Junk Science Number 17: The randomised, double blind, placebo-controlled Clinical Trial
Having read a report of the Dartington Debate which took place recently on the subject of Integrated Medicine, I was interested to read that some of the assembled gathering concluded that the only treatments that they would consider were those that had passed the ultimate medical gold standard test: The randomised, double blind, placebo controlled Clinical Trial. These people are sadly living in cloud cuckoo land.
First, for those of you that don’t know the term let me explain. This Clinical Trial involves two identical groups of people, one group taking the test treatment, the other taking a ‘placebo’ – an identical injection or pill just containing sugar. It is blind, because the recipients don’t know which they are receiving.
The test is double blind because the scientist doesn’t know which he is giving to whom either. And finally, it is randomised because a computer has assigned the people to each group in a matched way, but randomly.
An unequal playing field
This sort of test, according to Pharmaceutical companies, is very, very expensive to run. And thus it is very, very unlikely that any purveyor of a herb or vitamin would ever have the money to run such a test. Last year Astra Zeneca made over $8.6 billion in profit. The entire supplements industry in the UK was worth peanuts compared to that figure. I know of only one such UK ‘supplements’ test in the last year or so – A Leeds University Clinical Trial on concentrated fish oil omega 3 with pre-cancerous colon polyps (it worked and reduced the size of the polyps). This level of Clinical Trial demands serious funding, something simply beyond the means of the supplements companies – face facts!
Another reason that natural compounds and supplements are ruled out is because the drug companies are unlikely to help. The Leeds University trial prepared the omega-3 as if it were a drug, but others aren’t so fortunate. Professor Robert Thomas of Addenbrooks has been working with newly diagnosed prostate cancer patients and noted that those who followed a programme of broccoli and tomato consumption plus daily exercise pushed the evil date for surgery further into the future. To make any claims he needed to prove this observation scientifically and so he started to dry his broccoli and tomatoes. Ah, but if you want to do a proper trial you need to prepare them in pill form, so they are now classified as drugs and require a drugs company to prepare them. How easy do you think it is to get a drugs company to help with a test on natural compounds which can reduce the usage of their profitable drugs?
These anomalies would only be resolved in the UK if we had a properly Government-funded Institute of Complementary Health as they do in the USA. This needs to include someone responsible collating the information and providing guidelines.
Dubious selection criteria
You may feel that the ‘randomised’ selection process in the randomised, double blind, placebo-controlled test is fool-proof. You’d be completely wrong. New drugs tend to be compared against existing treatments which are used by the sick in all shapes, sizes, ages, smokers and non-smokers and so on. For the new Clinical Trials however, the participating company may well insist that the scientist rule out anybody who may have had a negative reaction in a previous trial, obese people, people with heart problems or anything that might jeopardise a good result. Thus the Clinical Trial can be a random sample chosen from a selected sample. Often a drug trial is conducted with young, healthy people (you’ve probably heard the radio ads recruiting volunteers) with 75 per cent of the volume of the resultant drug used by sick over 65 year olds, who will have a significantly different biochemical profile.
So let’s rule out all those treatments that haven’t passed this gold standard
Well of course curcumin as a preventative cancer treatment is ruled out. But then so are most statins – including those for the seemingly healthy to avoid unexpected heart attacks. But Doctors recommend the statins, don’t they?
Actually, come to mention it, about 95 per cent of drugs in use today would be ruled out, not just complementary and alternative therapies.
Two thirds of cancer patients have surgery but there has never been a randomised, double blind, placebo controlled Clinical Trial on any of it. And increasingly there is evidence that surgery may even spread cancer (See: http://www.canceractive.com/cancer-active-page-link.aspx?n=2976)
Next time your Doctor offers you a drug, ask him if it has been through a randomised, double blind, placebo controlled Clinical Trial and see what he says. If it is a serious condition it is very likely that he will want to give you three or four drugs. Don’t even bother asking about whether the combination has passed the gold standard test. As a cocktail it is almost certain not to have done, which may explain, in part, why prescription drugs are now the highest cause of death in states like Florida with a higher incidence of older people.
Level of evidence?
If, like me you believe that ‘research is for the guidance of wise men and the obedience of fools’, you may consider that there is actually enough evidence to warrant all of the over-50’s in the UK being offered statins along with overweight kids too. As a doctor you may feel the evidence is enough, even if all the Dartington audience using their gold standard filter may not have agreed.
But if you feel it is enough and you offer statins to all, why not consider telling people with pre-cancerous colon conditions about fish oils or curcumin? Both are known to help prevent colon cancer – the former also has Clinical Trials, the latter has a stack of evidence on its side and is even being used as a treatment in some US cancer hospitals.
Why do oncologists offer surgery at the outset of cancer yet they don’t think to offer immune boosting herbs like astragalus or supplements like resveratrol and grape seed extract, which do have good supporting evidence behind them?
Why do some oncologists even criticise cancer patients when they correct their diets? The research is quite clear; ‘overwhelming’ according to the American Cancer Society. Diet and exercise can increase survival times.
A clear legal duty
Only recently we had two women in a week tell us that their oncologist had refused to discuss complementary therapies with them as ‘He may get struck off’. Actually the opposite is true. Your oncologist has a legal duty to inform you fully of all your treatment options. Omitting treatments deliberately is illegal. Ignorance is no defence. Oncologists had better start wising up on complementary and alternative therapies fast. The patient backlash is just around the corner.
The sting?
As part of my preparation for this article, I looked up the ‘randomised, double blind, placebo-controlled Clinical Trial’ on my Internet search engine. Five of the top six listings were definitions but one was actually a trial for a treatment. Here it is. Unfortunately I think some of the ‘skeptic’ attackers of complementary medicine at Dartington might find it a little embarrassing:
Efficacy of a complex homeopathic medication (Sinfrontal) in patients with acute maxillary sinusitis: a prospective, randomized, double-blind, placebo-controlled, multicenter clinical trial.
Zabolotnyi DI, Kneis KC, Richardson A, Rettenberger R, Heger M, Kaszkin-Bettag M, Heger PW.
Source
Research Institute for Ear, Nose, and Throat Diseases, Kiev, Ukraine.
Abstract
BACKGROUND:
There is a demand for clinical trials that demonstrate homeopathic medications to be effective and safe in the treatment of acute maxillary sinusitis (AMS).
OBJECTIVE:
The objective of this clinical trial was to demonstrate the efficacy of a complex homeopathic medication (Sinfrontal) compared with placebo in patients with AMS confirmed by sinus radiography.
DESIGN:
A prospective, randomized, double-blind, placebo-controlled, phase III clinical trial was conducted for a treatment period of 22 days, followed by an eight-week post treatment observational phase.
INTERVENTIONS:
Fifty-seven patients received Sinfrontal and 56 patients received placebo. Additionally, patients were allowed saline inhalations, paracetamol, and over-the-counter medications, but treatment with antibiotics or other treatment for sinusitis was not permitted.
MAIN OUTCOME MEASURES:
Primary outcome criterion was change of the sinusitis severity score (SSS) from day zero to day seven. Other efficacy assessments included radiographic and clinical cure, improvement in health state, ability to work or to follow usual activities, and treatment outcome.
RESULTS:
From day zero to day seven, Sinfrontal caused a significant reduction in the SSS total score compared with placebo (5.8 +/- 2.3 [6.0] points vs 2.3 +/- 1.8 [2.0] points; P < .0001). On day 21, 39 (68.4%) patients on active medication had a complete remission of AMS symptoms compared with five (8.9%) placebo patients. All secondary outcome criteria displayed similar trends. Eight adverse events were reported that were assessed as being mild or moderate in intensity. No recurrence of AMS symptoms occurred by the end of the eight-week post treatment observational phase.
CONCLUSION:
This complex homeopathic medication is safe and appears to be an effective treatment for acute maxillary sinusitis.
PMID:
17362845
[PubMed – indexed for MEDLINE]
