Melatonin for the prevention and treatment of jet lag Herxheimer A, Petrie kj
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- Spitzer 87
- Cover sheet Melatonin for the prevention and treatment of jet lag Reviewer(s)
- Issue protocol first published
- Most recent changes
- Sources of support Extramural sources of support to the review
- Cochrane Library number
- List of comparisons Fig 01 GLOBAL JET-LAG RATINGS
- Table 02 Single case reports of possible adverse effects reported in cases outside RCTs Trial Number of flights
- Case no/ Ref Effects and comment Days use Sex / Age
- Table of included studies
- Study Methods Participants Interventions Outcomes Notes A co
- Table of excluded studies Table of ongoing studies
- Study Reason for exclusion Arendt 95, 97a, 97b
- Comperatore 96
Spitzer 87 Spitzer RL, Terman M, Terman JS, Williams JBW. Columbia jet lag scale. Biometrics Res.
Waterhouse J, Reilly T, Atkinson. Jet-lag. Lancet 1997;350:1611-16. Winget 84 Winget CM, DeRoshia CW, Markley CL, Holley DC. A review of the human physiological changes associated with desynchronosis of biological rhythms. Aviat Space Environ Med 1984;55:1085-96. Zhdanova 00 Zhdanova IV. The role of melatonin in sleep and sleep disorders. In: Culebras A, editor (s). Sleep Disorders and Neurological Disease. New York - Basel: Marcel Dekker, 2000:137-157. Cover sheet Melatonin for the prevention and treatment of jet lag Reviewer(s) Herxheimer A, Petrie KJ Contribution of Reviewer(s) AH wrote the protocol, searched for relevant papers, assessed and reviewed them, wrote the text of the review KJP contributed to the protocol, searched for relevant papers, assessed and reviewed them, and contributed to the text of the review
Information not available Issue review first published Information not available Date of most recent amendment 11 May 2001 Date of most recent substantive amendment 22 August 2000 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 Information not supplied by reviewer Sources of support Extramural sources of support to the review ! No sources of support supplied Intramural sources of support to the review ! University of Auckland NEW ZEALAND ! UK Cochrane Centre UK Synopsis Jet-lag is caused by the body's de-synchronisation of the body clock and the day-night cycle at the traveller's destination, which is out of balance. In order to prevent jet-lag, researchers have examined melatonin (an important hormone), which plays a key role in regulating the body's natural rhythm. Randomised trials were carried out in airline passengers, airline staff and military personnel, in order to assess whether the oral use of melatonin would decrease the symptoms of jet-lag. In nine out of ten trials, melatonin decreased the symptoms of jet-lag. High dosages are not needed, but timing of the dose is critical. It was concluded that melatonin is effective in preventing or reducing jet-lag and it aids overall adaptation to the different time zones Tables & Graphs ! MetaView graphs The figures and graphs in Cochrane Reviews display the Peto Odds Ratio and the Weighted Mean Difference by default. These are not always the methods used by reviewers when found and included/excluded Date reviewers' conclusions section amended Information not supplied by reviewer Contact address Dr Andrew Herxheimer Emeritus Fellow UK Cochrane Centre 9 Park Crescent London N3 2NL UK Telephone: +44 20 8346 5470 Facsimile: +44 20 8346 0407 E-mail: andrew_herxheimer@compuserve.com Cochrane Library number CD001520
Editorial group Cochrane Depression Anxiety & Neurosis Group Editorial group code HM-DEPRESSN combining data in their review. You should check the text of the review for a description of the statistical methods used. ! List of comparisons ! Additional tables ! Table of included studies ! Table of excluded studies ! Table of ongoing studies List of comparisons Fig 01 GLOBAL JET-LAG RATINGS 01.01.00 Global jet-lag ratings
87 Arendt Placebo 9, Melatonin 8 9.8 SD 0.8 55.4 SD 4.5
-45.6 (2.2)
88 Arendt [crossover study] Placebo 52, Melatonin 52 18.1 SD
15.5 40.5 SD
15.5 -22.6
(4.6) Within-subject comparisons
89 Petrie [NZ- London-NZ, crossover study] Placebo 20, Melatonin 20 35.8 SD 16.5
56.7 SD 24.5
-20.9 (0.66)
Eastward & westward results not reported separately
Claustrat Placebo 15, Melatonin 15 28.0 SD 7.4
47.7 SD 12.2 28.0 SD 7.4 -19.7
(3.7)
Nickelsen - eastward flights Placebo 9, Melatonin 9 52.3 SD 21.7
66.3 SD 19.7
-14 (9.8) Not statistically significant
TOTAL
participants & Weighted Means Placebo 105, Melatonin 104 25.3
48.1 -22.8
[Nickelsen - westward flights] [Placebo 9, Melatonin 9] 26 35
- 9
Case no/ Ref Effects and comment Days use Sex / Age BRAIN
1 Force 97 transient psychotic episode [possible overdose] ? F 73
2 Dalton 00 mixed affective state in depressed woman - withdrawn from clinical trial of M for insomnia 7 d
F
3 11 NZ hallucination, paranoia - recovered on stopping 2 d M ?
4 10 US
confusion, insomnia, tachycardia, abnormal thinking. Recurred on rechallenge 1 d F 38
5 07 US
ataxia, dizziness, headache. "recovered with sequelae" 4 d F 81
6 29 US
headache, hypertonia, tremor - improved on stopping. [was also taking unspecified vitamins] 5 d
F 28
7 35 US paraesthesia, tachycardia - improved on stopping 1 d F 41
8 Ellis 96 headache, odd taste in mouth - reported during clinical trial of M for insomnia [2 patients?] 7 d ??
9* Sheldon 98 convulsant effects in 4 of 6 severely neurologically disabled children with seizures, treated with M for sleep disorders
14 d 7months; 7, 8 & 9 yr
10 40 US convulsion - recurrence when medication was continued ? M 40
BLOOD CLOTTING
11* 08 US eye haemorrhage, purpura, reduced prothrombin - suspected interaction with warfarin 8 d
M 84
12* 09 US nosebleed, reduced prothrombin - suspected interaction with warfarin 5 d F 51
13* 21 US reduced prothrombin - suspected interaction with warfarin. Was taking M 10mg daily ? M 48
14* 24 US reduced prothrombin - suspected interaction with warfarin. Also taking digoxin, frusemide, diclofenac ? F 72 15* 26 US prothrombin affected [not clear how] - suspected interaction with warfarin.
?
16* 27 US prothrombin affected [not clear how] - suspected interaction with warfarin. ? M 61
CARDIOVASCULAR
17 16 US ventricular arrhythmia ? ?F 18 41 AUS chest pain, dyspnoea, fatigue, atrial fibrillation, paresis - recovered, no sequelae
1 d
F 58
Table of included studies 19 47 CAN tachycardia
? F ?
20 05 US arrhythmia, tachycardia, dizziness, paraesthesia - also on nicotine, pyridoxine
8 d
F 46
21 06 US angina, palpitation, hypotension - also on vitamins, oestrogen, testosterone
?
22 13 US chest pain, dyspnoea - also on thyroxine ? M 45 23 37 US fatigue, syncope 1 d
F 63
SKIN
24/25* Bardazzi 98 IT fixed drug eruption in 2 men: erythemato- vesicular plaques on the penis, appearing 6-8 hr after rechallenge, disappearing within 10 d few d M 35 & 42
Methods Participants Interventions Outcomes Notes A co 87 Arendt Double-blind. Treatment allocated according to a computer programme, decoded only after data collection was complete. 17
volunteers (10 women, 7 men) aged 29-68 years flying from San
Francisco or Los Angeles eastwards to London (8 time zones) after having stayed in California for 14 days. Oral
melatonin 5mg + 300mg lactose in gelatine capsule (n=8) or lactose 300mg (n=9) taken at 18.00 local time on day of
departure and 2 preceding days, and then at
bedtime (22.00 - 24.00) for the first 4 days after return to the UK.
['pre+post'] Activity patterns measured by wrist meters (n=16), oral temperature, mood self-rating, psychological tests, sleep duration and quality, rating of subjective feelings of jet lag. Urine assays for major metabolite of melatonin and of cortisol.
A 88 Arendt Double-blind cross-over study
52 of 61 participants flying from the UK to Melatonin 5mg or
placebo. For eastward Self-rated jet lag (VAS), symptoms
This study is briefly
reported by Skene 1989 B
Australia & New
Zealand and back
completed the
crossover. flights this was taken for 2 days before the flight at the local time, which corresponded to 2am at the destination time zone, and for 4 days after arrival at the local bedtime ['pre+post']. For westward flights
melatonin or placebo was taken at the local bedtime for 4 days after arrival in congress proceedings 89 Petrie Double-blind, placebo
controlled, cross-over trial 20
volunteers (8 women, 12 men) aged 28 to 68, flying eastward from New Zealand to London through 12 time zones on a 26-hour flight. They returned on a similar westward flight 3 weeks later. Gelatin capsule of melatonin 5mg +
lactose, or lactose daily at between 10.00 and 12.00 local time for 3 days before each flight and on the day of flight, then between 22.00 and 24.00 (destination time) for 3 days after their arrival. Participants were randomised to receive melatonin either on the outward or the return flight
['pre+post'] Feelings of jet lag and tiredness assessed by analogue scales, profile of mood states questionnaire, hours of sleep. On 10th day after arrival, retrospective rating of jet lag, estimate of how many days it had taken for sleep pattern and energy to return to normal. The participants recorded possible side effects
B 91 Nickelsen Double-blind 36 volunteers (26M 10F) flying westward from Frankfurt to USA and 2 weeks later in the reverse
direction. In 12 the time shift was 6-7 hr, in 12 8-9 hr, in 12 10- 11 hr.
After the westbound flight participants took melatonin 5mg or placebo at bedtime for 7 consecutive days. After the eastbound flight they took the same dose for 5 days ['post'] Sleepiness self-rated on Stanford scale, log of rest/ activity schedule
B 92 Claustrat Double-blind 30 healthy volunteers flying from North America to France, having
stayed in N America for 7 days or longer
Melatonin 8mg capsule (n=15; 8 men) or
placebo (n=15; 10 men) on the day of flight and at bedtime on the following 3 days ['post'] Sleepiness, mood, sleep, tiredness, efficiency at work, sleep latency, global effectiveness, symptoms Three
volunteers performed a double-blind cross-over trial within the study B
international airline cabin crew ( 26 M, 26 F) returning to New Zealand
from London via Los Angeles to complete a 9-day tour of duty
3 treatment groups:
melatonin (5mg daily at a time corresponding to evening/night at the destination) from 3 days before arrival until 5 days after arrival) n=14 ['pre+post']; melatonin (placebo for 3 days then melatonin 5mg daily for 5 days)
['post']. n=15; and placebo, Self-rated jet lag (VAS), tiredness, drowsiness; SSS (Stanford sleepiness scale), POMS (Profile of Mood States)
n=15. 97 Spitzer Double-blind 257 volunteers travelling eastwards across 6 time zones Melatonin 5mg or 0.5mg at bedtime or early evening on day of flight and then for 5 further days ['post']
Jet lag measured by new Columbia Jet Lag scale Insufficient adaptation in the new time zone before performing the study on the return flight B
Suhner a Double-blind 320 volunteers (age range 20 - 65 years; 172 men) from the
University of Zurich travel clinic, flying
eastwards through six to eight time zones.
Exclusion criteria: use of a beta- blocker or hypnotic, psychiatric disorder, severe sleep disorder, leukaemia, endocrine disorder, melanoma, severe
allergy, pregnancy. 142 travelled from America to Europe, 92 from Europe to Asia. These
numbers exclude 86 people who were either a) Melatonin 0.5mg b) melatonin 5mg c)
melatonin 2mg
controlled- release d) placebo. All were taken daily at bedtime for the first 4 days after the flight ['post']. Sleep quality and daytime sleepiness (sleep logs and Karolinska sleepiness scale), mood (POMS) and symptoms (questionnaire).Compliance was assessed using the electronic Medication Event Monitoring System [MEMS] and a questionnaire. Symptoms were noted Participants were asked to maintain a regular sleep-wake cycle during the baseline and the four testing days and to limit their
nicotine, caffeine and alcohol consumption to normal levels
A Table of excluded studies Table of ongoing studies A table of ongoing studies is not available for this review The Cochrane Library non-
compliant or withdrew for a medical reason.
98 Suhner b Double-blind; computer randomisation 160 volunteer travellers (80 men) flying eastwards from America to Switzerland across 6 to 9 time zones after a stay of at least 7 days in
America. 137
completed the study. Four groups: a) melatonin 5mg, b) zolpidem 10mg, c) both, or d) placebo, using the double dummy
technique. The
medication was taken between 5 and 9 pm local time on the day of the flight and then for 4 days at bedtime
['post'] Sleep quality, profile of mood states, symptoms, wrist activity monitoring (n=80), subjective rating of jet lag, and of efficacy of the medication. Compliance was assessed electronically (MEMS) and by questionnaire. 23 participants who missed one or more doses were excluded from the analysis. Symptoms were noted
A
Reason for exclusion Arendt 95, 97a, 97b These three broad reviews only briefly summarise the authors' controlled and uncontrolled studies and puts together the results for 474 subjects given melatonin and 112 given placebo; of these 86 took part in both arms of a crossover study. Randomisation is not mentioned.
The study examined the effect of melatonin on sleep loss and cognitive impairment in soldiers engaging in night operations immediately on arrival in the Middle East after flying eastwards across eight time zones. Neither adaptation to local time, nor jet lag was assessed Yüklə 194,99 Kb. Dostları ilə paylaş:
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