Sun Zhe, Jiang Lei, Xing Yan, Luo Fang
Department of Day Surgery, Beijing Tiantan Hospital Affiliated to Capital Medical University, Beijing, China.
Department of Pain Management, Beijing Tiantan Hospital, Beijing, China
BMJ Open. 2025 Jun 23;15(6):e099793. doi: 10.1136/bmjopen-2025-099793.
As a disorder of gut-brain interaction, irritable bowel syndrome (IBS) is a common reason for patient visits in primary and specialist care settings. IBS is associated with recurrent abdominal pain, altered bowel habit, resulting in alternating constipation and diarrhoea, bloating, without serious organic diseases. The bidirectional relationship between IBS and psychological factor is also complex. Studies have suggested that tricyclic antidepressants can effectively control the concomitant symptoms of IBS, especially some severe and refractory symptoms. At present, the conventional treatment of IBS remains somewhat unsatisfactory. Studies have shown that the antidepressant effects of esketamine are rapid and significant, whether a single low dose of esketamine is effective in IBS deserves further investigation. In this study, we hypothesise that a single low dose of esketamine will be effective for IBS.
This is a single-centre, randomised, double-blind, placebo-controlled trial. Patients with IBS are divided into three levels according to the severity of IBS: mild, moderate and severe. 92 patients in the esketamine group and 92 patients in the control group who are scheduled for colonoscopy will be prospectively recruited in each level. The primary outcome is the IBS Severity Scoring System at baseline and at 3 days, 1 week, 3 weeks, 6 weeks after colonoscopy. The secondary outcome includes IBS-Quality of Life, Bristol Stool Form scale, Hospital Anxiety and Depression Scale, Patient Health Questionnaire-12 Somatic Symptom Score and adverse events. The allocation sequence is assigned by a random number table using a block randomisation method by SPSS (Version 26, IBM Inc., USA) Statistics software. All enrolled patients, anaesthesiologist B and researchers responsible for follow-up and data collection and analysis are therefore fully blinded. All data will be performed using SPSS Statistics software, and a p value <0.05 will be considered statistically significant.
The protocol has been approved by the Medical Ethics Committee of Beijing Tiantan Hospital affiliated to Capital Medical University (KY2024-414-02). All participants will sign a written informed consent form. The results will be submitted for publication in peer-reviewed journals, presented at international conferences, and shared with participants via hospital newsletters.
Efficacy of Esketamine for Patients With Irritable Bowel Syndrome (NCT06788444).
肠易激综合征（IBS）作为一种肠-脑相互作用障碍，是基层医疗和专科医疗环境中患者就诊的常见原因。IBS与反复腹痛、排便习惯改变（导致便秘和腹泻交替出现）、腹胀相关，且无严重器质性疾病。IBS与心理因素之间的双向关系也很复杂。研究表明，三环类抗抑郁药可有效控制IBS的伴随症状，尤其是一些严重和难治性症状。目前，IBS的传统治疗仍不尽人意。研究表明，艾氯胺酮的抗抑郁作用迅速且显著，单次低剂量艾氯胺酮对IBS是否有效值得进一步研究。在本研究中，我们假设单次低剂量艾氯胺酮对IBS有效。
这是一项单中心、随机、双盲、安慰剂对照试验。根据IBS的严重程度将IBS患者分为三个级别：轻度、中度和重度。每个级别将前瞻性招募92例计划进行结肠镜检查的艾氯胺酮组患者和92例对照组患者。主要结局是结肠镜检查后基线时以及3天、1周、3周、6周时的IBS严重程度评分系统。次要结局包括IBS生活质量、布里斯托大便形状量表、医院焦虑抑郁量表、患者健康问卷-12躯体症状评分和不良事件。分配序列通过使用SPSS（美国IBM公司第26版）统计软件的区组随机化方法由随机数字表分配。因此，所有入组患者、麻醉医生B以及负责随访和数据收集与分析的研究人员均完全不知情。所有数据将使用SPSS统计软件进行分析，p值<0.05将被视为具有统计学意义。
本方案已获得首都医科大学附属北京天坛医院医学伦理委员会批准（KY2024-414-02）。所有参与者将签署书面知情同意书。研究结果将提交至同行评审期刊发表，在国际会议上展示，并通过医院通讯与参与者分享。
艾氯胺酮治疗肠易激综合征患者的疗效（NCT06788444）
