Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Psychosomaric Research Center, Imam Hospital, Tehran University of Medical Sciences, Tehran, Iran.
J Psychosom Res. 2023 Sep;172:111389. doi: 10.1016/j.jpsychores.2023.111389. Epub 2023 May 31.
This is an investigation of the efficacy and safety of famotidine, a selective histamine H2 receptor antagonist, on improvement of cognitive impairment, depression and anxiety symptoms developing post-COVID-19, in a 12-week, randomized controlled trial.
A total of 50 patients with a confirmed diagnosis of COVID-19 and a score ≤ 23 on the Mini-Mental State Examination (MMSE) test or a score ≤ 22 on the Montreal Cognitive Assessment (MoCA) were randomly assigned to either the famotidine (40 mg twice daily) or the placebo group. Changes in MMSE scores at weeks 6 and 12 were the primary outcome, while changes in other scales were the secondary outcomes. Participants and evaluators were blinded.
At weeks 6 and 12, patients in the famotidine group had significantly higher MMSE scores (p = 0.014, p < 0.001, respectively). Regarding the MoCA scale, the famotidine group had a significantly higher score at weeks 6 and 12 (p = 0.001, p < 0.001, respectively). Considering the HAM-D scale (Hamilton Depression Rating Scale), at weeks 6 and 12, the famotidine group experienced a larger reduction (p = 0.009, p = 0.02, respectively). Additionally, comparison of the HAM-A scale scores (Hamilton Anxiety Rating Scale) at weeks 6 and 12 showed a statistically significant larger reduction in the famotidine group (p = 0.04, p = 0.02, respectively). The two groups did not differ in the frequency of adverse effects.
Our study supports safety and efficacy of famotidine in treating cognitive impairment, depression and anxiety symptoms induced by COVID-19.
This trial was registered at the Iranian registry of clinical trials (IRCT: www.irct.ir; registration number: IRCT20090117001556N138).
本研究旨在通过 12 周的随机对照试验,调查法莫替丁(一种选择性组胺 H2 受体拮抗剂)对改善 COVID-19 后认知障碍、抑郁和焦虑症状的疗效和安全性。
共纳入 50 例确诊 COVID-19 且 MMSE 评分≤23 分或 MoCA 评分≤22 分的患者,随机分为法莫替丁(40mg,每日 2 次)组或安慰剂组。主要结局为第 6 周和第 12 周时 MMSE 评分的变化,次要结局为其他量表的变化。参与者和评估者均设盲。
第 6 周和第 12 周时,法莫替丁组的 MMSE 评分显著升高(p=0.014,p<0.001)。在 MoCA 量表上,法莫替丁组在第 6 周和第 12 周时的评分也显著升高(p=0.001,p<0.001)。在 HAM-D 量表(汉密尔顿抑郁评定量表)上,第 6 周和第 12 周时,法莫替丁组的减分幅度更大(p=0.009,p=0.02)。此外,第 6 周和第 12 周时 HAM-A 量表(汉密尔顿焦虑评定量表)评分的比较显示,法莫替丁组的减分幅度更大(p=0.04,p=0.02)。两组不良反应的发生频率无差异。
本研究支持法莫替丁治疗 COVID-19 引起的认知障碍、抑郁和焦虑症状的安全性和有效性。
本试验在伊朗临床试验注册中心(IRCT:www.irct.ir;注册号:IRCT20090117001556N138)注册。