Fixed Combinations of Pheasant's Eye herb and Lily-of-the-Valley herb

Fixed combinations of pheasant's eye herb and lily-of-the-valley herb.

Fixed combinations consisting of:

• Pheasant's eye corresponding to DAB 10;
• Lily-of-the-valley herb corresponding to DAB 10;
• as well as their preparations.  

The leading glycoside of pheasant's eye herb is cymarin, of lily-of-the-valley leaf is convallatoxin.

The actions of cardiac glycosides on the heart are:

1. positive inotropic (increasing contractile strength and velocity while delaying relaxation);
2. negative chronotropic (decreasing the time or rate of contraction);
3. negative dromotropic (decreasing stimulus conduction);
4. positive bathmotropic (increasing stimulation of the ventricular muscle).  

Pharmacokinetics

Cymarin:

• The indication for the absorption of cymarin lies between 15 and 47 percent.  The half-life of elimination is given as 13 - 23 hours.  Elimination of cymarin occurs mainly by renal discharge.  The subsidence rate is 50 percent.
• Recent investigations, particularly of cymarin's actions in combinations, are not available.  

Convallatoxin:

• For convallatoxin an absorption rate of 10 percent and a subsidence rate of 40 - 50 percent are given.  The absorption rate is supposedly increased by saponins contained in the herb.  No information is available concerning its metabolism in humans.  A renal/biliary excretion is assumed.  The binding to plasma proteins lies between 16 and 23 percent.  

Pharmacodynamic and pharmacokinetic studies with the fixed combination of pheasant's eye herb and lily-of-the-valley herb are not available.  Pertaining to the cumulative effect and pharmacokinetics affecting patients at risk, e.g., patients with kidney insufficiency, there are no data available for the herbs and their fixed combinations.

Clinical Data

Preparations of the fixed combinations of pheasant's eye herb and lily-of-the-valley herb are used for heart problems, vascular problems, circulatory ailments, decompensated geriatric heart function, stress and hypertonic heart function, mild to moderate heart muscle insufficiency, for myocardia, as a tonic for the cardiovascular system after coronary infarction, continuation treatment after digitalis therapy, for functional heart and circulatory disturbances, nervous heart (cardiac neurosis), mild irregular heart action, support of the cardiovascular system prior to and after surgery, treatment of pressure and sensation of constriction in the heart area, improvement of blood and oxygen supply of the heart, for declining heart capacity, strengthening of the heart muscle and for a more efficient cardiac capacity.

There is no useful information available for the claimed uses.

The effectiveness for the claimed applications is not documented.

Not to be used in case of therapy with digitalis glycosides, digitalis intoxication, hypercalcemia, potassium deficiency, bradycardia, ventricular tachycardia.

Since no investigations for the use by children are available, the application is contraindicated.

Caution if nervous conduction disturbances exist and i.v.  calcium therapy is applied.

Side effects which may occur:

• nausea, vomiting, gastric disturbances, irregular pulse and cardiac dysrhythmia.  

Increase in effectiveness, and thus also side effects, occur with simultaneous administration of quinidine, calcium, saluretics, laxatives and long-term therapy with glucocorticoids.

Positive monographs are available for the individual herbs.

Sufficient validated information concerning the dosage of the herb in the combination products, as well as the ratio of the herbs to each other, is not available.

Because of the inadequate pharmacodynamic and pharmacokinetic study, as well as inadequate clinical study pertaining to the fixed combination, effectiveness and safety of preparations of pheasant's eye herb and lily-of-the-valley herb cannot be evaluated.

Without further study, the risks of the combination cannot be evaluated.  Cardiac glycosides have a comparatively narrow therapeutic range, making respective investigations necessary, especially if a prolonged therapy is demanded.  The risks are not biased to the fixed combination as compared to the individual herbs.  No scientific information is available for the effectiveness of this medicinal combination.