STYPTYSATE NOT ADMITTED TO N. N. R.

Report of the Council on Pharmacy and Chemistry

The Council has authorized publication of the following report, declaring Styptysate (Ernst Hischoff Co., Inc.) inadmissible to New and Non­official Remedies.

W. A. Puckner, Secretary.

Styptysate, according to the advertisement of Ernst Bischoff Co., Inc., New York, is “obtained by dialysis from Bursa Pastoris (Sheppard’s [sic!] Purse).” It is claimed to be “The Remedy For Hemorrhages,” to be “Superior to Ergot and Hydrastis,” “of particular advantage in Menorrhagia and Metrorrhagia” and to have been “found of great value in vesical hemorrhages and hemorrhages from mucous membranes in general.” The Styptysate label bears the synonym “Dialysate Herba Bursa Pastoris”; the statement that it contains “alcohol 11 per cent.” and that it is “made in Germany.” No other statement of the composition or strength of “Styptysate” is furnished nor is the name of the German manufacturer disclosed.

In an advertising circular entitled “Styptysate, a New Reliable Hemostatic,” it is declared that in recent years the plant, Shepherd’s Purse (Capsella bursa pastoris), “has been submitted to clinical tests in the form of a concentrated dialysate, known as Styptysate, by Loewy, Oppenheim, Krummacher and others, and that their reports coincide in regard to Styptysate as a hemostatic par excellence, particularly in uterine hemorrhages, even in cases where ergot and hydrastis had failed to produce satisfactory results.” The circular also reprints some “short clinical reports” without reference to their authorship; one ascribed to Krummacher and two ascribed to “B.H.M., Kansas City, Mo.,” and the following references: “A. Krummacher, M.D., Monthly Review for Obstetrics and Gynecology, Berlin, Vol. XLIX, 4, and Vol. LII.” “H. Oppenheim, M.D., Medical Clinic, Berlin, 1920, 35.”

Shepherd’s Purse is a weed common in the United States and in Europe. Like most other herbs, it has some reputation as a folk medicine. It is used by eclectics and homeopaths, being included in the Homeopathic Pharmacopeia of the United States. Shepherd’s Purse receives no consideration at the hands of the authors of standard works on materia medica, pharmacology or therapeutics.

From an examination of recent German medical publications, it appears that the use of Shepherd’s Purse was proposed as a substitute for ergot and hydrastis, when the latter drugs became scarce in Germany. These publications, in the main, emanate from those in the employ of pharmaceutical firms and deal with proprietary preparations or they are written by physicians who used these proprietary preparations at the solicitation of the manufacturers. For this reason the reported results must be accepted with reserve.

One of the proprietary preparations discussed in the German publications is Styptysate, manufactured by Isalfabrik Johannes Buerger, Wernigerode. It is said to be produced by submitting the juice of fresh Shepherd’s Purse to dialysis and preserving the dialysate by the addition of alcohol. There is no statement as to the drug strength or the chemical or biological standards, if any, used in its manufacture; hence, the preparation is essentially a secret one. As first produced, the preparation seems to have been fortified by the addition of cotarnin: the dose was then given as ten to fifteen drops. Later, as the cost of cotarnin went up, this drug was omitted, and the drug strength increased; the dose of the new preparation is given as twenty-five to thirty drops. Just what relation, if any, the Styptysate of Ernst Bischoff Co., Inc., bears to that of the Isalfabrik Johannes Buerger, Wernigerode, cannot be determined from the Bischoff advertising. If it has any relationship the announcement that no narcotic order is required when ordering Styptysate would indicate that the new preparation is supplied; the old one with its addition of cotarnin would require a narcotic order. On the other hand, the recommended dose of the cotarnin-free preparation is twenty-five to thirty-drops, whereas the product sold by Bischoff and Co. is to be given in doses of ten to fifteen drops—that is, in the amount proposed for the cotarnin-fortified product.

What justification is there for the claim that Styptysate has been submitted to clinical tests by Loewy, Oppenheim and Krummacher and found to be a hemostatic par excellence and efficient even where ergot had failed to give satisfactory results? Loewy (Zentralblatt für Gynäcologie 42:920, 1921) made some pharmacologic tests on guinea-pigs with the cotarnin-containing preparation, but reported no clinical trials. Hans Oppenheim (Medizinische Klinik, Aug. 29, 1920, p. 906) reported that he was agreeably surprised at the excellent results (vorzueglichem Erfolg) obtained with the drug but he did not assert that it is superior to ergot.

Krummacher reported on thirteen cases of profuse menstruation in which the patients were treated with Styptysate, using for a part, the preparation containing cotarnin and for the other a preparation without cotarnin. He reported as good results with the cotarnin-free preparation in larger dosage, as with the cotarnin-containing preparation in smaller dosage. Krummacher did not compare Styptysate with ergot. Some of Krummacher’s cases are quoted, with some typographical errors, in the Bischoff circular.

On the assumption that the product discussed in German publications is the Styptysate marketed in the United States, the best that can be said for it is, that during a shortage of ergot it was used in place of that established drug. There is no evidence to warrant the use of this indefinite proprietary in place of the biologically standardized fluidextract of ergot or other standardized ergot preparations.

Styptysate (Ernst Bischoff and Co., Inc.) is inadmissible to New and Non­official Remedies because its composition is semisecret and indefinite and there is no evidence that its uniformity and strength is controlled (Rules 1 and 2); further, it is inadmissible because the therapeutic claims advanced for it are exaggerated and unwarranted (Rule 6) and because there is no evidence that it possesses any advantage over established drugs such as the biologically standardized fluidextract of ergot or the definite ergot preparations admitted to New and Non­official Remedies.—(From The Journal A. M. A., Feb. 11, 1922.)