Clinical white paper
PMS Relief Capsule: formulation and evidence review
This page is a condensed, citation-preserving summary; the linked PDF is the complete document.
Executive summary
This page is a condensed, citation-preserving summary of the full white paper; the linked PDF is the complete document.
We designed PMS Relief Capsule for cyclical use around menstruation, combining magnesium and vitamin D with plant compounds selected for normal inflammatory, antioxidant, mast-cell, and nervous-system pathways.[5][7][8] Our registered open-label crossover study adds finished-formula observations but cannot establish a placebo-controlled effect.
Formulation rationale
A cyclical, multi-pathway formula
We use a cyclical regimen because menstrual discomfort has a defined time course and inflammatory mediators change around menstruation.[5][15] We included magnesium and vitamin D because human studies evaluated nutrient status and supplementation in menstrual symptoms.[9][10][11] We mapped the remaining botanicals across normal prostaglandin, leukotriene, oxidative, mast-cell, and stress-response pathways, while recognizing that mechanistic evidence is not finished-formula proof.[13][16][17]
Formula at a glance
Published literature
The evidence we used
Our 21-source review includes measurement research, nutrient interventions, mechanistic reviews, and observational studies; each evidence type answers a different question.[1][11][21][1][2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22]
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Measurement and timingFoundational and clinical reviews
Validated symptom measurement and menstrual-discomfort biology define what to measure and when.[1][5]
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Magnesium and vitamin DHuman evidence
Studies evaluated oral magnesium, vitamin D status, and vitamin D supplementation in deficient participants.[9][10][11]
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Inflammatory pathwaysMechanistic and clinical context
Prostaglandin and leukotriene literature supports a multi-pathway research rationale.[15][16]
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Mast-cell biologyTranslational reviews
Reviews describe emerging mast-cell biology; they do not show that this product changes a disease outcome.[17][18][19][20]
Finished-formula evidence
Our open-label crossover study
In our third-party open-label crossover study, 48 participants recorded a baseline menstrual cycle, began the formula on day four of menstruation according to the source protocol, and used their subsequent cycle as the within-person comparison.[22] Participants reported significant reductions at p<0.01 in every surveyed symptom, including cramping, digestive upset, mood swings, and bloating.[22] hs-CRP moved in the hypothesized direction but did not meet the study's significance threshold, so we do not present it as an efficacy result.[22] Without blinding or placebo control, reported changes do not establish causation.[22]
Funding disclosure: The study was independently conducted by Citrus Labs and funded by Semaine.
Full references
- Chesney MA, Tasto DL. Development of the menstrual symptom questionnaire. Behav Res Ther. 1975;13:237-244.Measurement
- Oladosu FA, et al. Nonsteroidal antiinflammatory drug resistance in dysmenorrhea. Am J Obstet Gynecol. 2018;218:390-400.Review
- Stosic R, et al. Responsible self-medication and OTC analgesic use. Int J Pharm Pract. 2011;19:236-245.Survey
- Kantor ED, et al. Trends in dietary supplement use among US adults. JAMA. 2016;316:1464-1474.Epidemiology
- Harel Z. Dysmenorrhea in adolescents and young adults. J Pediatr Adolesc Gynecol. 2006;19:363-371.Clinical review
- Chocano-Bedoya PO, et al. Mineral intake and premenstrual syndrome risk. Am J Epidemiol. 2013;177:1118-1127.Cohort study
- Attiq A, et al. Natural products and inflammatory pathways. Front Pharmacol. 2018;9:976.Review
- Maroon JC, et al. Natural anti-inflammatory agents. Surg Neurol Int. 2010;1:80.Review
- Facchinetti F, et al. Oral magnesium and premenstrual mood changes. Obstet Gynecol. 1991;78:177-181.Human clinical
- Abdul-Razzak KK, et al. Vitamin D and PTH status in severe dysmenorrhea. J Pediatr Adolesc Gynecol. 2014;27:78-82.Observational
- Moini A, et al. Vitamin D in primary dysmenorrhea with vitamin D deficiency. Gynecol Endocrinol. 2016;32:502-505.Randomized trial
- Olafsdottir LB, et al. Irritable bowel syndrome and dysmenorrhea: 10-year follow-up. Gastroenterol Res Pract. 2012;2012:534204.Cohort study
- Augoulea A, et al. Endometriosis, inflammation, and oxidative stress. Arch Gynecol Obstet. 2012;286:99-103.Review
- Lousse JC, et al. Peritoneal endometriosis and inflammatory biology. Front Biosci. 2012;4:23-40.Review
- Strömberg P, et al. Vasopressin and prostaglandins in premenstrual pain and dysmenorrhea. Acta Obstet Gynecol Scand. 1984;63:533-538.Human study
- Abu JI, Konje JC. Leukotrienes in gynecology. Hum Reprod Update. 2000;6:200-205.Review
- Zhang L, et al. Mast cells and irritable bowel syndrome. J Neurogastroenterol Motil. 2016;22:181-192.Review
- Kirchhoff D, et al. Mast cells in endometriosis. Expert Opin Ther Targets. 2012;16:237-241.Review
- Hart DA. Mast cells in multiple sclerosis and endometriosis. Int J Inflam. 2015;2015:452095.Review
- Binda MM, et al. Targeting mast cells in endometriosis. Expert Opin Ther Targets. 2017;21:67-75.Review
- Bertone-Johnson ER, et al. Inflammation markers and menstrual symptom severity. Hum Reprod. 2014;29:1987-1994.Observational
- Semaine Health. PMS Relief Capsule white paper, v7. Observational open-label crossover study and results.Finished-formula observational
These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.