Efficacy and Safety of Parecoxib/Phloroglucinol Combination Therapy Versus Parecoxib Monotherapy for Acute Renal Colic: A Randomized, Double-Blind Clinical Trial

• Published in: Cell biochemistry and biophysics Vol. 69; no. 1; pp. 157 - 161
• Main Authors: Fu, Weihua, Yao, Jiwei, Li, Qianwei, Wang, Yongquan, Wu, Xiaojun, Zhou, Zhansong, Li, Wei-Bing, Yan, Jun-An
• Format: Journal Article
• Language: English
• Published: Boston Springer US 01.05.2014; Springer Nature B.V
• Subjects: Adolescent; Adult; Aged; Biochemistry; Biological and Medical Physics; Biomedical and Life Sciences; Biophysics; Biotechnology; Cell Biology; Cyclooxygenase 2 Inhibitors - therapeutic use; Double-Blind Method; Drug Synergism; Drug Therapy, Combination; Female; Humans; Injections, Intravenous; Isoxazoles - therapeutic use; Life Sciences; Male; Middle Aged; Original Paper; Pain; Pain Measurement; Parasympatholytics - therapeutic use; Pharmacology/Toxicology; Phloroglucinol - therapeutic use; Renal Colic - drug therapy; Renal Colic - physiopathology; Treatment Outcome; Visual analog scale; Analgesia; Parecoxib; Pain; Renal colic; Phloroglucinol
• ISSN: 1085-9195; 1559-0283
• DOI: 10.1007/s12013-013-9782-6

To investigate whether the addition of phloroglucinol to parecoxib could improve the efficacy in patients with acute renal colic. Patients of acute renal colic were randomly allocated to receive intravenous Parecoxib 40 mg plus placebo or Parecoxib 40 mg plus phloroglucinol 80 mg, respectively. Pain intensity was recorded using a visual analog scale (VAS) before drug administration and 5, 15, 30, 60, and 120 min after treatment start. The primary outcome was the mean pain intensity difference (PID) at each checkpoint and the effectiveness of drugs (≥50 % decrease in VAS score at the end checkpoint). The need for rescue analgesics and the incidence of adverse effects were considered as secondary outcome of the study. Among 236 patients enrolled in the study, 119 patients received intravenous parecoxib plus placebo and 114 patients received intravenous parecoxib plus phloroglucinol, the remaining 3 patients given up treatment. Baseline demographics were similar between two groups. There are significant differences in the PID at 15 and 30 min between two groups ( P 15 min  = 0.011, P 30 min  = 0.013). Rescue analgesics were required by 17 patients (14.3 %) receiving parecoxib, 7 patients (6.1 %) receiving parecoxib plus phloroglucinol ( P  = 0.041). There were no differences in PID at other checkpoints between two groups, as well as in the incidence of adverse events and the drug effectiveness. Parecoxib in combination with phloroglucinol for acute renal colic has a faster action, also reduces the demand of rescue analgesics.