Sc24.05 Comparative Efficacy Of Two Primary Care Interventions To Assist Withdrawal From Long Term Benzodiazepine Use: A Clustered Randomised Clinical Trial. Preliminary Results.

C. Vicens1, F. Fiol1, C. Mateu1, I. Socias1, A. Leiva1, E. Sempere2, F. Bejarano3, V. Palop2, E. Aragones3, G. Lera2;
1rediAPP, Palma de Mallorca, Spain, 2rediAPP, Valencia, Spain, 3Catsalut, Tarragona, Spain.
Caterina Vicens
Centro de Salud Son Serra-La Vileta ibsalut
Palma de Mallorca
Phone: 636744907
Long-term use of benzodiazepines (BZD) is not recommended because of their potential adverse effects, the risks of tolerance and dependence, and an increased risk of hip fractures, motor vehicle accidents, and memory impairment. Nevertheless they are widely prescribed in general population.
The objective of this study is to compare the effectiveness and safety of two stepped care interventions in primary care to discontinue long-term BZD use with that of routine care.
We present the methodology, the baseline data and preliminary results at 6 months.
The Design is a three-arm cluster randomized controlled trial. General practitioners (GP) were randomly allocated to: a) structured interview followed by fortnightly follow-up visits (SIF) b) a structured interview plus written instructions (SIW) to self-reduce BZD dose, or c) routine care (RC).
A total of 528 patients were recruited, inclusion criteria were age 18 to 80 and taking BZD for at least 6 months. Eight patients per GP were included before GP randomisation.
Groups were homogeneous at baseline characteristics. Median age was 64(55-72) years, 72,1%(324/519) were women and median BZD use was 53,5(24-112,5) months; BZD had been prescribed in 74,4%(381/512) patients by their GP. According to Hospital Depression and Anxiety (HAD) score, 13,3%(69/518) patients were depressed and 30,3%(156/515) were anxious. 29,6%(154/520) were dissatisfied with their sleep quality and 36,6%(188/514) had BZD dependence by Severity Dependence Scale score.
At six months, 38,2%(71/186) from SIF and 44,4%(71/160) from SIW groups had discontinued BZD compared with 14,1%(24/170) from RC group. In a multilevel analysis adjusted by the cluster effect, odds ratios for SIF and SIW were 3,73(IC95%=2,12-6,55) and 4,9(IC95%=2,75-8,69) respectively, there were no statistically significant effect of the cluster of the GP (Median Odds Ratio= 1,44 p-value=0,1456). There were no statistically significant differences in anxiety and depression score by groups, neither increased alcohol consumption nor dissatisfaction with sleep quality.
Baseline characteristics within groups are homogeneous. Both interventions are about four times more effective than RC to discontinue BZD use with no statistical differences between SIW and SIF groups. Interventions were safe as there were no increase in anxiety, depression, alcohol consumption or dissatisfaction with sleep quality.
Comparative efficacy of two primary care interventions to assist withdrawal from long term benzodiazepine use: A clustered randomised clinical trial. Preliminary results.