management of adverse experiences from the use of herbal ... · anaphylactic shock exfoliative...
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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
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
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: [email protected]
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