Table 5 Summary of cases adjudicated
Case | Age, Sex, Ethnicity | Smoking history, Alcohol consumption | Self-reported medication use (Oral administration unless otherwise specified) | Chinese herbal medicine consumed (Oral administration unless otherwise specified) | Adverse Event, Duration | Causality Assessment Outcome (WHO, Naranjo) |
|---|---|---|---|---|---|---|
1 | 84, Female, Chinese | None, None | Osimertinib | Panax ginseng, Astragalus membranaceus, Atractylodes macrocephala, Citrus reticulata, Scutellaria barbata, Scutellaria baicalensis, Hedyotis diffusai, Angelica sinensis, Radix Scrophulariae, Hordeum vulgare, Hottuynia cordata, Stemona tuberosa, Aster tataricus, Tussilago farfara, Chicken's Gizzard-membrane, Crataegus pinnatifida | Persistent rash and itch, 1 year | Unlikely, Doubtful |
2 | 34, Male, Chinese | None, None | Empagliflozin/Linagliptin | Schisandra sinensis, Lycium barbarum, Plantago asiatica, Rubus chingii, Cuscuta chinensis, Ligustrum lucidum, Codonopsis pilosula, Atractylodes macrocephala, Poria cocos, Eucommia ulmoides, Taxillus chinensis, Epimedium grandiflorum, Anemarrhena asphodeloides, Taraxacum officinale, Citrus reticulata, Nelumbo nucifera, Lablab purpureus, Adenophora stricta, Wurfbainia villosa | Diarrhea and feeling bloated and gassy in stomach, 3 weeks | Likely, Possible |
3 | 56, Male, Chinese | None, None | Etoricoxib | †Herbal formula 1: Shu Jin Huo Xue Tang Additional herbs: Morus alba, Pueraria montana, Lonicera japonica, Scutellaria baicalensis | Malaise and lethargy, 1 week | Possible, Possible |
4 | 62, Female, Chinese | None, None | Metformin, Aspirin | †Herbal formula 1: An Shen He Ji †Herbal formula 2: Tong Luo Hua Tan He Ji †Herbal formula 3: Bao He He Ji †Herbal formula 4: Qing Gan Ming Mu Pian | Headache and dizziness, 1 week | Possible, Possible |
5 | 34, Male, Chinese | None, None | Hydroxyzine | Bupleurum chinense, Paeonia lactiflora, Nepeta cataria, Saposhnikovia divaricata, Citrus reticulata, Poria cocos, Polygonum multiflorum, Dictamnus dasycarpus, Ligusticum striatum, Platycodon grandiflorus, Glycyrrhiza glabra, Paeonia suffruticosa, Gardenia jasminoides, Lycopus lucid, Radix Scrophulariae, Rehmannia glutinosa, Angelica sinensis, Ziziphus spinosa, Ossis Mastodi Fossilia | Stomach discomfort (churning) and diarrhea, 1 month | Unlikely, Possible |
6 | 61, Male, Chinese | None, None | Aspirin, Simvastatin | †Herbal formula 1: Shao Yao Gan Cao He Ji †Herbal formula 2: Mu Xiang Shun Qi He Ji †Herbal formula 3: Guan Jie Gu Tong Pian | Stomach discomfort (mild pain) and diarrhea, 1 week | Unlikely, Doubtful |
7 | 76, Female, Chinese | None, None | Aspirin, Carbimazole | †Herbal formula 1: Dan Zhi Xiao Yao He Ji †Herbal formula 2: Gan Lu Yin †Herbal formula 3: Ban Xia Xie Xin He Ji †Herbal formula 4: Yue Ju Bao He Pian | Stomach discomfort (mild pain) and headache, 2 weeks | Unlikely, Doubtful |
8 | 47, Female, Chinese | None, None | Bisoprolol, Atorvastatin, Letrozole, Trastuzumab (Intravenous infusion) | Astragalus membranaceus, Atractylodes macrocephala, Poria cocos, Codonopsis pilosula, Glycyrrhiza glabra, Akebia quinata, Spatholobus suberectus, Coix lacryma-jobi, Ophiopogon japonicus, Schisandra sinensis, Alisma orientale, Gastrodia elata, Cibotium barometz, Eucommia ulmoides, Maydis seigma, Coptis chinensis | Occasional nausea and vomit, 3 weeks | Unlikely, Possible |
9 | 72, Male, Chinese | None, None | Amlodipine, Labetalol | †Herbal formula 1: Xiang Sha Liu Jun Zi Ke Li Additional herbs: Maydis seigma, Magnolia liliiflora, Xanthium strumarium, Coptis chinensis, Forsythia suspensa, Atractylodes lancea, Alisma orientale, Citrus reticulata, Peucedanum praeruptorum, Perilla frutescens, Sinapis alba, Raphanus sativus, Descurainia sophia, Bile Arisaema, Lysimachia nummularia, Siegesbeckia orientalis, Agrimonia pilosa, Platycladus orientalis, Astragalus membranaceus, Spatholobus suberectus, Anemarrhena asphodeloides | Recurring headache every morning, 2 weeks | Unlikely, Doubtful |
10 | 31, Female, Indonesian | None, None | Estradiol, Norgestrel | Pseudostellaria heterophylla, Schisandra sinensis, Lycium babarum, Cuscuta chinensis, Rubus chingii, Plantago asiatica, Dipsacus asperoides, Ligustrum lucidum, Angelica sinensis, Curcuma aromatica, Pinellia ternata, Scutellaria baicalensis, Prunella vulgaris, Codonopsis pilosula, Dioscorea opposita, Bupleurum chinense | Stomach discomfort (mild pain), 1 week | Possible, Possible |
11 | 77, Female, Chinese | None, None | Aspirin | Paeonia lactiflora, Bupleurum chinense, Poncirus trifoliata, Magnolia officinalis, Angelica sinensis, Pinellia ternata, Perilla frutescens, Prunus armeniaca, Raphanus sativus, Chicken's Gizzard-membrane, Medicated Leaven, Trichosanthis Radix, Polygonum multiflorum, Platycladus orientalis, Ziziphus spinosa, Ligusticum striatum, Astragalus membranaceus, Pseudostellaria heterophylla, Aloe vera, Glycyrrhiza glabra | Stomach-ache (cramping sensation), 1 week | Possible, Possible |
12 | 32, Male, Chinese | None, None | Codeine, Fexofenadine, Estazolam | Bupleurum chinense, Angelica sinensis, Poria cocos, Atractylodes macrocephala, Paeonia lactiflora, Glycyrrhiza glabra, Paeonia suffruticosa, Gardenia jasminoides, Mentha canadensis, Ziziphus spinosa, Lilii bulbus, Codonopsis pilosula, Ophiopogon japonicus, Schisandra sinensis, Ossis Mastodi Fossilia, Ostrea edulis | Fatigue and sleepiness, 1.5 weeks | Unlikely, Possible |
13 | 42, Female, Chinese | None, None | Propanolol | †Herbal formula 1: Liu Wei Di Huang Wan †Herbal formula 2: Dan Zhi Xiao Yao San Additional herbs: Eucommia ulmoides, Radix Scrophulariae, Prunella vulgaris, Ostrea edulis, Fritillaria thunbergii, Anemarrhena asphodeloides, Phellodendron amurense, Pinellia ternata, Citrus reticulata, Forsythia suspensa, Pueraria montana, Coix lacryma-jobi | Stomach discomfort (churning) and bloating, 1 week | Unlikely, Possible |
14 | 74, Female, Chinese | None, None | Rivaroxaban, Rabeprazole | Astragalus membranaceus, Spatholobus suberectus, Codonopsis pilosula, Atractylodes macrocephala, Pogostemon cablin, Pueraria montana, Ophiopogon japonicus, Citrus reticulata, Cimicifuga simplex, Bupleurum chinense, Paeonia lactiflora, Poncirus trifoliata, Saposhnikovia divaricata, Heracleum hemsleyanum, Cibotium barometzou, Moghania philippinensis, Achyranthes bidentata, Coix lacryma-jobi, Nelumbo nucifera, Glycyrrhiza glabra | Recurring diarrhea after food or medicine consumption, 1 week | Unlikely, Possible |
15 | 53, Female, Chinese | None, None | Prospan, Acetylcysteine | †Herbal formula 1: Chuan Xiong Cha Tiao San †Herbal formula 2: Xin Yi Tang †Herbal formula 3: Zhe Bei He Ji †Herbal formula 4: Ming Mu Di Huang Wan †Herbal formula 5: Yi Qi Sheng Jin Jiao Nang | Recurring diarrhea 10 min after CHM consumption, 4 days | Possible, Possible |
16 | 23, Male, Chinese | None, None | Acetaminophen, Dequalinium lozenges | †Herbal formula 1: Sha Shen Mai Dong Tang Additional herbs: Taraxacum officinale, Dendrobium officinale, Trichosanthis Radix, Coix lacryma-jobi, Dioscorea opposita, Rehmannia glutinosa, Cyperus rotundus, Bupleurum chinense | Occasional nausea after CHM or WMPD consumption, 2 weeks | Unlikely, Doubtful |
17 | 53, Female, Chinese | None, None | Pembrolizumab(Intravenous infusion) | †Herbal formula 1: Yang Yin Qing Fei Ke Li Additional herbs: Spatholobus suberectus, Liquidambar formosana, Akebia quinata, Astragalus membranaceus, Ziziphus spinosa, Polygala sibirica, Dendrobium officinale, Lilii bulbus | Recurring dull stomach pain, 1 week | Unlikely, Doubtful |
18 | 84, Male, Chinese | None, None | Aspirin, Tamsulosin, Carbimazole | Rosa laevigata, Mantidis ootheca, Lindera aggregata, Alpinia oxyphylla, Glycyrrhiza glabra, Schisandra sinensis, Panax ginseng, Astragalus membranaceus, Cinnamomum verum, Rehmannia glutinosa, Donkey-hide Gelatin, Ophiopogon japonicus, Ziziphus jujuba, Spatholobus suberectus, Liquidambar formosana, Achyranthes bidentata, Heracleum hemsleyanum | Stomach discomfort (churning) and diarrhea, 3 days | Unlikely, Possible |