LETTER TO THE EDITOR
|Year : 2017 | Volume
| Issue : 2 | Page : 167-169
Response to reader's queries
Kirti Vishwakarma1, Juhi Kalra2, Ravi Gupta3, Mukesh Sharma4, Taruna Sharma2
1 Department of Pharmacology, Himalayan Institute of Medical Sciences, Dehradun, Uttarakhand; Department of Pharmacology, TMMC and RC, Moradabad, Uttar Pradesh, India
2 Department of Pharmacology, Himalayan Institute of Medical Sciences, Dehradun, Uttarakhand, India
3 Department of Psychiatry and Sleep Clinic, Himalayan Institute of Medical Sciences, Dehradun, Uttarakhand, India
4 Department of Community Medicine, TMMC and RC, Moradabad, Uttar Pradesh, India
|Date of Web Publication||8-May-2017|
Department of Psychiatry and Sleep Clinic, Himalayan Institute of Medical Sciences, Swami Ram Nagar, Jolly Grant, Dehradun - 248 016, Uttarakhand
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Vishwakarma K, Kalra J, Gupta R, Sharma M, Sharma T. Response to reader's queries. Ann Indian Acad Neurol 2017;20:167-9
We are thankful to the reader for his interest in our paper and for the concerns raised. This was a noninferiority trial where we wanted to analyze whether the bupropion and iron-folate were as efficacious as ropinirole in the short-term treatment of Willis–Ekbom disease/Restless legs syndrome (WED/RLS). The consort diagram is provided with this letter [Figure 1]. As already mentioned, random allocation was done using a list of random numbers, and this has been reported to be an effective method. Author who was responsible of measuring the improvement was blinded of the group allocation that removes the observer's bias. We agree with the statement mentioned that “both groups were neither superior nor equivalent to the ropinirole,” and we have already mentioned it in the paper “Pair-wise comparison depicted that ropinirole group differed from other two groups in International RLS Severity Rating (IRLS) score (F = 7.06; P= 0.001), which were comparable to each other” [Table 1]. As pointed out by the reader, in the absence of placebo control group, it cannot be commented whether bupropion or iron-folate combination was better than placebo. Placebo group could not be included because of restrictions from the regulatory bodies. However, it must be noted that placebo is not an inert substance and this has been found effective in a number of disorders including WED/RLS., In this study, mixed ANOVA was used, and in this statistical method, effect size was depicted using partial eta square. In this study, partial eta square value was 0.145 with 95% power for between-subjects' effect, and thus, effect size may be considered large. Intention to treat analysis, as mentioned by the reader has its own limitations. One of them is, subjects who do not receive treatment, are assumed to have taken treatment with resultant effect and this may have bearing on the results. Thus, we removed five subjects who did not come for any follow up and the intention to treat analysis was done after including 8 subjects who attended at least one follow-up visit. We used last observation carry forward method of imputation. This method did not change the results as published in the initial paper.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Kim J, Shin W. How to do random allocation (randomization). Clin Orthop Surg 2014;6:103-9.
Vishwakarma K, Kalra J, Gupta R, Sharma M, Sharma T. A double-blind, randomized, controlled trial to compare the efficacy and tolerability of fixed doses of ropinirole, bupropion, and iron in treatment of restless legs syndrome (Willis-Ekbom disease). Ann Indian Acad Neurol 2016;19:472-7.
] [Full text]
Ethical Guidelines for Biomedical Research on Human Participants. New Delhi: Indian Council for Medical Research; 2006.
Benedetti F. Placebo effects: From the neurobiological paradigm to translational implications. Neuron 2014;84:623-37.
Fulda S, Wetter TC. Where dopamine meets opioids: A meta-analysis of the placebo effect in restless legs syndrome treatment studies. Brain 2008;131(Pt 4):902-17.
Lakens D. Calculating and reporting effect sizes to facilitate cumulative science: A practical primer for t
-tests and ANOVAs. Front Psychol 2013;4:863.
Armijo-Olivo S, Warren S, Magee D. Intention to treat analysis, compliance, drop-outs and how to deal with missing data in clinical research: A review. Physical Ther Rev 2009;14:36-49.