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Clinical Evaluation of Antipruritic Drugs: Consideration of Orally or Parenterally Administered Agents

Clinical Evaluation of Antipruritic Drugs: Consideration of Orally or Parenterally Administered... Abstract Recently, an attempt was made to evaluate the antipruritic effect of an analgesic drug. Some of the problems encountered will be discussed, and a blueprint for the proper clinical investigation of antipruritic drugs will be presented. Experimental Procedure In previous animal experiments, the drug was found to depress the perception of cutaneous stimuli. In addition, it was found to have potent local anesthetic activity, mild antihistaminic action, and potentiation of analgesia. The case material consisted of patients with severe chronic pruritus. In a pilot study on 23 patients, the drug showed considerable promise, and a subsequently administered placebo was ineffective. The experiment was then continued with 79 additional cases, with use of a carefully planned, double-blind, randomized technique. Statistical analysis of the complete data demonstrated that the test drug was not superior to the placebo. Appreciation of the difficulties and pitfalls inherent in the study led to a References 1. Pillsbury, D.; Zimmerman, M., and Baldridge, G.: Experimental Controls in Clinical Dermatologic Investigation , J. Invest. Dermat. 14:359 ( (May) ) 1950. 2. Albritton, E. C.: The 6 Unities in Medical Research , J. A. M. A. 161:328 ( (May 26) ) 1956.Crossref 3. Livingood, C.: Clinical Investigation in Dermatology , J. Invest. Dermat. 25:203 ( (Oct.) ) 1955.Crossref 4. Bross, I.: Therapy for Intellectual Obesity or Common Sense in Reducing Figures , Am. J. Obst. & Gynec. 69:372 ( (Feb.) ) 1955. 5. Bross, I.: Statistics and the Clinician , Ann. Int. Med. 43:442 ( (Aug.) ) 1955. 6. Bross, I.: Memo-Outline of Format. 7. Moyer, J.: Psychosomatic Problem in Drug Evaluation , A. M. A. Arch. Int. Med. 98:608 ( (Nov.) ) 1956. 8. Beecher, H.: Appraisal of Drugs Intended to Alter Subjective Responses, Symptoms , J. A. M. A. 158:399 ( (June 4) ) 1955. 9. Cormia, F., and Kuykendall, V.: Experimental Histamine Pruritus: III. Influence of Drugs on the Itch Threshold , A. M. A. Arch. Dermat. & Syph. 69:206 ( (Feb.) ) 1954. 10. Cormia, F.; Dougherty, J. W., and Unrau, S.: Proteolytic Activity in Dermatoses: Preliminary Observations on Inflammation and Pruritus , J. Invest. Dermat. 28:425 ( (June) ) 1957. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png A.M.A. Archives of Dermatology American Medical Association

Clinical Evaluation of Antipruritic Drugs: Consideration of Orally or Parenterally Administered Agents

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Publisher
American Medical Association
Copyright
Copyright © 1959 American Medical Association. All Rights Reserved.
ISSN
0096-5359
DOI
10.1001/archderm.1959.01560140034005
Publisher site
See Article on Publisher Site

Abstract

Abstract Recently, an attempt was made to evaluate the antipruritic effect of an analgesic drug. Some of the problems encountered will be discussed, and a blueprint for the proper clinical investigation of antipruritic drugs will be presented. Experimental Procedure In previous animal experiments, the drug was found to depress the perception of cutaneous stimuli. In addition, it was found to have potent local anesthetic activity, mild antihistaminic action, and potentiation of analgesia. The case material consisted of patients with severe chronic pruritus. In a pilot study on 23 patients, the drug showed considerable promise, and a subsequently administered placebo was ineffective. The experiment was then continued with 79 additional cases, with use of a carefully planned, double-blind, randomized technique. Statistical analysis of the complete data demonstrated that the test drug was not superior to the placebo. Appreciation of the difficulties and pitfalls inherent in the study led to a References 1. Pillsbury, D.; Zimmerman, M., and Baldridge, G.: Experimental Controls in Clinical Dermatologic Investigation , J. Invest. Dermat. 14:359 ( (May) ) 1950. 2. Albritton, E. C.: The 6 Unities in Medical Research , J. A. M. A. 161:328 ( (May 26) ) 1956.Crossref 3. Livingood, C.: Clinical Investigation in Dermatology , J. Invest. Dermat. 25:203 ( (Oct.) ) 1955.Crossref 4. Bross, I.: Therapy for Intellectual Obesity or Common Sense in Reducing Figures , Am. J. Obst. & Gynec. 69:372 ( (Feb.) ) 1955. 5. Bross, I.: Statistics and the Clinician , Ann. Int. Med. 43:442 ( (Aug.) ) 1955. 6. Bross, I.: Memo-Outline of Format. 7. Moyer, J.: Psychosomatic Problem in Drug Evaluation , A. M. A. Arch. Int. Med. 98:608 ( (Nov.) ) 1956. 8. Beecher, H.: Appraisal of Drugs Intended to Alter Subjective Responses, Symptoms , J. A. M. A. 158:399 ( (June 4) ) 1955. 9. Cormia, F., and Kuykendall, V.: Experimental Histamine Pruritus: III. Influence of Drugs on the Itch Threshold , A. M. A. Arch. Dermat. & Syph. 69:206 ( (Feb.) ) 1954. 10. Cormia, F.; Dougherty, J. W., and Unrau, S.: Proteolytic Activity in Dermatoses: Preliminary Observations on Inflammation and Pruritus , J. Invest. Dermat. 28:425 ( (June) ) 1957.

Journal

A.M.A. Archives of DermatologyAmerican Medical Association

Published: Feb 1, 1959

References

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