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Clinical Research: Constipation Sections
Author Biography
Introduction
What is constipation?
Understanding the problem
Objective Measurement
Subjective Measurement
Measuring Components
Currently Selected Section: Precipitating Factors
Therapeutic Comparisons
Research Questions
Conclusion




Chapter 3: Methods for Clinical Research in Constipation: Precipitating Factors in Constipation
          
Figure 7.2 Laxative And Opioid Doses
Graphic depiction of laxative and opioid doses, described in text.
A graph to show the relationship between opioid and laxative doses. Mean laxative doses are displayed by quartile of mean opioid dose. (Note that non-opioid takers are shown for comparison and 95% confidence intervals for the means are indicated.) (Sykes, 1998)

An intrinsic difficulty in this type of study is that of deciding a basis for the comparison of different laxatives. It is rarely practicable in a study of any size in a general clinical setting to completely control the types of laxatives that are given, principally because of issues of patient tolerance. Also, it is probably appropriate in opioid-induced constipation that a combination of softening and stimulant agents is used. How are these different drugs to be combined into an expression of "laxative dose"?

The simplest method is to ignore the fact that different preparations are involved and to calculate the volume or number of tablets that are given. If a mixture of tablets and liquids is used some judgment needs to be made of their relative potency. This is easy if the same drug is involved but less straightforward if they are not, because there are few data by which to compare laxative potencies.

Different investigators utilize different methods for standardizing or quantifying laxative potencies.

Approaches to Comparing Laxatives
(Click each for details)

Laxatives & Softeners (Fallon and Hanks, 1999)

Laxative Units
(Sykes, 1998)

Laxative Units
(Daeninck and Bruera, 1999)


Currently, the accuracy of any system of comparing laxatives cannot be known clearly. In a comparative trial the level of distortion will depend on the degree to which the groups received an equal variety of laxative preparations. In a trial such as that of the constipating effect of morphine the assumption is that no particular laxative was used preferentially within one morphine dose range more than others.

 

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