RESUMEN
BACKGROUND: Benzodiazepines are frequently prescribed for sleep disturbances. However, benzodiazepines are associated with side effects, and may be ineffective when used for a prolonged period of time. OBJECTIVES: To investigate for individual patients whether placebo was as effective as temazepam, or whether 10 mg was as effective as 20 mg temazepam, and whether these results influenced their future temazepam use. METHODS: A series of randomized double-blind N-of-1 trials were conducted in general practices in The Netherlands for patients who were using temazepam regularly. Each patient received five pairs of treatments consisting of one week of temazepam (10 or 20 mg) and one week of the control intervention (placebo or 10 mg temazepam). Per pair, the sequence of treatments was randomized. Main outcome measures were: time to fall asleep, and the individual main complaint. RESULTS: Twelve out of 15 patients completed their trial. In three patients there was no difference, in five a large difference, and in four a small difference in favour of temazepam. At follow-up, seven patients had stopped or reduced their temazepam use. CONCLUSION: The results regarding the efficacy of temazepam varied across patients. N-of-1 trials seem to be valuable in patients who are motivated to stop or reduce their temazepam use. They clearly demonstrate the efficacy of temazepam, and may give patients additional confidence to discontinue regular hypnotic use. The value of N-of-1 trials for patients who are less motivated is unclear, as the size of treatment effect does not seem to influence future hypnotic use.
Asunto(s)
Ansiolíticos/farmacología , Sueño/efectos de los fármacos , Temazepam/farmacología , Anciano , Ansiolíticos/administración & dosificación , Relación Dosis-Respuesta a Droga , Método Doble Ciego , Femenino , Humanos , Masculino , Persona de Mediana Edad , Motivación , Países Bajos , Temazepam/administración & dosificaciónRESUMEN
OBJECTIVES: To investigate for individual patients who have been using NSAIDs regularly, whether paracetamol is as effective as non-steroidal anti-inflammatory drugs (NSAIDs) in the treatment of pain and disability related to osteoarthritis of the hip or knee. METHODS: A series of n of 1 trials were conducted in general practices in Amsterdam and the surrounding area. Each patient was his or her own control and received five pairs of treatments comprising two weeks of an NSAID and two weeks of paracetamol. For each pair, the order of treatments was randomised. Outcome measures were severity of individual main complaints, intensity of pain, satisfaction with drugs, function test, and side effects. RESULTS: Thirteen patients were selected. Six patients did not complete the study. For five patients completing the study little or no difference was found between NSAIDs and paracetamol, for one patient the results favoured the NSAID, and for one patient there was no association between outcome and type of drug. It was recommended that six patients changed to paracetamol; the others continued with NSAIDs. Three months after the end of the study, four of the six patients for whom paracetamol had been recommended were taking NSAIDs for practical reasons or perceived lack of efficacy. CONCLUSION: The results of the n of 1 trials varied across patients. n of 1 trials can be used to investigate which treatment is best for any specific person, thus avoiding unnecessary prolonged treatment with NSAIDs. However, practical reasons may cause patients to switch from NSAIDs to paracetamol or not.