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INTRODUCTION: Nonspecific chronic low back pain (NCLBP) became a public health and economic problem. Acupoint injection was used widely for patients with NCLBP. However, there were inconsistent results on the efficacy for these people. Therefore, this review was performed to systematically assess the efficacy and safety of acupoint injection. MATERIALS AND METHODS: The literature sources were collected via EMBASE, Medline, CENTRAL, CINAHL, CNKI, VIP, Wanfang, and Sino-Med Database from their inception to October 13, 2019. Endnote X7, widely used document management software, was used to manage and screen the literature sources. Each record was screened according to the predetermined inclusion criteria by two review authors independently. Quality assessment tool, "Risk of table," was used to assess the quality of the included studies according to the recommendation of the Cochrane Handbook for Systematic Reviews of Interventions. Data extraction was performed by one reviewer and verified by another reviewer. Any disagreement was addressed via consulting with a third reviewer in the abovementioned processes. All procedures were performed according to the Cochrane Handbook for Systematic Reviews of Interventions. RESULTS: This review included 13 studies involving 1381 patients with NCLBP. Quantitative analysis results indicated that there is no sufficient evidence that acupoint injection can improve the pain of patients with low back pain based on two trails: Visual Analogue Scale (VAS: MD = -1.33, 95% confidence interval (95% CI) -3.30 to 0.64, P=0.18, random-effect model). When assessing the effectiveness of acupoint injection therapy, the results indicated that acupoint injection can improve the effective rate for nonspecific chronic low back pain (OR = 3.64, 95% CI 2.4 to 5.21, P < 0.0001, fixed-effect model). CONCLUSION: There is insufficient evidence to indicate that acupoint injection therapy could improve the pain for patients with NCLBP. However, the level of evidence was downgraded to "very low quality" because of the poor methodological quality and clinical heterogeneity. The results should be interpreted with caution. Higher quality RCTs with more appropriate comparison, more objective outcome instruments, and adequate follow-up periods are necessary to assess the efficacy of acupoint injection for NCLBP. The PROSPERO Research registration identifying number is CRD42019119158.
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Akebia Saponin D (ASD) or asperosaponin VI is the most abundant constituent of the rhizome of Dipsacus asper, which has been used for the treatment of lower back pain, traumatic hematoma and bone fractures. In recent years, it was reported that ASD was a potential treatment strategy for Alzheimer's disease (AD). However, the low bioavailability of ASD limited its clinical utility. Microcrystalline preparation is one of the effective methods to improve drug absorption. The drugs prepared by different methods can present different solid forms (polymorphs), and different polymorphs have significantly different bioavailabilities. The objective of this study was to prepare ASD polymorphs using the different preparation processes and to evaluate their physicochemical properties and oral absorption. ASD-2 obtained by the antisolvent process was simpler and had higher recovery (78.5%) than that of ASD-1 by a two-step macroporous resin column separation (56.5%). The ASD polymorphs were characterized using differential scanning calorimetry (DSC), thermogravimetry analysis (TGA), powder X-ray diffraction (PXRD) and scanning electron microscopy (SEM). The results revealed that ASD-2 existed in microcrystalline form, while ASD-1 was amorphous. Furthermore, the equilibrium solubility, dissolution in aqueous solution and pharmacokinetic parameters of the samples were determined. ASD-2 showed lower aqueous solubility than that of ASD-1 (p < 0.01). In addition, ASD-2 showed lower dissolution with only 65% of the drug released while ASD-1 had a higher dissolution with 99% of drug released at the end of the 180 min testing period. Although ASD-1 significantly increased solubility and dissolution, the AUC 0-20h of ASD-2 was 4.3 times that of the amorphous ASD-1 in vivo. Data suggest that the microcrystalline preparation of ASD-2 is not only reasonable in economy and suitable for large-scale preparation, but also a promising method to enhance bioavailability of ASD.