Cevoli Sabina, Giannini Giulia, Favoni Valentina, Terlizzi Rossana, Sancisi Elisa, Nicodemo Marianna, Zanigni Stefano, Bacchi Reggiani Maria Letizia, Pierangeli Giulia, Cortelli Pietro
IRCCS Institute of Neurological Sciences of Bologna, UOC Clinica Neurologica, Bellaria Hospital, Via Altura 3, 40139, Bologna, Italy.
Department of Biomedical and NeuroMotor Sciences (DiBiNeM), Alma Mater Studiorum - University of Bologna Italy, Bologna, Italy.
J Headache Pain. 2017 Dec;18(1):56. doi: 10.1186/s10194-017-0763-9. Epub 2017 May 12.
Drug withdrawal still remains the key element in the treatment of Medication Overuse Headache (MOH), but there is no consensus about the withdrawal procedure. Still debated is the role of the steroid therapy. The aim of this study was to evaluate the effectiveness of methylprednisolone or paracetamol in the treatment of withdrawal headache in MOH.
We performed a pilot, randomized, single-blinded, placebo controlled trial. MOH patients, unresponsive to a 3 months prophylaxis, underwent withdrawal therapy on an inpatient basis. Overused medications were abruptly stopped and methylprednisolone 500 mg i.v (A) or paracetamol 4 g i.v. (B) or placebo i.v. (C) were given daily for 5 days. Patients were monitored at 1 and 3 months.
Eighty three consecutive MOH patients were enrolled. Fifty seven patients completed the study protocol. Nineteen patients were randomized to each group. Withdrawal headache on the 5th day was absent in 21.0% of group A, in 31.6% of group B and in 12.5% of group C without significant differences. Withdrawal headache intensity decreased significantly after withdrawal without differences among the groups. Rregardless of withdrawal treatment, 52% MOH patients reverted to an episodic migraine and 62% had no more medication overuse after 3 months.
This study suggests that in a population of severe MOH patients, withdrawal headache decreased significantly in the first 5 days of withdrawal regardless of the treatment used. Methylprednisolone and paracetamol are not superior to placebo at the end of the detoxification program.
药物戒断仍是药物过量使用性头痛(MOH)治疗的关键要素,但关于戒断程序尚无共识。类固醇疗法的作用仍存在争议。本研究的目的是评估甲泼尼龙或对乙酰氨基酚治疗MOH戒断性头痛的有效性。
我们进行了一项前瞻性、随机、单盲、安慰剂对照试验。对3个月预防性治疗无反应的MOH患者,在住院基础上接受戒断治疗。突然停用过度使用的药物,每天静脉注射500毫克甲泼尼龙(A组)或4克对乙酰氨基酚(B组)或静脉注射安慰剂(C组),持续5天。在1个月和3个月时对患者进行监测。
连续纳入83例MOH患者。57例患者完成了研究方案。每组随机分配19例患者。第5天时,A组21.0%、B组31.6%、C组12.5%无戒断性头痛,差异无统计学意义。戒断后戒断性头痛强度显著降低,组间无差异。无论戒断治疗如何,52%的MOH患者在3个月后恢复为发作性偏头痛,62%不再有药物过度使用情况。
本研究表明,在重度MOH患者群体中,无论采用何种治疗方法,戒断性头痛在戒断的前5天均显著减轻。在解毒方案结束时,甲泼尼龙和对乙酰氨基酚并不优于安慰剂。