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LETTER TO THE EDITOR
Year : 2017  |  Volume : 20  |  Issue : 2  |  Page : 166-167
 

Bupropion and iron for restless leg syndrome: Do they have efficacy similar to ropinirole?


Department of Psychiatry, Kasturba Medical College, Manipal, Karnataka, India

Date of Web Publication8-May-2017

Correspondence Address:
Samir Kumar Praharaj
Department of Psychiatry, Kasturba Medical College, Manipal - 576 104, Karnataka
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0972-2327.205775

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How to cite this article:
Praharaj SK. Bupropion and iron for restless leg syndrome: Do they have efficacy similar to ropinirole?. Ann Indian Acad Neurol 2017;20:166-7

How to cite this URL:
Praharaj SK. Bupropion and iron for restless leg syndrome: Do they have efficacy similar to ropinirole?. Ann Indian Acad Neurol [serial online] 2017 [cited 2019 Oct 22];20:166-7. Available from: http://www.annalsofian.org/text.asp?2017/20/2/166/205775


Sir,

I read with interest the study on efficacy and tolerability of ropinirole, bupropion, and iron for the treatment of restless leg syndrome (RLS) reported by Vishwakarma et al.[1] in October-December issue of 2016. The authors have rightly pointed out that the dopamine agonist, ropinirole is considered as the standard treatment of idiopathic RLS (beside pramipexole and rotigotine), at a dose ranging from 1.5 to 4.6 mg in the systematic review and meta-analysis by Aurora et al.[2] Similar conclusions were reached in the meta-analysis by Scholz et al.[3] There is only one randomized, placebo-controlled trial [4] that found bupropion to be efficacious than placebo in RLS at 3 weeks but not at 6 weeks. Although iron therapy has been evaluated in six randomized-controlled trials, the meta-analysis by Trotti et al.[5] found that the evidence is not sufficient to conclude that it is beneficial in RLS. In the current study, the authors have compared fixed-dose bupropion and combination of iron with folic acid, with ropinirole, which is the standard treatment available and acts as an active control. However, the authors have not specified whether this is a superiority or a noninferiority trial; the latter can be conducted with smaller sample sizes.[6]

The authors have recruited 103 patients but presented the data for 90 patients. It is not clear whether the 13 dropouts received treatment and did not complete 6-week follow-up and at which stage they were lost. A CONSORT diagram depicting the flow of participants in the study is desirable, which improves the understanding of the results.[7] Furthermore, in addition to completer analysis, an intention-to-treat analysis including all randomized patients would reduce the bias in reporting results.[8] Furthermore, from the description, it is not clear about the process of randomization and the allocation concealment.[9]

For the primary outcome, i.e., International Restless Legs Scale (IRLS) score, there were significant effect of time, which suggests improvement in all the three groups, and significant group × time interaction, suggesting differences in efficacy between the treatment groups. Post hoc comparison suggested ropinirole be more effective than bupropion and iron and folate combination as shown in [Figure 1] of Vishwakarma et al.[1] However, in the absence of control group, it was assumed that both bupropion and iron and folate combination were effective treatment in RLS. In reality, both treatment groups were neither superior nor equivalent to ropinirole, which is considered as standard treatment. In such situations, it is better to report the effect sizes of the differences with 95% confidence intervals and discuss the practical significance of the finding, i.e., reduction in IRLS scores. Furthermore, it was interesting to observe that ropinirole was effective at a dose of 0.5 mg/day, which is much lower than the recommended dose of 1.5–4.6 mg/day.[2]

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

 
   References Top

1.
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.  Back to cited text no. 1
[PUBMED]  [Full text]  
2.
Aurora RN, Kristo DA, Bista SR, Rowley JA, Zak RS, Casey KR, et al. The treatment of restless legs syndrome and periodic limb movement disorder in adults – An update for 2012: Practice parameters with an evidence-based systematic review and meta-analyses: An American Academy of Sleep Medicine Clinical Practice Guideline. Sleep 2012;35:1039-62.  Back to cited text no. 2
    
3.
Scholz H, Trenkwalder C, Kohnen R, Riemann D, Kriston L, Hornyak M. Dopamine agonists for restless legs syndrome. Cochrane Database Syst Rev 2011;3:CD006009.  Back to cited text no. 3
    
4.
Bayard M, Bailey B, Acharya D, Ambreen F, Duggal S, Kaur T, et al. Bupropion and restless legs syndrome: A randomized controlled trial. J Am Board Fam Med 2011;24:422-8.  Back to cited text no. 4
    
5.
Trotti LM, Bhadriraju S, Becker LA. Iron for restless legs syndrome. Cochrane Database Syst Rev 2012;5:CD007834.  Back to cited text no. 5
    
6.
Vieta E, Cruz N. Head to head comparisons as an alternative to placebo-controlled trials. Eur Neuropsychopharmacol 2012;22:800-3.  Back to cited text no. 6
    
7.
Andrade C. Examination of participant flow in the CONSORT diagram can improve the understanding of the generalizability of study results. J Clin Psychiatry 2015;76:e1469-71.  Back to cited text no. 7
    
8.
Ranganathan P, Pramesh CS, Aggarwal R. Common pitfalls in statistical analysis: Intention-to-treat versus per-protocol analysis. Perspect Clin Res 2016;7:144-6.  Back to cited text no. 8
[PUBMED]  [Full text]  
9.
Clark L, Schmidt U, Tharmanathan P, Adamson J, Hewitt C, Torgerson D. Poor reporting quality of key randomization and allocation concealment details is still prevalent among published RCTs in 2011: A review. J Eval Clin Pract 2013;19:703-7.  Back to cited text no. 9
    




 

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