Article ; Online: The effect of Ding-kun-dan comparing with Marvelon on primary dysmenorrhea: A prospective, double-blind, multicenter, randomized controlled trial
Journal of Ethnopharmacology. 2024 Jan., v. 318 p.116975-
2024
Abstract: Ding-kun-dan (DKD), as one of well-known traditional Chinese medicine (TCM), is considered as an effective prescription to regulate menstruation, benefit Qi and nourish the blood. Previous studies had showed that DKD could improve sex hormone levels, ... ...
| Abstract | Ding-kun-dan (DKD), as one of well-known traditional Chinese medicine (TCM), is considered as an effective prescription to regulate menstruation, benefit Qi and nourish the blood. Previous studies had showed that DKD could improve sex hormone levels, insulin resistance, metabolism abnormalities and regulate immunity in animal models with polycystic ovary syndrome or endometriosis, however, little study conducted to reveal its clinical efficacy in Primary Dysmenorrhea (PD). To compare the effect of Ding-kun-dan (DKD) with Marvelon on relief of symptoms and change of serum pain-related factors in patients with primary dysmenorrhea. 136 patients with primary dysmenorrhea were randomly assigned to the DKD group (n = 73, take one tablet per day from 5th day of the menstrual cycle for 10 days every 28 days) and the Marvelon group (n = 63, take one tablet per day from 5th day of the menstrual cycle for 21 days every 28 days), the therapeutic effects were analyzed through evaluating the change of VAS scores, CMSS scores and the level of PGF₂ₐ, PGE₂, PGF₂ₐ/PGE₂ and NO during the 12 weeks intervention. Both DKD and Marvelon could effectively relief pain and other associated symptoms at each visit (Baseline, 4ᵗʰ week, 8ᵗʰ week and 12ᵗʰ week). Although Marvelon was significantly superior to DKD in reducing VAS scores, the total CMSS, CMSS severity and duration scores at each posttreatment follow-up (P < 0.01), VAS scores in the DKD group decreased significantly over time while scores in the COC group only dropped rapidly after the first two months of treatment. Efficacy gap between two interventions continuously narrowed over time and the efficacy of DKD became non-inferior at the 12ᵗʰ week compared to that of Marvelon (the difference between groups, – 0.78%; 95% confidence interval (CI), −13.67%–12.75%; non-inferiority margin, 15%). DKD group had better efficacy on mild pain compared to that of the COC group with no statistical difference (75% VS 61.9%, P > 0.05). DKD and Marvelon could effectively reduce PGF₂ₐ, PGE₂ and higher PGF₂ₐ/PGE₂ in patients with PD. There was no statistical difference in the level of PGF₂ₐ, PGE₂, PGF₂ₐ/PGE₂ and NO between DKD and Marvelon group at each follow-up. No serious adverse effect was observed. Ding-kun-dan is another available, effective and safe method for patients with primary dysmenorrhea to choose, especially for those who are suffered from mild pain and/or contraindicated to hormonal agents. |
|---|---|
| Keywords | Oriental traditional medicine ; adverse effects ; animals ; blood serum ; confidence interval ; endometriosis ; immunity ; insulin resistance ; menstruation ; metabolism ; pain ; polycystic ovary syndrome ; therapeutics ; Primary dysmenorrhea ; Ding-kun-dan ; Marvelon ; VAS ; CMSS ; PGF2a ; PGE2 ; PGF2a/PGE2 |
| Language | English |
| Dates of publication | 2024-01 |
| Publishing place | Elsevier B.V. |
| Document type | Article ; Online |
| ZDB-ID | 134511-4 |
| ISSN | 1872-7573 ; 0378-8741 |
| ISSN (online) | 1872-7573 |
| ISSN | 0378-8741 |
| DOI | 10.1016/j.jep.2023.116975 |
| Database | NAL-Catalogue (AGRICOLA) |
More links
Kategorien
In stock of ZB MED Bonn / Germany
| Z 90/710: Show issues |
Order via subito
This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.
Inter-library loan at ZB MED
Your chosen title can be delivered directly to ZB MED Cologne location if you are registered as a user at ZB MED Cologne.