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      The Efficacy of Thai Herbal Prasaplai Formula for Treatment of Primary Dysmenorrhea: A Short-Term Randomized Controlled Trial

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          Abstract

          This study aims to compare the efficacy of pain relief between a specific Thai herbal Prasaplai formula (PPF) and placebo in patients with primary dysmenorrhea. Forty women with primary dysmenorrhea symptoms were randomized into two groups. The experimental group received PPF capsules 1000 mg orally three times per day before meals for three days starting from the first day of menstruation. The placebo group received placebo as the same dose and time. Average pain intensity from the first day to the third day of cycle significantly decreased in both groups ( p < 0.001), but with no statistically significant difference between groups. Using a pre- and posttreatment difference in NRS of at least 2, a greater proportion of patients in PPF group experienced pain relief compared to placebo during the first and second day of period. A greater proportion of PPF group also experienced no pain compared to the placebo group on day 1 and day 3 by using multidimensional scoring. The PPF demonstrates pain relief activity when used during menstruation in primary dysmenorrhea patients, with no adverse effects. However, further studies are needed in order to assess the value of PPF as a long-term prophylaxis for primary dysmenorrhea.

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          Most cited references25

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          Primary dysmenorrhea: advances in pathogenesis and management.

          Primary dysmenorrhea is painful menstrual cramps without any evident pathology to account for them, and it occurs in up to 50% of menstruating females and causes significant disruption in quality of life and absenteeism. Current understanding implicates an excessive or imbalanced amount of prostanoids and possibly eicosanoids released from the endometrium during menstruation. The uterus is induced to contract frequently and dysrhythmically, with increased basal tone and increased active pressure. Uterine hypercontractility, reduced uterine blood flow, and increased peripheral nerve hypersensitivity induce pain. Diagnosis rests on a good history with negative pelvic evaluation findings. Evidence-based data support the efficacy of cyclooxygenase inhibitors, such as ibuprofen, naproxen sodium, and ketoprofen, and estrogen-progestin oral contraceptive pills (OCPs). Cyclooxygenase inhibitors reduce the amount of menstrual prostanoids released, with concomitant reduction in uterine hypercontractility, while OCPs inhibit endometrial development and decrease menstrual prostanoids. An algorithm is provided for a simple approach to the management of primary dysmenorrhea.
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            Nonsteroidal anti-inflammatory drugs and hormonal contraceptives for pain relief from dysmenorrhea: a review.

            This article is a comprehensive overview of dysmenorrhea and a systematic review of the available literature on the use of nonsteroidal anti-inflammatory drugs (NSAIDs) and hormonal contraceptives for the therapy and management of dysmenorrhea. A comprehensive search of the PubMed database for clinical trials and observational studies of dysmenorrhea treatments from 2004 onwards. Eighteen publications were identified. Ten randomized controlled trials (RCTs) assessing NSAIDs for treating primary dysmenorrhea demonstrated superior pain relief compared with placebo, but no superiority was established among different NSAIDS. Two RCTs and six nonrandomized observational or prospective studies assessing the effect of hormonal contraceptives on dysmenorrhea strongly suggest a beneficial effect for dysmenorrheic pain relief and were conducted mainly in larger populations (N=41-6169) than those in the NSAID trials (N=10-337). Ethinylestradiol/chlormadinone acetate was the only formulation that provided a more pronounced relief of dysmenorrheic pain compared with a parallel alternative or previously used hormonal contraceptive. Methodological inconsistencies were widespread between the hormonal contraceptive studies. The findings of this review support the use of NSAIDs as a first-line therapy for pain relief from dysmenorrhea in women without wish for contraception. For women who wish contraception, combined oral contraceptives (COCs) are the preferential therapy for pain relief from dysmenorrhea as the additional noncontraceptive benefit of pain relief from dysmenorrhea is not linked to additional risks, eliminates the risks associated with taking NSAIDs and is a more suitable long-term option. Recommendations are made to strengthen the impact of future trials through improved methodology. Copyright (c) 2010 Elsevier Inc. All rights reserved.
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              Variability among nonsteroidal antiinflammatory drugs in risk of upper gastrointestinal bleeding.

              Traditional nonsteroidal antiinflammatory drugs (NSAIDs) increase the risk of upper gastrointestinal (GI) bleeding/perforation, but the magnitude of this effect for coxibs in the general population and the degree of variability between individual NSAIDs is still under debate. This study was undertaken to assess the risk of upper GI bleeding/perforation among users of individual NSAIDs and to analyze the correlation between this risk and the degree of inhibition of whole blood cyclooxygenase 1 (COX-1) and COX-2 in vitro. We conducted a systematic review of observational studies on NSAIDs and upper GI bleeding/perforation published between 2000 and 2008. We calculated pooled relative risk (RR) estimates of upper GI bleeding/perforation for individual NSAIDs. Additionally, we verified whether the degree of inhibition of whole blood COX-1 and COX-2 in vitro by average circulating concentrations predicted the RR of upper GI bleeding/perforation. The RR of upper GI bleeding/perforation was 4.50 (95% confidence interval [95% CI] 3.82-5.31) for traditional NSAIDs and 1.88 (95% CI 0.96-3.71) for coxibs. RRs lower than that for NSAIDs overall were observed for ibuprofen (2.69 [95% CI 2.17-3.33]), rofecoxib (2.12 [95% CI 1.59-2.84]), aceclofenac (1.44 [95% CI 0.65-3.2]), and celecoxib (1.42 [95% CI 0.85-2.37]), while higher RRs were observed for ketorolac (14.54 [95% CI 5.87-36.04]) and piroxicam (9.94 [95% CI 5.99-16.50). Estimated RRs were 5.63 (95% CI 3.83-8.28) for naproxen, 5.57 (95% CI 3.94-7.87) for ketoprofen, 5.40 (95% CI 4.16-7.00) for indomethacin, 4.15 (95% CI 2.59-6.64) for meloxicam, and 3.98 (95% CI 3.36-4.72) for diclofenac. The degree of inhibition of whole blood COX-1 did not significantly correlate with RR of upper GI bleeding/perforation associated with individual NSAIDs (r(2) = 0.34, P = 0.058), but a profound and coincident inhibition (>80%) of both COX isozymes was associated with higher risk. NSAIDs with a long plasma half-life and with a slow-release formulation were associated with a greater risk than NSAIDs with a short half-life. The results of our analysis demonstrate that risk of upper GI bleeding/perforation varies between individual NSAIDs at the doses commonly used in the general population. Drugs that have a long half-life or slow-release formulation and/or are associated with profound and coincident inhibition of both COX isozymes are associated with a greater risk of upper GI bleeding/perforation.
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                Author and article information

                Journal
                Evid Based Complement Alternat Med
                Evid Based Complement Alternat Med
                ECAM
                Evidence-based Complementary and Alternative Medicine : eCAM
                Hindawi Publishing Corporation
                1741-427X
                1741-4288
                2016
                18 October 2016
                18 October 2016
                : 2016
                : 2096797
                Affiliations
                1Center of Applied Thai Traditional Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
                2Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
                3Office for Research and Development, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
                4Department of Pharmacology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
                Author notes

                Academic Editor: Jairo Kennup Bastos

                Author information
                http://orcid.org/0000-0002-8594-0995
                http://orcid.org/0000-0001-7937-2306
                Article
                10.1155/2016/2096797
                5088276
                220dbb35-8a8c-4b15-b585-dd3e60cdec7e
                Copyright © 2016 Manmas Vannabhum et al.

                This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 14 June 2016
                : 26 September 2016
                Funding
                Funded by: Mahidol University
                Categories
                Research Article

                Complementary & Alternative medicine
                Complementary & Alternative medicine

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