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18 October 2011
A systematic review and meta-analysis1 of three randomised controlled trials (RCTs) conducted in UK general practices found that a simple intervention in the form of a tailored letter (with or without additional support, such as consultation with the GP) for long-term users of benzodiazepines, can help them to reduce or stop their medication at six months, without causing adverse consequences. The ‘number needed to post’ for the tailored letter was about 12 for one additional person to stop using benzodiazepines at six months.
Level of evidence:
Level 3 (other evidence) according to the SORT criteria.
Action
Prescribers should be familiar with NICE guidance on insomnia which advises that after non-drug therapies have been explored, hypnotics should be used in the lowest dose possible for no more than 4 weeks with benzodiazepines, or 2 – 4 weeks with Z drugs (zopiclone, zolpidem, zaleplon). NICE guidance on generalised anxiety disorder (GAD) in adults recommends that benzodiazepines are not offered for the treatment of GAD in primary or secondary care except as a short-term measure during crises.
For patients who have been using benzodiazepines long-term, it would seem reasonable to consider trying a simple intervention, such as a tailored letter advising them to reduce or stop taking their benzodiazepine, or a single consultation by their GP. Some key elements of these letters are highlighted below .
What is the background to this?
Risks associated with long term use of hypnotic drugs have been well recognised for many years. In 1988, the Committee on Safety of Medicines (CSM) raised concerns about adverse events including the risk of dependence. Long-term users of benzodiazepines may have been taking them for years and may be heavily dependent on them. They may have no wish to change, and indeed would find it extremely difficult to stop taking these drugs. However, there are many who can be readily encouraged to change.
While simple measures such as a letter to patients from their GP advising them to reduce or stop taking hypnotics can be effective for some, more resource-intensive interventions such as cognitive behavioural therapy (CBT) may be required for others. This study was a systematic review of three RCTs that compared the effectiveness of simple ‘minimal interventions’ to reduce or stop the long-term use of benzodiazepines in adults in primary care, versus allowing patients to continue on their usual dose, over a period of six months.
* ‘Minimal interventions’ were defined as a letter, self-help information, or short consultation with a GP. These explained:
- concern over the patient’s long-term use of hypnotics;
- their potential side effects; and
- advice for patients to gradually reduce or cease their benzodiazepine, with less likelihood of withdrawal symptoms.
What does this study claim?
All three RCTs (615 patients, mean age >60 years) that were included in the systematic review, reported reductions in benzodiazepine consumption in the ‘minimal intervention’ group compared to control groups, over a follow-up period of six months. The pooled risk ratio (RR) showed twice the reduction in benzodiazepine use in the ‘minimal intervention’ groups (either letter or letter and short consultation groups) compared to those on usual care (RR 2.04, 95% confidence interval [CI] 1.48 to 2.83, P<0.001). In the pooled analysis of cessation of benzodiazepine use, the ‘minimal intervention groups’ were associated with twice the rate of cessation of the usual care group (RR 2.31, 95%CI 1.29 to 4.17, P=0.003). The reviewers calculated that for tailored letters the ‘number needed to post’ is about 12 for one additional person to stop using benzodiazepines at six months. Additional details of what this review found are discussed in the ‘study details’ below.
So what?
Prescribing data in England show that prescribing rates of benzodiazepines in general practice have remained steady, and are not decreasing [personal communication from NHS Business Service Authority (NHSBSA), 2011]. This would suggest that there is still room for improvement in reviewing long-term benzodiazepine use to ensure that these drugs are being prescribed as per NICE guidance on insomnia and generalised anxiety disorder.
Older people are not always given appropriate information and advice on the risks associated with hypnotics. A study which explored the beliefs and attitudes among 192 older people who were long-term users of benzodiazepine hypnotics as well as GP practice staff, in the London area found most patients had not worried about the possible harmful effects of hypnotics, perhaps because they did not know about them. Two thirds of patients said that they had not been told of possible harms and fewer than 1 in 5 had received information about harms, or about treatment in general, from their GP. Despite taking hypnotics, two thirds still experienced sleep problems.
Analysis of the trials in this systematic review consistently shows that a simple letter intervention could reduce benzodiazepine use in patients who have been using them long-term. According to the reviewers there appeared to be no additional advantage in either self-help information or a short consultation with a GP. However, the individual RCTs were only designed to compare ‘minimal interventions’ versus continuation of usual dose, and not versus each other. Therefore, there is scope for further research to find methods to enhance the impact of such minimal interventions.
Furthermore, this review reported on the effect of ‘minimal interventions’ (such as letters to patients) on benzodiazepine use at six months. It does not tell us whether the reductions or cessation in benzodiazepine use seen were maintained in the long term. The review also did not assess the impact of these ‘minimal interventions’ on patient-orientated outcomes such as falls and hip fractures in the elderly.
The reviewers concluded that while only a modest percentage of patients will reduce or stop their benzodiazepines, the minimal effort and resource required for sending tailored letters to long-term users suggests it would have a high benefit-to-effort ratio. Therefore, it would make sense to consider this as an initial step ahead of more resource-intensive interventions such as CBT.
The current study identified the following as key elements of primary care practitioners’ letters to reduce hypnotic use:
- Explain your concern over the individual patient’s long-term use of a hypnotic/s – ideally name
- the specific drug(s) and possibly the extent of use over a defined period.
- Highlight potential side effects when taken over a prolonged period.
- Ask the patient to consider a reduction in their use.
- Include advice on how to feasibly, gradually, and safely reduce or cease use.
OR
- Include advice on how to gradually reduce or cease use in a manner that is not only feasible
- but can also decrease the likelihood of withdrawal symptoms.
- Invite the patient to discuss the issue further with you.
Clinical Knowledge Summaries provide further guidance on helping people to withdraw from benzodiazepines. NICE has published audit criteria to support those wishing to review local prescribing of hypnotic drugs. More details about reducing benzodiazepine use are available in section 3 of the NPC e-learning event on insomnia.
Design
Systematic review and meta-analysis of three RCTs in UK general practices.
Patients
Patients included: 615 adults aged over 18 years who had used benzodiazepines for more than 3 months.
Intervention and comparison
This study aimed to systematically review RCTs that evaluated the effectiveness of simple ‘minimal interventions’ to reduce or stop the long-term use of benzodiazepines in adults in primary care, compared to those allowed to continue on the usual dose.
Outcomes and results
See ‘What does this study claim? ’ for primary outcomes.
Two of the studies reported a proportional reduction in consumption of benzodiazepines from baseline to six months in those given ‘minimal interventions’ compared to those allowed to continue with their usual benzodiazepine dose (observed 20 to 35% reduction in the intervention group compared to a 10 to 15% reduction in the control group).
Secondary outcomes examined the impact of ‘minimal interventions’ on parameters such as general health status and the adverse effects of withdrawal. Within some of the studies reviewed there was no significant difference in general health status (for example, measured by a 12-item General Health Questionnaire [GHQ] and/or Short From [36] Health Survey [SF-36]). In terms of the adverse effects of withdrawal, one of the studies reported that at the six-month follow-up period, the proportion of patients who suffered from psychiatric morbidity, according to GHQ, was 11% lower in those who received ‘minimal interventions’ compared to those who did not (3%).
Sponsorship
NHMRC Australia Fellowship
Further information can be found on NHS Evidence and in section 3 of the NPC e-learning event on insomnia on NPC website.
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