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Thread: Japanese Study

  1. #1
    Sik
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    Japanese Study

    Translation of "the Japanese" study lifted from Eyedunno at ECF

    Original Post http://www.e-cigarette-forum.com/for...ml#post3221984

    Actual Study documentation http://www.jstage.jst.go.jp/article/...55_59/_article

    I. Introduction

    Nicotine contained in tobacco is habit-forming and addictive. In addition
    cigarettes have many carcinogens and toxins, so they are known to have a role
    in the onset of various respiratory and circulatory ailments, and also, they are
    known to increase the risk of a great number of malignancies leading to lung cancer.
    Also, sidestream smoke contains toxins beyond even those in mainstream smoke, and
    damage to health due to passive smoking has become a big problem [1]. Since 2004,
    when they were first sold in China, electronic cigarettes as a nicotine delivery
    system have amassed worldwide popularity [2]. These devices generally are made up
    of a cartridge containing a liquid which includes nicotine, propylene glycol or
    glycerin, and various flavorings. a heating element, and a battery, and by sucking
    in the heating element is activated, and the solution is vaporized so that it can be
    inhaled. As opposed to what one may call regular cigarettes, fire is not used, so
    tar and carbon monoxide that accompany combustion and sidestream smoke from the tip
    are not produced. Laugesen calls these nicotine-containing electronic cigarettes a
    safer alternative to cigarette smoking [3]. On the other hand, the World Health
    Organization has claimed that electronic cigarettes of this sort have not been
    recognized as nicotine replacement therapy [4]. In addition, the U.S. Food and Drug
    Administration has disassembled cartridges from two separate manufacturers and has
    cited, in addition to nicotine, the presence of carcinogens such as tobacco-specific
    nitrosamines, impurities characteristic of tobacco, and toxic diethylene glycol in
    order to point out the danger of these devices [5]. In addition, because of the
    flavors available, there is apprehension about young people getting their hands on
    nicotine products [6]. Also, clinical trials concerning their safety have not been
    done [7].

    Against this background, electronic cigarettes free of nicotine were developed. The
    object of this research is to test the safety of nicotine-free electronic cigarettes
    developed by JBS Corporation when used by smokers. By sucking on these electronic
    cigarettes, the glycerin-containing liquid inside the cartridge is heated and turns
    into a vapor that is white in color. Through the inhalation of this vapor, the
    devices are used as a tobacco-replacement product. In this study, subjects who were
    smokers used these electronic cigarettes for 28 days, and tests were performed to
    assess the devices' safety. Furthermore, as of October 2008, these devices were
    already on the market.

    When glycerin is heated, the toxic substance acrolein may be produced. This
    substance is produced in the process of cooking food, and is also found in the
    atmosphere [8]. With this in mind, the production of acrolein in the vapor emitted
    by these electronic cigarettes was tested.

    II. Methodology

    1. Test equipment
    Product name: Mild Smoker Next (JBS Corp.)
    Device construction (Figure 1)
    --
    Filter Cartridge
    Joint (atomizer)
    Main unit (rechargeable battery)
    --
    Figure 1 Test equipment (electronic cigarette) configuration
    --

    Main unit (rechargeable battery)
    Joint (atomizer)
    Filter Cartridge


    Contents of filter cartridge used in tests
    Aqueous glycerin solution (approx. 0.25 g.)
    Composition: Food-additive-grade glycerin, purified water


    2. Subjects
    Male and female volunteers 20 or older who were habitual smokers using 20 or more
    cigarettes per day were chosen as subjects. Further, those who had used electronic
    cigarettes before, those with an existing history of heart and/or respiratory
    conditions, those with a predisposition for allergies or chronic dermatitis, and
    others who were judged by the doctors in charge of testing to be unfit for this
    study were excluded. Ultimately, 34 people who met the above conditions were
    selected. The age of the participants was 44.9±13.7 (mean±standard deviation), with
    26 males and 8 females. This study was carried out with the approval of the Osaka
    City University Graduate Medical Research Ethics Committee (approval number 1794),
    and the study was carried out upon receiving the written consent of participants
    after thoroughly explaining the goals and content of the study in accordance with
    the Declaration of Helsinki (revised 2008).

    3. Testing Schedule
    The testing schedule is shown in figure 2. First, prescreening using an advance
    checklist was carried out, and those who were found to be suitable were requested to
    enter the clinic as candidate subjects. The period of electronic cigarette use was
    set for July 10 - August 6, 2010, with participants coming to the clinic a total of
    three times - once before use began, once one week into use, and once the day after
    the last day of use. The first time they came to the clinic, participants were
    informed of testing procedures and their written consent was acquired.

    --
    Ethics Committee approval -> Recruitment and prescreening of subjects -> Entry and
    acquisition of consent / Screening / Assessment of eligibility (First visit [before
    beginning testing]) -> Electronic cigarette use - 28 days (Second visit [after one
    week of use]) (Third visit [upon completion])
    --
    Figure 2 Testing schedule
    --

    At the first and third visits subjects were given a physical examination, and blood
    and urine samples were collected. Further, intake of anything other than water was
    prohibited from 9 P.M. of the night before these visits. It was recognized that a
    single cartridge did not produce much smokelike vapor after 150 puffs. Based on
    this, participants were instructed to replace the filter cartridge with a new one
    every day, and after taking 150 puffs in a day or upon experiencing a sharp decline
    in vapor output. No particular restrictions were placed on subjects' smoking during
    the course of the study.

    4. Checkup Provisions
    1) Physical examination: Weight, BMI, blood pressure, pulse
    During the first visit, heights were measured, and BMI was calculated using weight
    measurements obtained at each visit. Also, blood pressure and pulse were measured on
    an individual basis after 5-10 minutes of rest using an automatic sphygmomanometer.
    2) Hematological analysis
    Leukocyte count, erythrocyte count, platelet count, hemoglobin, hematocrit, MCV
    (mean corpuscular volume), MCH (mean cell hemoglobin), MCHC (mean corpuscular
    hemoglobin concentration)
    3) Biochemical blood analysis
    Albumin, blood urea nitrogen, creatinine, total bilirubin, AST, ALT, γ-GTP, total
    cholesterol, triglyceride, HDL cholesterol, blood sugar (empty stomach)
    4) Urinalysis
    D-glucose, protein, and urobilinogen were assessed qualitatively on urinalysis
    forms.
    5) Interview examination
    Interviews were given during the three visits. At the first visit, history of
    illness, present health condition, and history of allergies was confirmed, and upon
    completion of the study subjects were interviewed about any changes in physical
    condition due to use of the test devices. Also, at the second visit, along with an
    interview concerning changes in physical condition, consumption was determined by
    measuring the change in the weight of spent filter cartridges, and in the case of
    conspicuously low consumption of glycerin, guidance was given on inhalation
    technique.
    6) Journal
    Participants were requested to keep a journal noting frequency of use of the test
    device, changes in physical condition, and use of pharmaceuticals over the course of
    the four weeks of use of the test devices.

    5. Tests Concerning Acrolein Production
    The toxic substance acrolein can be produced by heating glycerin. Therefore,
    acrolein formation in the vapor emitted by electronic cigarettes was tested. For
    this test, a chemical assessment research group was consulted. Vapor produced by
    electronic cigarettes was trapped and cooled with liquid nitrogen, and 0.3 g. of the
    resulting liquid was kept at a constant volume with methanol and subjected to
    analysis by gas chromatography.

    6. Statistical Analysis
    All data were arranged based on mean value ± standard deviation. For assessment of
    safety, weight, BMI, blood pressure, pulse, and the values from clinical blood tests
    from before the test began and from after four weeks of use were analyzed using a
    paired t-test, and a risk rate below 5% was considered significant. SPSS 15.0J for
    Windows (SPSS Inc., Chicago, IL) was used for statistical analysis.

    III. Results
    34 people consented to this study, and up to the second visit, all were still
    participating, but by the third visit, two participants had dropped out of the study
    due to personal reasons, so 32 subjects successfully completed the study. As for the
    test devices, weight of filter cartridges before and after use were compared on an
    electronic scale (that measures in grams to up to three decimal places), and
    compliance was confirmed based on these measurements and on the journal entries. All
    subjects who successfully completed the study had used the device on over 90% of
    days (proportion of days: 97.7±4.4%). Mean amount consumed was 0.181±0.040 g., and
    compared with filter cartridges used in preliminary testing where 150 puffs used an
    amount of 0.235±0.021 g. (n=13), compliance was judged to be good at over 70%.
    Current Vape: Variable Wattage mod, EPM Boge tanks, Something Fruity

  2. #2
    Sik
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    1. Influence on blood pressure and body weight
    Table 1 displays the changes before and after electronic cigarette use in body
    weight, BMI, systolic blood pressure, diastolic blood pressure, and pulse. No change
    was seen in weight and BMI. Both systolic and diastolic blood pressure showed a
    statistically significant increase after four weeks of using the test devices, but
    it was slight and judged to be within the normal physiological range of
    fluctuation.

    2. Blood tests
    Table 2 shows the values from hematological analysis before and after use of
    electronic cigarettes. Leukocyte count, erythrocyte count, platelet count,
    hemoglobin, and MCHC were not affected by use of the test devices. On the other
    hand, hematocrit, MCV, and MCH showed a statistically significant decrease over the
    four weeks using the test devices, but it was a very small change and was within the
    normal physiological rate of fluctuation.

    Table 3 shows the values from biochemical blood analysis before and after electronic
    cigarette use. Stasistically significant changes in blood albumin density,
    creatinine content, AST, and HDL cholesterol were registered after the four weeks of
    use, but they were slight and judged to be within the normal physiological range of
    fluctuation.

    3. Urinalysis
    Out of the 32 subjects, irregularities were noticed in urinalysis results for two
    subjects. One showed an increase of one in urine proteins, while the other showed an
    increase of three in urine proteins and an increase in urine sugars of two, but
    there were no fluctuations over the study period and electronic cigarettes had no
    influence (Table 4).

    4. Interviews and journals
    Five subjects complained of throat irritation, one complained of lip irritation, and
    two complained of coughing or phlegm due to use of the test devices. These symptoms
    went away after testing was completed (Table 5).

    5. Testing related to acrolein production
    Results of testing two filter cartridges showed per-cartridge acrolein levels of
    2.31 μg and 7.08 μg.

    IV. Observations


    This study targeted smokers and tested the safety of electronic cigarettes when used
    with glycerin as an ingredient at the rate of one cartridge per day for 28 days.
    Urine and blood analysis, subject journals, interviews by physicians, and also
    physical examinations were done before using the test devices and again after four
    weeks of use, but abnormal fluctuations in clinically tested variables and critical
    signs of harm that could be considered to have a causal relationship to these test
    devices were not found. While it was found that 7 out of 32 subjects (22%)
    experienced mild symptoms of upper respiratory irritation while using the test
    devices, these symptoms disappeared after the study's conclusion. Subjects continued
    to smoke ordinary cigarettes during the study period. Accordingly, there is the
    possibility that use of these devices can give upper respiratory irritation to a
    certain proportion of people. When Bullen et al. compared the frequency of oral
    cavity and throat irritation for groups of users of nicotine-free electronic
    cigarettes, nicotine-containing electronic cigarettes, and the Nicorette® inhaler,
    they reported finding 22%, 38%, and 88% respectively for the three groups [9].
    These results match those of this study, and there were not thought to be any
    problems with tolerability.

    That acrolein is produced from the application of heat to the aqueous glycerin
    solution in the test cartridges was evident from testing. Acrolein is formed when
    cooking foods containing carbohydrates, vegetable oils, and animal fats and amino
    acids, and is also obtained from the burning of petroleum and biodiesel fuels [8].
    When administered orally to mice, rats, and dogs, acrolein did not show
    carcinogenicity in tests for the same. Tests with exposure through inhalation were
    also reported, but there were problems with the number of animals and with the
    duration of the study, and data sufficient for evaluation were not obtained. As a
    result, it is classified as Group 3 (agents not classifiable as to their
    carcinogenicity to humans) by the International Agency for Research on Cancer (IARC)
    [10]. Nevertheless, acrolein is found in nature, and human daily intake is 4.6 μg
    from the atmosphere, 0.30 μg from drinking water, and 88 μg from dietary sources
    [10]. In the case of tobacco, mainstream smoke from one cigarette contains
    9.93-116 μg of acrolein, and sidestream smoke from one cigarette contains 288-348 μg
    [10,11]. To give specific examples, Mild Sevens contain 47.6-110 μg per cigarette
    and Frontier Lights contain 9.9-38.0 μg [11]. The filter cartridges used in this
    study can be used over 150 times, and this is thought to be equal to a pack of (20)
    cigarettes. Considering this carefully, while one cannot completely deny the
    potential harm of acrolein, the amount of acrolein inhaled from one filter
    cartridge in the test device is roughly equivalent to the amount humans are exposed
    to from the atmosphere, and is less than the lowest amounts of acrolein found in the
    mainstream smoke from one cigarette, so when one considers that these devices are
    used by smokers for the purpose of reducing smoking, we may come to think of this
    toxicity as unproblematic.

    --
    y-axis: cigarettes smoked (number / day)
    x-axis: [left] before beginning the study [right] fourth week of the study
    --
    Figure 3 Change in number of cigarettes smoked as a result of using the test devices
    --

    This study showed a statistically significant decrease in cigarettes consumed while
    the test devices were being used (figure 3). Since the filter cartridges used did
    not contain nicotine, it cannot be simply thought that it was because of a decrease
    in the desire for cigarettes that accompanies nicotine dependence, but a correlation
    between use of the device and a decrease in cigarettes consumed was evident. The
    reason for the decrease in cigarettes consumed is unclear, but it is possible that
    compulsion to inhale from the device at least 150 times per day cut into
    opportunities to smoke. Among 45 flavors offered under 25 brand names domestically,
    nicotine was detected in 15 flavors under 11 brand names [12]. These cartridges and
    devices that vaporize nicotine are in violation of the Pharmaceutical Business Law
    [13]. Similar issues have been raised by the U.S. Food and Drug Administration, and
    this can be considered a problem that should be given heed [6].

    V. Summary

    The safety of electronic cigarettes employing an aqueous glycerin solution for four
    weeks was tested for smokers (of more than 20 cigarettes per day). In addition, the
    change in amount smoked over the period the electronic cigarettes were used was
    investigated. Blood tests, urinalysis, subject journals, and physician interviews
    took place both before and after use, but abnormal fluctuations in clinically tested
    variables and critical signs of harm that could be considered to have a causal
    relationship to these test devices were not found, and the safety of the electronic
    cigarettes used in this study was confirmed. Acrolein was detected in the vapor
    produced by the electronic cigarettes, but it was less than the lowest amounts found
    in the mainstream smoke from a single cigarette, and when used by smokers this is
    not considered problematic. In addition, consumption of cigarettes declined
    appreciably in correlation with use of these electronic cigarettes. Consequently,
    the possibility that the electronic cigarettes tested are a safer alternative for
    smokers is suggested.

    Japanese sources:
    10) Shin enerugī sangyō gijutsu sōgō kaihatsu kikō. Akurorein. Kagaku busshi�tsu no
    shoki risuku hyōka sho 2006.
    [New Energy and Industrial Technology Development Organization. Acrolein.
    Preliminary chemical risk assessment paper. 2006.]

    11) Kōsei rōdō shō. Heisei 11-12 nendo tabako-en no seibun bunseki ni tsuite
    (gaiyō).
    [Ministry of Health, Labour, and Welfare. Concerning constituent analysis of tobacco
    smoke, Heisei 11-12 {1999-2000} (Outline)]

    12) Dokuritsu gyōsei hōjin kokumin seikatsu sentā. Denshi tabako no anzensei o
    kangaeru. http://www.kokusen.go.jp/news/data/n-20100818_1.html
    [National Consumer Affairs Center. Considering the safety of electronic cigarettes.
    http://www.kokusen.go.jp/news/data/n-20100818_1.html ]

    13) Yaku shoku kan ma hatsu 0818 dai 5 gō (Heisei 22-nen 8-gatsu 18-nichi tsuki).
    Nikochin o gan'yū suru denshi tabako ni kansuru yakuji kanshi no tettei ni tsuite
    (irai).
    [Pharmaceutical and Food Safety Bureau - Compliance and Narcotics Division report
    No. 0818 Volume 5 (Heisei 22 {2010} August 18th)
    Concerning thoroughness of the Pharmaceutical Business Law oversight of electronic
    cigarettes containing nicotine (request).]

    (Cited URLs were accessed in September 2010)
    Current Vape: Variable Wattage mod, EPM Boge tanks, Something Fruity

  3. #3
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    Nice one!

    More solid evidence that vaping is far, far less potentially harmful than smoking.

    More ammo for the fight against stupidity and vested interests!

  4. #4
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    great find sik,thanks for posting it

    Interestign the evidence on acroleine, has always concerned me .. but the logic there is pretty good. I am still concerned that acoleine may be more prevalent in higher voltage devices as its production is heat related.

    pity they didnt try it with nicotine and have the particpants actually stop smoking, may have shown some more physiological changes then.
    In order of useful: Provari V2 and V1, vamo, eGo twist, Katana v3, Hex, Orion v2, LavaTube, eGo x 6, VMAX, 510N, Tick V2, Tick V1, noEgo 18650, noEgo 14650 , Indulgence x 2, 905 6v mod, KR808D



  5. #5
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    It is more ammo for us and PG may seem even better(conjecture).
    RC

 

 

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