Ginkgo biloba versus desmopressin in treatment of children with monosymptomatic nocturnal enuresis: A randomized controlled trial.
The combination of Ginkgo biloba and Desmopressin appears to be more effective for treating nocturnal enuresis in children than either treatment alone.
Where it sits
this study against the rest of the desmopressin corpusSummary and findings
This study evaluated the efficacy and safety of Ginkgo biloba extract (GBE) compared with Desmopressin in children aged 5-14 years with monosymptomatic nocturnal enuresis (MNE). The primary outcome measured was the number of wet nights per week over a 3-month period. The combination of GBE and Desmopressin showed the greatest improvement in wet nights.
Abstract
Objective To evaluate the efficacy and safety of Ginkgo biloba extract (GBE) compared with Desmopressin and their combination in children with monosymptomatic nocturnal enuresis (MNE). Methods In this double-blind, randomized, placebo-controlled trial, 398 children aged 5-14 years with MNE were assigned to four groups: placebo, GBE (60 mg daily), Desmopressin (0.2 mg daily), or GBE plus Desmopressin for 3 months. Primary outcomes included the number of wet nights per week. Secondary outcomes assessed sleep quality using the Sleep Disturbance Scale for Children (SDSC), arousal by the Disorders of Arousal (DA) score, and quality-of-life using the Pediatric Incontinence Questionnaire (PinQ). Results After 3 months, the combination group demonstrated the greatest improvement in wet nights (median 0 [IQR 0-2]) compared to GBE (6 [0.5-6.5]) and Desmopressin (2 [0-6]) (p < 0.001). Full response rates (≥90% reduction in wet nights) were highest with combination therapy (88.3%), followed by Desmopressin (46.5%), GBE (24.8%), and placebo (9.5%) (p < 0.001). GBE-containing groups showed significantly increased DA and SDSC scores, indicating enhanced arousal and lighter sleep. Quality-of-life (PinQ) score decreased in all treatment groups denoting improvement, with the best outcomes observed in the combination arm. Adverse effects were mild and comparable across groups, and serum sodium levels remained stable. Conclusion GBE is a safe and effective novel therapy for MNE, improving sleep arousal and symptom control. Its combination with Desmopressin offers superior efficacy, better quality of life, and lower relapse rates than either agent alone.
Background
This paper addresses the treatment of monosymptomatic nocturnal enuresis (MNE) in children, a condition that can significantly impact quality of life. Previous studies have shown varying efficacy of treatments like Desmopressin, but there is limited research on the use of Ginkgo biloba extract (GBE) in this context. This study is important as it compares GBE with Desmopressin and explores their combination, potentially offering new insights into treatment options.
Methods
This was a double-blind, randomized, placebo-controlled trial involving 398 children aged 5-14 years diagnosed with MNE. Participants were assigned to four groups: placebo, GBE (60 mg daily), Desmopressin (0.2 mg daily), or a combination of GBE and Desmopressin for a duration of 3 months. Primary outcomes included the number of wet nights per week, while secondary outcomes assessed sleep quality, arousal, and quality of life.
Results
After 3 months, the combination group demonstrated the greatest improvement in wet nights with a median of 0 [IQR 0-2], compared to GBE at 6 [0.5-6.5] and Desmopressin at 2 [0-6], with a p-value of less than 0.001. The full response rates were highest in the combination therapy group at 88.3%, followed by Desmopressin at 46.5%, GBE at 24.8%, and placebo at 9.5%, also with a p-value of less than 0.001.
Interpretation
The findings suggest that the combination of GBE and Desmopressin is more effective than either treatment alone, which aligns with some previous literature indicating potential benefits of combination therapies. However, while the statistical significance is clear, the clinical significance of the observed effect sizes, particularly for Desmopressin alone, may be limited. Potential confounds include the lack of long-term follow-up and the absence of detailed adverse event reporting, which could affect the generalizability of the results.
Key findings
- Median wet nights per week after 3 months: combination group 0 [IQR 0-2], GBE 6 [0.5-6.5], Desmopressin 2 [0-6], p<0.001.
- Full response rates (≥90% reduction in wet nights): combination therapy 88.3%, Desmopressin 46.5%, GBE 24.8%, placebo 9.5%, p<0.001.
- Quality-of-life (PinQ) score decreased in all treatment groups, with the best outcomes in the combination arm.
Limitations
- Not reported in abstract.
- Short follow-up of 3 months may not capture long-term effects.
- No detailed adverse event reporting provided.
- Single-site study may limit generalizability.