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J Bellorini, IJ Chamberlain, MJ Burton Cochrane Database of Systematic Reviews 2008 Issue 4 (Status: Unchanged) Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. DOI: 10.1002/14651858.CD007165 This version first published online: 23 April 2008 in Issue 2, 2008 This record should be cited as: Bellorini J, Chamberlain IJ, Burton MJ. Acupressure for motion sickness. (Protocol) Cochrane Database of Systematic Reviews 2008, Issue 2. Art. No.: CD007165. DOI: 10.1002/14651858.CD007165.
Definition, prevalence and symptoms Motion sickness is a very common response to real or perceived motion. It is a long-recognised malady: the word 'nausea' is derived from the Greek 'naus' meaning ship, and Hippocrates noted c400 BC that "Sailing on the sea shows that motion disorders the body" (MIT Classics 2007). Motion sickness is often experienced when travelling (by car, aeroplane, boat, in space etc.) or when subject to movement, for example on a ride at an amusement park. Actual movement, however, is not essential for symptoms to develop and motion sickness can also be provoked by purely visual stimuli such as movies, video games or flight simulators. Early symptoms may include bodily warmth, general gastric discomfort ("stomach awareness" (Shupak 2006), increased salivation and eructation (belching) which, with continued exposure to stimulus, may proceed to pallor, sweating, nausea and eventually retching/vomiting. Drowsiness, headache and fatigue may also be experienced and symptoms may continue for some hours after the inducing stimulus has ceased. The severity of symptoms varies widely from mild discomfort to complete incapacitation depending on the susceptibility of the individual and the magnitude of the stimulus. Motion sickness is also characterised by the capacity of sufferers to habituate (generally after 36 to 72 hours of exposure) and this habituation may be maintained if the provoking stimulus is regularly experienced (Shupak 2006). Motion sickness is common. A large questionnaire survey conducted in 1998 collected data from 20,029 passengers on 114 voyages aboard nine vessels: six ships, two hovercraft and one jetfoil. Overall, vomiting at some time during the journey was reported by 7% of passengers, with 21% reporting feeling "slightly unwell," 4% "quite ill" and 4% "absolutely dreadful" (Lawther 1988). A questionnaire survey of 923 passengers on 38 commercial airline flights was conducted in 2000. Concurrent measurements of aircraft motion on each flight were also taken. Overall, 0.5% of passengers reported vomiting, 8.4% nausea and 16.2% illness during flight (Turner 2000). For specific flights the prevalence of nausea and illness ranged from 0% to 38.4% and 47.8% respectively. Individuals whose professions require them to be in a moving environment are also commonly affected. Authors of a 1991 survey of commercial airline pilots reported that 29% of the 4345 respondents had been incapacitated on at least one occasion during their career, 58% with gastro-intestinal symptoms (James 1991). A 1978 study of Royal Naval personnel aboard two warships found that 67% and 73% of the crew had been
seasick during their career, and 42% and 56% respectively had been seasick in the previous 12 months. Whilst under assessment during sea trials which took place in rough weather, 38% and 47% of the crew on the two vessels were sick on at least one occasion (Pethybridge 1978). A study of space sickness in astronauts during 24 flights of the Space Shuttle recorded that 67% had symptoms, 13% of which were severe (Davis 1988). Children under two are rarely affected by motion sickness. Susceptibility increases between the ages of four and ten years, and then gradually declines, and women generally are more commonly affected than men (Lawther 1988; Turner 1995). A visual stimulus is not essential as motion sickness has also been shown to affect blind people (Graybiel 1970). In fact, motion sickness can be induced in almost anyone with a functioning vestibular system under test conditions, although patients with a non-functioning labyrinth have been shown to be 'immune' to the condition (Kennedy 1968). Aetiology Motion sickness is generally thought to be caused by a mismatch between visual and vestibular sensation (the 'sensory conflict theory') (Guedry 1970; Reason 1975; Reason 1978). The human sense of movement is generated by three systems: visual, proprioceptive and vestibular (the semicircular canals detecting angular acceleration, and the otolith organs linear acceleration). Where there is conflict between inputs from the visual and vestibular systems, or between the two parts of the vestibular system, motion sickness can be provoked, although why this is the case is still debated. Current concepts on the aetiology of motion sickness have been reviewed by Shupak (Shupak 2006). Diagnosis Motion sickness is not difficult to diagnose although, with the exception of vomiting, symptoms can be difficult to quantify. Diagnostic scales (e.g. Graybiel 1968) are based on a combined weighting of symptoms and signs. Treatment options The prevention and treatment of the symptoms of motion sickness includes pharmacological interventions, complementary therapies (e.g. ginger, homeopathic remedies, acupuncture and acupressure) and general preventative strategies. Generally, persons susceptible to motion sickness are advised to: • • • • • • • eat a light meal no less than three hours before travel/exposure; avoid alcohol, smoking and unpleasant odours; increase ventilation and exposure to fresh, cool air; avoid visual stimuli (e.g. reading); focus on the horizon or a stable external object; limit head movements; stay in a central location (e.g. if on a boat or plane);
• sit in the front seat of the car (if a passenger) or drive; and/or • lie in a supine position (Gahlinger 1999). Many sufferers, however, elect to try drug or other treatments. Treatment choice generally will depend on several factors, such as the level of individual susceptibility and the type, duration and intensity of the stimulus. For example, a passenger (who is able to rest, sleep etc.) may be able to tolerate a drug with adverse effects such as drowsiness and reduced performance, whilst a crew member or driver/pilot (who must remain fully alert) cannot. The approach will also differ depending on whether the goal is to prevent motion sickness from occurring or to treat symptoms which are already established. Drug treatments generally need to be taken 30 to 60 minutes before exposure to allow adequate time for absorption, as motion sickness may impair normal gastric processes (Stewart 2000). The pharmacological interventions for motion sickness are primarily anticholinergics and antihistamines, although other drugs (such as sympathomimetics, antiemetics and opioids) have been used. Anticholinergics reduce the effects mediated by acetylcholine in the central and peripheral nervous system. By interfering with the signal from the vestibular nucleus to the central nervous system, they are able to inhibit the vomiting impulse (Donnerer 2003). The most commonly used anticholinergic is scopolamine (hyoscine), which is available in both oral form (which will last for six to eight hours) and in a transdermal patch (which will last up to three days). Scopolamine is less sedative than antihistamines and has less impact on psychomotor performance (Golding 2005; Gordon 2001; Parrott 1989) however, it does have side effects, which include dry mouth, blurred vision, dilated pupils and bradycardia. Side effects are fewer with the transdermal patches. The effectiveness of scopolamine for motion sickness has been assessed in a Cochrane review (Spinks 2007), which found it to be effective in preventing motion sickness although its relative effectiveness compared to other drug treatments, such as antihistamines, could not be established. Antihistamines (H1 receptor antagonists) are widely used for the prevention and treatment of motion sickness, and are available to patients both on prescription and over-the-counter (OTC). Although they are commonly used to relieve the symptoms of allergy they also have anticholinergic properties and are therefore also useful for their anti-emetic effects (Gahlinger 1999; Kranke 2002; Simons 2004). The most frequent side effects of antihistamines are sedation and reduced psychomotor performance, the severity of which varies between different antihistamines, and they may also cause headache, psychomotor impairment, and antimuscarinic effects such as urinary retention, dry mouth, blurred vision and gastro-intestinal disturbances (BNF 2007). The effectiveness of antihistamines for preventing and treating motion sickness will also be assessed in a Cochrane review (Bellorini 2008). Acupressure Acupressure is a component of Chinese Traditional Medicine (TCM) which involves applying pressure (by hand or other device) to specific acupuncture points on the body, and has traditionally been used to treat a wide range of conditions. In TCM acupuncture and acupressure are used to 'balance the pattern of energy flow (Qi) along meridians throughout the body'; a system which is culturally completely distinct from the understanding of anatomy and physiology in Western medicine. In scientific terms the mechanism of action of acupuncture/acupressure is unknown but basic research has ascertained some physiological effects, including the release of opioids and other peptides in the central and peripheral nervous system, and changes in neuroendocrine function (NIH Consensus 1997).
For nausea and vomiting, the 'pericardium 6' or 'P6' acupuncture point (also known as the Neiguan point, meaning 'inner pass' or 'inner gate' in Chinese) is stimulated. The P6 point is found on the wrist, between the tendons of the palmaris longus and flexor carpi radialis muscles, three patient finger breadths above the flexor crease (Streitberger 2006). Although acupressure can be applied using the fingers alone, a number of commercial products are available for the treatment of motion sickness; most consisting of a simple wristband with a plastic disc or nodule on the underside, which is designed to rest on the P6 point and apply continuous pressure. Brand names include Acuband®, Travelband® and Sea-Band©. Some are marketed for more general nausea (BioBands®) and others incorporate TENS (Transcutaneous Electrical Nerve Stimulation) or electrical stimulation technology (iTrans®, ReliefBand®). Acupressure bands can be used prophylactically to prevent motion sickness developing, or at the onset of symptoms. Side effects are generally considered to be minor; those mentioned in individual trials have included skin irritation, mild discomfort and swollen wrists (Lee 2004). P6 acupoint stimulation has been studied in randomised controlled trials for the treatment of pregnancy-related, chemotherapy-induced and postoperative nausea and vomiting. Several recent Cochrane reviews have evaluated the anti-emetic effects of P6 stimulation. A recently updated review of P6 acupuncture point stimulation (by a variety of methods) for postoperative nausea and vomiting found a significant reduction in nausea (but not vomiting) when P6 stimulation was compared to a group of different antiemetics in a pooled analysis (Lee 2004). Another recent Cochrane review of acupuncture point stimulation for chemotherapy-induced nausea and vomiting (Ezzo 2006) found that P6 stimulation (of all types, when used in addition to anti-emetic drugs) reduced the incidence of acute vomiting (but not delayed nausea severity) when compared to anti-emetics alone in a pooled comparison. Results for P6 acupressure or acupuncture for nausea and vomiting in early pregnancy are less clear (Jewell 2003). P6 acupressure for motion sickness has been studied in randomised controlled trials (Alkaissi 2005; Estrada 2007; Hu 1995) and controlled clinical trials (Bruce 1990; Miller 2004; Stern 2001; Warwick-Evans 1991) with varying results; some studies reporting evidence of effectiveness in reducing symptoms (Alkaissi 2005; Hu 1995; Stern 2001), with others reporting no evidence of benefit. Some of these studies have been summarised in a general, nonCochrane review of acupressure for nausea and vomiting (Streitberger 2006). Korean hand acupuncture/acupressure, developed in the 1970s, is related to TCM but uses a different set of acupoints to achieve an effect and has been studied as an anti-emetic therapy in a number of clinical trials, including a recent randomised controlled trial of motion sickness in pre-hospital trauma care (Bertalanffy 2004). Rationale for review Motion sickness is a very common condition which causes discomfort for many people and significant incapacitation for a considerable number, including those whose profession requires regular exposure to provoking stimulus. A Cochrane systematic review of the effectiveness of acupressure in preventing and treating motion sickness is therefore warranted.
To assess the effectiveness of acupressure for preventing and treating motion sickness.
Criteria for considering studies for this review
Types of studies Randomised controlled trials. Types of participants Adults or children who 1) are about to experience the types of stimulus likely to induce motion sickness, or 2) have established symptoms of motion sickness. We will also include studies where motion sickness has been deliberately induced under test conditions, but these may be analysed separately. Types of intervention Any type of acupressure, applied using any method to the P6 acupuncture point versus: placebo/sham acupressure (i.e. applying pressure at a point other than P6); no treatment; pharmaceutical interventions (e.g. antihistamines, anticholinergics, sympathomimetics, antiemetics, opioids); or other interventions: complementary therapies (e.g. acupuncture, homeopathy, ginger) or behavioural methods (e.g. controlled breathing). We will also include studies of Korean hand acupressure, but these will be analysed separately. Types of outcome measures Primary outcome measure • Proportion of patients in which motion sickness is prevented • Proportion of patients whose symptoms of motion sickness are relieved Secondary outcome measures • Change in the frequency, intensity or duration of motion sickness symptoms (using any subjective symptom rating scale) • Changes in physiological parameters (heart rate, nystagmus, vagal tone, electrogastrography) • Side effects (e.g. skin irritation, swelling, pain) • • • •
Search methods for identification of studies
See: Cochrane Ear, Nose and Throat Disorders Group methods used in reviews. We will search the Cochrane Ear, Nose and Throat Disorders Group Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, current issue), MEDLINE (1950 onwards), EMBASE (1974 onwards), CINAHL (1982 onwards), AMED (1985 onwards), LILACS, KoreaMed, IndMed, PakMediNet, ZETOC, Cambridge Scientific Abstracts (Conference Proceedings Database), ISI Proceedings (Web of Science), IMEMR (Index Medicus for WHO Eastern Mediterranean Region), IMSEAR (Index Medicus for WHO South-East Asian Region), the National Research Register (NRR), the UK Clinical Research Network Portfolio Database (UKCRN), the World Health Organization International Clinical Trials Registry Platform (ICTRP), the Research Findings Register (ReFeR) and the meta-Register of Controlled Trials (mRCT). The Cochrane Central Register of Controlled Trials (CENTRAL) will be searched using the terms: #1 ACUPRESSURE single term (MeSH) #2 ACUPUNCTURE POINTS single term (MeSH) #3 PRESSURE single term (MeSH) #4 WRIST single term (MeSH) #5 #3 OR #4 #6 #2 AND #5 #7 acupress* OR acustim* OR (acupunct* AND pressure*) OR tuina OR tui NEXT na OR wristband* OR wrist NEXT band* OR relief NEXT band* OR sea NEXT band* OR travel NEXT eze* #8 #1 OR #6 OR #7 #9 MOTION SICKNESS explode all trees (MeSH) #10 car NEAR sick* or sea NEAR sick* or motion NEAR sick* or air NEAR sick* or travel NEAR sick* or space NEAR sick* #11 carsick* OR airsick* OR seasick* OR motionsick* OR travelsick* OR spacesick* OR kinetos* #12 #9 OR #10 OR #11 #13 #8 AND #12 Strategies for all other databases will be modelled on the CENTRAL version. These terms will be combined with the highly sensitive search strategy designed by The Cochrane Collaboration for identifying randomised controlled trials and controlled clinical trials in MEDLINE, and with adapted versions of this filter in EMBASE and CINAHL. Reference lists of identified publications will be scanned for additional trials and trial authors contacted if necessary. A search for existing meta-analyses and non-Cochrane systematic reviews will also be performed and their reference lists scanned for additional trials. There will be no language, publication year or publication status restrictions on searching.
Methods of the review
Study selection Two authors (JB and IC) will independently screen the results of the search to identify studies which loosely meet the inclusion criteria of the review. These studies will be obtained in full text and the inclusion criteria applied independently. We will resolve any disagreement over which studies to include by discussion, or by referral to the third author (MB). Data extraction Data will be extracted independently by two authors (JB and IC) using standardised, pre-piloted data extraction forms. Where data are missing or unclear JB will attempt to contact the authors of the trial for unpublished data or clarification. Quality assessment We will base assessment of study quality on the method outlined by Schultz 1995. The following study characteristics will be assessed: Adequacy of the randomisation process A: Adequate sequence generation is reported, e.g. using random number tables, computer random number generation, coin tossing, or shuffling. B: The adequate reported methods in (A) are not mentioned but the method of randomisation is described. C: Other methods of allocation used that may not be random. Adequacy of the allocation concealment process A: Adequate: for example, central randomisation; serially numbered, opaque or sealed envelopes (i.e. a randomisation method that would not allow an investigator/participant to know or influence an intervention group before entry to the study is described). B: Unclear: 'randomisation' is mentioned, but no information on the method used is reported or a method that is clearly inadequate is described. C: Inadequate: a clearly inadequate method of randomisation is used, such as alternate medical record numbers or unsealed envelopes; or any indication in the report that investigators or participants could influence the intervention group. Potential for selection bias after allocation A: Adequate: it is specifically reported by the authors that intention-to-treat analysis was undertaken and confirmed on assessment of the study, or it is not stated in the report but evident from study assessment that intention-to-treat was undertaken. B: Unclear: intention-to-treat analysis is reported (but cannot be confirmed by assessment of the study), or intention-to-treat analysis is not reported (and unable to confirm by study assessment). C: Inadequate: absence of intention-to-treat analysis is confirmed on assessment of the study (i.e. patients who were randomised were not included in the analysis because they did not receive the study treatment, they dropped out from the study or were excluded because of
protocol violation) regardless of whether intention-to-treat was reported or not. Completeness of follow up The percentage of participants for whom data was complete at the defined study end-point. Level of masking (treatment provider, patient, outcome assessor) A: Adequate: blinding of either outcome assessor, treatment provider or patient. B: Unclear: unclear whether blinding was used. C: Inadequate: blinding not used. Where all the above criteria are clearly met we will allocate the study an overall 'A' grade. Where one or more criteria are only partly met or unclear we will allocate a 'B' grade. Studies where one or more of the above criteria are not met will be graded 'C'. Data analysis We will use Review Manager 4.2 (RevMan 2003) for data analysis. For dichotomous data, we will calculate individual and pooled statistics as relative risk (RR) with 95% confidence intervals (CI). When appropriate, continuous data will be analysed using weighted mean differences (WMD) with 95% confidence intervals. We will consider meta-analysis in the absence of significant clinical or statistical heterogeneity. We will test for heterogeneity using the I2 statistic (in RevMan) and will assume significant heterogeneity if the I2 is greater than 40% (i.e. more than 40% of the variability in outcome between trials could not be explained by sampling variation) (Higgins 2003). We will use a fixed-effect model in the absence of statistical heterogeneity and a random-effects model if heterogeneity is apparent. We anticipate that subgroup analysis might be appropriate in differentiating between experimentally and 'naturally' induced motion sickness. Studies of Korean hand acupressure for motion sickness will be analysed separately. If possible, study quality will be used in a sensitivity analysis.
Potential conflict of interest
We are grateful to Carolyn Doree for the design and running of the search strategy.
Sources of support
External sources of support • No sources of support supplied Internal sources of support • No sources of support supplied
Title Author(s) Acupressure for motion sickness Bellorini J Chamberlain IJ Burton MJ Jenny Bellorini: drafting the text of the protocol and review; screening search results; organising retrieval of papers; contacting trial authors for additional information; data extraction; quality assessment; data analysis. Ian Chamberlain: screening search results; data extraction; quality assessment; data analysis. Martin Burton: appraisal of drafts at all stages of review; screening search results; interpretation of results; guarantor for the review. Issue protocol first published 2008 Issue 2 Date of most recent February 19, 2008 amendment Date of most recent February 19, 2008 SUBSTANTIVE amendment Contact address Mrs Jenny Bellorini Cochrane ENT Disorders Group
Contribution of author(s)
DOI Cochrane Library number Editorial group Editorial group code
Dept of Otolaryngology - Head and Neck Surgery Level LG1 - West Wing John Radcliffe Hospital Oxford UK OX3 9DU E-mail: firstname.lastname@example.org Web site: http://www.cochrane-ent.org Tel: +44 1865 231054 Fax: +44 1865 231091 10.1002/14651858.CD007165 CD007165 Cochrane Ear, Nose and Throat Disorders Group HM-ENT
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