Petruzzi Massimo, Lauritano Dorina, De Benedittis Michele, Baldoni Marco, Serpico Rosario
Department of Odontostomatology and Surgery, University of Bari, Italy.
J Oral Pathol Med. 2004 Feb;33(2):111-4. doi: 10.1111/j.1600-0714.2004.0194n.x.
Burning mouth syndrome (BMS) is a major diagnostic and therapeutic problem. Systemic and topical treatments (capsaicin, lidocaine, anti-histamines, sucralfate and benzydiamine) have been tried, but they appear to be inadequate. Topical capsaicin is bitter, may cause burning and has low therapeutic efficacy. We hypothesized that systemic administration of capsaicin could reduce the limitations of topical administration and have better therapeutic efficacy; this hypothesis was tested in a controlled trial.
Systemic oral capsaicin 0.25% was used for patients with BMS, recruited in our single centre. After the diagnosis of BMS, patients were dentally and medically examined. They were alternatively assigned to treatment with capsaicin or to a shape/smell/taste/color matched placebo. The severity of symptoms was scored at trial entry and 30 days thereafter by investigators who were unaware of the assigned intervention. The visual analogical scale (VAS) measure was used to score the severity of pain, and results for the treated and untreated groups were compared by Fisher's exact test. Analysis was performed by intention-to-treat. Statistical significance was considered for values of P < 0.05. Data are expressed as mean +/- SD.
Fifty patients were enrolled (25 assigned to systemic capsaicin and 25 to placebo). The VAS score was significantly lower in treated patients (5.84 +/- 1.17) as compared to the placebo-control group (6.24 +/- 0.96). The use of systemic capsaicin implied significant gastric toxicity (referred gastric pain) with eight cases (32%) documented in the treatment group as compared to zero cases (0%) in the placebo control group.
Systemic capsaicin is therapeutically effective for the short-term treatment of BMS but major gastrointestinal side-effects may threaten its large-scale, long-term use. This preliminary study suggests that more, adequately powered, randomized controlled trials are necessary and worthy to come to a definitive assessment of this matter.
灼口综合征（BMS）是一个主要的诊断和治疗难题。已经尝试了全身和局部治疗方法（辣椒素、利多卡因、抗组胺药、硫糖铝和苯海拉明），但这些方法似乎并不充分。局部用辣椒素味苦，可能会引起烧灼感，且治疗效果不佳。我们推测，全身应用辣椒素可以减少局部应用的局限性，并具有更好的治疗效果；这一假设在一项对照试验中得到了验证。
在我们的单中心研究中，对患有BMS的患者使用0.25%的全身口服辣椒素。在诊断出BMS后，对患者进行牙科和医学检查。他们被交替分配接受辣椒素治疗或形状/气味/味道/颜色匹配的安慰剂治疗。在试验开始时和30天后，由不知道分配干预措施的研究人员对症状的严重程度进行评分。使用视觉模拟量表（VAS）来评估疼痛的严重程度，并通过Fisher精确检验比较治疗组和未治疗组的结果。分析采用意向性治疗。P < 0.05的值被认为具有统计学意义。数据以平均值±标准差表示。
招募了50名患者（25名分配接受全身辣椒素治疗，25名分配接受安慰剂治疗）。与安慰剂对照组（6.24±0.96）相比，治疗组患者的VAS评分显著更低（5.84±1.17）。全身应用辣椒素会导致明显的胃部毒性（提及胃痛）——治疗组有8例（32%）记录在案，但安慰剂对照组为零例（0%）。
全身应用辣椒素对BMS的短期治疗有效，但严重的胃肠道副作用可能会威胁到其大规模、长期使用。这项初步研究表明，需要进行更多样本量充足的随机对照试验，才能对这一问题做出明确评估。
