Lysy J, Sistiery-Ittah M, Israelit Y, Shmueli A, Strauss-Liviatan N, Mindrul V, Keret D, Goldin E
Department of Gastroenterology, Hadassah University Hospital, Hebrew University Medical School, Jerusalem, Israel.
Gut. 2003 Sep;52(9):1323-6. doi: 10.1136/gut.52.9.1323.
Pruritus ani is a common and embarrassing proctological condition which can be very difficult to treat. We report the results of a double blind placebo controlled study of treatment with capsaicin.
Firstly, a pilot open study was carried out on five patients to establish which of two doses was the most acceptable by comparing effectiveness and side effects. Secondly, a double blind, placebo controlled, crossover study of topical capsaicin was performed. This study involved two four week treatment phases separated by a one week washout phase. Forty four patients were randomised to receive locally either active capsaicin (0.006%) or placebo (menthol 1%) ointment over a four week period (22 patients per group). After four weeks of treatment and a one week washout period, the placebo group began to receive capsaicin while the treated group received placebo (menthol 1%) for another four weeks. At the end of the controlled study, responders from both groups continued with capsaicin treatment in an open labelled manner.
Thirty one of 44 patients experienced relief during capsaicin treatment periods and did not respond to menthol; all patients not responding to capsaicin also failed on menthol (p<0.0001). In 13 patients, treatment with capsaicin was unsuccessful: eight patients did not respond to capsaicin treatment, one responded equally to capsaicin and placebo, and four others dropped out because of side effects. During the follow up period (mean 10.9 (SD 5.8) months), 29 "responders" needed a mean application of capsaicin every day (1.6 (SD 1.2); range 0.5-7 days) to remain symptom free (or nearly symptom free).
Capsaicin is a new, safe, and highly effective treatment for severe intractable idiopathic pruritus ani.
肛门瘙痒是一种常见且令人尴尬的直肠疾病，治疗起来可能非常困难。我们报告了一项关于辣椒素治疗的双盲安慰剂对照研究结果。
首先，对5名患者进行了一项初步开放性研究，通过比较有效性和副作用来确定两种剂量中哪种最易被接受。其次，进行了一项关于局部使用辣椒素的双盲、安慰剂对照、交叉研究。该研究包括两个为期四周的治疗阶段，中间有一周的洗脱期。44名患者被随机分为两组，在四周内局部使用活性辣椒素（0.006%）或安慰剂（1%薄荷醇）软膏（每组22名患者）。治疗四周后经过一周的洗脱期，安慰剂组开始接受辣椒素治疗，而治疗组接受安慰剂（1%薄荷醇）治疗另外四周。在对照研究结束时，两组中的有反应者以开放标签的方式继续接受辣椒素治疗。
44名患者中有31名在辣椒素治疗期间症状缓解，对薄荷醇无反应；所有对辣椒素无反应的患者对薄荷醇也无反应（p<0.0001）。13名患者使用辣椒素治疗未成功：8名患者对辣椒素治疗无反应，1名对辣椒素和安慰剂反应相同，另外4名因副作用退出。在随访期（平均10.9（标准差5.8）个月），29名“有反应者”平均每天需要使用辣椒素（1.6（标准差1.2）；范围0.5 - 7天）以保持无症状（或几乎无症状）。
辣椒素是一种治疗重度顽固性特发性肛门瘙痒的新型、安全且高效的疗法。
