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BMJ Clinical Evidence Aug 2015A woman has premenstrual syndrome (PMS) if she complains of recurrent psychological and/or physical symptoms occurring during the luteal phase of the menstrual cycle,... (Review)
Review
INTRODUCTION
A woman has premenstrual syndrome (PMS) if she complains of recurrent psychological and/or physical symptoms occurring during the luteal phase of the menstrual cycle, and often resolving by the end of menstruation. Symptom severity can vary between women. Premenstrual symptoms occur in 95% of women of reproductive age. Severe, debilitating symptoms occur in about 5% of those women. There is no consensus on how symptom severity should be assessed for PMS, which has led to the use of a wide variety of symptom scores and scales, thus making it difficult to synthesise data on treatment efficacy. The cyclical nature of the condition also makes it difficult to conduct RCTs.
METHODS AND OUTCOMES
We conducted a systematic overview, aiming to answer the following clinical question: What are the effects of continuous hormonal treatments in women with premenstrual syndrome? We searched: Medline, Embase, The Cochrane Library, and other important databases up to April 2014 (Clinical Evidence overviews are updated periodically; please check our website for the most up-to-date version of this overview).
RESULTS
At this update, searching of electronic databases retrieved 132 studies. After deduplication and removal of conference abstracts, 132 records were screened for inclusion in the overview. Appraisal of titles and abstracts led to the exclusion of 102 studies and the further review of 30 full publications. Of the 30 full articles evaluated, one systematic review and three RCTs were added to this overview. We performed a GRADE evaluation for three PICO combinations.
CONCLUSIONS
In this systematic overview, we categorised the efficacy for three interventions based on information relating to the effectiveness and safety of continuous combined oral contraceptives, continuous transdermal estradiol, and continuous subcutaneous estradiol implants.
Topics: Administration, Cutaneous; Contraceptives, Oral, Combined; Drug Implants; Estradiol; Female; Humans; Infusions, Subcutaneous; Premenstrual Syndrome
PubMed: 26303988
DOI: No ID Found -
Therapeutic Delivery Feb 2020
Topics: Angiogenesis Inhibitors; Drug Implants; Intravitreal Injections
PubMed: 31914868
DOI: 10.4155/tde-2019-0081 -
Fertility and Sterility Nov 2018To assess the efficacy of an etonogestrel (ENG)-releasing contraceptive implant or the 52-mg levonorgestrel-releasing intrauterine system (LNG-IUS) in the control of... (Randomized Controlled Trial)
Randomized Controlled Trial
Control of endometriosis-associated pain with etonogestrel-releasing contraceptive implant and 52-mg levonorgestrel-releasing intrauterine system: randomized clinical trial.
OBJECTIVE
To assess the efficacy of an etonogestrel (ENG)-releasing contraceptive implant or the 52-mg levonorgestrel-releasing intrauterine system (LNG-IUS) in the control of endometriosis-associated pelvic pain.
DESIGN
Noninferiority randomized clinical trial in which women with endometriosis were assigned to use an ENG implant (experimental treatment) or an LNG-IUS (active comparator). Monthly follow-up visits were conducted up to 6 months.
SETTING
University teaching hospital.
PATIENT(S)
One hundred three women, with endometriosis-associated chronic pelvic pain, dysmenorrhea, or both for more than 6 months. In cases of deep endometriosis, vaginal ultrasonography and magnetic resonance imaging were used as additional diagnostic tools.
INTERVENTION(S)
The ENG implant or the LNG-IUS were inserted within the first 5 days of the menstrual cycle.
MAIN OUTCOME MEASURE(S)
Daily scores of noncyclic pelvic pain and dysmenorrhea were evaluated using a daily visual analogue scale. Health-related quality of life was evaluated using the Endometriosis Health Profile-30 questionnaire at baseline and up to 6 months. Bleeding patterns were assessed daily from a menstrual calendar.
RESULT(S)
Both contraceptives improved significantly the mean visual analogue scale endometriosis-associated pelvic pain and dysmenorrhea, without significant differences between treatment group profiles. Health-related quality of life improved significantly in all domains of the core and modular segments of the Endometriosis Health Profile-30 questionnaire, with no difference between both treatment groups. The most common bleeding patterns at 180 days of follow-up were amenorrhea and infrequent bleeding and infrequent bleeding and spotting among ENG implant and LNG-IUS users, respectively.
CONCLUSION(S)
In this noninferiority study both contraceptives improved significantly pelvic pain, dysmenorrhea, and health-related quality of life in endometriosis.
CLINICAL TRIAL REGISTRATION NUMBER
Clinicaltrials.gov under number NCT02480647.
Topics: Adult; Contraceptive Agents, Female; Desogestrel; Drug Implants; Drug Liberation; Endometriosis; Female; Follow-Up Studies; Humans; Intrauterine Devices, Medicated; Levonorgestrel; Pain Management; Pelvic Pain
PubMed: 30396557
DOI: 10.1016/j.fertnstert.2018.07.003 -
European Journal of Pharmaceutics and... Feb 2021In the field of drug delivery, the most commonly used treatments have traditionally been systemically delivered using oral or intravenous administration. The problems... (Review)
Review
In the field of drug delivery, the most commonly used treatments have traditionally been systemically delivered using oral or intravenous administration. The problems associated with this type of delivery is that the drug concentration is controlled by first pass metabolism, and therefore may not always remain within the therapeutic window. Implantable drug delivery systems (IDDSs) are an excellent alternative to traditional delivery because they offer the ability to precisely control the drug release, deliver drugs locally to the target tissue, and avoid the toxic side effects often experienced with systemic administration. Since the creation of the first FDA-approved IDDS in 1990, there has been a surge in research devoted to fabricating and testing novel IDDS formulations. The versatility of these systems is evident when looking at the various biomedical applications that utilize IDDSs. This review provides an overview of the history of IDDSs, with examples of the different types of IDDS formulations, as well as looking at current and future biomedical applications for such systems. Though there are still obstacles that need to be overcome, ever-emerging new technologies are making the manufacturing of IDDSs a rewarding therapeutic endeavor with potential for further improvements.
Topics: Delayed-Action Preparations; Drug Approval; Drug Compounding; Drug Implants; Drug-Eluting Stents; History, 20th Century; History, 21st Century; Humans; United States; United States Food and Drug Administration
PubMed: 33338604
DOI: 10.1016/j.ejpb.2020.12.005 -
Dermatology Online Journal May 2018The role of exogenous progestin in the development of acne is unclear. Progestins are known for their androgenic potential, but newer generations of progestins have low... (Review)
Review
The role of exogenous progestin in the development of acne is unclear. Progestins are known for their androgenic potential, but newer generations of progestins have low or anti-androgenic activity. This review will evaluate the association between progestins found in hormonal long-acting reversible contraceptives (intrauterine devices and subdermal implants) and acne, as well as the role of oral contraceptives in acne management. Our review demonstrates that the cause and effect relationship between progestins and acne is difficult to establish and future studies that seek to understand how progestins modulate acne are necessary.
Topics: Acne Vulgaris; Androgens; Contraceptives, Oral; Drug Implants; Humans; Intrauterine Devices, Medicated; Progestins
PubMed: 30142728
DOI: No ID Found -
Journal de Gynecologie, Obstetrique Et... Dec 2016To establish guidelines of the French National College of Gynecologists and Obstetricians about post-abortion contraception. (Review)
Review
OBJECTIVE
To establish guidelines of the French National College of Gynecologists and Obstetricians about post-abortion contraception.
MATERIALS AND METHODS
A systematic review of the literature about post-abortion contraception was performed on Medline and Cochrane Database between 1978 and March 2016. The guidelines of the French and foreign scientific societies were also consulted.
RESULTS AND DISCUSSION
After an abortion, if the woman wishes to use a contraception, it should be started as soon as possible because of the very early ovulation resumption. The contraception choice must be done in accordance with the woman's expectations and lifestyle. The contraindications of each contraception must be respected. The long-acting reversible contraception, intra-uterine device (IUD) and implant, could be preferred (grade C) as the efficacy is not dependent on compliance. Thus, they could better prevent repeat abortion (LE3). In case of surgical abortion, IUD should be proposed and inserted immediately after the procedure (grade A), as well as the implant (grade B). In case of medical abortion, the implant can be inserted from the day of mifépristone, the IUD after an ultrasound examination confirming the success of the abortion (no continuing pregnancy or retained sac) (grade C).
Topics: Abortion, Induced; Contraceptive Agents, Female; Drug Implants; Female; Humans; Intrauterine Devices; Pregnancy
PubMed: 27773547
DOI: 10.1016/j.jgyn.2016.09.017 -
Medecine Sciences : M/S Jan 2017Implants for controlled drug delivery can be very helpful to improve the therapeutic efficacy of a medical treatment, and at the same time reduce the risk of toxic side... (Review)
Review
Implants for controlled drug delivery can be very helpful to improve the therapeutic efficacy of a medical treatment, and at the same time reduce the risk of toxic side effects. In this article, four different strategies are exemplarily presented: hybrid bone substitutes combining hydroxyapatite and chitosan hydrogels; vascular stents coated with a bio-inspired polymer; cochlear implants for local dexamethasone delivery; and in-situ forming implants for periodontitis treatment. But this is only a restricted selection, and numerous other approaches and applications based on implants releasing a drug (or a combination of drugs) exist. Compared to conventional implants or pharmaceutical dosage forms, they might offer decisive advantages.
Topics: Animals; Cochlear Implants; Dental Implants; Drug Delivery Systems; Drug Implants; Drug-Eluting Stents; Graft Occlusion, Vascular; Humans; Periodontium; Polymers
PubMed: 28120753
DOI: 10.1051/medsci/20173301006 -
Pharmaceutical Research Jan 2022Drug-filled implants (DFIs) have emerged as an innovative approach to control the delivery of drugs. These devices contain the drug within the structure of the implant...
Drug-filled implants (DFIs) have emerged as an innovative approach to control the delivery of drugs. These devices contain the drug within the structure of the implant itself and avoid the need to include additional drug carrier materials such as a polymers, which are often associated with inflammation and delayed healing/tissue regeneration at the implant site. One common feature of in vitro experiments to generate drug release profiles is stirring or agitation of the release medium. However, the influence of the resulting fluid flow on the rate of drug release from DFIs has yet to be quantified. In this paper we consider two DFIs, which although similar in shape and size, employ different strategies to control the release of drug: a porous pin with pores on the order of μm and a pin drilled with orifices of the order of mm. We develop a multiphysics mathematical model of drug release from these DFIs, subject to fluid flow induced through stirring and show that fluid flow greatly influences the drug release profile for the orifice pin, but that the porous pin drug release profile is relatively insensitive to flow. We demonstrate that drug release from the porous pin may adequately be described through a simplified radial 1D dissolution-diffusion model, while a 3D dissolution-advection-diffusion model is required to describe drug release from the orifice pin. A sensitivity analysis reveals that that the balance of reaction-advection-diffusion in terms of key nondimensional numbers governs the overall drug release. Our findings potentially have important implications in terms of devising the most relevant experimental protocol for quantifying drug release from DFIs.
Topics: Diffusion; Drug Implants; Drug Liberation; Polymers; Porosity
PubMed: 34997423
DOI: 10.1007/s11095-021-03127-4 -
European Journal of Pharmaceutics and... Aug 2022The aim of this study was to better understand the importance of the diameter of poly(lactic-co-glycolic acid) (PLGA)-based implants on system performance, in particular...
The aim of this study was to better understand the importance of the diameter of poly(lactic-co-glycolic acid) (PLGA)-based implants on system performance, in particular the control of drug release. Different types of ibuprofen-loaded implants were prepared by hot melt extrusion using a Leistritz Nano 16 twin-screw extruder. Drug release was measured in well agitated phosphate buffer pH7.4 bulk fluid and in agarose gels in Eppendorf tubes or transwell plates. Dynamic changes in the implants' dry & wet mass, volume, polymer molecular weight as well as inner & outer morphology were monitored using gravimetric analysis, optical macroscopy, gel permeation chromatography and scanning electron microscopy. The physical states of the drug and polymer were determined by DSC. Also pH changes in the release medium were investigated. Irrespective of the type of experimental set-up, the resulting absolute and relative drug release rates decreased with increasing implant diameter (0.7-2.8 mm). Bi-phasic drug release was observed in all cases from the monolithic solutions (ibuprofen was dissolved in the polymer): A zero order release phase was followed by a final, rapid drug release phase (accounting for 80-90% of the total drug dose). The decrease in the relative drug release rate with increasing system diameter can be explained by the increase in the diffusion pathway lengths to be overcome. Interestingly, also the onset of the final rapid drug release phase was delayed with increasing implant diameter. This can probably be attributed to the higher mechanical stability of thicker devices, offering more resistance to substantial entire system swelling.
Topics: Drug Implants; Drug Liberation; Ibuprofen; Polylactic Acid-Polyglycolic Acid Copolymer; Polymers
PubMed: 35659920
DOI: 10.1016/j.ejpb.2022.05.020 -
Journal of Controlled Release :... Mar 2022The aim of this study was to better understand to which extent and in which way the presence of an agarose gel (mimicking living tissue) around a PLGA...
The aim of this study was to better understand to which extent and in which way the presence of an agarose gel (mimicking living tissue) around a PLGA [poly(lactic-co-glycolic acid)] implant affects the resulting drug release kinetics. Ibuprofen-loaded implants were prepared by hot melt extrusion. Drug release was measured upon exposure to phosphate buffer pH 7.4 in Eppendorf tubes, as well as upon inclusion into an agarose gel which was exposed to phosphate buffer pH 7.4 in an Eppendorf tube or in a transwell plate. Dynamic changes in the implants' dry & wet mass and dimensions were monitored gravimetrically and by optical macroscopy. Implant erosion and polymer degradation were observed by SEM and GPC. Different pH indicators were used to measure pH changes in the bulk fluids, gels and within the implants during drug release. Ibuprofen release was bi-phasic in all cases: A zero order release phase (~20% of the dose) was followed by a more rapid, final drug release phase. Interestingly, the presence of the hydrogel delayed the onset of the 2nd release phase. This could be attributed to the sterical hindrance of implant swelling: After a certain lag time, the degrading PLGA matrix becomes sufficiently hydrophilic and mechanically instable to allow for the penetration of substantial amounts of water into the system. This fundamentally changes the conditions for drug release: The latter becomes much more mobile and is more rapidly released. A gel surrounding the implant mechanically hinders system swelling and, thus, slows down drug release. These observations also strengthen the hypothesis of the "orchestrating" role of PLGA swelling for the control of drug release and can help developing more realistic in vitro release set-ups.
Topics: Drug Implants; Drug Liberation; Ibuprofen; Phosphates; Polylactic Acid-Polyglycolic Acid Copolymer; Sepharose
PubMed: 35085697
DOI: 10.1016/j.jconrel.2022.01.028