Showing posts with label RCT. Show all posts
Showing posts with label RCT. Show all posts

Saturday, 16 January 2010

Homeopathy effective in treating neo-natal pigs with diarrhoea, new paper shows

A paper published yesterday (15/1/10) in the peer-reviewed journal Homeopathy by Camerlink et al (2010) found that the homeopathic remedy Coli 30K was highly significantly (p< 0.0001) more effective than placebo in a placebo-controlled, observer blind RCT on the treatment of diarrhoea in neo-natal pigs.

52 sows of pigs form a commercial farm who were in their last month of gestation and had never been vaccinated against E.coli were randomly assigned to either a placebo group or treatment group. This included 300 pigs.

Both groups would receive either the homeopathic remedy Coli 30k or placebo twice a week in their last four weeks pre-partum.

It was found that the treatment group had significantly less E.coli diarrhoea than the placebo group (P <0.0001). Furthermore in the homeopathic treatment group the diarrhoea was less severe, there was less transmission and duration appeared shorter.

Camerlink I, Ellinger L, Bakker EJ and Lantinga EA (2010) Homeopathy as replacement to antibiotics in the case of Escherichia Coli diarrhoea in neonatal pigs, Homeopathy, Vol.99 (57-62)


That's another nail in the "homeopathy is just placebo" coffin - That coffin is looking pretty nailed in to me!

Sunday, 10 January 2010

Meta-analysis shows homeopathy to be more effective than placebo

HMRG report with overview of clinical research in homeopathy, identified 184 controlled clinical trials. They selected the highest quality randomised control trials, which included a total of 2617 patients for meta-analysis. This meta-analysis resulted in p< 0.000036 indicating that homeopathy is more effective than placebo. The researchers concluded that the "hypothesis that homeopathy has no effect can be rejected with certainty."

(Homeopathic Medicine Research Group. Report to the European Commission directorate XII: science, research and development. Vol. 1 (short version). Brussels: European Commission, 1996: 16-7)

Saturday, 19 December 2009

Goldacre et al, Projection and a Meta-analysis in the Lancet showing the effectiveness of homeopathy beyond placebo.

I would like to draw your attention to a meta-analysis that was published in the Lancet (yes the very journal that proclaimed the "END" of homeopathy) in 1997. It clearly shows that homeopathy does work beyond the placebo effect. But first I would like to consider why the critics of homeopathy so fiercely claim that there is no evidence for homeopathy.

So where exactly do Ben Goldacre et al get their nonsensical data from? There is a mountain of evidence supporting homeopathy working beyond the placebo effect yet they still preach the same message - "there is no evidence to show homeopathy to work beyond placebo." I have faith however that the British public can make their own rational decision on whether they believe homeopathy to work if they are given the correct information.

Those with an agenda will bend and twist homeopathy into what they want, but ultimately the truth prevails. We have to wonder why some people would want to do this? I honestly can't answer that question for the likes of Ernst, Goldacre et al. Why would someone feel so threatened that they would feel the need to lie and manipulate the public into believing their own belief structures, hence why I used the word "preach" earlier. They are preaching a belief structure that does not hold up to scientific questioning.

Ironically this is what homeopaths are accused of time and again by their critics. However there is a principle in psychology called Projection which is simply defined as something you project unconsciously of yourself onto another individual, believing that they have the same attributes as yourself. Often however this is as a result of denial of yourself, and the fact that it is actually yourself that holds those attributes.

For example, critics of homeopathy claim it to be unscientific, mumbo-jumbo that is based upon belief and not actual substance. Now this could be true if it weren't for the fact that there is a lot of scientific evidence supporting homeopathy, so now we have to ask the question of why they so strongly believe themselves to be right? This is where the role of psychological projection comes in, because they deny that they themselves are unscientific and biased in their approach.

So homeopathy must take the brunt of their own denial of themselves. Which is obvious for all to see as their writings are so clearly based upon bias and nonsense. There is evidence that homeopathy works, yes scientific evidence not just anecdotal, and yes published in "prestigious" journals like the Lancet as I will show below. So what are they going on about? Hence the conclusion of projection, maybe they should acquaint themselves with the writings of Freud and Jung.

Here is the abstract of the meta-analysis promised

"Meta-analysis of 89 trials on homeopathic medicine versus placebo. Result: significantly in favour of homeopathy (OR 2.45 (95% CI 2.05-2.93)). This meta-analysis included 186 placebo-controlled studies of homeopathy published until mid-1996, of which data for analysis could be extracted from 89. The overall ratio was 2.45 (95% confidence intervals 2.05-2.93) in favour of homeopathy, which means that the chances that homeopathy would benefit the patient were 2.45 times greater than placebo. When considering just those trials of high quality published in MEDLINE listed journals, and with predefined primary outcome measures, the pooled odds ratio was 1.97 and significant. Even after correction for publication bias the results remained significant. The main conclusion was that the results "were not compatible with the hypothesis that the effects of homeopathy are completely due to placebo." If the results of new trials were to show no difference between homeopathy and placebo, we would have to add 923 trials with no effect with 18 patients in each order to balance the two."

Linde K, Clausius N, Ramirez G, et al. Are the clinical effect of homeopathy placebo effect? A meta-analysis of placebo-controlled trials. Lancet 1997; 350:834-43.

Sunday, 27 September 2009

Is Homeopathy Evidence Based?

Within the media there are many erroneous comments made such as "there is no evidence that homeopathy works." This comment can be attributed to a number of "science" journalists. Well the fact is, is that they are very far from the truth. But why should we question them? They are after all "science" journalists, so we must assume that they have researched their information thoroughly? Well it appears they have not.

What is evidence-based medicine? (EBM)

First we shall take a look at what is EBM. This was a concept that, whilst being used since the origins of medicine, came to prominence in the early 90's, and was thought of as a way to ensure that medicine was based on true evidence, and not just the clinician's own bias, which may be wrong. It was supposed to eliminate treatments that had poor clinical effectiveness and treatments that didn't work, and lead to an all-round better medical system, which was more effective.

There is a hierarchy of clinical effectiveness, ranging from Level 1++ which includes high quality meta-analyses and Randomised Controlled Trials (RCTs) with a very low risk of bias to Level 4 which includes expert opinion (page 2, http://www.rcplondon.ac.uk/pubs/contents/304df931-2ddc-4a54-894e-e0cdb03e84a5.pdf).

In the last 20 years there has been a massive shift towards clinicians only making decisions based on the evidence from RCTs. This has lead to Doctors possibly ignoring some treatments that have a very small evidence base, even though they may work very well in a clinical environment. RCTs cost a lot of money, and this can rule out therapies that are effective but do not have the financial-backing to produce good quality RCTs. For example, the median cost of 153 RCTs undertaken during 2005 and 2006 was £3202000 (page 18, http://www.rcplondon.ac.uk/pubs/contents/304df931-2ddc-4a54-894e-e0cdb03e84a5.pdf)

Sir Michael Rawlins, the chair of NICE, is critical of the over-use of RCTs in the decision making process used by Doctors to determine clinical efficacy.

An Overview of Clinical Evidence

From current knowledge, the BMJ have determined just how much of the 2500 most commonly used treatments are actually based on evidence that proves them to be beneficial.

"So what can Clinical Evidence tell us about the state of our current knowledge? What proportion of commonly used treatments are supported by good evidence, what proportion should not be used or used only with caution, and how big are the gaps in our knowledge? Of around 2500 treatments covered 13% are rated as beneficial, 23% likely to be beneficial, 8% as trade off between benefits and harms, 6% unlikely to be beneficial, 4% likely to be ineffective or harmful, and 46%, the largest proportion, as unknown effectiveness (see figure 1)."

Figure 1.

(http://clinicalevidence.bmj.com/ceweb/about/knowledge.jsp)
Now this graph quite clearly shows that the majority of decisions made by clinicians is made without reference to the clinical evidence base. Now there is a very good reason for this, as there would not be many treatments left if they were to rule out the treatments that have no RCT evidence for their use!

So this leads me to why do they reject homeopathy on the basis that there is "no good quality evidence" showing that it works , even if this statement were true, it would be a fallacy to think that they base all of their decisions on the criteria of RCTs. So why the different rules for different therapies?

As Dr. Brian Kaplan points out is it not ironic/hypocritical that "they" criticise homeopathy for having a lack of evidence, when conventional medicine itself does not seem to be based on such evidence? (http://drkaplan.co.uk/2009/03/pie-man-strikes/the-pie-man-cometh/)

The Evidence Base for Homeopathy

Now contrary to what many "science" journalist (I keep putting "science," with quote marks, as a true scientist would base their decision on evidence and science and not on their own personal judgement or bias) there is evidence that homeopathy works. And you can take your pick from many different types of evidence.

RCTs

Starting with RCTs, there is currently "a total of 138 RCTs in homeopathy have been published in good quality scientific journals: positive effects have been reported in 60 (44% of the total) and negative findings have been reported in 10 (7%), while 68 (49%) have not been conclusively positive or negative " (http://www.trusthomeopathy.org/research/the_evidence_for_homeopathy.html).

So only 7% of good quality RCTs into homeopathy have been found to be negative i.e. no more beneficial than placebo, whereas 44% has been found to be more beneficial than placebo. So how can "skeptics" say that there is no evidence that homeopathy is more beneficial than placebo?

A good example of a RCT into homeopathy, is a study carried out in 1986 (Day, Clinical trials into Bovine mastitis, The British Homeopathic Journal) that looked into the homeopathic treatment of cows with mastitis. There was a homeopathic nosode (30c potency) delivered into the water trough of half of the cows (treatment group), and the other half were given a placebo (control group). The control group showed an occurrence of mastitis in 25% of the group, whereas the treatment group had only a 2.5% occurrence of mastitis. The control group also showed a reduced severity of the mastitis.

Homeopathy is used extensively throughout the farming industry, as it is proved to be effective in treating all kinds of diseases. Indeed why would a farmer use homeopathy if it didn't work? He would soon notice if it wasn't effective. Can we really suggest that this is down to placebo effect? Even though the cows in the trial above didn't know that they were being administered any sort of medicine?

This is just one example of the clinical RCT evidence for homeopathy. If you would like to read further please do research more clinical trials. A source I would recommend for this is the website of the Homeopathic Research Institute (http://homeoinst.org/Publications.php), they have some publication on here, and should be able to point you in the right direction if you would like to find more. I also strongly recommend the book Homeopathy: Science or Myth by Bill Gray MD. It's a book which discusses homeopathy from all aspects including the principles, clinical evidence and the physics of potentised water.

So does that look like no evidence to you from RCTs?

Now the oft-quoted Lancet Article, which has been used by the many "Skeptics" of homeopathy, is quite clearly a work of fiction and bias. The author of the piece provided no reference to which RCTs he used in his meta-analysis of homeopathy against Allopathy (conventional medicine). How can an academic paper not require reference to which information was used to write the paper?! Indeed how do we even know that he used RCTs at all and didn't just make the article up?! Does this not show the bias against homeopathy in the mainstream academic journals? That they would publish a paper with no reference to the work included?(http://ecam.oxfordjournals.org/cgi/content/full/3/1/145)

Now also this study only took 8 trials of allopathic medicine against 6 trials of homeopathy, an extremely small amount of trials to consider, and as I have mentioned, we have no idea which references were used!

Is this the good-quality journal that the "Skeptics" so often quote?

Unfortunately it is a sad reflection of the state of medical science today. That they would rather publish a quite clearly biased article than face up to the fact that they do not know it all.

In fact "four out of five major systematic reviews of RCTs in homeopathy have concluded that homeopathy has an effect greater than placebo." In the total of the 23 systematic reviews carried out re. homeopathy 10 are positive with 5 having "little or no evidence" to its use(http://homeoinst.org/material/HomeoEvidenceOverviewJune2008.pdf). Yet again, does someone see the fallacy the "skeptics" make by saying there is "no evidence" for homeopathy? Are they just ignorant of the truth, or do they possess other motives for withholding this vital information?

So clearly we are beginning to understand that there is clinical RCT evidence for homeopathy.

Northern Ireland CAM Pilot Project

This pilot project was undertaken to see if increasing the use of CAM within the NHS would be beneficial based on several objectives, including benefiting patients health and freeing up GPs time to deal with other patients.

With regards to homeopathy the project found that 64% of GPs recorded an improvement in their patients health after being referred to homeopath (http://www.dhsspsni.gov.uk/final_report_from_smr_on_the_cam_pilot_project_-_may_2008.pdf).

Anecdotal Evidence

There is much anecdotal evidence to support the use of homeopathy. There are approx. 500 million people worldwide who use homeopathy, are all of these people deluded? Have all of these people had their ailments cured, including cancer, merely through placebo?

If one really wanted to know if homeopathy works, all they would have to do is to take a 3-week trip to India and see it's use in a busy clinical environment. Homeopathic Doctors in India will often see a patient in 3/4 mins, and will see around 200 patients a day. In India it is considered a mainstream medicine and indeed it is very effective. They have medical charts, X-rays, MRI scans etc. showing quite clearly that homeopathy does not only work with psychosomatic illness but also with advanced pathological conditions such as Cancer. It would be a damn sight cheaper to visit India than conducting a RCT for £3million!

Indeed in India many medical students are choosing to study homeopathy ahead of allopathic medicine, due to its proven efficacy in treating the underlying problems of disease(http://timesofindia.indiatimes.com/news/city/hyderabad/Medicine-takes-an-alternative-route/articleshow/5058553.cms).

Conclusion

Clearly the statement that "there is no evidence for the effectiveness of homeopathy beyond placebo" is a fallacy, and a costly one at that, as the NHS and its crippling budget will tell you. It is also a costly one in that many patients are denied an effective treatment, based not on evidence but on bias.