title: Multicenter randomized study of inosine pranobex versus acyclovir in the treatment of recurrent herpes labialis and recurrent herpes genitalis in Chinese patients.
abstract: The objective of the study is to evaluate the efficacy and safety of oral inosine pranobex as compared with acyclovir in the treatment of recurrent herpes labialis (RHL) and recurrent herpes genitalis (RHG). A multicenter double-blind, double-dummy, randomized, controlled, parallel group trial was conducted in 144 patients with RHL and 144 RHG. Patients were assigned to treatment in one of two groups: (i) inosine pranobex group (active inosine pranobex, 1 g four times daily, and acyclovir placebo); or (ii) acyclovir group (active acyclovir, 200 mg five times daily, and inosine pranobex placebo). The total symptom score (TSS) of patients with RHL did not differ in the inosine pranobex and acyclovir group on the 3rd or 7th day of treatment. There was also no difference in the efficacy rates between the two groups. No difference of TSS was observed between patients with RHG taking inosine pranobex and acyclovir on days 3 or 5 of the treatment, respectively. The short-term clinical recurrence rate of RHG at 3-month follow-up was much lower in the inosine pranobex group than acyclovir group. The incidence of hyperuricemia was higher in the inosine pranobex group than acyclovir group. In conclusion, inosine pranobex was as effective as acyclovir in treating RHL and RHG with significantly greater reduction of the short-term recurrence rate of herpes genitalis at 3-month follow up. Long-term recurrence rates at 6 months or longer remain to be determined. Hyperuricemia should be monitored during the treatment.
authors.affiliation: Department of Dermatology, Southwest Hospital, Nanjing, China.
authors.forename: Yi
authors.initials: Y
authors.lastname: You
authors.affiliation: Department of Dermatology, Southwest Hospital, Nanjing, China.
authors.forename: Li
authors.initials: L
authors.lastname: Wang
authors.affiliation: Department of Epidemiology, College of Preventive Medicine, Third Military Medical University, Chongqing, China.
authors.forename: Yafei
authors.initials: Y
authors.lastname: Li
authors.affiliation: Institute of Dermatology, Chinese Academy of Medical Sciences, Nanjing, China.
authors.forename: Qianqiu
authors.initials: Q
authors.lastname: Wang
authors.affiliation: Department of Dermatology, Affiliated Hospital of Nantong University, Nantong, China.
authors.forename: Shuanglin
authors.initials: S
authors.lastname: Cao
authors.affiliation: Department of Dermatology, Xiehe Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
authors.forename: Yating
authors.initials: Y
authors.lastname: Tu
authors.affiliation: Department of Dermatology, Tongji Hospital, Tongji Medical College, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.
authors.forename: Shenqiu
authors.initials: S
authors.lastname: Li
authors.affiliation: Department of Dermatology, First Hospital of Shanxi Medical University, Taiyuan, China.
authors.forename: Li
authors.initials: L
authors.lastname: Bai
authors.affiliation: Department of Dermatology, The Third Xiangya Hospital of Central South University, Changsha, China.
authors.forename: Jianyun
authors.initials: J
authors.lastname: Lu
authors.affiliation: Department of Dermatology, The Affiliated Hospital of Xuzhou Medical College, Xuzhou, China.
authors.forename: Zhiping
authors.initials: Z
authors.lastname: Wei
authors.affiliation: Department of Dermatology and Allergy, Technical University of Munich, Munich, Germany.
authors.forename: Wenchieh
authors.initials: W
authors.lastname: Chen
authors.affiliation: Department of Dermatology, Southwest Hospital, Nanjing, China.
authors.forename: Fei
authors.initials: F
authors.lastname: Hao
mesh_terms: D000212:Acyclovir / Q000627:therapeutic use*; D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D002681:China; D004311:Double-Blind Method; D005260:Female; D006558:Herpes Genitalis / Q000188:drug therapy*; D006560:Herpes Labialis / Q000188:drug therapy*; D006801:Humans; D007542:Inosine Pranobex / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D012008:Recurrence
chemical_list: D000998:Antiviral Agents; D007542:Inosine Pranobex; D000212:Acyclovir
keywords: acyclovir; clinical trial; inosine pranobex; recurrent herpes genitalis; recurrent herpes labialis