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Papp R., Schuback G., Beck E., Burkard G., Bengel J., Lehrl S. and Belon P. (1998) ‘Oscillococcinum® in patients with influenza-like syndromes: a placebo-controlled double-blind evaluation’, British Homeopathic Journal, vol. 87, pp. 69-76. [permalink]

Links: [abstract, science direct]

Responses:

[Scepticblog] - “[Papp 1998] was published in the British Homeopathic Journal. This is a publication dedicated to the promotion of homeopathy; by no conceivable argument can it be considered a scientific journal. It’s essentially a place for the marketers of homeopathic products to send their press releases in order to be able to say that their research is ‘published’.”

[Quackdown] - “The Papp R et al. study, aside from finding that at 7-10 days after the start of the trial the differences in recovery between the treatment (verum) group and the placebo group were not statistically significant, included the statement that:

“’The health of 12.6% of the patients of the verum group (16% of the placebo group) had not improved after 48% hours. Almost one third of the patients in the verum group took other medication during the trial. The fact that according to final assessment, 80% of the patients of the verum group (77 % of the placebo group) had recovered is not surprising since the disease lasts only 5-10 days even without medication ...’

“… the study found no statistically significant difference between the recovery groups, [and] dates back to 1998, which again presents the question of whether or not this is sufficiently up to date and current...”

[EdzardErnst.com] - “This ‘confirmation’ (Papp et al) was undertaken soon afterwards, namely in the beginning of 1991, but the results were only published in 1998 and cannot be found on Pubmed. In this paper the definitions are somewhat different, but Papp et al. report that of 334 patients (167 verum) a total of 57 (32 verum) were cured in 48 hours. Now 25 versus 32 is not remarkable at all. One doesn’t need any elaborate computation for this. Calculation gives p=0.4. So one might think that the Ferley hypothesis was soundly refuted. But Papp et al. used something they call ‘the Krauth test’, probably some kind of automated post hoc fishing trip to select the best criteria to distinguish the placebo and verum groups. They claim that this ‘test’ gives p=0.0028. They specifically refer to ‘the null hypothesis (the number of patients free of symptoms after 48 hours is equal in both treatment groups)’, so their computation is wrong. The most remarkable thing about Papp et al. is that nobody seems to have to have noticed the large discrepancy between what the numbers say and the claim of the paper.”

[Science-based medicine] - “... beginning 1991, other researchers among which [was] the boss of Boiron Clinical Research Lab, repeated the test. In their paper (Papp et al) you have to look carefully to find how the Ferley hypothesis fared. Notwithstanding that they changed the definitions of sick and cured they got only p=0.44 for the Ferley hypothesis. Next they concocted out of 17 variables a ‘trend’ which was ‘significant’. It is hard to believe that they already had precisely this trend in mind before the test. Then it took them about 7 years to find a journal willing to publish their stuff.”

Despite the authors' attempt at a positive spin on their results, “The clinical trial showed that treatment of influenza-like syndromes with Oscillococcinum® has a positive effect on the decline of symptoms and on the duration of the disease”, the effect on the subjects in this study was marginal. Even in the abstract it is apparent that they are clutching at statistical straws by emphasising the few times when homeopathy appeared to do well but failing to mention the times when it did less well.

It is important to note the ®, registered trademark, symbol in the title and text of this paper. The paper was published in a pro-homeopathy journal and refers to a product manufactured by the multi-national  homeopathic pharmacy, Boiron, with its annual turnover of many millions of dollars. That's pretty rich (literally) coming from a branch of alternative medicine which has, as one of its main recurring arguments, the power of so called “big-pharma” to influence trial results. This trial has got “vested interest” written all over it.

In addition, it is thoroughly out of step with other research on the subject, such as Guo et al 2007 and, most notably the Cochrane database in a study carried out by homeopathic stalwarts Mathie and Fisher, in 2012. Even they had to admit (rather grudgingly) “given the low quality of the eligible studies, the evidence is not compelling” that Oscillococcinum® can either prevent or treat influenza.

I'll leave the final word on this subject to the Food and Drugs Administration of the USA in a legal action against a company selling Oscillococcinum under the false pretense that it could cure or prevent flu, in this instance the potentially lethal H5N1 strain of avian flu:

“The FDA has determined that your website offers products for sale that are intended to diagnose, mitigate, prevent, treat... or cure the H1N1 Flu Virus in people. These products have not been approved or otherwise authorized by FDA for [this] use in theH1N1 Flu Virus... The marketing and sale of unapproved or uncleared H1N1 Flu Virus -related products that are not authorized by and used in accordance with the conditions of an Emergency Use Authorization, is a potentially significant threat to the public health.”.

Paris, A., Gonnet, N., Chaussard, C., Belon, P., Rocourt, F., Saragaglia, D. and Cracowski, J.L. (2008) ‘Effect of homeopathy on analgesic intake following knee ligament reconstruction: a phase III monocentre randomized placebo controlled study’, British Journal of Clinical Pharmacology, vol. 65, no. 2, pp. 180-187.

Links: [abstract pubmed]:[full text, pubmed central]:[full text, Wiley online]:[full text, pdf, BJCP]:[DC Science]

”an add-on randomized controlled study with three parallel groups: a double-blind homeopathic or placebo arm and an open-label noninterventional control arm... The complex of homeopathy tested in this study was not superior to placebo in reducing 24 h morphine consumption after knee ligament reconstruction... In addition, these parameters were not different in patients enrolled in the open-label noninterventional control arm.”

According to the DC Science blog in 2007: “Another thing that makes the paper interesting is that one of the authors is Philippe Belon. who is a director of the huge French homeopathic company, Boiron. This is properly declared at the end:

“’Conflicts of interest: Dr Belon is the head of the clinical research department of Laboratoires Boiron. The Laboratoires Boiron financially supported the study. None of the other investigators had any conflict of interest.’

“Boiron makes profits from homeopathy of about 20 million euros a year, on net operating revenues of about 300 million euros. It is big business.”

Parmen, V. (2014) 'Electroacupuncture Analgesia in a Rabbit Ovariohysterectomy', Journal of Acupuncture and Meridian Studies, vol. 7, no. 1, pp. 15-24, (https://doi.org/10.1016/j.jams.2013.05.004). [permalink]

Links: [full text, html (OA)]

To be frank, this is one of the most cruel papers on any subject I have come across. I was so utterly shocked by it I couldn’t believe what I was reading and hoped I had misunderstood what the experimenters had done here in the name of acupuncture research. So I asked Martin Whitehead, of the Campaign for Rational Veterinary Medicine to take a look for me. It turns out I hadn’t misunderstood, the authors of this paper had actually operated on rabbits, surgically opening their abdomens and removing their uterus and ovaries while they were fully conscious and tied down to a metal frame, without the benefit of any form of anaesthetic or pain relief, while at the same time administering electric shocks to them and claiming this was “acupuncture anaesthesia” (a discredited technique which is illegal in many countries). As a colleague said when I mentioned this paper to her, “how is that not torture?”

Comment from Dr Martin Whitehead:

This paper makes me feel queasy. That it had ethical approval from the university make me feel even more queasy.

It is clear that the acupuncture group rabbits were given no anaesthesia or analgesia (other than any resulting from the acupuncture and unknown-intensity electric currents passing through the rabbit).

The neuroleptanalgesia group were given ketamine (no analgesic action) and xylazine (which does have some analgesic action) but no other analgesia.

From Table 1 it appears that the rabbits were tied down in the metal device shown in Fig. 1 and receiving the electroacupuncture for at least 42-55 mins. Even if there was no surgery, not a nice thing to do to a rabbit – assuming they are conscious throughout, which certainly seems to have been the case.

In section 2.3. it says “the intensity of the electric current stimulation was slowly increased from zero until the animals showed signs of discomfort and twitching. After that, the intensity was slowly increased to 4, 6, and finally to 8 V for the abdominal site; for dorsal stimulation, the intensity was slowly increased to 2.2 V and then to 2.7 V.” That sounds grim.

Only voltages are stated, with no idea what current was being used (e.g., for comparison with a TENS machine), so it is not possible to tell what sort of effect this current would have on nerves or muscles.

From Fig. 3, the heart rate was lower in the electroacupuncture group, except at the time of actual surgery when it was much higher, which is not a promising sign. The respiratory rate was far higher in the electroacupuncture group before and during surgery, also not a promising sign. Those findings could be interpreted as indicating that the electroacupuncture rabbits were feeling more pain than the neuroleptanalgesia rabbits.

The one scrap of comfort I get is the very last sentence of the Results section – there was no “screaming related to stress or pain”. I hope that means there was no screaming at all.

So, the next time someone says, with regard to Complementary and Alternative Veterinary Medicine, “where’s the harm”, you might like to point them to this paper. How delusional must the authors be to think this was, in any way, a humane procedure?

Penson, R.T., Castro, C.M., Seiden, M.V., Chabner, B.A. and Lynch, T.J. (2001) ‘Complementary, Alternative, Integrative, or Unconventional Medicine?’, The Oncologist, vol. 6, no. 5, pp. 463-473.

A transcript of interviews plus list of references with links. The account is of a cancer sufferer who induced liver damage and reduced the effectiveness of his chemotherapy by taking herbal meds and mega doses of vitamins. There is a discussion of the side effects of vitamins and herbal remedies and the expenditure on CAM.

Links: [full text - html, the Oncologist]

Perry, R., Terry, R. and Ernst, E. (2010) ‘A systematic review of homoeopathy for the treatment of fibromyalgia’, Clinical Rheumatology, vol. 29, no. 5, pp. 457-464.

Homoeopathy is often advocated for fibromyalgia (FM) and many FM patients use it. To critically evaluate all randomised clinical trials (RCTs) of homoeopathy as a treatment for FM, six electronic databases were searched to identify all relevant studies. Data extraction and the assessment of the methodological quality of all included studies were done by two independent reviewers. Four RCTs were found, including two feasibility studies. Three studies were placebo-controlled. None of the trials was without serious flaws. Invariably, their results suggested that homoeopathy was better than the control interventions in alleviating the symptoms of FM. Independent replications are missing. Even though all RCTs suggested results that favour homoeopathy, important caveats exist. Therefore, the effectiveness of homoeopathy as a symptomatic treatment for FM remains unproven.

Which is exactly what every impartial observer of homeopathy says - yes there is plenty of so-called evidence around but it’s of such low quality as to be meaningless

Links: [abstract - Springerlink]

Posadzki, P., Alotaibi, A. and Ernst, E. (2012) ‘Adverse effects of homeopathy: a systematic review of published case reports and case series’, International Journal of Clinical Practice, vol. 66, no. 12, pp. 1178–1188.

Links: [full text - html - Medscape]:[full text - pdf - google scholar]:[full text - pdf - Wiley]

Responses: [Edzard Ernst - blog]
Tournier et al: [full text - html - Wiley]:[full text - pdf - Wiley]
Posadzki and Ernst: [full text - html - pubmed]

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