Efficacy and Safety of Propionibacterium Extract Gel Versus 0.4% Glyceryl Trinitrate Ointment in the Treatment of Chronic Anal Fissure: a Randomised Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- REALISE score
研究概览
简要总结
The study compares the efficacy and safety of a Propionibacterium extract gel with 0.4% glyceryl trinitrate ointment in the treatment of chronic anal fissure.
详细描述
Patients were randomly allocated to a PeG or GTN group and medication was taken every 12 hours for 40 days. Primary outcome was the success rate as measured by a decrease in the REALISE score at 10, 20 and 40 days after starting either treatment. The secondary out-comes were the healing rate, the partial or complete resolution of itching and burning, the rate of complications and adverse events, patients' quality of life and satisfaction at the same time points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 接受健康志愿者
- 否
入选标准
- •Consecutive patients diagnosed with chronic anal fissure aged between 18 and 75 years
排除标准
- •Fecal incontinence
- •Inflammatory bowel disease
- •Previous history of anal surgery
- •Previous or concomitant treatment for anal fissure, sexually transmitted disease, cancer, immune-suppressive treatment
- •Current pregnancy or breastfeeding
- •Known allergy to one of the agents contained into the evaluating drugs
研究组 & 干预措施
Propionibacterium extract gel
The Propionibacterium extract gel is a topical product that protect the skin and mucous membranes from external agents. Its film forming property on the epidermis helps reduce inflammation, itching and pain, while the adjunct of antioxidant ingredients helps promote the healing process.
Patients were instructed to squeeze out from the aluminium tubes containing the Propionibacterium extract gel, 3 grams of gel (3 cm), applying it twice a day for 40 days in the distal anal canal and perianal area.
干预措施: Propionibacterium Acnes (Drug)
0.4% glyceryl trinitrate ointment
0.4% glyceryl trinitrate ointment is a well-known nitric oxide donor which promotes fissure healing by decreasing resting anal pressure and increasing anoderm blood flow, via the stimulation of the intracellular cyclic GMP resulting in a consequent reduction in cytosolic calcium. The success rate is variable, with 28% of patients experiencing transient headache often leading to drug discontinuation and poor compliance to treatment.
Patients were instructed to squeeze out from the aluminium tubes containing 0.4% glyceryl trinitrate ointment approximately 1.5 mg of the ointment applying it to the distal anal canal and perianal area with a gloved finger, every 12 hours for 40 days.
干预措施: glyceryl trinitrate (Drug)
结局指标
主要结局
REALISE score
时间窗: From baseline to visit 3 (40 days after the start of the treatment)
REALISE (scoRing systEm for AnaL fIsSurE), was used to assess pain (minimum score = 0, maximum score = 10)
次要结局
- Burning(From baseline to visit 3 (40 days after the start of the treatment))
- Physical and mental health(At visit 3 (40 days after the start of the treatment))
- Patients' satisfaction(At visit 3 (40 days after the start of the treatment))
- Itching(From baseline to visit 3 (40 days after the start of the treatment))
- Epithelialization(From baseline to visit 3 (40 days after the start of the treatment))