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Herbal Medicine for Traumatic Brain Injury: A Systematic Review and Meta-Analysis of Randomized Controlled Trials and Limitations.

ABSTRACT: Background: This systematic review aimed to evaluate the effectiveness (functional outcomes and clinical symptoms) and safety (incidence of adverse events) of herbal medicine (HM) as monotherapy or adjunctive therapy to conventional treatment (CT) for traumatic brain injury (TBI). Methods: We comprehensively searched 14 databases from their inception until July 2019. Randomized controlled trials (RCTs) using HM as monotherapy or adjunctive therapy to treat TBI patients were included. The primary outcome was functional outcomes, consciousness state, morbidity, and mortality. Meta-analysis was performed to calculate a risk ratio (RR) or mean difference (MD) with 95% confidence intervals (CIs), when appropriate data were available. Methodological quality of RCTs and the strength of evidence were also assessed. Results: Thirty-seven RCTs with 3,374 participants were included. According to meta-analysis, HM as a monotherapy (RR 1.29, 95% CI: 1.21-1.37) or an adjunctive therapy to CT (RR 1.21, 95% CI: 1.16-1.27) showed significantly better total effective rate based on clinical symptoms, compared to CT alone. Subgroup analysis showed that HM had significantly improved post-concussion syndrome, dizziness, headache, epilepsy, and mild TBI, but not traumatic brain edema, compared to CT. Moreover, HM combined with CT had significantly improved post-concussion syndrome, mental disorder, headache, epilepsy, and mild TBI-like symptoms, but not cognitive dysfunction and posttraumatic hydrocephalus, compared to CT alone. When HM was combined with CT, functional outcomes such as activities of daily living and neurological function were significantly better than in patients treated using CT alone. In terms of the incidence of adverse events, HM did not differ from either CT (RR 0.88, 95% CI: 0.33-2.30) or placebo (RR 2.29, 95% CI: 0.83-6.32). However, HM combined with CT showed better safety profile than CT alone (RR 0.64, 95% CI: 0.44-0.93). Most studies had a high risk of performance bias, and the quality of evidence was mostly rated "very low" to "moderate," mostly because the included studies had a high risk of bias and imprecise quantitative synthesis results. Conclusion: The current evidence suggests that there is insufficient evidence for recommending HM for TBI in clinical practice. Therefore, further larger, high-quality, rigorous RCTs should be conducted.

SUBMITTER: Lee B

PROVIDER: S-EPMC7530840 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Herbal Medicine for Traumatic Brain Injury: A Systematic Review and Meta-Analysis of Randomized Controlled Trials and Limitations.

Lee Boram B Leem Jungtae J Kim Hyunho H Jo Hee-Geun HG Kwon Chan-Young CY

Frontiers in neurology 20200918

<b>Background:</b> This systematic review aimed to evaluate the effectiveness (functional outcomes and clinical symptoms) and safety (incidence of adverse events) of herbal medicine (HM) as monotherapy or adjunctive therapy to conventional treatment (CT) for traumatic brain injury (TBI). <b>Methods:</b> We comprehensively searched 14 databases from their inception until July 2019. Randomized controlled trials (RCTs) using HM as monotherapy or adjunctive therapy to treat TBI patients were include ...[more]

PMID: 33071922

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Project description:Background Chinese herbal medicines reportedly increase efficacy and minimize toxicity of chemotherapy; however, little attention has been paid to how poor study quality can bias outcomes. Methods We systematically searched MEDLINE, TCMLARS, EMBASE, and Cochrane Library for randomized controlled trials of Chinese herbal medicines combined with fluorouracil-based chemotherapy compared with the same chemotherapy alone. We screened for eligibility, extracted data, and pooled data with random-effects meta-analysis. Outcome measures were survival, toxicity, tumor response, performance status, quality of life, and Cochrane Risk of Bias (ROB) criteria to critically evaluate the quality of reporting in the randomized trials included in the meta-analysis. Results We found 36 potentially eligible studies, with only 3 (those with low ROB) qualifying for meta-analysis. Two reported chemotherapy-related diarrhea reduced by 57% (relative risk [RR] = 0.43; 95% CI = 0.19-1.01; I(2) test for variation in RR due to heterogeneity = 0.0%), with nonsignificant results. Two reported white blood cell toxicity reduced by 66% (RR = 0.34; 95% CI = 0.16-0.72; I(2) test for variation in RR due to heterogeneity = 0.0%), with statistically significant results. Stratifying analysis by studies with high versus low ROB, we found substantial overestimation of benefit: Studies with high ROB overestimated by nearly 2-fold reduction of platelet toxicity by Chinese herbal medicines (RR = 0.35, 95% CI = 0.15-0.84 vs RR = 0.65, 95% CI = 0.11-3.92). Studies with high ROB overestimated by nearly 2-fold reduction of vomiting toxicity (RR = 0.45, 95% CI = 0.33-0.61 vs RR = 0.87, 95% CI = 0.48-1.58). And, studies with high ROB overestimated by 21% the reduction in diarrhea toxicity (RR = 0.34, 95% CI = 0.20-0.58 vs RR = 0.43, 95% CI = 0.19-1.01). Studies with high ROB also overestimated by 16% improvement in tumor response (RR = 1.39, 95% CI = 1.18-1.63 vs RR = 1.20; 95% CI = 0.81-1.79). Not accounting for ROB would have exaggerated evidence of benefit and failed to detect nonsignificance of results. Conclusions In the present analysis, involving 36 studies, 2593 patients, 20 outcomes, 36 medical institutions, and 271 named research authors, 92% of the data points were from studies at high ROB. Given the poor quality of the data in studies identified, it cannot be concluded whether combining Chinese herbs with chemotherapy reduces toxicity of chemotherapy.

Project description:Background: Parkinson's disease (PD) is a debitlitating, chronic, progressive neurodegenerative disorder without modifying therapy. Here, we aimed to evaluate the available evidence of herbal medicine (HM) formulas for patients with PD according to randomized double-blind placebo-controlled clinical trials. Methods: HM formulas for PD were searched in eight main databases from their inception to February 2018. The methodological quality was assessed using Cochrane Collaboration risk of bias tool. Meta-analysis was performed using RevMan 5.3 software. Results: Fourteen trials with Seventeen comparisons comprising 1,311 patients were identified. Compared with placebo groups, HM paratherapy (n = 16 comparisons) showed significant better effects in the assessments of total Unified Parkinson's Disease Rating Scale (UPDRS) (WMD: -5.43, 95% CI:-8.01 to -2.86; P < 0.0001), UPDRS I (WMD: -0.30, 95% CI: -0.54 to -0.06; P = 0.02), UPDRS II (WMD: -2.21, 95% CI: -3.19 to -1.22; P < 0.0001), UPDRS III (WMD: -3.26, 95% CI:-4.36 to -2.16; P < 0.00001), Parkinson's Disease Quality of Life Questionnaire (p < 0.01) and Parkinson's Disease Questionnaire-39 (WMD: -7.65, 95% CI: -11.46 to -3.83; p < 0.0001), Non-motor Symptoms Questionnaire (p < 0.01) and Non-Motor Symptoms Scale (WMD: -9.19, 95% CI: -13.11 to -5.28; P < 0.00001), Parkinson's Disease Sleep Scale (WMD: 10.69, 95% CI: 8.86 to 12.53; P < 0.00001), and Hamilton depression rating scale (WMD: -5.87, 95% CI: -7.06 to -4.68; P < 0.00001). The efficiency of HM monotherapy (n = 1 comparison) was not superior to the placebo according to UPDRS II, UPDRS III and total UPDRS score in PD patients who never received levodopa treatment, all P > 0.05. HM formulas paratherapy were generally safe and well tolerated for PD patients (RR: 0.41, 95% CI: 0.21 to 0.80; P = 0.009). Conclusion: The findings of present study supported the complementary use of HM paratherapy for PD patients, whereas the question on the efficacy of HM monotherapy in alleviating PD symptoms is still open.

Project description:This review aimed to investigate the efficacy of integrative medicine (herbal medicine combined with drug therapy) in the treatment of Behcet's disease (BD). Eleven databases were searched from their inception to 7 December 2020, for randomized control trials (RCTs) that reported the effects of integrative medicine in treating BD. The risk of bias was assessed using seven domain criteria from the Cochrane Collaboration tool. Grading of Recommendations Assessment, Development, and Evaluation (GRADE) was used to assess the quality of evidence. The direction of the effect is also shown in the form of an albatross plot. Sixteen trials met the inclusion criteria and were analyzed. The overall risk of bias was determined to be uncertain. The meta-analysis showed a superior response rate with herbal medicine plus drug therapy (relative risk (RR) 1.19, 95% confidence interval (CI) 1.13 to 1.25, n = 1034, p < 0.00001, I2 = 0%, low certainty of evidence (CoE)) compared to drug therapy. Integrative medicine also lowered the recurrence rate after 2 months of follow-up (RR 0.27, 95% CI 0.09 to 0.76, n = 120, p = 0.01, I2 = 0%, low CoE). The erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) level, and skin lesions were also significantly improved using integrative medicine, but equivalent effects were seen for oral ulcers, genital ulcers, and eye inflammation. Minor adverse events were reported in both groups. Our findings suggest that herbal medicine combined with drug therapy is more effective for the treatment of BD than drug therapy alone. Although the type of drug therapy used varied across the studies, integrative medicine was shown to improve the total response rate, skin lesions, the ESR, and the CRP level. However, the overall risk of bias of the studies was concerning, and the CoE was low. Information on adverse events (AEs) was also insufficient. In addition, the number of studies included for data synthesis for most outcomes was small. Future studies with rigorous RCTs may help establish the efficacy of integrative medicine in the treatment of BD.

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Dataset Information

Herbal Medicine for Traumatic Brain Injury: A Systematic Review and Meta-Analysis of Randomized Controlled Trials and Limitations.

Publications

Herbal Medicine for Traumatic Brain Injury: A Systematic Review and Meta-Analysis of Randomized Controlled Trials and Limitations.

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