Ginkgo

Discussion in 'Fibromyalgia Main Forum' started by GEC, Aug 20, 2002.

  1. GEC

    GEC New Member

     Interesting. this was in the Journal of the American Medical Association. it is featured on the website as well.

    gail

    Ginkgo for Memory Enhancement  
     
    A Randomized Controlled Trial 
     
      Paul R. Solomon, PhD; Felicity Adams, BA; Amanda Silver, BA; Jill Zimmer, BA; Richard DeVeaux, PhD


    Context  Several over-the-counter treatments are marketed as having the ability to improve memory, attention, and related cognitive functions in as little as 4 weeks. These claims, however, are generally not supported by well-controlled clinical studies.

    Objective  To evaluate whether ginkgo, an over-the-counter agent marketed as enhancing memory, improves memory in elderly adults as measured by objective neuropsychological tests and subjective ratings.

    Design  Six-week randomized, double-blind, placebo-controlled, parallel-group trial.

    Setting and Participants  Community-dwelling volunteer men (n = 98) and women (n = 132) older than 60 years with Mini-Mental State Examination scores greater than 26 and in generally good health were recruited by a US academic center via newspaper advertisements and enrolled over a 26-month period from July 1996 to September 1998.

    Intervention  Participants were randomly assigned to receive ginkgo, 40 mg 3 times per day (n = 115), or matching placebo (n = 115).

    Main Outcome Measures  Standardized neuropsychological tests of verbal and nonverbal learning and memory, attention and concentration, naming and expressive language, participant self-report on a memory questionnaire, and caregiver clinical global impression of change as completed by a companion.

    Results  Two hundred three participants (88%) completed the protocol. Analysis of the modified intent-to-treat population (all 219 participants returning for evaluation) indicated that there were no significant differences between treatment groups on any outcome measure. Analysis of the fully evaluable population (the 203 who complied with treatment and returned for evaluation) also indicated no significant differences for any outcome measure.

    Conclusions  The results of this 6-week study indicate that ginkgo did not facilitate performance on standard neuropsychological tests of learning, memory, attention, and concentration or naming and verbal fluency in elderly adults without cognitive impairment. The ginkgo group also did not differ from the control group in terms of self-reported memory function or global rating by spouses, friends, and relatives. These data suggest that when taken following the manufacturer's instructions, ginkgo provides no measurable benefit in memory or related cognitive function to adults with healthy cognitive function.

    JAMA. 2002;288:835-840


    Some over-the-counter treatments are marketed as having the ability to improve memory, attention, and related cognitive functions. These claims are generally not supported by well-controlled clinical studies. Ginkoba claims to "enhance mental focus and improve memory and concentration."1 Several published studies reported beneficial effects of ginkgo on cognition. These studies, however, either report cognitive improvement in only 1 of many memory tests administered2, 3 or report cognitive enhancement in cognitively impaired clinical populations such as patients with cerebrovascular or Alzheimer disease.4, 5 In contrast, advertising claims imply that the compound is broadly beneficial to those both with and without clinically significant cognitive impairments. Specific advertising claims cite more than 50 clinical trials that demonstrate benefit centered around concentration and memory. These studies were conducted for periods ranging from 14 days to 2 months. The manufacturer claims benefit with "at least 4 weeks of uninterrupted use."6

    The purpose of the present study was to evaluate ginkgo in healthy elderly volunteers in a randomized, double-blind, placebo-controlled trial using standardized tests of memory, learning, attention and concentration, and expressive language as well as subjective ratings by participants and family.

    METHODS


    Participants
     
    Following approval by the Williams College institutional review board, participants were recruited from newspaper advertisements that solicited individuals who would participate in a study designed to improve memory. An initial telephone interview was conducted to determine if the participant was likely to meet entry criteria for the study. Those who passed the screen provided informed consent and a medical history including current medications, neurologic or psychiatric illness, and incidence of head trauma, stroke, mental illness, mental retardation, or life-threatening illness over the last 5 years. Participants were included in the study if they were community dwelling, older than 60 years, and could provide informed consent. They also needed to have a companion who had contact with them on a regular basis (>4 times per week for 1 hour) and was willing to complete a questionnaire. The baseline Mini-Mental State Examination7 score was required to be greater than 26. All participants reported to be independent in instrumental activities of daily living including shopping, transportation, and managing finances. Participants were excluded if they had a history of psychiatric or neurologic disorder or had a life-threatening illness in the last 5 years. They were also excluded if they had taken antidepressant or other psychoactive medications in the past 60 days. A total of 338 community-dwelling participants were screened over a 26-month period from July 1996 to September 1998, and 230 participants (98 men and 132 women) aged 60 to 82 years were randomized in the study.

    Study Design
     
    A 6-week double-blind placebo-controlled study was conducted at a single site. Figure 1 summarizes the study participation. Participants were randomly assigned to 1 of 2 conditions: ginkgo (Ginkoba, Boehringer Ingelheim Pharmaceuticals)1 or placebo control (1:1 ratio). Random assignment of participants to each condition was determined by 1 of the investigators (P.R.S.) using a table of random numbers.8 Medication was placed in sealed envelopes by a research assistant and provided to the participants by 1 of 3 other investigators (F.A., A.S., J.Z.). Dosages for ginkgo were determined by following the manufacturer's label instructions: 1 tablet (40 mg) 3 times a day, with meals. The placebo group took lactose gelatin capsules of similar appearance and on the same schedule as the ginkgo group. At the beginning of the double-blind period, participants were provided with sealed and dated envelopes, each containing medication for 1 day.

    One day prior to taking ginkgo or placebo and again at the end of the 6-week double-blind period (while still taking ginkgo and within 3 days of the end of the study), participants underwent neuropsychological evaluation including tests of learning, memory, attention and concentration, and expressive language. They also completed a questionnaire regarding subjective impressions of their memory. Additionally, at the end of the 6 weeks of treatment, the companion was asked to complete a global questionnaire designed to provide an overall impression of change in memory for the participant. Evaluators (F.A., A.S., J.Z.) were blinded to which randomized treatment the participants received.

    Participants were contacted by telephone twice (at the end of weeks 2 and 4) during the 6-week period to evaluate compliance. They were excluded from the study if they missed 6 doses in any 2-week period or did not take 3 consecutive doses. At this time, they were asked to stop taking study medication. As an additional measure of compliance, participants were asked to return all dated envelopes at the end of the study.

    Outcome Measures
     
    Outcome measures consisted of the following standardized tests of learning, memory, attention and concentration, expressive language, and mental status. Tests of learning and memory included the California Verbal Learning Test (CVLT),9 in which the participant is asked to learn a 16-item shopping list over 5 trials and then to later recall and subsequently recognize the information; the Logical Memory subscale of the Wechsler Memory Scale–Revised (WMS-R),10 in which the participant is asked to recall paragraphs both immediately after hearing them and then after a 30-minute delay; and the Visual Reproduction subscale, in which the participant is asked to draw designs both immediately after seeing them and after a 30-minute delay.

    Tests of attention and concentration included the Digit Symbol subscale of the Wechsler Adult Intelligence Scale–Revised (WAIS-R),11 in which the participant must rapidly copy symbols that are paired with numbers; the Stroop Test,12 which requires the participant not to be distracted by extraneous aspects of stimuli; the Digit Span (WMS-R), which requires the participant to repeat increasingly longer strings of numbers immediately after hearing them; and Mental Control (WMS-R), in which the participant must recite strings of numbers and letters.

    Tests of expressive language included the Controlled Category Fluency test,12 which requires the participant to name members of a particular category (animals) over a 1-minute period; and the Boston Naming Test,13 which requires the participant to name pictures of items.

    Additionally, the Memory Questionnaire14 as well as a global evaluation completed by a spouse, relative, or friend with whom the patient had regular contact (at least 4 interactions per week) was completed. The Memory Questionnaire consisted of 27 questions that asked the participant to rate how often certain memory lapses occurred. The participant answered on a 4-point scale with descriptors used as anchors: 1 indicating very often, 2 indicating sometimes, 3 indicating rarely, and 4 indicating not at all. The global evaluation was based on the Caregiver Global Impression of Change rating scale.15 Informants were asked to indicate the option that best described the change in memory over the preceding 6 weeks. The options included: (1) very much improved, (2) much improved, (3) minimally improved, (4) no change, (5) minimally worse, (6) much worse, or (7) very much worse.

    All outcome measures, with the exception of the global evaluation, were administered at both the beginning and end of the study. The global evaluation was administered only at the end of the study. Participants who withdrew from the study, or who were dropped because of noncompliance, were asked to return at the end of the study for evaluation. Adverse events were not specifically monitored in this study. Patients who experienced an adverse event were instructed to discontinue study medication and to contact their primary care physician.
    [This Message was Edited on 08/20/2002]
    [This Message was Edited on 08/20/2002]
  2. GEC

    GEC New Member

     Interesting. this was in the Journal of the American Medical Association. it is featured on the website as well.

    gail

    Ginkgo for Memory Enhancement  
     
    A Randomized Controlled Trial 
     
      Paul R. Solomon, PhD; Felicity Adams, BA; Amanda Silver, BA; Jill Zimmer, BA; Richard DeVeaux, PhD


    Context  Several over-the-counter treatments are marketed as having the ability to improve memory, attention, and related cognitive functions in as little as 4 weeks. These claims, however, are generally not supported by well-controlled clinical studies.

    Objective  To evaluate whether ginkgo, an over-the-counter agent marketed as enhancing memory, improves memory in elderly adults as measured by objective neuropsychological tests and subjective ratings.

    Design  Six-week randomized, double-blind, placebo-controlled, parallel-group trial.

    Setting and Participants  Community-dwelling volunteer men (n = 98) and women (n = 132) older than 60 years with Mini-Mental State Examination scores greater than 26 and in generally good health were recruited by a US academic center via newspaper advertisements and enrolled over a 26-month period from July 1996 to September 1998.

    Intervention  Participants were randomly assigned to receive ginkgo, 40 mg 3 times per day (n = 115), or matching placebo (n = 115).

    Main Outcome Measures  Standardized neuropsychological tests of verbal and nonverbal learning and memory, attention and concentration, naming and expressive language, participant self-report on a memory questionnaire, and caregiver clinical global impression of change as completed by a companion.

    Results  Two hundred three participants (88%) completed the protocol. Analysis of the modified intent-to-treat population (all 219 participants returning for evaluation) indicated that there were no significant differences between treatment groups on any outcome measure. Analysis of the fully evaluable population (the 203 who complied with treatment and returned for evaluation) also indicated no significant differences for any outcome measure.

    Conclusions  The results of this 6-week study indicate that ginkgo did not facilitate performance on standard neuropsychological tests of learning, memory, attention, and concentration or naming and verbal fluency in elderly adults without cognitive impairment. The ginkgo group also did not differ from the control group in terms of self-reported memory function or global rating by spouses, friends, and relatives. These data suggest that when taken following the manufacturer's instructions, ginkgo provides no measurable benefit in memory or related cognitive function to adults with healthy cognitive function.

    JAMA. 2002;288:835-840


    Some over-the-counter treatments are marketed as having the ability to improve memory, attention, and related cognitive functions. These claims are generally not supported by well-controlled clinical studies. Ginkoba claims to "enhance mental focus and improve memory and concentration."1 Several published studies reported beneficial effects of ginkgo on cognition. These studies, however, either report cognitive improvement in only 1 of many memory tests administered2, 3 or report cognitive enhancement in cognitively impaired clinical populations such as patients with cerebrovascular or Alzheimer disease.4, 5 In contrast, advertising claims imply that the compound is broadly beneficial to those both with and without clinically significant cognitive impairments. Specific advertising claims cite more than 50 clinical trials that demonstrate benefit centered around concentration and memory. These studies were conducted for periods ranging from 14 days to 2 months. The manufacturer claims benefit with "at least 4 weeks of uninterrupted use."6

    The purpose of the present study was to evaluate ginkgo in healthy elderly volunteers in a randomized, double-blind, placebo-controlled trial using standardized tests of memory, learning, attention and concentration, and expressive language as well as subjective ratings by participants and family.

    METHODS


    Participants
     
    Following approval by the Williams College institutional review board, participants were recruited from newspaper advertisements that solicited individuals who would participate in a study designed to improve memory. An initial telephone interview was conducted to determine if the participant was likely to meet entry criteria for the study. Those who passed the screen provided informed consent and a medical history including current medications, neurologic or psychiatric illness, and incidence of head trauma, stroke, mental illness, mental retardation, or life-threatening illness over the last 5 years. Participants were included in the study if they were community dwelling, older than 60 years, and could provide informed consent. They also needed to have a companion who had contact with them on a regular basis (>4 times per week for 1 hour) and was willing to complete a questionnaire. The baseline Mini-Mental State Examination7 score was required to be greater than 26. All participants reported to be independent in instrumental activities of daily living including shopping, transportation, and managing finances. Participants were excluded if they had a history of psychiatric or neurologic disorder or had a life-threatening illness in the last 5 years. They were also excluded if they had taken antidepressant or other psychoactive medications in the past 60 days. A total of 338 community-dwelling participants were screened over a 26-month period from July 1996 to September 1998, and 230 participants (98 men and 132 women) aged 60 to 82 years were randomized in the study.

    Study Design
     
    A 6-week double-blind placebo-controlled study was conducted at a single site. Figure 1 summarizes the study participation. Participants were randomly assigned to 1 of 2 conditions: ginkgo (Ginkoba, Boehringer Ingelheim Pharmaceuticals)1 or placebo control (1:1 ratio). Random assignment of participants to each condition was determined by 1 of the investigators (P.R.S.) using a table of random numbers.8 Medication was placed in sealed envelopes by a research assistant and provided to the participants by 1 of 3 other investigators (F.A., A.S., J.Z.). Dosages for ginkgo were determined by following the manufacturer's label instructions: 1 tablet (40 mg) 3 times a day, with meals. The placebo group took lactose gelatin capsules of similar appearance and on the same schedule as the ginkgo group. At the beginning of the double-blind period, participants were provided with sealed and dated envelopes, each containing medication for 1 day.

    One day prior to taking ginkgo or placebo and again at the end of the 6-week double-blind period (while still taking ginkgo and within 3 days of the end of the study), participants underwent neuropsychological evaluation including tests of learning, memory, attention and concentration, and expressive language. They also completed a questionnaire regarding subjective impressions of their memory. Additionally, at the end of the 6 weeks of treatment, the companion was asked to complete a global questionnaire designed to provide an overall impression of change in memory for the participant. Evaluators (F.A., A.S., J.Z.) were blinded to which randomized treatment the participants received.

    Participants were contacted by telephone twice (at the end of weeks 2 and 4) during the 6-week period to evaluate compliance. They were excluded from the study if they missed 6 doses in any 2-week period or did not take 3 consecutive doses. At this time, they were asked to stop taking study medication. As an additional measure of compliance, participants were asked to return all dated envelopes at the end of the study.

    Outcome Measures
     
    Outcome measures consisted of the following standardized tests of learning, memory, attention and concentration, expressive language, and mental status. Tests of learning and memory included the California Verbal Learning Test (CVLT),9 in which the participant is asked to learn a 16-item shopping list over 5 trials and then to later recall and subsequently recognize the information; the Logical Memory subscale of the Wechsler Memory Scale–Revised (WMS-R),10 in which the participant is asked to recall paragraphs both immediately after hearing them and then after a 30-minute delay; and the Visual Reproduction subscale, in which the participant is asked to draw designs both immediately after seeing them and after a 30-minute delay.

    Tests of attention and concentration included the Digit Symbol subscale of the Wechsler Adult Intelligence Scale–Revised (WAIS-R),11 in which the participant must rapidly copy symbols that are paired with numbers; the Stroop Test,12 which requires the participant not to be distracted by extraneous aspects of stimuli; the Digit Span (WMS-R), which requires the participant to repeat increasingly longer strings of numbers immediately after hearing them; and Mental Control (WMS-R), in which the participant must recite strings of numbers and letters.

    Tests of expressive language included the Controlled Category Fluency test,12 which requires the participant to name members of a particular category (animals) over a 1-minute period; and the Boston Naming Test,13 which requires the participant to name pictures of items.

    Additionally, the Memory Questionnaire14 as well as a global evaluation completed by a spouse, relative, or friend with whom the patient had regular contact (at least 4 interactions per week) was completed. The Memory Questionnaire consisted of 27 questions that asked the participant to rate how often certain memory lapses occurred. The participant answered on a 4-point scale with descriptors used as anchors: 1 indicating very often, 2 indicating sometimes, 3 indicating rarely, and 4 indicating not at all. The global evaluation was based on the Caregiver Global Impression of Change rating scale.15 Informants were asked to indicate the option that best described the change in memory over the preceding 6 weeks. The options included: (1) very much improved, (2) much improved, (3) minimally improved, (4) no change, (5) minimally worse, (6) much worse, or (7) very much worse.

    All outcome measures, with the exception of the global evaluation, were administered at both the beginning and end of the study. The global evaluation was administered only at the end of the study. Participants who withdrew from the study, or who were dropped because of noncompliance, were asked to return at the end of the study for evaluation. Adverse events were not specifically monitored in this study. Patients who experienced an adverse event were instructed to discontinue study medication and to contact their primary care physician.
    [This Message was Edited on 08/20/2002]
    [This Message was Edited on 08/20/2002]
  3. MicheleF

    MicheleF New Member

    anything you don't need is senseless. The latest study was done on Healthy elderly adults...according to the dr. on CNN today, he noted that it would be interesting to see gingko studies done on people who Do have cognitive difficulties.

    This seems to have been a very controlled study, which is good, to evaluate the effects on healthy individuals. I would like to see as controlled of a study done on people who do suffer from memory/cognitive impairment. That would be of great benefit to people of fms and/or cfids.

    It's amazing, isn't it, the number of studies done which do not control other factors, which make the results not as newsworthy as some think. (and no, I'm not talking about the aforementioned study, just poorly done studies)

    I feel the jury's still out on gingko's effects on us fibrofog cases...so I'll take my gingko until I find it doesn't help or people start reporting serious side effects (of which I've not heard yet).

    Thanks for sharing and best wishes, Gail. Michele

  4. metoo110

    metoo110 New Member

    on the news tonight, they talked about ginko not being effective. my husband was not happy to here this. he thought he was having pretty good results with it.

    i wish i hadn't told him. sometimes the mind is a powerfull thing(no pun intended). if he THOUGHT he was getting results maybe he'd feel better about the way is mind is.

    donna
  5. Suze

    Suze New Member

    I've never taken ginkgo for memory enhancement (for that I reach for lecithin granules), but from time to time I've taken it when I get especially lightheaded from turning my head or looking up, etc. I think it's well documented that ginkgo increases blood flow to the brain.

    For a while I tried giving it to my husband, who has dementia. It didn't do anything for his memory, but it produced a noticable difference. Since it wasn't an improvement, just a lateral change, I didn't keep it up.

    Suze
  6. GEC

    GEC New Member

    i also watched the news last night and saw a piece on the ginkgo supplement. i was actually thinking of using it because me fibro fog is in full force lately. but now i think i might wait it out and see if anything else pops up about it. This study really made me think twice about it.

    thanks for your imput!
    take care.
    gail
  7. Jackie F

    Jackie F New Member

    The report on the news late evening--how many did they test?

    DID you hear that? 250 people--I can tell you just from this site--that is crappy numbers--not even effective--IMO!!

    How Many of you dearly love your Elavil/Amitry?
    I HATE it! Does that mean it does NOT work? That would be assinine to believe. BUT I KNOW that for me--it would have been deadly. BUT does that mean it will happen to you?

    JUST because you read it or someone said it--find out for yourself--if you can afford it health & cost wise.

    You can bet when I say that chiro works--I am basing it on much higher numbers than 250 people. Do you 'see' what I mean here?

    BTW to American's: Has the government ever been wrong when it comes to our health??? A NO Brainer for sure!
    I still read what they say and take it all with a grain of salt.

    Jackie F
  8. GEC

    GEC New Member

    it is very silly to think that just because one posts an article, it is implied that the poster believes it to be true. very silly. i like to post things to make people more aware, to give someone something to think about, i dont necessarily believe this article, but it gives me something to think about. i am a very cautious person, paranoid even. i never believe everything i read, nor do i believe everything i am told. It is very healthy to weigh out both sides. please remember that if an article is posted, it is for the benefit of keeping everyone aware.

    take care!

    gail
  9. Rene_M

    Rene_M New Member

    Yes, I was just reading the report on this at MSN. I've clipped the end of their article as I feel it does help to balance the issue. This is exactly the kind of "stuff" media like to get hold of & the drug Co's too. Makes their day!

    I've taken Ginkoo foor at least a couple of years now. let's be realistic, would I spend an extra $10 or so a month on something that really didn't work - Placebo theory only goes so far with these things, in my opinion. And I'm quite well aware that it may not be effective for everyone. In the meantime, I'll continue, thank you very much! [and I also take more than those in this particular study]

    It is also possible to introduce researcher bias into so called controlled studies with various subtle cues, and thatt's been researched, too - lol.


    HERB SUPPORTERS SPEAK OUT
    Supporters of herbal remedies countered that the latest study was just one among dozens, many of which have shown ginkgo can help sharpen the mind, especially in those suffering mild to moderate mental impairment.

    “When taken by mentally impaired older adults, ginkgo produced significant improvements in short-term memory and combined scores on cognitive tests,” Michael McGuffin, president of the American Herbal Products Association, said.

    McGuffin faulted the research for not altering the dosage and the length of the study, adding there was a long history of antagonism between the medical establishment and believers in herbal remedies.

    Some herbalists prefer to make their own herbal treatments from natural ingredients, he said, which might have a more pronounced effectiveness.

    But Solomon said his study, funded by the government and two foundations, involved the same type of rigorous testing required by the Food and Drug Administration for pharmaceutical drugs, though supplements like gingko are not FDA-regulated.

    The same battery of mental tests was given at the beginning and end of the study. While both groups’ scores improved the same slight amount, that likely was because they’d taken the tests before, Solomon said.

    Ginkgo is thought to exert its beneficial effects by improving blood flow to small veins and capillaries, ostensibly helping deliver oxygen to the brain. It also contains antioxidants, substances that absorb chemicals called free radicals produced during metabolism that are thought to damage cells.

    Dr. Steven DeKosky, chairman of the University of Pittsburgh’s neurology department, said the study doesn’t address whether larger doses taken for a longer duration or taken by people who already have memory problems would be beneficial.

    DeKosky is the lead researcher in a government-funded study examining whether ginkgo in doses equal or double those in the JAMA study can help prevent Alzheimer’s disease. Participants in his study are older than 75, have normal mental function or slight memory problems and are taking ginkgo for five years. Resources on supplements

    • National Center for Complementary and Alternative Medicine

    • Office of Dietary Supplements

    • American Dietetic Association

    • American Botanical Council

    • ConsumerLab.com


    Solomon said it’s possible ginkgo pills would show some mental benefits in healthy people if taken longer than six weeks, the study’s duration. But he noted that the tablets used in the study, Pharmaton Natural Health Products’ Ginkoba, are marketed as producing noticeable benefits after just four weeks at the study’s dose, 120 milligrams daily.

    Pharmaton’s David Morrison said the findings are from a single study that doesn’t “negate the vast body of evidence showing that ginkgo biloba is effective.”

    [This Message was Edited on 08/21/2002]