Corazziari E, Badiali D, Habib F I, Reboa G, Pitto G, Mazzacca G, Sabbatini F, Galeazzi R, Cilluffo T, Vantini I, Bardelli E, Baldi F
Cattedra di Gastroenterologia I. Universitá La Sapienza, Rome, Italy.
Dig Dis Sci. 1996 Aug;41(8):1636-42. doi: 10.1007/BF02087913.
The present multicenter double-blind placebo-controlled trial evaluates the therapeutic effectiveness of small-volume daily doses of an isosmotic polyethylene glycol (PEG) electrolyte solution in the treatment of chronic nonorganic constipation. After a complete diagnostic investigation, patients still constipated at the end of a four-week placebo-treatment run-in period were enrolled and randomized to receive either placebo or PEG solution 250 ml twice a day for the following eight weeks. Patients were assessed at four and eight weeks of treatment, and they reported frequency and modality of evacuation, use of laxatives, and relevant symptoms daily on a diary card. Oroanal and segmental large-bowel transit times were assessed with radiopaque markers during the fourth week of the run-in period and the last week of the treatment period. During the study period, dietary fiber and liquids were standardized and laxatives were allowed only after five consecutive days without a bowel movement. Of the 55 patients enrolled, five dropped out, three because of adverse events and two for reasons unrelated to therapy; another two were excluded from the efficacy analysis because of protocol violation. Of the remaining 48 patients (37 women, age 42 +/- 15 years, mean +/- SD), 23 were assigned to placebo and 25 to PEG treatment. In comparison to placebo, PEG solution induced a statistically significant increase in weekly bowel frequency at four weeks and at the end of the study (PEG: 4.8 +/- 2.3 vs placebo: 2.8 +/- 1.6; P < 0.002) and a significant decrease in straining at defecation (P < 0.01), stool consistency (P < 0.02), and use of laxatives (P < 0.03). Oroanal, left colon, and rectal transit times were significantly shortened by PEG treatment. There was no difference between controls and PEG-treated patients as far as abdominal symptoms and side effects were concerned. In conclusion, PEG solution at 250 ml twice a day is effective in increasing bowel frequency, accelerating colorectal transit times, and improving difficult evacuation in patients with chronic nonorganic constipation and is devoid of significant side effects.
本多中心双盲安慰剂对照试验评估了小剂量每日服用等渗聚乙二醇（PEG）电解质溶液治疗慢性非器质性便秘的疗效。在完成全面的诊断性检查后，入选在为期四周的安慰剂治疗导入期结束时仍便秘的患者，并将其随机分组，在接下来的八周里，一组接受安慰剂，另一组接受每天两次、每次250毫升的PEG溶液。在治疗的第四周和第八周对患者进行评估，患者每天在日记卡上记录排便频率和方式、泻药使用情况及相关症状。在导入期的第四周和治疗期的最后一周，使用不透X线的标志物评估口肛和节段性大肠转运时间。在研究期间，膳食纤维和液体摄入量标准化，只有在连续五天无排便后才允许使用泻药。在入选的55例患者中，5例退出，3例因不良事件退出，2例因与治疗无关的原因退出；另外2例因违反方案被排除在疗效分析之外。其余48例患者（37例女性，年龄42±15岁，均值±标准差），23例被分配到安慰剂组，25例接受PEG治疗。与安慰剂相比，PEG溶液在治疗四周时和研究结束时使每周排便频率有统计学意义的显著增加（PEG组：4.8±2.3次 vs 安慰剂组：2.8±1.6次；P<0.002），排便时用力程度（P<0.01）、粪便硬度（P<0.02）和泻药使用情况（P<0.03）显著降低。PEG治疗显著缩短了口肛、左半结肠和直肠的转运时间。就腹部症状和副作用而言，对照组和PEG治疗组患者之间没有差异。总之，每天两次、每次250毫升的PEG溶液可有效增加排便频率、加速结直肠转运时间并改善慢性非器质性便秘患者的排便困难，且无明显副作用。
