黑种草粉治疗幽门螺杆菌感染患者的随机、双盲、安慰剂对照临床试验。
Nigella sativa powder for helicobacter pylori infected patients: a randomized, double-blinded, placebo-controlled clinical trial.
机构信息
Department of Clinical Nutrition, School of Nutrition and Food Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.
Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran.
出版信息
BMC Complement Med Ther. 2023 Apr 17;23(1):123. doi: 10.1186/s12906-023-03955-4.
OBJECTIVE
This double-blind, placebo-controlled, clinical trial was conducted to define the effects of Nigella sativa (N. Sativa) powder plus conventional medical treatment of Helicobacter pylori (H. pylori) on serum ghrelin level and appetite in H. pylori-infected patients.
METHODS
In the present study, 51 H. pylori-positive patients were randomly allocated to treatment (n = 26) or placebo (n = 25) groups. They received 2 g/day N. Sativa with quadruple therapy or 2 g/day placebo plus quadruple therapy for 8 weeks. The serum level of ghrelin was assessed before and after the intervention. Appetite was evaluated at the onset and at the end of the intervention.
RESULTS
At the end of the study, the appetite of the treatment group improved significantly compared with the placebo group (P = 0.02). Statistically, the difference in serum ghrelin levels between the study's groups was insignificant (P > 0.05).
CONCLUSION
Supplementation with N. Sativa powder may be a beneficial adjunctive therapy in H. pylori-infected patients.
TRIAL REGISTRATION
This study was registered in the Iranian Registry of Clinical Trials (IRCT20170916036204N7) on 08/08/2018.
目的
本双盲、安慰剂对照临床试验旨在确定黑种草（N. Sativa）粉末加常规幽门螺杆菌（H. pylori）治疗对幽门螺杆菌感染患者血清胃饥饿素水平和食欲的影响。
方法
本研究中，51 例 H. pylori 阳性患者被随机分配至治疗（n=26）或安慰剂（n=25）组。他们接受 2g/天的黑种草粉末加四联疗法或 2g/天安慰剂加四联疗法，疗程为 8 周。干预前后评估血清胃饥饿素水平。在干预开始时和结束时评估食欲。
结果
研究结束时，治疗组的食欲明显优于安慰剂组（P=0.02）。两组间血清胃饥饿素水平的差异无统计学意义（P>0.05）。
结论
黑种草粉末补充剂可能是幽门螺杆菌感染患者的一种有益的辅助治疗方法。
试验注册
本研究于 2018 年 8 月 8 日在伊朗临床试验注册中心（IRCT20170916036204N7）注册。
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