1.Clinicoradiological Risk Factors Associated with Inability to Achieve Minimum Clinically Important Difference in Operated Cases of Cervical Spondylotic Myelopathy
Shankar ACHARYA ; Varun KHANNA ; Rupinder Singh CHAHAL ; Kashmiri Lal KALRA ; Gayatri VISHWAKARMA
Asian Spine Journal 2023;17(5):904-915
Methods:
We analyzed 124 operated CSM cases from March 2019 to April 2021 for preoperative clinical features, cervical sagittal radiographic parameters, and magnetic resonance imaging (MRI) signal intensities (SI). The risk factors associated with missing the MCID (poor outcome) on mJOA at the final follow-up were identified using binary logistic regression. Multivariate analysis was used to find significant risk factors, and odds ratios (OR) were computed.
Results:
A total of 110 men (89.2%) and 14 women (10.8%) with an average age of 53.5±13.2 years were included in the analysis. During the last follow-up, 89 cases (72.1%) achieved MCID (meaningful gains following surgery) while 35 (27.9%) could not. The final model identified the following parameters as significant risk factors for poor outcome: increased duration of symptoms (OR, 6.77; p=0.001), lower preoperative mJOA scale (OR, 0.75; p=0.029), the presence of multilevel T2-weighted (T2W) MRI SI (OR, 4.79; p=0.004), and larger change in cervical sagittal vertical axis (ΔcSVA) (OR, 1.06; p=0.013). Also, an increase in cSVA postoperatively correlated with a reduced functional recovery rate (r=−0.4, p<0.001).
Conclusions
Surgery for CSM leads to significant functional benefits. However, poorer outcomes are observed in cases of greater duration of symptoms, higher preoperative severity with multilevel T2W MRI SI, and a larger increase in the postoperative cSVA (sagittal imbalance).
2.Discovery and preclinical development of IIIM-160, a Bergenia ciliata-based anti-inflammatory and anti-arthritic botanical drug candidate.
Sandip B BHARATE ; Vikas KUMAR ; Sonali S BHARATE ; Bikarma SINGH ; Gurdarshan SINGH ; Amarinder SINGH ; Mehak GUPTA ; Deepika SINGH ; Ajay KUMAR ; Surjeet SINGH ; Ram A VISHWAKARMA
Journal of Integrative Medicine 2019;17(3):192-204
OBJECTIVE:
Bergenia ciliata (Haw.) Sternb. is used in the Indian traditional system of medicine to treat various ailments including rheumatism and to heal wounds. The objective of the present study was to perform a preclinical characterization of the B. ciliata-based botanical extract IIIM-160.
METHODS:
IIIM-160 was chemically standardized and analyzed for heavy metal content, aflatoxins, pesticides and microbial load. The in vitro and in vivo efficacies were determined in suitable models of inflammation, arthritis and nociception. An acute oral toxicity study was performed in Swiss albino mice. A suitable oral formulation was developed and characterized.
RESULTS:
Bergenin was found to be the major component (9.1% w/w) of IIIM-160. The botanical lead displayed inhibition of lipopolysaccharide-induced production of proinflammatory cytokines in THP-1 cells, with selectivity toward interleukin-6 (IL-6) and had an excellent safety-window. It showed anti-inflammatory, anti-arthritic and antinociceptive activity in animal models and was not toxic at oral doses up to 2 g/kg in Swiss-albino mice. The gastroretentive, sustained-release capsule formulation showed sustained-release of the bergenin over the period of 24 h, resulting in improved plasma-exposure of bergenin in Sprague-Dawley rats.
CONCLUSION
The dual-activity of IL-6 inhibition and antinociception marks the suitability of IIIM-160 for treating rheumatoid arthritis. This study will serve as the benchmark for further research on this botanical formulation.