پاسخ نویسندگان به نامه به سردبیر،"تأثیرات نانو امولسیون اوژنول بر درد ناشی از کانولاسیون فیستول شریانی در بیماران همودیالیزی: یک کارآزمایی بالینی تصادفی کنترل شده دوسوکور"

عنوان انگليسی

Authors’ response to letter to the editor, “The effects of eugenol nanoemulsion on pain caused by arteriovenous fistula cannulation in hemodialysis patients: A randomized double-blinded controlled cross-over clinical trial”

خلاصه انگلیسی

Complementary Therapies in Medicine 54 (2020) 102544Available online 23 August 20200965-2299/© 2020 Elsevier Ltd. All rights reserved.Authors’ response to letter to the editor, “The effects of eugenol nanoemulsion on pain caused by arteriovenous fistula cannulation in hemodialysis patients: A randomized double-blinded controlled cross-over clinical trial” To the Editor We should appreciate the provided continued opportunity to discuss our manuscript entitled “The effects of eugenol nanoemulsion on pain caused by arteriovenous fistula cannulation in hemodialysis patients: A randomized double-blinded controlled cross-over trial”.1 Also, we would like to thank Dr. Soltani-Kermanshahi and Dr. Mansori for their great interest in our paper and for their time to discuss some method-ological issues about our paper.2 In their letter to the editor, two concerns were raised by them. We agree with their concerns about possible methodological flaws resulting in non-reliable findings. As we discussed earlier, there are rising con-cerns about evidence-based complementary therapies in medicine. Sometimes, there is ambiguous data on its efficacy and safety.3,4 Therefore, clinical trials on complementary therapies should employ the most robust designs and methods.5 The first matter mentioned in their letter, is the necessity to impose a washout period between different interventional periods. As it has been shown in the CONSORT flowchart of our study, there was a washout period before patients’ crossover. Their second concern was checking the carryover effect. Is this sta-tistical test required for every crossover trial? It seems that the response is “NO”! It depends on the nature of intervention and possibility of carryover its effect at the next intervention. In addition, there are two major disadvantage for use of statistical tests on assessment of carryover effect: 1) “the unconditional Type I error rate operates at a much higher level than desired”. 2) this statistical approach may cause one-half of our re-sults to be left unused.6 Therefore, it is strongly recommended to choose an appropriate length for the washout period (depending on the half-life of the drug) to assure about avoiding this effect.

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