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You are viewing: Testimonials & Research - Limitations of RCTs - Level 2

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Scroll right for photos of the real Placebos >>>

The World's First RCT?

Photo James Lind

James Lind
 Born Edinburgh 1716
 On HMS Salisbury in 1747
he allocated 12 men with scurvy
o Cider
o Seawater
o Horseradish, mustard, garlic
o Nutmeg
o Elixir Vitriol
o Oranges and Limes

 Limitations of Research Trials

The Two RDBPC Trial Approaches

There are in the main two approaches for Homeopathic Randomised Double Blind Placebo Controlled (RDBPC) trials

1. Clinical Trials concerned with the efficacy of a Homeopathic remedy for the specific treatment of a disease. This type of trial is directly concerned with the healing effects and clinical aspects of a Homeopathic remedy. Most of the trials done to date fall into this Clinical Trail category.

The problem for the Homeopath here is at once easy to define but seemingly intractable of resolution in practice. The problem is that homeopathy operates according to a paradigm that is different from the paradigm of conventional (allopathic) medicine and cannot be measured utilizing the same research instruments. The essential differences are:

- Homeopathy is individualistic. In the case of say a skin complaint one remedy at a single potency may cure one particular patient when administered over a 7 day period. In the case of a second patient the same skin complaint may require the use of different remedies at different potencies in a different sequence over a longer 48 day time frame. Such flexibility of approach is not catered for in this rigid type of trial.

- Homeopathy allows for Sensitivities. By this is meant that some patients are more hypersensitive to Homeopathic remedies than others a factor which Homeopathic prescriptions cater for through variation of potency and dosage.

- The definition of cure also provides a problem. Continuing with the skin complaint example all a conventional drug has to do in order to demonstrate cure is to attenuate the skin condition which it does through suppression. The cure here is unlikely to be permanent resulting in reoccurrence upon withdrawal of the medication. In the case of Homeopathy a permanent cure is being sought from within the bodys own natural immune system resulting in a permanent cure even after the remedy is withdrawn. No account is taken in Clinical trials of patient condition after drug withdrawal.

- Duration of trial is another aspect of debate. It is not unusual for a conventional drug to act quickly to produce a suppressive cure whilst Homeopathy working through the natural organs of the body takes longer. Often a trial is terminated after the benefit of the quick conventional cure is evident and before the slower acting but more permanent Homeopathic cure has been effected. Thus a negative or undetermined result is recorded against Homeopathy whereas had the trial continued a different result may have resulted.

- The relationship between patient/physician is also another area for controversy. Homeopaths believe that the process of cure and the context in which it is achieved is a fundamental part of effective treatment and that the physician is an essential element in the mix.

- Finally failure to allow for the biphasic nature of Homeopathic remedies as per Arndt Schultz Law has resulted in many inconclusive clinical trial results. In simple terms this means that because a Homeopathic remedy has been selected in accordance with the Law of Similars (ie because the remedy in mother tincture phase produces similar symptoms to that of the illness) in order for it to successfully oppose the illness it must be diluted to the biphasic point (ie it must be potentised to the point at which the remedy acts in an opposite manner in order to cure the illness). These trials being rigid in approach do not allow for the use of sequentially increasing potency (in the event of a well chosen remedy not initially working) a standard Homeopathic principle.

2. Proving Trials are concerned with remedy proving only. This type of trial is more about the foundational question of whether nano-pharmaceuticasls are effective at all rather than with their disease prophylaxis. Whilst it does not prove medicinal efficacy it can demonstrate whether potentised doses (and hence the principle of potentisation) are effective. (ie one of the corner stones of Homeopathic philosophy.)

Advantages of the Proving Trial include:
- The problem of individuality is dispensed with. Patients are selected on the basis of their willingness to take part in a Homeopathic proving without consideration of arriving at an individualised similimum.
- As there is no clinical interpretation no patient/physician relationship exists
- The definition of cure does not arise
- Similarly the question of patient sensitiveness does not arise.

Disadvantages include:
- No allowance is usually made for increasing dosages in accordance with instructions in the Organon.
- However in some cases there may still be no response to a proving. This is only to be expected as a certain number of cases will always exist where due to lack of individualization the remedy has no similarity with the patient and hence will not react.
- Limited in objectivity in that clinical issues are not considered.

Suggestions for a Way Forward with RCTs

A Proving rather than a Clinical trial
may be the place to start as a positive result would be practically guaranteed. Once the efficaciousness of nano-pharmaceuticals have been established to everyones satisfaction progress to Clinical evaluation could follow.

From a Homeopathic point of view the following criteria would need to be catered for in a Proving trial:
Full flexibility to vary the administrative dose as required. The Organon states  that the 30 C potency should be used; that dosing is in the dry form; that it should commence low; that the remedy should be continued for several successive days; that if it becomes necessary to increase the dose this should be achieved through increases of dose size; that these higher to higher doses should be on a day by day basis (Aphorisms 128-132). In other words it is dose size that is important in proving rather than dose frequency. Practically this could be managed by a 2 pill administration of the 30 C remedy each morning for 7 days. If there were no symptoms to report then the dose should be increased by 2 pills each day for the next 7 days. This means that by day 14 eight times the normal dose is being administered (16 pills) and that the prover has received a total of 42 doses. In the unlikely event of there still being no symptoms I would discontinue the proving with that prover. The lack of response can be attributed to the fact that individualization was not considered when selecting a prover and that a total lack of similarity exists between the remedy and prover. Hahnemann states (Aphorism 281) that variability in response between patients can be in the order of 1:1000.

Symptoms to be noted down immediately they appear with a description of symptom; time of occurrence; duration after taking remedy; length of time it continued. These symptom details should be collected from each prover by the trial co-ordinator on a daily basis. (Aphorism 139)

A physical measurement of health should also be introduced as part of symptom observation. Thus in the case of say Pyrogenum I would measure body temperature; Thyroidinum pulse rate; Syzygium blood sugar, Digitalis blood pressure; Belladonna eye pupil size etc. In other cases it may be possible for the prover to be linked to a polygraph (or similar) so that skin temperature and moisture etc could be measured. These physical observations would be free of subjectivity and could be readily done several times a day.

- Prover safety must be paramount in all situations especially in cases of unresponsive provers where higher and higher doses are being used. To limit this situation it may be advisable to initially screen provers for individualization (sensitivity) before the commencement of the trial. This strategy has the other advantage of permitting a larger percentage of responders while the dosing routine is still at a relatively small size. In this way, any untoward reactions might at least be minimized in frequency and severity.
There is a requirement to strictly standardize conditions for all provers particularly with regards to diet, drugs and medication. This is because of the possibility that a substance, such as a spicy food could affect an individual in the control group thus effectively increasing production of placebo response! After all if a substance such as even spicy foods which are much less strong than medication, affected an individual in the control group, any symptom they produced would be interpreted as placebo.

In Conclusion it is my strong belief and hope that a way forward can be found to
incorporate RCTs into Homeopathic research and at the same time make the results more rewarding.
I believe the clear delineation provided above could achieve that objective. Additionally when reviewing future RCT results, we may have a clear sense of the context in which decisions regarding protocol design have been  made. It has been too long that research scientists have built their observations upon incompetent experimental designs, and then complained that homeopaths are back pedaling when, after conclusion of the trial, they nit pick the results. It is time to build some Quality Assurance into the trial design process in the first place, so that some reasonable work may be accomplished in pursuit of greater understanding of homeopathic process.

Limitations of RDBPC Trials

Whilst I have spent some time above endeavouring to seek an objective way forward for the use of RTCs in Homeopathic research their overall status in Homeopathic eyes should not be forgotten. There is an increasing tendency for RTCs to be referred to as the gold standard in the medical press providing the very essence of evidence based research work. Now I admit RTCs have a place in research wok but quite why they are regarded with such veneration, when there are obvious and significant limitations, is something of a mystery. Here are some points to consider

If RCTs are such a fool proof method then why consistently over the years have medications, all of which have gone through the random trial process, been withdrawn on a global basis for dangerous side effects? Over the last 39 years from 1980 there have been 35 worldwide drug recalls. In addition there have been many times more local withdrawals and recommendation amendments. Quite obviously the system is far from perfect.

Why do advocates of random tests promote it above other types of testing and often decry empirical/anecdotal data as worthless? Perhaps it needs to be pointed out that only 15% of medical procedures are evidenced based in terms of RCT verification. The other 85% is all based on empirical results. Does that mean that 85% of medical procedures today are worthless?

For photo  montage inspired by evidence based RCT on parachute efficacy !!  >>>
?See below for full text ?


- Some research subjects clearly dont lend themselves to random control testing. In 2003 the BMJ published a paper by Gordon Smith and Jill Bell entitled Parachute use to prevent death and major trauma related to gravitational challenge; a system review of RCTs with the objective to conduct a meta analysis of RCTs to prove the effectiveness of parachutes in preventing gravitational death. Their conclusion was that there was a lack of compelling scientific evidence to support the claim and that parachutes had not been subjected to rigorous evaluation using RTCs. Their final comment was that we are left in the unfortunate situation of having only empirical/anecdotal data to support their use. Maybe someone will organize one day a double blind randomized placebo controlled cross over trial of the parachute

- Some conventional medical treatments cannot be tested using the RCT model, and so evidence of effectiveness is based on the clinical/empiricle evidence of cases. One example is surgery, another is psychiatry, and it is even the case that some drugs are prescribed on the basis of clinical/empiricle evidence, rather than on the evidence from RCTs.   In addition, drugs are usually withdrawn on the basis of the clinical/empiricle evidence revealing dangers not identified in the RCTs, so clinical evidence is actually considered more important in the evaluation of treatent than RCTs

- RCT data can be easily managed, controlled and manipulated to create any result required to fit the evidence sought. In a similar way to that of consultation exercises RCT data can be filtered so that the apparent result
suits that which is required.

- In a reversal of the above process any challenge of the data and its conclusions can be suppressed by carefully chosen statistics and selective dissemination of information.

By way of an illustration of data manipulation I would quote Merks current claims that Gardasil is a vaccine which prevents cancer in pre teenage girls. As far as I am aware the vaccine tests were conducted on women between 15 and upwards. In the data available to the public no pre teenage trial data has been presented.

- RCTs are not suitable for chronic situations which typically develop over a long period of time. The cost, organisation and practicability aspects render it defunct.

- RCTs are not suitable for rare conditions. For example if one is looking for a condition that relates to say 1-2% of the population the RCT size would of nesessity involve thousands of patients. This would clearly be an impossible task.

- RTCs cannot measure cuase they only measure effect. That is they cannot help to determine the cause of say diabetes. They may assist in how to treat diabetes. Homeopathy as we have seen is directed at cure (ie the cause) of a disease. Consequently comparing Homeopathy vs a conventioal medicine using RCTs is fraught with difficulties.

- RCTs are conducted in artificial environments. The absence of an every day environmental situation can change results as well as lead to difficulties of application and result interpretation.
 

- Disengagement between patient and investigator is required under RCT protocol. The patient can find this procedure stressful especially as it is a procedure not encouraged in outside practice. The possibility exists of a change in outcome as a result.

RCTs deny patient choice a procedure which must render the process open to the criticism of introducing a new level of patient stress as well as less applicable to general practice.

- Questionable replicability in practice. In order to control variability RCT protocols can be drawn up within very strict guide lines which bear little relationship to the way in which the treatment will be conducted and interpreted in practice. Validity of the RCT results are then questionable when they are used outside of the original parameters of the trial.

- A Black Box mentality is often exhibited when little or no information is released regarding the methodology employed for establishing randomization. This lack of transparency results in the inability of reviewers to determine the merits/demerits of the trial design.

- Blinding procedures are similarly not reported. Recent work in this area suggests that up to 41% of procedures fall short of complete blinding effectiveness. Again there is a lack of transparency.

RCTs do not randomise investigator bias. If an investigator harbours an initial prejudice as to the merits/demerits of the treatment on trial the whole RCT can be in jeopardy from an impartiality point of view. There is no randomisation here. Quite clearly investigator bias has occurred in the past (ie the Lancet death of Homeopathy report is a prime example).


In Conclusion RCTs are a valuable research tool but by no means are they the only valid one. Other tools including empiricism have stood the test of time and remain valid research methods. Empiricism is at the centre of most of the scientific knowledge we take for granted today. To be told now that information gathered in such a manner is untrustworthy and only RCT data is reliable is to deny our history. And speaking of which history teaches that all regimes intolerant to the views of others are fascist in nature and end in disaster.

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The Real Placebos
Photo The 3 Placebos
All Three
Stefan, Steve & Brian

Photo Brian op Placebos
Brian Molko (American)

Photo Steph of Placebos
Steve Hewitt (British)

Photo Stev of PPlacebos
Stefan Olsdal (Swedish)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

RCT on parachute efficacy!!

Photo Parachute
Jumping Out

Photo Parachute
Meeting Up

Photo Parachute
All Together

Photo Mushroom
Land Based Parachute

Photo Parachute
Still Above the Clouds

Photo Parachute
Land in Sight

Phto Dandelion
Nature's Parachute

Photo Parachute
Safe Landing

Photo Parachute
Assisted Landing

Photo Failed Parachute
Crash Landing

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