Queensland Centre for Mental Health Research, The Park Centre for Mental Health, Wacol, Australia.
QIMR Berghofer Medical Research Institute, Herston, Australia.
JAMA Netw Open. 2020 Nov 2;3(11):e2024335. doi: 10.1001/jamanetworkopen.2020.24335.
There is evidence that sodium benzoate (BZ) may be an effective adjunctive treatment for schizophrenia. The clinical efficacy of BZ has been investigated in chronic schizophrenia; however, the efficacy of this agent has not been studied in individuals with early psychosis.
To examine the clinical efficacy of the adjunctive use of BZ for symptoms in people with early psychosis.
DESIGN, SETTING, AND PARTICIPANTS: Using a placebo-controlled double-masked parallel-group design, this randomized clinical trial was conducted from August 2015 to July 2018. Participants aged between 15 and 45 years experiencing early psychosis were enrolled from 5 major clinical sites in Queensland, Australia. Data analysis was conducted from October 2018 to February 2020.
Participants were randomized 1:1 (50 participants in each group) to receive 500 mg of sodium benzoate twice daily or placebo for 12 weeks.
The primary efficacy outcome was the Positive and Negative Syndrome Scale (PANSS) total score at 12 weeks. The key secondary efficacy measures were (1) the Clinical Global Impression score, (2) the Hamilton Depression Rating Scale for depression, (3) functioning as assessed by the clinician-rated Global Assessment of Function, and (4) the Assessment of Quality of Life Scale. The PANSS subscale scores and impact on selected amino acid concentrations were also assessed.
The study comprised 100 participants with a mean (SD) age of 21.4 (4.1) years, of whom 73 (73%) were male individuals. The mean (SD) baseline PANSS score was 75.3 (15.4). We found no improvement in total PANSS score in the BZ group compared with the placebo group. The end result of least-squares mean difference (SE) for total PANSS was -1.2 (2.4) (P = .63). There were no differences in any subscales of the PANSS, any secondary measures, nor any amino acid concentrations. The dose of BZ was well tolerated without any clinically significant treatment-emergent adverse event differences between BZ and placebo groups.
In this randomized clinical trial, there was no evidence that adjunctive use of 500 mg of BZ twice daily is an effective treatment for individuals with early psychosis.
anzctr.org.au Identifier: ACTRN12615000187549.
有证据表明，苯甲酸钠（BZ）可能是治疗精神分裂症的有效辅助治疗药物。BZ 的临床疗效已在慢性精神分裂症中进行了研究；然而，尚未研究该药物在早期精神病患者中的疗效。
研究苯甲酸钠辅助治疗早期精神病患者症状的临床疗效。
设计、地点和参与者：本研究采用安慰剂对照双盲平行组设计，于 2015 年 8 月至 2018 年 7 月进行，招募了来自澳大利亚昆士兰州 5 个主要临床地点的 15 至 45 岁之间经历早期精神病的参与者。数据于 2018 年 10 月至 2020 年 2 月进行分析。
参与者以 1:1（每组 50 名）的比例随机分配接受 500 毫克苯甲酸钠每日两次或安慰剂治疗 12 周。
主要疗效结局为 12 周时阳性和阴性综合征量表（PANSS）总分。主要次要疗效指标包括（1）临床总体印象评分，（2）汉密尔顿抑郁评定量表评估的抑郁，（3）临床医生评定的功能评估的功能，以及（4）生活质量评估量表。还评估了 PANSS 分量表评分和对选定氨基酸浓度的影响。
该研究纳入了 100 名参与者，平均（标准差）年龄为 21.4（4.1）岁，其中 73 名（73%）为男性。平均（标准差）基线 PANSS 评分为 75.3（15.4）。我们发现苯甲酸钠组与安慰剂组相比，PANSS 总分无改善。最小二乘均数差异（SE）的最终结果为-1.2（2.4）（P = .63）。PANSS 的任何分量表、任何次要测量指标或任何氨基酸浓度均无差异。苯甲酸钠的剂量耐受良好，苯甲酸钠组与安慰剂组之间无任何临床显著的治疗后不良事件差异。
在这项随机临床试验中，没有证据表明每日两次服用 500 毫克苯甲酸钠是治疗早期精神病患者的有效方法。
anzctr.org.au 标识符：ACTRN12615000187549。
