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

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20<br />

Results<br />

(Richards-Hall et al, 1995; Maestri-Banks & Burns,<br />

1996), and <strong>in</strong>creas<strong>in</strong>g fluid <strong>in</strong>take has been<br />

recommended as a method <strong>of</strong> prevent<strong>in</strong>g<br />

constipation (Klauser & Müller-Lissner, 1993;<br />

Marshall, 1990). However, <strong>the</strong>re appear to<br />

have been few studies which have demonstrated<br />

<strong>the</strong> effects <strong>of</strong> low fluid <strong>in</strong>take on<br />

constipation while controll<strong>in</strong>g adequately<br />

for o<strong>the</strong>r factors. A background search on<br />

Medl<strong>in</strong>e (1966–96) was carried out for this<br />

review but no trials were found <strong>in</strong> which<br />

constipated adults had been treated by<br />

<strong>in</strong>creas<strong>in</strong>g hydration. Several observational<br />

studies have studied <strong>in</strong>creased fluid <strong>in</strong>take<br />

but this has typically been an adjuvant to some<br />

o<strong>the</strong>r dietary manipulation, such dietary fibre<br />

supplementation (Hope & Down, 1986;<br />

Maddi, 1979).<br />

Summary<br />

Observational studies which have <strong>in</strong>creased<br />

dietary fruit and fibre <strong>in</strong>take have emphasised<br />

<strong>the</strong>ir effectiveness <strong>in</strong> prevent<strong>in</strong>g constipation.<br />

However, RCTs are likely to be less biased than<br />

non-randomised observational studies which<br />

tend generally to produce <strong>in</strong>flated estimates<br />

<strong>of</strong> <strong>the</strong> effects <strong>of</strong> treatment. For example, <strong>in</strong> <strong>the</strong><br />

current context <strong>the</strong> few RCTs which have been<br />

carried out to exam<strong>in</strong>e <strong>the</strong> effectiveness <strong>of</strong> fibre<br />

<strong>in</strong> prevention <strong>of</strong> constipation have not supported<br />

<strong>the</strong> results <strong>of</strong> observational studies, although<br />

larger studies with a higher degree <strong>of</strong> compliance<br />

with treatment may be required. RCTs <strong>of</strong> <strong>the</strong><br />

effects <strong>of</strong> fruit mixtures appear not to have<br />

been carried out. Specific recommendations<br />

for research <strong>in</strong> this area appear at <strong>the</strong> end <strong>of</strong><br />

this report.<br />

RCTs <strong>of</strong> <strong>the</strong> effectiveness <strong>of</strong><br />

laxatives <strong>in</strong> treat<strong>in</strong>g constipation<br />

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

The supplementary search across additional<br />

databases found 13 RCTs <strong>of</strong> laxative treatment<br />

<strong>of</strong> constipation. Twelve studies did not <strong>in</strong>clude<br />

elderly patients and were <strong>the</strong>refore excluded<br />

from <strong>the</strong> current review. Five reports were from<br />

Germany, three were English, three were Italian,<br />

and one Swedish. Details <strong>of</strong> <strong>the</strong>se studies have<br />

been passed to <strong>the</strong> Cochrane review group to<br />

be assessed for <strong>in</strong>clusion <strong>in</strong> <strong>the</strong> next update <strong>of</strong><br />

<strong>the</strong> systematic review <strong>of</strong> laxatives <strong>in</strong> adults. One<br />

unpublished RCT <strong>in</strong> elderly patients was identified<br />

but did not meet <strong>the</strong> <strong>in</strong>clusion criteria.<br />

The results <strong>of</strong> <strong>the</strong>se trials are described <strong>in</strong><br />

Appendix 4.<br />

Two RCTs <strong>of</strong> <strong>the</strong> use <strong>of</strong> laxatives to treat<br />

constipation <strong>in</strong> <strong>the</strong> elderly were found which<br />

had not been identified <strong>in</strong> <strong>the</strong> review by<br />

Tramonte and colleagues (1997). Data were<br />

abstracted from <strong>the</strong>se studies (Marchesi, 1982;<br />

D<strong>of</strong>foel et al, 1990) and analysed toge<strong>the</strong>r with<br />

data from <strong>the</strong> n<strong>in</strong>e trials <strong>in</strong> <strong>the</strong> elderly already<br />

identified (us<strong>in</strong>g data abstracted by Tramonte<br />

and colleagues).<br />

RCTs compar<strong>in</strong>g s<strong>in</strong>gle laxative agents<br />

with placebo<br />

Characteristics <strong>of</strong> trials<br />

Ten trials were <strong>the</strong>refore identified <strong>in</strong> which<br />

s<strong>in</strong>gle agents were compared with placebo <strong>in</strong><br />

<strong>the</strong> treatment <strong>of</strong> constipation <strong>in</strong> <strong>the</strong> elderly,<br />

<strong>in</strong> a total <strong>of</strong> 367 patients (Table 5). The mean<br />

age <strong>of</strong> <strong>the</strong> patients <strong>in</strong> <strong>the</strong>se trials was estimated<br />

to be 74 years. Two <strong>of</strong> <strong>the</strong> ten trials which were<br />

identified presented no <strong>in</strong>formation on <strong>the</strong> sex<br />

<strong>of</strong> <strong>the</strong> participants; <strong>in</strong> <strong>the</strong> o<strong>the</strong>r eight trials, just<br />

over half <strong>of</strong> <strong>the</strong> patients <strong>in</strong>cluded were<br />

women (54%).<br />

In <strong>the</strong> majority <strong>of</strong> <strong>the</strong>se studies (n = 7) elderly<br />

patients were exam<strong>in</strong>ed <strong>in</strong> an <strong>in</strong>stitutional sett<strong>in</strong>g,<br />

such as nurs<strong>in</strong>g homes or hospitals. One study<br />

reported results for out-patients who were liv<strong>in</strong>g<br />

<strong>in</strong> <strong>the</strong> community (Chesk<strong>in</strong> et al, 1995) and one<br />

study did not report a sett<strong>in</strong>g (Wesselius-de-<br />

Casparis, 1968). One study <strong>in</strong>volved adults with<br />

diverticular disease with constipation as <strong>the</strong>ir<br />

<strong>in</strong>itial compla<strong>in</strong>t but who were o<strong>the</strong>rwise healthy<br />

(Ewerth et al, 1980). Four trials exam<strong>in</strong>ed <strong>the</strong><br />

effectiveness <strong>of</strong> bulk laxatives, three exam<strong>in</strong>ed<br />

osmotic laxatives, two exam<strong>in</strong>ed stimulant laxatives,<br />

and one trial exam<strong>in</strong>ed <strong>the</strong> effectiveness <strong>of</strong> a<br />

faecal s<strong>of</strong>tener.<br />

Effect <strong>of</strong> laxatives on frequency<br />

In trials compar<strong>in</strong>g s<strong>in</strong>gle active treatments with<br />

placebo, seven were identified which presented<br />

data on frequency <strong>of</strong> bowel movements. Data<br />

on bowel movement frequency was estimated<br />

from a graph <strong>in</strong> one study (Vanderdonckt<br />

et al, 1990).<br />

The trials identified are shown <strong>in</strong> Figure 4<br />

(a summary <strong>of</strong> <strong>the</strong> characteristics and outcomes<br />

<strong>of</strong> <strong>the</strong> trials is also given <strong>in</strong> Table 5). The figure<br />

shows <strong>the</strong> <strong>in</strong>crease <strong>in</strong> bowel movements per week<br />

associated with treatment <strong>in</strong> each trial identified.<br />

When adequate <strong>in</strong>formation has been provided<br />

by authors, confidence <strong>in</strong>tervals are plotted.<br />

When not enough <strong>in</strong>formation was presented <strong>in</strong><br />

<strong>the</strong> paper, <strong>the</strong> authors were contacted. However,<br />

several trials (for example, Chesk<strong>in</strong> et al, 1995;

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