Page 151 - 15Diarrhoeaandvomiting

Diarrhoea and vomiting caused by gastroenteritis in children under 5 years

Combined results suggested that children receiving homeopathy had a statistically significantly
shorter duration of diarrhoea (3.1 ± 2.0 days versus 3.8 ± 1.9 days; P = 0.008) and statistically
significantly fewer number of stools per day (2.7 ± 2.0 versus 3.4 ± 2.0 stools per day; P = 0.004)
compared with those receiving placebo. However, as overall children in the placebo group were
younger and smaller than those receiving homeopathy, the reliability of the meta-analysis results
are questionable.
One RCT recruited 292 children aged between 5 months and 6 years who presented to a
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municipal acute care clinic in Honduras. [EL = 1+] The children had acute diarrhoea that was
confirmed visually by study staff (defined as the passage of three or more unformed stools in the
previous 24 hours). Children were excluded if the diarrhoea had lasted more than 4 days, there was
visible blood in the stool, they were severely dehydrated or they lived outside the catchment area of
the clinic. Once enrolled, the participants’ parents were given bottles of premixed ORT and a vial of
tablets. Randomisation was performed by sequential assignment of children to pre-randomised and
coded vials of either placebo (n = 134) or homeopathic combination therapy (n = 131) tablets. The
combination therapy was prepared in the USA by a homeopathic pharmacist and contained the five
most common single remedies – Arsenicum album, Calcarea carbonica, chamomilla, podophyllum
and sulphur – in a liquid homeopathic dilution in the 30C potency. Parents were instructed to give
their child two tablets after each unformed stool, to be dissolved in the mouth, and to give ORT
according to WHO recommendations. Follow-up was performed by parents and auxiliary nurses
for 7 days after the initial visit or until symptoms resolved, if sooner (defined as two consecutive
days with fewer than three unformed stools each day). The main outcome measures were duration
of diarrhoea, mean rate of unformed stool passage per day during follow-up and total number of
unformed stools during follow-up. All study staff and the patients were blind to treatment allocation.
Results were presented for 265 children (9% loss to follow-up). The groups were similar for age,
sex, height, weight, body temperature, vomiting, dehydration status and duration of diarrhoea
and unformed stools prior to study entry. There were no statistically significant differences in the
distribution of identified pathogens between the treatment and placebo groups. No statistically
significant differences between treatment with homeopathic combination therapy or placebo
were reported for the three main outcomes of duration of diarrhoea, mean rate of unformed
stool passage per day during follow-up or total number of unformed stools during follow-up.
Univariate adjustment for baseline characteristics did not alter these results.

Evidence summary
Evidence from a systematic review and meta-analysis of three RCTs suggested that individualised
homeopathy treatment reduced the duration and stool frequency of diarrhoea compared with
placebo in young children. [EL = 1+] However, as overall the treatment groups were not similar
for age, weight and height at baseline, these findings should be treated cautiously as they may
overestimate the true treatment effect size.

Evidence from an RCT examining the effects of a combined homeopathy tablet compared with
placebo found that there were no differences in effect on duration of diarrhoea, mean rate of
unformed stool passage per day during follow-up or total number of unformed stools during
follow-up in young children. [EL = 1+]

GDG translation from evidence to recommendation

The GDG considered that the clinical trials assessing homeopathy had significant methodological
limitations. Moreover, there was a lack of consistency in the evidence. Therefore, no
recommendation was made for the use of homeopathy.

8.5 Probiotics

In 1985, a lactobacillus was identified through screening of bacteria in fermented milk products
that was acid and bile resistant, adhered to intestinal epithelial cells. 140,194 This was Lactobacillus
rhamnosus GG, a non-pathogenic organism. The current view of probiotic therapy is based on the
concept of a normal balanced intestinal microbiota. 195 Much research has been directed towards
examining the potential benefit of a variety of probiotics, including various lactobacillus species

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