[LupusDoc]

Сообщение от Adonin

http://www.nextbio.com/b/literature/...n-lefa&author=

The effect of drotaverine hydrochloride in acute colicky pain caused by renal and ureteric stones. ..

PATIENTS AND METHODS: In a placebo-controlled, multicentre, multinational, randomized, double-blind study ...


RESULTS: Drotaverine was effective in 79% of patients and placebo in only 46% (P < 0.001).

Во-первых, речь шла не о почечной колике, а о печеночной:

ведь очень даже хорошо зарекомендовали себя спазмолитики - а кто может померять напряжения гладких мышц желчных путей и кто требует этого, чтобы кому-то доказать, что но-шпа именно так и работает.

Покажите мне результаты хоть одного РКИ дротаверина при печеночной колике.

Во-вторых, у меня лично результаты этого РКИ вызывают больше вопросов, нежели дают ответов. Так, вроде бы эффективность оценивалась по мнению пациента, но заключение об эффективности выносил врач.

The relief of pain was evaluated by the patient using the VAS and by the investigator considering the patients' opinions on a pain intensity (PI) and a pain-relief scale (PRS) [13]. From these were calculated the pain intensity difference (PID), the total pain intensity difference (SPID), the pain relief (PR) and total pain relief (TPR). The PI and PRS were assessed by the patient and the investigator on a four-grade scale (0, no pain, to 4, unbearable pain; and 0, no pain relief, to 4, complete cessation of pain). The investigators registered the relevant data by questioning the patient at 20-min intervals. The PID and PR were the difference between the initial and recorded values; the SPID and TPR were then calculated as the area bordered by the PID and PR curves and the time axis.

The question for the primary endpoint ('Is the treatment effective?') was answered as 'yes' or 'no' by the investigator and checked in the study from all the documents supervised by the sponsor's representative. The treatment was considered efficient if the pain ceased or its intensity decreased on the VAS by ≥ 40% and/or on the PI by at least half within 40 min after either the first or the second injection. The study drug was considered ineffective if the pain-killing effect developed after either the first or the second injection, but the pain recurred within 1 h, or if there was no painkilling effect. The tolerability was evaluated by the investigators and patients, and was supervised by the sponsor's representative, considering the observed adverse events.

Т.е. дротаверин оказался эффективнее плацебо именно по мнению исследователей...

И тут же:

As assessed by the patient, 91% reported the placebo and 96% drotaverine to be good or very good (Table 1).

Может Вы сможете мне пояснить в чем тут фишка?