WHO monographs on selected medicinal plants - travolekar.ru

Cortex Phellodendron
Clinical pharmacology
While no clinical studies evaluating the safety and efficacy of the crude
drug could be found, there have been numerous studies evaluating the efficacy
of berberine, the major chemical constituent of the plant. Therefore,
summaries of these clinical studies have been included in the monograph.
The direct applicability of these clinical data to the crude drug is
unknown and needs to be further investigated.
In several clinical trials, berberine was effective in the treatment of secretory
diarrhoea (16–21). However, few trials have compared the efficacy
of berberine with a positive control, such as tetracycline, in treating fluid
loss caused by diarrhoea in patients with cholera or in those with noncholera
diarrhoea (16, 17, 19, 61).
A randomized, placebo-controlled, double-blind clinical trial involving
400 patients with acute watery diarrhoea compared the antisecretory and
vibriostatic effects of berberine and tetracycline (16). Of 185 patients with
cholera, those given tetracycline or tetracycline and berberine had a reduced
volume and frequency of stools, and duration of diarrhoea. In the
group treated with berberine, following oral administration of 100.0 mg
four times a day, stool volume was reduced and the concentration of cyclic
adenosine monophosphate in the stools was reduced by 77%. Neither
berberine nor tetracycline exhibited any benefit over placebo in patients
with non-cholera diarrhoea of unspecified etiologies (16).
A randomized comparison-controlled trial of 165 patients assessed
the antisecretory activity of a 400.0-mg single-bolus dose of berberine
sulfate for enterotoxigenic Escherichia coli-induced diarrhoea, and either
400.0 mg as a single oral dose or 1200.0 mg of berberine sulfate (400.0 mg
every 8 hours) for the treatment of cholera (19). In patients with Escherichia
coli-induced diarrhoea who received a single oral dose of berberine,
the mean stool volumes were significantly less than those of controls
during three consecutive 8-hour periods after treatment (p < 0.05).
At 24 hours after treatment, patients with Escherichia coli-induced diarrhoea,
who were treated with berberine, had a lower stool volume and
frequency than patients in the control group (42% versus 20%, p < 0.05).
Patients with cholera, who received 400.0 mg of berberine, also had a
reduction in stool volume, while those treated with 1200.0 mg of berberine
plus tetracycline did not. No adverse effects were observed in the
patients receiving berberine. The results of this study indicated that berberine
was an effective and safe antisecretory drug for treatment of Escherichia
coli-induced diarrhoea, but had only a modest antisecretory
effect in cholera patients, in whom the activity of tetracycline alone was
superior (19).
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