Sleep

Short-Term Association of Add-On Gosha-Jinki-Gan with Sleep and Nocturia Outcomes in Patients with Persistent Nocturia Despite Desmopressin: A Real-World Study.

TL;DR

Add-on Gosha-jinki-gan therapy was associated with improvements in nocturia-related parameters and prolongation of hours of undisturbed sleep in patients with persistent nocturia despite desmopressin treatment.

Key Findings

Add-on Gosha-jinki-gan was associated with a significant reduction in nocturnal voiding frequency over 4 weeks.

  • Nocturnal voiding frequency decreased from 3.38 to 2.60 episodes/night (p < 0.0001)
  • Study included 40 men aged ≥60 years with nocturnal polyuria who had ≥2 nocturnal voids or HUS ≤3 h despite desmopressin treatment
  • Gosha-jinki-gan was administered as an add-on at 7.5 g/day while concomitant medications were continued
  • Assessments were made via voiding diaries before treatment and at 1 and 4 weeks

Add-on Gosha-jinki-gan was associated with a significant increase in hours of undisturbed sleep (HUS).

  • Mean HUS increased from 116 to 186 minutes at 4 weeks (p < 0.0001)
  • This represents an extension of approximately 70 minutes
  • The increase exceeded the clinically meaningful 3-hour threshold
  • HUS was a primary outcome measure assessed via voiding diaries

Nocturnal urine volume was significantly reduced following add-on Gosha-jinki-gan therapy.

  • Nocturnal urine volume reduction was statistically significant (p < 0.0001)
  • Nocturnal urine volume and nocturnal polyuria index were both primary outcome measures
  • The mean voided volume before desmopressin treatment was low at 109.9 mL, suggesting reduced functional bladder capacity

Sleep quality as assessed by the Athens Insomnia Scale improved significantly with add-on Gosha-jinki-gan therapy.

  • Athens Insomnia Scale was a secondary outcome measure
  • Improvement in sleep quality was described as statistically significant
  • Assessments were conducted before treatment and at 1 and 4 weeks

No serious adverse events were observed during the short-term add-on Gosha-jinki-gan treatment period.

  • Safety was monitored across the 4-week treatment period
  • The study population was 40 men aged ≥60 years
  • Concomitant medications including desmopressin were continued throughout the study

The study population had low mean voided volume before desmopressin treatment, suggesting reduced functional bladder capacity as a contributing factor to persistent nocturia.

  • Mean voided volume before desmopressin treatment was 109.9 mL
  • Participants were selected for having persistent nocturia (≥2 nocturnal voids or HUS ≤3 h) despite ongoing desmopressin treatment
  • All participants had nocturnal polyuria
  • This finding suggests that reduced functional bladder capacity, not just nocturnal polyuria, may contribute to desmopressin treatment failure

Secondary outcomes including International Prostate Symptom Score (IPSS) and Overactive Bladder Symptom Score (OABSS) were assessed alongside Patient Global Impression of Improvement (PGI-I).

  • IPSS, OABSS, Athens Insomnia Scale, and PGI-I were all secondary outcome measures
  • These validated questionnaires were assessed before treatment and at 1 and 4 weeks
  • The retrospective real-world design included 40 men aged ≥60 years

What This Means

This research looked at a Japanese herbal medicine called Gosha-jinki-gan, added on top of an existing medication called desmopressin, in men who were still waking up frequently at night to urinate despite already taking desmopressin. The study included 40 older men (aged 60 and above) who were waking up at least twice per night or were only able to sleep undisturbed for 3 hours or less. After 4 weeks of adding Gosha-jinki-gan (7.5 g/day) to their existing treatment, participants showed meaningful improvements: they woke up about one fewer time per night to urinate on average, and their first uninterrupted stretch of sleep grew by about 70 minutes — going from roughly 2 hours to over 3 hours, crossing a threshold considered clinically meaningful. Sleep quality scores and nighttime urine production also improved, and no serious side effects were reported. The study also found that these patients had a notably low average bladder volume before starting desmopressin (about 110 mL), which suggests that reduced bladder capacity — not just excess urine production at night — may be part of why desmopressin alone wasn't fully working for them. Gosha-jinki-gan, which has traditionally been used for urinary symptoms in East Asian medicine, may address this bladder capacity component in a way that desmopressin alone does not. This research suggests that adding Gosha-jinki-gan to desmopressin therapy may be a promising option for people whose nighttime urination problems haven't fully responded to desmopressin alone. However, the authors caution that this was a small, retrospective, real-world study without a control group, meaning these findings should be considered preliminary and hypothesis-generating. Larger, prospective, controlled clinical trials are needed to confirm whether this combination truly provides benefits beyond desmopressin alone.

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Citation

Kurose H, Kishimoto H, Komiya K, Ueda K, Chikui K, Uemura K, et al.. (2026). Short-Term Association of Add-On Gosha-Jinki-Gan with Sleep and Nocturia Outcomes in Patients with Persistent Nocturia Despite Desmopressin: A Real-World Study.. Medicina (Kaunas, Lithuania). https://doi.org/10.3390/medicina62081466