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Neurology. 2018 Apr 24;90(17):e1523-e1529. doi: 10.1212/WNL.0000000000005351. Epub 2018 Mar 23.

Aminophylline for treatment of postdural puncture headache: A randomized clinical trial.

Author information

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 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.

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