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Herba Chelidonii
A placebo-controlled, double-blind clinical trial assessed the efficacy
of tablets prepared from an aqueous-ethanol extract of the crude drug
corresponding to a daily dose of 24 mg of total alkaloids (calculated as
chelidonine) in patients suffering from epigastric complaints or cramps in
the biliary system and/or the upper gastrointestinal tract. Sixty patients
were treated for 14 days with the extract or a placebo. Outcomes measured
after 4 and 6 weeks included the global assessment of a clinician and
the patient’s self-rating according to the von Zerssen Complaint Scale.
After 6 weeks of treatment, 60% of the treated patients and 27% of the
placebo group were considered to be responders (p = 0.038), according to
the global assessment of a clinician. The von Zerssen Complaint Scale
score was also 15% lower (p = 0.003) in patients after treatment with the
extract than for those in the group treated with the placebo. The treatment
reduced symptoms, such as stomach ache, bile-related complaints,
flatulence, nausea and bloating (56).
Adverse reactions
Excessive ingestion of the decoction of the crude drug may cause nausea
and other gastrointestinal symptoms (60). In rare cases, hepatic inflammation
and an increase in liver enzyme activity and serum bilirubin have
been reported, all of which are reversible following discontinuation of
therapy (78). A case of contact dermatitis was described after external use
of the aerial parts of the plant (79). Ten cases of acute hepatitis induced by
preparations of the crude drug have been noted. The course of hepatitis
was mild to severe. Marked cholestasis was observed in five patients, but
liver failure did not occur. Other possible causes of liver disease were excluded
by laboratory tests and imaging procedures, and liver biopsy specimens
were consistent with drug-induced damage. After discontinuation
of therapy, rapid recovery was observed in all patients and liver enzyme
levels returned to normal in 2–5 months (80). One case of haemolytic
anaemia after oral ingestion of an extract of crude drug was reported.
Presentation included liver cytolysis, thrombocytopaenia, renal failure
and intravascular haemolysis. The direct antiglobulin test was positive.
The patient was treated with steroids, red cell and platelet transfusion and
subjected twice to haemodialysis, with complete resolution of the clinical
features by about the twelfth day (81).
Cases of acute hepatitis after use of Herba Chelidonii preparations
have been observed (82, 83).
A case of contact-derived allergic balanoposthitis and paraphimosis
(lesions of the penis) was observed after topical application of Herba
Chelidonii juice (84).
83