Aromatherapy and behaviour disturbances in dementia: a randomized controlled trial. Efficacy of aromatherapy (Lavandula angustifolia) as an intervention for agitated behaviours in Chinese older persons with dementia: a cross-over randomized trial. Aromatherapy as a safe and effective treatment for the management of agitation in severe dementia: the results of a double-blind, placebo-controlled trial with Melissa. Lavender oil as a treatment for agitated behaviour in severe dementia: a placebo controlled study. Aromatherapy in childbirth: a pilot randomised controlled trial. Inhalation aromatherapy during radiotherapy: results of a placebo-controlled double-blind randomized trial. Efficacy of an evidence-based cognitive stimulation therapy programme for people with dementia: randomised controlled trial. [Effectiveness of brief infusions with Ginkgo biloba Special Extract EGb 761 in dementia of the vascular and Alzheimer type]. A randomized controlled trial of the effects of multi-sensory stimulation (MSS) for people with dementia.
A random controlled trial of the relaxing effects of an aromatherapy massage on disordered behaviour in dementia was conducted. Twenty-one patients were randomly allocated into one of three conditions, aromatherapy and massage (AM), conversation and aromatherapy (CA) and massage only (M). AM showed the greatest reduction in the frequency of excessive motor behaviour of all three conditions. This reached statistical significance between the hours of three and four pm (p < 0.05). Post hoc analysis suggested that at this time of day the AM consistently reduced motor behaviour when compared with CA (p = 0.05). This provides preliminary evidence of a measurable sedative effect of aromatherapy massage on dementia within a robust scientific paradigm. Further research is recommended with an expanded sample size.
                Copyright 2001 John Wiley & Sons, Ltd. Agitated behaviours among persons with dementia are distressing to both patients and their caregivers. As pharmacological interventions may be limited by their potentially adverse effects, the use of complementary therapies for treatment of agitation has become more popular and aromatherapy is the fastest growing one.
                This study investigates the effectiveness of lavandula angustifolia (lavender) in treating agitated behaviours of demented people in Hong Kong.
                It was a cross-over randomized trial. Seventy Chinese older adults with dementia were recruited; half were randomly assigned to the active group (lavender inhalation) for three weeks and then switched to control group (sunflower inhalation) for another three weeks; the other half did the opposite. Clinical response was evaluated using the Chinese versions of Cohen-Mansfield Agitation Inventory (CCMAI) and Neuropsychiatric Inventory (CNPI).
                The mean CCMAI total scores decreased from 24.68 to 17.77(t=10.79, df=69, p<0.001). The CNPI scores changed from 63.17 (SD=17.81) to 58.77 (SD=16.74) (t=14.59, df=69, p<0.001) after receiving Treatment A (Lavandula Angustifolia). There were no period and sequential effects noted.
                In summary, lavender is effective as an adjunctive therapy in alleviating agitated behaviours in Chinese patients with dementia. In a patient population particularly vulnerable to side effects of psychotropic medications, aromatherapy using lavender may offer an alternative option.
                Copyright (c) 2007 John Wiley & Sons, Ltd. Behavioral and psychological symptoms in dementia are frequent and are a major management problem, especially for patients with severe cognitive impairment. Preliminary reports have indicated positive effects of aromatherapy using select essential oils, but there are no adequately powered placebo-controlled trials. We conducted a placebo-controlled trial to determine the value of aromatherapy with essential oil of Melissa officinalis (lemon balm) for agitation in people with severe dementia.
                Seventy-two people residing in National Health Service (U.K.) care facilities who had clinically significant agitation in the context of severe dementia were randomly assigned to aromatherapy with Melissa essential oil (N = 36) or placebo (sunflower oil) (N = 36). The active treatment or placebo oil was combined with a base lotion and applied to patients' faces and arms twice a day by caregiving staff. Changes in clinically significant agitation (Cohen-Mansfield Agitation Inventory [CMAI]) and quality of life indices (percentage of time spent socially withdrawn and percentage of time engaged in constructive activities, measured with Dementia Care Mapping) were compared between the 2 groups over a 4-week period of treatment.
                Seventy-one patients completed the trial. No significant side effects were observed. Sixty percent (21/35) of the active treatment group and 14% (5/36) of the placebo-treated group experienced a 30% reduction of CMAI score, with an overall improvement in agitation (mean reduction in CMAI score) of 35% in patients receiving Melissa balm essential oil and 11% in those treated with placebo (Mann-Whitney U test; Z = 4.1, p < .0001). Quality of life indices also improved significantly more in people receiving essential balm oil (Mann-Whitney U test; percentage of time spent socially withdrawn: Z = 2.6, p = .005; percentage of time engaged in constructive activities: Z = 3.5, p = .001).
                The finding that aromatherapy with essential balm oil is a safe and effective treatment for clinically significant agitation in people with severe dementia, with additional benefits for key quality of life parameters, indicates the need for further controlled trials. To determine whether aromatherapy with lavender oil is effective in the treatment of agitated behaviour in patients with severe dementia.
                A placebo controlled trial with blinded observer rater.
                A long-stay psychogeriatric ward.
                Fifteen patients meeting ICD-10 diagnostic criteria for severe dementia and suffering from agitated behaviour defined as a minimum score of three points on the Pittsburgh Agitation Scale (PAS).
                A 2% lavender oil aromatherapy stream was administered on the ward for a two hour period alternated with placebo (water) every other day for a total of ten treatment sessions.
                For each subject 10 total PAS scores were obtained. Five during treatment and five during placebo periods.
                Nine patients (60%) showed an improvement, five (33%) showed no change and one patient (7%) showed a worsening of agitated behaviour during aromatherapy compared with placebo. A comparison of the group median PAS scores during aromatherapy showed a significant improvement in agitated behaviour during aromatherapy compared with placebo (median PAS scores 3 c.f. 4; Wilcoxon Signed-Ranks test p = 0.016 (one-tailed)).
                Lavender oil administered in an aroma stream shows modest efficacy in the treatment of agitated behaviour in patients with severe dementia.
                Copyright 2002 John Wiley & Sons, Ltd. We aimed to determine the feasibility of conducting a randomised controlled trial (RCT) on the use of aromatherapy during labour as a care option that could improve maternal and neonatal outcomes.
                RCT comparing aromatherapy with standard care during labour.
                District general maternity unit in Italy.
                Two hundred and fifty-one women randomised to aromatherapy and 262 controls.
                Participants randomly assigned to administration of selected essential oils during labour by midwives specifically trained in their use and modes of application.
                Intrapartum outcomes were the following: operative delivery, spontaneous delivery, first- and second-stage augmentation, pharmacological pain relief, artificial rupture of membranes, vaginal examinations, episiotomy, labour length, neonatal wellbeing (Apgar scores) and transfer to neonatal intensive care unit (NICU).
                There were no significant differences for the following outcomes: caesarean section (relative risk [RR] 0.99, 95% CI: 0.70-1.41), ventouse (RR 1.5, 95% CI: 0.31-7.62), Kristeller manoeuvre (RR 0.97, 95% CI: 0.64-1.48), spontaneous vaginal delivery (RR 0.99, 95% CI: 0.75-1.3), first-stage augmentation (RR 1.01, 95% CI: 0.83-1.4) and second-stage augmentation (RR 1.18, 95% CI: 0.82-1.7). Significantly more babies born to control participants were transferred to NICU, 0 versus 6 (2%), P = 0.017. Pain perception was reduced in aromatherapy group for nulliparae. The study, however, was underpowered.
                This study demonstrated that it is possible to undertake an RCT using aromatherapy as an intervention to examine a range of intrapartum outcomes, and it provides useful information for future sample size calculations. To determine whether the inhalation of aromatherapy during radiotherapy reduces anxiety.
                Three hundred thirteen patients undergoing radiotherapy were randomly assigned to receive either carrier oil with fractionated oils, carrier oil only, or pure essential oils of lavender, bergamot, and cedarwood administered by inhalation concurrently with radiation treatment. Patients underwent assessment by the Hospital Anxiety and Depression Scale (HADS) and the Somatic and Psychological Health Report (SPHERE) at baseline and at treatment completion.
                There were no significant differences in HADS depression or SPHERE scores between the randomly assigned groups. However, HADS anxiety scores were significantly lower at treatment completion in the carrier oil only group compared with either of the fragrant arms (P =.04).
                Aromatherapy, as administered in this study, is not beneficial. A recent Cochrane review of reality orientation therapy identified the need for large, well-designed, multi-centre trials.
                To test the hypothesis that cognitive stimulation therapy (CST) for older people with dementia would benefit cognition and quality of life.
                A single-blind, multi-centre, randomised controlled trial recruited 201 older people with dementia. The main outcome measures were change in cognitive function and quality of life. An intention-to-treat analysis used analysis of covariance to control for potential variability in baseline measures.
                One hundred and fifteen people were randomised within centres to the intervention group and 86 to the control group. At follow-up the intervention group had significantly improved relative to the control group on the Mini-Mental State Examination (P=0.044), the Alzheimer's Disease Assessment Scale - Cognition (ADAS-Cog) (P=0.014) and Quality of Life - Alzheimer's Disease scales (P=0.028). Using criteria of 4 points or more improvement on the ADAS-Cog the number needed to treat was 6 for the intervention group.
                The results compare favourably with trials of drugs for dementia. CST groups may have worthwhile benefits for many people with dementia. In a placebo-controlled, randomized, double-blind clinical trial, 40 patients with a mean age of 68 (+/- 12.5) years suffering from moderate dementia (Alzheimer, vascular, or mixed type) according to DSM-III-R criteria were included. Severity of the disease had to correspond to stages 4 or 5 of Reisberg's Global Deterioration Scale. Infusions of either EGb 761 or placebo were administered 4 days per week for 4 weeks. Primary outcome measure was the activities of daily living as assessed by the Nürnberger-Alters-Beobachtungsskala (NAB). The Clinical Global Impressions of change (CGI, item 2) and the actual intelligence as assessed by the Kurztest für Allgemeine Intelligenz (KAI) were further target variables. No relevant group differences could be detected at baseline. After therapy, patients of the active substance group scored significantly better (p < 0.05) on each outcome measure than those who received placebo. Using a sequential testing procedure, a global significance level of p < 0.05 could be assured. Superiority of EGb 761 therapy was also found with respect to a self-rating scale for instrumental activities of daily living (Nürnberger-Alters-Alltagsaktivitätenskala), the improvement of the most prominent symptom of illness, and the decrease of depression. Thus clinical efficacy of EGb 761 could be shown on three planes of assessment: the behavioral, the psychopathologic and the psychometric plane. It could be confirmed that, in patients with moderate dementia, short-term intravenous infusion therapy with EGb 761 results in an improvement of psychopathology and cognitive performance, which is reflected in an increased ability to cope with the demands of daily living. To investigate short-term effects of Multi-Sensory Stimulation (MSS) on behaviour, mood and cognition of older adults with dementia, the generalization of effects to day hospital and home environments and the endurance of any effects over time.
                A randomized controlled trial comparing MSS with a credible control of one-to-one activities.
                Fifty patients with diagnoses of moderate to severe dementia were randomized to either MSS or Activity groups. Patients participated in eight 30-minute sessions over a 4-week period. Ratings of behaviour and mood were taken before, during and after sessions to investigate immediate effects. Pre, mid, post-trial, and follow-up assessments were taken to investigate any generalization of effects on cognition, behaviour at the day hospital and behaviour and mood at home and endurance of effects once sessions had ceased.
                Immediately after MSS and Activity sessions patients talked more spontaneously, related better to others, did more from their own initiative, were less bored/inactive, and were more happy, active or alert. Both groups were more attentive to their environment than before, with a significantly greater improvement from the MSS group. At the day hospital, patients in the Activity group improved on their 'speech skills' (amount of speech; initiation of speech), whereas the MSS group remained unchanged during the trial. The MSS group showed a significant improvement in mood and behaviour at home compared to the Activity group whose behaviour deteriorated. No longer-term benefits were shown; indeed, behaviour declined sharply during the month follow-up period.
                Both MSS and Activity sessions appear to be effective and appropriate therapies for people with dementia.
Aroma therapy showed benefit for people with dementia in the only trial that contributed data to this review, but it is important to note there were several methodological difficulties with this study. More well designed large-scale RCTs are needed before clear conclusions can be drawn on the effectiveness of aroma therapy. Additionally, several issues need to be addressed, such as whether different aroma therapy interventions are comparable and the possibility that outcomes may vary for different types of dementia.