Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Food or edible as carrier for pharmaceutical
Reexamination Certificate
1999-04-30
2001-04-03
Naff, David M. (Department: 1651)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Food or edible as carrier for pharmaceutical
C424S195110
Reexamination Certificate
active
06210701
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to dietary supplements and medical foods for treating inflammation-related diseases. The compositions of the present invention include rosemary.
BACKGROUND OF THE INVENTION
In 1948, the World Health Organization defined health as not only the absence of disease, but also the presence of physical, mental, and social well-being. (Constitution of the World Health Organization. In: World Health Organization, Handbook of Basic Documents. 5th ed. Geneva: Palais des Nations, 3-20 (1952)). The status of a patient's physical, mental, and social functioning is often referred to in the literature as quality-of-life and is used as a measure of health outcome. In the past 25 years, there has been a nearly exponential increase in the evaluation of quality-of-life as a technique of clinical research as a component of determining clinical benefit from an intervention protocol. For example, in 1973, only five articles listed quality-of-life as a key word in the Medline database, whereas in the subsequent four years there were successively 195, 273, 490, and 1,252 such articles. (Testa M A and Simonson D C,
N Eng J Med.
334:835-840 (1996). In 1998, approximately 3,724 articles listed quality-of-life as a key word. Thus, the health outcome, or quality-of-life, associated with a clinical intervention has been recognized as an important tool in measuring effectiveness and costs of medical care. (Wilson I B and Cleary P D.,
JAMA.,
273:59-65 (1995)).
Extensive research has resulted in the development of instruments that measure health outcome using quality-of-life tools that follow academically well-established and statistically validated psychometric principles. (Ware J E Jr.,
J Chronic Dis.,
40:473-480 (1987); Spilker B., Quality of Life and Pharmacoeconomics in Clinical Trials, 2nd ed. Philadelphia, Pa.: Lippincott-Raven Co; 1995.) One such tool is the SF-36 (Short form-36), which has been widely used in clinical trials and in clinical practice to assess health outcome. (Clancy C M and Eisenberg J M,
Science,
282:245-246 (1998)). The SF-36 was derived from the Medical Outcomes Study, which involved 11,336 patients from 523 different clinical sites. (Ware J E, Sherbourne C D, Davies A R. Developing and testing the MOS 20-item short-form health survey. In: Stewart A L and Ware J E, eds., Measuring functioning and well-being: The Medical Outcomes Study approach. Durham, N.C.: University Press, 277-290 (1992); Ware J E. SF-36 Health Survey: manual and interpretation guide. Boston, Mass.: Nimrod Press; 2:1-3:22 (1993)). The validity and reliability of the SF-36 has been proven in several studies in which researchers tested internal consistency, within subject reliability, and differentiation between patient populations. (McHorney C A, et al.,
Medical Care,
31:247-263 (1993); McHorney C A, et al.,
Medical Care,
30:S253-S265 (1992); Jenkinson C, et al.,
Br Med J,
306:1436-1440 (1993); Brazier J E, et al.,
Br Med J.
305:160-164 (1992)). The SF-36 has been shown to predict the course of depression during a two-year study, and to be lower overall in patients who experience chronic health disorders. (Wells K B, et al.,
Archives General Psychiatry,
49:788-794 (1992); Schlenk E A, et al.,
Quality of Life Res.,
7:57-65 (1998)).
The SF-36 is a 36-item questionnaire that assesses eight dimensions of health outcome: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Results from the questionnaire can be reported as a relative number on a scale of 0 to 100, in which 100 is the highest or most functional and 0 is the most compromised for that category of functioning. A summary of the meaning of high and low scores for each category is shown in Table 1.
TABLE 1
Description of Very High and Very Low Scores for the Eight
Categories of the MOS SF-36 Questionnaire.
SF-36
Interpretation
Interpretation
Category
of a Low Score
of a High Score
Physical
Limited in performing all
Performs all types of physical
Functioning
physical activities
activities including the most
(PF)
including bathing or
vigorous without limitations
dressing due to health
due to health
Role-
Problems with work or
No problems with work or
Physical(RP)
other daily activities as
other daily activities as a
a result of physical health
result of physical health
Bodily
Very severe and
No pain or limitations due
Pain(BP)
extremely limiting pain
to pain
General
Evaluates personal health
Evaluates personal health as
Health(GH)
as poor and believes it
excellent
is likely to get worse
Vitality(VT)
Feels tired and worn out
Feels full of pep and energy
all of the time
all of the time
Social
Extreme and frequent
Performs normal social
Functioning
interference with normal
activities without interference
(SF)
social activities due to
due to physical or emotional
physical or emotional
problems
problems
Role-
Problems with work or
No problems with work or
Emotional
other daily activities as
other daily activities as a
(RE)
a result of emotional
result of emotional problems
problems
Mental
Feelings of nervousness
Feels peaceful, happy, and
Health(MH)
and depression all of
calm all of the time
the time
The latter half of the twentieth century has been characterized by an increasing prevalence of chronic disorders. Indeed, seven of the ten leading causes of death in the USA are chronic in nature, accounting for 72% of the deaths from all causes. (National Center for Health Statistics. Health, United States, 1995. Hyattsville, Md.: Public Health Service, 1995.) Chronic disorders such as rheumatic disorders, chronic pain, and fatigue contribute to the 6% of the population that is impaired to some extent in the conduct of major life activities such as work, school, and self-care. (US Department of Health and Human Services, Public Health Service. Healthy People 2000: National Health Promotion and Disease Prevention Objectives. Hyattsville, Md.: Public Health Service; 1991.) Health care use also appears to be substantial for patients with chronic conditions.
In chronic conditions such as rheumatic disorders and chronic pain, biological and physiological factors have an inconsistent relationship to symptoms. (Wilson I B, Cleary P D.,
JAMA,
273:59-65 (1995)). Therefore, they are difficult to measure by laboratory values. In fact, in clinical practice, anywhere from 30% to 80% of patients who see a physician may have conditions for which no physiological or organic cause is found after routine investigation. (Wilson I B and Cleary P D, JAMA, 273:59-65 (1995)).
In these chronic conditions, pain and fatigue are often suffered over many years without correlation to a diagnosable or definable acute or chronic disease. Therefore, without anatomical or physical correlation, a patient's response to therapy must be monitored by measuring the level of symptoms they report over a period of time. The MOS SF-36 questionnaire is particularly suited to this type of analysis. For example, patients with chronic disorders have been reported to score lower than the norm in several categories of the MOS SF-36, including bodily pain, role-physical, role-emotional, and vitality. See, e.g., Ware J E., SF-36 Health Survey: manual and interpretation guide. Boston, Mass.: Nimrod Press; 2:1-3:22 (1993); Schlenk E A, et al., Health-related quality of life in chronic disorders: a comparison across studies using the MOS SF-36,
Quality Life Research,
7:57-65 (1998)).
Although similarities in different categories of the MOS can be observed, data from patients who experience chronic conditions suggests that these patients may show higher variability when analyzing individual MOS categories than with the PCS and MCS summary scores. This variability may result from the frequent coexistence of chronic conditions.
Taking these considerations into accounts, Ware et al. have used principal component analysis on the MOS SF-36 data collected from 2,474 subjects from the US general population to derive summary scores for the eight categories shown abo
Bland Jeffrey S.
Darland Gary K.
Irving Tracey A.
Liska DeAnn J.
Lukaczer Daniel O.
Healthcomm International, Inc.
Johnson Kindness PLLC
Meller Michael V.
Naff David M.
O'Connor Christensen
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