List of Abbreviations
ALT — alanine aminotransferase
AST — aspartate aminotransferase
GABA — gamma-aminobutyric acid
GGT — gamma-glutamyl transferase
HPO axis — hypothalamic-pituitary-ovarian axis
GnRH — gonadotropin-releasing hormone (per ATC – Gonadotropin-releasing hormone analogues)
DEXA — dual-energy X-ray absorptiometry (per NMU – X-ray densitometry)
HRT — hormone replacement therapy
COC — combined oral contraceptives (per ATC – Progestogens and estrogens, fixed combinations)
CBT — cognitive behavioral therapy
LNG-IUS — levonorgestrel-releasing intrauterine system
MC — menstrual cycle
BMD — bone mineral density
NSAIDs — nonsteroidal anti-inflammatory drugs (per ATC – Anti-inflammatory and antirheumatic products, non-steroids)
PMDD — premenstrual dysphoric disorder
PMR — premenstrual disorder
PMS — premenstrual syndrome
SSRIs (ATC code: N06AB Selective serotonin reuptake inhibitors) — selective serotonin reuptake inhibitors
CNS — central nervous system
BI-RADS – Breast Imaging Reporting and Data System
Terms and Definitions
PMR – premenstrual disorder – represents a neuroendocrine disorder that includes premenstrual syndrome (PMS) and premenstrual dysphoric disorder (PMDD) [1]
PMS – a recurrent disorder (≥ 2–3 consecutive menstrual cycles) developing in the luteal phase of the menstrual cycle and resolving or abating after the onset of menstruation. This disorder is characterized by somatic, psychoemotional, cognitive, and behavioral (affective) symptoms that negatively affect a woman's quality of life and social activity [1].
PMDD – a type of depressive disorder characterized by cyclic, often severe, and disabling changes in affect, such as emotional lability, irritability, dysphoria, and anxiety. Clinical symptoms of PMDD develop in the luteal phase of the cycle and resolve or abate after the onset of menstruation [2], [3], [4].
1. Brief information on the disease or condition
1.1 Definition of the disease or condition
PMS – a recurrent disorder (≥ 2–3 consecutive menstrual cycles) developing in the luteal phase of the menstrual cycle and resolving or abating after the onset of menstruation. This disorder is characterized by somatic, psychoemotional, cognitive, and behavioral (affective) symptoms that negatively affect a woman's quality of life and social activity [1]
PMDD – a type of depressive disorder characterized by cyclic, often severe, and disabling changes in affect, such as emotional lability, irritability, dysphoria, and anxiety. Clinical symptoms of PMDD develop in the luteal phase of the cycle and resolve or abate after the onset of menstruation [2], [3], [4].
1.2 Etiology and pathogenesis of the disease or condition (group of diseases or conditions)
To date, the etiology and pathophysiology of PMS remain incompletely understood. There is no organic pathology underlying the development of PMS. The main theory of PMS development is an inadequate central nervous system (CNS) response to physiological fluctuations in sex hormone levels due to dysfunction of neurotransmitter systems, specifically serotonin and gamma-aminobutyric acid (GABA) [5], [6].
It has been established that PMS symptoms are absent before menarche, during pregnancy, and in postmenopause [7]. A direct correlation between PMS and specific hormone levels has not been proven, as studies have shown that estrogen and progesterone levels do not significantly differ between women with and without PMS [8].
The theory of central neurotransmitter metabolism disruption suggests that declining estrogen levels in the late luteal phase of the menstrual cycle can trigger or exacerbate serotonin metabolism dysregulation [6], [7]. Several studies have identified lower blood platelet serotonin levels in patients with PMS [9], [10], [11]. This theory is supported by the role of serotonin in the pathophysiology of other psychoemotional disorders (including depression and anxiety) and the proven efficacy of selective serotonin reuptake inhibitors (SSRIs) (ATC code: Selective serotonin reuptake inhibitors) in the treatment of PMS [12].
It is believed that PMS may be associated with the effects of progesterone and its metabolite allopregnanolone on the GABAergic system. Allopregnanolone is a neuroactive steroid with antidepressant and anxiolytic effects, as well as the ability to enhance the sedative effect of GABA on the CNS [13], [14]. Women with PMS may have increased sensitivity to physiological changes in allopregnanolone levels during the luteal phase of the menstrual cycle, as well as experience a "withdrawal effect," leading to various psychoemotional symptoms [15]. Administration of allopregnanolone preparations is associated with a reduction in PMDD symptoms [15], [16], [17], [18]. SSRI medications (ATC code: N06AB Selective serotonin reuptake inhibitors) modulate allopregnanolone levels [19], [20], which explains their rapid therapeutic effect [21].
1.3 Epidemiology of the Disease or Condition
Up to 90% of women of reproductive age have experienced at least one symptom of PMS [22]. Of these, 20–30% experience symptoms meeting the criteria for PMS [23], [24], and 2 to 8% [25] of women have severe symptoms meeting the diagnostic criteria for PMDD [2].
Studies have shown that many women with PMS do not receive effective medical care because they either do not seek medical attention or seek help but the treatment does not lead to significant symptom relief [26], [27].
1.4 Features of Coding the Disease or Condition
N94.3 – Premenstrual tension syndrome
1.5 Classification of the disease or condition
In PMS, cyclic symptoms negatively affect a woman's quality of life, but do not significantly limit her daily activities (physical and social).
In 1994, the American Psychiatric Association classified the most severe manifestations of PMS as a distinct nosological entity — "premenstrual dysphoric disorder" (PMDD) [2]. In PMDD, symptoms significantly affect quality of life and limit daily activities.
Based on etiopathogenesis and clinical manifestations, PMS is divided into the main form and variant forms [28].
The main form of PMS presents with typical behavioral, psychoemotional, and/or physical symptoms that occur in the luteal phase of the menstrual cycle and resolve or significantly abate with the onset or during the first days of menstruation. The number and spectrum of symptoms are not critical for making the diagnosis. The presence of symptoms during menstruation does not exclude a diagnosis of PMS, but an asymptomatic period between menstruation and the middle of the cycle/approximate time of ovulation is mandatory for diagnosis.
Variant forms of PMS include:
premenstrual exacerbation of an underlying condition
PMS resulting from ovarian activity unrelated to ovulation
PMS in the absence of menstruation
progestogen-induced PMS [28], [3]
In the case of premenstrual exacerbation of an underlying condition (such as depression, epilepsy, migraine, etc.), symptoms may be observed throughout the entire menstrual cycle, but they become more intense during the luteal phase.
PMS resulting from ovarian activity not associated with ovulation is observed in women without ovulation. The mechanism underlying this type of variant form of PMS is insufficiently studied.
PMS in the absence of menstruation is observed in women after hysterectomy with conservation of the ovaries, endometrial ablation, and also with the use of a levonorgestrel-releasing intrauterine system (LNG-IUS – Levonorgestrel [intrauterine therapeutic system]).
Progestogen-induced PMS is an iatrogenic form of PMS in which ovulation in a woman is absent or suppressed, but the administration of exogenous progestogen provokes the appearance of PMS-like symptoms [28], [3].
1.6 Clinical presentation of the disease or condition
PMS manifestations are diverse and can occur in various combinations [29], [30]. The nature and intensity of symptoms are individual for each woman and variable from cycle to cycle. The intensity of symptoms depends on the physical and psycho-emotional state of the woman at a specific period of time [31].
PMS symptoms are conventionally divided into:
1) psychological and behavioral symptoms (mood swings, depressed mood, tearfulness, fatigue, weakness, irritability, anxiety, decreased cognitive function, aggression, anger, sleep disturbance, increased appetite)
2) physical symptoms (breast tenderness, abdominal bloating, nausea, weight gain, edema, skin rash, headaches, back pain, tachycardia, thirst, chills, shortness of breath, impaired coordination of movement not associated with muscle weakness, etc.).
There are 6 symptoms most pathognomonic for PMS: anxiety/tension, mood swings, lower abdominal pain, loss of appetite, cramps, and decreased interest in daily activities [32].
3) atypical symptoms (hyperthermia, cyclic severe allergic reactions, ulcerative gingivitis and stomatitis, cyclic "bronchial asthma", intractable vomiting, etc.)
2. Diagnostics, medical indications and contraindications for diagnostic methods
The following criteria are used to diagnose PMS:
1) presence of one or more PMS symptoms (physical, psycho-emotional, or behavioral)
(2) symptoms develop only in the luteal phase of the menstrual cycle
(3) negative impact of symptoms on the patient's quality of life, without significant restriction of her daily activity (physical, social) [33].
Diagnostic criteria for severe PMS (PMDD) include [34]:
A: In most menstrual cycles, at least five symptoms must be present in the final week before the onset of menses, start to improve within a few days after the onset of menses, and become minimal or absent in the week post-menses.
B: One (or more) of the following symptoms must be present:
- Marked affective lability (e.g., mood swings; feeling suddenly sad or tearful).
- Marked irritability or anger or increased interpersonal conflicts.
- Marked depressed mood, feelings of hopelessness, or self-deprecating thoughts.
- Marked anxiety, tension, and/or feelings of being keyed up or on edge.
C: One (or more) of the following symptoms must additionally be present, to reach a total of five symptoms when combined with symptoms from Criterion B above:
- Decreased interest in usual activities (e.g., work, school, friends, hobbies).
- Subjective difficulties with concentration.
- Mild fatigability or marked lack of energy.
- Eating disorders (changes in appetite; overeating; or cravings for specific foods).
- Somnolence or insomnia.
- Feeling overwhelmed.
- Physical symptoms such as breast tenderness or engorgement, joint or muscle pain, bloating, or weight gain.
Note. Symptoms specified in criteria A–C must be present during the majority of menstrual cycles over the past 12 months.
D: Symptoms are associated with clinically significant distress or interfere with normal social activities or interpersonal relationships.
E: Symptoms are not an exacerbation of another disorder (e.g., depression, panic disorder, or personality disorder).
F: Criterion A must be confirmed by prospective daily ratings during at least two menstrual cycles.
Note: a diagnosis may be made prior to confirmation.
G: Symptoms are not attributable to the physiological effects of a substance/alcohol or another medical condition (e.g., hyperthyroidism).
PMS is a diagnosis of exclusion that can be established after ruling out other possible causes of premenstrual symptoms.
Differential diagnosis of PMS is performed with various mental disorders. Unlike PMS, most chronic psychiatric disorders manifest throughout the entire menstrual cycle, whereas clinical manifestations of PMS appear approximately 2 weeks before the onset of the cycle and cease/substantially subside with the onset of menstruation [35], [36].
Women with PMDD have a higher risk of suicidal behavior [37], [38]. Eating disorders, sleep disorders, and addictive behaviors (increased nicotine and alcohol use) may be associated with PMDD [39], [40].
When PMDD is suspected, the management of the patient is decided by a medical board consisting of an obstetrician-gynecologist, a general practitioner, and a psychiatrist.
2.1 Complaints and Anamnesis
It is recommended to record the presence of the following symptoms during patient interviews, recurring in the luteal phase of the menstrual cycle for at least 2–3 consecutive cycles, for the diagnosis of PMS [1], [41]:
- psychological and behavioral — depressed mood, mood swings, irritability, nervousness, anxiety, fatigue, asthenia, cognitive decline, aggression, anger, sleep disturbance, increased appetite.
- physical — breast tenderness, bloating, nausea, weight gain, edema, skin rash, headaches, back pain, tachycardia, thirst, chills, dyspnea, impaired coordination not related to muscle weakness.
- atypical — episodes of difficulty breathing, intractable vomiting, fever, oral ulcerations, etc.
GCR CLOE 5Grade of Recommendation C (Level of Evidence – 5).
Comments: for the diagnosis of PMS, special attention should be paid to the timing of symptom onset (regular manifestation in the luteal phase of the menstrual cycle) and the degree of their impact on the woman's daily life.
Depending on the clinical manifestations of PMS, specialists from various fields may be involved in the patient's examination.
It is recommended that patients with PMS keep a menstrual calendar/symptom diary for 2–3 consecutive cycles in order to analyze the cyclicity of symptoms and assess their severity [1], [41].
Level CLevel 5Level of recommendation evidence C (reliability level of evidence – 5).
Comments: To establish a diagnosis of PMS, the cyclic appearance of symptoms in the luteal phase of the cycle and their complete resolution/substantial improvement in the first days of menstruation must be prospectively confirmed.
Retrospective symptom assessment should be used only for making a provisional diagnosis [41], [42], [35].
It is recommended that all patients undergo a thorough anamnestic evaluation to identify diseases and conditions that may cause variant forms of PMS [1].
Level CLevel 5Level of recommendation evidence C (reliability level of evidence – 5).
2.2 Physical Examination
It is recommended that all patients with PMS undergo a standard physical examination, which includes visual inspection of the external genitalia, bimanual pelvic examination, visual inspection and palpation of the mammary glands, [44]
Level CLevel 5Level of recommendation evidence C (reliability level of evidence – 5).
It is recommended that all patients with PMS have their body weight and height measured, and body mass index (BMI) calculated for the diagnosis of overweight and obesity [45], [46], [47]
GRC CLEL 4Grade of Recommendation C (Level of Evidence – 4)
It is recommended that all adult patients with PMS have their waist circumference (WC) measured as a key indicator of abdominal/visceral obesity [47], [48]
GPP CLOE 4Grade of Recommendation C (Level of Evidence – 4).
Comments: In women with obesity, low physical activity, WC greater than 80 cm, as well as increased carbohydrate and fat intake, PMS occurs significantly more frequently than in women without these factors [48], [49]. The severity of PMS symptoms also depends on the intake of high-fat foods and the level of physical activity [50].
2.3 Laboratory Diagnostics
Laboratory tests are not specific for the diagnosis of PMDD.
2.4 Instrumental Diagnostics
Instrumental examinations are not specific for the diagnosis of PMDD.
It is recommended that all patients with PMS undergo comprehensive pelvic ultrasound (transvaginal and transabdominal) to rule out organic pathology [51].
GCR CLOE 4Grade of Recommendation C (Level of Evidence 4).
2.5 Other Procedures
It is recommended to take a medical history and perform a comprehensive examination in women before prescribing CHCs (ATX – G03AA Progestogens and estrogens, fixed combinations) and other hormonal drugs for the treatment of PMS (dydrogesterone** ATX G03DB01 Progestogens, micronized progesterone** ATX G03DA04 Progesterone) in order to identify contraindications to their use and/or the risk of potential adverse events.
- comprehensive pelvic ultrasound examination
(transvaginal and transabdominal);
- comprehensive breast examination: visual inspection, palpation, X-ray mammography in two projections evaluated using the BI-RADS and ACR (A-D) system / breast ultrasound (See Appendix G1, Table 1)
- blood pressure measurement, [52]
LeR CLoE 5Level of Evidence C (Level of Confidence of Data 5).
It is recommended to perform a series of additional examinations before initiating PMS treatment in women with relevant history data and indications pointing to contraindications to therapy:
- determination of the G20210A prothrombin polymorphism in the coagulation factor II gene; molecular genetic testing for the G1691A mutation in the coagulation factor V gene (Factor V Leiden mutation) [43]
LeR CLoE 5Level of Evidence C (Level of Confidence of Data 5).
It is recommended that women receiving long-term GnRH agonists (ATX – Gonadotropin-releasing hormone analogues) (more than 6 months) undergo an annual dual-energy X-ray absorptiometry (DEXA) of the lumbar spine and proximal femur (NMU – X-ray densitometry of the lumbar spine; X-ray densitometry of the proximal femur) to assess bone mineral density (BMD) [42]
GCR CLEL 5Grade of Recommendation C (Level of Evidence – 5).
Comments: GnRH analogues (ATX – Gonadotropin-releasing hormone analogues) are approved for the treatment of PMS in adults for up to 6 months [53], as longer use is associated with bone mineral density (BMD) loss. If GnRH analogues are used for more than 6 months, or in repeated courses (upon PMS symptom recurrence), monophasic combined estrogen-progestogen therapy (ATX – Progestogens and estrogens, fixed combinations ["add-back" therapy]) should be prescribed to prevent BMD loss and correct estrogen deficiency symptoms. [54], [55].
3. Treatment, including drug and non-drug therapies, diet therapy, and pain management
3.1 Medical treatment
The goals of PMS treatment are to reduce the intensity of physical and psychoemotional symptoms and improve the patients' quality of life. The physician and the patient should discuss various treatment approaches based on goals, benefits, and risks of potential treatment options, as well as the patient's personal preferences.
For women with severe PMS (PMDD), a multidisciplinary team consisting of an obstetrician-gynecologist, a general practitioner, and a psychiatrist should be involved in treatment [1], [42].
The patient should be informed that PMS treatment may be long-term, as discontinuing therapy may lead to symptom recurrence.
It is recommended to prescribe drospirenone-containing CHCs (ATX – G03AA12 Drospirenone and estrogens) as a first-line therapy for severe PMS in adults and adolescent girls after menarche and the establishment of regular menstrual cycles to suppress ovulation and prevent the development of symptoms in the luteal phase [56], [42], [1], [57], [58], [59], [60], [61], [62].
For adolescents – Level of Recommendation C (Level of Evidence 5)
For adults – Level of Recommendation A (Level of Evidence 1)
Comment: The mechanism of the positive effect of CHCs on PMS symptoms is associated with the suppression of ovulation. In several RCTs, CHCs containing various progestins (ATC: Progestogens) demonstrated a significant reduction in the severity of premenstrual symptoms compared with placebo.
A CHC containing drospirenone 3 mg + ethinylestradiol 0.02 mg in a single tablet in a 24/4 regimen (24 active tablets and 4 placebo tablets; ATC: G03AA12 Drospirenone and estrogen) [60] has an approved indication in the Russian Federation for the treatment of severe PMS in postmenarchal women.
A CHC containing drospirenone 3 mg + ethinylestradiol 0.02 mg + [levomefolate calcium] 0.451 mg in a single tablet in a 24/4 regimen (24 active tablets and 4 tablets of levomefolate calcium 0.451 mg; ATC: G03AA12 Drospirenone and estrogen) has an approved indication in the Russian Federation for the treatment of severe PMS in postmenarchal women [63].
RCTs have shown that in adults, the efficacy of CHCs regarding depressive symptoms of PMS is comparable to placebo [57], [56]. In pediatric patients, the efficacy of CHCs regarding depressive symptoms of PMS has not been studied.
CHCs with a shortened hormone-free interval of 4 days have advantages over the 21/7 regimen in treating PMS, as withdrawal symptoms (headache, bloating, etc.) are less pronounced or absent in the 24/4 regimen [64].
A continuous CHC regimen is more preferable for the treatment of PMS than a cyclic regimen [65].
Treatment regimens are presented in Appendix A3
It is recommended to prescribe SSRIs (ATC: N06AB Selective serotonin reuptake inhibitors) to patients with severe PMS symptoms (PMDD) or with prevailing psycho-emotional PMS symptoms as a first-line therapy [1], [42], [12].
GCR BLeE 1Grade of Recommendations B (Level of Evidence – 1)
Comment:
Clinical efficacy usually takes 4 to 8 weeks to achieve.
For the treatment of PMS, a cyclic (luteal phase only) or continuous regimen of SSRIs is used with comparable clinical efficacy [42], [12].
The issue of prescribing SSRIs is determined by a medical panel involving related specialists.
#Sertraline is approved in children and adolescents for the treatment of severe depressive, panic, post-traumatic stress disorders, and obsessive-compulsive conditions starting from 6 years of age, but the use of SSRIs for PMS has not been thoroughly evaluated [1]. #Sertraline at a dosage of 50 to 150 mg per day can be prescribed in adolescents with PMS for continuous therapy, or up to 100 mg per day for use during the luteal phase from the 14th day of the menstrual cycle until the onset of menstruation [61], [66]
When prescribing SSRIs to adolescents, patients should be monitored for the emergence or worsening of suicidal thoughts and/or suicidal behavior, especially during the first few months after starting treatment and when the dose is increased or decreased. If suicidal thoughts appear, the medication should be stopped immediately and a child and adolescent psychiatrist should be consulted [1].
Treatment regimens are presented in Appendix A3
It is recommended to use Vitex agnus-castus fruit extract (ATC: G02CX03 Vitex agnus-castus fruit) for the symptomatic treatment of premenstrual symptoms in adults [67], [1], [68], [69], [70].
SOR BLOE 1Strength of recommendation B (level of evidence –1)
Comment: Data from a systematic review showed that medicinal products based on Vitex agnus-castus fruit extract are superior to placebo, #pyridoxine, and magnesium supplements in the efficacy of treating PMS symptoms [71] [72]. In another study, it was comparable in efficacy to fluoxetine** in the treatment of PMDD in adults [71]. Medicinal products based on Vitex agnus-castus fruit extract are well tolerated with a minimal number of adverse effects in adults [72],[73]. A few studies have investigated the use of #Vitex agnus-castus fruit extract in adolescents aged 16 and older using the following regimen: 30 drops twice a day starting 5 days before menstruation for 3 cycles, or 1 tablet per day for 3 menstrual cycles [74], [72].
The medicinal product Mastodynon fruit extract of Vitex agnus-castus is used in adults and children over 12 years of age in the combination therapy of premenstrual syndrome accompanied by mastodynia, breast tenderness, mental lability, constipation, edema, and headache/migraine [75].
Treatment regimens are presented in Appendix A3
It is recommended to prescribe GnRH agonists (ATC: Gonadotropin-releasing hormone analogues) to women with severe, refractory PMS symptoms when other treatments are ineffective [42], [1], [54].
GOM BLoE 1Grade of Recommendation B, Level of Evidence 1).
Comment: for the prevention of bone mineral density (BMD) loss and alleviation of estrogen deficiency symptoms during treatment with GnRH agonists, it is recommended to additionally prescribe monophasic combined estrogen-progestogen (G03AA Fixed combinations of progestogens and estrogens) "add-back" therapy (transdermally or orally), or #Tibolone (in adults, 2.5 mg, 1 tablet per day) [76].
Hormonal "add-back" therapy does not reduce the efficacy of GnRH agonists in the treatment of PMS [42], [4], [1]. GnRH agonists are generally not used to treat PMS in adolescents due to a lack of data on efficacy in this population and adverse long-term consequences for bone health [1].
Treatment regimens are presented in Appendix A3
It is recommended to prescribe progestogens (ATC: Progestogens) as a second-line therapy for women with PMS who have contraindications to hormonal contraception, do not need contraception, do not wish to take antidepressants/GnRH agonists (ATC: Gonadotropin-releasing hormone analogues), as well as for patients with oligomenorrhea [77], [78], [1], [79].
GOM CLoE 5Grade of Recommendation C (Level of Evidence 5)
Comment: Currently, data on the efficacy of progestogens (ATC: Progestogens) in the treatment of PMS are contradictory [77], [78].
In the Russian Federation, for the treatment of PMS in adults, dydrogesterone** can be prescribed orally at 10 mg twice daily from the 11th to the 25th day of the menstrual cycle, or micronized progesterone** at 200 or 400 mg daily from the 17th to the 26th day of the menstrual cycle. Alternatively, dydrogesterone** orally at 10 mg twice daily during the last 14 days of the menstrual cycle taking into account its duration, or micronized progesterone** at 200 or 400 mg daily from the 17th to the 26th day of the menstrual cycle [80], [81], [82].
Treatment regimens are presented in Appendix A3
It is recommended to prescribe #spironolactone** for the correction of somatic symptoms (edema, mastalgia) of PMS in adults and adolescent girls after the onset of menarche [42], [83], [61].
GOM BLoE 2Grade of Recommendation B (Level of Evidence 2) for adults
GOM CLoE 5Grade of Recommendation C (Level of Evidence 5) for adolescents
Comments: #Spironolactone** is a potassium-sparing diuretic with antimineralocorticoid and antiandrogenic effects. It is prescribed to adults at a dose of 100 mg daily from the 14th day of the menstrual cycle until the first day of the next menstruation [42], [56]. #Spironolactone** in adolescents has been shown to be effective for breast pain and abdominal bloating [61]. It is prescribed to adolescents at a dose of 100 mg daily from the 12th day of the menstrual cycle until the first day of the next menstruation. Potassium levels should be monitored, and its use in patients with impaired renal function should be avoided.
Treatment regimens are presented in Appendix A3
It is recommended to use calcium preparations in adults and adolescent girls (ATC: A12AA Calcium) to reduce the severity of PMS symptoms [56], [84], [85], [86], [87], [88].
GOM CLoE 3Grade of Recommendation C, (Level of Evidence 3).
Treatment regimens are presented in Appendix A3
It is recommended to use nonsteroidal anti-inflammatory drugs (NSAIDs) (ATC: Anti-inflammatory and antirheumatic products, non-steroids) for the treatment of pain syndrome in patients with PMS [56], [89], [90].
GOM CLoE 5Grade of Recommendation C, (Level of Evidence 5).
Comments: NSAIDs (Anti-inflammatory and antirheumatic products, non-steroids) are associated with a reduction in physical premenstrual symptoms (e.g., abdominal cramps, headaches) as well as a reduction in psycho-emotional symptoms as a consequence of pain relief [90].
#Diclofenac in the form of a gel (2 g of gel, 2.23 mg of diclofenac) was effective in the treatment of cyclic mastalgia compared with placebo at a dose of approximately 50 mg applied to the breast skin every 8 hours in adult women [91]
NSAIDs should be prescribed to children in accordance with the clinical guidelines for "Dysmenorrhea".
In an efficacy study of the drug #Naproxen, its administration at a dose of 550 mg twice daily every month starting 7 days before menstruation and continuing through the 4th day of the menstrual cycle demonstrated efficacy superior to placebo in adult women [92].
Treatment regimens are presented in Appendix A3
3.2 Non-drug treatment
It is recommended to consult a psychotherapist and undergo cognitive behavioral therapy (CBT) for the treatment of psychoemotional PMS symptoms [1], [42]
GCR CLOE 5Grade of Recommendation C (Level of Evidence 5).
It is recommended to implement lifestyle modifications (regular physical activity, diet, fat restriction, obesity management) in patients with PMS to reduce the severity of physical and psychoemotional symptoms
GCR CLOE 5Grade of Recommendation C (Level of Evidence 5).
3.3 Surgical Treatment
It is recommended to perform surgical treatment of PMS in the form of oophorectomy and/or hysterectomy with adnexa in adult women with severe PMS (PMDD) when conservative therapy fails to yield a positive effect [1], [4], [42].
GCR CLOE 5Grade of Recommendation C (Level of Evidence 5).
Comment: Due to the risks associated with this type of treatment, bilateral oophorectomy should be prescribed to adult patients with severe symptoms refractory to medical treatment [4], patients requiring long-term therapy with GnRH agonists (Anatomical Therapeutic Chemical [ATC] classification: Gonadotropin-releasing hormone analogues) for symptom control, and patients with severe premenstrual disorder (PMD) symptoms who have other indications for bilateral oophorectomy [1], [42]. Prior to surgery, a 2-to-3-month "trial" therapy with GnRH agonists (with or without add-back therapy) should be performed to predict the response to surgical treatment [1].
4. Medical Rehabilitation and Sanatorium-Resort Treatment
It is recommended that all patients undergo an examination (consultation) by a physical therapy physician to determine a rehabilitation program [93]
GDR CLE 5Grade of recommendation C (level of evidence – 5)
5. Prevention and Dispensary Observation
It is recommended to maintain a normal BMI, engage in regular physical activity, and quit bad habits, excessive alcohol consumption, and caffeine-containing products as preventive measures [1]
GDR CLE 5Grade of recommendation C (level of evidence – 5)
6. Organization of Medical Care
Inpatient treatment is not indicated.
7. Additional Information
Not applicable
Criteria for Evaluating the Quality of Medical Care
№ | Quality criteria | Performance evaluation |
|---|---|---|
1. | Anamnesis data were collected | Yes/No |
2. | An evaluation was performed of the patient's prospective recording of PMS symptoms for at least 2–3 consecutive cycles (menstrual calendar/symptom diary) | Yes/No |
3. | Visual inspection of the external genitalia and visual and bimanual vaginal examination were performed | Yes/No |
4. | Visual inspection and palpation of the mammary glands were performed | Yes/No |
5. | Waist circumference measurement and BMI calculation were performed | Yes/No |
6. | Comprehensive pelvic ultrasound examination was performed (transvaginal and transabdominal) | Yes/No |
7. | The following were performed: breast examination (visual inspection, palpation, two-view screening mammography with BI-RADS and ACR (A-D) assessment) / breast ultrasound | Yes/No |
8. | Dual-energy X-ray absorptiometry (DEXA) of the lumbar spine and proximal femur (according to the Nomenclature of Medical Services: X-ray densitometry of the lumbar spine; X-ray densitometry of the proximal femur) was performed to assess bone mineral density (BMD) in patients receiving long-term GnRH agonist therapy (ATC: Gonadotropin-releasing hormone analogues) (for more than 6 months) | Yes/No |
9. | Medical/non-medical treatment for PMS symptoms was prescribed | Yes/No |
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Luteal phase administration of paroxetine for the treatment of premenstrual dysphoric disorder: a randomized, double-blind, placebo-controlled trial in Canadian women / M. Steiner, A. V. Ravindran, J.-M. LeMelledo [et al.] // The Journal of Clinical Psychiatry. – 2008. – Vol. 69. – Luteal phase administration of paroxetine for the treatment of premenstrual dysphoric disorder. – No. 6. – P. 991-998.
Lee, J. Practical and illustrated summary of updated BI-RADS for ultrasonography / J. Lee. – Text: electronic // Ultrasonography. – 2017. – Vol. 36. – No. 1. – P. 71-81. – URL: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5207351/ (date of access: 09/16/2024).
Appendix A1. Working Group Composition
Leyla V. Adamyan – Academician of the Russian Academy of Sciences, Doctor of Medical Sciences, Professor, Deputy Director of the V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology of the Russian Ministry of Health, Honored Scientist of Russia, Head of the Department of Obstetrics, Gynecology and Reproductive Medicine at the Russian University of Medicine, Chief Freelance Gynecologist of the Russian Ministry of Health, member of the Society for Reproductive Medicine and Surgery, the Russian Association of Endoscopic Gynecologists, the Russian Endometriosis Association, and the Russian Society of Obstetricians and Gynecologists.
Elena N. Andreeva – Doctor of Medical Sciences, Professor, Deputy Director – Director of the Institute of Reproductive Medicine, Head of the Department of Endocrine Gynecology, Professor at the Department of Endocrinology, National Medical Research Center for Endocrinology of the Russian Ministry of Health, Professor at the Department of Obstetrics, Gynecology and Reproductive Medicine at the Russian University of Medicine, President of the International Association of Obstetricians, Gynecologists and Endocrinologists, member of the Russian Association of Endoscopic Gynecologists, the Russian Endometriosis Association, the Russian Society of Obstetricians and Gynecologists, and ROSGEM.
Natalya V. Artymuk – Doctor of Medical Sciences, Professor, Head of the Department of Obstetrics and Gynecology named after Professor G.A. Ushakova at Kemerovo State Medical University of the Russian Ministry of Health, Chief Freelance Specialist in Obstetrics and Gynecology of the Russian Ministry of Health in the Siberian Federal District, member of the Russian Society of Obstetricians and Gynecologists.
Tatyana E. Belokrinitskaya – Doctor of Medical Sciences, Professor, Head of the Department of Obstetrics and Gynecology at the Faculty of Additional Professional Education, Chita State Medical Academy of the Russian Ministry of Health, Honored Physician of the Russian Federation, Chief Freelance Specialist in Obstetrics and Gynecology of the Russian Ministry of Health in the Far Eastern Federal District (Chita), member of the Russian Society of Obstetricians and Gynecologists, President of the Trans-Baikal Society of Obstetricians and Gynecologists.
Zaira Kh. Kumykova – Candidate of Medical Sciences, Senior Research Fellow at the 2nd Gynecological Department, V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology of the Ministry of Health of the Russian Federation.
Antonina A. Smetnik – Candidate of Medical Sciences, Head of the Department of Gynecological Endocrinology, V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology of the Ministry of Health of the Russian Federation, President of the Russian Society of Gynecological Endocrinology and Menopause Specialists.
Larisa V. Suturina – Doctor of Medical Sciences, Professor, Chief Research Fellow, Head of the Department of Reproductive Health Protection, Scientific Centre for Family Health and Human Reproduction Research, member of the Association of Gynecological Endocrinologists of Russia, member of the Androgen Excess and Polycystic Ovary Syndrome Society (AE-PCOS Society).
Natalya I. Tapilskaya - Doctor of Medical Sciences, Professor, Head of the Department of Reproductology, D.O. Ott Research Institute of Obstetrics, Gynecology and Reproductology, Professor at the Department of Obstetrics and Gynecology, Saint Petersburg State Pediatric Medical University.
Elena V. Uvarova – Corresponding Member of the Russian Academy of Sciences, Doctor of Medical Sciences, Professor, Honored Scientist of the Russian Federation, Head of the 2nd Gynecological Department, V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology of the Ministry of Health of the Russian Federation, Professor at the Department of Obstetrics, Gynecology and Reproductology, Institute of Professional Education, I.M. Sechenov First Moscow State Medical University (Sechenov University) of the Ministry of Health of the Russian Federation, Chief Freelance Pediatric and Adolescent Gynecologist of the Ministry of Health of the Russian Federation, President of the Association of Pediatric and Adolescent Gynecologists of Russia, member of the Russian Society of Obstetricians and Gynecologists.
Svetlana V. Yureneva – Doctor of Medical Sciences, Professor, Deputy Director of the Institute of Oncogynecology and Mammology, V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology of the Ministry of Health of the Russian Federation, Professor at the Department of Obstetrics and Gynecology, V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology of the Ministry of Health of the Russian Federation, member of the Russian Association of Obstetricians and Gynecologists, Vice-President of the Interregional Association of Gynecological Endocrinologists, member of the Presidium of the Russian Association on Osteoporosis.
Maria I. Yarmolinskaya – Professor of the Russian Academy of Sciences, Doctor of Medical Sciences, Professor, Head of the Department of Gynecology and Reproductive Endocrinology, D.O. Ott Research Institute of Obstetrics and Gynecology, Professor at the Department of Obstetrics and Gynecology, I.I. Mechnikov North-Western State Medical University of the Russian Ministry of Health, member of the Russian Society of Obstetricians and Gynecologists.
Appendix A2. Methodology for Developing Clinical Guidelines
Target audience for these clinical guidelines:
1. Obstetrician-gynecologists
2. Endocrinologists
3. General practitioners
4. Psychiatrists
Table 1. Level of Evidence (LoE) grading scale for diagnostic methods (diagnostic interventions)
LoE | Definition |
|---|---|
1 | Systematic reviews of studies with reference standard control or systematic reviews of randomized controlled trials with meta-analysis |
2 | Individual studies with reference standard control or individual randomized controlled trials and systematic reviews of studies of any design, except randomized controlled trials, with meta-analysis |
3 | Studies without consecutive reference standard control or studies with a reference standard not independent of the test method, or non-randomized comparative studies, including cohort studies |
4 | Non-comparative studies, case report |
5 | There is only a rationale for the mechanism of action or expert opinion |
Table 2. Level of Evidence (LoE) grading scale for prevention, treatment, and rehabilitation methods (preventive, therapeutic, and rehabilitative interventions)
LoE | Definitions |
|---|---|
1 | Systematic review of RCTs with meta-analysis |
2 | Individual RCTs and systematic reviews of studies of any design except RCTs, with meta-analysis |
3 | Non-randomized comparative studies, including cohort studies |
4 | Non-comparative studies, case reports or case series, case-control studies |
5 | There is only a rationale for the mechanism of action of the intervention (preclinical studies) or expert opinion |
Table 3. Grade of Recommendation (GoR) scale for prevention, diagnostic, treatment, and rehabilitation methods (preventive, diagnostic, therapeutic, and rehabilitative interventions)
GoR | Definition |
|---|---|
A | Strong recommendation (all considered efficacy criteria (outcomes) are important, all studies are of high or acceptable methodological quality, and their conclusions on the outcomes of interest are consistent) |
B | Conditional recommendation (not all considered efficacy criteria (outcomes) are important, not all studies are of high or acceptable methodological quality, and/or their conclusions on the outcomes of interest are inconsistent) |
C | Weak recommendation (lack of evidence of proper quality; all considered efficacy criteria [outcomes] are unimportant, all studies have low methodological quality, and their conclusions regarding outcomes of interest are inconsistent) |
Procedure for updating clinical guidelines.
The mechanism for updating clinical guidelines provides for their systematic revision at least once every three years, as well as upon the emergence of new evidence-based medicine data on the diagnosis, treatment, prevention, and rehabilitation of specific diseases, or in the presence of justified additions/comments to previously approved clinical guidelines, but no more frequently than once every 6 months.
Appendix A3. Reference Materials
Table of treatment regimens with combined estrogen-progestogen drugs (ATC code – Progestogens and estrogens, fixed combinations)
[60], [57]
Drug name | Dosages and administration frequency | Duration of use |
|---|---|---|
Drospirenone + ethinylestradiol, tablets (for severe PMS) (ATC code: G03AA12 Drospirenone and ethinylestradiol) [57], [62] | 3 mg + 0.02 mg 1 tablet continuously for 28 days (24 active tablets and 4 placebo tablets) for adults and adolescents post-menarche | For 6 months to 1 year; further duration of therapy is determined individually |
Drospirenone + Ethinylestradiol + [Calcium levomefolate] and Calcium levomefolate for the treatment of severe premenstrual syndrome symptoms (ATC code: G03AA12 Drospirenone and ethinylestradiol) [63] | 3 mg + 0.02 mg + 0.451 mg and 0.451 mg 1 tablet continuously for 28 days for adults and adolescents post-menarche | For 6 months to 1 year; further duration of therapy is determined individually |
Table of treatment regimens with GnRH agonists (Gonadotropin-releasing hormone analogues)[54], [42]
Drug name | Dosages and administration frequency | Duration of use |
|---|---|---|
#Goserelin**[1], [94] | Adult women: 3.6 mg subcutaneously into the anterior abdominal wall every 28 days | For 3–6 months; further duration of therapy is determined individually |
#Buserelin** [95] (in the dosage form of lyophilisate for suspension for prolonged-release intramuscular injection) | Adult women: 3.75 mg intramuscularly every 28 days [96] | For 3–6 months; further duration of therapy is determined individually |
Progestogen treatment schedule table (ATC – Progestogens) [78], [77]
Drug name | Dosages and administration frequency | Duration of use |
|---|---|---|
Dydrogesterone**[1], [97] | Oral, 10 mg twice daily from day 11 to day 25 of the menstrual cycle, or oral, 10 mg twice daily during the last 14 days of the menstrual cycle depending on its duration See text in thesis, references 79, 80, 81, SmPC attachment | Adult women for 3–6 months, further therapy duration is determined individually |
Micronized progesterone** [79] | 200 or 400 mg daily from day 17 to day 26 of the menstrual cycle orally. | Adult women for 3–6 months, further therapy duration is determined individually |
“Add-back” therapy schedule table [8], [42], [98], [76]
Drug name | Dosages and administration frequency | Duration of use |
|---|---|---|
#Estradiol 0.1% transdermal gel + micronized #progesterone (vaginal) (by ATC - Progestogens) [99] | #Estradiol 0.1% transdermal gel is prescribed as: 2–4 doses of gel + micronized #progesterone 100 mg/day Or 1.5 mg of 0.1% gel daily + micronized #progesterone 400 mg vaginally for 14 days in the second phase of the cycle | Adult women For 3–6 months, further therapy duration is determined individually [98] |
#Tibolone, tablets (by ATC – Other estrogens) [76] | 2.5 mg, 1 tablet daily | Adult women for 3–6 months, further therapy duration is determined individually |
Table. Non-hormonal treatment options for PMS
SSRI treatment schedule table (by ATC - N06AB Selective serotonin reuptake inhibitors) [42], [1]
Drug name | Dosages and administration frequency | Duration of use, after which therapy duration is determined individually |
|---|---|---|
#Paroxetine** [12], [100] | 10–30 mg/day | Adult women for 2–4 months, further therapy duration is determined individually |
#Fluoxetine** [12] | 10–60 mg/day | Adult women for 2–3 months, further therapy duration is determined individually |
#Sertraline** [66] | 25–105 mg/day Adolescents 50–150 mg for continuous therapy or 100 mg for use in the luteal phase [61] | For 2–3 months, further therapy duration is determined individually |
#Citalopram [12] | 20–50 mg/day | Adult women for 3 months, further therapy duration is determined individually |
#Escitalopram [12] | 10–20 mg/day | Adult women for 3 months, further therapy duration is determined individually |
NSAID treatment schedule table (by ATC - Nonsteroidal anti-inflammatory and antirheumatic products) [92], [1]:
Drug name | Dosages and administration frequency | Duration of use |
|---|---|---|
#Naproxen 550 mg [92] #Diclofenac in gel form (2 g of gel, 2.23 mg of diclofenac) [91] ATC - Nonsteroidal anti-inflammatory and antirheumatic products | Adult women 550 mg twice daily monthly 7 days before the expected menstruation until the 4th day of the cycle 50 mg applied to the skin of the mammary glands every 8 hours in adult women with cyclic mastalgia Adolescents: treatment in accordance with the clinical guidelines for "Dysmenorrhea" | For 6 months For 6 months |
Treatment schedule table for #Spironolactone**(by ATC – Aldosterone antagonists) [83]:
Drug name | Dosages and administration frequency | Duration of use |
|---|---|---|
#Spironolactone** (by ATC – Aldosterone antagonists) [66], [61] | Prescribed to adults in the luteal phase of the menstrual cycle at a dose of 100 mg daily from day 14 of the menstrual cycle until the first day of the next menstruation Prescribed to adolescents at 100 mg daily from day 12 of the menstrual cycle until the first day of the next menstruation PMS until the first day of the next menstruation | Therapy duration is determined individually |
Treatment schedule table for Vitex agnus-castus (by ATC - G02CX03
Agnus castus fruit) [73]:
Drug name | Dosages and administration frequency | Duration of use |
|---|---|---|
Vitex agnus-castus fruit extract, 2.36–4 mg. #Vitex agnus-castus fruit extract [73], [74], [69] Mastodynon** (no INN) | 1 tablet once daily for adults over 18 years of age In adolescents from 16 years of age, 30 drops twice daily 5 days before menstruation for 3 cycles, or 1 tablet daily [73] 1 tablet twice daily or 30 drops 3 times daily | at least 3 months 3 menstrual cycles At least 3 months |
Table of treatment regimen for calcium preparations [86], [1]:
Drug name | Dosages and administration frequency | Duration of use |
|---|---|---|
#Calcium carbonate + Calcium lactogluconate (A12AA20 Calcium preparations in combination) [86] | 500 mg, 1 tablet 2 times daily | Therapy duration is determined individually |
#Calcium carbonate + Calcium lactogluconate (A12AA20 Calcium preparations in combination) [86] | Adolescents: 1200 mg daily 500 mg, 1 tablet 2 times daily | Therapy duration is determined individually For 3 menstrual cycles |
Appendix B. Physician Action Algorithms
Appendix C. Patient Information
Premenstrual syndrome (PMS) is a disorder observed in the second half of the menstrual cycle after the estimated day of ovulation. Its symptoms subside with the onset or during the first days of menstruation. The exact causes of PMS are not established, but scientific theories highlight the role of hormonal fluctuations and dysfunctional changes in the central nervous system (CNS).
PMS manifestations vary: physical symptoms include breast tenderness, bloating, nausea, weight gain, edema, skin rash, headaches, back pain, tachycardia, thirst, chills, dyspnea, and others; psychoemotional and behavioral symptoms include mood swings, depressed mood, crying spells, fatigue, weakness, irritability, anxiety, anger, sleep disturbances, increased appetite, and others; there are also atypical PMS symptoms (fever, coughing attacks, dyspnea, intractable vomiting, severe allergic reactions, and others).
PMS symptoms can reduce the quality of life, but do not severely limit a woman's daily activities. However, in some cases, the severity of symptoms prevents a woman from engaging in routine tasks (at family, at work), which may indicate the extreme severity of PMS—premenstrual dysphoric disorder (PMDD).
If PMS symptoms are present, a woman should consult an obstetrician-gynecologist for necessary examination and treatment recommendations.
There are various approaches to treating PMS depending on its form and severity. Medications that a doctor may offer are divided into hormonal and non-hormonal. Hormonal medications include fixed combinations of progestogens and estrogens, progestogens, and others. Non-hormonal medications include SSRI antidepressants (according to ATC - N06AB Selective serotonin reuptake inhibitors), herbal remedies, and others.
An important strategy for maintaining overall health and reducing the severity of PMS is maintaining a normal body weight, quitting bad habits, proper nutrition, and regular physical activity.
Appendix G. Assessment Scales, Questionnaires, and Other Evaluation Tools
Appendix G1 Table 1. Classification of study results according to the BI-RADS system and recommended management tactics [101]
Table passport:
Title in Russian: Classification of study results according to the BI-RADS system and recommended management tactics.
Source: American College of Radiology (ACR). ACR-BI-RADS®--5th Edition. ACR Breast Imaging Reporting and Data System, Breast Imaging Atlas; BI-RADS. Reston, VA: American College of Radiology; 2014.
Type (underline):
- rating scale
Content (template): The table consists of 3 columns: the first column contains the study results according to the BI-RADS system, the 2nd column contains the probability of breast cancer, and the 3rd column contains management tactics depending on the study results (with 3 subsections: Ultrasound, Mammography, MRI).
Key (interpretation): Allows determining patient management tactics based on examination results according to the BI-RADS system.
Explanations: The classification of examination results according to the BI-RADS system and recommended management are presented.
Classification category | Probability of breast cancer | Management tactics depending on the examination performed | ||
|---|---|---|---|---|
Mammography | ultrasound | MRI | ||
BI-RADS 0: Incomplete assessment – additional imaging evaluation needed (and/or comparison with previous mammograms in case of mammographic screening) | Not applicable | Recall for additional imaging evaluation, comparison with previous results, or both | Recall for additional imaging evaluation | Recommended as additional imaging: mammography or targeted ultrasound |
BI-RADS 1: Negative | Probability of malignancy is essentially 0% | Routine screening | Routine screening | Routine screening if the cumulative lifetime risk of breast cancer is ≥20%⃰ |
BI-RADS 2: Benign findings | Probability of malignancy is essentially 0% | Routine screening | Routine screening | Routine screening if the cumulative lifetime risk of breast cancer is ≥20%⃰ |
BI-RADS 3: Probably benign findings | Probability of malignancy >0% but ≤2% | Short-interval (6-month) follow-up with dynamic mammography | Short-interval (3–6 month) follow-up with dynamic ultrasound | Short-term (6-month) follow-up interval as indicated by the radiologist |
BI-RADS 4: Suspicious for malignancy | Probability of malignancy >2% but <95% | Mammography, breast ultrasound, possibly contrast-enhanced breast MRI to assess the extent of the process Diagnosis is established based on biopsy results | ||
BI-RADS 5: Highly suggestive of malignancy | Probability of malignancy >95% | |||
BI-RADS 6: Biopsy-proven malignancy | Not applicable | Surgical treatment if clinically indicated | ||
⃰cumulative breast cancer risk is calculated using a computer program based on the GAIL model (NCCN, 2017) (available at https://www.cancer.gov/bcrisktool/Default.aspx)