A scoping review of over-the-counter products for depression, anxiety and insomnia in older people.

Rachael Frost, Silvy Mathew, Verity Thomas, Sayem Uddin, Adriana Salame et al.

Review BMC complementary medicine and therapies 2024 5 اقتباسات

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Study Design

نوع الدراسة: Review
حجم العينة: 47

التدخل: A scoping review of over-the-counter products for depression, anxiety and insomnia in older people. None
المقارن: Placebo
اتجاه التأثير: Mixed
خطر التحيز: Unclear

Abstract

BACKGROUND: Depression, anxiety, and insomnia are prevalent in older people and are associated with increased risk of mortality, dependency, falls and reduced quality of life. Prior to or whilst seeking treatment, older people often manage these symptoms or conditions using products purchased over the counter (OTC), such as medication or herbal products. This review aims to map the evidence available for OTC medications, herbal medicines and dietary supplements for depression, anxiety and insomnia in older adults. METHODOLOGY: We carried out a scoping review, including searches of five databases to identify relevant randomised controlled trials (inception-Dec 2022). We took an inclusive approach to products to represent the wide range that may be available online. Trials were summarised according to condition and product. RESULTS: We included 47 trials and 10 ongoing trial protocols. Most targeted insomnia (n = 25), followed by depression (n = 20), and mixed conditions (n = 2). None evaluated products targeted at anxiety alone. Where reported, most products appeared to be safe for use, but studies rarely included people with multiple comorbidities or taking concomitant medication. Some types of melatonin for insomnia (n = 19) and omega-3 fatty acids for depression (n = 7) had more substantive evidence compared to the other products. CONCLUSION: There is a substantial gap in evidence for OTC products for anxiety in older people. This should be addressed in future trials. Research should also focus on products that are widely used, and these need to be tested in older populations that are similar to those who would use them in practice.

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Fig. 1

PRISMA flow diagram illustrating the study selection process for a scoping review of over-the-counter products used for depression, anxiety, and insomnia in older adults.

flowchart

Fig. 2

Summary of evidence from the scoping review, categorizing the types of over-the-counter products examined for depression, anxiety, and insomnia management in older populations.

chart

Tables

Table 1

PICOS	Inclusion	Exclusion
Population	Adults aged 60+; community-dwelling (including residential care); with symptoms or a diagnosis of insomnia, anxiety, depression, or psychological distress using a questionnaire or diagnostic criteria.	Inpatients; participants with no baseline symptoms or minimum threshold of depression, anxiety, or insomnia (e.g. sleep quality in healthy people), including if it was a symptom of another condition (e.g. substance abuse); other mental health conditions (e.g. stress, dementia).
Intervention	Orally administered preparations of OTC medicines, herbal medicines (single or in combination), homeopathic medicines, and dietary supplements (single or in combination), with no restrictions on dosage.	Prescription-only medications (e.g. selective serotonin reuptake inhibitors (SSRIs), Z-drugs); non-oral routes (e.g. topical); other non-pharmacological remedies, devices or mobile applications (e.g. aromatherapy); individualized approaches including consultation with a practitioner; treatment duration < 1 week; products given as part of a larger lifestyle intervention study where effects cannot be separated; tryptophan depletion studies; diet-based interventions.
Comparator	Any, including no treatment, placebo or active treatment	No comparator arm
Outcome	Depressive, anxiety, or insomnia symptoms using validated questionnaires; remission (resolution of symptoms below a threshold); other mental health symptoms; quality of life; functioning; adherence; adverse events; study withdrawal.
Study Design	Randomised controlled trials (including crossover, cluster, and parallel-group), economic evaluations.	Subgroup analyses (e.g. older people from a larger study of all adults), pre-post test studies involving only a single intervention group, systematic reviews.

Table 2

Defining OTC products can be challenging due to the large array of potential products and variation in regulatory frameworks for these across countries (e.g. Kava is available in Australia but not the UK, melatonin is available in France but not the UK, but these products may be purchasable online). As this review is based in the UK, the UK Medicines and Healthcare Regulatory Agency (MHRA) product definitions [42] were used as a starting point. In brief, these are:

• Medicines: substances presented as able to treat or prevent disease in humans, with a view to restoring, correcting or modifying physiological functions through pharmacological activity. OTC medicines includes general sales and pharmacy-only medicines.

• Herbal medicines: the active medicinal product ingredients are herbal substances or preparations only. Usually provided under a Traditional Herbal Regulation registration.

• Dietary supplements: a concentrated source of a vitamin, mineral or other substance, alone or in combination, which has a physiological or nutritional effect, and aims to supplement the normal diet.

• Homeopathic medicine: diluted substances primarily given in tablet form.

However, to ensure findings were more widely applicable, we included products that may be accessed OTC by older people even if their status is not classed in this way in the UK (e.g. melatonin, herbal products without a Traditional Herbal Regulation registration), after discussion with our clinical and PPI team members. We excluded Traditional Chinese Medicine combination products and other clinically unrecognisedproducts (e.g. eel’s head powder) as these are often poorly defined in terms of their composition, are not widely used in a UK setting and would be problematic to assess. To this end, it should also be noted that different product definitions can overlap, particularly dietary supplements (a term used especially in the USA) and herbal (medicinal) products (used commonly in Europe) or listed medicines (Australia), and classification is not always straightforward.

Table 3

Study IDCountry, N recruitedComorbidities	Product details and duration	Comparator	Depression outcome(s)	Effective on ≥ 1 depression outcome?	Safety
Dietary supplements
Rondanelli et al., 2011 [53] Italy N = 226	Omega-3 long chain polyunsaturated fatty acids (1.67 g EPA and 0.83 g DHA), 2.5 g/day 8 weeks	Placebo (paraffin oil)	GDS	Yes	No side effects.
Rondanelli et al., 2010 [55] Italy N = 271	Omega-3 long chain polyunsaturated fatty acids, 2.5 g/day 8 weeks	Placebo (paraffin oil)	GDS	Yes	No serious adverse events
Chang et al., 2020 [84] Taiwan N = 237 Comorbidity- Chronic heart disease	Omega-3 long chain polyunsaturated fatty acids (2 g EPA + 1 g DHA)/day 2 weeks	Placebo (soybean oil 3 g/day)	HAM-D BDI	No	Not reported
Pomponi et al., 2014 [83] Italy N = 96 Comorbidity-Parkinson’s disease	Omega-3 fatty acid (800 mg/d DHA and 290 mg/d EPA) 6 months	Placebo (vegetable oil)	HAM-D	Yes	Not reported
Rizzo et al. 2012 [54] Italy N = 46	Omega-3 oil (1 tbsp or 2.5 g) 1/day 2 months	Placebo (1 tbsp paraffin oil with similar lemony taste)	HAM-D SDS CGI	Yes	No side effects
Tajalizadekhoob et al., 2011 [50] Iran N = 66 Comorbidity-dementia	Fish oil (1 g cod liver oil, glycerol, and water; 180 mg EPA and 120 mg DHA) 6 months	Placebo (gelatin capsule containing medium-chain triglycerides, glycerol, and water)	GDS	Yes	Mild effects (gastrointestinal disturbances), settled after a month.
Da Silva et al., 2008 [82] Brazil N = 250 Comorbidity- Parkinson’s disease	1. Fish oil capsules (180 mg EPA, 120 mg DHA and tocopherol) 4/day 2. Fish oil plus antidepressant 3 months	1. Placebo x 2 (mineral oil) 2. Placebo plus antidepressant	MADRS CGI BDI	Yes	Not reported
Alavi et al., 2019 [46] Iran N = 255	Vitamin D3 50,000 IU weekly at mealtime. 8 weeks	Placebo	GDS	Yes	No side effects were noted.
Koning et al. 2019 [88] Netherlands N = 155	Vitamin D3 (400 IU cholecalciferol) 3/day + advice to consume ≥ 3 dairy/day or 500 mg/day calcium tablet for 8 weeks 12 months	Placebo	CES-D MDD incidence (CIDI)	No	No serious adverse effects.
Almeida et al., 2014 [86] Australia N = 153 Some comorbidities in sample	Vitamin B (0.5 mg B12, 2 mg folic acid, 25 mg B6) 1 capsule + citalopram 52 weeks	Citalopram + placebo	MDD relapse (DSM-IV) MADRS	Did not enhance, antidepressant treatment, but antidepressant response sustained over 1 year.	No differences in adverse events between study groups
Walker et al., 2012 [77] Australia N = 909 2 × 2 × 2 factorial design	1. Vitamin B (400 µg folic acid and 100 µg vitamin B-12) 1/day. After safety review, protocol changed to 2 daily doses (200 µg FA + 50 µg vitamin B-12 each) + physical activity + mental health literacy 2. Supplement + physical activity and pain information 3. Supplement + nutritional information + mental health literacy 4. Supplement + nutritional information + pain information 24 months	4 groups include placebo + other interventions	PHQ-9	Yes	Not reported
Bersani et al., 2013 [59] Italy N = 80	L-acetylcarnitine, 1 g, 3/day 7 weeks	Fluoxetine 20 mg/day	HAM-D CGI BDI	Yes	Lesser side effects were noted for L-acetylcarnitine compared to fluoxetine.
Garzya et al., 1990 [57] Italy N = 28	L-acetyl-carnitine, 500 mg, 3/day 60 days	Placebo	HAM-D BDI SCAG	Yes	No statistical difference in side effects between groups
Passen et al., 1993 [58] Italy N = 120 Comorbidity-dementia	5’-Methyltetrahydrofolic acid 50 mg/day (1 tablet in the morning) 8 weeks	Trazodone 100 mg/day (2 tablets)	HAM-D	Yes	No side effects were noted.
Herbal products
Meleppurakkal et al., 2021 [79] India N = 75	1. Ashwagandha (Withania somnifera (Linn) Dunal) 3.75 g + Vacha (Acorus calamus L.) 250 mg, 4 g powder 2/day with water 2. Yoga + Ashwagandha and Vacha 30 days	Yoga alone	HAM-D	Yes (most significant in group plus yoga)	Not reported
Liang et al., 2019 [65] China N = 93 Comorbidity- Ischaemic stroke	Ginkgo (Gingko biloba L.) 40 mg, 3/day + venlafaxine 75 mg/day 8 weeks	Venlafaxine 75 mg/day only	HAM-D SDS	Yes	Fewer adverse events in experimental group
Tiwari et al., 2011 [80] India N = 60	Saraswata Churna (preparation involved Kustha, Ashwagandha, Ajmmoda, Sweta and Krisna Jiraka, Sunthi, Marich, Pipali, Patha, Sankhpuspi, and Vacha powder) 1.5 g, 2/day with 1tsp (5 ml) ghrita & 0.5tsp (2.5 ml) honey, after meals 3 months	Citalopram 20 mg once a day	HAM-D	Yes	No side effects were noted.
Bazrafshan et al., 2020 [49] Iran N = 114	Lavender tea (2 g teabag, genus and species not reported) steeped for 10–15 min in 300 mL hot water, 2/day 2 weeks	No treatment	BDI	Yes	No side effects were noted.
Harrer et al., 1999 [70] Germany & Austria N = 161	St John’s Wort (Hypericum perforatum L. dry extract, LoHyp-57) 200 mg, 2/day 6 weeks	5.6 mg of fluoxetine hydrochloride (equivalent to 5 mg fluoxetine)	HAM-D SDS CGI	St John’s Wort was non-inferior to fluoxetine.	12 adverse drug reactions in LoHyp-57 (6 abandoned treatment) and 17 in fluoxetine (8 abandoned treatment)
Steger et al., 1985 [72] Germany N = 100	St John’s Wort (Hypericum perforatum L., 90-100 mg standardised to 0.05 mg hypericin) and Valerian (Valeriana officinalis L. 50 mg 6:1 extract) extract Sedariston Konzentrat^® 6 weeks	Desipramin hydrochloride 25 mg	CGI D-S	Yes	Occasionally tiredness, dizziness, tachycardia dry mouth - all minor complaints

Table 4

Study IDCountryN recruitedComorbidities	Product details	Comparator	Insomnia outcome(s)	Effective for ≥ 1 insomnia outcome?	Safety
Dietary supplements
Garzon et al., 2019 [76] Spain N = 22	Melatonin 5 mg/day at bedtime 8 weeks	Placebo	NHSMI Discontinuation of hypnotic drugs	Yes	Treatment well tolerated; 1 patient had palpitations
Gooneratne et al.,2012 [61] USA N = 56	1. 0.1 mg immediate and 0.4 mg controlled release melatonin tablets 30 min before bed 2. 1.0 mg immediate release and 4.0 mg controlled release melatonin 30 min before bed 42 days	Placebo	PSQI PSG	No	No serious adverse events
Wade et al., 2007 [89] Scotland N = 523	Prolonged release melatonin 2 mg/day 2 h before bedtime 24 weeks	Placebo	LSEQ (QOS, BFW and total) PSQI (total and Q2 and Q4) QON and QOD (sleep diary) CGI	Yes	1 severe adverse event (emotional distress due to a bereavement) in PR-melatonin group, also nasopharyngitis (n = 5) and headache (n = 4)
Wade et al., 2010 [73, 85] Scotland N = 930 Some comorbidities in sample	Prolonged release melatonin, 2 mg/day, 1–2 h before bed 3 weeks, followed by re-randomisation and 26 weeks extension period	Placebo	Sleep latency (sleep diary) PSQI CGI	Yes	19 drug-related adverse events. No significant difference between the 2 groups, and 1 SUSAR (palpitations in melatonin group)
Wade et al., 2014 [69] UK & USA N = 80 Comorbidity- Alzheimer’s disease	Prolonged release melatonin 2 mg/day, 1–2 h before bed. Patients instructed to spend 2 h/day in outdoor daylight. 24 weeks	Placebo	PSQI Sleep diary	Yes	PRM well tolerated, adverse event profile similar to placebo
Lähteenmäki et al.,2013 [87] Finland N = 211 Benzodiazepine withdrawal	Controlled release melatonin 2 mg tablet daily 6 months	Placebo	Total BZD withdrawal Reduction in BZD use	No insomnia endpoints (primary outcome benzodiazepine withdrawal)	No serious adverse events in either group
Haimov et al.,1995 [90] Israel N = 26 3 arm crossover RCT	1. Sustained-release melatonin 2 mg 2 h before bed 2. Fast-release melatonin 2 mg 2 h before desired bedtime 1 week (2 washout period)	Placebo	Actigraphy	Yes for sustained release vs. placebo, no for fast release vs. placebo	NR
Ahn et al., 2020 [81] South Korea N = 34 Comorbidity- Parkinson’s disease	Prolonged-release melatonin 2 mg 1 h before bed 4 weeks	Placebo	PSQI ESS	Yes	No side effects.
Lemoine et al., 2007 [71] France & Israel N = 170 Comorbidity- cardiovascular disease	Prolonged-release melatonin. 2 mg 1-2 h before bed and after evening meal 3 weeks	Placebo	LSEQ (QOS, BFW) QON Rebound insomnia Withdrawal following discontinuation	Yes	Low incidence of adverse events and most side-effects were of minor severity
Hadi et al., 2022 [48] Iran N = 130 Comorbidity – Parkinson’s disease	Melatonin 3 mg/day 4 weeks	1. Clonazepam 1 mg/day 2. Trazodone 50 mg/day	PSQI	Yes	Mild adverse events reported: clonazepam (n = 3), trazodone (n = 2), melatonin (n = 0)
Luthringer et al.,2009 [91] France N = 52	Prolonged release melatonin, 2 mg 2 h before bed and after food 3 weeks	Placebo	PSG LSEQ parameters	Yes	Adverse events reported by 11 patients in each group (most commonly headache), none treatment related.
Hughes et al.,1998 [63] USA N = 26 4 group crossover trial	1. 0.5 mg immediate release melatonin taken 30 min before bedtime (+ placebo 4 h after) 2. 0.5 mg continuous release taken 30 min before bedtime (+ placebo 4 h after) 3. 0.5 mg immediate release melatonin 4 h after bedtime (+ placebo 30 min before bed) 2 weeks (2 week washout period)	Placebo capsules (lactose) taken 30 min before and 4 h after bedtime	PSG Actigraphy	Yes	NR
Singer et al., 2003 [62] USA N = 244 Comorbidity-Alzheimer’s disease	1. Sustained-release melatonin (2.5 mg) 1 h before bed 2. Immediate release (10 mg) melatonin 1 h before bed 2 months	Placebo	Actigraphy	No	No differences in number, severity, seriousness, or relatedness ratings of spontaneously reported adverse events across the 3 groups
Baskett et al., 2003 [78] New Zealand N = 40 Crossover trial	Fast release melatonin, 5 mg at bedtime 4 weeks (4 week washout period)	Placebo	Actigraphy Sleep diary	No	Very few side effects reported, 1 participant excessive drowsiness in both melatonin and placebo groups
Russcher et al., 2013 [75] Netherlands N = 67 Comorbidity- Haemodialysis patients	Immediate-release melatonin tablets 3 mg at 10pm 12 months	Placebo	Actigraphy	Yes	NR
Jing-gui et al.,2005 [67] China N = 41	Melatonin 2 × 6 mg capsules, 60 min before bed 6 months	Placebo	PSQI ESS PSG	Yes	No serious adverse events occurred
Shahrokhi et al., 2021 [51] Iran N = 101 Comorbidity- Colorectal cancer	Melatonin, 2 × 3 mg before bed 30 nights	Zolpidem (2 × 5 mg)	PSQI GSQS	No (similar improvements)	Fatigues (n = 2), next morning dizziness (n-1), and GI effects (n = 10). No statistical difference between groups.
Abbasi et al., 2012 [45] Iran N = 46	Magnesium tablet (414 mg magnesium oxide as 250 mg elemental Magnesium), 500 mg per day 8 weeks	Placebo	ISI Sleep diary	Yes	NR
Pigeon et al., 2010 [60] USA N = 15 2 arm crossover trial	Tart cherry juice (TCJ) beverage (CherryPharm, Inc), 1 × 8oz servings 8-10am and 1–2 h before bedtime. 2 weeks (2 week washout period)	Placebo (unsweetened black cheery kool-aid)	ISI Sleep diary	Yes	NR
Rondanelli et al., 2011 [56] Italy N = 226	5 mg melatonin, 225 mg magnesium and 11.25 mg zinc conveyed in 100 g pear pulp, once a day 1 h before bedtime. 8 weeks	Placebo (100 g pear pulp alone)	PSQI LSEQ ESS SWAI SDQ Actigraphy	Yes	Patients tolerated the treatment, 2 mild headaches in treatment group
Herbal supplements
Taibi et al., 2009 [64] USA N = 18 2 arm crossover trial	Valerian (Valeriana officinalis L. root) Nature’s Resource 100 mg softgels standardised to 0.8% valerenic acid, 30 min before bed 2 weeks (2 week washout period)	Placebo (600 mg lactose)	MSQ PSG Sleep diary Actigraphy	No	No serious adverse events occurred
Aliakbari et al., 2018 [52] Iran N = 87 Comorbidity- Chronic heart failure	Melissa officinalis L. syrup 12 ml/day an hour before going to bed + conventional CHF treatment 1 month	Alprazolam + conventional CHF treatment	PSQI	Yes	NR
Mixture
Xie et al., 2015 [66] China N = 100	SurAsleep (calcium, magnesium, valerian root (Valeriana officinalis L.), oat straw (Avena sativa L.), L-theanine and melatonin) 1 capsule, 30–60 min before bed 12 weeks	Placebo	PSQI Insomnia symptom questionnaire designed for study	Yes	No significant adverse events reported.
Medication
Van de Glind et al., 2014 [74] Netherlands N = 61	Acetaminophen 1000 mg/day at bedtime 3 weeks	Placebo	ISI Sleep diary VAS of sleep quality	No	No adverse effects were reported

Table 5

Study Details

Product used

Comparator used

Measure(s) used

Effective?

Side effects

Etedali et al., 2022 [47]

Iran N = 63

Comorbidity-prostate cancer

Melatonin 3 mg twice a day

4 weeks

No treatment

PSQI

HAM-A

BDI

Yes (for insomnia, not depression or anxiety)

Excessive daytime sleepiness with melatonin

Yu et al., 2019 [68]

China N = 90

Comorbidity- Obstructive sleep apnoea

1. Rhodiola rosea L.

0.6 g twice a day

2. Rhodiola rosea L. + CPAP machine

3 months

CPAP machine only

SDS

SAS

Yes for depression and anxiety when used with CPAP but not alone

Not reported

References

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A scoping review of over-the-counter products for depression, anxiety and insomnia in older people.

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