SINKINA
Report of the Council on Pharmacy and Chemistry
Sinkina is a malaria “cure” put on the market by the Metropolitan Pharmacal Company, New York. The product was presented to the Council on Pharmacy and Chemistry for admission to New and Nonofficial Remedies and was rejected because insufficient evidence was submitted to substantiate the improbable claims made for it. The manufacturers were sent a copy of the report stating that their product was refused recognition. In view of the advertising that was persisted in after its rejection, the Council’s referee for Sinkina submitted the preparation to clinical tests. Both the original report and the results of the clinical tests are given in the following report, which was submitted to the Council and recommended for publication. The complete report having been sent to the manufacturers and their reply considered, the Council authorizes its publication.
W. A. Puckner, Secretary.
THE COUNCIL’S FIRST REPORT
The Council, after investigating the claims made for Sinkina, declared the product unworthy of recognition and adopted the following report, which was sent to the manufacturers:
No experimental evidence regarding the therapeutic value has been submitted. The clinical evidence is scant and not of such character as to deserve much consideration, no sufficient precautions having been adopted to avoid wrong conclusions. Judging from the evidence at hand the preparation is simply a dilute sugar-alcohol-water solution containing a little oil of cumin—Roman caraway. It is highly improbable that such a liquid would have the therapeutic effects claimed for it by the Metropolitan Pharmacal Company. In view of the improbable claims made for Sinkina, and the failure to substantiate them by suitable evidence, it is recommended that the preparation be refused recognition without at this time considering the claims made in regard to the identity and amount of the drug claimed to be the essential constituent.
In spite of its rejection Sinkina was persistently advertised. It was thought advisable, therefore, to submit the preparation to clinical tests. This was done and the results are given in the following report:
THE CLINICAL REPORT
The following quotations indicate the claims made for this preparation:
“In malarial conditions there is nothing that acts so promptly and efficaciously as Sinkina. Sinkina destroys radically every trace of the parasite in the blood from the time of its first appearance, builds up the damaged corpuscles, revitalizes the system, and completely eliminates every trace of the disease. Sinkina is deservedly termed the Specific for Malaria.”
These claims were supported by testimonials which usually gave no indication of a demonstration of the presence or absence of malarial plasmodia in the blood. The following is an example showing the character of most of the evidence presented by the manufacturers:
“Three weeks ago I prescribed Sinkina for a negro man 40 years of age suffering from a double tertian malarial infection having a chill every afternoon for four consecutive days. He came to my office about 8 a. m. and was due to have a chill about 6 p. m. I gave him the sample of Sinkina and directed him to take a tablespoonful at once, also at noon and again at 4 p. m., and to continue taking it in same size dose three times a day till he had taken it all. He reported to me in a week from that date and told me he was feeling fine and that he hadn’t had any more chills. The patient up to this time is apparently cured.”
As the claims were supported by a few testimonials purporting to be based on exact investigations, the Council submitted the preparation to careful laboratory and clinical tests. For this investigation the Council was fortunate in securing the help of physicians actively engaged in the study of malaria.
Experiments were made in vitro with the preparation; 1 ounce of Sinkina was used, and its action was compared with that of 10 grains of quinin sulphate. When these were added to cultures of malarial plasmodia in proportion corresponding to 1 ounce of Sinkina or 10 grains of quinin sulphate for a 150-pound man, the quinin was found to be unfailingly antagonistic to the malarial organism, the drug prevented the segmentation of the organism, and finally killed it in about thirty-six hours. The Sinkina did not kill the parasite after seventy-two hours of continued action, and the parasites segmented in the presence of it just as actively as they did in the control.
The investigator was furnished with two sets of preparations in plain prescription bottles so as to avoid all influence of the personal equation. One set consisted of Sinkina, the other of a mixture of alcohol, sugar and water with some oil of cumin. The investigator reported that, so far as the tests on the cultures of malarial plasmodia were concerned, he could not determine any difference in the results obtained with the oil of cumin preparation, made in the laboratory of the Association, and those obtained with the Sinkina of the Metropolitan Pharmacal Company. Clinical trials were made by three independent investigators. Two of them received the two sets of preparations described.
FIRST INVESTIGATION
The first investigator treated two cases with Sinkina: one was of the ordinary estivo-autumnal type and the other an ordinary tertian.
Cases 1 and 2.—A good many schizonts were present in the blood of each patient forty-eight hours after the administration of Sinkina. In the instance of the case of tertian the patient had his chill forty-eight hours after the medicine had been started. As the Sinkina failed to produce any effect the patients were then put on quinin to stop the disease.
Case 3.—The patient had taken 10 grains of quinin on the day on which the experiment was begun. He had the tertian form of the disease, and plasmodia were quite numerous at the beginning. The quinin was discontinued and Sinkina was given in doses of 1 ounce three times a day. The day following the administration of 10 grains of quinin and 1 ounce of Sinkina, no parasites could be found in the blood. The Sinkina was continued in the doses mentioned. On the seventh day the patient had another chill, and a great many parasites were found in his blood. The Sinkina was discontinued and the patient was at once relieved by quinin.
This investigator gives it as his opinion, based on these observations, that the preparation (Sinkina) is absolutely worthless in the treatment of malaria, and he does not think it necessary to make any further experiments with it.
SECOND INVESTIGATION
The second investigator treated two cases of tertian malarial fever with these preparations until it was satisfactorily proved that the drug was having no effect on the presence of the parasites in the blood, when he began the administration of quinin.
Case 4.—After the use of the remedies for one week the investigator still found young rings half-grown and gametes present in the blood. Apparently there was a relative increase in the number of parasites. He then began the administration of quinin. Blood-smears taken the next day after 40 grains of quinin had been taken showed one parasite after eighteen minutes’ search of one slide, and two after thirty minutes’ search of a second slide. At the end of a week’s treatment the patient was discharged recovered. The blood examination of two slides was negative.
Case 5.—This was a case of tertian malaria. After treatment for five days with Sinkina the blood still showed tertian parasites with increase in the size of the spleen, and the preparation was without effect on the clinical course of the disease. Quinin was then begun, and the blood examination became negative at the end of three days.
The investigator concludes that the preparations furnished him were absolutely worthless in the treatment of two cases of the tertian form of malarial fever, and that these solutions had no effect on the presence of the parasites in the peripheral circulation. In a case of quartan malaria, both of the preparations (cumin oil mixture and Sinkina), sent by the Association Laboratory, were without effect on the plasmodia in the blood. This investigator employed the solution made by the Association Laboratory (cumin oil mixture) as well as Sinkina, and was unable to note any differences between them.
THIRD INVESTIGATION
The third investigator began the trial of Sinkina at the instance of the manufacturers, and used it in three cases, two of them being benign tertian malaria and one case of mixed infection (benign tertian and estivo-autumnal).
Case 6.—This was one of the cases of benign tertian malaria. The patient gave a clinical history of malaria with chills occurring on alternate days for a little over a week. There was an immediate cessation of all clinical symptoms, and three days after the patient had been on 1⁄2 ounce of Sinkina three times daily there was no evidence of any plasmodia in his blood; his additional treatment consisted of 5 grains of calomel the evening of the first day with a saline the next morning. Before the patient was put on treatment, numerous parasites of both the asexual and sexual forms were observed. The patient remained in bed for a few days, and then returned to work. A week later he was again taken ill with a return of all of his previous clinical symptoms.
Case 7.—This case was one of mixed infection (benign tertian and estivo-autumnal). The patient had a clinical history of malaria dating back two weeks, with a maximum temperature of 104 on admission. Tertian rings, estivo-autumnal rings and crescents were found in the blood. The patient was placed in bed, given thorough eliminating treatment, and 1⁄2 ounce of Sinkina was administered four times daily. His clinical symptoms ran on for two days with no change, and there was no difficulty in finding the plasmodia in blood-smears, which were taken twice daily. The dose was then doubled and at the end of four days more there was no change in either his clinical symptoms or the blood-findings. The patient was then placed on 10 grains of quinin sulphate with 15 drops of diluted hydrochloric acid three times daily, to which he responded in less than forty-eight hours and made an uneventful recovery.
Case 8.—This was the other case of benign tertian malaria. The patient had chills every other day while on the treatment, and laboratory diagnosis confirmed the clinical findings. Experimental treatment was carried on for four days, with a negative result.
The investigator calls attention to the fact that the first case in which improvement resulted does not show any necessary connection with the Sinkina administered, for many cases of benign tertian malaria will clear up in just as short a time under any line of treatment, while practically all will eventually do so. This investigator later reported another case and transmitted a clinical chart.
Case 9.—This patient was admitted to the hospital, Dec. 30, 1912, with a history of having had malaria for some weeks. The diagnosis was confirmed by a blood examination. He was then carried for four days without treatment other than rest in bed and a liquid diet. His symptoms subsided by the third day. On the fourth day a count of the parasites was made which showed that there were 1,160 asexual parasites and 260 sexual forms to every thousand leukocytes. The following day he was placed on Sinkina, 1 ounce three times daily. There was exacerbation of symptoms on the following day, which gradually increased until the fourth day, remaining about stationary for a day or so. The fifth day after the patient had been placed on Sinkina, another count of the parasites showed 5,600 asexual parasites and 300 sexual forms to the thousand leukocytes, this being an increase of 4,440 asexual forms and forty sexual forms to every thousand leukocytes. With the second count of parasites the dose of Sinkina was increased to 2 ounces every four hours, the patient being kept on this until January 14, without result. He was then placed on quinin, with a complete reduction of the temperature to normal and the disappearance of the parasites from the blood.
The investigator also reported a case of benign tertian malaria.
Case 10.—This was in a child of 8 years which was treated by the investigator’s confrère and gave similar negative results. Blood examination showed numerous parasites. The child was placed on 1 ounce of Sinkina three times a day and kept on it for two weeks. The clinical picture remained unaltered, and parasites could be detected in numbers whenever examinations were conducted. A gradually increasing enlargement of the spleen was also noted. At the end of two weeks quinin was substituted, and the child went on to a rapid and uneventful recovery.
This investigator also concludes that the claim put forth by the Metropolitan Pharmacal Company that Sinkina is a specific in the treatment of the malarial fevers is entirely without foundation, and that the firm will be unable to demonstrate to the contrary.
These investigations demonstrate that Sinkina is not a specific against malaria, and that it has no more effect than a mixture of oil of cumin, sugar, alcohol and water. They further show the fallacy, first, of concluding from a temporary cessation of the symptoms in malaria that the disease has been cured and, second, of ascribing such temporary improvement to the influence of a remedy which has no known effect on the malarial organism.—(From the Journal A. M. A., Sept. 27, 1913.)