The global herbal medicine market has grown every year, and the total estimated retail sales of herbal supplements in the United States reached almost $7 billion after increasing by 7.5% in 2015 [
As the interest in herbal medicines increases, there is a growing need to ensure their safety. The goal of the World Health Organization (WHO) Traditional Medicine Strategy is to promote the safe and effective use of Traditional and Complementary Medicine (T&CM). Regulations on the safety of herbal medicine have increased in order to achieve this goal. The numbers of policies and regulations to ensure the safety and efficacy of T&CM were 69 and 119, respectively [
South Korea is a country with a long history of herbal medicine usage. However, until recently, there has not been a systematic report of adverse events, which would be the foundation of enhancing safety. According to the data of Korean Regional Pharmacovigilance Centers in 2007, there was only one case of adverse drug reaction reported from herbs among the observed 1,418 cases [
This study surveyed in detail the characteristics of consumers in Korea and the adverse events from herbal medicines, as well as the perceived safety of products. The objective of this study was to investigate Korean consumers’ usage patterns with respect to herbal medicines and to provide research-based evidence for enhancing their safety.
This study was a survey of the characteristics of herbal medicine users in South Korea. The survey was conducted by Macromill Embrain (
There was no special method for determining the sample size; we only sought to have as many people as possible complete the survey during the survey period. The minimum number of participants was determined to be 1,000, with additional recruitment on-going until the end of the study period. The participants were stratified based on gender and age to get the status of general population. Those under 20 years old and over 70 years old were excluded.
The questionnaire was developed by five traditional Korean medicine (TKM) experts who discussed and selected investigation items. A draft questionnaire was developed through two rounds of review, placing emphasis on the easy comprehension of the questionnaire to gear to the general population. The experts examined face reliability as well as readability of the questionnaire. Then, a pilot test was conducted that targeted 10 people who were not medical practitioners. A group of experts collected feedback and completed the final version of the questionnaire.
The questionnaire consisted of two categories: (1) questions related to the herbal medicines usage over the past year and (2) questions related to adverse events experienced relating to the herbal medicines. The questionnaire is shown in Supplement 1 (in Supplementary Material available online at
The detailed variables are as follows: Demographic information: sex, age, occupation, and education level Usage patterns: opinion on safety of herbal medicines, experiences related to taking herbal medicines, places from which the herbal medicines were purchased, the types of herbal medicines used, reasons for taking herbal medicines, and reasons for not taking herbal medicines Adverse events: experiences of adverse events relating to herbal medicines, types of adverse events, whether adverse events were reported, to which institutions the adverse events were reported, reasons for not reporting adverse events, how to deal with adverse events, and opinions on herbal medicines after experiencing adverse events
A frequency analysis was performed for all variables. The chi-squared test was also employed in order to determine differences by sex, age, occupation, and education level. IBM SPSS ver. 18.0 (IBM Co., Armonk, NY, USA) was used for analysis.
All participants were briefed with an explanation of the study’s purpose prior to the initiation of the survey. Only those who voluntarily agreed to participate and to have their data collected to be published were enrolled in the study. This survey was conducted anonymously. The entire survey process was approved by the Institutional Review Board of Kyung Hee University (IRB number KHSIRB1-15-039).
There were total of 1,134 respondents, consisting of 591 (52.1%) men and 543 (47.9%) women. Table
Basic characteristics of respondents.
Demographic characteristics |
|
% |
---|---|---|
Sex | ||
Men | 591 | 52.1 |
Women | 543 | 47.9 |
Age (years) | ||
20–29 | 209 | 18.4 |
30–39 | 237 | 20.9 |
40–49 | 277 | 24.4 |
50–59 | 253 | 22.3 |
60–69 | 158 | 13.9 |
Occupation | ||
Executives professionals | 214 | 18.9 |
Office workers | 392 | 34.6 |
Service sales workers | 83 | 7.3 |
Agriculture, forestry, and fishery workers | 4 | 0.4 |
Craft mechanical workers | 41 | 3.6 |
Simple labourers | 15 | 1.3 |
Self-employed, part-time employees, and freelancers | 25 | 2.2 |
Students, housewives, and unemployed | 360 | 31.7 |
Level of education | ||
Middle school | 9 | 1.1 |
High school | 218 | 19.2 |
College | 784 | 69.1 |
Graduate school | 120 | 10.6 |
|
||
Total | 1134 | 100.0 |
Of the 1,134 respondents, there were 693 (61.1%) who had taken herbal medicines within the past year and 441 (38.9%) who had not. There was no difference in demographic factors between users and nonusers of herbal medicines (Table
Basic characteristics of herbal medicines users and nonusers.
Demographic characteristics | Users ( |
Nonusers ( |
|
---|---|---|---|
Sex | |||
Men | 361 (52.1) | 230 (52.2) | 1.000 |
Women | 332 (47.9) | 211 (47.8) | |
Age (years) | |||
20–29 | 130 (18.8) | 79 (17.9) | 0.221 |
30–39 | 151 (21.8) | 86 (19.5) | |
40–49 | 159 (22.9) | 118 (26.8) | |
50–59 | 147 (21.2) | 106 (24.0) | |
60–69 | 106 (15.3) | 52 (11.8) | |
Occupation | |||
Executives professionals | 146 (21.1) | 68 (15.4) | 0.229 |
Office workers | 244 (35.2) | 148 (33.6) | |
Service sales workers | 45 (6.5) | 38 (8.6) | |
Agriculture, forestry, and fishery workers | 2 (0.3) | 2 (0.5) | |
Craft mechanical workers | 23 (3.3) | 18 (4.1) | |
Simple labourers | 7 (1.0) | 8 (1.8) | |
Self-employed, part-time employees, and freelancers | 15 (2.2) | 10 (2.3) | |
Students, housewives, and unemployed | 211 (30.4) | 149 (33.8) | |
Level of education | |||
Middle school | 6 (0.9) | 6 (1.3) | 0.172 |
High school | 119 (17.2) | 99 (22.4) | |
College | 490 (70.7) | 294 (66.7) | |
Graduate school | 78 (11.3) | 42 (9.5) |
All data are in
Of the total 1,134 participants, 726 (64.0%) people responded that herbal medicine is safe and the remaining 408 (36.0%) people considered herbal medicine unsafe. Women tended to distrust the safety of herbal medicines more compared to men, and those over the age of 50 were more skeptical of herbal medicine (Table
Opinion on safety of herbal medicines.
Herbal medicine is safe ( |
Herbal medicine is not safe ( |
| |
---|---|---|---|
Sex | |||
Men | 430 (59.2) | 161 (39.5) | >0.001 |
Women | 296 (40.8) | 247 (60.5) | |
Age (years) | |||
20–29 | 154 (21.2) | 55 (13.5) | >0.001 |
30–39 | 166 (22.9) | 71 (17.4) | |
40–49 | 176 (24.2) | 101 (24.8) | |
50–59 | 148 (20.4) | 105 (25.7) | |
60–69 | 82 (11.3) | 76 (18.6) | |
Occupation | |||
Executives professionals | 145 (20.0) | 69 (16.9) | 0.142 |
Office workers | 252 (34.7) | 140 (34.3) | |
Service sales workers | 52 (7.2) | 31 (7.6) | |
Agriculture, forestry, and fishery workers | 4 (0.6) | 0 | |
Craft mechanical workers | 32 (4.4) | 9 (2.2) | |
Simple labourers | 11 (1.5) | 4 (1.0) | |
Self-employed, part-time employees, and freelancers | 14 (1.9) | 11 (2.7) | |
Students, housewives, and unemployed | 216 (29.8%) | 144 (35.3) | |
Level of education | |||
Middle school | 10 (1.4) | 2 (0.4) | 0.610 |
High school | 138 (19.0) | 80 (19.6) | |
College | 499 (68.7) | 285 (69.9) | |
Graduate school | 79 (10.9) | 41 (10.0) |
All data are in
The most common place to purchase herbal medicines was TKM hospital or clinic (63.6%). Pharmacy (17.0%), traditional herb market (17.0%), health food store (14.6%), oriental pharmacy (12.8%), home shopping (11.0%), and hypermarket (11.0%) were reported as other places to purchase them. The most predominantly used type of herbal medicines was a decoction from TKM institutions (72.2%). Other types of herbal medicines were crude herbs, which are mainly used in food or tea (35.8%), health food (28.6%), national insurance-covered herbal medicines from TKM institutions (15.3%), national insurance-covered herbal medicines from pharmacies (15.0%), and others (0.8%) (Table
Patterns of herbal medicine use and reasons for taking or not taking herbal medicines.
Question |
Response |
|
---|---|---|
Have you taken herbal medicines in the past year? ( |
Yes | 693 (61.1) |
No | 441 (38.9) | |
|
||
Location where herbal medicines were purchased |
TKM hospital or clinic | 441 (63.6) |
Pharmacy | 120 (17.0) | |
Traditional herbal market | 118 (17.0) | |
Health food store | 101 (14.6) | |
Oriental pharmacy | 89 (12.8) | |
Home shopping | 76 (11.0) | |
Hypermarket | 76 (11.0) | |
Other | 8 (1.1) | |
|
||
Types of herbal medicines |
Decoction from a TKM institution | 500 (72.2) |
Crude herb (used for cuisine or tea) | 248 (35.8) | |
Health food | 198 (28.6) | |
National insurance-covered herbal medicines from TKM institutions | 106 (15.3) | |
National insurance-covered herbal medicines from pharmacies | 104 (15.0) | |
Other | 6 (0.8) | |
|
||
Reasons for taking herbal medicines |
Health improvement | 397 (57.3) |
Treatment from a Korean medicine institution | 279 (40.3) | |
Recommendation from acquaintance | 84 (12.1) | |
Recommendation from pharmacist | 66 (9.5) | |
Other | 6 (0.7) | |
|
||
Reasons for not taking herbal medicines |
Medication not necessary | 281 (63.7) |
Uncertainty of origins | 156 (35.4) | |
Expensive prices | 114 (25.9) | |
Anxiety about possible harmful substances | 105 (23.8) | |
Anxiety about possible adverse events | 59 (13.4) | |
Disbelief regarding expiry date | 41 (9.3) | |
No effectiveness | 39 (8.8) | |
Other | 7 (1.6) |
The reasons for taking the medication were as follows: 57.3% for “health improvement,” 40.3% for “treatment in KM hospitals or clinics,” 34.8% due to “recommendation from acquaintance,” 9.5% due to “recommendation from a pharmacist,” and others. The reasons for not taking herbal medicines were “medication was not necessary” (63.7%), “uncertainty of origins” (35.4%), “expensive prices” (25.9%), “anxiety related to the possibility of harmful substances” (25.9%), “anxiety related to the possibility of adverse events” (23.8%), and others (Table
Location where herbal medicines were purchased according to age groups.
Types of herbal medicines according to age groups.
Reasons for taking herbal medicines according to age groups.
Of the 693 participants who have taken herbal medicines within the past year, 46 (6.6%) responded that they had experienced adverse events from herbal medicines. The most common symptom was digestive disorders (52.2%), followed by skin disorders (34.8%) and nervous disorders (23.9%) (Table
The number of adverse events due to herbal medicines.
Question |
Response |
|
---|---|---|
Have you experienced adverse events from herbal medicines in the past year? |
Yes | 46 (6.6) |
No | 647 (93.4) | |
|
||
What types of adverse events have you experienced |
Digestive system | 24 (52.2) |
Skin | 16 (34.8) | |
Nervous disorder | 11 (23.9) | |
Systemic disorder | 6 (13.0) | |
Liver | 4 (8.7) | |
ENT and eye | 3 (6.5) | |
Cardiovascular system | 3 (6.5) | |
Circulatory system | 2 (4.3) | |
Kidney | 2 (4.3) | |
Urinary system | 2 (4.3) | |
Musculoskeletal system | 2 (4.3) | |
Respiratory system | 2 (4.3) |
After experiencing an adverse event, 20 participants (43.5%) were treated by KM doctors, 13 (28.5%) did not take any action, and 12 (26.1%) requested a refund. Seventeen participants (37.0%) felt that expert counselling may be needed after experiencing adverse events, and 14 (30.4%) responded that drugs can have adverse events and that they would continue taking herbal medicines. However, 13 people (28.3%) responded that they cannot trust herbal medicines anymore and they would not continue taking herbal medicines. Of the 46 respondents who experienced adverse events, 14 (30.4%) reported their adverse events and 20 (43.5%) did not because they had little information regarding to whom the report should be made (Table
Behaviours and opinions related to herbal medicine after experiencing adverse events.
Question (number of respondents) | Response |
|
---|---|---|
Did you report adverse events? |
Yes | 14 (30.4) |
No | 32 (69.6) | |
|
||
To whom did you report adverse events |
TKM institution | 10 (71.4) |
WM institution | 3 (21.4) | |
Pharmacy | 3 (21.4) | |
Public health centre | 2 (14.3) | |
Ministry of Health and Welfare | 2 (14.3) | |
Korea Consumer Agency | 1 (7.1) | |
KIDS | 1 (7.1) | |
MFDS | 1 (7.1) | |
|
||
Why did you not report adverse events? |
I did not know where to report | 20 (62.5) |
I felt it was unnecessary | 7 (21.9) | |
I felt lazy | 5 (15.6) | |
|
||
How did you deal with adverse events |
Consulted with TKM doctors | 20 (43.5) |
Nothing specific | 13 (28.3) | |
Requested refund | 12 (26.1) | |
Consulted with WM doctors | 7 (15.2) | |
Consulted with pharmacist | 3 (6.5) | |
|
||
What did you think after the adverse events? |
I need to see an expert | 17 (37.0) |
Drugs can have adverse events and I am going to continue taking herbal medicines | 14 (30.4) | |
I cannot trust herbal medicines anymore and I am not going to take herbal medicines | 13 (28.3) | |
I do not know | 2 (4.3) |
This study described the basic characteristics of those who had taken herbal medicines and those who had not taken them, the places that herbal medicines were purchased, the reasons for taking or not taking herbal medicine, and adverse events experienced due to herbal medicines and how the adverse events were addressed. In previous studies [
There have been several surveys in the past demonstrating consumers’ opinions about the safety of herbal medicines [
Most respondents purchased herbal medicines from TKM institutions (Table
Regarding the type of herbal medicines, a decoction from a TKM institution was the most frequently used, reflecting the preference of Koreans (Table
The main reasons for taking herbal medicines included “health improvement” and “treatment in TKM hospitals or clinics” (Table
This study also analysed the usage patterns of difference by age (Figures
Of the 1,134 respondents, 441 (38.9%) had not taken herbal medicines in the past year (Table
Adverse events from herbal medicines reported by 46 participants (6.6% of herbal medicines users) primarily included digestive, skin, and nervous disorders (Table
Although the Korean adverse drug reaction surveillance system was established in 1988 [
After experiencing adverse events, the majority of respondents (20; 43.5% of adverse event experiencers) visited TKM practitioners, and 17 (37.0%) felt that expert counsel would be necessary (Table
There are limitations of this survey study. Firstly, a recall bias may exist because this study was based on a retrospective survey. Secondly, there is a possibility of response bias because the participants are rather highly educated. This is because having recruited the participants through an online research company and the sample may not be representative of the general population. Lastly, the perception of the range of herbal medicines varies among Koreans. Some people only recognise herbal medicines from TKM institutions as herbal medicines, while others take into account every type of herb.
Nonetheless, this study is meaningful in that there are no previous surveys to date that systematically investigated experiences and opinions about herbal medicines. This survey, unlike other consumer surveys, included not only herbal medicines users but also nonusers as participants, which increased the representativeness of the general population.
This survey analysed the usage of herbal and medicinal products in South Korea. This study showed the demographic differences between herbal medicine users and nonusers, opinions on safety of herbal medicines, experiences of using herbal medicines, and adverse events experienced from using herbal medicines. The major reasons for not taking herbal medicines were based on a disbelief in their safety. Therefore, it is important to ensure not only the efficacy but also the safety of herbal medicines in order to expand herbal product markets. Specific regulations on herbal medicines are needed to resolve problems with their origins, possibility of containing harmful substances, and the expiry date.
World Health Organization
Traditional and Complementary Medicine
Traditional Korean medicine
Good Manufacturing Practice
Ministry of Food and Drug Safety
Korea Adverse Event Reporting System
Korea Institute of Drug Safety and Risk Management.
This survey was approved by Institutional Review Board of Kyung Hee University (IRB no. KHSIRB1-15-039).
This study did not contain any individual person’s data; however, it was notified that collected data would be published. All participants voluntarily agreed to participate in this survey.
The authors declare that there are no conflicts of interest regarding the publication of this paper.
Soobin Jang and Kyeong Han Kim drafted the manuscript. Eun-Kyung Lee and Seung-Ho Sun managed entire process of survey and extracted the data. Bo-Hyoung Jang and Ho-Yeon Go organized and conducted the study. Yong-Cheol Shin and Seong-Gyu Ko supervised the study. All authors read and approved the final manuscript.
This study was supported by a grant from the Ministry of Food and Drug Safety, Republic of Korea (15172 Natural Products 197).