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Letters to the Editor

Indian Pediatrics 2003; 40:180-181

Reply


We read with interest the comments of Amdekar et al. on our paper comparing the anti-pyretic effect of nimesulide and paracetamol in children attending a secondary level hospital. Let us examine the issues raised by them pointwise. It should be kept in mind that our primary objective was to compare these two drugs in a clinical setting that is more common and representative of the drug use by pediatricians.

1. Fever in an outpatient setting can be different at different level of hospitals. This could be in terms of cause of the fever and severity. This is so evident that I do not think, we need to elaborate further.

2. As already said we wanted to study this in a common clinical setting. It so happened that many of our participants required admission. We have not said in the paper that we planned to study only outpatients. We said we plan to recruit from an outpatient setting.

3. We have presented the effects of antipyretics in different ways. Assessing after a single dose does not change the results. We did not think it ethically appropriate to wait for a period after giving antipyretic before starting any specific therapy.

4. We are unaware of any standard guideline which states that Nimesulide is contra-indicated in infants.

5. We reanalysed the data in three age range groups for the primary outcome variable -time required to reach normal temperature. While the duration was higher in paracetamol group in all the age groups, it was significant in the age group (>5 years; n = 44) but not significant in <1 year (n = 25) and 1-4 years (n = 28). It should be noted here that the sample size becomes too small in sub-analysis and the power of the study to detect the difference becomes less. One should have enough numbers in each of this age group to really comment on it.

6. They point out limitations in the study which we have ourselves pointed out. This includes, dose, frequency of dosing and frequency of measuring temperature. Regarding the last issue, we do not see how it would bias the result as the frequency was same in both the groups.

7. The study was not designed to address the issue of side effects, especially rare ones. As regards laboratory monitoring, it is not recommended to have a full lab monitoring in a trial of a drug. The safety issues are either handled before a clinical trial or as a part of the post licensing watch.

8. The authors point out that five out of six references were from a single industry sponsored symposium, while it is only four. We had done an electronic search and have referred to only those which we could find.

However, what is more disturbing to us is the fact that this paper seems to have got more than its share of "feedback" in terms of letters to editor. In all of them there are hints about Drug Industry’s role. We are also keenly following the debate in this journal on Industry’s role in conferences etc. While the conflict of interest is explicitly demanded and stated in an original article, it is not so in a letter to the editor. May be, we should consider this.

S.K. Kapoor,
K. Anand,

CRHSP (AIIMS), Ballabgarh,
District Faridabad,
Haryana, India.

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