Fixed Combinations of Pheasant's Eye herb and/or Lily-of-the-Valley herb and/or Squill and/or Oleander leaf with chemically defined drugs

Published July 14, 1993.
List of German Commission E Monographs (Phytotherapy)

Name of Drug

Fixed combinations of Pheasant's Eye herb and/or Lily-of-the-valley herb and/or Squill and/or Oleander leaf with chemically defined drugs.

Composition of Drug

Fixed combinations of Pheasant's Eye herb and/or Lily-of-the-valley herb and/or Squill and/or Oleander leaf are available with the following chemically defined compounds:

Thiamine hydrochloride (B. Anz. No. 131 of July 21, 1987) Ascorbic acid (B. Anz. No. 18 of January 28, 1992) Camphor (B. Anz. No. 228 of December 5, 1984) Camylofine (B. Anz. No. 149 of August 11, 1989) Caffeine (B. Anz. No. 209 of November 8, 1988) Vitamin D3 (B. Anz. No. 147 of August 10, 1988) Dehydrocholic acid (B. Anz. No. 147 of August 10, 1988) Dehydroxypropyl theophyllin (Diprophyllin) Prepublication Ephedrine hydrochloride Prepublication Folic acid (B. Anz. No. 45 of March, 1987) Nitroglycerin (B. Anz. No. 43 of March 2, 1990) Guaiazulene (B. Anz. No. 128 of July 13, 1990) Potassium chloride (B. Anz. No. 103 of June 8, 1991) Potassium citrate (B. Anz. No. 103 of June 8, 1991) Magnesium sulfate (B. Anz. No. 118 of June 29, 1990) Nicotinamide (B. Anz. No. 148 of August 10, 1989) Antipyrine (Phenazone) (B. Anz. No. 145 of August 5, 1989) Procaine (B. Anz. No. 198 of October 23, 1991) Proscillaridin (B. Anz. No. 43 of March 2, 1990) Proxyphylline Prepublication Theobromine-Na-salicylate (B. Anz. No. 30 of February 13, 1993) Verapamil (B. Anz. No. 43 of March 2, 1990) Vitamin B2 (B. Anz. No. 46 of March 8, 1988) Vitamin B12 (B. Anz. No. 59 of March 29, 1989) This list of components will be supplemented according to the progress of the Commission's work.

Pharmacological Properties, Pharmacokinetics, Toxicology

For pheasant's eye herb, lily-of-the-valley herb, squill, oleander leaf, and chemically defined drugs refer to the respective individual monographs.

Clinical Data 1. Uses For the combination preparations, the following indications are claimed:
Cardiac and circulatory insufficiency, even with diminished kidney output, angina pectoris, coronary insufficiency, rhythmic disturbances of the heart, extrasystole, tachycardia, mild forms of bradycardia, endocarditis, myodegeneration of the heart, functional disorders of the heart, especially with added nervous overtones, such as of old age, after infectious diseases, during menopause, weather changes, delayed convalescence, by uncommon physical and psychological stress, geriatric heart, increased demand on the heart muscle, e.g., balneological treatments, hypotonic symptoms with dizziness, tendency to collapse, cardiac stenosis, acute cardiac neuralgia, nocturnal tachycardia, especially after abuse of alcohol and tobacco, as a tonic and stimulant for heart and circulation, peripheral and cerebral disturbances of blood flow, for interval treatment and as an adjuvant of digitalis and strophanthin therapy, digitalis intolerance, thyrotoxicosis, chronic cor pulmonale, prevention of arteriosclerosis, high blood pressure, post-treatment of severe high blood pressure with cardiac decompensation, for prevention and post-treatment of coronary infarction For treatment of symptoms of chronic venous insufficiency, varicosis, syndromes occurring after thrombosis, concomitant treatment of trophic changes, e.g., varicose ulcers Potassium and magnesium deficiency Bronchial asthma, cardiac asthma, acute, chronic bronchitis, especially with severe spasms of the bronchial muscles, spasms connected with emphysema of the lungs, allergic reactions, congestion of the respiratory tract, adjuvant for pertussis Edema, as a diuretic, acute and chronic diseases of the kidneys and the efferent urinary tract, such as acute and chronic interstitial nephritis, nephrosis, nephrosclerosis, pyelonephritis, nephrolithiasis, cystitis, difficulties of urination, for the ease of the discharge of stones, for the prevention of ascending infections of users of catheters, treatment of infections resistant to antibiotics and sulfonamide For gastrointestinal discomforts, such as pressure, spasms of unknown origin, feeling of fullness, bloating, heartburn, Roemheld's syndrome, as a laxative, for loss of appetite Gallbladder and liver ailments For spasms of the muscles and organs For conditions of anxiety and excitation, depression, mental stress, vegetative dystonia, spastic migraine, as a sedative, sleeplessness due to nervously caused circulatory disturbances, difficulty in falling asleep and staying asleep, nervousness, "vaso- and psychoneurosis," menopausal disorders, and decrease in vitality Impaired function of the glands, disturbances of development and growth, disinterest in school, and difficulty in learning. There is no worthwhile information available for the support of the claimed applications.

The effectiveness of the combinations for the claimed uses is not documented.

2. Risks

For the safety of these combination preparations, the information given in the individual monographs of the chemically defined compounds is adequate.

Interactions between the cardiac glycosides and the chemically defined substances have not been studied.

Pheasant's eye herb, lily-of-the-valley herb, squill and oleander leaf are classified under the cardiac glycosides. The following risks apply:

Not to be used during therapy with digitalis glycosides, digitalis intoxication, hypercalcemia, potassium deficiency, bradycardia, ventricular tachycardia Since there are no investigations for the application in children, the use is contraindicated Caution in cases of disturbances of conduction and during i.v. calcium therapy. Side effects which may occur:

nausea, vomiting, and cardiac arrhythmia. Effectiveness and, therefore, also side effects are increased with simultaneous administration of quinidine, calcium, saluretics, laxatives and long-term therapy with glucocorticoids.

Evaluation

Effectiveness for the individual components of the above-mentioned fixed combinations is documented for the indications specified in the respective monographs for the individual herbs and chemically defined drugs.

Regarding the combination of pheasant's eye herb and/or lily-of-the-valley herb and/or squill and/or oleander leaf with chemically defined drugs, no information is available from which a positive contribution to the effectiveness of this medicinal combination can be deduced. According to the results of the investigation by the Commission, the listed drugs neither contribute to the effectiveness, nor to the tolerance of the pheasant's eye herb and/ or lily-of-the-valley herb and/or squill and/or oleander leaf containing medicines.

The combination of pheasant's eye herb and/or lily-of-the-valley herb and/or squill and/or oleander leaf as cardiac glycoside medication cannot be recommended because of the narrow dosage range and high toxicity. Fixed combinations of plant pharmaceutics with cardiac glycosides and chemically defined substances, especially those with a narrow therapeutic range, are not reasonable. Permission of such combinations cannot be recommended.