Randomised control trial
Ian M Paul, Jessica S Beiler, Tonya S King, Edelveis R Clapp, Julie Vallati, Cheston M Berlin Jr,Vapor Rub, Petrolatum, and No Treatment for Children With Nocturnal Cough and Cold Symptoms
American Academy of Pediatrics
2010; 1092-1099
- Submitted by:Melissa Taylor - Resident
- Institution:Grand Rapids Medical Education Research Partners/Michigan State University
- Date submitted:20th April 2011
1
Objectives and hypotheses
1.1
Are the objectives of the study clearly stated?
Yes, to determine if a single application of a vapor rub (VR) or petrolatum is superior to no treatment for nocturnal cough, congestion, and sleep difficulty caused by upper respiratory tract infection
2
Design
2.1
Is the study design suitable for the objectives
Yes. Surveys were administered to parents on 2 consecutive days and then randomized to a partially double-blinded scheme.
2.2
Who / what was studied?
138 children aged 2 to 11 years; the effectiveness of a vapor rub combination of camphor,menthol, and eucalyptus oils to provide nocturnal symptom relief for children with cold symptoms cough, congestion, and sleep difficulty.
2.3
Was this the right sample to answer the objectives?
Yes; Patients were recruited from a university-affiliated pediatric practice. Eligible patients were aged 2 to 11 years with symptoms attributed to URIs characterized by cough, congestion, and rhinorrhea that lasted 7 days or longer. Appropriate exlusion criteria were utilized.
2.4
Is the study large enough to achieve its objectives? Have sample size estimates been performed?
Sample-size calculations indicated that 138 subjects (46 per arm) would have 80% power to detect a 1-point
Likert-scale difference between any 2 treatment groups on the basis of a Wil-coxon rank-sum test with Bonferroni-corrected alpha=.0167 to allow for 3 pairwise comparisons for outcomes related to cough, congestion, rhinorrhea, and sleep difficulty.
Likert-scale difference between any 2 treatment groups on the basis of a Wil-coxon rank-sum test with Bonferroni-corrected alpha=.0167 to allow for 3 pairwise comparisons for outcomes related to cough, congestion, rhinorrhea, and sleep difficulty.
2.5
Were all subjects accounted for?
there were 144 enrolled children and 138 completed the study.
2.6
Were all appropriate outcomes considered?
Yes, severity and frequency of cough, severity of stuffy and runny nose, ability of patient and parent to sleep were all included in the survey. Additional questions were included to assess additional treatments, including analgesics and nasal saline. Specificquestions about adverse effects such as hyperactivity, sleepiness, headache, rash, and skin redness were included as were some inquiring about symptoms associated with VR use (burning sensation of skin, nose, and eyes).
2.7
Has ethical approval been obtained if appropriate?
Paper does not mention
2.8
Were the patients randomised between treatments?
After stratification for age (2–5 and 6–11 years), each child was randomly assigned in a partially double-blinded fashion to 1 of 3 treatment groups: Vicks VapoRub; petrolatum oint. and no treatment. The randomization sequence was constructed by a statistician not affiliated with the study and was used to assign treatment groups.
2.9
How was randomisation carried out?
The randomization sequence was constructed by a statistician not affiliated with the study and was used to assign treatment groups.
2.10
Are the outcomes clinically relevant?
Yes
3
Measurement and observation
3.1
Is it clear what was measured, how it was measured and what the outcomes were?
A combined symptom score was calculated using all study outcomes: cough frequency; cough severity; congestion;
rhinorrhea; child sleep; and parent sleep. The wording of the outcomes is difficult to follow.
rhinorrhea; child sleep; and parent sleep. The wording of the outcomes is difficult to follow.
3.2
Are the measurements valid?
Yes; In addition to the significant 3-way treatment comparison (P<.001), Vapor Rub was significantly better than petrolatum (P=.03) and no treatment (P<.001) whereas petrolatum was marginally better than no treatment (P=.08).
3.3
Are the measurements reliable?
Yes, according to parents subjective view.
3.4
Are the measurements reproducible?
Yes.
3.5
Were the patients and the investigators blinded?
Partially-blinded; Although the investigators were blinded to all 3 treatment groups, one-third of the cohort, those in the no-treatment arm, were unblinded. Also, although every attempt was made to blind parents
to whether their child was treated with VR or petrolatum.
to whether their child was treated with VR or petrolatum.
4
Presentation of results
4.1
Are the basic data adequately described?
Yes
4.2
Were groups comparable at baseline?
No significant difference between treatment groups exists for any baseline characteristic.
4.3
Are the results presented clearly, objectively and in sufficient detail to enable readers to make their own judgement?
Yes, Figure 2. displays the results clearly.
4.4
Are the results internally consistent, i.e. do the numbers add up properly?
Yes
4.5
Were side effects reported?
Yes; questions about adverse effects such as hyperactivity, sleepiness, headache, rash, and skin redness were included as were some inquiring about symptoms associated with VR use (burning sensation of skin, nose, and eyes).
5
Analysis
5.1
Are the data suitable for analysis?
Yes.
5.2
Are the methods appropriate to the data?
They used subjective data from the parents.
5.3
Are any statistics correctly performed and interpreted?
Yes
6
Discussion
6.1
Are the results discussed in relation to existing knowledge on the subject and study objectives?
Yes, however there are few evidence-based therapes for children with cold symptoms.
6.2
Is the discussion biased?
It is possible the discussion is biased because Dr Paul has been a paid consultant for the Consumer Products Healthcare Association, McNeil Consumer Health Inc, the Procter and Gamble Company, Reckitt Benckiser Healthcare International Ltd, and Novartis Consumer Health Inc; the other authors have indicated they have no
financial relationships relevant to this article to disclose.
financial relationships relevant to this article to disclose.
7
Interpretation
7.1
Are the authors' conclusions justified by the data?
Yes
7.2
What level of evidence has this paper presented? (using CEBM levels)
2b
7.3
Does this paper help me answer my problem?
Not completely, but does offer some advice.
8
Implementation
8.1
Can any necessary change be implemented in practice?
No, it would not be considered necessary.
8.2
What aids to implementation exist?
Inexpensive, safe treatment that can be done at home
8.3
What barriers to implementation exist?
None