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  1. Suwankesawong W, Dhippayom T, Tan-Koi WC, Kongkaew C
    Pharmacoepidemiol Drug Saf, 2016 09;25(9):1061-9.
    PMID: 27174034 DOI: 10.1002/pds.4023
    PURPOSE: This study aimed to explore the current landscape and identify challenges of pharmacovigilance (PV) among Association of Southeast Asian Nations (ASEAN) countries.

    METHODS: This cross-sectional survey collected data from May 2014 to December 2015. Questionnaires seeking to collect information on resources, processes, roles and responsibility, and functions of PV systems were sent to relevant persons in the ASEAN countries. Functions of PV centers were measured using the minimum World Health Organization requirements for a functional national PV system. Performances of PV centers were measured by the following: (1) the indicators related to the average number of individual case safety reports (ICSR); (2) presence of signal detection activities and subsequent action; and (3) contribution to the global vigilance database.

    RESULTS: Cambodia, Indonesia, Laos, Malaysia, the Philippines, Singapore, Thailand, and Vietnam completed the survey. PV systems in four surveyed countries (Indonesia, Malaysia, Singapore, and Thailand) achieved all aspects of the World Health Organization minimum requirement for a functional national PV system; the remaining countries were deemed to have unclear communication strategies and/or no official advisory committee. Average numbers of recent ICSR national returns ranged from 7 to 3817 reports/year/million population; three countries (Malaysia, Singapore, and Thailand) demonstrated good performance in reporting system and reported signal detection activities and subsequent actions. All participating countries had submitted ICSRs to the Uppsala Monitoring Center during the survey period (2013-2015).

    CONCLUSIONS: Four participating countries had functional PV systems. PV capacity, functionality, and legislative framework varied depending on local healthcare ecosystem networks. Implementing effective communication strategies and/or technical assistance from the advisory committee are needed to strengthen PV in ASEAN. Copyright © 2016 John Wiley & Sons, Ltd.

  2. Dhippayom T, Kongkaew C, Chaiyakunapruk N, Dilokthornsakul P, Sruamsiri R, Saokaew S, et al.
    PMID: 25861373 DOI: 10.1155/2015/942378
    Objective. To determine the clinical effects of Thai herbal compress. Methods. International and Thai databases were searched from inception through September 2014. Comparative clinical studies investigating herbal compress for any indications were included. Outcomes of interest included level of pain, difficulties in performing activities, and time from delivery to milk secretion. Mean changes of the outcomes from baseline were compared between herbal compress and comparators by calculating mean difference. Results. A total of 13 studies which involved 778 patients were selected from 369 articles identified. The overall effects of Thai herbal compress on reducing osteoarthritis (OA) and muscle pain were not different from those of nonsteroidal anti-inflammatory drugs, knee exercise, and hot compress. However, the reduction of OA pain in the herbal compress group tended to be higher than that of any comparators (weighted mean difference 0.419; 95% CI -0.004, 0.842) with moderate heterogeneity (I (2) = 58.3%, P = 0.048). When compared with usual care, herbal compress provided significantly less time from delivery to milk secretion in postpartum mothers (mean difference -394.425 minutes; 95% CI -620.084, -168.766). Conclusion. Thai herbal compress may be considered as an alternative for osteoarthritis and muscle pain and could also be used as a treatment of choice to induce lactation.
  3. Chongmelaxme B, Sruamsiri R, Dilokthornsakul P, Dhippayom T, Kongkaew C, Saokaew S, et al.
    Complement Ther Med, 2017 Dec;35:70-77.
    PMID: 29154071 DOI: 10.1016/j.ctim.2017.09.009
    Zingiber cassumunar Roxb. known locally as "Plai" in Thai, has been used for treating bruise, sprain and musculoskeletal pain. Several pre-clinical studies demonstrated the anti-inflammatory effect of Plai. However, current evidence of clinical effects of Plai is still unclear. This study aimed to determine the clinical efficacy and safety of Plai among all identified indications. Of the 808 articles identified by a systematic review, six studies were included. Four studies were randomized controlled trials, while two studies were quasi-experimental studies involving 178 patients in intervention group and 177 patients in control group. Duration of treatment ranged from 7days to 2 months. Our findings showed that 14% Plai cream had a strong trend of benefits in pain reduction for muscle pain and ankle sprain. However, evidence supporting the effects of Plai on acne vulgaris treatment and anti-histamine effect are still unclear.
  4. Puttarak P, Dilokthornsakul P, Saokaew S, Dhippayom T, Kongkaew C, Sruamsiri R, et al.
    Sci Rep, 2017 09 06;7(1):10646.
    PMID: 28878245 DOI: 10.1038/s41598-017-09823-9
    Centella asiatica (L.) Urb. has been used as an herbal brain tonic for mental disorders and enhancing memory, but no review of the overall evidence of C. asiatica and cognitive function has been conducted. This study aims to determine the effects of C. asiatica on cognitive function and its related properties. The current systematic review includes five randomized controlled trials (RCTs) conducted to determine the effect of C. asiatica alone and six RCTs conducted to determine the effect of C. asiatica-containing products. Meta-analysis indicated that there are no significant differences in all cognitive function domains of C. asiatica when compared to placebo. However, it could improve mood by increasing alert scores [SMD: 0.71 (95% CI; 0.01 to 1.41); I2 = 30.5%] and decreasing anger scores at 1 hour after treatment [SMD: -0.81 (95%CI; -1.51 to -0.09); I2 = 36.6%]. None of the studies reported adverse effects of C. asiatica. In conclusion, there is not strong evidence to support the use of C. asiatica for cognitive function improvement in each cognitive domain. C. asiatica could improve alertness and relieve anger. However, some limitations should be aware including dose regimen, plant preparation, standardization, and product variation. Future well-designed clinical trials using suitable doses of standardized C. asiatica are still needed.
  5. Kongkaew C, Scholfield NC, Dhippayom T, Dilokthornsakul P, Saokaew S, Chaiyakunapruk N
    J Ethnopharmacol, 2018 Apr 24;216:162-174.
    PMID: 29409850 DOI: 10.1016/j.jep.2018.01.028
    ETHNOPHARMACOLOGICAL RELEVANCE: Pueraria candollei var. mirifica (Airy Shaw & Suvat.) Niyomdham (commonly termed P. mirifica, PM) growing in upland Thailand has a long history as a postmenopausal rejuvenant therapy for indigenants. Its amelioration of menopause symptoms in clinical trials was assessed.

    MATERIALS AND METHODS: International and Thai databases were searched from inception to February 2017. Clinical trials investigating effects of PM menopausal or postmenopausal women were included. Outcomes were self-reported menopausal symptoms, serum reproductive hormones, urino-genital tract function, and bone surrogates. Methodological quality was assessed by Cochrane risk-of-bias v2.0, and a 22-parameter quality score based on the CONSORT checklist for herbal medicines.

    RESULTS: Eight studies (9 articles) used data from 309 menopausal patients. Five-studies demonstrated that PM was associated with climacteric scores reduced by ~50% compared to baseline. Other PM studies using limited numbers of placebo participants suggested improved vaginal and other urogenital tract symptoms. Bone alkaline phosphatase halved (suggesting lowered bone turnover). Variable serum reproductive hormone levels suggested menopausal status differed between studies. PM active ingredients and sources were not defined. Adverse event rates (mastodynia, vaginal spotting, dizziness) were similar in all groups (PM, conjugated equine estrogen, and placebos) but serum C-reactive protein doubled. These studies had design and reporting deficiencies, high risks of biases, and low quality scores.

    CONCLUSIONS: The efficacy of PM on menopausal symptoms remains inconclusive because of methodological short-comings especially placebo effects inherent in self-assessment/recall questionnaires and no PM standardization. PM efficacy and safety need a fundamental re-appraisal by: (i) cohort (retro- and prospective) studies on current users to define its traditional use for rejuvenation; (ii) tightly coupling long-term efficacy to safety of well-defined PM and multiple end-points; (iii) using study design related to current understanding of menopause progression and estrogen pharmacology (iv) robust pharmacovigilance.

  6. Saokaew S, Wilairat P, Raktanyakan P, Dilokthornsakul P, Dhippayom T, Kongkaew C, et al.
    PMID: 27694558 DOI: 10.1177/2156587216669628
    Kaempferia parviflora (Krachaidum) is a medicinal plant in the family Zingiberaceae. Its rhizome has been used as folk medicine for many centuries. A number of pharmacological studies of Krachaidum had claimed benefits for various ailments. Therefore, this study aimed to systematically search and summarize the clinical evidences of Krachaidum in all identified indications. Of 683 records identified, 7 studies were included. From current clinical trials, Krachaidum showed positive benefits but remained inconclusive since small studies were included. Even though results found that Krachaidum significantly increased hand grip strength and enhanced sexual erotic stimuli, these were based on only 2 studies and 1 study, respectively. With regard to harmful effects, we found no adverse events reported even when Krachaidum 1.35 g/day was used. Therefore, future studies of Krachaidum are needed with regards to both safety and efficacy outcomes.
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