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Objective:
Experimental pain models in human healthy volunteers are advantageous for early evaluation of analgesics. All efforts to develop nonsteroidal anti-inflammatory drugs (NSAIDs) which are devoid of gastrointestinal and cardiovascular system effects are still far from achieving a breakthrough. Hence we evaluated the analgesic activity of an ayurvedic drug, Boswellia serrata by using validated human pain models which has shown its analgesic activity both in-vitro and preclinical studies to evaluate the analgesic activity of single oral dose (125 mg, 2 capsules) of Boswellia serrata compared to placebo using mechanical pain model in healthy human subjects.Materials and Methods:
After taking written informed consent, twelve healthy subjects were randomized (1:1) to receive single oral dose of Boswellia serrata (Shallaki®) 125 mg, 2 capsules or identical placebo in a crossover design. Mechanical pain was assessed using Ugo basile analgesymeter (by Randall Selitto test) at baseline and at 1 hr, 2 hrs and 3 hrs after test drug administration. Pain Threshold force and time and Pain Tolerance force and time were evaluated. Statistical analysis was done by paired t-test.Results:
Twelve healthy volunteers have completed the study. Mean percentage change from baseline in Pain Threshold force and time with Boswellia serrata when compared to placebo had significantly increased [Force: 9.7 ± 11.0 vs 2.9 ± 3.4 (P = 0.05) and time: 9.7 ± 10.7 vs 2.8 ± 3.4 (P = 0.04)] at third hr. Mean Percentage change from baseline in Pain Tolerance force and time with Boswellia serrata when compared to placebo had significantly (P ≤ 0.01) increased at 1 hr, 2 hrs and 3 hrs.Conclusion:
In the present study, Boswellia serrata significantly increased the Pain Threshold and Pain Tolerance force and time compared to placebo. Both study medications were well tolerated. Further multiple dose studies may be needed to establish the analgesic efficacy of the drug.KEY WORDS: Boswellia serrata, human pain models, randall selitto test, ugo basile analgesymeter 相似文献The traditional way to tackle Zenker’s diverticulum (ZD) has been flexible endoscopic septum division (FESD). Recently, the concept of per oral endoscopic myotomy has been found useful for managing diverticular diseases of the esophagus and has been termed DPOEM. We performed a systematic review and meta-analysis to evaluate the efficacy and safety of D-POEM in diverticular disease of the esophagus and to compare it with FESD. We systematically searched PubMed and Embase, for studies reporting clinical success, technical success and adverse events in D-POEM alone or D-POEM comparing with FESD. We computed pooled prevalence for D-POEM alone and risk ratio for D-POEM vs FESD using random effect method with inverse variance approach. Subgroup analysis for ZD, non-ZD and mixed diverticulum was conducted. Totally 19 studies including 341 patients were identified reporting on D-POEM. The pooled clinical, technical success and adverse event rates for D-POEM were 87.07%, 95.19% and 10.22%, respectively. The clinical success was significantly better than FESD while the technical success, adverse event rate, procedure time and length of hospital stay were comparable with FESD. The recurrence rate was negligible for D-POEM compared to FESD. On subgroup analysis by dividing into three groups of ZD, non-ZD and mixed, there was no difference between clinical, technical success and adverse event rate among the three groups. D-POEM is an effective and safe technique among both ZD and non-ZD patients and has better clinical success than FESD.
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