scholarly journals Clinical Efficacy and Safety of Human Mesenchymal Stem Cell Therapy for Degenerative Disc Disease: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

2021 ◽  
Vol 2021 ◽  
pp. 1-9
Author(s):  
Baocheng Xie ◽  
Shichun Chen ◽  
Yongxiang Xu ◽  
Weichao Han ◽  
Runkai Hu ◽  
...  
Keyword(s):  
Stem Cell ◽  
Back Pain ◽  
Clinical Efficacy ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Low Back ◽  
Efficacy And Safety ◽  
Disc Disease ◽  
Randomized Controlled ◽  
Vas Scores

Degenerative disc disease (DDD) can cause severe low back pain, which will have a serious negative impact on the ability to perform daily tasks or activities. For the past few years, mesenchymal stem cell (MSC) transplantation has emerged as a promising strategy for the treatment of DDD. However, the clinical efficacy of MSC in the treatment of DDD still lacks clinical evidence and is controversial. We conducted a meta-analysis with randomized controlled trials (RCTs) to evaluate the clinical efficacy and safety of MSC transplantation in patients with DDD. We searched major databases using terms from the database’s inception through March 2021. The Cochrane bias risk assessment tool was used to assess quality. The analysis showed that MSC therapy could decrease visual analog scale (VAS) scores ( SMD = − 0.50 , 95 % CI = − 0.68 ~ − 0.33 , P < 0.00001 ) and Oswestry Disability Index (ODI) scores ( SMD = − 0.27 , 95 % CI = − 0.44 ~ − 0.09 , P = 0.003 ). The outcomes with subgroup analysis showed that MSC therapy could decrease VAS scores in 3 months ( P = 0.001 ), 6 months ( P = 0.01 ), 12 months ( P = 0.02 ), and ≥24 months ( P = 0.002 ) and ODI scores in ≥24 months ( P = 0.006 ). Pooled analysis showed that MSC therapy has a higher ratio of patients at most thresholds but particularly at the MIC (minimally important change) ( P = 0.0002 ) and CSC (clinically significant change) ( P = 0.0002 ) in VAS and MIC ( P = 0.0005 ) and CSC ( P = 0.001 ) pain responders in ODI. Adverse events (AE) of treatment-emergent adverse events (TEAE), back pain, arthralgia, and muscle spasms were not statistically significant between the two groups. However, our further statistical analysis showed that MSC therapy may induce AE of TEAE related to study treatment ( OR = 3.05 , 95 % CI = 1.11 ~ 8.40 , P = 0.03 ). In conclusion, this study pooled the main outcomes and showed that MSC therapy could significantly decrease VAS and ODI scores in patients with DDD. Distinctly, the findings of this meta-analysis suggest a novel therapeutic strategy for patients with chronic low back pain (LBP) and lumbar dysfunction by DDD.

scholarly journals The Beneficial Effects of Traditional Chinese Exercises for Adults with Low Back Pain: A Meta-Analysis of Randomized Controlled Trials

Medicina ◽  
2019 ◽  
Vol 55 (5) ◽  
pp. 118 ◽  
Author(s):  
Yanjie Zhang ◽  
Paul D. Loprinzi ◽  
Lin Yang ◽  
Jing Liu ◽  
Shijie Liu ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Randomized Controlled Trials ◽  
Pain Intensity ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Low Back ◽  
Beneficial Effects ◽  
Randomized Controlled ◽  
Vas Scores

Objective: The aim of this meta-analytic review was to quantitatively examine the effects of traditional Chinese exercises (TCE) on pain intensity and back disability in individuals with low back pain (LBP). Methods: Potential articles were retrieved using seven electronic databases (Medline, Embase, Cinahl, Web of Science, Cochrane library, China National Knowledge Infrastructure, and Wanfang). The searched period was from inception to 1 March 2019. Randomized controlled trials (RCTs) assessing the effect of TCE on pain intensity and back disability in LBP patients were included. Pooled effect sizes were calculated using the random-effects models and 95% confidence interval (95% CI). Results: Data from eleven RCTs (886 individuals with LBP) meeting the inclusion criteria were extracted for meta-analysis. Compared with the control intervention, TCE induced significant improvements in the visual analogue scale (VAS) (Hedge’s g = −0.64, 95% CI −0.90 to −0.37, p < 0.001), Roland–Morris Disability Questionnaire (RMDQ) (Hedge’s g = −0.41, 95% CI −0.79 to −0.03, p = 0.03), Oswestry Disability Index (ODI) (Hedge’s g = −0.96, 95% CI −1.42 to −0.50, p < 0.001), and cognitive function (Hedge’s g = −0.62, 95% CI −0.85 to −0.39, p < 0.001). In a meta-regression analysis, age (β = 0.01, p = 0.02) and total exercise time (β = −0.0002, p = 0.01) were associated with changes in the VAS scores, respectively. Moderator analyses demonstrated that Tai Chi practice (Hedge’s g = −0.87, 95% CI −1.38 to −0.36, p < 0.001) and Qigong (Hedge’s g = −0.54, 95% CI −0.86 to −0.23, p < 0.001) reduced VAS scores. Interventions with a frequency of 1–2 times/week (Hedge’s g = −0.53, 95% CI −0.98 to −0.07, p = 0.02) and 3–4 times/week (Hedge’s g = −0.78, 95% CI −1.15 to −0.42, p < 0.001) were associated with reduced VAS scores, but this significant reduction on this outcome was not observed in the weekly training frequency of ≥5 times (Hedge’s g = −0.54, 95% CI −1.16 to 0.08, p = 0.09). Conclusions: TCE may have beneficial effects for reducing pain intensity for individuals with LBP, regardless of their pain status.

scholarly journals Comparison of Clinical Efficacy and Safety between Indacaterol and Tiotropium in COPD: Meta-Analysis of Randomized Controlled Trials

PLoS ONE ◽  
2015 ◽  
Vol 10 (3) ◽  
pp. e0119948 ◽  
Author(s):  
Jung Soo Kim ◽  
Jinkyeong Park ◽  
Seong Yong Lim ◽  
Yeon-Mok Oh ◽  
Kwang Ha Yoo ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Clinical Efficacy ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomized Controlled

scholarly journals Treatment of Degenerated Intervertebral Discs Using a Viable Disc Tissue Allograft for Chronic Discogenic Low Back Pain: A Randomized Controlled Trial Comparing Single-site Outcomes With Aggregate and Longer-Term Follow-Up Data

2021 ◽  
Author(s):  
Timothy Davis ◽  
Afrida Sara ◽  
Terry Nguyen ◽  
John Kenneth Burkus
Keyword(s):  
Randomized Controlled Trial ◽  
Back Pain ◽  
Controlled Trial ◽  
Single Site ◽  
Low Back ◽  
Disc Disease ◽  
Randomized Controlled ◽  
Disc Tissue ◽  
Tissue Allograft ◽  
Vas Scores

Abstract Background: Disruption of the internal structure of the nucleus pulposus commonly occurs with the development of painful degenerative lumbar disc disease. Supplementing disc tissue through autologous or allogeneic human cellular and tissue therapies has been tested in small sample clinical trials. A few investigators have reported substantial improvements in pain and function. A viable disc tissue allograft was developed to supplement tissue loss associated with intervertebral disc degeneration. Methods: We assessed results in a subgroup of patients from a large trial comparing this allograft with other treatments. A multicenter randomized controlled trial of 218 subjects with chronic low back pain secondary to degenerative disc disease was conducted. Patients were treated with the allograft, saline, or nonsurgical management and studied for 12 months. We assessed longer-term results in a single-site subgroup from this prospective trial.Results: At 12 months, subjects from the single-site subgroup who had been randomly assigned to the active allograft group (n=17) showed improvements in both mean Oswestry Disability Index (ODI) and Visual Analog Scale (VAS) scores. There was an overall reduction of 28.69 points in the ODI and 33.06 points in the VAS. This was similar to the aggregate ODI and VAS scores of the active allograft group. At 24 months postprocedure, 9 of the 10 patients remaining in the active allograft group at the single study site had mean ODI and VAS score improvements of 28.23 and 36.13, respectively. A similar improvement in pain scores occurred in the 4 patients at 36 months with mean ODI and VAS score improvements from preoperative scores of 25.21 and 51.35, respectively.Conclusions: Clinically meaningful improvements demonstrated in this single-site analysis were comparable to the aggregate study population at 12 months. Longer-term results from this single site at 24 and 36 months suggested durability of viable disc tissue allograft supplementation for patients with discogenic back pain.Trial registration: The trial was retrospectively registered 17 October 2018 on www.clinicaltrials.gov (NCT03709901) and was approved by the Sterling Institutional Review Board, Atlanta, Georgia (IRB no. 5792).

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