Of these, aroma therapy is reported to be the most widely used in the British Nattional Health Service and might be of use for people with dementia for whom verbal interaction may be difficult and conventional medicine of only marginal benefit.Aroma therapy has been used for people with dementia to reduce disturbed behaviour (e.g. Brooker 1997), promote sleep (e.g. Wolfe 1996), and stimulate motivational behaviour (e.g. MacMahon 1998).
Objective: To assess the efficacy of aroma therapy as an intervention for people with dementia.
Search strategy: The Cochrane Dementia and Cognitive Improvement Group's Specialized Register was searched on 29 October 2002 to find all relevant trials using the terms: aroma therapy, "aroma therapy", "complementary therapy", "alternative therapy" and "essential oil". The CDCIG Register contains records from all major health care databases and is updated regularly. Additionally, relevant journals were hand searched, and \'experts\' in the field of complementary therapies and dementia contacted.
Selection criteria: All relevant randomized controlled trials (RCTs) were considered. A minimum length of trial and requirements for a follow-up were not included, and participants in included studies had a diagnosis of dementia of any type and severity. The review considered all trials using fragrance from plants defined as aroma therapy as an intervention with people with dementia. Several outcomes were considered in this review, including cognitive function, quality of life, and relaxation.
Data collection and analysis: The titles and abstracts extracted by the searches were screened for their eligibility for potential inclusion in the review, which revealed 2 RCTs of aroma therapy for dementia. Neither of these had published results in a form that we could use. However, individual patient data from one trial were obtained (Ballard 2002) and additional analyses performed. Analysis of co-variance was used for all outcomes, using a random effects model.
Main results: The additional analyses conducted revealed a statistically significant treatment effect in favour of the aroma therapy intervention on measures of agitation and neuropsychiatric symptoms.
Reviewers' conclusions: Aroma therapy showed benefit for people with dementia in the only trial that contributed data to this review, but there were several methodological difficulties with this study. More well designed large-scale RCTs are needed before 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.
{mospagebreak}Background
"Complementary" (or "alternative") therapies have become more popular and commonly used over the last decade and have been applied to a wide range of health problems, including care for people with dementia care. Therapies have included massage (e.g. Kim 1999), aroma therapy (e.g. Vance 1999), acupuncture (e.g. Jiang 1995), and herbal medicine (e.g. Perry 1999). Of these, aroma therapy is reported to be the most commonly used in the British National Health Service (Lundie 1994), and is possibly the most widely used complementary therapy for people with dementia (Petit-Zeman 2000). It is also probably the complementary therapy most familiar to consumers, and seen as a relatively un-invasive procedure.
Aroma therapy is a part of the discipline of phytotherapy (the use of whole plants or parts of plants for medicinal purposes), and uses pure essential oils from fragrant plants (such as Peppermint, Sweet Marjoram, and Rose) to help relieve health problems and improve quality of life in general (OnHealth 2000). Essential oils have been defined as \'non-oily, highly fragrant essences extracted from plants by distillation, which evaporate readily\' (Tisserand 1988), and have been used by doctors in France for their antibiotic and antiviral properties for many years (Tisserand 1988). They are most commonly used in oil burners, in bath water, or massaged into the skin, thus the aroma of the essential oil evaporates and stimulates the olfactory sense. The healing properties of aroma therapy are claimed to include promotion of relaxation and sleep, relief of pain, and reduction of depressive symptoms (e.g. Halycon 2000), the rationale being that the essential oils have a calming and de-stressing effect. As such, aroma therapy might be of use as an intervention for people who have little or no preserved language function, are confused, or for whom verbal interaction is difficult and conventional medicine is seen as of only marginal benefit. Aroma therapy has therefore been used for people with dementia to reduce disturbed behaviour (Brooker 1997), promote sleep (e.g. Wolfe 1996), and stimulate motivational behaviour (e.g. MacMahon 1998).
Despite its frequent use, the rationale for aroma therapy is based on anecdotal rather than scientific evidence. Moreover, aroma therapy does impose a cost on consumers. It is also frequently used in combination with other therapeutic approaches, such as massage, which adds to the cost, is more intrusive, and increases the vulnerability of the recipients. Additionally, there remain some concerns regarding the safety of aroma therapy, as some essential oils have been found to have a significantly toxic effect on rodents (Tisserand 1996). Aroma therapy is currently not under any licensing restrictions, and is easily accessible from pharmacies and health product stores. There is therefore a need for the effects of aroma therapy to be adequately documented.
A number of papers have dealt with general issues related to aroma therapy : Connell 2001; Flanagan 1995; Garnett 1994; Henry 1993; Kirkpatrick 1998; Rose 1998; Tobin 1995; Vance 1999.
There have been several studies of aroma therapy in relation to people with dementia that were not RCTs.
{mospagebreak}Burleigh 1997 used a ABAB design to assess the effects of Lavender, Roman Chamomile, Rosemary and Marjoram on the Behaviour Assessment Scale of Later Life (Brooker 1993) of seven participants with dementia . They found a significant reduction of challenging behaviour for four of the five female participants, but an increase of challenging behaviour for the two male participants. Six of the participants additionally showed a decreased need for assistance with activities of daily living. West 1994 reported a single-case study of the effects of \'aromatic oils\' on the sleeping pattern on a person with dementia. Their results showed an improvement of sleep patterns and a decrease of agitation. Wolfe 1996 assessed the effects of Lavender and Roman Chamomile on sleep patterns in two people with severe dementia acting as their own controls. There was a mean increase of peaceful sleep for one participant, but a mean decrease of peaceful sleep for the other participant.
Kilstoff 1998 used the action research method, which is a qualitative method encouraging participants to design, implement, and evaluate an intervention, to assess the effects of Lavender, Mandarin and Geranium with hand massage on sixteen recipients of day-care who had dementia. The findings indicated a perceived strengthening of the relationship between the people with dementia and their carers, and an improvement in feelings of health and wellbeing for both recipients and carers.
MacMahon 1998 reported a single-subject AB design study of the effects of an aroma therapy intervention, 'Zeal', on the motivational behaviour of one person with dementia. The results show a significant improvement on the rating scale employed. Vetrivanathan (reference unavailable) used The Brief Agitation Scale (Finkel 1993 ) and The Relaxation Checklist (Luiselli 1982) to evaluate the effects of Lavender and massage on seven participants with dementia on an acute assessment ward. The results from this study showed some short-term decrease of agitation, an increase in relaxation one hour after the intervention, but a decrease in relaxation before and immediately after the intervention.
Henry 1993 used a cross-over design with nine patients with dementia in a hospital ward to investigate the effects of Lavender, using sleep charts as outcome measure. The results showed a significant increase in duration of sleep (p<0.05).
Gray 2002 studied 13 older people with dementia living in residential care. All participants were described as being consistently resistive to medication administration, and had displayed an ability to perceive aromas. Each participants was exposed to three different aromas by means of a cotton ball taped to their clothing 20 minutes before medication was administered. The essential oils used were Lavender, Sweet Orange and Tea Tree, with no aroma as the control condition. Duration of medication administration and frequency and duration of resistive behaviour during this was used as outcome, but no significant differences were found.
Bowles 2002 used a cross-over design to investigate the effects of Lavender, Sweet Marjoram, Patchouli and Vetiver on resistance to nursing care procedures and frequency and duration of \'dementia-related behaviours' (aggression etc.). Participants were 56 (36 after attrition) aged care facility residents with moderate to severe dementia. The essential oils were blended into an aqueous cream and massaged onto the bodies and limbs of the residents five times a day, and behaviour recorded throughout the 8 weeks of the trial. The control condition was cream only. They found a significant decrease in 'dementia-related behaviours' occurring at times other than during nursing care, while resistance to nursing care increased for half of the participants. A significant improvement was also found on the Mini Mental State Evaluation (Folstein 1975) for some participants.
{mospagebreak}Brooker 1997 reported on the effects of massage and Lavender, separately and in conjunction, on the disturbed behaviour of four people with dementia on a continuing care ward. The researchers developed individualized disturbed behaviour scales, which they tested for inter-rater reliability (p<.001). The results from this study showed a significant difference following the aroma therapy for one participant. For two participants, the massage and aroma therapy was associated with an increase of agitated behaviour.
Holmes 2001 investigated the effects of Lavender on agitated behaviour in 15 patients with severe dementia on a long-stay psychogeriatric ward. This was a placebo-controlled trial with blinded ratings, with the participants acting as their own controls. The outcome measure used was the Pittsburgh Agitation Scale (Rosen 1994). The results show a significant mean improvement of the group, but five of the participants showed no change, and one a worsening of agitated behaviour.
Objectives
The aim of this review is to assess the efficacy of aroma therapy for people with dementia.
Criteria for considering studies for this review
Types of studies
This review considered all relevant randomized controlled trials (RCTs). Owing to the nature of aroma therapy double-blinding may not be possible when combined with informed consent. A minimum length of trial and requirements for a follow-up were not inclusion criteria.
Types of participants
Participants in included studies were to have a diagnosis of dementia of any type and severity, based on diagnostic criteria such as ICD-10 (WHO 1993 ) and DSM-IV (APA 1994 ), or well validated assessment scales for cognitive function, such as the MMSE (Folstein 1975) and ADAS-Cog (Rosen 1994).
Types of intervention
This review considered trials using fragrance from plants, in an intervention defined as aroma therapy, for people with dementia. All doses, frequencies, and fragrances were considered.
Types of outcome measures
- The outcomes considered in this review were:
- 1. cognitive function
- 2. functional performance
- 3. behaviour
- 4. quality of life
- 5. relaxation
- 6. wandering
- 7. sleep
- 8. mood
{mospagebreak}Search strategy for identification of studies
See: Cochrane Dementia and Cognitive Improvement Group search strategy
The Cochrane Dementia and Cognitive Improvement Group\'s Specialized Register was searched on 29 October 2002 to find all relevant trials using the terms: aroma therapy, "aroma therapy", "complementary therapy", "alternative therapy" and "essential oil". At that time the Register contained records from the following databases:
- CCTR/Central: July 2002 (issue 3);
- MEDLINE: 1966 to 2002/09 (week 4);
- EMBASE: 1980 to 2002/08;
- PsycINFO: 1887 to 2002/7;
- CINAHL: 1982 to 2002/08;
- SIGLE (Grey Literature in Europe): 1980 to December 2001 (no further updates available at 29/09/02);
- ISTP (Index to Scientific and Technical Proceedings): to May 2000;
- INSIDE (BL database of Conference Proceedings and Journals): to June 2000;
- Aslib Index to Theses (UK and Ireland theses): 1970 to June 2001;
- Dissertation Abstract (USA): 1861 to June 2001;
- ADEAR (Alzheimer\'s Disease Clinical Trials Database): to September 2002;
- National Research Register: issue 3/2002;
- Current Controlled trials (last searched September 2002) which includes:
- Alzheimer Society
- GlaxoSmithKline
- HongKong Health Services Research Fund
- Medical Research Council (MRC)
- NHS R&D Health Technology Assessment Programme
- Schering Health Care Ltd
- South Australian Network for Research on Ageing
- US Dept of Veterans Affairs Cooperative Studies
- National Institutes of Health (NIH)
- ClinicalTrials.gov: last searched September 2002;
- LILACS:Latin American and Caribbean Health Science Literature: 40th edition, May 2001 (last one available on 29/09/02).
- The search strategies used to identify relevant records in MEDLINE, EMBASE, PsycInfo, CINAHL and Lilacs can be found in the Group's module.
- In addition the following online journals were searched: 'Complementary Therapies in Medicine', and 'Complementary Therapies in Nursing and Midwifery'.
- 'Experts' in the field of complementary therapies were contacted to identify ongoing and unpublished research as well as the Aroma Therapy Organisations Council.
{mospagebreak}Methods of the review
SELECTION OF TRIALS
- LMT and AS independently screened the titles and abstracts extracted by the searches for their eligibility for potential inclusion in the review based on the above criteria, which were discussed with MO. Although only 3 RCTs were detected, hard copies of all investigations thought to use aroma therapy as an intervention for people with dementia were retrieved, for the purpose of the discussion and suggestions for further research. Of the 26 publications obtained, 6 were descriptive papers, 4 did not use aroma therapy, 1 did not include people with dementia in its sample and 1 included people without dementia. Of the 14 studies using aroma therapy for people with dementia, 8 were case studies, 1 used an action research design, 1 was a non-randomized placebo-controlled trial, 1 was a non-randomized controlled trial with a cross-over design, and 3 were RCTs, but one of them had no information on blinding at all .
QUALITY ASSESSMENT
- A checklist for assessing the quality of all studies identified was developed, as presented below.
- Checklist for assessing methodological quality.
- Does the paper include:
- 1) A thorough review of the literature?
- 2) Hypothesis formulation/aims/power analysis?
- 3) Details of informed consent?
- 4) Description/justification of sampling procedure?
- 5) Description/justification of design (for non RCTs)?
- 6) Justification of lack of controls (for non RCTs)?
- 7) Details of randomization method(s) (selection bias)?
- 8) Number/details of drop-outs (attrition bias)?
- 9) Description/justification/standardization of outcome measures?
- 10) Blind assessment/details of assessor(s) (detection bias)?
- 11) Clearly presented results (appropriate statistics)?
- 12) A description of limitations of study/design (for non RCTs)?
- 13) Intention to treat analysis?
- 14) Suggestions for future research?
DATA COLLECTION
- Neither of the two included studies published results in a form that we could use. Professor Ballard allowed us access to the individual patient data from his study and we were able to perform analyses additional to those that had been published.
{mospagebreak}DATA ANALYSIS
- The design of Ballard 2002 was hierarchical with two levels, involving residents in nursing homes. Eight homes were matched in pairs, and within each pair the homes were randomized to treatment or control. Thus, the unit of randomization was the home. There were blocks within treatment group, the matched pairs of homes, which should have been taken into account for the analysis, but no information was available on the identity of the pairs.
Since the residents within homes were not the units of randomization, the mean assessments of all residents within a home were the outcomes values for each home. Analysis of co-variance was used for all outcomes, with the home being treated as a random effect. The change from baseline was analysed for all outcomes. The treatment effect for an outcome was the difference between the overall means of the four homes on treatment and the four homes on placebo. The contribution from each home was weighted and this weight depended on the precision of the mean value for each home. The PROC MIXED procedure in SAS® was used for all analyses.
There were several participant level covariates that could be included in the model, such as age, sex, baseline measures and the medication being taken (Table 01).
Description of studies
EXCLUDED STUDIES:
- Mitchell 1993 investigated the effects of 3% Lemon Balm (Melissa) in grape seed oil and 100% Lavender on criteria developed for the study to reflect functional disabilities and behavioural difficulties in a cross-over RCT. This study used a sample consisting of 12 older adults (64-91) with \'dementia related disorders\' in a day care and residential respite unit. The control condition was grape seed oil applied in the same manner as for the experimental condition. The outcome concerned the assessment of 6 possible functional and behavioural disabilities on a subjective scale of very poor, poor or satisfactory. These were repeated at baseline, and at weekly intervals. Mitchell 1993 found an increase of functional abilities, decrease of difficult behaviours, and somewhat increased restlessness at night. The intervention did not have a sedative effect, as was expected by the researcher. However, there are no details of how the assessments were carried out, how results were analysed, and there is no definition of 'mean satisfaction rating ' which appears in the histogram of results. The cited results cannot be treated seriously owing to the lack of essential information.
- The study report included a thorough review of the literature, but no hypothesis or details of informed consent or ethics approval. Not enough information was supplied to enter in a meta-analysis. In addition, the scales used to assess outcomes did not appear to have been sufficiently validated.
SELECTION BIAS: No details of randomization method were reported.
ATTRITION BIAS: No drop-outs were reported.
DETECTION BIAS: No blinding of raters to allocation was reported.
PERFORMANCE BIAS: No blinding of staff to allocation was reported.
{mospagebreak}INCLUDED STUDIES:
Ballard 2002 in an RCT used 10% Melissa and base lotion applied topically to arms and face twice daily for 1-2 minutes for 4 weeks as their intervention. The control condition was sunflower oil applied in the same way. The participants were 72 people with severe dementia, diagnosed with the Clinical Dementia Rating scale (Hughes 1982) and clinically significant agitation, from 8 NHS specialist nursing homes. Outcome measures were: Cohen-Mansfield Agitation Inventory (Cohen-Mansfield 1989), The Neuropsychiatric Inventory (Cummings 1994) and Dementia Care Mapping (Kitwood 1997).
The results of Ballard 2002 are outlined in the results section.
Smallwood 2001 report an RCT of the effects of Lavender applied topically through massage and Lavender in diffuser accompanied by conversation. The control condition was massage only. Their sample consisted of 21 patients with a prior diagnosis of dementia in a district general hospital ward. Assessments consisted of using a video camera to record behaviour for 15-minute periods over a day in a specified sequence and frequency. The video records were sampled and coded into 6 behaviour categories developed by two blinded raters. Inter-rater reliability was found to be 86% for a randomly chosen sample consisting of 20% ratings. The outcome used was the mean of several measurement of frequency of these defined behaviours, and analyses were conducted on the changes of this from baseline. Smallwood 2001 found no statistically significant difference between groups. The investigators found a significant interaction of treatment with time of day in the massage with AT condition (p<0.01), with the greatest improvement relative to the other conditions between 15.00 and 16.00 hours (p<0.05).
Methodological quality
Ballard 2002 included a thorough review of the literature, with a clearly stated hypothesis. Details of informed consent and ethics approval were given. The design randomized nursing homes, matching blocks of 2 for size of home. This is problematic, as only 8 homes were included, and great heterogeneity between these could have been present. Additionally, most participants were on medication to control behaviour during the trial. The medication could be changed during the trial if necessary and therefore was confounded with the aroma therapy.
SELECTION BIAS: Details of randomization method were reported.
ATTRITION BIAS: Drop-outs were accounted for.
DETECTION BIAS: Raters were blinded to allocation.
PERFORMANCE BIAS: Blinding of staff to allocation was ensured as far as possible within the constraints of the design.
Smallwood 2001 reported no details of analyses, and it is not possible to assess treatment effect. The rationale for looking at interaction with time of day is not given, may have been stimulated by inspection of the data, and is seemingly not very meaningful. The choice of Lavender as the aroma therapy intervention did not follow logically from the literature review, and details of informed consent were not given, although ethics permission was granted. Additionally, the duration of the trial was not reported.
{mospagebreak}SELECTION BIAS: No details of the method of randomization was reported.
ATTRITION BIAS: There was one drop-out from the 21 participants, following deterioration of health.
DETECTION BIAS: Raters were blinded to allocation.
PERFORMANCE BIAS: No blinding of staff to allocation was reported.
Results
There were two included studies, with a total of 93 patients. It was not possible to use the results from Smallwood 2001 in the meta-analysis.
- The only study that contributed was Ballard 2002, with 72 patients.
- The additional analyses conducted on the data obtained from Ballard 2002 revealed a statistically significant treatment effect in favour of the aroma therapy after 4 weeks treatment on several outcome measures (Table 02):
- From the Cohen-Mansfield Agitation Inventory (CMAI; Cohen-Mansfield 1989):
- CMAI total score [MD -11.1 95% CI -19.9 to -2.2 , P=0.022]
- CMAI physical non-aggression [MD -1.42 95% CI -8.8 to -1.9 , P=0.009]
- CMAI verbal non-aggression [MD -2.9 95% CI --5.1 to -0.7 , P=0.018]
- The Neuropsychiatric Inventory (NPI; Cummings 1994 ):
- NPI total [MD -15.8 95% CI -24.4 to -7.2, P=0.004]
- NPI agitation [MD -2.3 95% CI -4.5 to -0.1, P=0.041]
- NPI aberrant motor behaviour [MD-3.0, 95% CI -6.0 to 0.0, P=0.05]
The analysis of this trial has been described in the Data Analysis section. There were several participant level covariates that could be included in the model, such as age, sex, baseline outcomes and those describing the medication being taken (Table 01). When tested in the model for each outcome the only medication variable that had a significant effect was whether the patient was taking atypical neuroleptics. Sex and the baseline value of the outcome measure also had significant effects. Therefore, the estimate of the treatment effect was adjusted for sex, baseline measure of the outcome, and use of atypical neuroleptic medication.
{mospagebreak}Discussion
Only one RCT of aroma therapy for dementia with useable data was detected by the reviewers (Ballard 2002). The re-analysis of the results from this study revealed a significant effect in favour of the intervention on measures of agitation and neuropsychiatric symptoms. However, several methodological difficulties were detected. The participants included were taking a range of medication, including antipsychotics and neuroleptics. Any of these could have be altered during the trial, with a confounding effect on the results. The authors attempted to ensure double-blinding by randomizing centres and not individual participants, so that only one substance was used in each facility. However, this presents a problem as there might have been great variation between the 8 nursing homes included in the study, which could have further confounded the results from this trial.
A vast number of outcomes from aroma therapy for people with dementia were found in a literature consisting mostly of qualitative research, and small-scale trials of which only a few were RCTs. The majority of reports (58.2%) were in favour of the interventions used, and included outcomes such as relaxation/agitation (18.0%), behaviour (44.4%), functioning (12.7%), sleep (7.7%), cognition (4.9%) or other outcome variables, such as strengthening of relationships (11.3%). However, some (17.6%) outcomes were not in favour of aroma therapy, including sleep (30.2%), relaxation/agitation (58.1%), and behaviour (11.6%). However, the great majority of reported research on aroma therapy for people with dementia is of scientifically inadequate quality. In view of the possibility of a host of biases, no conclusions can be drawn. The reports can, however, give indications to inform researchers in the design of studies investigating aroma therapy. In finding some support for a beneficial effect of aroma therapy for people with dementia, the literature indicates that further, more adequate research is needed. Of equal importance are the findings of some adverse effects following aroma therapy, questioning the widespread assumption that it at least does no harm.
In reading the literature on aroma therapy for dementia several issues emerge that need to be considered in future research. Different forms of dementia as well as other variables, including sex, age, and severity of dementia might need to be investigated, in attempting to establish what effects aroma therapy has, and for whom. Additionally, the literature shows a variety of different essential oils being classed as aroma therapy interventions, including Lavender, Roman Chamomile, Mandarin, Geranium, Marjoram, Melissa, Patchouli, Vetiver, Sweet Orange and Tea Tree, as well as several combinations. The comparability of these fragrances has not been established. Furthermore, the interventions are given by people with a variety of levels of training, from completely untrained members of care staff teams to trained aroma therapists, and with different modes of application, frequencies and dosages. There are additional difficulties surrounding the disparate outcome measures used in the literature, from standardized, well validated instruments to individualized scales specifically designed for a particular study. There also seems to be great variation in the timing of follow-up assessments. Thus categorization of outcomes assessed for any future review and meta-analysis might be problematic. These are all issues that need to be addressed as more RCTs of aroma therapy for dementia are conducted.
{mospagebreak}In conclusion, the results from the one RCT of aroma therapy for dementia with useable data revealed a significant effect in favour of the intervention on measures of agitation and neuropsychiatric symptoms. However, there are at present several problems with evaluating and combining research evidence for aroma therapy for dementia. There are several essential oils currently being used, that may not be comparable. There is also great variation in assessment procedures and outcomes reported, and some have not controlled for other variables, such as medication use. There is also the possibility that, as with anti-dementia drugs, aroma therapy might have different effects on people with different types or severity of dementia; to date, few such differentiations have been looked for in the research. However, aroma therapy has only recently been investigated with scientifically rigorous trials; it is to be hoped that there are many more to come.
Reviewers\' conclusions
Implications for practice
There is plenty of non-randomized evidence of both benefit and harm for aroma therapy for dementia. The randomized evidence, available from only one trial, shows benefit for aroma therapy. At present, the assumption commonly held that aroma therapy at least does no harm to people with dementia may not be correct, and further evidence for its effectiveness is needed.
Implications for research
More well-designed large-scale RCTs of aroma therapy for dementia are needed before conclusions can be drawn as to its effectiveness. Many methodological issues need to be addressed such as the comparability of different interventions and the quality of the blinding. Treatment effects for the different types and severity of dementia also need to be investigated.
Acknowledgements
Margaret Butterworth for her contributions as consumer editor, and Professor Ballard for allowing us access to the data from his study.
Potential conflict of interest
None known.
{mospagebreak}Tables
Characteristics of included studies
Study | Ballard 2002 |
---|---|
Methods | Randomized controlled trialdouble-blindparallel-group4 week duration |
Participants | Country: UK8 specialist nursing homes were randomisedMean age of occupants 78.4 years72 participants 60% femalesInclusion criteria:Occupants of nursing homes were people with severe dementia (CDR=3) and clinically significant agitation (defined as occurring on a daily basis and causing moderate to severe management problems)There were no other restrictions other than meeting the inclusion criteria. Medication was allowed, but changes in psychotropic prescription were monitored and recorded. |
Interventions | 1. 10% Melissa essential oil & base oil (200mg/day divided into two doses), applied topically to the face and both arms twice a day by a care assistant2. 10%sunflower oil & base oil (200mg/day divided into two doses), applied topically to the face and both arms twice a day by a care assistant |
Outcomes | CMAINPIBarthel ScaleDementia Care Mapping |
Notes | The centres were matched in pairs according to number of residents,and then assigned randomly using the toss of a coin to active treatment or the control treatment. |
Allocation concealment | A |
Study | Smallwood 2001 |
Methods | Randomized controlled trialsingle-blindparallel-groupunknown duration. |
Participants | Country: UK21 patients in a district general hospital ward (12 female, 9 male)mean age 66.8 (11.5)Diagnosis of severe dementia made by psychiatrist |
Interventions | 1. Lavender in diffuser with conversation twice a week2. Lavender with massage twice a week3. Plain oil massage twice a week |
Outcomes | Video record to assess behaviour at base line and immediately after treatment |
Notes | Significant interaction with time |
Allocation concealment | A |
Characteristics of excluded studies
Study | Reason for exclusion |
---|---|
Mitchell 1993 | No information on blinding |
Opie 1999 | Literature review |
Woods 1996 | Not aroma therapy intervention |
{mospagebreak}Additional tables
Table 01 BASELINE CHARACTERISTICS FOR EACH GROUP (BALLARD 2002)
VARIABLE | CONTROL | TREATMENT |
---|---|---|
Age | 79.7 (8.5) | 77.2 (7.6) |
CMAITOT | 60.6 (16.6) | 68.3 (15.0) |
NPITOT | 34.9 (15.0) | 37.6 (17.6) |
Number taking atypical neuroleptic medication | 12/36 | 16/36 |
Number taking benzodiazepine | 19/36 | 16/36 |
Number taking antidepressant medication | 7/36 | 19/36 |
Number taking neuroleptic medication | 18/36 | 23/36 |
Number taking other psychotropic medication | 12/36 | 14/36 |
Number taking any psychotropic medication | 33/36 | 33/36 |
Number taking cognitive enhancer | 0/36 | 1/36 |
Table 02 EFFECT OF AROMA THERAPY COMPARED WITH PLACEBO (BALLARD 2002)
OUTCOME | EFFECT (S.E.) | T-VALUE | P-VALUE | 95% CONFIDENCE LIMIT | FAVOURS |
---|---|---|---|---|---|
CMAI TOTAL (CHANGE FROM BASELINE AT 4 WEEKS) | -11.08 (3.62) | -3.06 | 0.022 | -19.95 TO -2.21 | AROMA THERAPY |
CMAI PHYSICAL AGGRESSION (CHANGE FROM BASELINE AT 4 WEEKS) | -3.27 (1.78) | -1.84 | 0.115 | -7.62 TO 1.80 | - |
CMAI PHYSICAL NON-AGGRESSIVE (CHANGE FROM BASELINE AT 4 WEEKS) | -5.36 (1.42) | -3.77 | 0.009 | -8.84 TO -1.88 | AROMA THERAPY |
CMAI VERBAL AGGRESSIVE (CHANGE FROM BASELINE AT 4 WEEKS) | -0.39 (0.49) | -0.80 | 0.456 | -1.58 TO 0.81 | - |
CMAI VERBAL NON- AGGRESSIVE (CHANGE FROM BASELINE AT 4 WEEKS) | -2.92 (0.91) | -3.22 | 0.018 | -5.14 TO -0.70 | AROMA THERAPY |
NPI TOTAL (CHANGE FROM BASELINE AT 4 WEEKS) | -15.80 (3.50) | -4.51 | 0.004 | -24.37 TO -7.22 | AROMA THERAPY |
NPI AGITATION (CHANGE FROM BASELINE AT 4 WEEKS) | -2.31 (0.89) | -2.59 | 0.041 | -4.50 TO -0.12 | AROMA THERAPY |
NPI ABERRANT MOTOR BEHAVIOUR (CHANGE FROM BASELINE AT 4 WEEKS) | -3.01 (1.23) | -2.45 | 0.050 | -6.02 TO 0.00 | AROMA THERAPY |
{mospagebreak}References
References to studies included in this review
Ballard 2002 {published data only}
Ballard CG, O\'Brien JT, Reichelt K, Perry EK. Aromatherapy as a safe an effective treatment for the management of agitation in severe dementia: the results of a double-blind placebo-controlled trial with Melissa. Journal of Clinical Psychiatry 2002;63(7):553-558.
Smallwood 2001 {published data only}
Smallwood J, Brown R, Coulter F, Irvine E, Copland C. Aromatherapy and behaviour disturbances in dementia: a randomized controlled trial. International Journal of Geriatric Psychiatry 2001;16:1010-1013.
* indicates the major publication for the study
References to studies excluded from this review
Mitchell 1993
Mitchell S. Aromatherapy\'s effectiveness in disorders associated with dementia. The International Journal of Aromatherapy 1993;5(2):20-23.
Opie 1999
Opie J, Rosewarne R, O\'Connor DW. The efficacy of psychosocial approaches to behaviour disorders in dementia: a systematic literature review. Australian and New Zealand Journal of Psychiatry 1999;33(6):789-799.
Woods 1996
Woods DL, Craven R, Whitney J. The effects of therapeutic touch on disruptive behaviours of individuals with dementia of the Alzheimer\'s type. Alternative Therapies 1996;4(2):95-96.
Additional references
APA 1994
American Psychiatric Association. Diagnostic and statistical manual of mental disorders. 4th (DSM-IV) Edition. Washington, DC: American Psychiatric Association, 1994.
{mospagebreak}Bowie 1993
Bowie P, Mountain G. Using direct observation to record the behaviour of long stay patients with dementia. International Journal of Geriatric Psychiatry 1993;8:857-864.
Bowles 2002
Bowles EJ, Griffiths DM, Quirk L., Brownrigg A, Croot K. Effects of essential oils and touch on resistance to nursing care procedures and other dementia related behaviours in a residential care facility. International Journal of Aromatherapy 2002;12(1):22-29.
Brooker 1993
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{mospagebreak}Cover sheet
Aroma therapy for dementia
Reviewer(s) | Thorgrimsen L, Spector A, Wiles A, Orrell M |
Contribution of Reviewer(s) |
-LMT: Design of protocol, coordination with Cochrane Collaboration, updating protocol, drafting of review versions, search for trials, obtaining copies of trial reports, selection of trials for inclusion/exclusion, extraction of data, entry of data, and interpretation of data analyses. -Margaret Butterworth: consumer editor |
Issue protocol first published | 2001 issue 3 |
Issue review first published | 2003 issue 3 |
Date of last minor amendment | 19 May 2003 |
Date of last substantive amendment | 15 May 2003 |
Most recent changes | Information not supplied by reviewer |
Date new studies sought but none found | Information not supplied by reviewer |
Date new studies found but not yet included/excluded | Information not supplied by reviewer |
Date new studies found and included/excluded | 29 October 2002 |
Date reviewers\' conclusions section amended | Information not supplied by reviewer |
Contact address | Lene Marie Thorgrimsen No. 2 Cottage Cotbank of Barras Stonehaven UK AB39 2UH Telephone: +44 07855 311651 Facsimile: E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it. |
Cochrane Library number | CD003150 |
Editorial group | Cochrane Dementia and Cognitive Improvement Group |
Editorial group code | DEMENTIA |
{mospagebreak}Sources of support
External sources of support
- The Mental Health Foundation UK
Internal sources of support
- University College London (UCL) UK
Synopsis
The one small trial published is insufficient evidence for the efficacy of aroma therapy for dementia.
Aroma therapy is the use of pure essential oils from fragrant plants (such as Peppermint, Sweet Marjoram, and Rose) to help relieve health problems and improve the quality of life in general. The healing properties of aroma therapy are claimed to include promotion of relaxation and sleep, relief of pain, and reduction of depressive symptoms. Hence, aroma therapy has been used to reduce disturbed behaviour, to promote sleep and to stimulate motivational behaviour of people with dementia. Of the three randomized controlled trials found only one had useable data. The analysis of this one trial showed a significant effect in favour of aroma therapy on measures of agitation and neuropsychiatric symptoms. More large-scale randomized controlled trials are needed before firm conclusions can be reached about the effectiveness of aroma therapy.
Keywords
Human; *Aromatherapy; Dementia[*therapy]; Randomized Controlled Trials