C Garaizar1, J M Prats, E Zuazo. 1. Departamento de Pediatría, Hospital de Cruces, Barakaldo, Vizcaya, España.
Abstract
INTRODUCTION: Common childhood headaches seldom require prophylactic treatment which, nevertheless, is quite often unsatisfactory. OBJECTIVE: To study drug and non-drug related factors that may influence the therapeutic response. MATERIAL AND METHODS: A four-month follow-up study of all patients attended during a year at the neuropediatric, outpatient hospital-based clinic, with > or = 2 monthly migraine without aura attacks, > or = 10 tension-type headaches, or both types of headaches. Patients were randomized to be treated on an open basis, placebo controlled, with flunarizine or piracetam. Headache frequency was evaluated according to treatment and patients' basal characteristics. RESULTS:98 patients studied (56 migraine without aura, 24 tension-type headache, 18 mixed). 33% dropped out; they were school underachievers more frequently than those that completed the protocol. Of those completing the protocol and treated with placebo as the first choice of therapy, 27% reported total remission of symptomatology; those not remitting with placebo were high achievers at school significatively more frequently. At the end of the trial, 43% of the initially randomized patients still complained of headaches, regardless of treatment, showing a seasonal relationship. CONCLUSIONS: Prophylaxis of benign childhood headaches is needed in less than half of those reporting a high headache frequency; school achievement should be taken into consideration as another clue to compliance and headache persistence. On a short-term basis only the seasonal influence and the placebo effect can be held responsible for amelioration of symptomatology.
RCT Entities:
INTRODUCTION: Common childhood headaches seldom require prophylactic treatment which, nevertheless, is quite often unsatisfactory. OBJECTIVE: To study drug and non-drug related factors that may influence the therapeutic response. MATERIAL AND METHODS: A four-month follow-up study of all patients attended during a year at the neuropediatric, outpatient hospital-based clinic, with > or = 2 monthly migraine without aura attacks, > or = 10 tension-type headaches, or both types of headaches. Patients were randomized to be treated on an open basis, placebo controlled, with flunarizine or piracetam. Headache frequency was evaluated according to treatment and patients' basal characteristics. RESULTS: 98 patients studied (56 migraine without aura, 24 tension-type headache, 18 mixed). 33% dropped out; they were school underachievers more frequently than those that completed the protocol. Of those completing the protocol and treated with placebo as the first choice of therapy, 27% reported total remission of symptomatology; those not remitting with placebo were high achievers at school significatively more frequently. At the end of the trial, 43% of the initially randomized patients still complained of headaches, regardless of treatment, showing a seasonal relationship. CONCLUSIONS: Prophylaxis of benign childhood headaches is needed in less than half of those reporting a high headache frequency; school achievement should be taken into consideration as another clue to compliance and headache persistence. On a short-term basis only the seasonal influence and the placebo effect can be held responsible for amelioration of symptomatology.