Chuanjie Wu1, Dongsheng Guan1, Ming Ren1, Zhengfei Ma1, Changming Wan1, Yinglin Cui1, Ping Zhong1, Wenbo Zhao1, Chuanhui Li1, Feng Yan1, Jinqiu Xie1, Fang Xue1, Yajun Lian1, Hongbo Liu1, Cui Wang1, Xunming Ji1, Nanchang Xie2. 1. From the Department of Neurology (C. Wu, Y.L., H.L., C. Wang, N.X.), First Affiliated Hospital of Zhengzhou University; Department of Neurology (D.G., Y.C.), Second Affiliated Hospital of Henan University of Traditional Chinese Medicine; Department of Neurosurgery (M.R., W.Z., C.L., F.Y., X.J.), Xuanwu Hospital Capital Medical University, Beijing; Department of Neurology (Z.M., P.Z.), Suzhou Municipal Hospital, Anhui; Department of Neurology (C. Wan, J.X.), Jinzhou Central Hospital, Liaoning; and Department of Neurology (F.X.), Second Hospital of Hebei Medical University, Shijiazhuang, China. 2. From the Department of Neurology (C. Wu, Y.L., H.L., C. Wang, N.X.), First Affiliated Hospital of Zhengzhou University; Department of Neurology (D.G., Y.C.), Second Affiliated Hospital of Henan University of Traditional Chinese Medicine; Department of Neurosurgery (M.R., W.Z., C.L., F.Y., X.J.), Xuanwu Hospital Capital Medical University, Beijing; Department of Neurology (Z.M., P.Z.), Suzhou Municipal Hospital, Anhui; Department of Neurology (C. Wan, J.X.), Jinzhou Central Hospital, Liaoning; and Department of Neurology (F.X.), Second Hospital of Hebei Medical University, Shijiazhuang, China. xienanchanghn@163.com.
Abstract
OBJECTIVE: To investigate the efficacy and safety of IV aminophylline for patients with postdural puncture headache (PDPH). METHODS: We randomly assigned patients to groups receiving either 250 mg IV aminophylline or a placebo within 3 hours of symptom onset once daily for 2 consecutive days. The primary endpoint was headache severity 8 hours after treatment. We assessed this using visual analog scale (VAS) scores taken from patients in a standing position. We also recorded posttreatment VAS score changes, Patient Global Impression of Change (PGIC) scores, and adverse events. We performed an intention-to-treat analysis. RESULTS: We enrolled 126 patients with PDPH at 5 centers in China (62 assigned to theaminophyllinegroup and 64 to the placebo group). The median age was 37 years, and 96 (76.2%) patients were women. Compared to the placebo-treated patients, the aminophylline-treated patients had significantly lower mean VAS scores 8 hours after treatment (5.34 vs 2.98, p < 0.001) and were significantly more likely to report improvements on the PGIC (39.1% vs 72.6%, p < 0.01). This therapeutic effect was already evident at the 30-minute time point and persisted for 2 days. There was no significant difference in the incidence of adverse events (4.8% vs 1.6%, p = 0.589). CONCLUSIONS:IV aminophylline is an effective and safe early-stage treatment for patients with PDPH. CLINICALTRIALSGOV IDENTIFIER: NCT02522013. CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that for people with PDPH, IVaminophylline reduces headache severity.
RCT Entities:
OBJECTIVE: To investigate the efficacy and safety of IV aminophylline for patients with postdural puncture headache (PDPH). METHODS: We randomly assigned patients to groups receiving either 250 mg IV aminophylline or a placebo within 3 hours of symptom onset once daily for 2 consecutive days. The primary endpoint was headache severity 8 hours after treatment. We assessed this using visual analog scale (VAS) scores taken from patients in a standing position. We also recorded posttreatment VAS score changes, Patient Global Impression of Change (PGIC) scores, and adverse events. We performed an intention-to-treat analysis. RESULTS: We enrolled 126 patients with PDPH at 5 centers in China (62 assigned to the aminophylline group and 64 to the placebo group). The median age was 37 years, and 96 (76.2%) patients were women. Compared to the placebo-treated patients, the aminophylline-treated patients had significantly lower mean VAS scores 8 hours after treatment (5.34 vs 2.98, p < 0.001) and were significantly more likely to report improvements on the PGIC (39.1% vs 72.6%, p < 0.01). This therapeutic effect was already evident at the 30-minute time point and persisted for 2 days. There was no significant difference in the incidence of adverse events (4.8% vs 1.6%, p = 0.589). CONCLUSIONS: IV aminophylline is an effective and safe early-stage treatment for patients with PDPH. CLINICALTRIALSGOV IDENTIFIER: NCT02522013. CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that for people with PDPH, IV aminophylline reduces headache severity.