BackgroundDexketoprofen trometamol plus tramadol hydrochloride is a new oral combination of two analgesics, which have different mechanisms of action for the treatment of moderate to severe acute pain.MethodsRandomised, double-blind, parallel, placebo and active-controlled, single and multiple-dose study to evaluate the analgesic efficacy and safety of dexketoprofen/tramadol 25 mg/75 mg in comparison with the single agents (dexketoprofen 25 mg and tramadol 100 mg) in moderate to severe acute pain after abdominal hysterectomy.Patients received seven consecutive doses of study drug within a 3-day period, each dose separated by an 8-hour interval. A placebo arm was included during the single-dose phase to validate the pain model.Efficacy assessments included pain intensity, pain relief, patient global evaluation and use of rescue medication. The primary endpoint was the mean sum of pain intensity differences over the first 8 h (SPID8).ResultsThe efficacy analysis included 606 patients, with a mean age of 48 years (range 25–73). The study results confirmed the superiority of the combination over the single agents in terms of the primary endpoint (p <0.001). Secondary endpoints were generally supportive of the superiority of the combination for both single and multiple doses.Most common adverse drug reactions (ADRs) were nausea (4.6 %) and vomiting (2.3 %). All other ADRs were experienced by less than 2 % of patients.ConclusionsThe study results provided robust evidence of the superiority of dexketoprofen/tramadol 25 mg/75 mg over the single components in the management of moderate to severe acute pain, as confirmed by the single-dose efficacy, repeated-dose sustained effect and good safety profile observed.Trial registrationEU Clinical Trials Register (EudraCT number 2012-004545-32, registered 04 October 2012); Clinicaltrials.gov (NCT01904149, registered 17 July 2013).Electronic supplementary materialThe online version of this article (doi:10.1186/s12871-016-0174-5) contains supplementary material, which is available to authorized users.

OBJECTIVES: The primary clinical objective was to prospectively compare the effectiveness of the "single-incision MESH" technique versus sacrospinous ligament fi xation (ACSSF) in correcting the defect of pelvic organ prolapse (POP) in the anterior and apical compartments, Their effectiveness was assessed at a 1-year/3-year follow-up (FU). METHODS: In the period of 2013-2015, we have randomized 146 women into two groups, namely 73 into ACSSF group and 73 into MESH group RESULTS: At 1-year/3-year FU, we achieved an effectiveness of 92 %/87 % in the point Ba (≤ -1 cm) in the MESH group (48/52; 40/46) vs 70 %/66 % in the ACSSF group (35/50; 30/45); (p = 0.005/p = 0.021). At 1-year/3-year FU, in the area of point C (≤ -1 cm), we achieved a 94 %/91 % effectiveness in the MESH group (49/52; 42/46) vs 90 %/80 % in the ACSSF group (45/50; 36/45); (p = 0.005/p = 0.192). In the MESH group, we observed a more frequent occurrence of "de novo" SUI (11 % vs 6 %) and a defect in the unoperated (posterior) compartment (18 % vs 8 %); the difference was not statistically signifi cant. CONCLUSION: Our study showed that the vaginal synthetic mesh repair of POP did not improve women's outcomes in terms of effectiveness or adverse effects, while the patient satisfaction is the same as compared to that with sacrospinous ligament fi xation at a 3-year FU. In gynecology, there are situations in which the comparison replaces the scientifi c solution (Tab. 5, Fig. 2, Ref. 50).

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