Efficacy and Safety of Jiawei Suanzaoren Decoction Combined with Lorazepam for Chronic Insomnia: A Parallel‐Group Randomized Controlled Trial

Song, Meijuan; Chen, Liqiong; Shao, Qiong-Yan; Hu, Linlin; Liu, Wenjuan; Zhang, Yonghua

doi:10.1155/2020/3450989

Cited by 8 publications

(10 citation statements)

References 31 publications

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“…We included 9 completed and 6 ongoing trials ( Table S2 , Supplemental Material ) in this review. 25 , 34 - 37 , 42 - 45 …”

Section: Resultsmentioning

confidence: 99%

“…Participant populations varied in age and were predominantly female. Patients from 5 studies had a clinical diagnosis of primary insomnia disorder with moderate to severe intensity 25 , 36 , 43 - 45 ; in 2 studies, patients had chronic insomnia during cancer treatment, 42 or post-ischemic stroke. 35 The remaining 2 studies included patients who scored more than 5 on the PSQI and experienced general sleep disturbance due to methadone maintenance 34 or cancer.…”

Section: Resultsmentioning

confidence: 99%

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The Herbal Medicine Suanzaoren (Ziziphi Spinosae Semen) for Sleep Quality Improvements: A Systematic Review and Meta-analysis

et al. 2023

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Background: Sleep disturbances are common and bothersome among cancer and noncancer populations. Suanzaoren ( Ziziphi Spinosae Semen) is commonly used to improve sleep, yet its efficacy and safety are unclear. Methods: We systematically searched PubMed, Cochrane Library, and EMBASE from inception through October 5, 2021, to identify randomized trials of Suanzaoren. We included randomized trials comparing Suanzaoren to placebo, medications, cognitive behavioral therapy (CBT), or usual care for improving sleep outcomes in cancer and noncancer patients with insomnia or sleep disturbance. We performed a risk of bias analysis following Cochrane guidelines. Depending on heterogeneity, we pooled studies with similar comparators using fixed- and random-effects models. Results: We included participants with insomnia disorder (N = 785) or sleep disturbance (N = 120) from 9 trials. Compared with placebo, Suanzaoren led to significant subjective sleep quality improvements in participants with insomnia and patients with sleep disturbance combined (standard mean difference −0.58, 95% CI −1.04, −0.11; P < .01); Compared with benzodiazepines or CBT, Suanzaoren was associated with a significant decrease in insomnia severity (mean difference −2.68 points, 95% CI −5.50, −0.22; P = .03) at 4 weeks in the general population and cancer patients. The long-term effects of Suanzaoren were mixed among trials. Suanzaoren did not increase the incidence of major adverse events. The placebo-controlled studies had a low risk of bias. Conclusion: Suanzaoren is associated with short-term patient-reported sleep quality improvements among individuals with insomnia or sleep disturbance. Due to the small sample size and variable study quality, the clinical benefits and harms of Suanzaoren, particularly in the long term, should be further assessed in a sufficiently powered randomized trial. Registration: PROSPERO CRD42021281943

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“…We included 9 completed and 6 ongoing trials ( Table S2 , Supplemental Material ) in this review. 25 , 34 - 37 , 42 - 45 …”

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

The Herbal Medicine Suanzaoren (Ziziphi Spinosae Semen) for Sleep Quality Improvements: A Systematic Review and Meta-analysis

et al. 2023

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“…Regarding the CHM formulae, both post-stroke insomnia and primary insomnia favored the Suanzaoren decoction. Although the Suanzaoren decoction has been assessed in many preclinical and clinical studies for primary insomnia ( 58 – 60 ), a large-scale RCT with a rigorous design is required to evaluate its efficacy in post-stroke insomnia.…”

Section: Discussionmentioning

confidence: 99%

Traditional Chinese Medicine for Post-stroke Sleep Disorders: The Evidence Mapping of Clinical Studies

Zou²,

Gai³

et al. 2022

Front. Psychiatry

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Background and PurposeRecently, there are a number of clinical studies on traditional Chinese medicine (TCM) for post-stroke sleep disorders (PSSDs). This study aimed to map the current clinical studies and identify gaps to inform future study agendas.MethodsPubMed, Embase, Cochrane Library, and Chinese databases, including SinoMed, CNKI, and Wanfang, were searched for clinical studies on PSSDs treated with TCM from their inception to September 2021. Evidence sources, number of studies, types of PSSDs, intervention categories, effectiveness, and quality assessment were graphically displayed.ResultsThe evidence map involved 810 clinical studies, of which the earliest report was dated back to 1993, and an advanced growth of the whole evidence was observed in 2012. Randomized controlled trials (RCTs) were the most common type of study design (78.15%), and post-stroke insomnia was the most common type of sleep disorders (65.80%). The benefits of Chinese herbal medicine (CHM) and acupuncture therapies for post-stroke insomnia have been widely reported in RCTs (81.60% and 75.38%, respectively). However, the benefits of CHM interventions were assessed using a global approach rather than being based on a specific formula, and the highest level of evidence supporting the effectiveness of acupuncture therapies was of low methodological quality. In addition, evidence from primary studies was insufficient in the areas of TCM for post-stroke sleep-related breathing disorders (SBDs) and Chinese mind-body exercises for post-stroke insomnia.ConclusionsPSSDs treated with TCM have been widely assessed in clinical studies. For better evidence translation, clinical trials on specific CHM interventions and high-quality systematic reviews on acupuncture for post-stroke insomnia should be conducted. For a better solution to clinical questions, TCM on SBDs after stroke and the benefits of Chinese mind-body exercises for post-stroke insomnia should be explored in future clinical studies.

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“…In collaboration with the MSK Pharmacy department, IMS established an herbal formulary and dispensary to offer patients quality-controlled traditional Chinese medicine (TCM) herbal formulas with evidence of empirical use, safety, and preliminary efficacy for mood [ 16 ], insomnia [ 17 ], and gastrointestinal issues such as constipation or diarrhea [ 18 , 19 ], which are frequently encountered in oncology settings. This herbal formulary was prepared after careful discussions among experienced integrative medicine physicians on common, challenging symptoms encountered in our practice, where conventional medications do not meet the needs of some patients.…”

Section: Methodsmentioning

confidence: 99%

Integrating herbal medicine into oncology care delivery: development, implementation, and evaluation of a novel program

Hou

Chimonas

Gubili

et al. 2023

Support Care Cancer

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Objective To evaluate the feasibility of a novel program facilitating patient-provider communication about appropriate use of herbal medicine at a large academic cancer center and its impact on patient wellbeing. Methods In the Herbal Oncology Program (HOP), integrative medicine providers counseled patients about unmet symptom needs and prescribed traditional Chinese medicine (TCM) herbs when indicated, taking into consideration the clinical context, patient preference, and research evidence. To evaluate the feasibility and outcomes, we performed a retrospective analysis using medical record data (symptoms and other concerns that motivated patients to seek herbal products, types and numbers of dispensed TCM herbs, and demographic characteristics). We also conducted a survey to assess patient experience and satisfaction. Results All 851 participants were outpatients, with 712 (84%) in active treatment. HOP dispensed 1266 herbal prescriptions for a range of symptoms, most commonly GI symptoms (467, 37%); pain (353, 28%); and treatment-related fatigue, sleep, and mood disorders (346, 27%). Of 269 patients invited to the survey, 107 (40%) completed it. A majority of respondents 70.9% (73/103) were satisfied with the effectiveness of dispensed herbs in relieving their symptoms, and few 6.7% (7/104) had experienced mild adverse events that resolved after discontinuing herbal use. Conclusions The study’s findings support the feasibility of integrating herbal medicine into an academic oncology setting. Patient satisfaction with HOP was high, with limited adverse events. The patterns of herbal prescriptions in HOP suggest future areas for clinical research to strengthen the evidence base around safe and effective use.

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Efficacy and Safety of Jiawei Suanzaoren Decoction Combined with Lorazepam for Chronic Insomnia: A Parallel‐Group Randomized Controlled Trial

Cited by 8 publications

References 31 publications

The Herbal Medicine Suanzaoren (Ziziphi Spinosae Semen) for Sleep Quality Improvements: A Systematic Review and Meta-analysis

The Herbal Medicine Suanzaoren (Ziziphi Spinosae Semen) for Sleep Quality Improvements: A Systematic Review and Meta-analysis

Traditional Chinese Medicine for Post-stroke Sleep Disorders: The Evidence Mapping of Clinical Studies

Integrating herbal medicine into oncology care delivery: development, implementation, and evaluation of a novel program

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