The Role of Pistacia Lentiscus Oil in the Prevention of Chronic Rhinosinusitis Recurrence During Long-Term Therapy: A Retrospective Observational Case-Control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in Sino-Nasal Outcome Test-22 (SNOT-22) score
研究概览
简要总结
This retrospective, observational, case-control clinical study evaluated the safety and efficacy of nasal drops containing Pistacia lentiscus oil in preventing recurrence of chronic rhinosinusitis during long-term therapy. Adult patients with chronic rhinosinusitis who received isotonic saline wash plus Pistacia lentiscus oil drops were retrospectively compared with patients who received isotonic saline wash alone, with a total treatment duration of 12 months. The primary outcome was change in Sino-Nasal Outcome Test-22 (SNOT-22) scores, while secondary outcomes included ciliary motility, nasal secretion, biofilm presence, cytological changes, adverse events, and safety/tolerability.
详细描述
Chronic rhinosinusitis (CRS) is a common and recurrent condition associated with significant morbidity and impaired quality of life. Standard treatment approaches often provide only partial or temporary relief, and recurrence rates remain high. Pistacia lentiscus oil has demonstrated anti-inflammatory and mucosal protective properties, supporting its potential role as a preventive tool in CRS management.
This monocenter, non-profit, retrospective observational case-control clinical study was conducted to evaluate the long-term preventive effect of Pistacia lentiscus oil nasal drops on CRS recurrence. One hundred patients aged ≥18 years with diagnosed CRS were retrospectively evaluated and compared between patients receiving isotonic saline wash plus Pistacia lentiscus oil drops (5 drops per nostril twice daily for 30 days, followed by maintenance treatment for 15 days per month over 11 months) and patients receiving isotonic saline wash alone on the same schedule.
The primary endpoint was the change in disease-specific quality of life, measured by the Sino-Nasal Outcome Test-22 (SNOT-22) from baseline to 12 months. Secondary endpoints included assessments of ciliary motility, nasal secretion, presence of biofilm, supranuclear striae, bacterial cells, variations in inflammatory cellularity (neutrophils, eosinophils, mast cells), safety, and tolerability.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
盲法说明
Double-blind trial in which participants, care providers, investigators, and outcome assessors were unaware of group allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Clinical diagnosis of chronic rhinosinusitis
- •Nasal polypoid score ≤1
- •≥4 episodes of recurrence per year
- •SNOT-22 score ≥10 Willingness and ability to provide written informed consent
排除标准
- •Nasal polypoid score >2
- •<4 episodes of recurrence per year
- •SNOT-22 score <10
- •Known immune disorders
- •Neoplastic disorders
- •Neurological disorders
- •Psychiatric disorders
- •Inability to undergo treatment
- •Refusal or inability to provide informed consent
研究组 & 干预措施
Experimental: Pistacia lentiscus Oil Nasal Drops
Participants received isotonic saline nasal wash plus Pistacia lentiscus oil nasal drops. Dosage: 5 drops per nostril twice daily for 30 days, followed by maintenance therapy of 5 drops per nostril twice daily for 15 days each month over the subsequent 11 months.
干预措施: Pistacia lentiscus Oil Nasal Drops (Bactorinol®) (Other)
Saline Solution Control
Participants received isotonic saline nasal wash alone on the same administration schedule over the study period.
干预措施: Isotonic Saline Nasal Wash (Other)
结局指标
主要结局
Change in Sino-Nasal Outcome Test-22 (SNOT-22) score
时间窗: Baseline, 1 month, and 1 year
The SNOT-22 questionnaire measures disease-specific quality of life in chronic rhinosinusitis patients. Scores range from 0 (no symptoms) to 110 (worst symptoms).
次要结局
- Ciliary motility(Baseline, 1 month, and 1 year)
- Presence of Nasal Secretion(Baseline, 1 month, and 1 year)
- Characteristics of Nasal Secretion(Baseline, 1 month, and 1 year)
- Presence of biofilm(Baseline, 1 month, and 1 year)
- Presence of supranuclear striae(Baseline, 1 month, and 1 year)
- Presence of bacterial cells(Baseline, 1 month, and 1 year)
- Cellularity variation(Baseline, 1 month, and 1 year)
- Number of Participants With Treatment-Related Adverse Events(Throughout study period (up to1 year))
- Local Tolerability of Nasal Drops(Baseline, 1 month, and 1 year)
研究者
Dr. Amjad Khan
Professor of Clinical Biochemistry and Experimental Medicine
Liaquat University of Medical & Health Sciences