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Effectiveness of Laxatives in the Elderly - NIHR Health Technology ...

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Effective laxative treatments<br />

for constipation<br />

Significant improvements <strong>in</strong> bowel movement<br />

frequency have been observed with a stimulant<br />

laxative conta<strong>in</strong><strong>in</strong>g cascara and, also, with an<br />

osmotic laxative. Non-significant effects <strong>of</strong><br />

laxatives on frequency have been reported <strong>in</strong><br />

four o<strong>the</strong>r placebo-controlled RCTs. S<strong>in</strong>ce <strong>the</strong><br />

largest <strong>of</strong> <strong>the</strong>se trials had only 51 participants,<br />

<strong>the</strong> trials may simply have lacked <strong>the</strong> statistical<br />

power to detect an effect. Information on o<strong>the</strong>r<br />

outcomes, such as improvements <strong>in</strong> symptoms<br />

and stool consistency, are not reported for all<br />

trials. However, improvements <strong>in</strong> both stool<br />

consistency and symptoms have been reported<br />

<strong>in</strong> placebo-controlled trials <strong>of</strong> psyllium, lactulose<br />

and lactitol treatment.<br />

There is a commonly held cl<strong>in</strong>ical impression<br />

that fibre is less effective than o<strong>the</strong>r types <strong>of</strong><br />

laxative <strong>in</strong> improv<strong>in</strong>g bowel movement frequency.<br />

However, to exam<strong>in</strong>e this question <strong>in</strong> detail, direct<br />

comparisons between fibre and o<strong>the</strong>r laxative<br />

classes and types with<strong>in</strong> <strong>the</strong> same trial would be<br />

required. Very few <strong>of</strong> such direct comparisons<br />

appear to have been carried out <strong>in</strong> controlled trials.<br />

Eight trials compared laxative agents, and <strong>the</strong> two<br />

higher quality trials suggested that Agiolax may be<br />

more effective than lactulose.<br />

These f<strong>in</strong>d<strong>in</strong>gs are <strong>in</strong> accord with <strong>the</strong> systematic<br />

review <strong>of</strong> <strong>the</strong> treatment <strong>of</strong> constipation <strong>in</strong> adults<br />

by Tramonte and colleagues (1997), <strong>in</strong> which it<br />

was concluded that laxatives and fibre consistently<br />

<strong>in</strong>creased bowel movement frequency compared<br />

with placebo, with <strong>the</strong> <strong>in</strong>crease be<strong>in</strong>g <strong>of</strong> <strong>the</strong> order<br />

<strong>of</strong> 1.5 bowel movements per week. Direct comparisons<br />

were found to be <strong>in</strong>conclusive because <strong>of</strong> <strong>the</strong><br />

small number <strong>of</strong> studies found and methodological<br />

flaws. There was no direct evidence that fibre was<br />

more or less effective than any o<strong>the</strong>r laxative<br />

<strong>in</strong> adults.<br />

The results <strong>of</strong> <strong>the</strong> trials <strong>in</strong> elderly people<br />

can also be summarised separately for two<br />

specific groups.<br />

Chapter 5<br />

Summary and<br />

research recommendations<br />

<strong>Health</strong> <strong>Technology</strong> Assessment 1997; Vol. 1: No. 13<br />

• Ambulant elderly people<br />

The majority <strong>of</strong> trials have been conducted<br />

among a limited sample <strong>of</strong> elderly people.<br />

Most participants were recruited ei<strong>the</strong>r <strong>in</strong><br />

nurs<strong>in</strong>g homes or <strong>in</strong> hospitals, and only two<br />

trials <strong>in</strong>cluded elderly patients treated as<br />

out-patients. In one <strong>of</strong> <strong>the</strong>se, <strong>in</strong> which <strong>the</strong><br />

bulk laxative psyllium was compared with<br />

placebo, a larger weekly <strong>in</strong>crease <strong>in</strong> bowel<br />

movement frequency was found than <strong>in</strong> any<br />

o<strong>the</strong>r placebo-controlled trial, although <strong>the</strong><br />

numbers <strong>of</strong> participants <strong>in</strong> <strong>the</strong> trial were<br />

small and <strong>the</strong> difference was not statistically<br />

significant. The o<strong>the</strong>r trial among elderly<br />

out-patients compared two bulk laxatives,<br />

psyllium and calcium polycarbophil. Psyllium<br />

was more effective <strong>in</strong> improv<strong>in</strong>g bowel movement<br />

frequency and stool consistency, although<br />

<strong>the</strong> latter was a non-significant trend. These<br />

results suggest that fibre may be effective<br />

<strong>in</strong> <strong>the</strong> ambulant elderly.<br />

• <strong>Elderly</strong> people <strong>in</strong> hospitals and<br />

nurs<strong>in</strong>g homes<br />

The trials <strong>in</strong> hospital and nurs<strong>in</strong>g-home<br />

patients suggest that stimulant and osmotic<br />

laxatives may be more effective <strong>in</strong> <strong>the</strong>se<br />

patients than bulk agents <strong>in</strong> <strong>in</strong>creas<strong>in</strong>g bowel<br />

movement frequency. However, this result<br />

is based on a few studies and <strong>the</strong> results<br />

regard<strong>in</strong>g improvement <strong>in</strong> symptoms and<br />

stool consistency are <strong>in</strong>conclusive.<br />

The major criticism <strong>of</strong> <strong>the</strong> trials identified <strong>in</strong><br />

this area is that <strong>the</strong>y lack power and are, <strong>the</strong>refore,<br />

unlikely to detect effects <strong>of</strong> treatment. They are<br />

certa<strong>in</strong>ly too small to adequately assess effects<br />

<strong>of</strong> treatment on uncommon outcomes, such as<br />

impaction, and adverse effects.<br />

A fur<strong>the</strong>r potential problem lies <strong>in</strong> <strong>the</strong> assumption<br />

that <strong>the</strong> patients <strong>in</strong> <strong>the</strong> trials are a homogeneous<br />

group. There are many causes <strong>of</strong> constipation,<br />

some <strong>of</strong> which may be <strong>of</strong> particular relevance to<br />

<strong>the</strong> nurs<strong>in</strong>g home or hospital populations which<br />

feature <strong>in</strong> most <strong>of</strong> <strong>the</strong> trials, such as dietary,<br />

psychiatric and environmental causes (Moriarty<br />

33

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