YOU ARE NOW CONNECTED TO THE TOXLINE (1981 FORWARD, NON-ROYALTY) FILE. ==COLD, COMMON AND ZINC== 1 AUTHOR Mossad SB AUTHOR Macknin ML AUTHOR Medendorp SV AUTHOR Mason P TITLE Zinc gluconate lozenges for treating the common cold. A randomized, double-blind, placebo-controlled study [see comments] SOURCE Ann Intern Med; VOL 125, ISS 2, 1996, P81-8 ABSTRACT BACKGROUND. The common cold is one of the most frequent human illnesses and is responsible for substantial morbidity and economic loss. No consistently effective therapy for the common cold has been well documented, but evidence suggests that several possible mechanisms may make zinc an effective treatment. OBJECTIVE. To test the efficacy of zinc gluconate lozenges in reducing the duration of symptoms caused by the common cold. DESIGN. Randomized, double-blind, placebo-controlled study. SETTING. Outpatient department of a large tertiary care center. PATIENTS. 100 employees of the Cleveland Clinic who developed symptoms of the common cold within 24 hours before enrollment. INTERVENTION. Patients in the zinc group (n = 50) received lozenges (one lozenge every 2 hours while awake) containing 13.3 mg of zinc from zinc gluconate as long as they had cold symptoms. Patients in the placebo group (n = 50) received similarly administered lozenges that contained 5% calcium lactate pentahydrate instead of zinc gluconate. MAIN OUTCOME MEASURES. Subjective daily symptom scores for cough, headache, hoarseness, muscle ache, nasal drainage, nasal congestion, scratchy throat, sore throat, sneezing, and fever (assessed by oral temperature). RESULTS. The time to complete resolution of symptoms was significantly shorter in the zinc group than in the placebo group (median, 4.4 days compared with 7.6 days; P < 0.001). The zinc group had significantly fewer days with coughing (median, 2.0 days compared with 4.5 days; P = 0.04), headache (2.0 days and 3.0 days; P = 0.02), hoarseness (2.0 days and 3.0 days; P = 0.02), nasal congestion (4.0 days and 6.0 days; P = 0.002), nasal drainage (4.0 days and 7.0 days; P < 0.001), and sore throat (1.0 day and 3.0 days; P < 0.001). The groups did not differ significantly in the resolution of fever, muscle ache, scratchy throat, or sneezing. More patients in the zinc group than in the placebo group had side effects (90% compared with 62%; P < 0.001), nausea (20% compared with 4%; P = 0.02), and bad-taste reactions (80% compared with 30%; P < 0.001), CONCLUSION. Zinc gluconate in the form and dosage studied significantly reduced the duration of symptoms of the common cold. The mechanism of action of this substance in treating the common cold remains unknown. Individual patients must decide whether the possible beneficial effects of zinc gluconate on cold symptoms outweigh the possible adverse effects. 3 AUTHOR Godfrey JC AUTHOR Conant Sloane B AUTHOR Smith DS AUTHOR Turco JH AUTHOR Mercer N AUTHOR Godfrey NJ TITLE Zinc gluconate and the common cold: a controlled clinical study. SOURCE J Int Med Res; VOL 20, ISS 3, 1992, P234-46 ABSTRACT A report in 1984 on the success of zinc gluconate against common cold symptoms could not be confirmed in three subsequent studies, which are now known to have used formulations that inactivated zinc. A non-chelating formulation including glycine, which releases 93% of contained zinc into saliva, was tested in a randomized, placebo-controlled, double-blind trial in 73 young adults. Efficacy was recorded in symptom diaries using a symptom severity rating. Patients' symptoms first appeared 1.34 days prior to entry to the study in both groups. Disappearance of symptoms occurred after an additional 4.9 days for zinc-treated patients versus 6.1 days for placebo-treated patients. A difference was noted in the efficacy of treatment if it was started 1 day after symptom onset: cold duration was an additional 4.3 days in zinc-treated patients compared with 9.2 days for placebo-treated patients. Cough, nasal drainage and congestion were the symptoms most affected, and only mild side-effects were noted. 4 AUTHOR Farr BM AUTHOR Conner EM AUTHOR Betts RF AUTHOR Oleske J AUTHOR Minnefor A AUTHOR Gwaltney JM Jr TITLE Two randomized controlled trials of zinc gluconate lozenge therapy of experimentally induced rhinovirus colds. SOURCE Antimicrob Agents Chemother; VOL 31, ISS 8, 1987, P1183-7 ABSTRACT The therapeutic efficacy of zinc gluconate lozenge therapy in experimentally induced rhinovirus infection was assessed in two randomized controlled trials in susceptible adult volunteers. In trial 1, lozenges containing either zinc gluconate (23 mg of elemental zinc) or placebo were given 36 h after nasal inoculation of rhinovirus type 39 and administered eight times per day for 5 days. All of the volunteers had early cold symptoms at the time that treatment was begun. In trial 2, the same lozenge regimen was used, beginning 2 h after nasal inoculation with rhinovirus type 13, and continued for 7 days. Zinc therapy did not reduce the severity or duration of cold symptoms or the frequency or duration of viral shedding in either trial. Viral titers were measured in trial 2 and were shown to be unaffected by zinc therapy. Nasal mucus weights and the numbers of paper tissues used were slightly higher in zinc recipients. A statistically significant increase in levels of zinc in serum was documented in zinc recipients after 5 days of therapy. These data suggest that zinc gluconate lozenge therapy is not therapeutically useful in the treatment of rhinovirus colds. 6 AUTHOR Al-Nakib W AUTHOR Higgins PG AUTHOR Barrow I AUTHOR Batstone G AUTHOR Tyrrell DA TITLE Prophylaxis and treatment of rhinovirus colds with zinc gluconate lozenges. SOURCE J Antimicrob Chemother; VOL 20, ISS 6, 1987, P893-901 ABSTRACT Following a tolerance study, double-blind placebo controlled trials were conducted to determine the prophylactic effect of zinc gluconate lozenges on rhinovirus challenge and, in a third study, their therapeutic efficacy when given at the start of colds caused by virus inoculation was tested. In the prophylaxis study a total of 57 volunteers received lozenges of either zinc gluconate (23 mg) (29 volunteers) or matched placebo (28 volunteers) every 2 h while awake during a period of four and a half days. They were challenged with 10(2) tissue culture infecting dose (TCID50) of human rhinovirus 2 (HRV-2) on the second day of medication, and were monitored daily for symptoms and signs of colds and laboratory evidence of infection. Zinc reduced the total mean clinical score from 8.2 in the placebo group to 5.7 and the reduction of the mean clinical score was statistically significant on the second day after virus challenge. In the therapeutic study 69 volunteers were inoculated with 10(2) TCID50 of HRV-2 and those who developed cold symptoms were randomly allocated to receive either zinc gluconate lozenges (six volunteers) or matched placebo lozenges (six volunteers) every two hours they were awake for six days. Treatment of colds with zinc reduced the mean daily clinical score and this was statistically significant on the fourth and fifth day of medication. Similarly, medication also reduced the mean daily nasal secretion weight and total tissue count and these reductions were statistically significant on days two and six for nasal secretion weights and days four to six of medication for tissue counts when compared with placebo.(ABSTRACT TRUNCATED AT 250 WORDS) 7 AUTHOR Eby GA AUTHOR Davis DR AUTHOR Halcomb WW TITLE Reduction in duration of common colds by zinc gluconate lozenges in a double-blind study. SOURCE Antimicrob Agents Chemother; VOL 25, ISS 1, 1984, P20-4 ABSTRACT As a possible treatment for common colds, we tested zinc gluconate lozenges in a double-blind, placebo-controlled, clinical trial. One 23-mg zinc lozenge or matched placebo was dissolved in the mouth every 2 wakeful h after an initial double dose. After 7 days, 86% of 37 zinc-treated subjects were asymptomatic, compared with only 46% of 28 placebo-treated subjects (P = 0.0005). Side effects or complaints were usually minor and consisted mainly of objectionable taste and mouth irritation. Zinc lozenges shortened the average duration of common colds by about 7 days. 5 AUTHOR Farr BM AUTHOR Gwaltney JM Jr TITLE The problems of taste in placebo matching: an evaluation of zinc gluconate for the common cold. SOURCE J Chronic Dis; VOL 40, ISS 9, 1987, P875-9 ABSTRACT A recently published randomized, controlled, double-blind, study has reported efficacy of zinc gluconate lozenge treatment of the common cold. Because of a higher rate of side effects in the zinc group and the lack of any confirmatory evidence of blinding efficacy, we are concerned about the possible contribution of bias to the study result. Unflavored zinc gluconate tablets can be easily distinguished from the relatively tasteless, unflavored calcium lactate tablets, which were used as placebo in the cited study, increasing our concern about bias. In order to be able to test zinc lozenges in a second trial of common cold therapy, we developed a matching placebo containing denatonium benzoate (a bitter substance used to prevent thumb sucking in children) and then undertook a formal evaluation of blinding efficacy. This article reports the results of this evaluation, encompassing two randomized, controlled taste trials; the first trial of the placebo matching showed zinc recipients to exhibit a higher rate of side effects and also a significantly higher proportion of subjects believing they were on "active" treatment. Alterations in dosage before the second taste trial yielded comparability of the placebo and zinc lozenges. This study illustrates the pitfalls which may sometimes be encountered in performing and publishing studies in which placebos are either not tested at all or tested in too small a subject population to detect a significant subjective difference between the placebo and the active medication.