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Effect of Ashwagandha (Withania somnifera) extract on sleep: A systematic review and meta-analysis.

Kae Ling Cheah, Mohd Noor Norhayati, Lili Husniati Yaacob, Razlina Abdul Rahman
Meta-Analysis PloS one 2021 64 citas
PubMed DOI PDF
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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.

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Figures

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.

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
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.

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
Subgroup analysis by Ashwagandha dose examines whether higher extract concentrations are associated with greater sleep quality improvements compared to lower doses.

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
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.

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
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.

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
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.

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
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.

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
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.

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.

chart

Tables

Table 1

Author (Publish year)Study designSample size (Drop-outs)Patient’s characteristicsWS Form/ Route/ Daily doseControlDuration (follow up interval)Outcomes of interestConclusion of effect WS on sleep
Health statusMean age (SD)Sleep outcomesOther outcomes
Salve et al (2019)Randomize, DB, PCI1: 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 mgPlacebo capsule (starch power)8 weeks (week 4, 8)SQSHAMA-ABeneficial
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, PCI: 39 (1)Insomnia (DSM-IV)I: 38.83 (5.00)Root extract in capsule (KSM-66)/ Oral/ 600 mgPlacebo capsule (starch power)10 weeks (week 5, 10)SQS, PSQI, SOL, TST, WASO, TIB, Sleep efficiencyMental alertness scale, HAM-ABeneficial
C: 19 (1)C: 40.00 (6.21)
Kelgane et al (2020)Randomize, DB, PCI: 19 (6)Healthy elderly adultsI: 72.16 (4.36)Root extract in capsule (KSM-66)/ Oral/ 600 mgPlacebo capsule (starch power)12 weeks (week 4, 8, 12)SQSMental alertness scale, QoLBeneficial
C: 20 (5)C: 70.70 (4.47)
Deshpande et al (2020)Randomize, DB, PCI: 71 (4)Healthy adultsI: 36.8 (10.98)Root and leave extract in capsule (Shoden®)/ Oral/ 120 mgPlacebo capsule (rice powder)6 weeks (week 6)SOL, TST, WASO, TIB, Sleep efficiencyQoLBeneficial
C: 73 (2)C: 37.61 (10.32)
Langade et al (2021)Randomize, DB, PCI: 18 (2)P1: HealthyI: 35.60 (8.74)Root extract in capsule (KSM-66)/ Oral/ 600 mgPlacebo capsule (starch power)8 weeks (week 1, 4, 8)SQS, PSQI, SOL, TST, WASO, TIB, Sleep efficiencyMental alertness scale, HAM-ABeneficial
C: 18 (2)adultsC: 38.25 (7.83)
I: 20 (0)P2: InsomniaI: 38.70 (7.15)
C: 17 (3)(DSM-IV)C: 35.95 (5.49)

Table 2

OutcomesNo of studi-esCertainty assessmentNo of patientsAbsolute effect (95% Cl)Consistency
Study designRisk of biasInconsis- tencyIndirect- nessImpreci- sionOther consider- ationsWSPlacebo
Overall sleep5Random-ized trialsNot seriousSeriousaNot seriousNot seriousNone972792SMD 0.59 lower (0.75 lower to 0.42 lower)⨁⨁⨁◯ MODERATE
Sleep by Sleep Quality Scale4Random-ized trialsNot seriousSeriousaNot seriousSeriousbNone13593SMD 1.16 lower (1.65 lower to 0.66 lower)⨁⨁◯◯ LOW
Sleep by sleep onset latency3Random-ized trialsNot seriousNot seriousNot seriousSeriousbNone152129SMD 0.53 lower (0.77 lower to 0.29 lower)⨁⨁⨁◯ MODERATE
Sleep by total sleep time3Random-ized trialsNot seriousNot seriousNot seriousSeriousbNone152129SMD 0.45 lower (0.69 lower to 0.21 lower)⨁⨁⨁◯ MODERATE
Sleep by wake time after sleep onset3Random-ized trialsNot seriousNot seriousNot seriousSeriousbNone152129SMD 0.39 lower (0.62 lower to 0.15 lower)⨁⨁⨁◯ MODERATE
Sleep by sleep efficiency3Random-ized trialsNot seriousSeriousaNot seriousSeriousbNone152129SMD 0.68 lower (1.07 lower to 0.29 lower)⨁⨁◯◯ LOW
Sleep by treatment duration- ≥8 weeks5Random-ized trialsNot seriousNot seriousNot seriousNot seriousNone972792SMD 0.37 lower (0.46 lower to 0.27 lower)⨁⨁⨁◯ MODERATE

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