Cholinesterase inhibitors for people with delirium, not incl | Figure 1

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Cholinesterase inhibitors for people with delirium, not including those in intensive care units

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Review question

Is treatment with cholinesterase inhibitors effective and safe at reducing the severity or duration of delirium for people with delirium (not including those in intensive care units)?

Cochrane Review; one trial (15 participants with delirium). The average age of the participants was 82.5 years. Seven also had a history of dementia. This trial compared rivastigmine (a type of cholinesterase inhibitor used in the treatment of dementia) with an inactive treatment (placebo)

Background

During a period of illness, people can develop symptoms of confusion and altered consciousness, which is known as delirium. Compared to patients with no delirium, patients with delirium spend a longer time in hospital and are less likely to survive their illness. Treatment of delirium should focus on good care of the underlying illness and strategies such as reorientation of the patient. However, medication-based treatments are still often used. Medications used for treating the symptoms of dementia (cholinesterase inhibitors) may have a role in treating delirium.

Key results

The trial did not show any difference in effect between those participants given rivastigmine and those given placebo. The study was conducted and reported appropriately, but the small number of participants limits any conclusions that could be made about rivastigmine as a treatment for delirium.

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\ \ The use of benzodiazepines to treat adults with delirium, excluding patients being cared for in intensive care units (ICU)\ Background: Delirium is a serious complication of many illnesses, which occurs most commonly in young children and older adults. It usually presents as a sudden change in a patient's behaviour or mental state. Another name for it is ‘acute confusional state.’ Patients with delirium may not know where they are, what time it is, or what is happening to them. They may have frightening experiences, such as vivid hallucinations. They may become either restless or lethargic and inactive. Delirium can be very distressing for patients and for those who are caring for them. Studies show that about a third of patients on general medical wards develop delirium. It is a frequent complication after surgery (e.g. it happens in up to 60% of people who have surgery for a hip fracture). The effects of delirium can last for a long time. For older people, it can lead to longer hospital stays and it has been associated with increased risks of death, disability, loss of independence, and later dementia. It adds significantly to healthcare costs.\ Benzodiazepines are medicines that are often used as sedatives. Sometimes, healthcare workers prescribe them to treat delirium when other strategies have not helped. Currently, it is not clear if benzodiazepines are an effective treatment for patients with delirium or whether they can harm them.\ Review question: Patients need more and better treatment options for delirium. We wanted to know if benzodiazepines are a helpful treatment option for delirium in any healthcare setting except ICU (patients in ICU are very sick and they may need different kinds of treatment). To find the best answer, we looked for studies where the investigators compared any benzodiazepine to another medicine, or to a dummy medicine that does not contain any active ingredients (placebo). To make the comparison fair, patients in the studies must all have had the same random chance (like the flip of a coin) to receive the benzodiazepine or the other treatment.\ Search date: We searched the medical literature up to 10 April 2019.\ Study characteristics: We found only two small studies which were suitable to include in our review. In one study, the 58 patients who took part all had advanced cancer. They were treated in a specialist palliative care unit. The study compared lorazepam (a benzodiazepine) to placebo. In the second study, the 30 patients all had AIDS (acquired immune deficiency syndrome). They were treated in general medical wards. This study compared lorazepam to two different drugs that are sometimes used to treat delirium.\ Key results: We did not find any important benefits for patients who took lorazepam instead of the other treatment in these two studies. Patients who took it did not have better outcomes. We do not have any definite evidence that lorazepam was more harmful than the other treatment, but, in the study of patients with AIDS, the researchers stopped treating people with lorazepam after the first six people who took it all had serious side effects. Because there were only two suitable studies and both had small numbers of patients in them, we cannot draw any firm conclusions. Currently, there is no good evidence to tell us whether or not benzodiazepines should be used to treat patients with delirium. Clinicians, patients, and carers should be aware of the lack of evidence. We think there is a need for more research, and particularly for studies that involve older patients in general medical and surgical settings, where most delirium is treated.](https://app.figure1.com/case-detail/0390cc7d-ea27-4b61-9d5c-5801794036ad)

\ \ Review question\ What is the evidence for cholinesterase inhibitors (medicines designed to improve memory and thinking in people with dementia), when used with people who have vascular dementia?\ Background\ Vascular dementia (or vascular cognitive impairment) is a term used when a person has problems with memory and thinking that are caused by a disruption of blood supply. There are few drug treatments for vascular dementia.\ In this review, we evaluated three drugs from the cholinesterase inhibitor family, donepezil, rivastigmine, and galantamine. These medications are widely used in Alzheimer's dementia but may also be useful in people with vascular dementia. Previous reviews of these cholinesterase inhibitor drugs could not draw definitive conclusions for people with vascular dementia.\ Purpose of this review\ We wanted to learn whether cholinesterase inhibitors benefit people with vascular dementia. We were interested in their effects on memory, thinking, and daily functioning. We wanted to learn of any harms associated with these drugs.\ As some time has passed since the previous reviews, we wanted to update them by searching for new studies. We combined the three previous reviews on donepezil, rivastigmine and galantamine into one review.\ What we did\ We searched for studies that described the effects of donepezil, rivastigmine, and galantamine for people with vascular dementia. We searched databases of scientific studies and contacted drug manufacturers and experts in vascular dementia. Our search is current to 19 August 2020.\ To be included in our review, studies had to randomly assign people with vascular dementia to treatment with a cholinesterase inhibitor, or a dummy pill (placebo) and then compare the two groups. Studies comparing one cholinesterase inhibitor against another were also included. We combined the results of the included studies for each medicine to estimate how effective they were and how likely they were to cause side effects. We assessed how well the studies were conducted and how credible the results were.\ We did not find studies which compared different cholinesterase inhibitors with each other. To see whether the different cholinesterase inhibitor drugs differed in their effects, we used a technique called network meta‐analysis, which can provide an idea of how the medicines might perform if they were compared head‐to‐head.\ What we found\ We found 8 studies including a total of 4373 people with vascular dementia (or vascular cognitive impairment). The studies tested the drug donepezil at two different doses (5mg and 10mg daily), against each other and against placebo. Rivastigmine and galantamine were tested against placebo only. Rivastigmine is available as a skin patch, but the studies only tested the pill version. All eight studies evaluated participants when they first started taking the medicine or placebo and again six months later. Different tests were used to measure the effects. All studies included tests of memory, thinking and reported side effects.\ People taking donepezil or galantamine had better scores on memory and thinking tests than people taking placebo, but the benefits were modest and may not be large enough to be evident in daily life. There was no evidence of a difference for rivastigmine, but the evidence was less certain, and the doses taken by some participants may have been too low to show an effect. We found evidence that when compared to placebo, side effects such as nausea and diarrhoea, were more common in people taking donepezil 10mg and galantamine, but probably not donepezil 5mg. We were unable to draw conclusions about side effects of rivastigmine from the studies.\ No vascular dementia trials comparing the different cholinesterase against each other have been conducted. Using the information from the individual studies, we made indirect assessments of how the drugs would perform if tested head‐to‐head. The results suggested that donepezil 10 mg had the greatest effect on memory and thinking, but caused more side effects than donepezil 5 mg or galantamine.\ There were only a small number of studies for each drug. Certainty in the results varied between drugs and between outcomes, from high to very low certainty. The studies showed only a small benefit at most; however, in the absence of any other treatments, people living with dementia may still wish to consider use of these drugs.](https://app.figure1.com/case-detail/10edca9a-0f4d-4601-beed-79b6281cbf49)

\ \ Background\ Dementia is the term used to describe a group of illnesses, usually developing in late life, in which there is a deterioration in a person’s ability to think, remember, communicate and manage daily activities independently. It can be caused by several different brain diseases, but the most common form is dementia due to Alzheimer’s disease. At the moment, there are no medical treatments which can prevent dementia or stop it from progressing, but there are two classes of drugs – the cholinesterase inhibitors (donepezil, rivastigmine and galantamine) and memantine ‐ which are approved and widely prescribed to treat some of the symptoms. They are used mainly for dementia due to Alzheimer's disease but also sometimes for other types of dementia. Most of the trials studying the effects of these drugs have been quite short (typically six months) even though dementia usually lasts for years. The drugs can have unwanted side effects in some people. There is uncertainty about their long‐term effects and about how useful they are for severe dementia, with different countries making different recommendations. Therefore it can be difficult for doctors and patients to decide if and when these drugs should be stopped once they have been started.\ What was the aim of this review?\ In this review, we aimed to summarise the best evidence about whether stopping cholinesterase inhibitors or memantine was beneficial or harmful to people with dementia who had been taking them for at least two months.\ What we did\ We searched up to October 2020 for trials which had: recruited people with dementia who were taking a cholinesterase inhibitor or memantine, or both; divided them randomly into a group of patients who continued treatment and a group of patients who stopped treatment; and compared what happened in the two groups.\ What we found\ We found seven trials (759 participants) to include in the review. All of the participants had dementia due to Alzheimer’s disease, but in some trials, the disease was mild to moderate and in others, it was moderate to severe or very severe. Six trials investigated the effects of stopping a cholinesterase inhibitor and one trial investigated stopping either a cholinesterase inhibitor (specifically, donepezil) or memantine. We decided not to pool its results with the other six trials. Effects were measured over different periods of time in different trials. We looked separately at effects in the first 2 months (short term), between 3 and 11 months (medium term), and after a year or more (long term).\ When we looked at the effect on thinking skills and memory, we found that, compared to stopping treatment, continuing treatment with a cholinesterase inhibitor may be beneficial in the short term and medium term and is probably beneficial in the long term. For ability to carry out daily activities, there may be little or no effect in the short term, and the effect in the medium term was very uncertain, but there is probably a benefit to continuing treatment over the longer term. For mood and behavioural problems, continuing treatment may have benefits in the short term and medium term, but not in the long term. We found no clear evidence about the effects of stopping these drugs on patients’ physical health or risk of dying. There was very little evidence about effects on quality of life or on the likelihood of moving to a care home to live. There was not enough evidence for us to see whether results differed with the severity of dementia.\ Our certainty in the results varied from moderate to very low, mainly because of small numbers of trials and participants, some problems with the way the trials were conducted, and imprecise statistical results.\ Our conclusions\ Although there was uncertainty about the results, most of the evidence pointed to benefits of continuing treatment with cholinesterase inhibitors. There was no evidence about types of dementia other than Alzheimer’s disease, and we were unable to draw specific conclusions about continuing or stopping treatment at different stages of the illness. We found no trials that just investigated stopping memantine.\ These results may help patients and their doctors to make decisions about whether or not to continue treatment, although other factors, such as side effects in an individual patient and the patient’s preferences, are also important.](https://app.figure1.com/case-detail/198b6951-39ef-4467-8c9e-7b47373aaab7)

\ \ Background\ Delirium is common in people with a terminal illness. A person experiencing delirium may be confused, lack concentration, have disturbed patterns of sleep and waking, and experience hallucinations. Delirium can start suddenly and can cause distress to both the person and their family. Delirium may be caused by the underlying disease with which the person is affected, or as a side effect of drugs or other symptoms. Often it is not clear why a person has delirium. The multifaceted nature of delirium makes its management challenging. When it is not possible to identify the underlying cause, drug treatments are sometimes used to manage the symptoms.\ Study characteristics\ The aim of this review was to find out what we know about the effectiveness and side effects of drugs in the management of delirium in adults with a terminal illness. For the purpose of this review, terminally ill adults includes anyone with an advanced progressive illness such as advanced cancer, advanced dementia or organ failure, as well as those receiving hospice and end‐of‐life care. We compared drug therapy with placebo (a substance with no known active effect), usual care, or any other drug or non‐drug treatment.\ Key results\ Our search to July 2019 found four trials, involving 399 adults in total. Participants had advanced cancer (three studies) or advanced AIDS (one study), and all had symptoms of delirium. The drugs evaluated were antipsychotics (three studies) or benzodiazepines (one study), compared to placebo or each other, on their own or in combination with another drug or placebo.\ Most studies reported the outcomes we deemed most important: delirium symptoms, agitation, and adverse events (side effects).\ It was not possible to combine the data from different studies due to a lack of similarity between them. We found low‐quality evidence that certain drugs (haloperidol and risperidone) may slightly worsen delirium symptoms for terminally ill adults with mild‐ to moderate‐severity delirium. We found moderate‐quality evidence that haloperidol probably slightly increases adverse side effects for people with mild‐ to moderate‐severity delirium.\ Quality of the evidence\ We rated the quality of the evidence from studies using four levels: very low, low, moderate, or high. Very low quality evidence means that we are very uncertain about the results. High‐quality evidence means that we are very confident in the results. We found no high‐quality evidence. This was due to the small number of people taking part, the number of people dropping out of the studies, and the small number of studies.\ Conclusion\ We found low‐quality evidence that, compared to placebo, drug therapy (specifically haloperidol and risperidone) may slightly worsen delirium symptoms in terminally ill people with delirium of mild to moderate severity. We found low‐ to moderate‐quality evidence that these drugs may slightly increase adverse side effects. Given the small numbers of studies and participants on which current evidence is based, further research is essential.](https://app.figure1.com/case-detail/41b78176-e103-49d6-ab70-21a1a681df71)

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