ABSTRACT

Social, technological, and economical global factors drive three trends: (1) increase in prevalence of expensive and life-long non-communicable diseases (NCDs); (2) the high economic burden of NCDs demanding higher individual responsibility and active individual participation in disease prevention and self-care; and (3) a consequential increase in utilization of self-medication (over-the-counter medication, herbals, and supplements) with higher quality, greater safety and regulated substantiation of any health benefit claim. The convergence of these trends brings a new paradigm in the way natural remedies and OTC products will now be utilized together

1.1 Summary ..........................................................................................................1 1.2 New Global Trend and Socioeconomic Burden of

Non-Communicable Diseases...........................................................................2 1.3 Modifiable Risk Factors ....................................................................................3 1.4 Preventive Measures and Policies .....................................................................3 1.5 Polypill: A Self-Care Proposal to be Available to All Based on Age Alone....4 1.6 Utilization of Self-Care Medication and Dietary Supplements to Delay

Onset of NCDs ..................................................................................................5 1.7 Regulatory Environment and Policies ..............................................................5 1.8 Acceptable Criteria of Efficacy and Dietary Supplement Studies ....................8 1.9 Clinical Trials and Tribulations with Dietary Supplements .............................9 1.10 Detecting Treatment Effect in Clinical Trials with Dietary Supplements ..... 11 References ................................................................................................................ 13

with lifestyle changes to decrease the prevalence of NCDs globally. As most common NCDs have modifiable risk factors, health care systems are now emphasizing on preventive measures of low costs, easy access, and high therapeutic convenience. Globally, the utilization of traditional/natural medicine and supplements is growing significantly. However, only products with proven safety and efficacy demonstrated in randomized controlled clinical trials will be able to contribute to this new preventive aspect of the health care environment.