Thirty-eight normocalcemic patients with bone metastases from breast carcinoma were randomized to receive dichloromethylene diphosphonate (CL2MDP) in addition to their specific antitumor treatment (chemotherapy and/or hormone therapy), at a dose of 300 mg/day/i.v. or placebo for the first 7 dys. TheCL2MDP treatment then continued at a dose of 100 mg/day/i.m. for 3 weeks and finally at 100 mg/i.m. on alternate days for at least another 2 months. In both groups of patients there was a reduction in the intensity of pain (Scott-Huskisson analog), but there was a more frequent reduction in the daily consumption of analgesics in patients treated with CL2MDP (p = 0.02). Unlike the controls, the patients who received CL2MDPpresented a significant reduction in urinary calcium (p = 0.003) and in hydroxyproline (p = 0.05) on the 7th day. As regards the clinical evolution, negative events such as the appearance of hypercalcemia, pathological fractures, new bone lesions or a substantial increase in the preexisting ones, were observed in 9 of the 12 evaluable patients treated with placebo and in 3 out of 9 treated with CL2MDP. Thickening of the preexisting osteolytic lesions was reported in 2 patients treated with CL2MDP. Tolerance was excellent: only a few patients complained of pain at the intramuscular drug injection site.
Purpose
In this study, we aimed to determine the role of extracorporeal shockwave therapy (ESWT) in the management of Peyronie's disease (PD).
Materials and Methods
A total of 325 patients suffering from PD were enrolled in this single-arm clinical study. All patients were received ESWT using a schedule of 1 treatment/wk. Penile curvature was measured by a goniometer after intracavernosal drug-induced erection using Alprostadil. Plaque size was measured with a ruler and sexual function assessed by the international index of erectile function (IIEF)-15 score. Severity of erectile dysfunction was classified as severe (IIEF-15 ≤10), moderate (IIEF-15 between 11 and 16), or mild (IIEF-15 between 17 and 25). Results were evaluated at baseline and 3 months after the treatment.
Results
All the patients completed the study protocol. Median age was 59.0 years (55.0–64.0 years). After treatment, the median (interquartile range, IQR) plaque size reduced from 1.78 cm
2
(1.43–2.17 cm
2
) to 1.53 cm
2
(1.31–1.96 cm
2
) (p<0.001); the median (IQR) penile length in erection increased from 13.0 cm (12.0–14.0 cm) to 14 cm (13.0–15.0 cm) (p<0.001) and the median (IQR) penile curvature from 30.4° (22.2°–35.4°) to 25.0° (20.2°–30.4°) (p<0.001). We also observed a decrease in pain assessed by visual analogue scale (7
vs.
3; p<0.001), an improvement in each of the IIEF sub-domains (p<0.001) and an improvement in all three PD questionnaire domains (p<0.001).
Conclusions
Based on our findings, ESWT could be considered a safe and efficient minimally invasive option for the management of the patients suffering from PD.
Thirty-six patients suffering from severe pain due to bone involvement from cancer participated in an analgesic study that compared single doses of ketoprofen 100 or 400 mg iv or injectable acetylsalicylic acid 1 g. A double-blind, balanced incomplete block design was adopted, in which each patient received two of the three test treatments, with an interval of 24 hours. Ketoprofen 400 mg proved significantly superior to 100 mg of the same drug, and was superior to 1 g of the acetylsalicylic acid derivative in the patients' assessment of the overall response. This was expressed by a visual analog scale and preferences. No adverse reaction was observed with any treatment.
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