Efficacy of Prasaplai for Treatment of Primary Dysmenorrhea: a Meta-Analysis

Document Type : Review

Authors

1 Social Pharmacy Research Unit, Faculty of Pharmacy, Mahasarakham University, Kantharawichai, Maha Sarakham, Thailand.

2 Pharmaceutical Chemistry and Natural Products Research Unit, Faculty of Pharmacy, Mahasarakham University, Kantharawichai, Maha Sarakham, Thailand.

Abstract

Prasaplai is used in Thai traditional medicine for treatment of primary dysmenorrhea; however, clinical evidence is limited regarding the efficacy of Prasaplai for primary dysmenorrheal outcomes. This study has constituted a systematic review and meta-analysis to evaluate Prasaplai as an effective treatment for primary dysmenorrhea. Randomized controlled trials were retrieved and identified through electronic searches (PubMed, CINAHL, Cochrane Central Register of Controlled Trials, SCOPUS, Science Direct, and ThaiLis publications until May 2017). A hand search for relevant trials was also conducted. Quality of the selected trials was assessed using Jadad’s scoring and A Cochrane Risk of Bias Assessment Tool. Studies were recruited for the meta-analysis if 1) they were randomized controlled trials, 2) participants were diagnosed with primary dysmenorrhea, and 3) a pain score was included. Related outcomes and adverse events were also evaluated for all groups. Four randomized controlled trials met the criteria, totaling 460 participants. Results revealed that Prasaplai significantly improved pain scores. The pooled mean difference was -1.24 (95% CI -1.90 to -0.59; p = 0.0002). The results did not indicate significant effects of Prasaplai on menstrual characteristics and associated symptoms, compared with NSAIDs; however, participants receiving Prasaplai reported a low frequency of adverse effects compared to the NSAID group. Current evidence suggests that Prasaplai improved pain associated with primary dysmenorrhea. Prasaplai had no effect on menstrual characteristics and associated symptoms. Additional rigorously-designed trials with larger sample sizes are warranted to confirm the effects of Prasaplai on primary dysmenorrhea and related outcomes.
 

Keywords

Main Subjects


[1] Harlow SD, Park M. A longitudinal study of risk factors for the occurrence, duration and severity of menstrual cramps in a cohort of college women. Br J Obstet Gynecol. 1996; 104(3): 1134-1142.
[2] Ryan SA. The treatment of dysmenorrhea. Pediatr Clin North Am. 2017; 64(2): 331-342.
[3] Tangyuenyongwatana P, Gritsanapan W. A study on artifacts formation in the Thai traditional medicine Prasaplai. Planta Med. 2008; 74(11): 1403-1405.
[4] Waltenberger B, Schuster D, Paramapojn S, Gritsanapan W, Wolber G, Rollinger JM, Stuppner H. Predicting cyclooxygenase inhibition by three-dimensional pharmacophoric profiling. Part II: Identification of enzyme inhibitors from Prasaplai, a Thai traditional medicine. Phytomed. 2011; 18(2): 119-133.
[5] National Drug Committee. National list of essential medicinesA.D. 2013 (List of herbal medicinal products). Bangkok: Chumnum sahakorn karnkaset of Thailand Press Ltd, 2013.
[6] Nualkaew S, Gritsanapan W, Petereit F, Nahrstedt A. New fatty acid esters originate during storage by the interaction of components in Prasaplai, a Thai traditional medicine. Planta Med. 2004; 70(2): 1243-1246.
[7] Paramapojn S. Standardization and biological activities of Prasaplai, a Thai traditional medicine. Ph.D. thesis. Faculty of Graduate Studies, Mahidol University, Bangkok, Thailand, 2008.
[8] Tangyuenyongwatana P, Gritsanapan W. Prasaplai: an essential Thai traditional formulation for primary dysmenorrhea treatment. Tang. 2014; 4(2): 1-8.
[9] Gagnier JJ, Boon H, Rochon P, Moher D, Barnes J, Bombardier C. Recommendations for reporting randomized controlled trials of herbal interventions: explanation and elaboration. J Clin Epidemiol. 2006; 59(11): 1134-1149.
[10] Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJ, Gavaghan DJ, McQuay HJ. Assessing the quality of reports of randomized clinical trials: Is blinding necessary? Control Clin Trials. 1996; 17(1): 1-12.
[11] Higgins JP, Altman DG, Gøtzsche PC, Jüni P, Moher D, Oxman AD, Savovic J, Schulz KF, Weeks L, Sterne JA. The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials. Br Med J. 2011; Article ID 22008217.
[12] Sahebkar A. Are curcuminoids effective C-reactive protein-lowering agents in clinical practice? Evidence from a meta-analysis. Phytother Res. 2014; 28(5): 633-642.
[13] Chakchai K. Formulation and satisfaction assessment of Prasaplai in primary dysmenorrhea patient at primary care center, Mahasarakham University. PharmD. thesis. Mahasarakham University, Maha Sarakham, Thailand, 2008.
[14] Kamalashiran C, Lekskulchai O. The comparative study of the efficacy and side effect of Prasaplai extract versus mefenamic acid on relieving primary dysmenorrhea: a clinical phase II trials. Thammasat Med J. 2012; 12(4): 749-756.
[15] Sasum S. Formulation and clinical efficacy of Prasaplai extract capsules in women with primary dysmenorrheal. PharmD. thesis. Mahasarakham University, Maha Sarakham, Thailand, 2010.
[16] Sriyakul K, Kietinun S, Pattaraarchachai J, Ruangrungsi N. A Comparative double-blinded randomized study: the efficacy of Prasaplai herbal extract versus mefenamic acid in relieving pain among primary dysmenorrhea patients. Open Complement Med J. 2012; 6(4): 16-21.
[17] Higgins J, Green SE. Cochrane handbook for systematic reviews of interventions version 5.1.0. The Cochrane Collaboration 2016. [Accessed 2016]. Available from: http://www.handbook.cochrane.org.
[18] Nualkaew S, Tiangda C, Gritsanapan W. Inhibitory action on rat uterine muscle contraction in vitro and acute toxicity in rats of the Thai traditional preparation Prasaplai. Nat Prod Res. 2013; 27(4): 491-495.
[19] Kanjanapothi D, Soparat P, Panthong A, Tuntiwachwuttikul P, Reutrakul V. A uterine relaxant compound from Zingiber cassumunar. Planta Med. 1987; 53(4): 329-332.
[20] Rangsimantuchat S, Dhumma-upakorn P, Jianmongkol S. Antispasmodic effects of alcoholic extracts from polyherbal formulation “Prasaplai” on isolated rat uterine horn. Thai J Pharmacol. 2010; 32(1): 192-195.
[21] Tangyuenyongwatana P, Kowapradit J, Opanasopit P, Gritsanapan W. Cellular transport of anti-inflammatory pro-drugs originated from a herbal formulation of Zingiber cassumunar and Nigella sativa. Chin Med. 2009; 4: 1-5.
[22] Essential Medicines and Health Products Information Portal A World Health Organization resource 1996. [Accessed 2016]. Available from: http://apps.who.int/medicinedocs/en/d/Js2200e/.