Self-Designed Ningxin Anshen Formula for Treatment of Post-ischemic Stroke Insomnia: A Randomized Controlled Trial

Dai, Ning; Li, Yuanyuan; Sun, Jing; Li, Feng; Xiong, Hang

doi:10.3389/fneur.2020.537402

Cited by 6 publications

(28 citation statements)

References 51 publications

(58 reference statements)

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“…However, the clinical e cacy of Zhenjingdingzhi decoction was assessed by effective rate, which is a composite outcome indicator and could not re ect the true effect of TCM intervention [40]. Additionally, in the Self-Designed Ningxin Anshen Formula for Treatment of Post-ischemic Stroke Insomnia study, patients with blood-de cient and liver-heat syndrome were recruited and the scores of TCM Syndromes were included in the secondary outcomes though it was not validated [41]. Appropriate outcome measures are important for clinical trial design.…”

Section: Discussionmentioning

confidence: 99%

“…According to the theory of TCM, the liver is responsible for blood storage and catharsis. If the storage function is damaged, the catharsis would become dysfunctional, resulting in stagnation of liver-Qi and the subsequent liver-heat syndrome [28]. In the present study, we assessed the e cacy and safety of QGJY Herbal Formula Granule for patients with liver depression of heat syndrome.…”

Section: Introductionmentioning

confidence: 99%

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Efficacy and Safety of Qinggan Jieyu Herbal Formula Granule on Insomnia: A Prospective Randomized Controlled Trial

Han¹,

Feng²,

Cao³

et al. 2021

Preprint

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Background:Traditional Chinese Medicine (TCM) is widely used in China for insomnia treatment. The objective of this study was to evaluate the efficacy and safety of QingganJieyu (QGJY)Herbal Formula Granule for insomnia patients with liver depression of heat syndrome.Methods: In this randomized controlled clinical trial, 60patients were randomly assigned into the treatment group and the control group in a 1:1 ratio. Participants received QGJYHerbal Formula GranuleandWuling capsulerespectively for 4 weeksand were followed for another 4 weeks. The primary outcomes weresyndrome integral changes according to theliver depression of heat syndrome evaluation scaleand global and subscale score changes according to the Pittsburgh Sleep Quality Index (PSQI). The secondary outcome wasquality of life assessed by the Short-form 36 Questionnaire (SF-36). A correlation analysis was also done between syndrome integral and PSQI global score and subscale score. Results: Compared with pretreatment baseline, patients in both groups showed a decreasedtrend in TCM syndrome integral scores, especially for the main syndrome.There were significant differences in the total score of syndrome integral between the two groups at 2, 3, 4 weeks, and follow-up period (all Ps<0.05)).During the treatment period, patients in both groups experienced a lower trend and the differences in PSQI global score, sleep disturbance, sleep duration, and use of sleep medication between the two groups were statistically significant (all Ps<0.05).Concerning secondary outcome measure, quality of life was improved for patients in both groups and mental health on the SF-36 questionnaire improvement was significantly better for the treatment group (P<0.05). Additionally, a significant, positive correlation was found between sleep disorders and TCM syndrome integral change (Pearson r = 0.340, P < 0.001).Conclusions:Results of our study suggested that QGJY Herbal Formula Granule not only improved the liver depression of heat syndrome(syndrome) but also sleep disturbance, sleep duration, and use of sleep medication(disease). Additionally, QGJY Herbal Formula Granule promotes psychological health better. Considering therelationship between insomnia and adverse mental health, our findings may have important implications for the management of insomnia in the long run.Trial registration:ChiCTR, ChiCTR-TRC-14004469, Registered 24 January 2014- Retrospectively registered, http://www.chictr.org.cn/showproj.aspx?proj=5101.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Efficacy and Safety of Qinggan Jieyu Herbal Formula Granule on Insomnia: A Prospective Randomized Controlled Trial

Han¹,

Feng²,

Cao³

et al. 2021

Preprint

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“…All of the included studies were conducted in China and compared HM with psychotropic drugs. Of these, one was a placebo-controlled 3-arm trial comparing HM, placebo, and the zopiclone group [41]. Three studies [41,43,57] reported that they obtained approval of the institutional review board, and 13 [40][41][42][43][44]47,50,52,53,57,[59][60][61] reported that they had obtained consent of the participants.…”

Section: Study Characteristicsmentioning

confidence: 99%

“…Sample sizes ranged from 60 to 142, with a median of 81. Thirteen studies [40][41][42]44,47,50,52,53,[55][56][57]60,61] recruited participants through pattern identification; the most common pattern identification was blood stasis due to Qi or Yin deficiency or liver stagnation in five studies [40,47,[55][56][57]; followed by phlegm-heat in four studies [42,44,50,53]; liver stagnation in three studies [44,55,61]; blood deficiency and liver-heat syndrome in one study [41], and heart-kidney non-interaction, in one study [53]. Pattern identification categorizes the symptoms and signs of patients into a chain of syndrome concepts enabling individual treatment [63].…”

Section: Study Characteristicsmentioning

confidence: 99%

“…In most cases, RCS used pharmaceutical anti-coagulation, anti-platelet, vasodilators, and neurotrophic agents. As control interventions, three types of benzodiazepines (estazolam, alprazolam, diazepam) and one type of selective gamma-aminobutyric acid receptor (GABA)-A agonist (zopiclone) were used as follows: estazolam in ten studies [39,[42][43][44][45][47][48][49]56,61], alprazolam in nine studies [40,46,50,51,54,55,57,58,60], diazepam in two studies [59,62], and zopiclone in three studies [41,52,53]. TER was the most frequently used outcome in 20 studies [39,40,[42][43][44][45][46][47][48][49]51,[53][54][55][56][57][58][59][60][61], followed by PSQI in 19 studies [39][40][41]<...>…”

Section: Study Characteristicsmentioning

confidence: 99%

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Traditional East Asian Herbal Medicine for Post-Stroke Insomnia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Kim

Lim

2022

IJERPH

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Post-stroke insomnia (PSI) is a highly prevalent complication after stroke. Current evidence of psychotropic drug use for PSI management is scarce and indicates harmful adverse events (AEs). Traditional East Asian herbal medicine is a widely used traditional remedy for insomnia. However, so far, no study has systematically reviewed the efficacy and safety of traditional east asian herbal medicine (HM) for PSI. Therefore, we perform meta-analysis to evaluate the effectiveness and safety of HM for PSI. After a comprehensive electronic search of 15 databases, we review the randomized controlled trials (RCTs) of HM use as monotherapy for PSI. Our outcomes were the Pittsburgh sleep quality index and total effective rate. In total, 24 RCTs were conducted with 1942 participants. HM showed statistically significant benefits in sleep quality. It also appeared to be safer than psychotropic drugs in terms of AEs, except when the treatment period was two weeks. The methods used for RCTs were poor, and the quality of evidence assessed was graded “low” or “moderate.” The findings of this review indicate that the use of HM as a monotherapy may have potential benefits in PSI treatment when administered as an alternative to conventional medications. However, considering the methodological quality of the included RCTs, we were uncertain of the clinical evidence. Further, well-designed RCTs are required to confirm these findings.

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Comparative effectiveness of different treatments for post-stroke insomnia: A network meta-analysis

Song,

Ying chen,

et al. 2023

Heliyon

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Self-Designed Ningxin Anshen Formula for Treatment of Post-ischemic Stroke Insomnia: A Randomized Controlled Trial

Cited by 6 publications

References 51 publications

Efficacy and Safety of Qinggan Jieyu Herbal Formula Granule on Insomnia: A Prospective Randomized Controlled Trial

Efficacy and Safety of Qinggan Jieyu Herbal Formula Granule on Insomnia: A Prospective Randomized Controlled Trial

Traditional East Asian Herbal Medicine for Post-Stroke Insomnia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Comparative effectiveness of different treatments for post-stroke insomnia: A network meta-analysis

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