Rathi Ankit, Pagare Ravikiran
Department of Biological Sciences, School of Science, Sandip University, Nashik, Maharashtra, India.
Glob Adv Integr Med Health. 2024 Sep 17;13:27536130241286511. doi: 10.1177/27536130241286511. eCollection 2024 Jan-Dec.
Active drugs and nutraceutical supplements commonly induce various gastrointestinal illnesses, and constipation is a major gastrointestinal symptom accompanied with functional gastrointestinal disorders. Drug-induced imbalance in gut microbiota may play critical role in such physiological disturbances. Probiotics have been known for resuming normal and healthy gut microbiome.
To investigate the clinical efficacy and safety of LBSC in the treatment of drug induced constipation associated with functional gastrointestinal disorder (FGID) symptoms.
A prospective, interventional, randomized, double-blind, parallel, multi-arm, controlled trial with 168 patients experiencing drug induced constipation associated with FGID symptoms (DICAWFGID) screened through Rome IV criteria were randomized into 2 arms, i.e. placebo arm (n = 28) and atorvastatin, atenolol, metformin, amitriptyline, and calcium in test arm (n = 28/arm). Patients in both arms received similar dosages (1 g sachet, 3 times a day) for 35 days. The occurrence of constipation using Bristol Stool Form Scale, assessment of degree of constipation on 4-point Likert scale, occurrence of hard stool and degree of stool expulsion on 3-point scale, and defecation frequency were primary endpoints. While, secondary outcomes consisted of the changes in severity of FGID symptoms, visual analogue scale and tolerance to IP, along with reports of adverse events (AEs) and severe adverse events (SAEs).
There was a significant reduction in occurrence of constipation (≥98.6% and -value <0.05) in test arm over the placebo arm. Assessment of co-primary endpoints showed significant improvements in degree of stool consistency (-value 0.0232; CI: 0.1870, 1.1629), borderline significantly superior in degree of stool expulsion (-value 0.0553; CI: 0.0378, -0.4939), while the other co-primary efficacy endpoints displayed considerably improved advancement (non-significant, -value ≥0.05). The intra group analysis of symptoms at start of treatment (SOT) and end of treatment (EOT) revealed a significant reduction in scores for occurrence of constipation and degree of constipation, whereas significant improvement in the scores for degree of stool consistency and degree of stool expulsion (-value <0.001) after the intervention period. In secondary endpoints, the processed responses clearly signified a considerable positive improvement (non-significant, -value ≥0.05) in other symptoms of constipation associated with FGIDs as determined by the changes in the EOT-SOT score. The study data also highlighted the safety o LBSC at the studied dose. No AEs and/or SAEs were documented during the investigation.
At the studied dose, LBSC was safe for oral consumption and effective in the management of the drug induced constipation associated with FGIDs symptoms.
活性药物和营养保健品通常会引发各种胃肠道疾病，便秘是伴随功能性胃肠疾病出现的主要胃肠道症状。药物引起的肠道微生物群失衡可能在这种生理紊乱中起关键作用。益生菌已知可恢复正常且健康的肠道微生物群。
研究LBSC治疗与功能性胃肠疾病（FGID）症状相关的药物性便秘的临床疗效和安全性。
一项前瞻性、干预性、随机、双盲、平行、多臂对照试验，对168例经罗马IV标准筛查出的与FGID症状相关的药物性便秘（DICAWFGID）患者随机分为两组，即安慰剂组（n = 28）和试验组（阿托伐他汀、阿替洛尔、二甲双胍、阿米替林和钙剂，每组n = 28）。两组患者均接受相似剂量（每袋1 g，每日3次），持续35天。使用布里斯托大便分类法评估便秘的发生情况，采用4级李克特量表评估便秘程度，采用3级量表评估硬便的发生情况和排便程度，排便频率为主要终点。次要结局包括FGID症状严重程度的变化、视觉模拟量表和对IP的耐受性，以及不良事件（AE）和严重不良事件（SAE）的报告。
试验组便秘发生率较安慰剂组显著降低（≥98.6%，P值<0.05）。共同主要终点评估显示，粪便稠度程度有显著改善（P值0.0232；CI：0.1870，1.1629），排便程度临界显著更优（P值0.0553；CI：0.0378，-0.4939），而其他共同主要疗效终点显示有相当大的改善进展（无显著性，P值≥0.05）。治疗开始（SOT）和治疗结束（EOT）时症状的组内分析显示，便秘发生率和便秘程度评分显著降低，而干预期后粪便稠度程度和排便程度评分有显著改善（P值<0.001）。在次要终点中，处理后的反应明显表明，根据EOT - SOT评分的变化，与FGIDs相关的其他便秘症状有相当大的积极改善（无显著性，P值≥0.05）。研究数据还突出了所研究剂量的LBSC的安全性。调查期间未记录到AE和/或SAE。
在所研究的剂量下，LBSC口服安全，对治疗与FGIDs症状相关的药物性便秘有效。
