Published September 24, 1993.
List of German Commission E Monographs (Phytotherapy)
Fixed combinations of Belladonna, Atropa belladonna L. [Fam. Solanaceae], with drugs in homeopathic preparations.
Fixed combinations of Belladonna are available with the following compounds prepared according to homeopathic regulations:
Apis mellifica (B. Anz. No. 190a of October 10, 1985)
Arnica montana (B. Anz. No. 217a of November 22, 1985)
Calcium carbonicum (B. Anz. No. 44 of March 3, 1990)
Chamomilla recutita (B. Anz. No. 217a of November 22, 1985)
Chelidonium majus (B. Anz. No. 190a of October 10, 1985)
Gelsemium sempervirens (B. Anz. No. 217a of November 22, 1985)
Hamamelis virginiana (B. Anz. No. 29a of February 12, 1986)
Lycopus virginicus (B. Anz. No. 29a of February 12, 1986)
This list of components will be supplemented according to the development of preparations.
For Belladonna (Atropa belladonna) and the drugs of homeopathic preparations, refer to the respective monographs.
Ed. note: Homeopathic preparations are regulated in Germany by Commission D, not Commission E. Thus, they are not included in this publication.] --> Clinical Data 1. Uses The following indications are claimed for combination preparations:
Hemorrhoids Disturbances of gall production and gall secretion, disturbances of liver function, spasms in the area of the bile ducts, gastritis, duodenitis, supportive therapy for ulcus ventriculi and duodeni, gastroenteritis, colitis, digestive problems, especially constipation caused by liver insufficiency Angina, stomatitis, periarthritis, conservative treatment and pre-treatment of abscesses, panaritium, furuncles, adjuvant for pleurisy Sleeping disorders, vegetative dystonia, psychosexual disturbances, climacteric complaints, thyrotoxicosis, neurasthenia. The effectiveness of the combinations for the claimed uses has not been documented.
The harmlessness of these combination products is specified by the data given for the homeopathic preparations in the individual monographs.
The following risks are valid for Belladonna:
Do not use in case of tachycardiac arrhythmia, prostate edema with residual urine, narrow-angle glaucoma, acute edema of the lungs, mechanical stenoses of the gastrointestinal tract, megacolon. 3. Side Effects Dry mouth, decrease of perspiration gland function, accommodation disturbances, reddening and dryness of the skin, hyperthermia, tachycardia, difficulties in urination, hallucinations and spastic conditions, especially when overdosed.
The anticholinergic action of the drug can be enhanced by tricyclic antidepressants, amantadine and quinidine.
The indicated uses of the components are listed in their respective monographs. Concerning the combinations of Belladonna with homeopathically prepared drugs, no data are available from which a positive contribution to the effectiveness of these drug combinations can be deduced. According to the evaluation results of the homeopathic preparations, these neither contribute to the effectiveness nor to the tolerance of Belladonna-containing medicines.
The combination of Belladonna, an alkaloid drug with narrow dosage limitations and high toxicity, with other compounds is not recommended. The therapeutic principle of homeopathy generally does not agree with that of phytotherapy. Therefore, fixed combinations of homeopathic and phytotherapeutic preparations are not sensible.
Approval of such combination products cannot be recommended.