Effect of Ashwagandha (Withania somnifera) extract on sleep: A systematic review and meta-analysis.
Study Design
- Tipo de estudio
- Meta-Analysis
- Tamaño de muestra
- 400
- Duración
- 8 weeks
- Intervención
- Effect of Ashwagandha (Withania somnifera) extract on sleep: A systematic review and meta-analysis. ≥600 mg/day for ≥8 weeks (more effective subgroup)
- Comparador
- Placebo
- Dirección del efecto
- Positive
- Riesgo de sesgo
- Low
Abstract
OBJECTIVE: To determine the effect of Ashwagandha extract on sleep. METHODS: A comprehensive search was conducted in CENTRAL, MEDLINE, SCOPUS, Google Scholars, World Health Organization Trials Portal, ClinicalTrials.gov, Clinical Trial Registry of India, and AYUSH Research Portal for all appropriate trials. Randomized controlled trials that examined the effect of Ashwagandha extract versus placebo on sleep in human participants 18 years old and above were considered. Two authors independently read all trials and independently extracted all relevant data. The primary outcomes were sleep quantity and sleep quality. The secondary outcomes were mental alertness on rising, anxiety level, and quality of life. RESULTS: A total of five randomized controlled trials containing 400 participants were analyzed. Ashwagandha extract exhibited a small but significant effect on overall sleep (Standardized Mean Difference -0.59; 95% Confidence Interval -0.75 to -0.42; I2 = 62%). The effects on sleep were more prominent in the subgroup of adults diagnosed with insomnia, treatment dosage ≥600 mg/day, and treatment duration ≥8 weeks. Ashwagandha extract was also found to improve mental alertness on rising and anxiety level, but no significant effect on quality of life. No serious side effects were reported. CONCLUSION: Ashwagandha extract appears to has a beneficial effect in improving sleep in adults. However, data on the serious adverse effects of Ashwagandha extract are limited, and more safety data would be needed to assess whether it would be safe for long-term use.
Full Text
Figures
Fig 1
PRISMA flow diagram for the systematic review and meta-analysis on Ashwagandha extract and sleep shows the comprehensive search across seven databases, screening results, and final inclusion of randomized controlled trials.
flowchart
Fig 2
Forest plot of the meta-analysis on Ashwagandha extract's effect on overall sleep quality scores is presented, showing pooled standardized mean differences versus placebo across included trials.
forest_plot
Fig 3
Subgroup analysis by Ashwagandha dose examines whether higher extract concentrations are associated with greater sleep quality improvements compared to lower doses.
forest_plot
Fig 4
Forest plot of Ashwagandha's effect on sleep onset latency is presented, pooling data from trials that measured the time required to fall asleep in supplemented versus placebo groups.
forest_plot
Fig 5
Subgroup analysis by participant health status compares Ashwagandha's sleep effects in individuals with insomnia versus healthy volunteers, suggesting potentially greater benefits in those with baseline sleep disturbance.
forest_plot
Fig 6
Meta-analysis of Ashwagandha's effect on total sleep time presents pooled estimates from RCTs, assessing whether the herbal extract increases nightly sleep duration compared to placebo.
forest_plot
Fig 7
Risk of bias assessment across included Ashwagandha sleep studies is presented using the Cochrane tool, evaluating randomization, blinding, outcome reporting, and other methodological quality domains.
chart
Fig 8
Funnel plot from the Ashwagandha sleep meta-analysis assesses potential publication bias by visualizing the symmetry of effect estimates relative to study precision across included trials.
chartTables
Table 1
| Author (Publish year) | Study design | Sample size (Drop-outs) | Patient’s characteristics | WS Form/ Route/ Daily dose | Control | Duration (follow up interval) | Outcomes of interest | Conclusion of effect WS on sleep | ||
|---|---|---|---|---|---|---|---|---|---|---|
| Health status | Mean age (SD) | Sleep outcomes | Other outcomes | |||||||
| Salve et al (2019) | Randomize, DB, PC | I1: 19 (1) I2: 20 (0) C:19 (1) | Stressed healthy adults (PSS ≥20) | I1: 29.65 (6.36) | I1: Root extract in capsule (KSM-66)/ Oral/ 250 mg | Placebo capsule (starch power) | 8 weeks (week 4, 8) | SQS | HAMA-A | Beneficial |
| I2: 32.70 (8.79) | ||||||||||
| C: 30.35 (6.50) | ||||||||||
| I2: Root extract in capsule (KSM-66)/ Oral/ 600 mg | ||||||||||
| Langade et al (2019) | Randomize, DB, PC | I: 39 (1) | Insomnia (DSM-IV) | I: 38.83 (5.00) | Root extract in capsule (KSM-66)/ Oral/ 600 mg | Placebo capsule (starch power) | 10 weeks (week 5, 10) | SQS, PSQI, SOL, TST, WASO, TIB, Sleep efficiency | Mental alertness scale, HAM-A | Beneficial |
| C: 19 (1) | C: 40.00 (6.21) | |||||||||
| Kelgane et al (2020) | Randomize, DB, PC | I: 19 (6) | Healthy elderly adults | I: 72.16 (4.36) | Root extract in capsule (KSM-66)/ Oral/ 600 mg | Placebo capsule (starch power) | 12 weeks (week 4, 8, 12) | SQS | Mental alertness scale, QoL | Beneficial |
| C: 20 (5) | C: 70.70 (4.47) | |||||||||
| Deshpande et al (2020) | Randomize, DB, PC | I: 71 (4) | Healthy adults | I: 36.8 (10.98) | Root and leave extract in capsule (Shoden®)/ Oral/ 120 mg | Placebo capsule (rice powder) | 6 weeks (week 6) | SOL, TST, WASO, TIB, Sleep efficiency | QoL | Beneficial |
| C: 73 (2) | C: 37.61 (10.32) | |||||||||
| Langade et al (2021) | Randomize, DB, PC | I: 18 (2) | P1: Healthy | I: 35.60 (8.74) | Root extract in capsule (KSM-66)/ Oral/ 600 mg | Placebo capsule (starch power) | 8 weeks (week 1, 4, 8) | SQS, PSQI, SOL, TST, WASO, TIB, Sleep efficiency | Mental alertness scale, HAM-A | Beneficial |
| C: 18 (2) | adults | C: 38.25 (7.83) | ||||||||
| I: 20 (0) | P2: Insomnia | I: 38.70 (7.15) | ||||||||
| C: 17 (3) | (DSM-IV) | C: 35.95 (5.49) | ||||||||
Table 2
| Outcomes | No of studi-es | Certainty assessment | No of patients | Absolute effect (95% Cl) | Consistency | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Study design | Risk of bias | Inconsis- tency | Indirect- ness | Impreci- sion | Other consider- ations | WS | Placebo | ||||
| Overall sleep | 5 | Random-ized trials | Not serious | Seriousa | Not serious | Not serious | None | 972 | 792 | SMD | ⨁⨁⨁◯ MODERATE |
| Sleep by Sleep Quality Scale | 4 | Random-ized trials | Not serious | Seriousa | Not serious | Seriousb | None | 135 | 93 | SMD | ⨁⨁◯◯ LOW |
| Sleep by sleep onset latency | 3 | Random-ized trials | Not serious | Not serious | Not serious | Seriousb | None | 152 | 129 | SMD | ⨁⨁⨁◯ MODERATE |
| Sleep by total sleep time | 3 | Random-ized trials | Not serious | Not serious | Not serious | Seriousb | None | 152 | 129 | SMD | ⨁⨁⨁◯ MODERATE |
| Sleep by wake time after sleep onset | 3 | Random-ized trials | Not serious | Not serious | Not serious | Seriousb | None | 152 | 129 | SMD | ⨁⨁⨁◯ MODERATE |
| Sleep by sleep efficiency | 3 | Random-ized trials | Not serious | Seriousa | Not serious | Seriousb | None | 152 | 129 | SMD | ⨁⨁◯◯ LOW |
| Sleep by treatment duration- ≥8 weeks | 5 | Random-ized trials | Not serious | Not serious | Not serious | Not serious | None | 972 | 792 | SMD | ⨁⨁⨁◯ MODERATE |
References
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