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)

Abstract

Background:We aimed to compare the efficacy of fixed doses of bupropion and ropinirole and iron alone for the treatment of restless legs syndrome (RLS) and to look for the tolerability of these medications.Materials and Methods:Patients diagnosed with RLS were randomly divided into three groups with thirty patients in each group (Group A: Bupropion [300 mg/day], Group B: Ropinirole [0.25–0.5 mg/day], and Group C: Oral iron [150 mg elemental iron] along with folic acid [500 μg]). Each participant was then assessed for severity of RLS, as well as RLS-related quality at the baseline, and thereafter, every 14th day till 6 weeks based on the International Restless Legs Scale (IRLS) severity rating scale and Restless Legs Syndrome Quality of Life (RLSQoL) Questionnaire, respectively.Results:IRLS scores differed significantly from baseline visit to last (F = 4.85; P = 0.01). The interaction between the time x treatment group was significant (F = 10.37; P < 0.001) showing an improvement with the therapy in all the groups. Pair-wise comparison depicted that ropinirole group differed from other two groups in IRLS score (F = 7.06; P = 0.001), which were comparable to each other. Regarding quality of life of these cases, within each group scores differed among all the four visits (F = 5.12; P = 0.002). Unlike IRLS, there was no significant difference among the RLSQOL scores between groups at any point of time (F = 1.2; P = 0.28).Conclusion:RLS severity decreased across time in all three groups; however, the ropinirole treatment was better than the bupropion and iron-folate therapy. Moreover, RLS-related quality of life although improved among all groups, it was comparable among three groups.

Response to reader's queries

“…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]. [2] 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.…”

Nerve Decompression and Restless Legs Syndrome: A Retrospective Analysis

“…In fact, low brain iron concentration is often found in RLS patients. Iron supplementation produces some treatment benefit in RLS, but not to the same extent as other drugs such as dopaminergic agonists ( 33 ). This may be explained by the finding that brain iron concentrations are dissociated from peripheral iron content, which suggests ineffective CNS iron acquisition mechanisms as a causative factor in RLS development ( 34 ).…”

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

“…[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 .…”

“…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 .…”

“…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.…”