生姜对非刺激唾液流速的影响:一项双盲、随机、安慰剂对照试验

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引用次数: 0

摘要

目的:探讨标准化姜粉(SGP)对健康志愿者非刺激唾液流率(USFR)的影响及安全性。材料和方法:本研究是在泰国进行的单次访问、双盲、随机、安慰剂对照试验。年龄在18岁至60岁之间的健康志愿者如果符合所有标准,就有资格。他们被分成四组,采用分组随机化,以确保每组人数相等。对照组服用安慰剂,而其他三个实验组分别服用1000毫克、1500毫克和2000毫克的SGP。主要结果是USFR,通过改进的Schirmer试验测量。干预后45分钟测量USFR,并与基线USFR进行比较。研究助理给予安慰剂和SGP胶囊,外观相同。志愿者和研究者都不知道指定的干预措施。结果:共有368名志愿者被随机分为四组,每组92人。三个实验组均显示出USFR的变化。然而,只有2000 mg组显示USFR显著增加(平均差异9.47 mm/5分钟,95% CI 3.24至15.71,p=0.003)。大约32.6%的志愿者报告了副作用,主要是胃肠道事件,如打嗝(16.3%)和轻度腹部不适(7.9%)。结论:2000 mg SGP显著增加USFR,但效应不大。这可能是由于本研究中使用的SGP中生物活性化合物的浓度较低。所有的副作用都是轻微和暂时的。关键词:生姜;非刺激唾液流量;修正Schirmer检验
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The Effects of Ginger on Unstimulated Salivary Flow Rate: A Double-Blind, Randomized, Placebo-Control Trial
Objective: To investigate the effects and safety of standardized ginger powder (SGP) on healthy volunteers’ unstimulated salivary flow rate (USFR). Materials and Methods: The present study was a single-visit, double-blind, randomized, placebo-control trial conducted in Thailand. Healthy volunteers aged 18 to 60 were eligible if they met all the criteria. They were allocated to four groups using block randomization to ensure an equal number in each group. The control group received a placebo, while the other three experimental groups received 1,000 mg, 1,500 mg, and 2,000 mg SGP, respectively. The primary outcome was the USFR, measured by a modified Schirmer test. The post USFR was measured 45 minutes after the intervention and was compared to the baseline USFR. The research assistants administered placebo and SGP capsules, identical in their appearance. The volunteers and the investigator were unaware of the assigned interventions. Results: Total of 368 volunteers were randomly assigned to four groups, each consisting of 92 participants. All three experimental groups showed a change in USFR. However, only the 2,000 mg group showed a significant increase in the USFR (mean difference 9.47 mm/5 minutes, 95% CI 3.24 to 15.71, p=0.003). Approximately 32.6% of the volunteers reported side effects, mainly gastrointestinal events, such as belching (16.3%) and mild abdominal discomfort (7.9%). Conclusion: Two thousand mg SGP significantly increased USFR, yet the effect size was modest. This may be due to the low concentration of bioactive compounds in the SGP used in the present study. All side effects were minor and temporary. Keywords: Ginger; Unstimulated salivary flow rate; Modified Schirmer test
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