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A clinical study to evaluate the efficacy of the antihistamine doxylamine succinate in the relief of runny nose and sneezing associated with upper respiratory tract infection.
J Pharm Pharmacol 1995; 47(12A):990-3JP

Abstract

Antihistamines are widely used in common cold medications, although the role of histamine in the development of common cold symptoms is unclear and the use of antihistamines for the treatment of common cold is controversial. It is clear that antihistamines do not offer a cure for common cold but they may alleviate symptoms of sneezing and runny nose. The present study was designed to investigate the efficacy of an antihistamine, doxylamine, on the symptoms of runny nose and sneezing associated with common cold. We conducted a randomized double-blind study in cold sufferers. One thousand and one volunteers with cold symptoms were screened in four centres (UK, Denmark, Belgium, Germany) and 688 satisfied the entry criteria of the study. The main reasons for excluding subjects were a low nasal secretion weight (secretion weight < 0.2g, 72%) and a low subjective rhinorrhoea score (24%). Volunteers were randomized to receive either doxylamine succinate 7.5 mg by mouth four times a day up to nine doses (n = 345) or placebo (n = 343). The principal measurements were prospectively defined as runny nose and sneezing symptom scores. Data were analysed on an intention-to-treat basis, using Cochran-Mantel-Haenszel statistics controlling for baseline symptom scores. A between-group comparison showed that doxylamine-treated volunteers benefited from a significantly greater reduction in runny nose scores (P < 0.01) and sneezing scores (P < 0.001), than those volunteers in the placebo group. Doxylamine therapy was well tolerated; the incidence of unexpected side-effects was comparable with placebo. Of the expected side-effects, 13.3% of doxylamine-treated patients reported drowsiness. The incidence of sedative effects was lower than has been reported for other commonly used first-generation antihistamines.

Authors+Show Affiliations

Common Cold and Nasal Research Centre, University of Wales, Cardiff, UK.No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

8932681

Citation

Eccles, R, et al. "A Clinical Study to Evaluate the Efficacy of the Antihistamine Doxylamine Succinate in the Relief of Runny Nose and Sneezing Associated With Upper Respiratory Tract Infection." The Journal of Pharmacy and Pharmacology, vol. 47, no. 12A, 1995, pp. 990-3.
Eccles R, Van Cauwenberge P, Tetzloff W, et al. A clinical study to evaluate the efficacy of the antihistamine doxylamine succinate in the relief of runny nose and sneezing associated with upper respiratory tract infection. J Pharm Pharmacol. 1995;47(12A):990-3.
Eccles, R., Van Cauwenberge, P., Tetzloff, W., & Borum, P. (1995). A clinical study to evaluate the efficacy of the antihistamine doxylamine succinate in the relief of runny nose and sneezing associated with upper respiratory tract infection. The Journal of Pharmacy and Pharmacology, 47(12A), pp. 990-3.
Eccles R, et al. A Clinical Study to Evaluate the Efficacy of the Antihistamine Doxylamine Succinate in the Relief of Runny Nose and Sneezing Associated With Upper Respiratory Tract Infection. J Pharm Pharmacol. 1995;47(12A):990-3. PubMed PMID: 8932681.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A clinical study to evaluate the efficacy of the antihistamine doxylamine succinate in the relief of runny nose and sneezing associated with upper respiratory tract infection. AU - Eccles,R, AU - Van Cauwenberge,P, AU - Tetzloff,W, AU - Borum,P, PY - 1995/12/1/pubmed PY - 1995/12/1/medline PY - 1995/12/1/entrez SP - 990 EP - 3 JF - The Journal of pharmacy and pharmacology JO - J. Pharm. Pharmacol. VL - 47 IS - 12A N2 - Antihistamines are widely used in common cold medications, although the role of histamine in the development of common cold symptoms is unclear and the use of antihistamines for the treatment of common cold is controversial. It is clear that antihistamines do not offer a cure for common cold but they may alleviate symptoms of sneezing and runny nose. The present study was designed to investigate the efficacy of an antihistamine, doxylamine, on the symptoms of runny nose and sneezing associated with common cold. We conducted a randomized double-blind study in cold sufferers. One thousand and one volunteers with cold symptoms were screened in four centres (UK, Denmark, Belgium, Germany) and 688 satisfied the entry criteria of the study. The main reasons for excluding subjects were a low nasal secretion weight (secretion weight < 0.2g, 72%) and a low subjective rhinorrhoea score (24%). Volunteers were randomized to receive either doxylamine succinate 7.5 mg by mouth four times a day up to nine doses (n = 345) or placebo (n = 343). The principal measurements were prospectively defined as runny nose and sneezing symptom scores. Data were analysed on an intention-to-treat basis, using Cochran-Mantel-Haenszel statistics controlling for baseline symptom scores. A between-group comparison showed that doxylamine-treated volunteers benefited from a significantly greater reduction in runny nose scores (P < 0.01) and sneezing scores (P < 0.001), than those volunteers in the placebo group. Doxylamine therapy was well tolerated; the incidence of unexpected side-effects was comparable with placebo. Of the expected side-effects, 13.3% of doxylamine-treated patients reported drowsiness. The incidence of sedative effects was lower than has been reported for other commonly used first-generation antihistamines. SN - 0022-3573 UR - https://www.unboundmedicine.com/medline/citation/8932681/A_clinical_study_to_evaluate_the_efficacy_of_the_antihistamine_doxylamine_succinate_in_the_relief_of_runny_nose_and_sneezing_associated_with_upper_respiratory_tract_infection_ L2 - https://onlinelibrary.wiley.com/resolve/openurl?genre=article&amp;sid=nlm:pubmed&amp;issn=0022-3573&amp;date=1995&amp;volume=47&amp;issue=12A&amp;spage=990 DB - PRIME DP - Unbound Medicine ER -