Dr DIMITRIOS – JAMES MANOS

EMERGENCY MEDICINE AND GENERAL MEDICINE TEXTS

© All rights reserved


ENGLISH MEDICAL TEXTS
ENGLISH GENERAL INTEREST TEXTS
ENGLISH SPIRITUAL TEXTS
ENGLISH MEDICAL TEXTS FOR ALL

 

REVIEW: EVIDENCE BASED MEDICINE

 

Dr DIMITRIOS – JAMES MANOS
1 January 2012

Herbal medicine is a worldwide method of complementary medicine. However there are many stereotypes about its indications and its safety. Unfortunately there are fewer studies about herbal medicine, contrary to contemporary medications. Furthermore, tests have revealed that in some herbal or dietary supplement products the proportion of the active substance was in fact low (so it was in sub – therapeutical levels, namely in lower levels that it is needed to help) and also in some cases the product contained lead, a toxic heavy metal. Often, different products had different amounts of the main substance.

Other times the products did not contain sufficient – effective dose of the substance (e.g. a herb root), but a part of it (e.g. steams or leaves). Also, the effective dose of most of the herbs/ dietary supplements hasn’t been established for most of them!

The herbs/ dietary supplements (including herbs) are not under the full regulation of governmental authorities such as the FDA (Food & Drug Administration) of the USA and so the products aren’t regulated that strictly as the medications – see chapter I. NOTES FROM OFFICIAL ORGANIZATIONS SUCH AS THE FDA (US Food & Drug Administration)  

That means that for many herbs/ dietary supplements there is lack of safety and official scientific research (that leads to guidelines) for their indications, their safe therapeutical dose (that indeed treats a disease), their contraindications, their interactions (with other drugs or herbs) and all their side effects. Except perhaps fish oil, there aren’t any official medical guidelines for taking most dietary supplements (including herbs). Also for many herbs/ dietary supplements there is efficient, conclusive and ‘evidence based’ scientific proof that they help comparing to drugs (medicine) or placebo.

As medications, herbs and dietary supplements have specific indications, contraindications, interactions with other drugs and side effects such as allergy, nausea and gastrointestinal disturbance (5).

Herbalists have the specialty that can guide patients how to use sufficiently and safely herb medications and generally dietary supplements. A well qualified complementary medicine expert and also a doctor can also give herbs and dietary supplements (if he/she is well trained to). However, it is unacceptable for people to buy herbs on the supermarket or on the internet without counselling an expert (doctor, herbalist, complementary medicine expert etc).

About the question if there is evidence that herbs and dietary supplements work better than medical drugs or than placebo, generally for many herbs/dietary supplements there is lack of sufficient data to support that they work better.

Today it is important to check if a herb or a dietary supplement (or a medicine) really helps a patient and there is a specific way of checking it: Evidence Based Medicine. Also several trials and research is published at database such as the Medline.  

Many published studies have bias (one example is a medication that is studied by a manufactory company). They may are poor designed. They may have a small sample (e.g. it is different to involve 5 subjects and different to involve 5 000 subjects) and they may have logistic problems and inadequate publication of the statistic methods and results. They may also have published insufficient data. They may not be placebo controlled or double – blind and also may not be randomized controlled. Also many meta-analysis involve just a few RCTs (randomized controlled trials), for example they investigate just 3 – 4 studies or even 1 – 2 studies, so it is impossible to lead to a safe conclusion. Also a study may have short duration and this may influence the results. So the duration of a study is important.  In conclusion many studies are poor designed, so we need to check first if the quality of a study is good or poor. Cochrane meta-analysis are based on good designed studies that fulfil the inclusion criteria.

Evidence Based Medicine analyzes several trials (meta-analysis) and ends up to a safe conclusion about if a dietary supplement or a medication really helps a disease. A guideline is published to guide the doctors and the scientists in all over the word about its safe use (1), (2), (3), (4).

We should not accept any article – trial without References at the end of the publication. Of course many investigations are biased (e.g. if conducted from a drug company), and that’s why today scientists seek and analyze several trials (meta-analysis). Also trials are better if are randomized controlled and also double blind and placebo – controlled. These trials are analyzed by ‘Evidence Based Medicine’ and also the Cochrane’ Library. The Cochrane Library has meta-analysis that are more important than a single study e.g. on pubMed. However, many meta-analysis involve just a few RCTs (randomized controlled trials), for example they investigate just 3 – 4 studies or even 1 – 2 studies, so it is impossible to lead to a safe conclusion.

So, we all need to search on the web about Evidence Based Guidelines.

Evidence Based Medicine (EBM) aims to apply the best available evidence gained from the scientific method to clinical decision making. It seeks to assess the strength of evidence of the risks and benefits of treatments (including lack of treatment) and diagnostic tests. Evidence quality can range from meta-analyses and systematic reviews of double blind, placebo controlled clinical trials. EBM recognizes that many aspects of health care depend on individual factors such as quality and value of life judgments, which are only partially subject to scientific methods. EBP seeks to clarify those parts of medical practice that are in principle subject to scientific methods and to apply these methods to ensure the best prediction of outcomes in medical treatment, even as debate continues about which outcomes are desirable (1).

Evidence based Medicine recommendations, according to the US Preventive Service Task Force, can be categorized to the following categories:

  • Level A: there is good scientific evidence suggesting that the benefits of the clinical service substantially outweigh the potential risks. Clinicians should discuss the service with eligible patients.
  • Level B: there is at least fair scientific evidence suggesting that the benefits of the clinical service outweigh the potential risks. Clinicians should discuss the service with eligible patients.
  • Level C: there is at least fair scientific evidence suggesting that there are benefits provided by the clinical service, however the balance between benefits and risks are very close for making general recommendations. Clinicians need not offer it, unless there are individual considerations.
  • Level D: there is at least fair scientific evidence suggesting that the risks of the clinical service outweigh the potential benefits. Clinicians should not routinely offer the service to asymptomatic patients.
  • Level I: scientific evidence is lacking, has poor quality, or is conflicting, so that the risk against benefit balance can’t be assessed. Clinicians should help patients understand the uncertainty of surrounding the clinical service (1).

Always someone should make his/her own research and check a herb or a dietary supplement (by writing its name at the ‘search’ box) at the following sites:

1. Sites for Evidence Based Medicine are many e.g. http://ebm.bmj.com and http://www.dmoz.org/Health/Medicine/Evidence_Based_Medicine

2. Sites for Cochrane (it has matanalysis) are http://www.cochrane.org and http://www.thecochranelibrary.com   

3. Site for medline – PubMed is http://www.ncbi.nlm.nih.gov/pubmed

and for MedlinePlus

http://www.nlm.nih.gov/medlineplus/healthtopics.html

For quick search write on a search engine such as ‘google’ the keyword with the name of the supplement and next the phrase ‘PubMed’.

For a classic encyclopaedia go e.g. to Britannica at http://www.britannica.com  

Also for encyclopaedia go to http://en.wikipedia.org/wiki/Main_Page

OTHER SITES:   

Clinical evidence:

www.clinicalevidence.com

http://highwire.stanford.edu

www.eguidelines.co.uk

www.medicine.ucsf.edu/recourses/guidelines

www.guidelines.gov

http://www.nature.com/

 

For drugs (medications, medicines)

www.bnf.org

www.medicines.org.uk

www.ukmi.nhs.uk

www.fda.gov

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

http://www.drugs.com/

  • Further information on internet about herbs, dietary supplements and complementary medicine you can find at the sites:

 and

For a good dictionary (that follows the ‘corpus’) go to http://dictionary.cambridge.org

About buying medicine on the internet please read the FDA’s article:

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/BuyingMedicinesOvertheInternet/default.htm

It is strongly suggested to never stop a medication that a doctor prescribed or suggested in order to replace it with a herb or a dietary supplement. Instead, therapy with dietary supplements (including herbs), may be combined with prescribed drugs (guided by a specialist) and that is why we call this kind of medicine as complementary medicine.

Of course this combination may occur only if there aren’t any interactions between the dietary supplement and the medication (that’s why an expert needs to guide someone who takes a dietary supplement).

Complementary medicine offers a therapy (e.g. a herb/dietary supplement) that can help to a specific medical problem, WITHOUT the need of stopping the drugs (medications) of contemporary (modern) medicine. It is important especially for severe diseases such as cancer in which the medication therapy should not be stopped in order to be replaced by a herb/ dietary supplement in any way.

REFERENCE (LINKS)

1. http://en.wikipedia.org/wiki/Evidence_based_medicine

2. Simon C., Everitt H., Kendrick T., Oxford Handbook of General Practice, Oxford Medical Publications, 2nd edition, 2005.

3. Evidence Based Medicine, p. 668 – 669, Longmore M., Wilkinson I.B, Davidson E.D., Foulkes A., Mafi A.R., Oxford Handbook of Clinical Medicine, Oxford Medical Publications, 8th edition, 2010.

4. Evidence Based Medicine, p. 489, Collier J., Longmore M., Brinsden M., Oxford Handbook of Clinical Specialties, Oxford Medical Publications, 7th edition, 2006.

5. Herbal Medicine, p. 148 – 149, C. Simon, H. Everitt, T. Kendrick, Oxford Handbook of General Practice, Oxford Medical Publications, 2nd edition, 2005.

.

 

HOME