THE CLAIMED GALACTAGOGUE EFFECTS OF NUTROLACTIS AND GOAT’S RUE NOT SUBSTANTIATED

Report of the Council on Pharmacy and Chemistry

Specific lactagogues—drugs which stimulate the secretion of milk—are unknown to science. Yet medical publications give space to advertisements of a proprietary—“Nutrolactis”—which is said to increase the milk supply of nursing mothers. Since dependence on a preparation of this kind is likely to cause neglect of the only means of increasing a scanty milk supply of nursing mothers—care of the general health and a sufficient quantity of proper food—this proprietary and the drug “goat’s rue,” (Galega officinalis) which the proprietors hint as being the potent constituent, were subjected to a critical study to determine their possible influence on milk secretion. For this purpose the Council secured the help of A. J. Carlson, Ph.D., professor of physiology, University of Chicago. Dr. Carlson, with the aid of A. Woelfel, M.D., and Marian Lewis, Sc.M., undertook to estimate the effect of Nutrolactis and of goat’s rue on nursing dogs and goats with the intention of extending the study to nursing mothers if the animal experiments so warranted. The contribution, “The Alleged Galactagogue Action of Galega and Nutrolactis,” by Marian Lewis and A. J. Carlson from the Hull Physiological Laboratory of the University of Chicago, which appears below, shows that Nutrolactis and goat’s rue are without influence on the milk secretion in nursing animals.

The Council endorsed the work of Lewis and Carlson and held that the claimed galactagogue effects of Nutrolactis and goat’s rue are not substantiated.

W. A. Puckner, Secretary.


THE ALLEGED GALACTAGOGUE ACTION OF GALEGA AND NUTROLACTIS [E][F]

Marian Lewis, Sc.M., and A. J. Carlson, Ph.D.

CHICAGO

It is well established that the food best adapted to the energy and growth requirements of the infant is normal mother’s milk. Any decrease in quantity or deterioration in quality of the maternal secretion is soon followed by a parallel impairment of growth, loss of weight, or lowered resistance to infection in the infant. The widespread occurrence of deficient milk secretion is a matter of common knowledge. The discovery of true lactagogues, or specific substances which increase the quantity and quality of the milk on being administered to nursing mothers, would therefore be of very great importance. In view of this great medical and economic interest in true lactagogues it is not surprising to find that the medical and biologic literature records discoveries of lactagogues based on hope rather than demonstration, and that spurious lactagogues are on the market.

Some of the factors known to affect milk secretion are general health, food supply, psychic state, and heredity. The mechanism of secretion and the method by which these factors affect it are imperfectly understood. In general it has been observed that milk yield improves both in quantity and in quality with improvement in general health, better food supply, and more favorable psychic state. The influence of heredity is taken advantage of by dairymen who are well acquainted with the potential milk production of the different breeds of cattle.

Among the substances which have been reported to stimulate milk secretion may be mentioned the extract of the posterior lobe of the hypophysis. But pituitary extract is not a true lactagogue, because its action is confined to the smooth musculature of the gland ducts, causing a more or less complete ejection of the milk already formed; it has no effect on the gland cells or the actual secretory process in the direction of increasing the milk yield. Extracts of thymus, corpus luteum, ovaries, uterus, placenta, fetus, and the mammary gland itself have also been reported to have a temporary stimulating effect on the quantity of milk secreted, but when these extracts are given by mouth they are apparently without specific influence on the mammary gland.

Galega, or goat’s rue (Galega officinalis), is an herb described in the National Formulary as being slightly bitter and astringent. In 1873, Gillet-Damotti,[112] in a communication to the French Academy, stated that this plant when fed to cows increases the secretion of milk from 35 to 50 per cent. Other French writers have affirmed that goat’s rue is a lactagogue. In Germany, Fragner[113] made a preparation called Galegal, using galega as the active principle and combining it with lactose to give it a pleasant taste and make it soluble in water, milk, coffee, and tea. This preparation was reported on favorably by Scherer,[114] who asserts that he obtained positive results in fifty-four of the eighty cases in which he used it.

More recently Huët[115] tested the effects of Theinhardt’s Hygiama lactogene on four lactating women. This preparation is said to be composed of hygiama,[116] galega and anise. Analysis showed that it contains albumins, fat, soluble and insoluble carbohydrates, salts and water. Huët could not observe any influence from the use of this preparation, either on the quantity or on the composition of the milk secreted.

Nutrolactis[117] is a commercial preparation sold by the Nutrolactis Company of New York at $1 a bottle. The label states that it contains 5 per cent. of alcohol; that it contains fluid extracts of the family of “galactagogic plants,” and that it is intended to “increase the supply of mother’s milk.” It is recommended to maintain “quality and quantity until the end of normal lactation.” Nutrolactis is also recommended for a mother debilitated by lactation. It is claimed that “Nutrolactis does not force the secretion of milk but merely assists such secretion.” Years ago Millbank[118] reported good results from the use of Nutrolactis. After more than a year’s use he concluded that it was more satisfactory than any other lactagogue hitherto employed by him, which is not saying very much, as specific lactagogues are as yet unknown. Nutrolactis is still (1916) extensively advertised in various medical journals as a lactagogue.

METHODS OF INVESTIGATION

The alleged lactagogue action of galega and Nutrolactis was tested on lactating dogs and goats. In these animals the psychic factors, or suggestion, are largely eliminated. If the results had been positive or had indicated lactagogue action, the test would have been extended to nursing women. The puppies and kids were weighed before and after nursing and a record kept of the amount of milk obtained at each nursing (the animals nursing from three to five times daily). The mothers were fed with varying doses of the drugs, and the milk yield compared with that of a control period during which no drugs were administered. An effort was made to keep the conditions of the experiments uniform throughout.

The galega was ground and mixed with the food. The Nutrolactis was mixed with food given by the stomach tube, or in some cases with a spoon. Galega was tested on two goats and Nutrolactis on one goat and nine dogs. The results are given herewith:

GALEGA

Goat 1: Control period, 1,600 gm., milk av. daily yield for 7 days.
Galega period (30 gm. galega mixed with oats), 860 gm., milk av. daily yield for 8 days.
Kids weaned at end of period.

Goat 2: Control period, 1,161 gm. milk av. daily yield for 9 days.
Galega period (30 gm. galega mixed with oats), 860 gm. milk av. daily yield for 8 days. (25 gm. galega in same way), 810 gm. milk av. daily yield for 10 days.
Control period, 896 gm. milk av. daily yield for 6 days.

NUTROLACTIS

Goat 3: Control period, 896 gm. milk av. daily yield for 6 days.
Nutrolactis period (30 c.c. Nutrolactis mixed with oats), 658 gm. milk av. daily yield for 9 days.
Control period, 666 gm. milk av. daily yield for 5 days.

Dog 1: Control period, 176 gm. milk av. daily yield for 7 days.
Nutrolactis period (8 c.c. Nutrolactis by stomach tube), 55 gm. milk av. daily yield for 12 days.

Dog 2: Control period, 189 gm. milk av. daily yield for 6 days.
Nutrolactis period (8 c.c. Nutrolactis by stomach tube), 72 gm. milk av. daily yield for 11 days.

Dog 3: Control period, 93 gm. milk av. daily yield for 8 days.
Nutrolactis period (8 c.c. Nutrolactis on bread), 17 gm. milk av. daily yield for 5 days.

Dog 4: Control period, 28 gm. milk av. daily yield for 7 days.
Nutrolactis period (8 c.c. Nutrolactis by stomach tube), 47 gm. milk av. daily yield for 6 days.
(10 c.c. Nutrolactis by stomach tube), 43 gm. milk av. daily yield for 8 days.
Control period, 41.5 gm. milk av. daily yield for 6 days.
Nutrolactis period (10 c.c. Nutrolactis by stomach tube), 33.5 gm. milk av. daily yield for 4 days.

Dog 5: Control period, 67 gm. milk av. daily yield for 6 days.
Nutrolactis period (10 c.c. Nutrolactis on bread), 81 gm. milk av. daily yield for 6 days.

Dog 6: Control period, 40 gm. milk av. daily yield for 5 days.
Nutrolactis period (10 c.c. Nutrolactis by stomach tube), 33 gm. milk av. daily yield for 8 days.
Control period, 26 gm. milk av. daily yield for 4 days.

Dog 7: Control period, 283 gm. milk av. daily yield for 9 days.
Nutrolactis period (10 c.c. Nutrolactis by stomach tube), 155 gm. milk av. daily yield for 15 days.
(15 c.c. Nutrolactis by stomach tube), 82 gm. milk av. daily yield for 6 days.
Control period, 33 gm. milk av. daily yield for 3 days.

Dog 8: Control period, 238 gm. milk av. daily yield for 8 days.
Nutrolactis period (20 c.c. Nutrolactis on bread), 223 gm. milk av. daily yield for 4 days.
(20 c.c. Nutrolactis on bread), 46 gm. milk av. daily yield for 6 days.

Dog 9: Control period, 223 gm. milk av. daily yield for 6 days.
Nutrolactis period (10 c.c. Nutrolactis on bread), 178 gm. milk av. daily yield for 15 days.
(15 c.c. Nutrolactis on bread), 146 gm. milk av. daily yield for 5 days.

COMMENT AND CONCLUSION

Goat 1 had already been lactating for over two months, and the yield was gradually decreasing at the time the observations were begun. The administration of galega did not check this decrease. Goat 2 should have been a very favorable subject, for the kid was about a week old at the time the observations were begun. Both galega and Nutrolactis caused a decrease in milk yield of this animal. This decrease is perhaps partly due to the animal’s distaste for the drugs and her consequent failure to eat as well as during the control periods.

Administration of Nutrolactis was accompanied by an increase in milk in only two animals, Dog 4 and Dog 5. A detailed examination of the records of these two dogs shows that in both cases there was a progressive increase in milk yield during the control period and that administration of the drug failed to accelerate this increase. On the contrary, the curve for Dog 5 takes a sudden drop immediately after the first administration of the drug.

The records of Dogs 6 and 7 show that the yield during the second control period is lower than that of the preceding periods. Although the administration of the drug in both cases was followed by a decrease in the yield, it may be urged that the drug has some lactagogue action, for its discontinuance was followed by a decrease in yield. This effect, however, is also apparent rather than real, for the data show a gradual falling off in yield during the period of administration of the drug, which decrease was not accelerated by withdrawing the drug.

Our data show that galega and Nutrolactis, when taken by mouth, and the elements of suggestion excluded, had no beneficial effect on lactation—at least in so far as the quantity of milk is concerned.—(From The Journal A. M. A., May 26, 1917.)