Scientific test of No-Jet-Lag **

No-Jet-Lag Clinical Trial
Background
Considerable research has been conducted into methods of reducing the effects of jet-lag on long-haul air travellers, including the use of melatonin, special diets and bright light therapy, but most are complicated to use and/or have adverse side-effects. A homeopathic remedy, No-Jet-Lag, was developed to counter jet-lag, and informal testing and anecdotal reports indicated a significant reduction in the symptoms.

Hypothesis
That No-Jet-Lag would reduce the symptoms of jet-lag commonly experienced after long-haul travel.

Methods
Nineteen volunteers with previous inter-continental air travel experience were tested in a double blind placebo-controlled crossover trial on a flight from New Zealand to Europe and return (equivalent to travelling round the world), completing survey forms before departure and after arrival on each leg.

Results
The subjects taking the remedy showed less fatigue-inertia and had more vigor-activity compared to the subjects taking the placebo.

Conclusion
The homeopathic group remedy No-Jet-Lag can reduce jet-lag symptoms after long-haul flights.

Introduction

Jet-lag symptoms are a common problem for air travellers after long flights especially when passing through several time zones. They are regarded as a significant factor impairing the post-flight performance of business travellers, sports competitors and general users of long-distance air transport.

Jet-lag is attributed primarily to the body's need to resynchronize its endogenous circadian rhythm to the night and day cycle of the new environment. However, other factors also contribute to the jet-lag syndrome.

These include the traveller being tired, stressed, ill or hung-over at the start of the journey; the dryness and sometimes the staleness and lack of air in aircraft passenger cabins; alcohol consumption, which can exacerbate dehydration; restricted physical mobility during the flight; and pressure changes associated with the rapid climb to and descent from cruising altitudes of around 30,000 feet, which are not fully compensated even in pressurized aircraft.

One approach to jet-lag that has received much attention is the use of a synthetic form of melatonin, the hormone that regulates the body's inbuilt body-clock. It has been extensively trialled and found to be successful in alleviating jet-lag (3), but long term side-effects are a concern and yet to be fully established. In some countries including the European Community, Canada and Australia, such concerns have led to the status of melatonin being changed from over-the-counter to prescription-only sale. In the USA, melatonin remains freely available. The dosage is complicated, involving the taking of melatonin for several days before the flight and again for several days after the flight is completed. Timing of the dose has been found to be crucial, and incorrect use can result in jet-lag being made worse rather than better. One trial group which was given melatonin before instead of after arrival home from a nine-day trip made a worse recovery than a control group taking a placebo, reporting more jet-lag and fatigue symptoms (4). Some reports indicate that users who forgot to take melatonin on the third night after returning home found jet-lag symptoms returning the following day.

Bright light therapy is another approach to the problem of jet-lag, but as with melatonin, the treatment is complicated and can be very inconvenient. Eastward travel requires exposure to bright light early in the day after arrival and westward travel requires it at the end of the day (5). The light intensity required is 3,000 lux which is available outside in some regions and climatic conditions but not all, and not for those restricted to indoor activities (6). A solution to the lack of bright outdoor light is the use of light boxes. These range in price from US$40 to US$400 and usually weigh about 10lbs, making treatment by light boxes both expensive and cumbersome.

Another method is the anti jet-lag diet. Like melatonin this is only for people with lots of time on their hands who can devote several days before and after a trip to looking after themselves according to a strict regime. It is complicated and there is little evidence that it works, although it has some passionate devotees.

The impracticalities, complexities and expense of the above treatments suggest the need for other approaches to the problem of jet-lag. The homeopathic approach was adopted because of the simplicity and convenience of the dosage regimen, the low cost and the lack of toxic side effects.

Methods

The trial was designed to investigate the effects of No-Jet-Lag during and after a group's flight from Auckland, New Zealand, to Frankfurt, Germany, and return, in such a way that experiences of jet-lag and mood could be closely monitored for seven days after each part of the trip.

Subjects completed a Profile of Mood States questionnaire designed to measure six fluctuating affective states, two of which were relevant to jet-lag, namely, vigor-activity and fatigue-inertia. They were asked other questions on how anxious and energetic they felt. In addition a self-evaluation questionnaire was used to study issues related to jet-lag such as stress, nervousness, confusion, calmness and self-confidence. These questionnaires were filled in two hours prior to departure, and again the day after arrival at both Frankfurt and Auckland, and also seven days after arrival at both destinations. Subjects were also encouraged to make any comments they thought might be useful to the outcome of the trial.

All participants were seasoned travellers with experience of long inter-continental flights through at least five time zones, and were in good health. The group consisted of proficient skiers who had previously travelled from New Zealand to North American and European ski fields, and this was their annual trip to Europe to ski and buy equipment. Having a level of fitness higher than that of average travellers, they were possibly able to resist the effects of jet-lag better than most.

The subjects flew from Auckland to Frankfurt in an eastward direction through 12 time zones on a 23-hour flight, returning on a similar flight of 25 hours westwards 16 days later. The subjects were randomly assigned in a double blind procedure to receive No-Jet-Lag or the placebo on the outward flight and the other substance on the return journey. Each subject received one bottle of tablets in Auckland and the other bottle before departure in Frankfurt for the return journey. Each bottle was labelled with either a "M" or "F" for gender identification and a 3-digit code. These codes were placed on each sheet of the questionnaire. The subjects chewed one tablet on take-off, one tablet every three hours while flying and one tablet after landing.

No-Jet-Lag is manufactured according to guidelines of the Homeopathic Pharmacopoeia of the United States (HPUS) under GMP conditions.

Statistics

The trial used the POMS (Profile of Moods States) questionnaire to measure two fluctuating affective states relevant to jet-lag, namely vigor-activity and fatigue-inertia (7). Individual scale items were summed using standard procedures, and the data were analyzed with the statistical package for the social sciences, SPSS (8), with one-way analyses of variance and t tests.

Results

The data showed mean fatigue-inertia scores (Fig. 1) were consistently higher in subjects taking placebos than in subjects taking the remedy (9.47 vs 5.63; p = 0.026). The mean vigor-activity (Fig. 2) was also lower in subjects taking the placebo than in subjects taking the remedy (18.11 vs 21.16; p = 0.072). For all of the other states measured by the POMS questionnaire, which were less relevant to jet-lag, the p value was greater than 0.05.

No-Jet-Lag reduces fatigue/tiredness and increases energy/vigor compared with
taking a placebo or not using any treatment when flying long distances.

Fig. 1. Differences in fatigue-inertia scores between the two groups taking placebo and No-Jet-Lag (dose every three hours while flying) on a long-haul flight from Auckland to Frankfurt and return. N=19, P=0.026 which indicates a significant difference between the placebo and No-Jet-Lag administration.

Fig. 2. Differences in vigor-activity scores between the two groups placebo and No-Jet-Lag (dose every three hours while flying) on a long-haul flight from Auckland to Frankfurt and return. N=19, P=0.072.

Analysis of the survey forms completed after each leg showed subjects taking No-Jet-Lag experienced less jet-lag and took less time to recover from their shift across 12 time zones.

Those taking No-Jet-Lag slept without interruption on the first night after arrival and woke up the next morning refreshed and feeling quite normal, whereas those who took the placebo did not sleep well, woke up at strange times in the night and had difficulty getting back to sleep and woke up the next morning feeling jet-lagged. The difference was also borne out by their skiing performance after arrival in Europe. Those who had taken the remedy reported skiing well, while those who had taken the placebo were still tired and skied poorly the first day and even during later sessions on the slopes. When asked if they knew whether they had taken the remedy or the placebo, they said that on arrival in Germany the whole party all felt very tired but most were already fairly sure which treatment they had taken. By the next day when they had been skiing it was increasingly obvious which treatment they had taken. The consensus view by those taking No-Jet-Lag was that they were skiing as well as they would have on a local ski field at home, apart from slight tiredness. Those skiers who took the placebo took several days to return to their usual skiing ability.

After the trial was completed, subjects were asked if they thought No-Jet-Lag was effective in treating jet-lag. Of the 19 who completed the trial, 14 (74%) said it was effective, five said they were not sure, and none said it was not effective. Those who were not sure said they thought that No-Jet-Lag had helped.

On the outward journey, of the 19 taking part, 13 (68%) correctly guessed whether they had taken the placebo or No-Jet-Lag. Of the others, three did not know and three incorrectly assigned themselves to the wrong group. On the return journey, two were incorrect, three did not know and 14 (74%) correctly guessed. By comparison, a trial of melatonin (2) involving 17 travellers showed that on the outward leg, six guessed incorrectly, five guessed correctly, and nine did not know, while on the return leg five did not know, six were incorrect and nine (just over half) were correct. Subjects in the No-Jet-Lag trial were asked to comment on any side-effects or difficulties in taking either the placebo or the remedy. None were reported. This result was as expected, as there are no reported side effects of the ingredients in either the placebo or No-Jet-Lag.

The tour leader reported that in conversation with subjects at the time of completion of the last questionnaire, several commented that they had noticed when using No-Jet-Lag that they experienced less swelling of lower limbs, found it easier to sleep in flight and noted a lack of disrupted sleep in the days after arrival. These effects were not specifically tested for in the trial and warrant further tests.

The results of this study support the use of No-Jet-Lag as a remedy for jet-lag symptoms on long-haul flights. These results were consistent with those from informal testing of No-Jet-Lag carried out since 1988, including a survey of 55 flight attendants on routes between New Zealand and Asia, North America and Europe, which showed 75% considered the remedy effective (1).

The lack of any adverse side effects in subjects taking No-Jet-Lag suggests it is well tolerated at the dose used. Further trials are suggested to specifically test individual factors that may or may not contribute to jet-lag, for example the amount of water and alcohol drunk (as dehydration is suspected of making jet-lag worse). In such further trials the amount of non-alcoholic and alcoholic fluids should be carefully monitored and possibly controlled to remove this factor. It is possible that the results in our trial might have been different had we used subjects with only an average level of fitness rather than the higher level possessed by those doing the trial, although we have no firm reason to believe this would be so.

Authors:

Professor K. Kumar Ph.D.
Professor of Biopharmaceutics/Pharmacokinetics
Howard University, College of Pharmacy
Washington D.C. 20059
United States of America

Andrew Criglington
Director of Research
Miers Laboratories
Wellington 6038
New Zealand

References:

1. Miers Laboratories, Do flight professionals get jet-lag? Aviation, Space, and Environmental Medicine. Volume 69, Number 8, Page 810, Aug 1998.

2. Recht LD; Lew RA; Schwartz. A letter, Baseball teams beaten by jet-lag. Nature, 377 (6550): 583 1995 Oct 19.

3. Petrie K, Conaglen JV, Thompson L, Chamberlain K. Effect of melatonin on jet-lag after long-haul flights. Br Med J 1989; 298, 705-707.

4. Petrie K, Dawson AG, Thompson L, Brook R. A double-blind trial of melatonin as a treatment for jet-lag in international cabin crew. Biol Psychiatry 1993; 33:526-530.

5. Daan S, Lewy AJ. Scheduled exposure to daylight; a potential strategy to reduce jet-lag following transmeridian flight. Psychopharmacol Bull 1984; 20:566-568.

6. Wever RA. Light effects on human circadian rhythms: A review of Andechs studies. J. Biol Rhythms 1989;4:161-185.

7. McNair DM, Lorr M, Droppleman LF, Edits manual for the profile of mood states. San Diego: EDITS, 1981.

8. SPSS Incorporated. Users guide to statistical package for the social sciences - X. New York: McGraw-Hill, 1983.