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




Chapter3: Methods for Clinical Research in Constipation: Outstanding Research Questions in Constipation
          

Many questions in constipation research have been addressed inadequately or not at all. It still remains unclear which laxative agents offer the best combination of efficacy, low incidence of adverse effects (colic, diarrhea, bloating), acceptability, and cost. Comparative trials of adequate size are needed. Many previous trials have had limited statistical power and there is a tendency for the most significant results to arise from the trials of higher quality, raising the possibility that smaller trials have underestimated the effectiveness of the laxatives they have studied (Petticrew, Watt and Sheldon, 1997).

Figure 9.1 Effect size by quality score for adult trials identified by Cochrane review (excluding trials in the elderly)
Graphic depiction of effect size by quality score, described in text.
This graph of effect sizes (in bowel movements per week) from the trials of laxatives in adults shows and apparently higher effect size in higher quality trials. The implication is that poorer quality trials may underestimate the effects of treatment (Petticrew, Watt, and Sheldon, 1997)

Further trials should also be conducted to clarify whether there is any value, either in effectiveness or in reduction of adverse effects, to the practice of combining stimulant and softening laxatives. It may be that such combinations only hold value for certain types of patient, but currently the only information derives from a volunteer study (Sykes, 1996). Centres vary in what they do, and further evidence to direct practice would be useful.

While the essential aim of oral laxative therapy is to avoid the need for use of suppositories or enemas, these rectal laxatives will be needed for many patients sometimes and a few patients always. However, we currently lack comparative trials to show what types or combinations of suppositories and enemas are most effective and most economical in terms of price and nursing time.

Claims are regularly made for the use of alternative therapies in the relief of constipation, from abdominal massage to reflexology. Research in this area will be as difficult as in any other application of these therapies and must include an estimate of the cost of therapist time, but there is considerable public interest in the applications of non-pharmaceutical therapies to everyday complaints, and laxatives cost health systems significant amounts of money (about £13 million annually in the U.K.).

A number of drugs outside the current range of agents hold promise of effectiveness as laxatives. Some, such as cisapride, have already undergone a fair amount of clinical evaluation. Others, such as macrolide derivatives and oral opioid antagonists, have been studied less. There are deficiencies in our current armamentarium in terms of effectiveness and patient acceptability. Comparative trials of new drugs are needed in order to widen the range of options for our patients with constipation.

A great deal remains to be learned about the neurochemical and cellular basis of constipation either in health or disease, but research in these areas is outside the scope of this clinically based article.


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