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

Cancer

1 2 3 13

After 25 years of full-time research into alternative medicine, I thought that I have seen it all. But I was wrong! Here is an article that surpasses every irresponsible stupidity I can remember. It is entitled ‘Ginger is the monumentally superior alternative to chemotherapy‘:

Let’s say that your doctor has given you a cancer diagnosis. Let’s revisit animal wisdom. If a squirrel was looking over a tasty morsel of ginger on one side, or a vial full of Mehotrexate, Danorubicin or Tioguanine on the other, what would that intelligent squirrel choose? The answer is obvious. And it’s the right answer, because ginger roots, after being dried and cooked, manifest an ingredient called 6-shogaol.

This naturally occurring element is up to 10,000 times more effective at killing cancer cells than those vials of destructive drugs, reports David Guiterrez from Natural News, who states that “researchers found that 6-shogaol is active against cancer stem cells at concentrations that are harmless to healthy cells. This is dramatically different from conventional chemotherapy, which has serious side effects largely because it kills healthy as well as cancerous cells.”

END OF QUOTE

As David Guiterrez from Natural News might not be the most reliable of sources, I did a bit of searching for evidence. This is what I found:

A study examining the efficacy of ginger, as an adjuvant drug to standard antiemetic therapy, in ameliorating acute and delayed CINV in patients with lung cancer receiving cisplatin-based regimens. It concluded that as an adjuvant drug to standard antiemetic therapy, ginger had no additional efficacy in ameliorating CINV in patients with lung cancer receiving cisplatin-based regimens.

A randomized, double-blind, placebo-controlled, multicenter study in patients planned to receive ≥2 chemotherapy cycles with high dose (>50 mg/m2) cisplatin. Patients received ginger 160 mg/day (with standardized dose of bioactive compounds) or placebo in addition to the standard antiemetic prophylaxis for CINV, starting from the day after cisplatin administration. The authors found that in patients treated with high-dose cisplatin, the daily addition of ginger, even if safe, did not result in a protective effect on CINV. 

Yes, there are also a few trials to suggest that ginger is effective for reducing nausea and vomiting after chemotherapy, but by and large they are older and less rigorous. And anyway, this is besides the point. The question here is not whether there is good evidence to show that ginger is helpful against chemo-induced nausea; the question is whether Ginger is clinically effective in ‘killing cancer cells’. And the answer is an emphatic

NO!!!

And this means the above-quoted article irresponsible, unethical, perhaps even criminal to the extreme. I shudder to think how many cancer patients have read it and consequently given up their conventional treatments opting for Ginger instead.

I have just been in Sao Paulo to give a lecture at the opening of a new university institute, ‘Question of Science‘. Under the leadership of Natalia Pasternak, the institute will promote scepticism in Brazil, particularly in the area of alternative medicine. Brazil currently has no less than 29 types of alternative medicine paid for with public money, and even homeopathy is officially being recognised and taught at all Brazilian medical schools.

But the most peculiar case of Brazilian quackery must surely be phosphoethanolamine. Gilberto Chierice, a Chemistry Professor at the University of São Paulo, used resources from a campus laboratory to unofficially manufacture, distribute, and promote the chemical to cancer patients claiming that it was a cheap cure for all cancers without side-effects. Remarkably, this was in the total absence of through clinical testing. In September 2015, university administrators therefore began preventing him from continuing with this practice. However, in October 2015, several courts in Brazil ruled in favour of plaintiffs who wanted the compound to remain available. In an unusual move of defence of common sense, a state court overturned the lower courts’ decision a month later, and the secretary for Brazil’s science and technology ministry promised to fund further research on the compound. In 2016, a law was passed in Brazil allowing the sale of synthetic phosphorylethanolamine for cancer treatment. Due to opposition from the Brazilian Medical Association, the Brazilian Society of Clinical Oncology, and the regulatory agency ANVISA, the country’s Supreme Court then suspended the law. I was told that a stepwise plan of clinical testing had been implemented. As the drug even failed to pass the most preliminary tests, the program had to be aborted.

This story seems like a re-play of many similar tales of bogus cancer cures of the past. They all seem to follow a similar pattern:

  1. Someone dreams up a ‘cure’ for all cancers that is cheap and free of side-effects.
  2. This appeals to many desperate cancer patients who are fighting for their lives.
  3. It also attracts several entrepreneurs who are hoping to make a fast buck.
  4. The story is picked up by the press and consequently a sizable grass-roots movement of support emerges.
  5. Populist politicians jump on the vote-winning band-waggon.
  6. The experts caution that the bogus cancer ‘cure’ is devoid of evidence and might put patients’ lives at risk.
  7. The legislators get involved.
  8. Law suits start left, right and centre.
  9. Eventually, the cancer ‘cure’ is scientifically tested and confirmed to be bogus.
  10. Eventually, the law rules against the bogus ‘cure’.
  11. A conspiracy theory emerges stating that the cancer ‘cure’ was unjustly suppressed to protect the interests of Big Pharma.
  12. A few years later, the subject re-surfaces and the whole cycle starts from the beginning.

Such stories remind us that fighting bogus claims is hugely important, even if it does not always succeed or turns out to be merely an exercise of damage limitation. Every life saved by the struggle against quackery makes it worthwhile.

I wish the new Institute ‘Question of Science‘ all the luck it richly deserves and desperately needs.

I only recently came across this review; it was published a few years ago but is still highly relevant. It summarizes the evidence of controlled clinical studies of TCM for cancer.

The authors searched all the controlled clinical studies of TCM therapies for all kinds of cancers published in Chinese in four main Chinese electronic databases from their inception to November 2011. They found a total of 2964 reports (involving 253,434 cancer patients) including 2385 randomized controlled trials and 579 non-randomized controlled studies.

The top seven cancer types treated were lung cancer, liver cancer, stomach cancer, breast cancer, esophagus cancer, colorectal cancer and nasopharyngeal cancer by both study numbers and case numbers. The majority of studies (72%) applied TCM therapy combined with conventional treatment, whilst fewer (28%) applied only TCM therapy in the experimental groups. Herbal medicine was the most frequently applied TCM therapy (2677 studies, 90.32%). The most frequently reported outcome was clinical symptom improvement (1667 studies, 56.24%) followed by biomarker indices (1270 studies, 42.85%), quality of life (1129 studies, 38.09%), chemo/radiotherapy induced side effects (1094 studies, 36.91%), tumour size (869 studies, 29.32%) and safety (547 studies, 18.45%).

The authors concluded that data from controlled clinical studies of TCM therapies in cancer treatment is substantial, and different therapies are applied either as monotherapy or in combination with conventional medicine. Reporting of controlled clinical studies should be improved based on the CONSORT and TREND Statements in future. Further studies should address the most frequently used TCM therapy for common cancers and outcome measures should address survival, relapse/metastasis and quality of life.

This paper is important, in my view, predominantly because it exemplifies the problem with TCM research from China and with uncritical reviews on this subject. If a cancer patient, who does not know the background, reads this paper, (s)he might think that TCM is worth trying. This conclusion could easily shorten his/her life.

The often-shown fact is that TCM studies from China are not reliable. They are almost invariably positive, their methodological quality is low, and they are frequently based on fabricated data. In my view, it is irresponsible to publish a review that omits discussing these facts in detail and issuing a stark warning.

TCM FOR CANCER IS A VERY BAD CHOICE!

The Clinic for Complementary Medicine and Diet in Oncology was opened, in collaboration with the oncology department, at the Hospital of Lucca (Italy) in 2013. It uses a range of alternative therapies aimed at reducing the adverse effects of conventional oncology treatments.

Their latest paper presents the results of complementary medicine (CM) treatment targeted toward reducing the adverse effects of anticancer therapy and cancer symptoms, and improving patient quality of life. Dietary advice was aimed at the reduction of foods that promote inflammation in favour of those with antioxidant and anti-inflammatory properties.

This is a retrospective observational study on 357 patients consecutively visited from September 2013 to December 2017. The intensity of symptoms was evaluated according to a grading system from G0 (absent) to G1 (slight), G2 (moderate), and G3 (strong). The severity of radiodermatitis was evaluated with the Radiation Therapy Oncology Group (RTOG) scale. Almost all the patients (91.6%) were receiving or had just finished some form of conventional anticancer therapy.

The main types of cancer were breast (57.1%), colon (7.3%), lung (5.0%), ovary (3.9%), stomach (2.5%), prostate (2.2%), and uterus (2.5%). Comparison of clinical conditions before and after treatment showed a significant amelioration of all symptoms evaluated: nausea, insomnia, depression, anxiety, fatigue, mucositis, hot flashes, joint pain, dysgeusia, neuropathy.

The authors concluded that the integration of evidence-based complementary treatments seems to provide an effective response to cancer patients’ demand for a reduction of the adverse effects of anticancer treatments and the symptoms of cancer itself, thus improving patient’s quality of life and combining safety and equity of access within public healthcare systems. It is, therefore, necessary for physicians (primarily oncologists) and other healthcare professionals in this field to be appropriately informed about the potential benefits of CMs.

Why do I call this ‘wishful thinking’?

I have several reasons:

  1. A retrospective observational study cannot establish cause and effect. It is likely that the findings were due to a range of factors unrelated to the interventions used, including time, extra attention, placebo, social desirability, etc.
  2. Some of the treatments in the therapeutic package were not CM, reasonable and evidence-based. Therefore, it is likely that these interventions had positive effects, while CM might have been totally useless.
  3. To claim that the integration of evidence-based complementary treatments seems to provide an effective response to cancer patients’ is pure fantasy. Firstly, some of the CMs were certainly not evidence-based (the clinic’s prime focus is on homeopathy). Secondly, as already pointed out, the study does not establish cause and effect.
  4. The notion that it is necessary for physicians (primarily oncologists) and other healthcare professionals in this field to be appropriately informed about the potential benefits of CMs is not what follows from the data. The paper shows, however, that the authors of this study are in need to be appropriately informed about EBM as well as CM.

I stumbled across this paper because a homeopath cited it on Twitter claiming that it proves the effectiveness of homeopathy for cancer patients. This fact highlights why such publications are not just annoyingly useless but acutely dangerous. They mislead many cancer patients to opt for bogus treatments. In turn, this demonstrates why it is important to counterbalance such misinformation, critically evaluate it and minimise the risk of patients getting harmed.

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.

The ‘Schwaebische Tageblatt’ is not on my regular reading list. But this article of yesterday (16/10/2018) did catch my attention. For those who read German, I will copy it below, and for those who don’t I will provide a brief summary and comment thereafter:

Die grün-schwarze Landesregierung lässt 2019 den ersten Lehrstuhl für Naturheilkunde und Integrative Medizin in Baden-Württemberg einrichten. Lehrstuhl für Naturheilkunde und Integrative Medizin

Ihren Schwerpunkt soll die Professur im Bereich Onkologie haben. Strömungen wie Homöopathie oder Anthroposophie sollen nicht gelehrt, aber innerhalb der Lehre beleuchtet werden, sagte Ingo Autenrieth, Dekan der Medizinischen Fakultät in Tübingen am Dienstag der Deutschen Presse-Agentur. «Ideologien und alles, was nichts mit Wissenschaft zu tun hat, sortieren wir aus.»

Die Professur soll sich demnach mit Themen wie Ernährung, Probiotika und Akupunktur beschäftigten. Geplant ist laut Wissenschaftsministerium, die Lehre in Tübingen anzusiedeln; die Erforschung der komplementären Therapien soll vorwiegend am Centrum für Tumorerkrankungen des Robert-Bosch-Krankenhauses in Stuttgart stattfinden. Die Robert-Bosch-Stiftung finanziert die Professur in den ersten fünf Jahren mit insgesamt 1,84 Millionen Euro, danach soll das Land die Mittel dafür bereitstellen.

«Naturheilkunde und komplementäre Behandlungsmethoden werden von vielen Menschen ganz selbstverständlich genutzt, beispielsweise zur Ergänzung konventioneller Therapieangebote», begründete Wissenschaftsministerin Theresia Bauer (Grüne) das Engagement. Sogenannte sanfte oder natürliche Methoden könnten schwere Krankheiten wie etwa Krebs alleine nicht heilen, heißt es in einer Mitteilung des Ministeriums. Wissenschaftliche Ergebnisse zeigten aber, dass sie häufig zu Therapieerfolgen beitragen könnten, da sie den Patienten helfen, schulmedizinische Therapien gut zu überstehen – etwa die schweren Nebenwirkungen von Chemotherapien mindern.

Im Gegensatz zur Schulmedizin gebe es bisher aber kaum kontrollierte klinische Studien zur Wirksamkeit solcher Therapien, ergänzte Ingo Autenrieth. Ihre Erforschung am neuen Lehrstuhl solle Patienten Sicherheit bringen und ermöglichen, dass die gesetzlichen Krankenkassen die Kosten dafür übernehmen.

Hersteller alternativer Arzneimittel loben den Schritt der Politik. «Baden-Württemberg nimmt damit eine Vorreiterrolle in Deutschland und in Europa ein», heißt es beim Unternehmen Wala Heilmittel GmbH in Bad Boll. Die Landesregierung trage mit der Entscheidung dem Wunsch vieler Patienten und Ärzte nach umfassenden Behandlungskonzepten Rechnung.

Auch hoffen die Unternehmen, dass Licht in die oft kritische Debatte um Homöopathie gebracht wird. «Wir sehen mit Erstaunen und Befremden, dass eine bewährte Therapierichtung wie die Homöopathie, die Teil der Vielfalt des therapeutischen Angebots in Deutschland ist, diskreditiert werden soll», sagte ein Sprecher des Herstellers Weleda AG mit Sitz in Schwäbisch Gmünd der Deutschen Presse-Agentur. Deshalb begrüße man den Lehrstuhl: «Es ist gut, dass Forschung und Lehre ausgebaut werden, da eine Mehrheit der Bevölkerung Komplementärmedizin wünscht und nachfragt. Es braucht Ärzte, die in diesen Bereichen auch universitär ausgebildet werden.»

Laut Koalitionsvertrag will Baden-Württemberg künftig eine Vorreiterrolle in der Erforschung der Komplementärmedizin einnehmen. Bisher gab es im Südwesten mit dem Akademischen Zentrum für Komplementäre und Integrative Medizin (AZKIM) zwar einen Verbund der Unikliniken Tübingen, Freiburg, Ulm und Heidelberg, aber keinen eigenen Lehrstuhl. Bundesweit existieren nach Angaben der Hufelandgesellschaft, dem Dachverband der Ärztegesellschaften für Naturheilkunde und Komplementärmedizin, Lehrstühle für Naturheilkunde noch an den Universitäten Duisburg-Essen, Rostock und Witten/Herdecke sowie drei Stiftungsprofessuren an der Berliner Charité.

END OF QUOTE

And here is my English summary:

The black/green government of Baden-Wuerttemberg has decided to create a ‘chair of naturopathy and integrated medicine’ at the university of Tuebingen in 2019. The chair will focus in the area of oncology. Treatments such as homeopathy and anthroposophical medicine will not be taught but merely mentioned in lectures. Ideologies and everything that is not science will be omitted.

The chair will thus deal with nutrition, acupuncture and probiotics. The teaching activities will be in the medical faculty at Tuebingen, while the research will be located at the Robert-Bosch Hospital in Stuttgart. The funds for the first 5 years – 1.84 million Euro – will come from the Robert-Bosch Foundation; thereafter they will be provided by the government of the county.

So-called gentle or natural therapies cannot cure serious diseases on their own, but as adjuvant treatments they can be helful, for instance, in alleviating the adverse effects of chemotherapy. There are only few studies on this, and the new chair will increase patient safety and facilitate the reimbursement of these treatments by health insurances.

Local anthroposophy manufacturers like Wala welcomed the move stating it would be in accordance with the wishes of many patients and doctors. They also hope that the move will bring light in the current critical debate about homeopathy. A spokesperson of Weleda added that they ‘note with surprise that time-tested therapies like homeopathy are being discredited. Therefore, it is laudable that research and education in this realm will be extended. The majority of the public want complementary medicine and need doctors who are also university-trained.’

Baden-Wurttemberg aims for a leading role in researching complementary medicine. Thus far, chairs of complementary medicine existed only at the universities of Duisburg-Essen, Rostock und Witten/Herdecke as well as three professorships at the Charité in Berlin.

END OF MY SUMMARY

As I have occupied a chair of complementary medicine for 19 years, I am tempted to add a few points here.

  • In principle, a new chair can be a good thing.
  • The name of the chair is odd, to say the least.
  • As the dean of the Tuebingen medical school pointed out, it has to be based on science. But how do they define science?
  • Where exactly does the sponsor, the Robert-Bosch Stiftung, stand on alternative medicine. Do they have a track-record of being impractical and scientific?
  • In order to prevent this becoming a unrealistic prospect, it is essential that the new chair needs to fall into the hands of a scientist with a proven track record of critical thinking.
  • Rigorous scientist with a proven track record of critical thinking are very rare in the realm of alternative medicine.
  • The ridiculous comments by Wala and Weleda, both local firms with considerable local influence, sound ominous and let me suspect that proponents of alternative medicine aim to exert their influence on the new chair.
  • The above-voiced notion that the new chair is to facilitate the reimbursement of alternative treatments by the health insurances seems even more ominous. Proper research has to be objective and could, depending on its findings, have the opposite effect. To direct it in this way seems to determine its results before the research has started.
  • I miss a firm commitment to medical ethics, to the principles of EBM, and to protecting the independence of the new chair.

Thus, I do harbour significant anxieties about this new chair. It is in danger of becoming a chair of promoting pseudoscience. I hope the dean of the Tuebingen medical school might read these lines.

I herewith offer him all the help I can muster in keeping pseudoscience out of this initiative, in defining the remit of the chair and, crucially, in finding the right individual for doing the job.

After a previous post about aromatherapy, someone recently commented:

I love essential oils and use them daily. Essential oils became a part of my life! I do feel better with it! Why I need clinical trials so?

The answer is probably: you don’t need clinical trials for a little pampering that makes you feel good.

But, if someone claims that aromatherapy (or indeed any other treatment) is effective for this or that medical condition, we need proof in the form of a clinical trial. By proof, we usually mean a clinical trial.

One like this new study, perhaps?

The aim of this study was to evaluate the use of a lavender aromatherapy skin patch on anxiety and vital sign variability during the preoperative period in female patients scheduled for breast surgery. Participants received an aromatherapy patch in addition to standard preoperative care. Anxiety levels were assessed with a 10-cm visual analogue scale (VAS) at baseline and then every 15 minutes after patch placement. Vital sign measurements were recorded at the same interval. There was a statistically significant decrease (P = .03) in the anxiety VAS measurements from baseline to final scores.

The authors concluded that the findings from this study suggest the use of aromatherapy is beneficial in reducing anxiety experienced by females undergoing breast surgery. Further research is needed to address the experience of preoperative anxiety, aromatherapy use, and the challenges of managing preoperative anxiety.

No, not one like this study!

This study – its called it a ‘pilot study’ – tells us nothing of value.

Why?

  1. It was not a pilot study because it did not pilot anything; its aim was to evaluate aromatherapy.
  2. But it could not evaluate aromatherapy because it had no control group. This means the reduction in anxiety was almost certainly not a specific effect of the therapy, but a non-specific effect due to the extra attention, expectation, etc.
  3. This means that the conclusion (the use of aromatherapy is beneficial) is not justified.
  4. In turn, this means that the paper is not helpful in any way. All it can possibly do is to mislead the public.

In summary: another fine example of pseudo-research that, I believe, is worse than no research at all.

Dr Alok Pareek has been elected as the World President of the International Homeopathic Medical league (LMHI – Liga Medicorum Homoeopathica Internationalis), the largest, oldest and only association of Medical Homeopaths in the World. He is the first Asian in 4 decades to bring this honour to India. Dr Alok Pareek was elected at the 71st World Congress of the LMHI held in Buenos Aires, Argentina on 23rd August 2016. He was elected unopposed by over 70 member countries. He has been elected for a three year tenure from 2016 to 2019

Dr. Alok Pareek runs a homeopathic hospital together with his father R.S. Pareek in Agra, India with fifty beds, treating around two hundred patients daily. His clinical practice spans thirty years. This extensive experience has given him a wealth of opportunity to carry out and refine homeopathic treatment in a wide range of acute and emergency situations…  Dr. Pareek demonstrates that homeopathy has much to offer in acute and emergency settings. He aims to increase the confidence of practitioners, to improve results and encourage them to offer safe and effective treatment in this important field, enabling homeopathy to take its place alongside conventional approaches within mainstream medicine. “As an Emergency Medicine physician who deals with life threatening diseases on a daily basis, I found Dr. Pareek’s homeopathic approach to be full of well-rounded clinical criteria and plenty of wise advice to the homeopathic doctor. I truly hope to be in medicine long enough to see us practice ‘hand in hand’ and enjoy the great benefits of this marvelous ‘scientific marriage’ in my emergency medicine patients.” Gladys H. Lopez M.D., M.P.H. USA Board Certified in Emergency ­Medicine

These two quotes might give you a fairly good impression of Dr Alok Pareek.

But why do I dedicate an entire post to him?

The reason is that I was alerted to one of his books entitled ‘Cancer is curable with homeopathy’. Even though it is obviously a translation from English, I could not find the original; so you have to bear with me as I translate for you the German abstract copied below:

75 years of homeopathic experience by father and son from India are expressed in this book about the homeopathic cure of cancers. Based on excellently documented cases, it demonstrates how homeopathy is clearly superior to chemotherapy and radiotherapy. We experience how a cure is possible even for such a serious disease as cancer in advanced stages. Dr D. Spinedi (Switzeralnd) estimates the immense experience of the doctors Pareek as ‘essential basic knowledge that should be accessible to all homeopaths’. It is a book that gives courage to both patients and therapists.

Zusammen 75 Jahre homöopathischer Erfahrung von Vater und Sohn Pareek aus Indien mit Tausenden von Patienten finden in diesem Buch ihren Niederschlag in der homöopathischen Heilung von Krebserkrankungen. Anhand exzellent dokumentierter Fallbeispiele wird gezeigt, wie in klassischer Arbeitsweise die Homöopathie der Chemotherapie und der Strahlentherapie deutlich überlegen ist. Wir erleben mit, wie Heilung bei einer so schweren Krankheit wie Krebs auch noch in fortgeschrittenen Stadien durch Homöopathie möglich ist. Dr. D. Spinedi (Schweiz) wertet die immense Erfahrung der Dres. Pareek als “unverzichtbares Grundlagenwissen, das allen Homöopathen zugänglich sein sollte.” Ein Buch, das Patienten wie Therapeuten Mut macht!

It is by Jove not often that I am speechless, but today, that’s exactly what I am.

Endocrine therapy (ET) is often used to reduce the risk of recurrence in hormone receptor-expressing disease. It is associated with worsening of climacteric symptoms can therefore have a negative impact on the quality of life (QoL) of those affected. Homeopathy is sometimes recommended for management of hot flushes (HF), and a new study aimed to test whether it is effective.

In this multi-centre, double-blind, placebo-controlled RCT, women were included suffering from histologically proven non-metastatic localized breast cancer, with Eastern Cooperative Oncology Group-Performance Status (ECOG-PS) ≤ 1, treated for at least 1 month with adjuvant ET, and complaining about moderate to severe HF. Patients scheduled for chemotherapy, or radiotherapy, or those with associated pathology known to induce HF were excluded. After a 2- to 4-week placebo administration, patients were randomly assigned to receiving the homeopathic medicine complex Actheane® (arm A) or placebo (arm P). Randomization was stratified by adjuvant ET (taxoxifen/aromatase inhibitor) and recruiting site. HF scores (HFS) were calculated as the mean of HF frequencies before randomization, at 4, and at 8 weeks post-randomization (pre-, 4w,- and 8w-) weighted by a 4-level intensity scale. The primary endpoint was the variation between pre- and 4week-HFS. Secondary endpoints included HFS variation between pre- and 8week-HFS. Compliance and tolerance were assessed 8 weeks after randomization, and QoL and satisfaction were assessed at 4- and 8-week post-randomization.

In total, 138 patients were randomized (A, 65; P, 73). Median 4week-HFS absolute variation (A, - 2.9; P, - 2.5 points, p = 0.756) and relative decrease (A, - 17%; P, - 15%, p = 0.629) were not statistically different between the two arms. However, 4week-HFS decreased for 46 (75%) in A vs 48 (68%) patients in P arm. 4week-QoL was stable or improved for respectively 43 (72%) vs 51 (74%) patients (p = 0.470).

The authors concluded that the efficacy endpoint was not reached, and BRN-01 administration was not demonstrated as an efficient treatment to alleviate HF symptoms due to adjuvant ET in breast cancer patients. However, the study drug administration led to decreased HFS with a positive impact on QoL. Without any recommended treatment to treat or alleviate the HF-related disabling symptoms, Actheane® could be a promising option, providing an interesting support for better adherence to ET, thereby reducing the risk of recurrence with a good tolerance profile.

At the start of their abstract, the authors state that homeopathy might allow a better management of hot flushes (HF). Frankly, I fail to see the evidence for this statement. The only study I know of (by a known advocate of homeopathy) showed no effect of homeopathy.

Acthéane is a mixture marketed by Boiron of 5 ingredients:
– Actaea racemosa 4 CH : 0,5 mg
– Arnica montana 4 CH : 0,5 mg
– Glonoinum 4 CH : 0,5 mg
– Lachesis mutus 5 CH : 0,5 mg
– Sanguinaria canadensis 4 CH : 0,5 mg

I am not aware of evidence that this remedy might work.

If there is no plausible rationale for conducting a study, does that not mean it is ethically questionable to do it?

Apart from that, the study seems well-designed. It is not very well presented, but the paper is clear enough. Its results are as one would expect from a rigorous trial of homeopathy. The fact that the authors try to squeeze out some positive messages from this squarely negative study is, of course, pathetic. To mention in the abstract that 4week-HFS decreased for 46 (75%) in A vs 48 (68%) patients (not the primary outcome measure) in P arm is little more than an embarrassing tribute to the sponsor, in my view.

Boiron Canada state on their website that Acteane® is a homeopathic medicine used for the relief of perimenopause and menopause symptoms such as hot flashes, night sweats, sleep disorders, headache, irritability and mood swings.

The benefits of Acteane, a new solution for women:

• Hormone-free
• Soy-free
• Can be associated with other treatments used during perimenopause
• Non-drowsy
• Chewable tablets
• Does not require water

WILL THEY NOW ADD ‘EFFECT-FREE’ TO THEIR LIST?

Do musculoskeletal conditions contribute to chronic non-musculoskeletal conditions? The authors of a new paper – inspired by chiropractic thinking, it seems – think so. Their meta-analysis was aimed to investigate whether the most common musculoskeletal conditions, namely neck or back pain or osteoarthritis of the knee or hip, contribute to the development of chronic disease.

The authors searched several electronic databases for cohort studies reporting adjusted estimates of the association between baseline neck or back pain or osteoarthritis of the knee or hip and subsequent diagnosis of a chronic disease (cardiovascular disease , cancer, diabetes, chronic respiratory disease or obesity).

There were 13 cohort studies following 3,086,612 people. In the primary meta-analysis of adjusted estimates, osteoarthritis (n= 8 studies) and back pain (n= 2) were the exposures and cardiovascular disease (n=8), cancer (n= 1) and diabetes (n= 1) were the outcomes. Pooled adjusted estimates from these 10 studies showed that people with a musculoskeletal condition have a 17% increase in the rate of developing a chronic disease compared to people without a musculoskeletal condition.

The authors concluded that musculoskeletal conditions may increase the risk of chronic disease. In particular, osteoarthritis appears to increase the risk of developing cardiovascular disease. Prevention and early

treatment of musculoskeletal conditions and targeting associated chronic disease risk factors in people with long

standing musculoskeletal conditions may play a role in preventing other chronic diseases. However, a greater

understanding about why musculoskeletal conditions may increase the risk of chronic disease is needed.

For the most part, this paper reads as if the authors are trying to establish a causal relationship between musculoskeletal problems and systemic diseases at all costs. Even their aim (to investigate whether the most common musculoskeletal conditions, namely neck or back pain or osteoarthritis of the knee or hip, contribute to the development of chronic disease) clearly points in that direction. And certainly, their conclusion that musculoskeletal conditions may increase the risk of chronic disease confirms this suspicion.

In their discussion, they do concede that causality is not proven: While our review question ultimately sought to assess a causal connection between common musculoskeletal conditions and chronic disease, we cannot draw strong conclusions  due  to  poor  adjustment,  the  analysis methods employed by the included studies, and a lack of studies investigating conditions other than OA and cardiovascular disease…We did not find studies that satisfied all of Bradford Hill’s suggested criteria for casual inference (e.g. none estimated dose–response effects) nor did we find studies that used contemporary causal inference methods for observational data (e.g. a structured identification approach for selection of confounding variables or assessment of the effects of unmeasured or residual confounders. As such, we are unable to infer a strong causal connection between musculoskeletal conditions and chronic diseases.

In all honesty, I would see this a little differently: If their review question ultimately sought to assess a causal connection between common musculoskeletal conditions and chronic disease, it was quite simply daft and unscientific. All they could ever hope is to establish associations. Whether these are causal or not is an entirely different issue which is not answerable on the basis of the data they searched for.

An example might make this clearer: people who have yellow stains on their 2nd and 3rd finger often get lung cancer. The yellow fingers are associated with cancer, yet the link is not causal. The association is due to the fact that smoking stains the fingers and causes cancer. What the authors of this new article seem to suggest is that, if we cut off the stained fingers of smokers, we might reduce the cancer risk. This is clearly silly to the extreme.

So, how might the association between musculoskeletal problems and systemic diseases come about? Of course, the authors might be correct and it might be causal. This would delight chiropractors because DD Palmer, their founding father, said that 95% of all diseases are caused by subluxation of the spine, the rest by subluxations of other joints. But there are several other and more likely explanations for this association. For instance,  many people with a systemic disease might have had subclinical problems for years. These problems would prevent them from pursuing a healthy life-style which, in turn, resulted is musculoskeletal problems. If this is so, musculoskeletal conditions would not increase the risk of chronic disease, but chronic diseases would lead to musculoskeletal problems.

Don’t get me wrong, I am not claiming that this reverse causality is the truth; I am simply saying that it is one of several possibilities that need to be considered. The fact that the authors failed to do so, is remarkable and suggests that they were bent on demonstrating what they put in their conclusion. And that, to me, is an unfailing sign of poor science.

1 2 3 13
Recent Comments

Note that comments can be edited for up to five minutes after they are first submitted but you must tick the box: “Save my name, email, and website in this browser for the next time I comment.”


Click here for a comprehensive list of recent comments.

Categories