Oral enzyme combination versus diclofenac in the treatment of osteoarthritis of the knee – a double-blind prospective randomized study

The aim of this study was to compare the efficacy and safety of an oral enzyme–rutosid combination (ERC) containing rutosid and the enzymes bromelain and trypsin, with that of diclofenac in patients with osteoarthritis (OA) of the knee. A total of 103 patients presenting with painful episodes of OA of the knee were treated for 6 weeks in two study centers in a randomized, double-blind, parallel group trial. Altogether, 52 patients were treated in the ERC group and 51 patients were treated in the diclofenac group. Primary efficacy criteria were Lequesnes Algofunctional Index (LFI) and a complaint index, including pain at rest, pain on motion and restricted function. The efficacy criteria were analyzed by applying the Wilcoxon–Mann–Whitney test that provides the Mann–Whitney estimator (MW) as a measure of relevance. Non-inferiority was considered to be proven if the lower bound of the 97.5% one-sided confidence interval (CI-LB) was higher than MW=0.36 (benchmark of not yet relevant inferiority). Both treatments resulted in clear improvements. Within the 6-week observation period, the mean value of the LFI decreased from 13.0 to 9.4 in the ERC group and from 12.5 to 9.4 in the diclofenac group. Non-inferiority of ERC was demonstrated by both primary criteria, LFI (MW=0.5305; CI-LB=0.4171) and complaint index (MW=0.5434; CI-LB=0.4296). Considerable improvements were also seen in secondary efficacy criteria, with a slight tendency towards superiority of ERC. The global judgment of efficacy by physician resulted in at least good ratings for 51.4% of the ERC patients, and for 37.2% of the diclofenac patients. In the majority of patients tolerability was judged in both drug groups as very good or good. The current study indicates that ERC can be considered as an effective and safe alternative to NSAIDs such as diclofenac in the treatment of painful episodes of OA of the knee. Placebo-controlled studies are now needed to confirm these results.Abbreviations ERC Enzyme–rutosid combination - LFI Lequesnes Algofunctional Index Dr. Mehnaz Rashid was the Clinical Trials monitor on behalf of Pacific Pharmaceuticals (Lahore, Pakistan) and Dr. W. Schiess played the same role on behalf of Mucos Pharma (Germany)     

Proximal vaginal flap and needle suspension procedure in management of large urethral fistulas in females

We present a surgical technique for the management of large urethral fistulas associated with urinary incontinence in the female. The repair consists of the development of a well-vascularized proximal vaginal flap and a needle suspension procedure. Two females underwent such repair and are incontinence-free with normal micturition.     

Root formation by tooth germs following extraction of prematurely erupted upper first premolars. Case report

A case is described of a seven year-old boy in whom root formation continued following the premature extraction of both maxillary first premolars.     

Does radial use as a second arterial conduit for coronary artery bypass grafting improve long-term outcomes in diabetics?

Objectives: The evidence supporting the survival benefit of multiple arterial grafts in the general coronary bypass surgery (CABG) population is compelling. Alternatively, results of studies comparing 2 versus 1 internal thoracic artery (ITA) grafts in diabetics have reported conflicting survival data. The use of radial versus ITA as the second arterial conduit has not been studied. Methods: We obtained complete death follow-up in 1516 consecutive diabetic [64 ± 10 years (mean ± SD). Insulin/no insulin: There were 540 (36%)/976 (64%)] primary isolated CABG patients all with ≥1 ITA grafts. The series included 626 ITA/radial (41%) and 890 ITA/vein (59%) patients. Using separate radial-use propensity models, we matched one-to-one 475 (76%) ITA/radial to 475 (53%) unique ITA/vein patients; each including 166 insulin and 309 no insulin patients. Results: Unadjusted survival was markedly better for (1) ITA/radial (94.3%, 86.7% and 70.4% at 1, 5 and 10 years, respectively) versus ITA/vein (91.8%, 74.5% and 53.8%; p < 0.0001) and (2) for no insulin (94.2%, 82.8% and 65.5%) versus insulin (90.4%, 73.1% and 49.2%; p < 0.0001). In matched patients, 11-year Kaplan–Meier analysis showed essentially identical ITA/radial and ITA/vein survival for all diabetics combined (p = 0.53; log rank) and for the no insulin (p = 0.76) cohort. Lastly, a trend for better ITA/radial survival in insulin dependent diabetics after the second postoperative year did not reach significance (p = 0.13). Conclusions: Using radial as a second arterial conduit as opposed to vein grafting did not confer a survival benefit in diabetics. This unexpected result is perhaps related to relatively diminished radial graft patency and/or the augmented radial vasoreactivity characteristic of diabetics. These findings indicate that the radial survival advantage demonstrated in the general CABG population lies primarily in non-diabetics in whom this advantage may be underestimated.