Randomized open controlled clinical study on the efficacy and tolerance of an oral enzyme preparation in lymphadenectomy patients
May C.,1 Smola M.,2 Ruda C.,3 Scharnagl E.1
1) Clinical Department of Plastic Surgery, Graz University Hospital, Graz, Austria. 2) Clinical Department of General Surgery, Graz University Hospital, Graz:, Austria. 3) Clinical Department of Conservative Dentistry, Graz University Hospital, Graz, Austria.
Int. J. Immunotherapy 2001, Vol. XVII, No. 2/3/4, pp. 149-152- ISSN 0255-9625
218 K/375 (19-05-3)-(17-10-1)
Summary: We conducted a prospective randomized study to compare the efficacy and tolerance of an oral enzyme preparation with those of diclofenac in patients who had undergone axillary and inguinal lymphadenectomies. The investigation was conducted as an open controlled study in 58 patients of both sexes in randomized parallel groups. The patients’ subjective judgments, clinical test parameters and objective para meters such as limb circumference and volume were determined. The analysis was carried out exploratively according to the intention-to-treat principle, using the observed cases technique. In patients with inguinal lymphadenectomy, more favorable results were obtained in the enzyme group (p <0.05) on the seventh day in pain judgment and in the judgment of other complications (e.g., development of seroma, lymph fistulae). In the overall judgment of efficacy and tolerance, enzyme therapy yielded more favorable results (p <0.001) than did diclofenac. This study demonstrates that enzyme therapy is more effective than diclofenac in the immediate postoperative period following lymphadenectomy. Enzyme therapy showed a much better cost-benefit ratio and tolerance was good throughout.
Int. J. Immunotherapy 2001, Vol. XVII, No. 2/3/4, pp. 149-152- ISSN 0255-9625
218 K/375 (19-05-3)-(17-10-1)
Summary: We conducted a prospective randomized study to compare the efficacy and tolerance of an oral enzyme preparation with those of diclofenac in patients who had undergone axillary and inguinal lymphadenectomies. The investigation was conducted as an open controlled study in 58 patients of both sexes in randomized parallel groups. The patients’ subjective judgments, clinical test parameters and objective para meters such as limb circumference and volume were determined. The analysis was carried out exploratively according to the intention-to-treat principle, using the observed cases technique. In patients with inguinal lymphadenectomy, more favorable results were obtained in the enzyme group (p <0.05) on the seventh day in pain judgment and in the judgment of other complications (e.g., development of seroma, lymph fistulae). In the overall judgment of efficacy and tolerance, enzyme therapy yielded more favorable results (p <0.001) than did diclofenac. This study demonstrates that enzyme therapy is more effective than diclofenac in the immediate postoperative period following lymphadenectomy. Enzyme therapy showed a much better cost-benefit ratio and tolerance was good throughout.