Chuenjid Kongkaew Faculty of Pharmaceutical Sciences,

Naresuan University, Thailand

Management of Adverse !Experiences from the Use of !Herbal Medicines:!The Consumers’ Perspectives

Funding and conflicts of interest

Funded by the Annual Thai government statement of expenditure 2017 which had no influence on data collection not any part of this presentation.

Chuenjid Kongkaew has no conflicts of interest to declare

Introduction

Herbal medicines used worldwide Projected global market $140 billion. 22-77% of Asian use herbal medicines (Thailand 33%)

Herbal medicines in Thai vigilance database gastrointestinal problems most common adverse events. serious adverse events, e.g., Andrographis paniculata including: Stevens-Johnson syndrome anaphylactic shock exfoliative dermatitis

Safety of herbal medicines is worrying

Introduction

• Current reporting mechanisms for herbal medicines, but: •  s p o n t a n e o u s r e p o r t i n g r a t e s l o w • probably under-reported (Debbie, S., et.al., 2012)

• Consumer engagement •  improve such reporting •  crucial to understand consumer perception of adverse

events and how they act

Objectives

Explore how consumers manage

adverse experiences related to herbal medicines

S t u d y p e r i o d : M a r c h / A p r i l 2 0 1 7 setting: sub-district, south-east Thailand

2 0 k m

Background of participants

Questionnaire •  Participant demographics •  Participant usage of herbal medicines •  Access to herbal medicines and services •  Knowledge, attitude, and beliefs of herbal medicines •  Knowledge and understanding of drug allergies •  Participant opinion about self-care

Participant demographics

270 participants recruited •  Aged 40-59 yr, 56% •  Female, 70% •  Education: < primary school, 73% •  Marital status: married, 68% •  Occupation: agrarian, 57%

Herbal medicine usage of cohort

• Herbal medicines used Commonly: Andrographis paniculata

Curcuma longa Thunbergia laurifolia

Purposes: treatment or symptom relief (62%) disease prevention/health promotion (38%) Duration: >1 yr. (56%)

• Perceived benefits of herbal medicines (94%)

Access to herbal medicines and services

Access to herbal medicines Health centre/pharmacy/community hospital (30%) Home-grown/foraging (37%) Grocery shop/market/temple/direct sale (16%) Neighbour (11%) Traditional healer (6%)

Access to medical services • Paramedic/nurse care : < 5 km (74% participants) • Community hospital : > 10 km (78%)

Knowledge, attitude & beliefs

• Knowledge about herbals as medicines: (scored low) • Attitude: favour over standard medicines (47%) • Beliefs: herbal medicines provide benefits (56%) • Knowledge and understanding about drug allergy (80%)

Participant opinion about self-care of a severe adverse experience

Action N % Influencing factor

1. self-care 105 38.9

!Consumers living close (6-10 km) to a

hospital would seek care from hospital (66%)

rather than self-care. Reference group: consumers living >10km

from hospital. odds ratio 0.34, C.I. = 0.16 -0.68

1.1 self-care by self 6 2.2

1.2 talk to family 99 36.7

1.3 pharmacy 0 0

2. seek-care 160 59.3

2.1 hospital 142 52.6

2.2 primary care 18 6.7 3. Continue to use of herbal medicine 5 1.9

Total 270 100

Participant opinion about self-care of a mild/moderate adverse experience

Action N % Influencing factor

1. self-care 135 50.0 Participants who perceived benefits from herbal medicines

Reference group: consumers who were uncertain about benefits of herbals odds ratio 3.45, C.I. = 1.0 - 11.5 Good knowledge and understanding of

drug allergies Reference group: poor knowledge and understanding of drug allergies odds ratio 3.05, C.I. = 1.0 - 9.0

1.1 self-care by self 40 14.8

1.2 talk to family 89 33.0

1.3 pharmacy 6 2.2

2. seek-care 115 42.6

2.1 hospital 69 25.6

2.2 primary care centre 46 17.0 3. Continue to use of

herbal medicine 20 7.4

Total 270 100

Study Method

• A Multiple Case Study • Data collection as in-depth interviews • Criterion sampling •  Inclusion criteria

• Participants who had adverse experiences from herbal medicines • Age ≥20 yr living in the area • Consent to participate

• 9 informants fitted criteria

Age Sex Herbal medicine Adverse experience (or diagnosis)

1 55 M Stachytarpheta jamaicensis (L.) Vahl + Andrographis paniculata Dizziness

2 78 M Schefflera leucantha Muscle spasms

3 66 F Yellow powder medicinal herbs Dyspepsia

4 42 F Moringa oleifera Dizziness

5 62 F Chlorophyll Body Pain

6 56 F Ganoderma lucidum Dizziness

7 42 F Helicteres isora L. Frequent urination

8 55 F Medicago sativa Dizziness

9 79 F Herbal Capsule (Unknown) Impaired renal function

•  here

Management of adverse experiences from the use of herbal medicines

The perceived adverse reactions were managed by: (a) taking no action if symptoms were mild and that herbal

m e d i c i n e s w e r e b e l i e v e d t o b e s a f e (b) self-care including dose moderation or discontinuation,

sleeping, drinking a lot to increase excretion, or taking laural clock vine (Thunbergia laurifolia) to promote toxin loss

(c) seeking advice/care at sub-district health promoting hospital o r d r u g s t o r e a n d

(d) perform both self-care and care-seeking behaviours

Discussion •  S u s p e c t e d a d v e r s e e x p e r i e n c e s w a s v e r i f i e d b y :

( i ) r u l i n g - o u t o t h e r p o t e n t i a l c a u s e s ( i i ) d e - c h a l l e n g e a n d ( i i i ) r e - c h a l l e n g e

• Some participants use reactions from herbal medicines, e.g., aches/ feeling warm, to indicate the herbal is effective (“Sai” symptom)

• Unbiased information about herbals is needed especially about indication, dose, duration, adverse effect, and precautions to be a c c e s s i b l e v i a a m o b i l e p h o n e

• Need a dedicated user-friendly database for consumers to report a d v e r s e e v e n t s f r o m h e r b a l m e d i c i n e s

Challenges

! Ambiguity of preparation contents ! Different names for same herbal medicine ! Poorly defined and erratic doses ! Unclear definition of efficacy ! Differentiating therapeutic effects from adverse events ! No easy way of identifying long-term life threatening events,

e.g: • Carcinogenesis • Renal, liver failure

Conclusion

•  Consumers of herbal medicine are at risk of adverse events

•  Vigilance systems for herbal medicines could be established by p r o m o t i n g c o n s u m e r r e p o r t i n g

•  H e a l t h c a r e p r o f e s s i o n a l s c a n s t i l l c o n t r i b u t e

•  Improving the safe use of herbal medicines by providing unbiased i n f o r m a t i o n f o r u s e r s a n d l o n g - t e r m f o l l o w - u p

Contact detail: chuenjid@googlemail.com

Methods

•  Sequential mixed method research design using both quantitative and q u a l i t a t i v e s t u d y

•  Study settings: A sub-district, in the south-east of Thailand during March/A p r i l 2 0 1 7

•  Show a map of this

Phase1: A Cross-Sectional

Observational Study

•  Sample'size'270;'sampled'people'registered'with'the'primary'centre

•  Tool:'Interview'ques@onnaire' •  Inves@gate:'(1)'consumer'characteris@cs;'

•  (2)'the'usage'behaviour'of'herbal'medicines;'(3)'access'to'herbal'medicines,'(4)'knowledge'about'herbal'medicines;'(5)'aKtudes'about'the'use'of'herbal'medicines;'(6)'beliefs'about'the'use'of'herbal'medicines;'(7)'knowledge'and'understanding'about'drug'allergy;'(8)'opinions'about'selfNcare'when'they'encountered'adverse'experiences'

•  To'determine'factors'influencing'opinions'about'selfNcare'when'experienced'adverse'events'using'binary'logis@c'regression

Patterns of adverse experiences

•  9 key informants perceived the adverse experiences either severe or not severe during a course of herbal medicine treatment

“It’s severe, I never got this with other medications. Starting with muscle pain, feel like having fever, sore tendon, pain all over my body, I quickly closed my shop, thinking I’m dying that day” Code A05 •  They performed self-diagnosis of the adverse experiences and

observed abnormalities of the body using their own experiences. “muscles are jerking and then got cramped (demonstration and pointing at the area, which got cramped” Code A02 •  Not sure about any of this •  Some of them did not know if the experience was an adverse

reaction to herbal medicines. They perceived the reaction from herbal medicines (e.g., feeling hot) after use and called the reactions as “Sai” symptom, which can be good or bad effects.

•  Verifying the suspected experiences from herbal medicines was deduced by (i) ruling-out other potential causes (ii) d e - c h a l l e n g e a n d ( i i i ) r e - c h a l l e n g e