Displaying publications 1 - 20 of 44 in total

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  1. Permsuwan U, Chaiyakunapruk N, Dilokthornsakul P, Thavorn K, Saokaew S
    Appl Health Econ Health Policy, 2016 Jun;14(3):281-92.
    PMID: 26961276 DOI: 10.1007/s40258-016-0228-3
    BACKGROUND: Even though Insulin glargine (IGlar) has been available and used in other countries for more than a decade, it has not been adopted into Thai national formulary. This study aimed to evaluate the long-term cost effectiveness of IGlar versus neutral protamine Hagedorn (NPH) insulin in type 2 diabetes from the perspective of Thai Health Care System.

    METHODS: A validated computer simulation model (the IMS CORE Diabetes Model) was used to estimate the long-term projection of costs and clinical outcomes. The model was populated with published characteristics of Thai patients with type 2 diabetes. Baseline risk factors were obtained from Thai cohort studies, while relative risk reduction was derived from a meta-analysis study conducted by the Canadian Agency for Drugs and Technology in Health. Only direct costs were taken into account. Costs of diabetes management and complications were obtained from hospital databases in Thailand. Both costs and outcomes were discounted at 3 % per annum and presented in US dollars in terms of 2014 dollar value. Incremental cost-effectiveness ratio (ICER) was calculated. One-way and probabilistic sensitivity analyses were also performed.

    RESULTS: IGlar is associated with a slight gain in quality-adjusted life years (0.488 QALYs), an additional life expectancy (0.677 life years), and an incremental cost of THB119,543 (US$3522.19) compared with NPH insulin. The ICERs were THB244,915/QALY (US$7216.12/QALY) and THB176,525/life-year gained (LYG) (US$5201.09/LYG). The ICER was sensitive to discount rates and IGlar cost. At the acceptable willingness to pay of THB160,000/QALY (US$4714.20/QALY), the probability that IGlar was cost effective was less than 20 %.

    CONCLUSIONS: Compared to treatment with NPH insulin, treatment with IGlar in type 2 diabetes patients who had uncontrolled blood glucose with oral anti-diabetic drugs did not represent good value for money at the acceptable threshold in Thailand.

  2. Ounsirithupsakul T, Dilokthornsakul P, Kongpakwattana K, Ademi Z, Liew D, Chaiyakunapruk N
    Appl Health Econ Health Policy, 2020 08;18(4):579-587.
    PMID: 32009211 DOI: 10.1007/s40258-020-00553-0
    BACKGROUND: Pneumococcal diseases were estimated to cause 1.6 million deaths annually worldwide in 2008, with approximately half of these occurring in children aged under 5 years. The consequences and deaths adversely impact individuals' and caregivers' work productivity.

    OBJECTIVES: This study aimed to quantify the potential lifetime productivity loss due to pneumococcal diseases among the pediatric population in Thailand using productivity-adjusted life years (PALYs).

    METHODS: A decision analytic model was used to estimate the burden of pneumococcal diseases among the current Thai population aged 0-5 years and followed up until aged 99 years or death. Base-case analysis compared years of life and PALYs lost to pneumococcal diseases. Scenario analyses investigated the benefits of prevention with pneumococcal conjugated vaccine 13 (PCV 13). All health outcomes were discounted at 3% per annum.

    RESULTS: The base-case analysis estimated that 453,401 years of life and 457,598 PALYs would be lost to pneumococcal diseases, equating to a loss of US$5586 (95% CI 3338-10,302) million. Vaccination with PCV13 at birth was estimated to save 82,609 years of life and 93,759 PALYs, which equated to US$1144 (95% CI 367-2591) million in economic benefits. The incidence of pneumonia in those aged 0-4 years, vaccine efficacy, and the assumed period of protection were key determinants of the health economic outputs.

    CONCLUSIONS: The disease and financial burden of pneumococcal diseases in Thailand is significant, but a large proportion of this is potentially preventable with vaccination.

  3. Bamrungsawad N, Upakdee N, Pratoomsoot C, Sruamsiri R, Dilokthornsakul P, Dechanont S, et al.
    Clin Drug Investig, 2016 Jul;36(7):557-66.
    PMID: 27113227 DOI: 10.1007/s40261-016-0401-3
    Intravenous immunoglobulin (IVIG) has been recommended for steroid-resistant chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). The treatment, however, is very costly to healthcare system, and there remains no evidence of its economic justifiability. This study aimed to conduct an economic evaluation (EE) of IVIG plus corticosteroids in steroid-resistant CIDP in Thailand.
  4. Teerawattanapong N, Kengkla K, Dilokthornsakul P, Saokaew S, Apisarnthanarak A, Chaiyakunapruk N
    Clin Infect Dis, 2017 May 15;64(suppl_2):S51-S60.
    PMID: 28475791 DOI: 10.1093/cid/cix112
    Background: This study evaluated the relative efficacy of strategies for the prevention of multidrug-resistant gram-negative bacteria (MDR-GNB) in adult intensive care units (ICUs).

    Methods: A systematic review and network meta-analysis was performed; searches of the Cochrane Library, PubMed, Embase, and CINAHL (Cumulative Index to Nursing and Allied Health Literature) included all randomized controlled trials and observational studies conducted in adult patients hospitalized in ICUs and evaluating standard care (STD), antimicrobial stewardship program (ASP), environmental cleaning (ENV), decolonization methods (DCL), or source control (SCT), simultaneously. The primary outcomes were MDR-GNB acquisition, colonization, and infection; secondary outcome was ICU mortality.

    Results: Of 3805 publications retrieved, 42 met inclusion criteria (5 randomized controlled trials and 37 observational studies), involving 62068 patients (median age, 58.8 years; median APACHE [Acute Physiology and Chronic Health Evaluation] II score, 18.9). The majority of studies reported extended-spectrum β-lactamase (ESBL)-producing Enterobacteriaceae and MDR Acinetobacter baumannii. Compared with STD, a 4-component strategy composed of STD, ASP, ENV, and SCT was the most effective intervention (rate ratio [RR], 0.05 [95% confidence interval {CI}, .01-.38]). When ENV was added to STD+ASP or SCT was added to STD+ENV, there was a significant reduction in the acquisition of MDR A. baumannii (RR, 0.28 [95% CI, .18-.43] and 0.48 [95% CI, .35-.66], respectively). Strategies with ASP as a core component showed a statistically significant reduction the acquisition of ESBL-producing Enterobacteriaceae (RR, 0.28 [95% CI, .11-.69] for STD+ASP+ENV and 0.23 [95% CI, .07-.80] for STD+ASP+DCL).

    Conclusions: A 4-component strategy was the most effective intervention to prevent MDR-GNB acquisition. As some strategies were differential for certain bacteria, our study highlighted the need for further evaluation of the most effective prevention strategies.

  5. Boonlue T, Subongkot S, Dilokthornsakul P, Kongsakon R, Pattanaprateep O, Suanchang O, et al.
    Clinicoecon Outcomes Res, 2016;8:127-36.
    PMID: 27199568 DOI: 10.2147/CEOR.S97300
    Several clinical practice guidelines suggest using atypical over typical antipsychotics in patients diagnosed with schizophrenia. Nevertheless, cost-containment policy urged restricting usage of atypical antipsychotics and switching from atypical to typical antipsychotics.
  6. Permsuwan U, Dilokthornsakul P, Saokaew S, Thavorn K, Chaiyakunapruk N
    Clinicoecon Outcomes Res, 2016;8:521-529.
    PMID: 27703387
    The management of type 2 diabetes mellitus (T2DM) in elderly population poses many challenges. Dipeptidyl peptidase-4 (DPP-4) inhibitors show particular promise due to excellent tolerability profiles, low risk of hypoglycemia, and little effect on body weight. This study evaluated, from the health care system's perspective, the long-term cost-effectiveness of DPP-4 inhibitor monotherapy vs metformin and sulfonylurea (SFU) monotherapy in Thai elderly T2DM patients.
  7. 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.
  8. Mahlich J, Dilokthornsakul P, Sruamsiri R, Chaiyakunapruk N
    PMID: 29881328 DOI: 10.1186/s12962-018-0103-1
    Background: Health-care utilities differ considerably from country to country. Our objective was to examine the association of cultural values based on Hofstede's cultural dimensions' theory with utility values that were identified using the time trade off method.

    Methods: We performed a literature search to determine preference-based value algorithms in the general population of a given country. We then fitted a second-order quadratic function to assess the utility function curve that links health status with health-care utilities. We ranked the countries according to the concavity and convexity properties of their utility functions and compared this ranking with that of the Hofstede index to check if there were any similarities.

    Results: We identified 10 countries with an EQ-5D-5L-based value set and 7 countries with an EQ-5D-3L-based value set. Japan's degree of concavity was highest, while Germany's was lowest, based on the EQ-5D-3L and EQ-5D-5L value sets. Japan also ranked first in the Hofstede long-term orientation index, and rankings related to the degree of concavity, indicating a low time preference rate.

    Conclusions: This is the first evaluation to identify and report an association between different cultural beliefs and utility values. These findings underline the necessity to take local values into consideration when designing health technology assessment systems.

  9. Lai EC, Man KK, Chaiyakunapruk N, Cheng CL, Chien HC, Chui CS, et al.
    Epidemiology, 2015 Nov;26(6):815-20.
    PMID: 26133022 DOI: 10.1097/EDE.0000000000000325
    This study describes the availability and characteristics of databases in Asian-Pacific countries and assesses the feasibility of a distributed network approach in the region.
  10. Man KKC, Shao SC, Chaiyakunapruk N, Dilokthornsakul P, Kubota K, Li J, et al.
    Eur Child Adolesc Psychiatry, 2022 Jan;31(1):99-120.
    PMID: 33185773 DOI: 10.1007/s00787-020-01674-6
    It is known that younger patients treated with antipsychotics are at increased risk of metabolic events; however, it is unknown how this risk varies according to ethnicity, the class of antipsychotic and the specific product used, and by age group. We conducted a multinational sequence symmetry study in Asian populations (Hong Kong, Japan, Korea, Taiwan and Thailand) and non-Asian populations (Australia and Denmark) to evaluate the metabolic events associated with antipsychotics in both Asian and non-Asian populations, for typical and atypical antipsychotics, and by the subgroups of children and adolescents, and young adults. Patients aged 6-30 years newly initiating oral antipsychotic drugs were included. We defined a composite outcome for metabolic events which included dyslipidemia, hypertension and hyperglycemia. We calculated the sequence ratio (SR) by dividing the number of people for whom a medicine for one of the outcome events was initiated within a 12-month period after antipsychotic initiation by the number before antipsychotic initiation. This study included 346,904 antipsychotic initiators across seven countries. Antipsychotic use was associated with an increased risk of composite metabolic events with a pooled adjusted SR (ASR) of 1.22 (95% CI 1.00-1.50). Pooled ASRs were similar between Asian (ASR, 1.22; 95% CI 0.88-1.70) and non-Asian populations (ASR, 1.22; 95% CI 1.04-1.43). The pooled ASR for typical and atypical antipsychotics was 0.98 (95% CI 0.85-1.12) and 1.24 (95% CI 0.97-1.59), respectively. No difference was observed in the relative effect in children and adolescents compared to young adults. The risk of metabolic events associated with antipsychotics use was similar in magnitude in Asian and non-Asian populations despite the marked difference in drug utilization patterns.
  11. 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.
  12. Chaiyasothi T, Nathisuwan S, Dilokthornsakul P, Vathesatogkit P, Thakkinstian A, Reid C, et al.
    Front Pharmacol, 2019;10:547.
    PMID: 31191304 DOI: 10.3389/fphar.2019.00547
    Background: Currently, there is a lack of information on the comparative efficacy and safety of non-statin lipid-lowering agents (NST) in cardiovascular (CV) disease risk reduction when added to background statin therapy (ST). This study determine the relative treatment effects of NST on fatal and non-fatal CV events among statin-treated patients. Methods: A network meta-analysis based on a systematic review of randomized controlled trials (RCTs) comparing non-statin lipid-modifying agents among statin-treated patients was performed. PubMed, EMBASE, CENTRAL, and Clinicaltrial.gov were searched up to April 10, 2018. The primary outcomes were CV and all-cause mortalities. Secondary CV outcomes were coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), any stroke, and coronary revascularization. Risks of discontinuations were secondary safety outcomes. Results: Sixty-seven RCTs including 259,429 participants with eight interventions were analyzed. No intervention had significant effects on the primary outcomes (CV mortality and all-cause mortality). For secondary endpoints, proprotein convertase subtilisin/kexin type 9 inhibitor (PCSK) plus statin (PCSK/ST) significantly reduced the risk of non-fatal MI (RR 0.82, 95% CI 0.72-0.93, p = 0.003), stroke (RR 0.74, 95% CI 0.65-0.85, p < 0.001), coronary revascularization (RR 0.84, 95% CI 0.75-0.94, p = 0.003) compared to ST. Combinations of ST and all NST except PCSK and ezetimibe showed higher rate of discontinuation due to adverse events compared to ST. Conclusions: None of NST significantly reduced CV or all-cause death when added to ST. PCSKs and to a lesser extent, ezetimibe may help reduce cardiovascular events with acceptable tolerability profile among broad range of patients.
  13. Kotirum S, Muangchana C, Techathawat S, Dilokthornsakul P, Wu DB, Chaiyakunapruk N
    Front Public Health, 2017;5:289.
    PMID: 29209602 DOI: 10.3389/fpubh.2017.00289
    Current study aimed to estimate clinical and economic outcomes of providing the Haemophilus influenzae type b (Hib) vaccination as a national vaccine immunization program in Thailand. A decision tree combined with Markov model was developed to simulate relevant costs and health outcomes covering lifetime horizon in societal and health care payer perspectives. This analysis considered children aged under 5 years old whom preventive vaccine of Hib infection are indicated. Two combined Hib vaccination schedules were considered: three-dose series (3 + 0) and three-dose series plus a booster does (3 + 1) compared with no vaccination. Budget impact analysis was also performed under Thai government perspective. The outcomes were reported as Hib-infected cases averted and incremental cost-effectiveness ratios (ICERs) in 2014 Thai baht (THB) ($) per quality-adjusted life year (QALY) gained. In base-case scenario, the model estimates that 3,960 infected cases, 59 disability cases, and 97 deaths can be prevented by national Hib vaccination program. The ICER for 3 + 0 schedule was THB 1,099 ($34) per QALY gained under societal perspective. The model was sensitive to pneumonia incidence among aged under 5 years old and direct non-medical care cost per episode of Hib pneumonia. Hib vaccination is very cost-effective in the Thai context. The budget impact analysis showed that Thai government needed to invest an additional budget of 110 ($3.4) million to implement Hib vaccination program. Policy makers should consider our findings for adopting this vaccine into national immunization program.
  14. Nagendrababu V, Dilokthornsakul P, Jinatongthai P, Veettil SK, Pulikkotil SJ, Duncan HF, et al.
    Int Endod J, 2020 Feb;53(2):232-249.
    PMID: 31520403 DOI: 10.1111/iej.13217
    A systematic review aims to answer a focussed research question through a structured review of the evidence, using a predefined methodology, which often includes a meta-analysis. A meta-analysis is a statistical method used to combine the effect estimates from the individual studies included in a systematic review. Systematic reviews and meta-analyses are positioned at the highest level in the hierarchy of clinical evidence. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement was introduced in 2009 to help authors improve the quality and reliability of systematic reviews and meta-analyses. Recently, the volume of systematic reviews and meta-analyses in the field of Endodontology has increased; however, the quality of the published manuscripts has been reported to be sub-optimal, which does not take account of the systematic reviews that were rejected because of more obvious deficiencies. The aim of this paper is to present a comprehensive glossary of terminology commonly used in systematic reviews and meta-analyses in an attempt to provide easily understood definitions and explanations to assist authors when reporting systematic reviews and meta-analyses and to allow those wishing to read them to become better informed.
  15. Kongwatcharapong J, Dilokthornsakul P, Nathisuwan S, Phrommintikul A, Chaiyakunapruk N
    Int J Cardiol, 2016 May 15;211:88-95.
    PMID: 26991555 DOI: 10.1016/j.ijcard.2016.02.146
    Recent studies have suggested that dipeptidyl peptidase-4 inhibitors (DPP-4 inhibitors) may be associated with increased risk of heart failure (HF), but evidence was inconclusive. We aimed to determine the effects of DPP-4 inhibitors on risk of HF.
  16. Mongkhon P, Dilokthornsakul P, Tepwang K, Tapanya K, Sopitprasan C, Chaliawsin P, et al.
    Int J Cardiol Heart Vasc, 2017 Jun;15:9-14.
    PMID: 28616566 DOI: 10.1016/j.ijcha.2017.03.003
    BACKGROUND: Accessibility of primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI) in primary care settings is limited. Referring patients to PCI-capable hospitals might increase cardiac events. Hence, fibrinolytic injection before referring patients to PCI-capable settings decreases cardiac events, however, the effect of fibrinolytic injection before the referral has not been systematically evaluated. This study aimed to systematically review the effect of fibrinolytic injection before referring patients with STEMI to PCI-capable settings.

    METHODS: A systematic search with Embase, Cochrane CENTRAL, Google scholar, and PubMed was conducted. Studies conducted in patients with STEMI presented to non PCI-capable settings and compared fibrinolytic injection with no injection before referring patients to PCI-capable settings were included. The primary outcome was the composite outcomes of major adverse cardiac events (MACEs) at 30 days. Meta-analyses were performed using random-effect model.

    RESULTS: Of 912 articles, three RCTs and three non-RCTs were included. Based on RCTs, fibrinolytic injection before the referral has failed to decrease MACEs compared to non-fibrinolytic injection [relative risk (RR) 1.18; 95% confidence interval (CI), 0.89-1.57, p = 0.237]. Fibrinolytic injection has also failed to decrease mortality, re-infarction, and ischemic stroke. On the other hand, fibrinolytic injection was associated with a higher risk of major bleeding.

    CONCLUSIONS: In non PCI-capable settings, fibrinolytic injection before referring patients with STEMI to PCI-capable settings has no clinical benefit but could increase risk of major bleeding. Clinicians might more carefully consider whether fibrinolytic injection should be used in patients with STEMI before the referral.

  17. Dilokthornsakul P, Chaiyakunapruk N, Termrungruanglert W, Pratoomsoot C, Saokaew S, Sruamsiri R
    Int. J. Gynecol. Cancer, 2013 Nov;23(9):1544-51.
    PMID: 24172091 DOI: 10.1097/IGC.0b013e3182a80a21
    OBJECTIVE: The potential therapeutic effects of metformin on several cancers were reported. However, the evidence of the effects of metformin on ovarian cancer is still limited and inconclusive. This systematic review and meta-analysis study aim to summarize the existing evidence of the therapeutic effects of metformin on ovarian cancer.

    METHODS: We performed systematic searches using electronic databases including PubMed and EMBASE until December 2012. Key words included "metformin" AND ("ovarian cancer" OR "ovary tumor"). All human studies assessing the effects of metformin on ovarian cancer were eligible for inclusion. All articles were reviewed independently by 2 authors with a standardized approach for the purpose of study, study design, patient characteristics, exposure, and outcomes. The data were pooled using a random-effects model.

    RESULTS: Of 190 studies retrieved, only 3 observational studies and 1 report of 2 randomized controlled trials were included. Among those studies, 2 reported the effects of metformin on survival outcomes of ovarian cancer, whereas the other 2 reported the effects of metformin on ovarian cancer prevention. The findings of studies reporting the effects on survival outcomes indicated that metformin may prolong overall, disease-specific, and progression-free survival in ovarian cancer patients. The results of studies reporting the effects of metformin on ovarian cancer prevention were meta-analyzed. It indicated that metformin tended to decrease occurrence of ovarian cancer among diabetic patients with the pooled odds ratio of 0.57 (95% confidence interval, 0.16-1.99).

    CONCLUSIONS: Our findings showed the potential therapeutic effects of metformin on survival outcomes of ovarian cancer and ovarian cancer prevention. However, most of the evidence was observational studies. There is a call for further well-conducted controlled clinical trials to confirm the effects of metformin on ovarian cancer survival and ovarian cancer prevention.

  18. Dilokthornsakul P, Chaiyakunapruk N, Ruamviboonsuk P, Ratanasukon M, Ausayakhun S, Tungsomeroengwong A, et al.
    Int J Ophthalmol, 2014;7(1):145-51.
    PMID: 24634881 DOI: 10.3980/j.issn.2222-3959.2014.01.27
    To determine healthcare resource utilization and the economic burden associated with wet age-related macular degeneration (AMD) in Thailand.
  19. 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.

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