Premenstrueel syndroom (PMS)

Initiatief: NVOG Aantal modules: 14

Cognitieve gedragstherapie als behandeling bij vrouwen met PMS

Uitgangsvraag

Wat is de plaats van cognitieve gedragstherapie in de behandeling van PMS?

Aanbeveling

Overweeg cognitieve gedragstherapie als behandeling van PMS.

 

Weeg de gevraagde tijdsinvestering en benodigde motivatie mee en beslis samen met de patiënte of cognitieve gedragstherapie ingezet wordt als behandeling van PMS.

Overwegingen

Voor- en nadelen van de interventie en de kwaliteit van het bewijs

Op basis van de resultaten van de literatuuranalyse lijkt cognitieve gedragstherapie (CGT) te leiden tot een vermindering van PMS-symptomen (overall score), lichamelijke PMS-symptomen (subdomein score) en depressieve symptomen bij vrouwen met PMS. De overall bewijskracht is gegradeerd met een lage GRADE, dit heeft ermee te maken dat er ernstige risk of bias is (alle geïncludeerde studies zijn beoordeeld als high risk of bias). Geen van de geïncludeerde studies rapporteerde specifiek het effect van CGT op buikpijn, mastalgie, of oedeem (GRADE zeer laag), maar er werd wel in 2 studies een score gegeven voor fysieke symptomen (subdomein score van PMS-vragenlijst).

 

In de literatuuranalyse worden de uitkomstmaten gerapporteerd die vooraf in de PICO waren gedefinieerd. De geïncludeerde studies lieten daarnaast ook op een aantal andere uitkomstmaten die niet in onze PICO zaten, maar wel PMS-gerelateerde symptomen zijn, een positief effect van CGT zien, te weten een verbetering van:

  • Angstklachten (op basis van Beck Anxiety inventory en HADS subdomein angst) (gestandaardiseerd gemiddeld verschil -0.55 (95%CI -1.02 tot -0.09); (Blake, 1998; Panahi, 2016; Sepehrirad, 2018; Ussher, 2017)).
  • Gedragsmatige klachten (samengestelde maat van psychologische symptomen op basis van de Daily Symptom Records questionnaire) (gestandaardiseerd gemiddeld verschil -1.17 (95%CI -1.84 tot -0.49; Askari, 2018).
  • Premenstruele distress (op basis van Subjective Evaluation of PMDs Questionnaire (SEPQ)) (gestandaardiseerd gemiddeld verschil -1.13 (95%CI -1.70 tot -0.55; Ussher, 2017).
  • Gebrek aan energie of interesse (op basis van subdomein Premenstrual Symptoms Screening Tool (PSST)) (gestandaardiseerd gemiddeld verschil -0.47 (95%CI -1.01 tot 0.06); Ussher, 2017).
  • Agressie (op basis van Agression Questionnaire (AGQ)) (gestandaardiseerd gemiddeld verschil -1.40 (95%CI -2.21 tot -0.59); Sepehridad, 2018).
  • Emotionele reactiviteit (op basis van subdomein (PSST)) (gestandaardiseerd gemiddeld verschil -0.34 (95%CI -0.87 tot 0.20)).

Cognitieve gedragstherapie omvat doorgaans aanpassingen in de leefstijl en interventies gericht op het doorbreken van gevoelens van machteloosheid en depressie. Hiervan zijn weinig tot geen negatieve bijwerkingen bekend en dit kan daarom laagdrempelig worden overwogen.

 

Naast cognitieve gedragstherapie is er beperkt onderzoek gedaan naar psycho-educatie. In de literatuursearch kwam 1 studie naar voren (Taghizadeh, 2013), maar deze voldeed niet aan de PICO criteria. Deze studie rapporteerde, net als Basogul (2019)een positief effect van psycho-educatie in vergelijking met controle groep op totale PMS-klachten, angst en depressieve gevoelens in vrouwen met PMS.

 

Waarden en voorkeuren van patiënten

Vrouwen met PMS wensen een efficiënte behandeling voor hun klachten. Bovenstaande literatuursearch laat zien dat cognitieve gedragstherapie een vermindering van PMS-klachten kan geven op verschillende niveaus waaronder fysieke klachten, depressieve gevoelens en angst. Het voordeel van cognitieve gedragstherapie is dat het geen bijwerkingen kent, niet invasief is en langdurig effect kan hebben gezien de aanpassing van leefstijl/ gedrag. Het vergt echter wel een tijdsinvestering en motivatie; patiënten zullen ervoor open moeten staan.

 

Kosten (middelenbeslag)

Er is geen systematisch literatuuronderzoek bekend over de mogelijk kosteneffectiviteit van cognitieve gedragstherapie bij de behandeling van PMS. Het is aannemelijk dat aangezien de behandeling geen risico’s kent en langdurig effect kan hebben, het de kosten waard zou kunnen zijn.

 

Aanvaardbaarheid, haalbaarheid en implementatie

Het is onbekend in hoeverre cognitieve gedragstherapie haalbaar en aanvaardbaar is bij patiënten. Aangezien er tijd en motivatie nodig is voor een dergelijk proces zal cognitieve gedragstherapie niet bij iedereen hetzelfde resultaat geven.

 

Rationale van de aanbeveling: weging van argumenten voor en tegen de interventies

De resultaten van de literatuuranalyse zijn beoordeeld met een lage bewijskracht, vanwege de hoge kans op bias in alle geïncludeerde studies. Cognitieve gedragstherapie lijkt in de behandeling van PMS in vergelijking met geen behandeling een reductie te geven van algemene PMS-klachten, fysieke PMS-klachten en depressieve gevoelens in vrouwen met PMS.

 

Vanwege het effect op gedrag en leefstijl, en afwezigheid van bijwerkingen/ risico’s kan cognitieve gedragstherapie overwogen en besproken worden. De nadelen van de tijdsinvestering en noodzaak tot motivatie zullen per patiënte gewogen worden.

Onderbouwing

In de praktijk wordt cognitieve gedragstherapie (CGT) als behandeling van PMS weinig toegepast, mogelijk vanwege te weinig kennis/acceptatie. Er lijkt echter wel een positief effect te zijn van CGT; een update van literatuur is gewenst. Afhankelijk van de presentatie en wens van de patiënte is er wellicht plaats voor CGT in de behandeling van PMS.

1. Overall PMS symptoms

Low

GRADE

Cognitive behavioral therapy compared to no treatment or wait-list control might lead to a reduction of overall PMS symptoms in women with PMS.

 

Sources: Askari, 2018; Blake, 1998; Panahi, 2016 and Ussher, 2017

2. Physical PMS symptoms

Low

GRADE

Cognitive behavioral therapy compared to no treatment or wait-list control might lead to a reduction of physical PMS symptoms in women with PMS.

 

It is unclear which physical symptoms (lower abdominal pain, pain unspecified, mastalgia, oedema or bloating) could be reduced by cognitive behavioral therapy (no grade or very low grade).

 

Sources: Askari, 2018 and Ussher, 2017

3. Depressive symptoms

Low

GRADE

Cognitive behavioral therapy compared to no treatment or wait-list control might lead to less depressive symptoms in women with PMS.

 

Sources: Blake, 1998; Panahi, 2016 and Ussher, 2017

Description of studies

In total, 6 studies were included in the literature analysis (Askari, 2018; Basogul, 2019; Blake, 1998; Panahi, 2018; Sepehridad, 2018; Ussher, 2017). A table with a detailed description of the intervention and control group conditions per study can be found in the appendix.

 

Askari (2018) reported the results of a randomized controlled trial (RCT) that examined the effects of mindfulness-based CBT compared to no intervention (control group). Students from one Iranian University with PMS were eligible for study participation. PMS diagnosis was based on the Daily Symptom Records Questionnaire, a validated Iranian questionnaire to determine PMS. Inclusion criteria were being 18 to 35 years of age, accessibility within the next six months, PMS questionnaire score 33 to 64, being single, and having regular menstrual periods (21 to 35-day cycles and 3 to 10 days of bleeding), no known mental and physical disorders, no adverse events during the last three months, no surgery in the past three months, and no use of antidepressants or hormonal drugs in the past three months. Exclusion criteria: alcohol addiction, absence more than three sessions, being a student or graduated from counseling/ psychology program. In total, 40 women were eligible for study inclusion and randomized to either group-based mindfulness cognitive therapy (n=20) or no intervention (n=20). The intervention includes training of meditation and psychoeducation on cognitive processing, see the table under ‘Bijlagen’ for elaborate description. Measurements were performed at baseline, 2 months post-baseline (post-test measurement) and 3 months post-baseline (1 month follow-up). Patient characteristics did not differ at baseline between groups. Lost to follow-up was not reported.

 

Basogul (2019) reported the results of a single-blinded RCT that examined the effectiveness of a cognitive behavioral approach of psychoeducation in women with PMS. Inclusion criteria were a score of 110 points or higher on the PMS scale (Premenstrual Syndrome Questionnaire) as developed by Gençdoğan (2006). It is a self-report questionnaire that covers 9 subscales and 44 items. Participants responded on a 5‐point Likert scale. Subdomains were: depressive affect, anxiety, fatigue, anger, depressive thoughts, pain, appetite, sleepiness and bloating. Lowest score possible was 44 points, highest 220. Exclusion criteria were refusal to participate in the study and having an irregular menstrual cycle, the use of oral contraceptives (because it affects PMS) and failure to attend the sessions in the intervention group. In total, 90 women (mean age 19.09 years (SD 1.69)) were 1:1 randomized to either a cognitive behavioral approach of psychoeducation or control group (no intervention). Two women in the intervention group were excluded due to absence from intervention group sessions. Therefore, in total 43 women in the intervention group and 45 women in the control group were assessed. Measurements were performed at baseline and 3 months post-baseline. Patient characteristics did not differ at baseline between groups, but data was not shown.

 

Blake (1998) reported the results of an RCT that examined the effects of cognitive therapy as a psychological treatment for PMS, compared to waitlist control. Women complaining of premenstrual symptoms were referred by general practitioners and gynecologists. During an initial period of 2 months, these women completed daily diaries of premenstrual symptoms diary. These diaries were used to select women with PMS as defined by specific criteria explained in what follows. Inclusion criteria were: (a) regular menstruation; (b) the woman had consistently (6 month history) experienced symptoms during the luteal phase of the cycle; and (c) the diagnosis of PMS was prospectively confirmed from two consecutive cycles recorded in the diaries, which was a modified version of the Moos Menstrual Distress Questionnaire. Exclusion criteria were major psychiatric disorders, other gynecological disorders, drug or alcohol abuse, or any condition requiring psychotropic medication. In total, 11 were allocated to the immediate treatment group, who began cognitive therapy within 2 weeks of allocation; and 12 were allocated to a waiting list group. At baseline n=24 women were allocated, but one woman declined after allocation, presumably in the intervention group. No other reports of lost to follow-up or incomplete outcome measurement was reported in text. Measurements were performed at baseline and 12 weeks post-baseline (post-treatment). Patient characteristics did not differ at baseline between groups.

 

Panahi (2016) reported the results of an RCT that examined the effects of mindfulness based CBT compared to no intervention (control group). Students from one Iranian University with mild to moderate PMS and who had depressive symptoms were eligible for study participation. PMS diagnosis was based on the results of the Premenstrual Assessment Scale (PAS) for at least two menstrual cycles, using the American College of Obstetricians and Gynecologist criteria to confirm diagnosis. Women had to have had a normal menstruation for at least two years to be included. Mild or moderate depression was based on Beck Depression Inventory (BDI) (score 16 to 47). Exclusion criteria were currently taking any psychotherapy, using any support group or relaxation technique, taking any antidepressant drugs, no depressive symptoms (BDI score  <16), severe depressive symptoms (BDI > 47), or PMDD. In total, 60 women were eligible for study inclusion and randomized to either group-based mindfulness cognitive therapy (n=30) or no intervention (n=30). The intervention was an integrative program of mindfulness based stress reduction and CBT, see the table under ‘Bijlagen’ for elaborate description. Measurements were performed at baseline and 8 weeks post-baseline (post-test measurement). Patient characteristics did not differ at baseline between groups. Lost to follow-up was not reported.

 

Sepehrirad (2018) reported the results of quasi experimental RCT that examined the effectiveness of CBT and CBT with nutrition advice compared to no intervention (control group). Adult women with moderate to severe PMS who did not have physical and psychological illness and were not pregnant and did not receive any other treatment were included in the study. The diagnosis of moderate to severe PMS was based on the Premenstrual Symptom Screening Tool (PSST) questionnaire. Women who needed to take medication for any reason and had specific psychiatric conditions, pregnant women, and were reluctant to participate in the project were excluded. In total, 45 women eligible for study inclusion were randomized to either CBT (n=15), CBT with nutrition (n=15) or control group (n=15). Measurements were performed at baseline, after 2 months intervention (post-intervention) and at 2 months follow-up after the intervention ended. Patient characteristics did no differ at baseline between groups. Lost to follow-up was not reported. For the purpose of the analysis, the results from the CBT with nutrition group are not reported here. Detailed information on the nutrition advice based on Iranian cuisine is provided full text by Sepehrirad (2018).

 

Ussher (2017) reported the results of an RCT that examined the effectiveness of couple-based CBT and one-to-one CBT compared to wait-list control in women with premenstrual disorders. Participants were eligible if they were aged between 18 and 45 years, having regular cycles (21 to 35 days); presently not taking hormonal medication (excluding contraceptives), psychotropic medication, or having been diagnosed with a major psychiatric illness; not having been pregnant or lactating within the previous 12 months. Criteria for a PMDs diagnosis were assessed with the Premenstrual Symptoms Screening Tool (PSST), with confirmation by daily diary measures, demonstrating a 30% difference in symptoms between the pre- and post-menstrual period, for two consecutive months, which cause moderate-severe impairment. If women did not report a 30% increase in premenstrual symptoms after two cycles, they were invited to complete a third, and sometimes fourth, cycle of daily diaries. In total, 96 women were eligible for study participation and randomly allocated to one of three arms. However, after allocation 13 women withdrew from the study (presumably, n=4 couple based therapy; n=2 one-to-one therapy; n= 7 waitlist control; but this was not explicitly reported by the authors). Therefore, 28 women started couple-based CBT, 30 women started one-to-one therapy and 25 women were on waitlist control. Patient characteristics did no differ at baseline between groups. The study did not specify the number of women with PMDD or PMS based on the screening questionnaire PSST. Measurements were performed at baseline, after 5 months intervention (post-intervention) and at 3 months follow-up after the intervention ended. Women in the control group did not complete the follow-up measurement, reasons were not reported. Presumably the women then entered the intervention themselves after being on waitlist control. Lost to follow-up was high and reasons why were not described in detail. In the couple-based CBT group 13/28 (46%) women were lost to follow-up, 9/30 (30%) women in one-to-one therapy and 4/25 (16%) women in waitlist control.

 

Results

Below are reported the results from the literature analysis per outcome measure as defined in the PICO. Meta-analyses were performed where possible. The study by Ussher (2017) compared couple-based CBT and one-to-one CBT with control. Whenever Ussher (2017) was included in the analysis, the results from the one-to-one CBT intervention are reported. The results from the couple-based CBT showed a similar effect in all analyses (data not shown).

 

1. Overall PMS symptoms

Five studies reported the outcome measure overall PMS symptoms (Askari, 2018; Basogul, 2019; Blake, 1998; Panahi, 2016; Ussher, 2017). Blake (1998) reported results based on diary entry, but as no exact data were reported, we can only descriptively report their results below.

 

Askari (2018) reported overall PMS symptomology based on the Daily Symptom Records (DSR) questionnaire at post-test (2 months post-baseline) and 1 month follow-up (3 months post-baseline). The DSR total score was used, which is a mean score of symptoms from a week prior to the menstrual bleeding to five days afterward. The severity of physical symptoms was calculated by adding the score of the symptoms such as headache, breast tenderness, acne, swelling, bloating, palpitations, and the severity of psychological symptoms was determined by a total score of the symptoms including irritability, tension, sleep problems, mood swings, food cravings, willingness to be alone, depression, forgetfulness, anxiety, poor concentration, crying, commitment to suicide, decreased libido, and fatigue.

 

Basogul (2019) used the PMS scale (Premenstrual Syndrome Questionnaire) as developed by Gençdoğan (2006). It is a self-report questionnaire that covers 9 subscales and 44 items. Participants responded on a 5‐point Likert scale at 3 months post-test. Subdomains were: depressive affect, anxiety, fatigue, anger, depressive thoughts, pain, appetite, sleepiness and bloating.

 

Panahi (2016) used the PAS (Premenstrual Assessment Scale) at post-test (2 months post-baseline). The PAS is a self-reported questionnaire designed in an Iranian project. It contains two subscales that cover somatic and psychological symptoms (not described in detail).

 

Ussher (2017) used the Premenstrual Symptoms Screening Tool (PSTT) at post-test (5 months post-baseline), which assesses emotional reactivity/mood, lack of energy/interest and physical symptoms (not described in detail).

 

In all studies, a higher score implicated more symptoms. A meta-analysis was performed with a random-effects model and standardized mean difference as effect measure, due to different questionnaires used to assess post-treatment effects.

 

The standardized mean difference in overall PMS symptoms at post-test measurement was -1.10 (95%CI -1.83 to -0.37) between women in the CBT group compared to women in the control group (Figure 4.8.1 Overall PMS symptoms at post-test measurement, comparison CBT versus control).

 

Figure 4.8.1 Overall PMS symptoms at post-test measurement, comparison CBT versus control

 

Blake (1998) did not report exact data, but described that treatment was associated with an overall reduction in symptoms (premenstrual, menstrual and severe symptoms) reported in the diary.

 

One study reported follow-up data. Askari (2018) reported a similar effect at 1 month follow-up (3 months post-baseline), with a standardized mean difference of -1.58 (95%CI -2.30 to -0.86). Mean difference was -12.00 (95%CI -16.60 to -7.40).

 

2. Physical PMS symptoms

Two studies reported the outcome measure physical PMS symptoms (Askari, 2018; Ussher, 2017). Askari (2018) used the Daily Symptom Records (DSR) questionnaire, subdomain physical PMS symptoms at post-test (2 months post-baseline) and 1 month follow-up (3 months post-baseline). The DSR subdomain physical symptoms was calculated by adding the score of the symptoms such as headache, breast tenderness, acne, swelling, bloating, palpitations. Ussher (2017) used the PSTT questionnaire, subdomain physical PMS symptoms (not defined in text), at post-test (5 months post-baseline).

The standardized mean difference in physical PMS symptoms at post-test measurement was -1.01 (95%CI -1.80 to -0.22) between women in the CBT group compared to women in the control group (Figure 4.8.2 Physical PMS symptoms at post-test measurement, comparison CBT versus control).

 

Figure 4.8.2 Physical PMS symptoms at post-test measurement, comparison CBT versus control

 

One study reported follow-up data. Askari (2018) reported a similar effect at 1 month follow-up (3 months post-baseline), with a standardized mean difference of -1.38 (95%CI -2.08 to -0.69). Mean difference was -5.15 (95%CI -7.41 to -2.89).

 

2.1 Lower abdominal pain

This outcome measure was not reported in the included studies.

 

2.2 Pain (unspecified)

One study reported the outcome measure pain (Basogul, 2019). It was not specified what kind of pain this was, or whether this was general pain. As reported before, Basogul (2019) used the PMS scale (Premenstrual Syndrome Questionnaire) as developed by Gençdoğan (2006), which is a self-report questionnaire that covers 9 subscales and 44 items. Pain was one of the subscales, with a higher score indicating more pain as reported at 3 months post-intervention.

 

The mean difference in pain (unspecified) was -0.30 (95%CI -1.47 to 0.87) between women with PMS in the CBT guided psychoeducation group compared to the control group.

 

2.3 Mastalgia

This outcome measure was not reported in the included studies.

 

2.4 Oedema

This outcome measure was not reported in the included studies.

 

2.5 Bloatedness

One study reported the outcome measure bloating (Basogul, 2019). Basogul (2019) used the PMS scale (Premenstrual Syndrome Questionnaire) as developed by Gençdoğan (2006), which is a self-report questionnaire that covers 9 subscales and 44 items. Bloating was one of the subscales, with a higher score indicating more bloating reported at 3 months post-intervention.

 

The mean difference in bloating was - 0.07 (95%CI -1.38 to 1.52) between women with PMS in the CBT guided psychoeducation group compared to the control group.

 

3. Depression

Four studies reported the outcome measure anxiety (Basogul, 2019; Blake, 1998; Panahi, 2016; Ussher, 2017). Basogul (2019) used the PMS scale, as reported before. This scale contains 2 subdomains, i.e. depressive affect and depressive thoughts. Two studies used the Beck Anxiety Inventory (Blake, 1998; Panahi, 2016), one study use the Hospital Anxiety and Depression scale (HADS), subdomain depression (Ussher, 2017). Post-test measurements were at 12 weeks, 2 months, 3 months, and 5 months post-baseline, respectively (Blake, 1998; Panahi, 2016; Basogul, 2019; Ussher, 2017).

 

The standardized mean difference in depression at post-test measurement was -0.72 (95%CI -1.27 to -0.18) between women in the CBT group compared to women in the control group (Figure 4.8.3 Depression at post-test measurement, comparison CBT versus control). When depressive affect instead of depressive thoughts as reported by Basegul (2019) was included as post-test depression score, the standardized mean difference reported an effect in similar direction, albeit somewhat less strong  (SMD -0.58 (95%CI -1.28 to 0.12)) (data not shown in Figure).

 

Figure 4.8.3 Depression at post-test measurement, comparison CBT versus control

 

Level of evidence of the literature

Randomized controlled trials start at a high level of evidence.

 

The level of evidence regarding the outcome measure overall PMS symptoms was downgraded by two levels to a low GRADE, because of serious risk of bias (see risk of bias table in appendix). We did not downgrade for indirectness due to an unknown number of PMDD patients included in the study by Ussher (2017). The results from this study (mixed PMS and PMDD population) showed results in the same direction as the PMS studies included.

 

The level of evidence regarding the outcome measure physical PMS symptoms was downgraded by two levels to a low GRADE, because of serious risk of bias.

 

The level of evidence regarding the outcome measure lower abdominal pain was not graded because none of the included studies reported the outcome.

 

The level of evidence regarding the outcome measure pain (unspecified) was downgraded by three levels to a very low GRADE because of serious risk of bias (Basogul (2019) was at high risk of bias) and because of indirectness (cognitive behavioral approach of psychoeducation is not entirely the same as CBT).

 

The level of evidence regarding the outcome measure mastalgia was not graded because none of the included studies reported the outcome.

 

The level of evidence regarding the outcome measure oedema was not graded because none of the included studies reported the outcome.

 

The level of evidence regarding the outcome measure bloatedness was downgraded by three levels to a very low GRADE because of serious risk of bias (Basogul (2019) was at high risk of bias) and because of indirectness (cognitive behavioral approach of psychoeducation is not entirely the same as CBT).

 

The level of evidence regarding the outcome measure depressive symptoms was downgraded by two levels to a low GRADE, because of serious risk of bias.

A systematic review of the literature was performed to answer the following question:

What is the effectiveness of cognitive behavioural therapy (CBT) compared to a placebo or no treatment in women with premenstrual syndrome (PMS)?

 

P:      Women with PMS.

I:       Cognitive behavioural therapy (CBT).

C:      Placebo or no treatment.

O:      PMS symptoms: lower abdominal pain, mastalgia, oedema, bloatedness, depressive symptoms.

 

Relevant outcome measures

The guideline development group considered PMS symptoms as critical outcome measure for decision making.

 

A priori, the working group did not define the outcome measures listed above but used the definitions used in the studies.

 

A 25% difference in the relative risk for dichotomous outcomes or a 0.5 difference in standard deviation for continuous outcomes - was taken as a minimal clinically important difference.

 

Search and select (Methods)

 

Search strategy in 2010

In 2010, the literature search was based on the search from the Royal College of Obstetricians and Gynaecologists (RCOG) PMS guideline (Panay, 2007) and supplemented with searches in the databases Pubmed and Embase (via OVID; both searched from 2006 till September 2010) and PsychInfo (searched from 2005 till December 2010). In total, 419 unique studies were retrieved. The selection criteria were not reported. The number of articles selected for title and abstract screening were not reported. The search strategy is depicted under the tab Methods. In total, 1 review on CBT was selected (Lustyk, 2009). This review identified one RCT that adheres to our PICO (Blake, 1998).

 

Search strategy in 2021

In 2021 the search was updated. The databases Medline (via OVID) and Embase (via Embase.com) were searched with relevant search terms until March 26, 2021. The detailed search strategy is depicted under the tab Methods. The systematic literature search resulted in 57 hits. Studies were selected based on the following criteria: 1) studies reporting on women with PMS; 2) studies comparing a CBT intervention with a placebo or no intervention; 3) at least one PMS symptom was reported as outcome measure. 22 studies were initially selected based on title and abstract screening. After reading the full text, 17 studies were excluded (see the table with reasons for exclusion under the tab Methods) and 6 studies were included.

 

Results

In total, six studies were included in the analysis of the literature. Important study characteristics and results are summarized in the evidence tables. The assessment of the risk of bias is summarized in the risk of bias tables.

  1. Askari, Saeedeh, Nasser Behroozi, and Zahra Abbaspoor. "The effect of mindfulness-based cognitive-behavioral therapy on premenstrual syndrome." Iranian Red Crescent Medical Journal 20.2 (2018): e57538
  2. Başoğul, C., Aydın Özkan, S., & Karaca, T. (2020). The effects of psychoeducation based on the cognitive‐behavioral approach on premenstrual syndrome symptoms: A randomized controlled trial. Perspectives in psychiatric care, 56(3), 515-522.
  3. Blake F, Salkovskis P, Gath D, Day A, Garrod A. Cognitive therapy for premenstrual syndrome: a controlled trial. J Psychosom Res. 1998 Oct;45(4):307-18.
  4. Gençdogan B. A new instrument for premenstrual syndrome. Psychiatry in Turkey. 2006;8:81‐87.
  5. Panahi F, Faramarzi M. The Effects of Mindfulness-Based Cognitive Therapy on Depression and Anxiety in Women with Premenstrual Syndrome. Depress Res Treat. 2016;2016:9816481.
  6. Sepehrirad, M., H. R. Bahrami, and M. R. Noras. "Effectiveness of Nutritional program and cognitive-behavioral training in Anxiety, anger & aggression Premenstrual Syndrome." Journal of Babol University of Medical Sciences 20.1 (2018): 26-20.
  7. Ussher JM, Perz J. Evaluation of the relative efficacy of a couple cognitive-behaviour therapy (CBT) for Premenstrual Disorders (PMDs), in comparison to one-to-one CBT and a wait list control: A randomized controlled trial. PLoS One. 2017 Apr 18;12(4):e0175068.

Research question: What is the effectiveness of cognitive behavioural therapy (CBT) compared to a placebo or no treatment in women with premenstrual syndrome (PMS)?

Study reference

Study characteristics

Patient characteristics

Intervention (I)

Comparison / control (C)

 

Follow-up

Outcome measures and effect size

Comments

Askari, 2018

Type of study: RCT

 

Setting and country: single University, Iran.

 

Funding and conflicts of interest:

Inclusion criteria: 18 - 35 years, accessibility within the next six months, PMS questionnaire score 33 - 64, being  single, and regular

menstrual periods (21 - 35-day cycles and 3 - 10 days of

bleeding), no known mental and physical disorders, no adverse events during the last three months, no surgery in the past three months, and no use of antidepressants or

hormonal drugs in the past three months.

 

PMS questionnaire was Daily Symptom Records Questionnaire, validated Iranian questionnaire.

 

Exclusion criteria: alcohol addiction, absence more than three

sessions, being a student or graduated from counseling/

psychology program

 

N total at baseline:40

Intervention:  20

Control: 20

 

Important prognostic factors:

For example

age ± SD:

I: 21.55 ± 1.73

C: 21.50 ± 1.35

 

Sex: 100%F

 

Groups comparable at baseline? Yes

 

Describe intervention (treatment/procedure/test):

 

Mindfulness based cognitive therapy.

 

The participants in the intervention group received eight 1-hour sessions of mindfulness-based cognitive behavioural counselling presented by the corresponding author.

 

Mindfulness-based cognitive therapy includes training of meditation and psychoeducation on cognitive processing according to the following standard protocol:

1- Attentional control that is maintaining a moment-bymoment awareness.

2- How to disengage from judgmental and evaluative

language by processing and moving to an experiential attention of the present moment.

3- How to disengage from negative thoughts and emotions and physical sensations.

Mindfulness-based intervention allows the practitioners to act more reflectively rather than impulsively. In the

present study, MBCT was implemented within eight sessions.

The first session included rapport with the client,

gathering the information, providing psychoeducation on mindfulness, cognitive-behavioral therapy (CBT), identifying depression, stress, anxiety, and automatic thoughts,

and guiding the client through mindfulness meditation. In the next session, awareness of bodily sensations and in the third session, dealing with barriers as well as short

breathing meditation, while being compassionate with

her, was trained. In the fourth session, the client was helped to understand most of her thoughts are not necessarily a fact, and

she learned how to use the thought records; also, training on cognitive distortion was provided. In the fifth session the ability to live at the time while being aware of attachments and aversions was trained; then, deep breathing and sleep health benefits were explained and the client

learned how to have a brief body exercise. In the sixth session, the thoughts and emotions were accepted as fleeting events; then, daily mindfulness, mindful eating, and mindful labeling of thoughts, feelings, and

behaviors were also trained.

In the next session, the client was familiarized with

the symptoms of depression, stress, and rumination thinking. Also, the client was trained how to accept rumination

thinking without judgment and use the diffusion technique to reduce it. In the last session, the insights and techniques found most useful by the client as well as identifying the obstacles to practice mindfulness was reviewed, and a checklist of techniques presented in the program was provided (31-33).

Describe control (treatment/procedure/test):

 

No intervention.

Length of follow-up: 3 months total > baseline, post-test (2 months post baseline) and 1 month follow-up (3 months post baseline)

 

Loss-to-follow-up: NOT REPORTED

Intervention:

N (%)

Reasons (describe)

 

Control:

N (%)

Reasons (describe)

 

Incomplete outcome data: NOT REPORTED.

Interestingly, absence from more than 3 sessions resulted in study exclusion on forehand, not reported whether this occurred. It is not listed as reason for exclusion in the flowchart.

 

Intervention:

N (%)

Reasons (describe)

 

Control:

N (%)

Reasons (describe)

 

 

Outcome measures and effect size (include 95%CI and p-value if available):

 

1. PMS symptoms

Outcome measures below were determined based on the Daily Symptom Records questionnaire. A 32-item self-report, standard inventory developed to determine PMS. Higher score is worse symptoms. Validated questionnaire in Iranian population.

 

The DSR total score was used, which is a mean score of symptoms from a week prior to the menstrual bleeding to five days afterward, comprised of the physical and behavioural scores.

 

Post-test

I: 27.65 ± 7.43

C: 40.05 ± 7.85

 

Follow-up

I: 28.15 ± 7.13

C: 40.15 ± 7.71

 

2. Physical symptoms

The DSR subdomain physical symptoms was calculated by adding the score of the symptoms such as headache, breast tenderness, acne, swelling, bloating, palpitations.

 

Post-test

I: 9.55 SD 3.10

C: 15 SD 4.29

 

Follow-up

I: 9.95 SD 2.99

C: 15.10 SD 4.2

 

3. Behavioural symptoms

The DSR subdomain behavioral symptoms comprised of psychological symptoms, including irritability, tension, sleep problems, mood swings, food cravings, willingness to be alone, depression, forgetfulness, anxiety, poor concentration, crying, commitment to suicide, decreased libido, and fatigue.

Post-test

I: 18.10 ± 6.33

C: 25.55 ± 6.17

 

Follow-up

I: 18.20 ± 6.22

C: 25.55 ± 6.12

 

 

 

Basogul, 2019

Type of study: RCT

 

Setting and country: singly University, Turkey.

 

Funding and conflicts of interest: The authors declare that there are no conflict of interests. Funding not reported.

Inclusion criteria: volunteering to participate in the study and receiving 110 points and more on the

PMS scale (Premenstrual

Syndrome Questionnaire by Gencdogan et al.).

 

Exclusion criteria:  rejecting to participate in the

study, having an irregular menstrual cycle, the use of oral contraceptives because it affects PMS, and failure to attend the sessions.

 

N total at baseline: 90

Intervention: 45

Control: 45

 

Important prognostic factors2:

For example

age ± SD: 19.09 SD 1.69 years

I: not reported

C: not reported

 

Sex: 100%F

 

Groups comparable at baseline? Yes (only reported in text, not shown).

 

Describe intervention (treatment/procedure/test):

 

Cognitive-behavioural approach psychoeducation

 

A booklet entitled “How can I cope with PMS?” was

prepared for distribution to participants in the psychoeducation group. The booklet included  information about the content of the sessions, worksheets, exercises, and assignments.

 

The students in the psychoeducation group were contacted via the nicknames and signs used in the forms. This group attended psychoeducation meetings that lasted 40 to

50 minutes. The program consisted of five sessions performed over a 4‐week period. A nurse researcher with a doctorate degree

in psychiatry nursing and who received education in this field applied the psychoeducation. The psychoeducation included verbal instruction, question and answer, and assignments. The participants were given the booklet entitled “How can I cope with PMS?”

They were asked to fill in the tables in the workbook, which were related to the topic, and complete the assignments, which were all

assessed in the following sessions. No fees were asked from the participants for the booklets. See table 1 in the fulltext paper for elaborate description of each session.

Describe  control (treatment/procedure/test):

 

No intervention.

 

NB. It is not explicitly explained whether the control group received no intervention at all, but it can be assumed based on the text.

Length of follow-up: 3 months (baseline – and 3 months post-test (follow-up measurement).

 

Loss-to-follow-up:

 

Intervention:

N (%) 2 (4.4%)

Reasons (describe) discontinued intervention (absence more then session in the intervention period n=2).

 

Control:

N (%) 0

Reasons (describe)

 

Incomplete outcome data: NOT reported.

Intervention:

N (%)

Reasons (describe)

 

Control:

N (%)

Reasons (describe)

 

 

Outcome measures and effect size (include 95%CI and p-value if available):

 

  1. PMS symptoms

The PMS scale was developed by Gençdoğan and included 9

subscales and 44 items. Participants responded on a 5‐point Likert scale (never, rarely, sometimes, frequently, and always). The lowest

and highest scores obtained from each subscale were 7 to 35, respectively, for depressive affect, 7 to 35 for anxiety, 6 to 30 for fatigue, 5 to 25 for anger, 7 to 35 for depressive thoughts, 3 to 15 for pain, 3 to 15 for appetite changes, 3 to 15 for sleep changes, and 3 to

15 for bloating. The lowest score obtained from the total scale was 44, and the highest score was 220. The presence of PMS was indicated when the highest score from the total scores and subscales exceeded 50%.

 

The PMS symptoms were experienced during the week

before menstruation.

 

Total score, see above.

 

Post-test

I: 124.88 ± 24.29

C: 135.71 ± 24.41

 

2. Physical symptoms

 

Pain

Not further defined, see above.

 

Post-test

I: 9.41 ± 2.92 (3‐15)

C: 9.71 ± 2.66 (5‐15)

 

Bloating

Not further defined, see above.

 

Post-test

I: 8.09 ± 3.21 (3‐15)

C: 8.02 ± 3.71 (3‐15)

 

3. Depressive symptoms

 

Depressive affect

Not further defined, see above.

 

Post-test

I: 22.35 (SD 5.88)

C: 22.16 (SD 4.01)

 

Depressive thoughts

Not further defined, see above.

 

Post-test

I: 18.65 ± 5.90

C: 20.98 ± 5.14

 

 

 

Blake, 1998

Type of study: RCT

 

Setting and country:

 

Funding and conflicts of interest: The study was supported by the Medical research Council and the Oxford Regional Health Authority. Paul Salkovskis is a Wellcome Trust Senior Research Fellow.

Inclusion criteria: women with regular menstruation, 6-month history of PMS symptoms occurring in the second half of the cycle. A diary based on a modified Moos Menstrual Distress Questionnaire was used as a selection tool, (a) the woman had consistently experienced symptoms during the luteal phase of the cycle; and (b) the diagnosis of PMS was prospectively confirmed from two consecutive cycles recorded in the diaries. If the woman was to be admitted to the study, the diaries must fulfill two previously determined criteria. First, there should be four symptoms of severity of >4 (moderate) for 4 of the 6 premenstrual days. Also, there should be no more than two symptoms of severity >4

on no more than 2 days in the 6 days following the menstrual week.

 

Exclusion criteria: major psychiatric disorder, other gynaecological disorder, drugs or alcohol abuse, or any other condition requiring psychotropic medication.

 

N total at baseline: 24 (1 refused trial participation)

Intervention: 11

Control: 12

 

Important prognostic factors2:

For example

age ± SD: 31.7 SD 6.4

I: not reported per group

C: not reported per group

 

Sex: 100%F

 

Groups comparable at baseline? Yes.

 

Describe intervention (treatment/procedure/test):

 

Cognitive therapy


Twelve weekly sessions of individual cognitive therapy, each session lasted about 1 hour.

 

The reality of their symptoms and the associated distress was explicitly acknowledged. Therapy was based on the establishment of a good therapeutic alliance involving collaboration between therapist and patient. The model was explained, and was usually highly acceptable. As the therapeutic relationship

was established, therapist and patient set treatment goals and agreed upon a formulation of the problems, their likely origins, and the key current maintaining factors, which were to be the target of therapy. The therapist encouraged the patient to face the problem of PMS squarely, to clarify precipitating and

perpetuating factors, and to identify unhelpful or restrictive attitudes. The therapy was collaborative and

educational and the patient was asked to set the agenda for the session, to determine priorities, and to

collect information. Each patient was asked to try out new behaviors between sessions as homework.

Each woman was encouraged to focus on specific incidents that illustrated particular target problems, and from these specific examples the therapist explored the wider issues of present  circumstances, stressors, relationships, and the patient’s reactions to these. Attention was drawn to specific links between

thoughts, feelings, behaviors and physical symptoms. Particular attention was paid to how changes in thoughts and beliefs can improve feelings and lead to new, more helpful behavior. Thought records collected between sessions were used to help the patient to learn more about her thoughts and beliefs as mediators of distress and to modify these. Incidents noted frequently revealed

repeated patterns of distress and vicious circles that prevented the crucial negative thoughts from changing, thus blocking the development of more adaptive coping strategies. As therapy progressed, reviewing several such specific incidents commonly revealed attitudes and assumptions underlying the problematic reactions characteristic of premenstrual distress. In the later stages of therapy, the woman gained ideas about actively limiting the effects of her premenstrual change, together with new perspectives on her concept of control. In addition to changing attitudes in herself, she was encouraged to elicit the help of other people more assertively.

Describe  control (treatment/procedure/test):

 

Waitlist-control group

Length of follow-up: 28 weeks.

Baseline – post-test (12 weeks post-baseline)-  2 months follow-up (20 weeks post-baseline) – 4 months follow-up (28 weeks post-baseline).

 

Loss-to-follow-up: 1, not reported to which group this woman was allocated. In total 24 women entered the trial, 1 woman refused. There was no reported lost to follow-up during the trial.

 

Intervention:

N (%)

Reasons (describe)

 

Control:

N (%)

Reasons (describe)

 

Incomplete outcome data: NOT reported.

Intervention:

N (%)

Reasons (describe)

 

Control:

N (%)

Reasons (describe)

 

 

Outcome measures and effect size (include 95%CI and p-value if available):

 

1. PMS symptoms

Blake et al. studied the outcome based on daily diary data. However, no exact data can be extracted from text. Descriptively can be concluded that:

Treatment was associated with an overall reduction in symptoms reported in the diary. Analyses indicated a consistent pattern of association between the treatment and significant overall improvement in symptoms (premenstrual, menstrual and severe symptoms).

 

2. Physical symptoms

Not specified.

 

3. Depressive symptoms

Based on Beck Depression Inventory

 

Post-test

I: mean 4.1 (SD 7.4)

C: mean 14.1 (SD 10.5)

 

Anxiety

Based on Beck Anxiety Inventory

 

Post-test

I: mean 5.6 (SD 6.8)

C: mean 12.5 (SD 9.1)

Blake et al. also studied the effects of PMS measured on the Social adjustment scale:

There was a significant effect of treatment on global ratings of difficulties experienced premenstrually (F(1, 19)56.73, p,0.01), and on global ratings of interference

with life F(1, 19)54.85, p,0.05). Ratings of impairment in ability to work were not

significantly different between treatment groups (F(1, 19)52.16, p.0.1). Similarly,

ratings of impairment were not significant for social leisure life (F(1, 19)51.11,

p.0.3) or for leisure activities (F(1, 19)52.87, p.0.1). Treatment was associated

with significant improvements in PMS-related impairment of home management

(F(1, 19)55.9, p.0.025) and in general relationship with partner (F(1, 17)56.47,

p,0.025). Sexual relationship was not significantly changed, although there was a

nonsignificant trend (F(1, 17)53.66, p50.074). In each instance, treatment effects

indicated that the treated group had improved relative to the waitlist control group

Panahi, 2016

Type of study: RCT

 

Setting and country: students from 1 University, Iran.

 

Funding and conflicts of interest: The authors declare that there is no conflict of interests

regarding the publication of this paper. Funding details not reported.

Inclusion criteria: normal menstruation for at least two years, willingness to participate in the study, a diagnosis of PMS and mild or

moderate depression (Beck score 16–47), and not currently

taking any psychotherapy, not using any support group or relaxation technique, and not taking any antidepressant

drugs. Premenstrual Assessment Scale (PAS) for diagnosis and severity of PMS for at least two menstrual cycles. The students were asked to complete the PAS one week before and after menstruation (17). A diagnosis of PMS

was confirmed with at least two symptoms (one physical and one psychological), according to the American College

of Obstetricians and Gynecologists criteria (17).

 

Exclusion criteria: Women with no depressive symptoms (BDI score

less than 16), severe depressive symptoms (BDI greater than

47), or PMDD (exhibiting more than five of the following

symptoms: depressed mood, hopelessness, humiliation, anxiety, tension, irritability, excitement, mood swings, withdrawal

from people, marked anger, increased conflict, and restlessness.

 

N total at baseline: 60

Intervention: 30

Control: 30

 

Important prognostic factors2:

For example

Age =< 20 years

I: 8 (26.6%)

C: 6 (20.0%)

 

>20 years

I: 22 (73.4%)

C: 24 (80%)

 

Sex: 100% F

 

Groups comparable at baseline? Yes

Describe intervention (treatment/procedure/test):

 

Intervention = mindfulness-based cognitive therapy.

8 group sessions, 120 min. each, over 8 weeks. 8-12 participants per group.

 

A female therapist trained in MBCT by a supervisor (M. Faramarzi) before the trial conducted the

sessions. The MBCT program consisted of integrating elements of mindfulness-based stress reduction and CBT with

guided depression/anxiety meditations. The program drew on traditional mindfulness meditation techniques, as well as guided meditation (daily activity related to  depression/anxiety), to address specific issues pertaining to depression/anxiety.

 

MBCT is conceptualized as a way of increasing the awareness of automatic patterns and then to disengage undesirable

reactivity (36). For individual practice, participants read

printed copies of material about an important part of the program, did daily formal practice for 30 minutes, did informal practice, and listened to a 20–60-minute prerecorded

CD two times daily over a period of 8 weeks (37). At the beginning of each session, the therapist asked the patients to do mindfulness skills during class and described one person’s individual experience with mindfulness out of class. The therapist then helped the patients to archive the corrected mindfulness skills

 

See full text paper for detailed session description (or guideline module).

Describe  control (treatment/procedure/test):

 

Control = Patients in the control group did not receive any intervention

 

 

Length of follow-up: 8 weeks (baseline and 8 weeks post-baseline).

 

 

Loss-to-follow-up: NOT REPORTED.

Intervention:

N (%)

Reasons (describe)

 

Control:

N (%)

Reasons (describe)

 

Incomplete outcome data: NOT REPORTED

Intervention:

N (%)

Reasons (describe)

 

Control:

N (%)

Reasons (describe)

 

 

Outcome measures and effect size (include 95%CI and p-value if available):

 

1. PMS symptoms

Based on PAS (Premenstrual Assessment Scale), higher score is worse. Iranian questionnaire, validity 0.92 and reliability 0.84. Covers somatic and psychological symptoms.

 

Post-test

I: 42.86 (SD 8.02)

C: 58.93 (SD 8.47)

 

2. Physical symptoms

Not specified

 

3. Depressive symptoms

 

Depression

Based on BDI (Beck Depression Inventory). Validated Persian was used. Higher score is worse symptoms.

 

Post-test:

I: 15.73 (SD 6.99)

C: 25.36 (SD 7.14)

 

Anxiety

Based on BAI (Beck Anxiety Inventory). Validated Persian was used. Higher score is worse symptoms.

 

Post-test

I: 16.96 (SD 7.78)

C: 26.60 (SD 9.38)

 

 

Sepehrirad (2018)

Type of study: quasi-experimental RCT

 

Setting and country: single centre, Iran.

 

Funding and conflicts of interest: not reported.

Inclusion criteria: Women with moderate to severe PMS who did

not have physical and psychological illness (death of

relatives, divorce, marriage) and were not pregnant and

did not receive any other treatment were included in

the study. The diagnosis of moderate to severe PMS was based on the Premenstrual Symptom Screening

Tool (PSST) questionnaire.

 

Exclusion criteria: Women who needed to take medication for any

reason and had specific psychiatric conditions,

pregnant women, and were reluctant to participate in

the project were excluded.

 

N total at baseline: 45

Intervention – CBT : 15

Intervention – CBT + nutrion: 15

Control: 15

 

Important prognostic factors2:

For example

Age:

20-30 years

CBT: 1(6.6)

CBT +N: 1(6.6)

Control: 3(20)

 

31-40 years:

CBT: 8(53)

CBT+N: 11(73.3) Control: 7(47)

41-50 years:

CBT: 6(40.1)

CBT+N: 3(20)

Control: 5(33)

 

Sex: 100%F

 

Groups comparable at baseline? Yes

Describe intervention (treatment/procedure/test):

 

Intervention group – CBT: The test group received 8 sessions of 90 minutes

and received training for 2 months.

 

See full text or guideline module for full description of each session.

 

Intervention group – CBT + nutrition: The test group received 8 sessions of 90 minutes and received training for 2 months.  This group also received a food program along with CBT

 

 The nutrition program was provided in a form in

order to subject begins the program two weeks before

the menstruation and observes it until the end of the menstrual period and write and mark all used

materials. The recommendations include the use of  five dried fig daily, daily servings of milk in the evening, egg yolk and carrot jam for breakfast two

days in between, rice milk or porridge with almonds,

saffron and cinnamon at dinner or breakfast, sweat or dip of Citrus aurantium daily one to two times in the morning and at night, sesame oil as an used oil,

avoiding the pumpkin, cucumber, watermelon, thyme, ginger, chicory, sour foods, salty foods, verjuice,

lentils, eggplants, fast foods, protein and industrial drinks. If they had headache, it was recommended to

avoid cinnamon, saffron, walnuts, cumin, garlic,

onions and pepper due to its Temperament quality and excessive heat production

Describe  control (treatment/procedure/test):

 

Control group: no intervention took place.

Length of follow-up: baseline, 2 month intervention (post-test), 2 month follow-up post-intervention (follow-up). Total 4 months.

 

Loss-to-follow-up: NOT REPORTED.

 

Intervention:

N (%)

Reasons (describe)

 

Control:

N (%)

Reasons (describe)

 

Incomplete outcome data:  NOT REPORTED.

Intervention:

N (%)

Reasons (describe)

 

Control:

N (%)

Reasons (describe)

 

 

Outcome measures and effect size (include 95%CI and p-value if available):

 

1. PMS symptoms

Not specified.

 

2. Physical symptoms

Not specified

 

3. Depressive symptoms

 

Anxiety

Based on Beck Anxiety Inventory  (BAI)

 

Post-test

I CBT: 15.7 SD 8.15

I CBT + nutrition: 13.8 SD 6

Control: 26.2 SD 8.15

 

2 month follow-up measurement

I CBT: 15.1 SD 7.16

I CBT + nutrition: 13.8 SD 6.1

Control: 25.1 SD 7.59

 

P-value CBT versus control: 0.018

 

Aggression

Based on Aggression Questionnaire (AGQ)

 

Post-test

I CBT: 42.2 SD 3.21

I CBT + nutrition: 41.8 SD 6.68

Control: 49 SD 5.86

 

2 month follow-up measurement

I CBT: 41.8 SD 2.24

I CBT + nutrition: 40.3 SD 6

Control: 48.9 SD 5.01

 

P-value CBT versus control: 0.018

 

 

Ussher, 2017

Type of study: RCT

 

Setting and country: single centre, Australia.

 

Funding and conflicts of interest: This study was funded by an Australian

Research Council Discovery Grant DP0984913

awarded to JU and JP. The authors have declared

that no competing interests exist.

Inclusion criteria: Participants were eligible if they were aged between 18–45 years, having regular cycles (21–35 days); presently not taking  hormonal medication (excluding contraceptives),

psychotropic medication, or having been diagnosed with a major psychiatric illness; not having been pregnant or lactating within the previous 12 months. Criteria for a PMDs diagnosis

were assessed with the Premenstrual Symptoms Screening Tool (PSST) (50), with confirmation by daily diary measures (51), demonstrating a 30% difference in symptoms between the pre- and post-menstrual period, for two consecutive months, which cause moderate-severe impairment (3, 52, 53). If women did not report a 30% increase in premenstrual symptoms after two cycles, they were invited to complete a third, and sometimes fourth, cycle of daily diaries.

 

Exclusion criteria:

 

N total at baseline: 83

Intervention – couple version: 28

Intervention – one to one version: 30

Control: 25

 

Important prognostic factors2:

For example

age ± SD:

I- couple: 35.14 (SD 7.67)

I-one to one: 34.67 (SD 8.07)

C: 34.56 (SD 8.29)

 

Sex: 100%F

 

Groups comparable at baseline? Yes

 

Describe intervention (treatment/procedure/test):

 

Intervention – one to one therapy:

Based on a woman-centred PMDs CBT intervention previously demonstrated to be effective in reducing premenstrual distress in both a face-to face (17)

and self-help modality (56). It consisted of four 90-minute sessions, conducted over a five month period (three sessions offered on a monthly basis, and one session at two month follow-up), delivered by a woman clinical psychologist. The aims of the intervention were to examine women’s attributions for  premenstrual distress within a bio-psycho-social framework, and to challenge negative self-blaming beliefs that may exacerbate  symptomatology,

such as “I should be calm and controlled all of the time”, “I should always be able to cope”, “I

shouldn’t be angry or irritable”. Behavioural coping skills, including relaxation training, taking

time out for self-care, diet and exercise were also examined and encouraged across the menstrual cycle. Finally, the relational context of premenstrual distress was explored, and assertiveness training techniques used to encourage calm expression of emotion, concerns or needs throughout the month (22). Women were given homework following each of the sessions and

a written booklet containing detailed information about each session, to supplement the meetings with the psychologist.

 

Intervention – couple version: followed the same format as one-to-one therapy, with inclusion of Couples Dialogue techniques to facilitate couple communication. This allows for the active involvement of the woman’s partner in understanding PMDs, and in strategies of prevention and amelioration.

 

 

Describe  control (treatment/procedure/test):

 

Wait-list control

 

Length of follow-up: baseline-5 month intervention- 3 months follow-up (control group not tested at 3 months follow-up, probably started their own treatment then). Total 8 month follow-up intervention group; until 5 months for the control group.

 

Loss-to-follow-up:

After allocation: n=13 (presumably, n=4 couple based therapy; n=2 one-to-one therapy; n= 7 waitlist control).

Reasons: declined to participate when contacted (n=?); withdrew participation after allocation (n=?).

 

During 5 month intervention

Intervention -couple:

N (%) 9/28

Reasons (describe): n=2 discontinued; n=7 lost to follow. Not described in more detail.

 

Intervention – one-to-one therapy:

N (%) 7/30

Reasons (describe); n=3 lost to follow-up; n=4 discontinued. Not described in more detail.

 

Control:

N (%) 4/25

Reasons (describe): n=3 lost to follow-up; n=1 discontinued.

 

During 3 month follow-up

Intervention -couple:

N (%) 4/19

Reasons (describe): n=4 lost to follow. Not described in more detail.

 

Intervention – one-to-one therapy:

N (%) 2/23

Reasons (describe); n=2 lost to follow-up. Not described in more detail.

 

Control:

N (%) 0/21

Reasons (describe): n.a.

 

Total lost to follow-up:

I – couple: 13/28 (46%)

I – one-to-one: 9/30 (30%)

Control: 4/25 (16%)

 

Incomplete outcome data:

Intervention:

N (%) 0

Reasons (describe)

 

Control:

N (%) 0

Reasons (describe)

 

 

Outcome measures and effect size (include 95%CI and p-value if available):

 

1. PMS symptoms

Not specified

 

2. Physical symptoms

Based on PSTT score (higher score = worse symptoms)

 

Post-score

I – couple: 5.19 (SD 2.87)

I – one-to-one: 5.55 (SD 2.54)

C: 7.30 (SD 2.89)

 

Total premenstrual symptoms

Based on PSTT score (higher score = worse symptoms). Emotional reactivity/mood (5 items); Lack of energy/interest (5 items); and Physical symptoms (4 items)

 

Post-score

I – couple: 20.0 (SD 8.12)

I – one-to-one: 21.86 (SD 6.97)

C: 26.25 (SD 8.48)

 

Post-hoc ANOVA:

I couple versus control: MD = 6.25, SE = 2.55, p = .045

I one to one versus control: P>0.05 (data not shown)

 

Premenstrual distress

Based on Subjective Evaluation of PMDs questionnaire (SEPQ), subdomain premenstrual distress. (higher score = worse symptoms)

 

3. Depressive symptoms

 

Emotional reactivity/mood

Based on Premenstrual Symptoms Screening Tool (PSTT) score (higher score = worse symptoms)

 

Post-score

I – couple: 8.67 (SD 3.68)

I – one-to-one: 10.10 (SD 3.22)

C: 11.30 (SD3.87)

 

Lack of energy/interest

Based on PSTT score (higher score = worse symptoms)

 

Post-score

I – couple: 6.14 (SD 2.75)

I – one-to-one: 6.22 (SD 3.07)

C: 7.65 (SD 2.85)

 

Depression

Based on HADS (higher score = worse symptoms)

 

Post-score:

I – couple: 3.0  (SD 3.14)

I – one-to-one: 4.96 (SD 4.25)

C: 5.50 (SD 4.75)

 

Anxiety

Based on HADS (higher score = worse symptoms)

 

Post-score:

I – couple: 5.84  (SD 2.93)

I – one-to-one: 7.78 (SD 3.25)

C: 9.31 (SD 5.48)

PMDs = women with PMS or PMDD.

% of PMDD in this cohort is not reported.

 

Risk of bias table

Research question: What is the effectiveness of cognitive behavioural therapy (CBT) compared to a placebo or no treatment in women with premenstrual syndrome (PMS)?

Study reference

 

(first author, publication year)

Was the allocation sequence adequately generated?

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Definitely yes

Probably yes

Probably no

Definitely no

Was the allocation adequately concealed?

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Definitely yes

Probably yes

Probably no

Definitely no

Blinding: Was knowledge of the allocated

interventions adequately prevented?

 

Were patients blinded?

 

Were healthcare providers blinded?

 

Were data collectors blinded?

 

Were outcome assessors blinded?

 

Were data analysts blinded?

 

 

 

 

Definitely yes

Probably yes

Probably no

Definitely no

Was loss to follow-up (missing outcome data) infrequent?

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Definitely yes

Probably yes

Probably no

Definitely no

Are reports of the study free of selective outcome reporting?

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Definitely yes

Probably yes

Probably no

Definitely no

Was the study apparently free of other problems that could put it at a risk of bias?

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Definitely yes

Probably yes

Probably no

Definitely no

Overall risk of bias

If applicable/necessary, per outcome measure

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

LOW

Some concerns

HIGH

Askari, 2018

Probably yes.

 

Reason: table of random numbers

Probably yes

 

Reason: table of random numbers

Probably no

 

Reasons: patients and health care providers could not be blinded. However, the health care provider was also the first author and therefore probably the outcome assessor and data analysist. Risk of bias.

No information

 

Reason: not reported whether patients were lost to follow-up, presumably all patients completed the trial. In addition, it was not reported whether there were incomplete data.

Probably yes

 

Reason: previously reported study protocol.

 

No information

 

Reason: not reported

 

HIGH (PMS symptoms)

Blake, 1998

Probably yes.


Reason: not clearly stated, otherwise than that ‘patients were randomly allocated’.

No information

 

Reason: study doesn’t provide information on how trial was performed.

Probably not

 

Reason: patients and health care providers couldn’t be blinded. No information provided whether other parties involved were blinded.

No information

 

Reason: not reported whether patients were lost to follow-up, presumably all patients completed the trial. In addition, it was not reported whether there were incomplete data.

No information

 

Reason: not reported

 

No information

 

Reason: not reported

 

 

Basogul, 2019

Probably yes.

 

Reason: The identification of

the intervention and control groups was performed using a simple

randomization method. This calculation was performed using

the http://www.randomizer.org/form.htm web site. The students were ranked by the school number before the randomization. Ninety students to be involved in the study were divided into two groups (intervention and control). The number of participants in each group was 45, and the set range was between 1 and 90 (2 sets of 45 unique numbers per set range: from 1 to 90). The intervention and control groups were formed according to the numbers given by the program.

No information

 

Reason: study doesn’t provide information on how trial was performed.

Probably not

 

Reasons: patients and health care providers could not be blinded. Not reported whether others involved in data measurement and analyses were blinded. Risk of bias.

Probably not.

 

Reason: 4% lost to follow-up in the intervention compared to 0% in the control group can be judged as insignificant.

No information

 

Reason: not reported

 

No information

 

Reason: not reported

 

HIGH (PMS symptoms)

Panahi, 2016

Probably yes.

 

Reason: Block randomization was done based on paper list. Random numbers were supplied from 1 to 60 by the trial statistician and prepared by an investigator with no clinical involvement in the trial. Odd numbers were assigned to the

experimental group and even numbers to the control group.

 

Probably yes

 

Reason: Block randomization was done based on paper list. Random numbers were supplied from 1 to 60 by the trial statistician and prepared by an investigator with no clinical involvement in the trial. Odd numbers were assigned to the

experimental group and even numbers to the control group.

Probably no

 

Reason: patient and health care providers couldn’t be blinded. Data collectors were blinded (reported in text). Unclear whether outcome assessors and data analyst were blinded.

 

No information

 

Reason: not reported whether patients were lost to follow-up, presumably all patients completed the trial. In addition, it was not reported whether there were incomplete data.

 

No information

 

Reason: not reported, this paper was part of masters thesis and no study protocol was previously published.

 

No information

 

Reason: not reported

 

HIGH (PMS symptoms)

Sepehrirad (2018)

Probably yes

 

Reason: only reported that patients were randomized to one of three arms, using random numbers table

 

 

No information

 

Reason: not reported

 

No information

 

Reason: not reported

 

No information

 

Reason: not reported whether patients were lost to follow-up, presumably all patients completed the trial. In addition, it was not reported whether there were incomplete data.

No information

 

Reason: not reported

 

No information

 

Reason: not reported

 

HIGH (PMS symptoms)

Ussher, 2017

Definitely yes;

 

Reason: Generation of the random allocation sequence, using permuted block randomization, was conducted by the second author (JP). Allocation of participants to

conditions was conducted by a researcher who was not involved in the delivery of intervention.

Definitely yes

 

Reason: Generation of the random allocation sequence, using permuted block randomization, was conducted by the second author (JP). Allocation of participants to

conditions was conducted by a researcher who was not involved in the delivery of intervention.

Probably no;

 

Reason: Patients and health care providers could not be blinded due to the nature of the intervention. Blinding of outcome assessors not reported, but presumably not relevant due to solely use of questionnaires. Blinding of data collectors and analysts not reported, therefore small risk of bias.

Probably yes

 

Reason: lost to follow-up was high and infrequent between groups, adequate reasons for drop-out not reported. Analysis not corrected via imputation. Therefore risk of bias.

Definitely yes

 

Reason: All relevant outcomes were reported;

Definitely yes

 

Reason: No other problems noted

HIGH (PMS symptoms)

 

Table Detailed description of the intervention and control group of included studies in the literature analysis

Author (year of publication)

Intervention

Control condition

Askari, 2018

The participants in the intervention group received eight 1-hour sessions of mindfulness-based cognitive behavioural counselling presented by the corresponding author.

 

Mindfulness-based cognitive therapy includes training of meditation and psychoeducation on cognitive processing according to the following standard protocol:

1- Attentional control that is maintaining a moment-by moment awareness.

2- How to disengage from judgmental and evaluative

language by processing and moving to an experiential attention of the present moment.

3- How to disengage from negative thoughts and emotions and physical sensations.

 

The first session included rapport with the client, gathering the information, providing psychoeducation on mindfulness, cognitive-behavioral therapy (CBT), identifying depression, stress, anxiety, and automatic thoughts, and guiding the client through mindfulness meditation. In the next session, awareness of bodily sensations and in the third session, dealing with barriers as well as short breathing meditation, while being compassionate with her, was trained. In the fourth session, the client was helped to understand most of her thoughts are not necessarily a fact, and she learned how to use the thought records; also, training on cognitive distortion was provided. In the fifth session the ability to live at the time while being aware of attachments and aversions was trained; then, deep breathing and sleep health benefits were explained and the client learned how to have a brief body exercise. In the sixth session, the thoughts and emotions were accepted as fleeting events; then, daily mindfulness, mindful eating, and mindful labeling of thoughts, feelings, and behaviors were also trained. In the next session, the client was familiarized with the symptoms of depression, stress, and rumination thinking. Also, the client was trained how to accept rumination thinking without judgment and use the diffusion technique to reduce it. In the last session, the insights and techniques found most useful by the client as well as identifying the obstacles to practice mindfulness was reviewed, and a checklist of techniques presented in the program was provided.

No intervention.

Basogul, 2019

Five sessions of 40-50 minute meetings, scheduled over a 4-week period.

 

Session 1 – introduction + knowing about PMS + health behaviours: Meeting the group members, introducing psychoeducation, and sharing information about premenstrual syndrome, reasons, symptoms, and health behaviors in PMS (exercises, nutrition, sleep quality, and relaxation with breathing techniques to reduce anxiety). Assignment: writing on the premenstrual symptom diary

Session 2 – cognitive strategies (coping with depressive thoughts in PMS): Effects of thoughts on emotions, establishing connections between automatic thoughts, feelings and thought,s and relationships of emotions‐thoughts‐behaviors; sharing information in relation to the cycle of automatic thoughts and psychological state in PMS. Assignment: exercises about establishing connections between thoughts and emotions

Session 3 - Cognitive strategies (coping with depressive thoughts in PMS): Exploring automatic thoughts in PMS, evaluating automatic thoughts and cognitive distortions, exploring unhelpful thoughts in PMS (I am losing control; it should not be like this; I should not have gotten angry; I cannot cope), analyzing automatic thoughts and challenging them, and sharing information about the identification of the fundamental beliefs. Assignment: exploration and analysis of automatic thoughts, exercises for changing with alternative thoughts.

Session 4 - Behavioral strategies (increasing mobility): Developing behavioral changes and analyzing the effects of this change to settle helpful and balanced thoughts instead of unhelpful automatic thoughts, evaluating personal responsibility, investigating the positive effects of social activities on the emotional state in PMS. Assignment: exercises about planning and applying social activities and evaluating its effects

Session 5 - Problem solving + evaluation: Evaluation of the group members’ problem‐solving methods, sharing effective problem‐ solving steps, general revision, and evaluation of the psychoeducation.

 

Blake, 1998

Twelve weekly sessions of individual cognitive therapy, each session lasted about 1 hour.

 

The reality of their symptoms and the associated distress was explicitly acknowledged. Therapy was based on the establishment of a good therapeutic alliance involving collaboration between therapist and patient. The model was explained, and was usually highly acceptable. As the therapeutic relationship was established, therapist and patient set treatment goals and agreed upon a formulation of the problems, their likely origins, and the key current maintaining factors, which were to be the target of therapy. The therapist encouraged the patient to face the problem of PMS squarely, to clarify precipitating and perpetuating factors, and to identify unhelpful or restrictive attitudes. The therapy was collaborative and educational and the patient was asked to set the agenda for the session, to determine priorities, and to collect information. Each patient was asked to try out new behaviors between sessions as homework. Each woman was encouraged to focus on specific incidents that illustrated particular target problems, and from these specific examples the therapist explored the wider issues of present  circumstances, stressors, relationships, and the patient’s reactions to these. Attention was drawn to specific links between thoughts, feelings, behaviors and physical symptoms. Particular attention was paid to how changes in thoughts and beliefs can improve feelings and lead to new, more helpful behavior. Thought records collected between sessions were used to help the patient to learn more about her thoughts and beliefs as mediators of distress and to modify these. Incidents noted frequently revealed repeated patterns of distress and vicious circles that prevented the crucial negative thoughts from changing, thus blocking the development of more adaptive coping strategies. As therapy progressed, reviewing several such specific incidents commonly revealed attitudes and assumptions underlying the problematic reactions characteristic of premenstrual distress. In the later stages of therapy, the woman gained ideas about actively limiting the effects of her premenstrual change, together with new perspectives on her concept of control. In addition to changing attitudes in herself, she was encouraged to elicit the help of other people more assertively.

Waitlist control

Panahi, 2016

Mindfulness-based cognitive therapy (MBCT) (8 group sessions, 120 min. each, over 8 weeks. 8-12 participants per group).

 

MBCT is conceptualized as a way of increasing the awareness of automatic patterns and then to disengage undesirable reactivity. For individual practice, participants read printed copies of material about an important part of the program, did daily formal practice for 30  minutes, did informal practice, and listened to a 20–60-minute  prerecorded CD two times daily over a period of 8 weeks. At the beginning of each session, the therapist asked the patients to do mindfulness skills during class and described one person’s individual experience with mindfulness out of class. The therapist then helped the patients to archive the corrected mindfulness skills

 

Session 1: building a therapeutic alliance and obtaining information from the client, identifying automatic thoughts, introducing the body scan, raisin exercise, and introducing mindfulness meditation with in session practice. Assignment: reading about the body scan meditation technique, 30-minute daily formal practice (body scan meditation), informal practice, and awareness to some routine activity such as washing dishes or eating a meal (continued throughout trial period).

Session 2: helping the client recognize that thoughts are not facts, teaching use of the thought record, sitting meditation using breath as the primary object of awareness, and alternating this with the body scan (sitting one day, body scan the next, etc.). Assignment: reading about and doing formal and informal sitting meditation.

Session 3: dealing with automatic thoughts in life and in meditation and walking meditation. Assignment: mindful yoga.

Session 4: stopping one-minute breathing space. Assignment: mindful yoga and sitting meditation (continued throughout trial period).

Session 5: dealing with difficult emotions, wisdom meditation, and walking meditation. Assignment: mindful yoga.

Session 6: communication. Assignment: listening to others carefully and mindful yoga

Session 7: self-compassion. Assignment: loving yourself and mindful Yoga

Session 8: helping the client develop a practice of her own, reviewing progress, insights, and techniques, and individual evaluation of the sessions.

No intervention

Sepehrirad (2018)

The test group received 8 sessions of 90 minutes and received training for 2 months.

First session: Familiarity with each other, explaining the process of work and its components.

Second session: Natural menstrual cycle training, symptoms of PMS

Third session: Introducing CBT, anxiety model and its components

Fourth session: Psychological education: the importance of thoughts in creating excitement and cognitive errors (mindfulness, prophecy,

disaster, extreme extension)

Fifth session: Introducing how to write thoughts and strategies to deal with anxious thoughts

Sixth session: Interventional cognitive training (disaster relief, foot, evidence survey ...)

Sevenths session: Deep cognitions (conditional assumptions and underlying beliefs) and related techniques and problem solving methods

Eighth session: Anger management training and its components

No intervention

Ussher (2017)

In the intervention groups, women received four 90 minute sessions, conducted over 5 months.  Aims of the CBT intervention were to examine women’s attributions for premenstrual distress within a bio-psycho-social framework, and to challenge negative self-blaming beliefs that may exacerbate symptomatology. Behavioral coping skills, including relaxation training, taking time out for self-care, diet and exercise were also examined and encouraged across the menstrual cycle. Finally, the relational context of premenstrual distress was explored, and assertiveness training techniques used to encourage calm expression of emotion, concerns or needs throughout the month. Women were given homework following each of the sessions and a written booklet containing detailed information about each session, to supplement the meetings with the psychologist. The couple intervention followed the same format, with inclusion of Couples Dialogue techniques to facilitate couple communication.

Waitlist control

 

Table of excluded studies

Author and year

Reason for exclusion

Al Kiyumi, 2021

Same article as 2020

Alevizou, 2018

Narrative review

Chai, 2018

Does not comply to PICO (all women got CGT, comparison between mode of delivery (telephone or face-to-face)

Chin, 2017

Narrative review

Freeman, 2010

Narrative review

Hofmeister, 2016

Narrative review

Izadi-Mazidi, 2016

Does not comply to PICO (did not report on one of the prespecified outcomes)

Kancheva Landolt, 2020

Review of low quality (no methods, no search, no selection criteria, no descriptive analyses)

Kleinstuber, 2021

Included articles in review do not comply to PICO.

Kues, 2014

Study protocol

Lanza di Scalea, 2019

Narrative review

Nevatte, 2013

Does not comply to PICO (consensus paper)

Pearlstein, 2012

Narrative review

Sepede, 2016

Systematic review about treatment options PMDD

Shulman, 2010

Narrative review

Taghizadeh, 2012

Does not comply to PICO (psychoeducation instead of CGT)

Weise, 2019

Does not comply to PICO (women with PMDD; internet CBT versus waiting list)

Autorisatiedatum en geldigheid

Laatst beoordeeld  : 30-06-2023

Laatst geautoriseerd  : 30-06-2023

Geplande herbeoordeling  :

Initiatief en autorisatie

Initiatief:
  • Nederlandse Vereniging voor Obstetrie en Gynaecologie
Geautoriseerd door:
  • Nederlands Huisartsen Genootschap
  • Nederlandse Vereniging voor Obstetrie en Gynaecologie
  • Patiëntenfederatie Nederland
  • Stichting Bekkenbodem4All

Algemene gegevens

Onderstaande conceptrichtlijntekst wordt na het doorlopen van de commentaar- en autorisatiefase opgenomen in de Richtlijnendatabase (www.richtlijnendatabase.nl). Verwijzingen naar ‘tabbladen’ zijn in de huidige versie van de richtlijntekst terug te vinden in de ‘bijlagen’ aan het einde van de hoofdtekst. In verband met de modulaire opbouw van richtlijnen in de database wordt verwezen naar modules (in plaats van hoofdstukken) en aanverwante producten (bijlagen).

Samenstelling werkgroep

Voor het ontwikkelen van de richtlijnmodules zijn in 2020 per module schrijvers en meelezers benoemd. Deze personen werden aangewezen als vertegenwoordigers door de relevante beroepsgroepen die betrokken zijn bij de in de module beschreven zorg (zie hiervoor de Samenstelling van de werkgroep). Alle schrijvers van modules vallend onder één richtlijn vormden samen een schrijfgroep. Alle meelezers van modules vallend onder één richtlijn vormden samen een clusterwerkgroep. In totaal resulteerde dit dus in zes werkgroep en zes clusterwerkgroepen. 

 

Voorzitter project (technisch voorzitter)

Timmermans A. (Anne), gynaecoloog, AmsterdamUMC, NVOG

 

Werkgroep richtlijn Premenstrueel Syndroom

Dijkstra J.R. (Jeroen), gynaecoloog, Isala Ziekenhuis te Zwolle, NVOG

Traas-Hofmans M.A.F. (Maaike), gynaecoloog, Gelre Ziekenhuizen Apeldoorn en Zutphen, NVOG

Uijt de Haag J.A.M. (Jenna), ANIOS gynaecologie en obstetrie, Wilhelmina KinderZiekenhuis (WKZ), NVOG

van Leeuwen J. (Jeanette), gynaecoloog, UMCU te Utrecht, NVOG

Versluis M.A.C. (Marco), gynaecoloog, UMCG te Groningen, NVOG

 

Clusterwerkgroep richtlijn Premenstrueel syndroom

Bosch M. (Marlies), patiëntvertegenwoordiger, Bekkenbodem4All

de Boer M.K. (Marrit), psychiater, Synaeda Psycho Medisch Centrum te Leeuwarden, NVvP

de Voogd I. (Ingrid), huisarts, NHG

Labots-Vogelesang S.M. (Marijke), huisarts, NHG

Vlaardingerbroek, kinderarts-endocrinoloog, LUMC te Leiden, NVK

 

Ondersteuning project

Abdollahi M. (Mohammadreza), adviseur Kennisinstituut van de Federatie van Medisch Specialisten

Labeur Y.J. (Yvonne), junior adviseur, Kennisinstituut van de Federatie Medisch Specialisten

Olthuis-van Essen H. (Hanneke), adviseur, Kennisinstituut van de Federatie Medisch Specialisten

Sussenbach A.E. (Annelotte), junior adviseur Kennisinstituut van de Federatie van Medisch Specialisten

Verhoeven M. (Maxime), adviseur, Kennisinstituut van de Federatie van Medisch Specialisten

 

Projectleiding

Augustus 2022- nu Mostovaya I.M. (Irina) (projectleider), senior adviseur, Kennisinstituut van de Federatie Medisch Specialisten

April 2020 tot augustus 2021: Bijlsma-Rutte A. (Anne), adviseur, Kennisinstituut van de Federatie van Medisch Specialisten

September 2021 tot januari 2022: Venhorst K. (Kristie), adviseur, Kennisinstituut van de Federatie van Medisch Specialisten

Februari 2022 tot juni 2022: Göthlin M. (Mattias), adviseur, Kennisinstituut van de Federatie van Medisch Specialisten 

Belangenverklaringen

De Code ter voorkoming van oneigenlijke beïnvloeding door belangenverstrengeling is gevolgd. Alle werkgroepleden hebben schriftelijk verklaard of zij in de laatste drie jaar directe financiële belangen (betrekking bij een commercieel bedrijf, persoonlijke financiële belangen, onderzoek financiering) of indirecte belangen (persoonlijke relaties, reputatiemanagement) hebben gehad. Gedurende de ontwikkeling of herziening van een module worden wijzigingen in belangen doorgegeven. De belangenverklaring wordt opnieuw bevestigd tijdens de commentaarfase.

Een overzicht van de belangen van werkgroepleden en het oordeel over het omgaan met eventuele belangen vindt u in onderstaande tabel. De ondertekende belangenverklaringen zijn op te vragen bij het secretariaat van het Kennisinstituut van de Federatie Medisch Specialisten.

 

Werkgroeplid

Functie

Nevenfuncties

Gemelde belangen

Ondernomen actie

Timmermans (technisch voorzitter van het project)

Gynaecoloog, Amsterdam UMC (0.5 fte)
gynaecoloog, Bergman Vrouwenzorg Amsterdam (0.3 fte): gedetacheerd vanuit Amsterdam UMC

Commissie kwaliteitsdocumenten NVOG (onbetaald); projectgroep Gynae Goes Green NVOG (onbetaald)

Geen

Geen actie

Premenstrueel syndroom - werkgroep

Dijkstra

Gynaecoloog, fulltime, Isala Zwolle

(Plaatsvervangend) opleider gynaecologie, onbetaald
Bestuurslid sedatie commissie Isala, onbetaald
Lid onderzoeksgroep "my choiche trial" (The MYoma treatment Comparison study: High intensity image guided fOcused ultrasound versus standard (minimally) Invasive fibroid care - a (Cost) Effectiveness analysis, Trial NL8863), onbetaald
Voorzitter Werkgroep psychosomatische Obstetrie en Gynaecologie, onbetaald
Second opinion arts voor "de tweede arts online", betaald
Trainer voor het Myosure device, Hologic, betaald
Lid European advisory board Hologic, betaald

Geen

Louter betrokken bij besluitvorming rondom modules PMS. Niet betrokken bij de besluitvorming rondom HMB, myomectomieën, endometriumablatie etc.

Traas-Hofmans

Gynaecoloog - subspecialist voortplantingsgeneeskunde
Gelre Ziekenhuizen Apeldoorn en Zutphen

Secretaris NVOG-werkgroep Psychosomatische Obstetrie en Gynaecologie (onbetaald), tot 2021
Coördinator medisch team Buddy Runs Achterhoek (onbetaald)

Geen

Geen actie

Uijt de Haag

ANIOS gynaecologie en obstetrie, Wilhelmina KinderZiekenhuis (WKZ)

Geen

Geen

Geen actie

Van Leeuwen

Gynaecoloog UMC Utrecht/WKZ 0,8fte aandacht benigne gynaecologie & kindergynaecologie

Geen

Geen

Geen actie

Versluis

- Gynaecoloog, vakgroep gynaecologie, Universitair Medisch Centrum Groningen (0.9) fte
- Deelnemer werkgroep Premenstrueel Syndroom.

Geen

Geen

Geen actie

Premenstrueel syndroom - clusterwerkgroep

Bosch

Stichting Bekkenbodem4All. PR | Belangenbehartiging

Fotograaf Bisdom Groningen-Leeuwarden. Deels betaald, deels vrijwilligerswerk

Functie Belangenbehartiging Patiënten organisatie

Geen

De Boer

Psychiater/ eerste geneeskundige, Synaeda Psycho Medisch Centrum, Leeuwarden.

Copromotor, Universitair Centrum Psychiatrie, UMC Groningen. Onderwerp onderzoeksproject: hormonen en depressie. Onbetaald. Afgerond in 2021.

Geen

Geen

De Voogd

Praktijk-houdend huisarts

Kaderhuisarts Urogynaecologie

Geen

Geen betaling voor kaderhuisarts functies

Geen

Labots

Huisarts niet-praktiserend

Onderzoeker Radboudumc, afdeling Eerstelijnsgeneeskunde/  Vrouwenstudie Medische Wetenschappen . Onbezoldigd
Geen betaalde functie

Praktiserend huisarts ruim 30 jaar
Expertise als onderzoeker Premenstrueel syndroom
In verleden wetenschappelijk medewerker NHG, afd. Richtlijnontwikkeling en Wetenschap

Geen actie

Vlaardingerbroek

Kinderarts-endocrinoloog, LUMC Leiden

Geen

Geen

Geen actie

Inbreng patiëntenperspectief

Er werd aandacht besteed aan het patiëntenperspectief door het uitnodigen van Patiëntenfederatie Nederland en Stichting Bekkenbodem4All voor de schriftelijke knelpunteninventarisatie en voor deelname aan de clusterwerkgroepen. De verkregen input is meegenomen bij het opstellen van de uitgangsvragen, de keuze voor de uitkomstmaten en bij het opstellen van de overwegingen. De conceptrichtlijn is voor commentaar voorgelegd aan Patiëntenfederatie Nederland en Stichting Bekkenbodem4All en de eventueel aangeleverde commentaren worden bekeken en verwerkt.

Implementatie

Aanbeveling

Tijdspad voor implementatie:
< 1 jaar,

1 tot 3 jaar of

> 3 jaar

Verwacht effect op kosten

Randvoorwaarden voor implementatie (binnen aangegeven tijdspad)

Mogelijke barrières voor implementatie1

Te ondernemen acties voor implementatie2

Verantwoordelijken voor acties3

Overige opmerkingen

1e

< 1 jaar

Onbekend, vermoedelijk gelijk aan huidige situatie (zelfde aanbeveling)

Disseminatie van de richtlijn

Onbekend

Disseminatie van de richtlijn

NVOG

 

Werkwijze

AGREE

Deze richtlijnmodule is opgesteld volgens de eisen vermeld in het rapport Medisch Specialistische Richtlijnen 2.0 van de adviescommissie Richtlijnen van de Raad Kwaliteit. Dit rapport is gebaseerd op het AGREE II instrument (Appraisal of Guidelines for Research & Evaluation II; Brouwers, 2010).

 

Knelpuntenanalyse en uitgangsvragen

Tijdens de voorbereidende fase inventariseerden de werkgroep de knelpunten in de zorg en de actualiteit van de aanbevelingen beschreven in de te reviseren modules. Tevens zijn er knelpunten aangedragen door de Nederlandse Vereniging voor Obstetrie en Gynaecologie (NVOG), de Nederlandse Vereniging van Maag-Darm-Leverartsen (NVMDL), Vereniging Klinische Genetica Nederland (VKGN), Inspectie Gezondheidszorg en Jeugd (IGJ), Koninklijke Nederlandse Organisatie van Verloskundigen (KNOV), Nederlands Huisartsen Genootschap (NHG), Nederlandse Vereniging voor Bekkenfysiotherapie en Pré- en Postpartum Gezondheidszorg, Nederlandse Vereniging van Ziekenhuizen (NVZ), Patiëntenfederatie Nederland, Zorginstituut Nederland (ZiNL), Zelfstandige Klinieken Nederland (ZKN) en Zorgverzekeraars Nederland (ZN) via een schriftelijke knelpunteninventarisatie.

Op basis van de uitkomsten van de knelpuntenanalyse zijn door de werkgroep concept-uitgangsvragen opgesteld en definitief vastgesteld.

 

Uitkomstmaten

Na het opstellen van de zoekvraag behorende bij de uitgangsvraag inventariseerde de werkgroep welke uitkomstmaten voor de patiënt relevant zijn, waarbij zowel naar gewenste als ongewenste effecten werd gekeken. Hierbij werd een maximum van acht uitkomstmaten gehanteerd. De werkgroep waardeerde deze uitkomstmaten volgens hun relatieve belang bij de besluitvorming rondom aanbevelingen, als cruciaal (kritiek voor de besluitvorming), belangrijk (maar niet cruciaal) en onbelangrijk. Ook definieerde de werkgroep tenminste voor de cruciale uitkomstmaten welke verschillen zij klinisch (patiënt) relevant vonden.

 

Methode literatuursamenvatting

Een uitgebreide beschrijving van de strategie voor zoeken en selecteren van literatuur en de beoordeling van de risk-of-bias van de individuele studies is te vinden onder ‘Zoeken en selecteren’ onder Onderbouwing. De beoordeling van de kracht van het wetenschappelijke bewijs wordt hieronder toegelicht.

 

Beoordelen van de kracht van het wetenschappelijke bewijs

De kracht van het wetenschappelijke bewijs werd bepaald volgens de GRADE-methode. De basisprincipes van de GRADE-methodiek zijn: het benoemen en prioriteren van de klinisch (patiënt) relevante uitkomstmaten, een systematische review per uitkomstmaat, en een beoordeling van de bewijskracht per uitkomstmaat op basis van de acht GRADE-domeinen (domeinen voor downgraden: risk of bias, inconsistentie, indirectheid, imprecisie, en publicatiebias; domeinen voor upgraden: dosis-effect relatie, groot effect, en residuele plausibele confounding).

 

GRADE onderscheidt vier gradaties voor de kwaliteit van het wetenschappelijk bewijs: hoog, redelijk, laag en zeer laag. Deze gradaties verwijzen naar de mate van zekerheid die er bestaat over de literatuurconclusie, in het bijzonder de mate van zekerheid dat de literatuurconclusie de aanbeveling adequaat ondersteunt (Hultcrantz, 2017; Schünemann, 2013).

 

GRADE

Definitie

Hoog

  • Er is hoge zekerheid dat het ware effect van behandeling dicht bij het geschatte effect van behandeling ligt.
  • Het is zeer onwaarschijnlijk dat de literatuurconclusie klinisch relevant verandert wanneer er resultaten van nieuw grootschalig onderzoek aan de literatuuranalyse worden toegevoegd.

Redelijk

  • Er is redelijke zekerheid dat het ware effect van behandeling dicht bij het geschatte effect van behandeling ligt.
  • Het is mogelijk dat de conclusie klinisch relevant verandert wanneer er resultaten van nieuw grootschalig onderzoek aan de literatuuranalyse worden toegevoegd.

Laag

  • Er is lage zekerheid dat het ware effect van behandeling dicht bij het geschatte effect van behandeling ligt;
  • Er is een reële kans dat de conclusie klinisch relevant verandert wanneer er resultaten van nieuw grootschalig onderzoek aan de literatuuranalyse worden toegevoegd.

Zeer laag

  • Er is zeer lage zekerheid dat het ware effect van behandeling dicht bij het geschatte effect van behandeling ligt;
  • De literatuurconclusie is zeer onzeker.

 

Bij het beoordelen (graderen) van de kracht van het wetenschappelijk bewijs in richtlijnen volgens de GRADE-methodiek spelen grenzen voor klinische besluitvorming een belangrijke rol (Hultcrantz, 2017). Dit zijn de grenzen die bij overschrijding aanleiding zouden geven tot een aanpassing van de aanbeveling. Om de grenzen voor klinische besluitvorming te bepalen moeten alle relevante uitkomstmaten en overwegingen worden meegewogen. De grenzen voor klinische besluitvorming zijn daarmee niet één op één vergelijkbaar met het minimaal klinisch relevant verschil (Minimal Clinically Important Difference, MCID). Met name in situaties waarin een interventie geen belangrijke nadelen heeft en de kosten relatief laag zijn, kan de grens voor klinische besluitvorming met betrekking tot de effectiviteit van de interventie bij een lagere waarde (dichter bij het nul effect) liggen dan de MCID (Hultcrantz, 2017).

 

Overwegingen (van bewijs naar aanbeveling)

Om te komen tot een aanbeveling zijn naast (de kwaliteit van) het wetenschappelijke bewijs ook andere aspecten belangrijk en worden meegewogen, zoals aanvullende argumenten uit bijvoorbeeld de biomechanica of fysiologie, waarden en voorkeuren van patiënten, kosten (middelenbeslag), aanvaardbaarheid, haalbaarheid en implementatie. Deze aspecten zijn systematisch vermeld en beoordeeld (gewogen) onder het kopje ‘Overwegingen’ en kunnen (mede) gebaseerd zijn op expert opinion. Hierbij is gebruik gemaakt van een gestructureerd format gebaseerd op het evidence-to-decision framework van de internationale GRADE Working Group (Alonso-Coello, 2016a; Alonso-Coello 2016b). Dit evidence-to-decision framework is een integraal onderdeel van de GRADE-methodiek.

 

Formuleren van aanbevelingen

De aanbevelingen geven antwoord op de uitgangsvraag en zijn gebaseerd op het beschikbare wetenschappelijke bewijs en de belangrijkste overwegingen, en een weging van de gunstige en ongunstige effecten van de relevante interventies. De kracht van het wetenschappelijk bewijs en het gewicht dat door de werkgroep wordt toegekend aan de overwegingen, bepalen samen de sterkte van de aanbeveling. Volgens de GRADE-methodiek sluit een lage bewijskracht van conclusies in de systematische literatuuranalyse een sterke aanbeveling niet a priori uit, en zijn bij een hoge bewijskracht ook zwakke aanbevelingen mogelijk (Agoritsas, 2017; Neumann, 2016). De sterkte van de aanbeveling wordt altijd bepaald door weging van alle relevante argumenten tezamen. De werkgroep heeft bij elke aanbeveling opgenomen hoe zij tot de richting en sterkte van de aanbeveling zijn gekomen.

 

In de GRADE-methodiek wordt onderscheid gemaakt tussen sterke en zwakke (of conditionele) aanbevelingen. De sterkte van een aanbeveling verwijst naar de mate van zekerheid dat de voordelen van de interventie opwegen tegen de nadelen (of vice versa), gezien over het hele spectrum van patiënten waarvoor de aanbeveling is bedoeld. De sterkte van een aanbeveling heeft duidelijke implicaties voor patiënten, behandelaars en beleidsmakers (zie onderstaande tabel). Een aanbeveling is geen dictaat, zelfs een sterke aanbeveling gebaseerd op bewijs van hoge kwaliteit (GRADE gradering HOOG) zal niet altijd van toepassing zijn, onder alle mogelijke omstandigheden en voor elke individuele patiënt.

 

Implicaties van sterke en zwakke aanbevelingen voor verschillende richtlijngebruikers

 

Sterke aanbeveling

Zwakke (conditionele) aanbeveling

Voor patiënten

De meeste patiënten zouden de aanbevolen interventie of aanpak kiezen en slechts een klein aantal niet.

Een aanzienlijk deel van de patiënten zouden de aanbevolen interventie of aanpak kiezen, maar veel patiënten ook niet. 

Voor behandelaars

De meeste patiënten zouden de aanbevolen interventie of aanpak moeten ontvangen.

Er zijn meerdere geschikte interventies of aanpakken. De patiënt moet worden ondersteund bij de keuze voor de interventie of aanpak die het beste aansluit bij zijn of haar waarden en voorkeuren.

Voor beleidsmakers

De aanbevolen interventie of aanpak kan worden gezien als standaardbeleid.

Beleidsbepaling vereist uitvoerige discussie met betrokkenheid van veel stakeholders. Er is een grotere kans op lokale beleidsverschillen.  

 

Organisatie van zorg

In de knelpuntenanalyse en bij de ontwikkeling van de richtlijnmodule is expliciet aandacht geweest voor de organisatie van zorg: alle aspecten voor het verlenen van zorg (zoals coördinatie, communicatie, (financiële) middelen, mankracht en infrastructuur). Randvoorwaarden die relevant zijn voor het beantwoorden van deze specifieke uitgangsvraag zijn genoemd bij de overwegingen.

 

Commentaar- en autorisatiefase

De conceptrichtlijnmodule werd aan de betrokken (wetenschappelijke) verenigingen en (patiënt) organisaties voorgelegd ter commentaar. De commentaren worden verzameld en besproken met de werkgroep. Naar aanleiding van de commentaren wordt de conceptrichtlijnmodule aangepast en definitief vastgesteld door de werkgroep. De definitieve richtlijnmodule wordt aan de deelnemende (wetenschappelijke) verenigingen en (patiënt) organisaties voorgelegd voor autorisatie en akkoord.

 

Literatuur

Agoritsas T, Merglen A, Heen AF, Kristiansen A, Neumann I, Brito JP, Brignardello-Petersen R, Alexander PE, Rind DM, Vandvik PO, Guyatt GH. UpToDate adherence to GRADE criteria for strong recommendations: an analytical survey. BMJ Open. 2017 Nov 16;7(11):e018593.

Alonso-Coello P, Schünemann HJ, Moberg J, Brignardello-Petersen R, Akl EA, Davoli M, Treweek S, Mustafa RA, Rada G, Rosenbaum S, Morelli A, Guyatt GH, Oxman AD; GRADE Working Group. GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 1: Introduction. BMJ. 2016 Jun 28;353:i2016.

Alonso-Coello P, Oxman AD, Moberg J, Brignardello-Petersen R, Akl EA, Davoli M, Treweek S, Mustafa RA, Vandvik PO, Meerpohl J, Guyatt GH, Schünemann HJ; GRADE Working Group. GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 2: Clinical practice guidelines. BMJ. 2016 Jun 30;353:i2089.

Brouwers MC, Kho ME, Browman GP, Burgers JS, Cluzeau F, Feder G, Fervers B, Graham ID, Grimshaw J, Hanna SE, Littlejohns P, Makarski J, Zitzelsberger L; AGREE Next Steps Consortium. AGREE II: advancing guideline development, reporting and evaluation in health care. CMAJ. 2010 Dec 14;182(18):E839-42.

Hultcrantz M, Rind D, Akl EA, Treweek S, Mustafa RA, Iorio A, Alper BS, Meerpohl JJ, Murad MH, Ansari MT, Katikireddi SV, Östlund P, Tranæus S, Christensen R, Gartlehner G, Brozek J, Izcovich A, Schünemann H, Guyatt G. The GRADE Working Group clarifies the construct of certainty of evidence. J Clin Epidemiol. 2017 Jul;87:4-13.

Medisch Specialistische Richtlijnen 2.0 (2012). Adviescommissie Richtlijnen van de Raad Kwaliteit.

Neumann I, Santesso N, Akl EA, Rind DM, Vandvik PO, Alonso-Coello P, Agoritsas T, Mustafa RA, Alexander PE, Schünemann H, Guyatt GH. A guide for health professionals to interpret and use recommendations in guidelines developed with the GRADE approach. J Clin Epidemiol. 2016 Apr;72:45-55.

Schünemann H, Brożek J, Guyatt G, et al. GRADE handbook for grading quality of evidence and strength of recommendations. Updated October 2013. The GRADE Working Group, 2013.

Schünemann HJ, Oxman AD, Brozek J, Glasziou P, Jaeschke R, Vist GE, Williams JW Jr, Kunz R, Craig J, Montori VM, Bossuyt P, Guyatt GH; GRADE Working Group. Grading quality of evidence and strength of recommendations for diagnostic tests and strategies. BMJ. 2008 May 17;336(7653):1106-10. Erratum in: BMJ. 2008 May 24;336(7654).

Wessels M, Hielkema L, van der Weijden T. How to identify existing literature on patients' knowledge, views, and values: the development of a validated search filter. J Med Libr Assoc. 2016 Oct;104(4):320-324.

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