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The Quince ...

Issue 22 

In This Issue

The risks and benefits of an Rx-to-OTC switch. The case of over-the-counter H2-blockers
Evidence based on call
Systematic reviews

The risks and benefits of an Rx-to-OTC switch. The case of over-the-counter H2-blockers

A paper by Oster in Medical Care back in 1990 looked at this important topic. They are writing in a USA context but the findings appear to be of interest to us in the UK.

In recent years, many new over-the-counter (OTC) medications have resulted from the granting of OTC status to drug entities that previously were available only by prescription (Rx). While the benefits to consumers of Rx-to-OTC switches may be substantial, they also involve some degree of risk, as usage typically expands and physician supervision diminishes. Oster’s study explored the balance of benefits and risks. The study used the technique of decision analysis to examine drug regulatory policy.

Histamine H2 receptor antagonists (H2-blockers), which were available only by prescription, were presented as a case study and were examined to determine how OTC availability of these agents would be likely to alter the patterns, effectiveness, and risks of self-treatment for acid-peptic disorders.

In the USA about 5.7 million persons experience an episode of dyspepsia during any given quarter, of whom 3.5 million self-medicate with antacids. Study results indicate that OTC availability of H2-blockers would:

Increase the proportion of persons with dyspepsia who self-medicate from 61.8% currently to 64.1%;

Increase the proportion of persons who experience complete relief of their symptoms while self-medicating from 37.9% to 43.2%;

Result in 14 additional cases of serious haematological disorders and an additional 22,000 instances of minor side effects per quarter, but cause the overall rate of side effects among persons who self-medicate to decline

Cause an additional 300 persons per quarter with gastric cancer to self-medicate before seeking professional care, but cause no change in the median time between onset of symptoms and the decision to seek such care

Decrease by 277,000 the number of persons per quarter who seek professional care for dyspepsia.

On balance, results suggest that OTC H2-blockers may be a relatively safe and effective means of self-care for acid-peptic disorders, and may substantially reduce the number of patient encounters with the medical care system for minor gastrointestinal complaints.

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Evidence based on call

A team of clinicians at the Centre for Evidence-Based Medicine in Oxford,
has set up "Evidence-Based On-Call" to meet the challenge of providing clinically relevant evidence-based advice at the bedside.

The Oxford team will use high-quality techniques to search the literature for the best journal articles on specific on-call problems. EBOC has developed an internet authorising tool allowing clinicians with EBM experience to create one-page summaries of these articles.

These summaries, known as critically-appraised topics or CATs, will be added to a central electronic database to create clinical guidelines.

Clinicians from all specialities and at all levels of experience may participate in Evidence-Based On-Call.

The group are looking for contributors and reviewers:

Their website at http://cebm.jr2.ox.ac.uk/eboc/eboc.html gives a sample guideline and some CATs. Contact Chris Ball at:

EBOC Office, Cairns Library, Level 3 Academic Street, John Radcliffe Hospital
Oxford, OX3 9DU, UK.Telephone: +44 (0)1865 221945 email: cmball@eboc.u-net.com

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Systematic reviews

Andrew Booth has recently given a useful outline of what makes a systematic review.

He suggests there are four components to the review that make it systematic:

1. The literature search

2. The selection of the materials

3. The appraisal

4. The synthesis

A bona fide systematic review is only such if all elements have been done systematically - the methodology is not therefore study dependent (i.e. not necessarily RCTs only). The considerations that come into play are as follows:

1. All systematic reviews should give evidence of the widest possible strategy for identifying studies. This is done by listing all databases searched, strategies where available, performing funnel plots to look for publication bias etc.

With a qualitative review one obviously cannot prove that one has a statistically valid sample so one would look for the presence of data saturation - i.e. to search the literature persistently until you no longer find any new types of models. Citation searching is particularly important in this context.

2. Selection of materials should be done according to an a priori (i.e. up front) set of criteria. This includes a precise definition of studies to be included. Selection of criteria after retrieving articles is methodologically suspect.

3. Similarly criteria for appraisal should be existing systems/checklists rather than formulating your own.

4. The added value of the review, when done systematically, is in bringing together comparable studies and commenting on commonalties and differences. Guidance on how to do this for qualitative studies is found in a useful publication Metaethnography (full ref in Cochrane Review Methodology Database).

If your review meets the above then it is arguably a systematic review. If not then you could describe it according to those characteristics that it possesses, e.g. a systematic search and qualitative review, systematic search and concept analysis etc.

Often the problem lies in the synthesis if you are trying to analyse different sorts of studies - this will only be possible if you have subgroups of similar enough studies. "The mixing of diverse studies can make for a strange fruit salad: mixing apples and oranges may seem reasonable enough but when sprouts, turnips or even an old sock are added it can cast doubt on the meaning of any aggregate estimates".

This comes from the context of meta-analysis but the same principles apply.

The paper "What is meta-analysis?" has a very useful companion "What is a systematic review?". Both are available from the Bandolier site as downloadable documents in the "What is ....." series.

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Last updated:

Copyright 2003 | Norman Vetter


Send mail to njvetter@hotmail.com with questions or comments