CAM for sleep disturbances in the elderly

Many elderly people use some form of CAM. In a recent telephone survey of 1559 people over the age of 50, 63% reported utilising CAM.¹ Use is particularly high in elderly patients with certain conditions; the 2002 US National Health Interview Survey reports that among adults aged 65 or over, almost 70% of those with hypertension and over 80% of those with anxiety or depression used CAM for a range of indications.²

At the same time, CAM use in older adults presents several unique and important issues. Because older adults often present with various health complaints and the majority of patients with insomnia also have co-morbidities, they therefore use a range of CAM concurrently with other medical treatments.³ Elderly patients often self-medicate with allegedly ‘natural’ remedies without considering or discussing safety aspects with their doctors. The above-mentioned telephone survey reports that 75% of the respondents who in their lifetime had ever taken herbal products or dietary supplements currently took one or more prescription medicines.¹ An alarmingly high proportion of these (77%) did not discuss their CAM use with their healthcare provider. This is a serious issue as interactions with prescription or other self-administered drugs are pertinent.

Data from the 2002 National Health Interview Survey relating to sleep disturbances in the general population showed that the most popular therapies were biologically-based therapies such as herbal or other supplements (64.8%) and mind–body therapies (39.1%), followed by acupuncture (8.5%), and manipulative treatments (4.6%).³ The study also pointed out that those without co-morbidities preferred mind–body therapies, those with co-morbidities biologically-based therapies.

Little of the clinical evidence on CAM has been derived from studying elderly patients and trial data are usually extrapolated from other age groups. Physiological changes relating to digestion, metabolism, and excretion of ingested products that may impact the metabolism of drugs, herbs and other dietary supplements need to be considered in the elderly. Furthermore, osteoporosis is particularly common in elderly women, which has important implications for physical CAM approaches such as spinal manipulation or even vigorous massage. The effects of mind–body therapies might be affected by declining cognitive abilities and generally age-related differences in health beliefs.

Several CAM modalities are promoted for facilitating sleep, with melatonin and Valeriana spp. (valerian) being among the most popular.⁴,⁵ For only few of them, however, has effectiveness been evaluated using objective sleep measures.⁶,⁷ A systematic literature search of the databases Medline, AMED, EMBASE and the Cochrane Library from their respective inception until July 2008 using terms related to ‘CAM’ and ‘insomnia’ or ‘sleep disorders’ revealed RCTs or systematic reviews of the following CAM modalities: melatonin, Valeriana spp. (valerian), acupuncture, relaxation therapies, yoga, tai chi and music therapy. For many CAM modalities there is a paucity of effectiveness data in elderly subjects and results from systematic reviews including other age groups have been included where appropriate.

Melatonin

One systematic review in elderly patients (mean ages 65–79 years) included six double-blind, crossover RCTs with a total of 95 patients⁸. Sleep quality was assessed objectively, measured by wrist actigraphy (n = 4) and polysomnography (n = 2), as well as subjectively (n = 2). Sleep latency decreased significantly in four studies and other measures of sleep quality such as sleep efficiency, total sleep time and wake time during sleep improved in three studies. Subjective sleep quality did not, however, improve. No early-morning sleepiness occurred. Based on a comparison of these studies the authors concluded that melatonin is most effective in elderly insomniacs who chronically use benzodiazepines and/or with documented low melatonin levels during sleep.

Subsequently published RCTs of insomnia in the elderly reported improvements in subjective sleep parameters which are, however, not always supported by results from objective sleep measures. An RCT of 354 elderly insomnia patients receiving prolonged-release melatonin or placebo found statistically significant and clinically relevant improvements in QoL, quality of sleep, morning alertness and shortening of sleep latency to the same extent as most frequently used sleep medications.⁹ A further RCT reported significantly improved quality of sleep and morning alertness in 170 older insomnia patients receiving prolonged-release melatonin compared with placebo without withdrawal symptoms upon discontinuation.¹⁰ Melatonin compared with placebo administered to elderly residents in bright or dim light care facilities found melatonin to shorten sleep onset latency, increase sleep duration by 27 minutes but also to adversely affect mood. Combined treatment increased sleep efficiency and improved nocturnal restlessness.¹¹

RCTs in elderly patients with Alzheimer’s¹²,¹³ and Parkinson’s disease¹⁴ found no significant differences in objective, but did in subjective, sleep parameters. The first RCT of 157 elderly patients with Alzheimer’s disease, which compared two doses of melatonin and placebo, reported improved care-giver ratings of sleep quality in the low-dose melatonin group.¹² The second RCT in 33 institutionalised elderly with Alzheimer’s found that the addition of melatonin to light therapy, compared to light therapy alone, increased daytime wake time and activity levels.¹³ Similarly an RCT of melatonin compared with placebo in 18 patients with Parkinson’s disease reported no improvements of polysomnography abnormalities but of subjectively measured quality of sleep.¹⁴

One RCT in 40 healthy older adults with age-related sleep disturbances reported no significant improvements of any sleep parameter measured in the melatonin and placebo groups; there were, however, significant differences in self-reported sleep quality between groups at baseline.¹⁵

Recent systematic reviews are based on trials including patients from across the age groups. In a meta-analysis of 17 double-blind RCTs including 284 participants, melatonin treatment was reported to reduce sleep onset latency by 4.0 minutes, increase sleep efficiency by 2.2%, and total sleep duration by 12.8 minutes.¹⁶

A meta-analysis of exogenous melatonin for primary sleep disorders included 14 controlled trials with a total of 279 patients.¹⁷ While the overall evidence for patients across age groups suggests that melatonin may be of limited clinical use for primary sleep disorders, a subgroup analysis according to age showed that sleep efficiency was greater in the elderly population (66 years and older) compared to the adult population of ≤ 65.

The same authors also performed a meta-analysis of melatonin for secondary sleep disorders including six RCTs with 97 participants.¹⁸ It showed no evidence that melatonin had an effect on sleep onset latency. The effects of melatonin did not differ between age groups or with dose or duration of treatment.

Based on these studies and clinical use, melatonin is generally regarded as safe in recommended doses (0.01–10 mg) for short-term use. Overall adverse effects are not significantly more common with melatonin than placebo.¹⁷,¹⁸ The most commonly reported adverse effects of melatonin were nausea, headache, dizziness and drowsiness; however, these effects were not significant compared to placebo.

Valeriana spp. (valerian)

A systematic review of 29 clinical studies included three studies of older persons with general sleep disturbances or insomnia.¹⁹ The first RCT (n = 79), which used an aqueous Valeriana officinalis extract, concluded that a significant proportion reported improved sleep latency and sleep maintenance compared to the placebo group.²⁰ The second RCT of 14 elderly subjects also using an aqueous V. officinalis extract found no significant differences in sleep onset time or time awake after sleep onset, REM sleep and self-rated sleep quality.²¹ The third RCT used a high valepotriate preparation and noted a decrease in sleep disturbances but no statistical testing was reported.²²

A subsequently published RCT in 16 older women suffering from insomnia found no statistically significant differences between valerian and placebo on any measure of sleep latency, wake after sleep onset, sleep efficiency, and self-rated sleep quality.²³

Overall the above review concluded that most of the 29 clinical studies reported no significant differences between Valeriana spp. and placebo either in healthy individuals or in persons with general sleep disturbances or insomnia.¹⁹ None of the most recent studies, which were also the most rigorous, found significant effects on sleep. Earlier systematic reviews and meta-analyses concluded that the effects of valerian were promising but not conclusive.²⁴,²⁵

The most recent review also assessed safety aspects and included eight additional open-label studies in the safety assessment.¹⁹ It did not find any serious adverse effects in the reported studies. Most common were dizziness, headache and drowsiness or, mainly with high-valepotriate preparations, gastrointestinal complaints. Performance seems little or not impaired with Valeriana spp., especially when compared to benzodiazepines.

Acupuncture

A systematic review included seven studies of acupuncture and related techniques for insomnia.²⁶ Two of the included RCTs were performed in elderly individuals. One (n = 84) compared acupressure with sham acupressure and conversation only and reported positive outcomes for acupressure on sleep quality, sleep onset latency, and total sleep duration when compared with the sham treatment.²⁷ The other RCT (n = 120) used auricular therapy comparing magnetic pearls with auricular seed therapy and auricular placebo seed therapy, all stuck to auricular points.²⁸ Auricular magnetic pearl therapy but not auricular seed therapy was superior to auricular placebo seed therapy in improving sleep onset latency, sleep efficiency and sleep duration.

A more recent systematic review of auricular acupuncture for insomnia²⁹ included two additional RCTs.³⁰,³¹ Both trials, which were of low methodological quality, reported significant improvements in sleep scores on a Likert scale and self-satisfaction scale compared to no treatment.

Overall (including all age groups), the first review which included seven studies with a total of 590 patients suggested that acupuncture and acupressure may help to improve sleep quality scores when compared to placebo or no treatment.²⁶ However, the efficacy of acupuncture and related techniques was inconsistent between studies for many sleep parameters, such as sleep onset latency, total sleep duration and wake after sleep onset. The second review which included 10 RCTs of 846 patients, concluded that the evidence of effectiveness was limited due to the paucity and poor quality of the data.²⁸

Very few studies included in the above reviews assessed safety. Adverse events were mild and transient, e.g. pain on needling.

Relaxation techniques

An RCT of 89 older adults with insomnia found relaxation more effective than placebo on sleep continuity variables.³² Improvements in wake time after onset were recorded at post-treatment but not fully sustained at follow-up. Another trial of 51 elderly adults with insomnia secondary to illness reported mixed results.³³ Home-based audiotape relaxation was superior to cognitive behavioural therapy and waiting-list control in improving total sleep time and greater change than control in sleep efficiency, wake time after sleep onset, and Pittsburgh Sleep Quality Index at follow-up. A review of studies including patients across the age groups reports superior results of relaxation over and above placebo or waiting-list controls on some sleep outcomes.³⁴ Adverse events have not been reported in these studies.

Yoga

Yoga was evaluated in one RCT of 69 older adults.³⁵ It improved self-reported sleep measures, including a 1-hour improvement in total sleep time compared to baseline, and improvements were significantly higher than in the Ayurveda and wait-list control groups. Adverse events were not assessed in this trial.

Tai chi

One RCT assessed the effects of tai chi on self-rated quality of sleep and daytime sleepiness in 118 older adults.³⁶ It found that compared to exercise control older adults with moderate sleep complaints had improved self-rated sleep quality, including an increase of sleep duration by 48 minutes, through a 6-month, low- to moderate-intensity tai chi programme. No adverse events or injuries occurred in this trial.

Music therapy

In an RCT, 60 people aged 60–83 years with sleep disturbances listened to their choice among six 45-minute sedative Western or Chinese music tapes. Music resulted in significantly better sleep quality, as well as better components of sleep quality. Sleep improved weekly, indicating a cumulative dose effect.³⁷ Adverse events were not assessed in this trial.

Conclusion

Several CAM modalities are used for insomnia in the treatment of sleep disturbances in the elderly but for few is there robust evidence of effectiveness available from rigorous clinic trials. Positive evidence of effectiveness exists for melatonin as a short-term treatment of insomnia in elderly adults. The evidence for relaxation techniques is also encouraging, although only two trials are available specifically for older adults. For yoga, tai chi and music therapy the evidence is encouraging yet very limited as only few studies are available. Acupuncture may improve sleep quality scores but results are inconsistent for many sleep parameters. The use of Valeriana spp. for insomnia is not supported by good evidence of effectiveness from rigorous trials.

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