Research; Part 2

Question 1

Learning Outcomes:

Answer 1

• Biomedical research– The different types of research is implemented
• Reset ethics
• How to Read research
• What kind of research are best suited to natural medicine?
• Referencing and plagiarism
• Incorporating biomedical research into practice
• How should we engage in research as natural medicine practitioners?

Question 2

Revision of basic concepts

Answer 2

It is important to realise that any activity that involves active experimentation with health outcomes is legitimate research.
* This includes the empirical research (based on observation) conducted by pioneers of natural medicine, no matter that is not been ‘verified’ by conventional ‘scientific’ research.
* Much biomedical research is reductionist, dealing only with reduced portions of the reality at stake. We have provisionally called this isolated research.

Question 3

Biomedical research

Answer 3

Why learn about biomedical research?
* To be able to communicate with other professionals such as medical profession
* To understand concepts and mechanisms that might be applicable in clinical practice
* To avoid negative interactions between therapeutic choices
* To gain knowledge about levels of toxicity and safe upper limit for supplements or natural compounds

Question 4

Research models: quantitative and qualitative

Answer 4

Two basic research types:
* Quantitative research: refers to any research based on numerical data that can be accurately and precisely measured, such as blood chemistry, etc. Most medical research is quantitative.
* Quantitative research: refers to research based on more abstract data, that is more challenging to accurately and precisely measure, such as the way people about something, or why they prefer one thing over another. More helpful in natural medicine

Question 5

Quantitative biomedical research

Answer 5

Seeks to provide statistics in answer to specific questions and includes:
* In vitro (Latin = ‘in glass’) – done in laboratories
* Animal trials
* Human clinical trials, including RCTs
* Systematic review
* Literature review
* Meta-analysis
* Epidemiological studies
* Retrospective studies
* Prospect studies

Question 6

Biomedical research: Systematic review

Answer 6

Systematic review: a review of all available literature (i.e. clinical studies) on a drug, in order to analyse the evidence for or against its effectiveness; PG review of all herbal medicines used anxiety.

Question 7

Biomedical research: Literature review

Answer 7

Literature review: like systematic review, that may take other kinds of literature as evidence, such as the theory of pharmacology. Broader scope than the Systematic Review; e.g. review of the pharmacology and biological activity of Devil’s claw.

Question 8

Biomedical research: Meta-analysis

Answer 8

Meta analysis: that is the core procedure for combining data from multiple studies. The reality is that it often distorts evidenced by including research that is flawed.

Question 9

Biomedical research:
Epidemiological

Answer 9

Epidemiological: the ‘how and why’ of disease in particular population: e.g. “Why does Scotland have higher rates of multiple sclerosis?” (But often does not look at the whole picture).

Question 10

Biomedical research: Retrospective study

Answer 10

Retrospective study: a historical investigation of a particular issue or factor in health; usually involves comparison with the non-affected group.

Question 11

Biomedical research: Prospective study

Answer 11

Prospective study: follows a group of subjects over a period of time to find out what happens to them. Relies on the continuing availability and willingness of research participants.

Question 12

Biomedical research:
Descriptive study

Answer 12

Descriptive study: describes the current situation, e.g. “how many cancer patients have also tried homoeopathic remedies?”

Question 13

Ethics in research

Answer 13

Biomedical research: governed by Ethical codes of the World Medical Association Declaration of Helsinki.
Common principles include:
* Beneficence – the act of doing good
* Non-malfeasance – “do no harm”
* Confidentiality of research subjects
* Right to quit research at any time
* Right of research to be fully informed
* Correct and complete disposal of personal data
* Maintenance of high standards in science
However: research conducted on animals is cruel and, therefore not ethical. Animals have feelings too.

Question 14

Narrative Medicine (quantitative)

Answer 14

Narrative Medicine (quantitative): currently under development in the World Health Organisation as the counterbalance to the RCT model of quantitative research.
* An approach that utilises the narratives of patients in clinical practice and in research, in order to better understanding nature of their health problems.
* Involves paying particular attention to what patients actually say in the medical consultation

Question 15

Case studies

Answer 15

Case studies: Notes practitioners take in consultations with patients are an invaluable source of information about what works in treatment.
* Sharing case studies is a invaluable way for practitioners to compare notes and share their experiences of what works in practical applications
* Case studies deal with real people in all their complexity and are therefore useful in identifying individual responses to treatments
* Case studies are rich source of data

Question 16

Outcomes Research

Answer 16

Outcomes Research:
* Assesses the delivery of care in a particular context
* Can be used to demonstrate the effectiveness of specific therapeutic interventions
* Assesses the use of resources
* Is a multidisciplinary investigation, capable of covering a variety of issues
* Assesses the benefit to the users– Patients
* Is well-suited to the delivery of care in general, as opposed to the effectiveness of individual medications.

Question 17

Outcomes Research – Methods and Aims

Answer 17

Outcomes Research – Methods and Aims
* Questionnaire to all patients in clinic to get their impressions, levels of satisfaction, success of their treatment.
* May also assess the cost, convenience, geographical accessibility and patient preferences, as well as actual treatment.
* Enables service providers to insure the best use of resources
* Patients also have a stake in outcome research because it facilitates decision-making: what treatment is best for them, given they are ultimately paying service.

Question 18

Methods in qualitative research: Interview

Answer 18

Interview:
* Peoples opinions, attitudes, beliefs, behaviour.
* Good for complex or sensitive issues
* Disadvantage: time-consuming if many subjects are involved

Question 19

Methods in qualitative research: Questionnaires

Answer 19

Questionnaires:
* Gathering straightforward information from a large number of people
* Disadvantage: cannot handle individualized information

Question 20

Methods in qualitative research: Observation

Answer 20

Observation:
* Anthropology, ethnographic, study of cultures, narrative, e.g. Narrative Medicine, currently being explored by the World Health Organisation

Question 21

Methods in qualitative research: Emic vs. Etic perspectives

Answer 21

Emic vs. Etic perspectives:
Emic = originally coined in 1954 from phonemic by linguist Kenneth Pike
Etic = from Greek Etikos – pertaining to

• Used in anthropology: Emic approach looks into the thoughts and beliefs of local people “from the inside”, Etic approach to studies them ‘scientifically’ “from the outside”. Although seemingly opposite, these approaches are frequently combined for best results.

Question 22

Qualitative research in Natural Medicine

Answer 22

Why is qualitative research suited to natural medicine?
* Able to encompass variability and complexity
* Focuses on patients and practitioners experiences
* Admits changing perspectives and different models and theoretical approaches
* Able to choose a specific methodology that suits the perspective of the researcher, not bound to a narrow definition of science
* “Especially suited to areas that have both social and clinical dimensions.” (Poses & Isen, 1998)

Question 23

How to Read research

Answer 23

In this section we will outline the necessary skills and understandings to Read research and make up your own mind about:
* Research skills and resources
* Core principles of good research
* How to assess research
* How to critique research
* Some case examples

Question 24

Vested interests / Bias

Answer 24

• Find out who wrote it and what their vested interest is (dr, pharmacist, university professor, etc.)
• Find out who publishes it, and what their vested interests are (university, pharmaceutical company etc.)
• Find out who funds it, and what their vested interests are (pharmaceutical industry, charity, government etc.)
• Is there any suggestion of bias in the study?
• Is the interpretation of the results justified?
• What are the outcome measures? The choice of outcome may be selected by the researcher to “make the results work”.

Question 25

Research issues

Answer 25

• Look for declarations within the research paper in itself: if there are conflicts of interest these should be made clear.
• Sometimes the authors of research papers use their own previous research as ‘evidence’: this is NOT impartial. (look at the reference list bibliography).
• Is it isolated research? (if biomedical, then it usually is).
• Don’t automatically trust references to ‘P – value’ and ‘confidence interval’: these are supposed to be indicators of the reliability of research, but remember they are calculated according to the principles of isolated research.
• Has it been carried out on animals or using animal tissue?
• Does equate the symptom with the disease?

Question 26

The challenges of Biomedical research

Answer 26

What can go wrong with biomedical research?
* The external validity of research rests on lack of bias and confounding factors, declaration of conflicts of interest and the ethical conduct of researchers.
Bias (anything which prevents a fair and impartial result):
* Researchers setting out to ‘prove’ a specific point, resulting in bias in the interpretation of results.

• Confounding factors: problems in trial design or implementation. E.g. drop-out rates, Poor randomization, etc.
• Conflict-of-interest: the researchers have personal or commercial interests in the results: medical research is drug-led, i.e. comes with expectation of profits to be made.

Question 27

Pharmaceutical bias in Biomedical research

Answer 27

Pharmaceutical bias in biomedical research:
* The pharmaceutical industry commissions and funds its own research. Scientific papers are mostly commissioned and even ghost-written by the industry without disclosure.
* The pharmaceutical industry also funds doctors training.
* Clinical trials are often conducted on small groups of unrepresentative subjects.
* Negative data is sometimes with withheld, and results massaged to ‘prove’ what the researchers want to demonstrate.
* Researchers are often subject to ‘gagging orders’ to prevent them from disclosing the truth about their research.

Question 28

‘Bad Science’ –
An example

Answer 28

Statins were introduced onto the market in 1987, after the theory that raised cholesterol was responsible for heart disease gained ground. The story of how that happened raises several questions about so-called scientific research.
* The research that ‘proved’ the ‘cholesterol theory’ was partly conducted on rabbits, who were fed meat and then observed to develop arterial plaques.
* Rabbits are natural vegetarians, who are not supposed eat meat.
* The premise that we can predict human physiological response with reference to animal physiology is flawed.
In 2007 a review of all clinical trials on statins was undertaken, involving 192 separate studies.
* Industry-funded trials were found to be 20 times more likely to deliver positive results for statins that government funded trials
* A meta-analysis conducted in 2012 by the Cholesterol Treatment Trialists collaboration appeared to show a positive benefit preventing heart disease, however…
* When the data was analysed impartially, these results were shown to be questionable, and the risks and side-effects were found to be under-reported and down-played.
http://healthinsightuk.org/2013/10/30/statin-trials-exaggerating-benefits-and-ignoring-the-harm/

Question 29

Cholesterol

Answer 29

The truth is that only 15% of cholesterol found in the body is derived from our diet – the rest (85%) we make.
* Cholesterol is a vital nutrient in our body: it provides the building blocks for certain hormones, including cortisol, DHEA, oestrogen and testosterone.
* Cholesterol is also an important component of the membrane of every cell in our body; it helps maintain the integrity of the cell and regulates what goes in and out of cells.
* Cholesterol is also involved in the synthesis of vitamin D.
The brain comprises only 2% of the body’s weight but contains 25% of the total cholesterol in the body.

Recent research has found that high LDL (‘bad’) cholesterol may be protective against ageing and Alzheimer’s disease.

• Recent research has also suggested that raised cholesterol is NOT the cause of coronary arterial disease – lowering cholesterol too far could then actually be dangerous and damaging to the body
• The biggest risk factor for heart disease is refined sugar consumption
• Adverse affects of statins: muscle damage, liver damage, arthritis, diabetes, neuropathy, memory problems and… Heart disease
  http://www.youtube.com/watch?v=1AWMyh6f5P0

Question 30

Research into natural medicine

Answer 30

Look out for bias and confounding factors. Example: a lot of ‘research’ into the efficacy of herbal medicine gives a poor account of herbal medicine: why?
* It does not generally use whole herb, but ‘standardised extracts’ or isolated plant constituents.
* It does not take into account the ‘variables’ – patient constitution, lifestyle, emotional state, environment, etc.
* It assesses against narrow criteria; everything has to be measurable. The patients experience is not valued.
* It does not take into account the complexity of herbal medicine treatment– lifestyle, diet and exercise advice, or herbs themselves.

Question 31

An example of Poor Trial Design

Answer 31

Ngan, A. & Conduit, N. (2011): Double-blind, placebo-controlled investigation of the effects of Passiflora incarnata (passionflower) herbal tea on subjective sleep quality.
* Compared the use of passionflower tea as a sleep aid with parsley tea, as ‘placebo’.
* Look up parsley in Bartram’s encyclopaedia or botanical medicine and it tells you that parsley itself is a ‘mild sedative’.
* Therefore, parsley tea is not a placebo, and the results though positive have little scientific validity.

Question 32

Research into natural medicine: narrative bias

Answer 32

Look the obvious narrative bias: a search on “Naturopathy” research gives the following website:
http://sciencebasedmedicine.org/naturopathy-vs-science-facts-edition/

Quote from that website:
* “I understand the principles of homoeopathy, acupuncture, and naturopathy. And those principles are antagonistic to science-based-medicine.”
* Translated, this means: “I do NOT understand those principles, as they are antagonistic to my version of science”.
* ‘Science’, or a very narrow definition of it, is assumed to be absolute in much current literature.

Question 33

Your Research at CNM

Answer 33

You will be set some assignments that require you to engage with research:
* This will usually take the form of reviewing practice-orientated research and literature.
* You will need to observe rules of good research
* You will be required to reference your work using the specified referencing conventions
* You will be required to ensure the truthfulness and appropriateness of your sources
* You will be required to understand issues such as ethics and bias in relation to research, in order to evaluate.

Question 34

Referencing

Answer 34

Appropriate referencing is:
* An acknowledgement that you have used the ideas and written material belonging to another author
* A demonstration that you have undertaken appropriate reading and that you appreciate the links between theory and practice
* Your reference list is a comprehensive list of all citations used in your own text
* A Bibliography is a separate list of sources that informed your work but are NOT referenced in the body of your text
* Please familiarize yourself with the CNM referencing guide available online. This must be closely adhered to

Question 35

Plagiarism

Answer 35

Plagiarism is cheating.
Plagiarism is defined as: “the summarisation, presentation or sighting of another person’s thoughts, words, artefacts or software as though they were your own, and without reference to that person”.
* Plagiarism can now be detected by means of online software that assesses the originality of the work submitted

Question 36

Academic resources

Answer 36

• CNM website – includes science direct subscription
• Google scholar
• Textbooks: written by experienced practitioners.
  Go direct to the publishers website; often papers can be accessed free of charge there
• Abstracts: if full text not available, the abstract gives an idea of what you need from an article
• Libraries: local/national – e.g. The British Library.
• Online resources: libraries have online facilities
• Friend at university
• Write to the authors– many will be happy to send PDF

Question 37

Using biomedical research and practice; pyramid

Answer 37

As already discussed it is essential that you remember the limitations of the biomedical research model.
* If you consider the ‘inverted pyramid’, this would render standard biomedical research less important than your own experiences in practice.
* Study practice related textbook and literature, familiarise yourself with the principles And laws of the therapies you are learning.

Pyramid should look like this (1 = most important, 3 = least):
1. Practitioner and patient observations and experiences
2. Laws, principles and conclusions. Patient reports, case studies.
3. Patient questionnaires. Outcome research. Possibly RCTs & systematic reviews.

Question 38

Using biomedical research and practice: aligned with your therapeutic modality

Answer 38

You may read something in biomedical research that might be helpful. If so, always wait against the rules of your therapeutic modality.
* E.g. cinnamon extract lowers glucose, insulin and cholesterol in people with elevated serum glucose. This research identifies mechanisms to support patients with high blood sugar, however that does not mean that cinnamon helps in all cases of blood sugar problems and it only focuses on the symptoms not the underlying cause. It is better to apply the traditional and energetic rules of food/hands first.
* E.g. A review of garlic highlights many useful properties of its compounds. But what did you find with your patients? In some patients garlic will have unwanted reactions, according to their constitution and presenting energetic status. The rules of traditional medicine will guide you as to when it is, or is not, appropriate to use garlic.

Question 39

How can you engage with research?

Answer 39

Everyone is a researcher.
* Any time you need more information and you go looking for it, that is research
* Be careful where you look for it: many websites, for example, are there to sell something or to push certain point of view
* It’s important to engage with the professional literature in your field, for example the herbal journal, The Herbalist, is written by herbalists for herbalists:
http://associationofmasterherbalists.co.uk
* Case studies are among the most useful and informative types of research available

Question 40

Case Studies:

Answer 40

Case studies:
* Written about real life patients by practitioners
* Accurate case taking is, therefore, an important skill
* Gathers all relevant details of diagnosis– lifestyle, diet, individual factors, family history, etc.
* Well-written case notes can then be written up into a case study and can be used to share knowledge, experience and new findings
* You’ll be asked to prepare case studies from your clinical experience as part of your training CNM

Question 41

How can you engage with research?
Traditional medicine e.g. TCM, Ayurveda, Homeopathy

Answer 41

Traditional medicine e.g. TCM, Ayurveda, Homeopathy
* Acquaint yourself with natural therapies, and the way in which they were discovered and developed by specific researchers.
* Understand and apply their laws and principles, which were valid then and still are today.
* Natural therapies go back hundreds of thousands of years and are still practiced throughout the world.
* In natural therapy is the patient is more important than the pathology

Question 42

How can you engage with research?
Nutrition:

Answer 42

Nutrition: there is an abundance of research. In order to understand it you need to learn to:
* First read the Title and the Abstract in order to understand the major points (before you decide if you want to read on). Read through carefully and highlight any unfamiliar terms or acronyms.
* Next read the results. What are they telling you and do you understand what they mean? Read the discussion next for interpretation of the findings.
* Now rate your understanding of the section of the paper on a scale of 0-10. Also rate your understanding of the overall paper.

• Poorly written papers– logical connections are left out; too much jargon
• Reference back to a chain of previous papers– often that chain ends in a paper that describes several methods, and it is unclear which was used.
• Lack of criticism/open-mindedness by the author
• Can you use this information in clinical practice?
• Overstatement of importance – presenting results as well as well-established findings to get published in trendy journals

Question 43

Research: Conclusions

Answer 43

As a natural medicine practitioner, your most important research should be the research you conduct with your own patients. What do you find works?
* What have other practitioners of your discipline found to work well? Read about their experiences in specific cases
* Remember that there is “no one size fits all approach”. Treatment approaches cannot simply be standardized. The principles of all successful natural interventions are based on the individual patients, and their responses to the treatment.

• At CNM, we encourage you to follow and implement the natural principles that have been shown to work in practice
• Understand the philosophy, laws and principles of the therapy you are studying
• Know it works by applying what you’ve studied
• Don’t alter what works
• Remember that biomedical research is “isolated research”. Hence it should remain at the bottom of the Pyramid