nothing other than the adoption of the principles of good conventional cancer care?

No!

But in this case, ICT is just a confidence trick!

It is a confidence trick that allows the trickster to smuggle no end of SCAM into routine cancer care!

Or did I miss something here?

Am I perhaps mistaken?

Please, do tell me!

The American Chiropractic Association (ACA) have just published new guidelines for chiropractors entitled ‘Guidelines for Disaster Service by Doctors of Chiropractic’. Let me show you a few short quotes from this remarkable document:

… Doctors of Chiropractic are uniquely qualified to serve in emergency situations in various capacities.

… their assessment and treatments can be performed in austere environments, on site or at staging areas providing rapid attention to the injury, accelerating healing and often decreasing or substituting the need for pharmaceutical intervention…

Through their education as primary care physicians, Doctors of Chiropractic have demonstrated competence in first aid and resuscitation skills and are able to assess, diagnose and triage so they may serve as first responders in the immediate care of victims at a disaster site…

During and after the disaster, the local Doctors of Chiropractic should interface with the state association and ACA to report on execution of action and outcome of the situation, make suggestions for response to future disasters and report any significant contacts made.

END OF QUOTES

Please allow me to make just 10 corrections and clarifications:

  1. Chiropractors are not medical doctors; to use the title in any medical context is misleading, to use it in the context of medical emergencies is quite simply reckless.
  2. Chiropractors are certainly not qualified to serve in emergency situations. This would require a totally different training, experience and set of skills.
  3. I am not aware of any good evidence that chiropractic can accelerate healing of any medical condition.
  4. I am also not aware that chiropractic might decrease or substitute the need for pharmaceutical interventions in emergency situations.
  5. Chiropractors are not primary care physicians.
  6. Chiropractors have not demonstrated competence in first aid and resuscitation skills.
  7. Chiropractors are not trained to diagnose the complex and often life-threatening conditions that occur in disaster situations.
  8. Chiropractors are not trained as first responders in disaster situations.
  9. Chiropractors are not qualified or trained to report on execution of action and outcome of disaster situation.
  10. Chiropractors are not qualified or trained to make suggestions for response to future disasters.

The new ACA guidelines are but a thinly disguised attempt to boost chiropractic. They have the potential to endanger lives. And they are an insult to those professionals who have trained hard to acquire the skills to respond to emergencies and disaster situations.

In other words, they are guidelines not for dealing with disasters, but for creating them.

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