Cough suppressants should not be used widely to treat respiratory tract infections
Saturday, March 26, 2011
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Summary Full article
- AVC ER, Vallati J, Berlin CM Jr. Vapor rub, petrolatum, and no Treatment for Children with nocturnal cough and cold Symptoms.
- Pediatrics. 2010; 126:1092-9. DOI: 10.1542/peds.2010-1601.
- Reviewers: García Vera C 1
- , Buñuel Alvarez JC 2
1 ; emollients: therapeutic use;
Keywords: cough ; emollients: therapeutic use ;
antitussive agents: therapeutic use
Received: 17/03/2011 cold medications valued more than the natural therapies and recommends that further well designed clinical trials to discern the usefulness of these products. As a counterpoint to the clinical effect, also called attention to the high risk of AD as the product VR is, almost half of those treated with VR for only five cases in the PT group and one in the NI group, although the effects were mostly mild skin.
How to cite this article
CS-Nightingales. Zaragoza (Spain). 2 basic area of \u200b\u200bSalut Girona-4. Institut Català de la Salut. Girona (Spain). Correspondence: César García Vera. Email: cgarciavera@gmail.com
Keywords: cough ; emollients: therapeutic use;
antitussive agents: therapeutic use
Keywords: cough ; emollients: therapeutic use ; antitussive agents: therapeutic use
Received: 17/03/2011
Accepted: 21 / 03/2011 Release Date: 23/03/2011
Objective: determine the effectiveness of vapor rub (VR) and petrolatum (PT) compared to no intervention (NI), to relieve the clinical symptoms of upper respiratory tract infections (URTI). Design: -label clinical trial.
Location: ambulance. Pediatric of a university in Hershey (Pennsyilvania, USA. UU.). study with inclusion criteria were: children aged between two and 11 years with symptoms of URI (cough, congestion and runny nose of ≥ 7 days). We excluded children who had other respiratory diseases like asthma, pneumonia, croup, sinusitis or allergic rhinitis. Were also excluded children with a history of asthma or seizures, and children who the day before joining the study used antitussives, antihistamines, honey or other medication that contains any of the components of VR. Were included in the study 144 patients between October 2008 and February 2010. 138 finished the trial (95.8%). Intervention:
participants were stratified into two age groups (2-5 years and 6-11 years). Were randomized (randomization list was generated by a statistician outside the study) to three comparison groups (in brackets shows the number of participants who completed the study): VR (n = 44), PT (n = 47) and NI (n = 47). The amount of ointment given to children in the VR group and PT was 5 ml in children aged 2-5 years and 10 ml in 6-11 years. Masking procedures were used part of treatment for parents but not for children. Outcome measures:
the intensity of each sign or symptom (cough frequency, cough severity, severity of congestion, rhinorrhea intensity, child's ability to sleep, parenting skills sleeping and combined score of all symptoms) was assessed using a visual analogue scale 7-point Likert (1 point: absence of symptoms, 7 points: severe symptoms). The scale was completed by parents night prior to the start of the study and the day after the fulfillment. The results of this second survey were collected by researchers outside the study. Was considered clinically important variation from one point Likert scale before and after the study. Were also measured adverse effects (EA). Main results: of the six losses, four were the VR group, a group PT and the NI group. Does not detail the reasons therefor. Children who received VR showed statistically significant improvement compared to NI group in the following variables: frequency of cough (p \u0026lt;0.01), cough severity (p = 0.006), intensity of congestion (p = 0.01), ability to sleep in the parents (p \u0026lt;0.01 ) and children (p \u0026lt;0.01) and scale combined score of symptoms (p \u0026lt;0.01). No significant differences concerning the intensity of rhinorrhea. Compared to the PT, the VR showed statistically significant improvement in the following variables: ability to sleep of children (p = 0.006) and parents (p = 0.008) and the combined rating scale of symptoms (p = 0 , 03). The remaining comparisons were not significant. No significant differences between PT and NI in any comparisons. As for EA, 20 (46% of children in the VR group) had at least one AE. In this group, the total number of EA detected was 32, compared with five in the PT group and one from group NI. AEs more frequent in the VR group were burning the skin (28%), nose (14%) and eyes (16%), followed by rash (5%), redness ( 5%), hyperactivity (2%), somnolence (2%) and headache (2%).
Conclusion: VR-treated children experienced symptom relief of ITRS than those who received PT or NI.
Conflict of interest: IMP, first author of the study, is a paid consultant, including laboratories, Procter and Gamble Company, manufacturer of laboratory VapoRub ointment.
Funding: National Institutes of Health .
Critical Commentary
Justification
cough and cold medications have not proven effective in children to date, either for lack of studies or because the studies address placebo showed no significantly better results. Few studies have been conducted on so-called Anglo-Saxon literature as such "counter" (over-the-counter Medications). However, there is a Cochrane systematic review 1
that addresses the issue and concluded that no convincing evidence for or against the effectiveness of these drugs in acute cough. This study aims to investigate the utility of alternatives such as VR or PT in the treatment of catarrhal symptoms (cough, congestion and difficulty sleeping). Validity Scientist:
the study was conducted on a group of appropriate patients, the interventions are well specified and the outcome variables seem right, although the authors do not provide enough information to judge the clinical significance of symptom scale used ( curiously restricted the use of saline to avoid interference in the results). You can not tell if the allocation procedure was adequate to conceal the randomization sequence, although it is possible that the partial masking help it. What could hardly be achieved is the masking of the treatment to parents who are the ones who completed the symptom scale. Moreover, the significant difference in previous use of antipyretics (36, 16 and 9% in the VR group, PT and NI, respectively) between groups casts doubt on their homogeneity. Although the losses are small (\u0026lt;20%), which were more frequent in those treated with VR (about 10%) suggests that adverse effects may be related to such losses. The data analysis is not done by intention to treat. The results were not detailed (only shows a graphical presentation), so that magnitudes can not be translated into clinical utility. Statistical analysis of EA is not one group to the analysis of effectiveness, "diluting" of Thus the high incidence of them in the VR group. Clinical significance:
in the current study, VR has a statistically significant improvement with respect to PT and NI, but not detailed the magnitude of the effect can not judge its clinical importance. For most symptoms, the difference in the scale used is between 1 and 1.5 point improvement (on a scale of 7 points), suggesting limited clinical significance. Very few and very old are the studies can be found on the usefulness of these products could be termed as "natural medicine." Yes it has recently a clinical trial of the same author who appreciates the usefulness of honey as a cough suppressant 2, with significant beneficial effects compared to placebo: decreased frequency of coughing and improvement of a combination of symptoms. The Cochrane review cited above 1
Applicability in clinical practice:
even assuming that we managed to drugs or products that effectively improve the catarrhal symptoms in children, should be questioning them in most cases, as in cases minor (most prevalent) symptoms such as fever or cough not high production would be beneficial for the resolution of the picture. However, in certain circumstances more serious and extremely distressed child, it would be good to know what drugs or other products are really useful for the relief of symptoms. For the design problems of this study and the adverse effects of VR, we should not incorporate it widely to our recommendations for treatment of cough and cold media in children. García Vera C, Buñuel Alvarez JC. Suppressants topics should not be used widely to treat upper respiratory infections. Pediatr Evid. 2011; 7:33. Bibliography
Smith SM, Schroeder K, Fahey T. Counter medications for acute cough in children and adult outpatients (Cochrane Review). In: The Cochrane Library, 2008 Issue 4. Oxford: Update Software Ltd. Available at: http://www.update-software.com . (Translated from The Cochrane Library, 2008 Issue 3. Chichester, UK: John Wiley & Sons, Ltd.).
Paul IM, Beiler J, McMonagle A, Shaffer ML, Duda L, Berlin CM Jr. Effect of honey, dextromethorphan, and no Treatment on Nocturnal Cough and Sleep Quality for Coughing Children and Their Parents. Arch Pediatr Adolesc Med 2007; 161:1140-6
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