ACOG updates its recommendations for treatment of Dysmenorrhea and Endometriosis in the Adolescent

The American College of Obstetrics and Gynecology (ACOG) has issued new guidance on diagnosing and relieving dysmenorrhea in adolescents, published in December issue of Journal Obstetrics and Gynecology.

Obstetrician and gynecologists frequently come across adolescents with dysmenorrhea in their practice due to high prevalence ranging between 50% to 90%. It is also responsible for recurrent short-term school absenteeism and reduced quality of life.

Most of the adolescents suffering from dysmenorrhea have primary dysmenorrhea–– painful menstruation in the absence of pelvic pathology.

If the physician suspects it to be primary dysmenorrhea, no pelvic examination or ultrasound is indicated in the initial evaluation. The patient should be put on empirical therapy after a careful history and physical examination.

If the patient does not respond to empirical therapy with NSAIDs and hormonal treatment in 3-6 months, she should be investigated for secondary causes or irregular treatments.

The most common cause of secondary dysmenorrhea is endometriosis, the other being obstructive anomaly of the reproductive tract (hymenal, vaginal, or Mullerian), uterine fibroids and polyps, adenomyosis, cervical stenosis, and adhesions.

Patients who do not respond to treatment for primary dysmenorrhea should be investigated for secondary causes which include pelvic examination and pelvic ultrasound. If pathology is detected, treatment of the cause is warranted.

If no pathology is seen, suspect endometriosis and consider a diagnostic laparoscopy. About 75% of adolescents and young adults with dysmenorrhea who do not respond to NSAIDs and hormonal therapy have endometriosis as the primary pathology. 

Endometriotic lesions present a different appearance in adolescents as compared to a young woman and are typically transparent or red and are challenging to diagnose.   

If a young woman is diagnosed with endometriosis, treatment consists of biopsy of the lesions along with destruction, ablation, or excision of the visible lesions at the time of initial laparoscopy. The patient should also be started on suppressive medical therapy to prevent further endometrial proliferation.

Consideration should be given to placing a levonorgestrel-releasing intrauterine system (LNG-IUS) at the of diagnostic laparoscopy to minimize the pain of insertion later. 

If patients do not respond to conservative surgical therapy and suppressive hormonal therapy, they often benefit from at least six months of gonadotropin-releasing hormone (GnRH) agonist therapy with add-back medicine.

NSAIDs are the principal medications used for pain relief in endometriosis, and there is no role of long-term opioids in the management of endometriosis, besides being used by a specialized pain management team.

ACOG committee opinion No. 760

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Oral diclofenac potassium plus cervical lidocaine cream eases the pain during hysterosalpingography

Oral diclofenac potassium tab 30 minutes before hysterosalpingography (HSG) and cervical lidocaine cream 5% significantly relieves pain and eases patient anxiety during the procedure and for half an hour after reports the results of a randomized trial published in September issue of journal Fertility and Sterility.

According to American Society for Reproductive Medicine (ASRM) tubal factor infertility accounts for 25%-30% of causes of female infertility, and HSG is simple and cost-effective method for evaluation of tubal patency.

Often patients are very apprehensive of the procedure because of pain felt during the procedure. This small randomized trial investigated the effect of 50 mg of oral diclofenac potassium half an hour before the procedure with lidocaine gel 5% applied to the anterior cervical lip, followed by 3 ml placed in the cervical canal using a sterile needless syringe vs placebo in alleviating the pain felt with the procedure.

The trial recruited 140 infertile women, comparable in demographic, parity and prior mode of delivery and randomized to receive either diclofenac plus gel vs placebo.

The patients self-evaluated the pain they felt during various steps of procedure like placing the speculum, holding the anterior lip, injection of the dye and 5 minutes and 30 minutes after the procedure and rated it on a 10 cm Visual Analog Scale(VAS).

A 2 cm difference between pain rating between both the study arms was considered clinically significant. The researchers also looked at any need of additional analgesic and side effects of the test itself.

It was seen that women in the diclofenac arm reported considerable less pain during pushing of the dye, 5 minutes and 30 minutes post procedure (median: 4 vs. 7, p=0.0001; 2 vs. 4, p=0.0001; 1 vs. 2.5, p= 0.0001, respectively)

Nearly 50% more women in the placebo group asked for additional analgesic (p=0.245).

The researchers concluded that diclofenac potassium and cervical lidocaine is considerably effective in reducing the pain during and after HSG test.

Full text

Comparable results achieved with marsupialization vs. Word catheter in Bartholin’s abscess/cyst.

 It is estimated that approximately 2% of women of reproductive age will develop Bartholin cyst/abscess once in their lifetime.[1] Culture results showed causative organisms as E. coli in 43.7% of cases with 37% recurrence in future.[2]

Word Catheter 

A review of literature identified multiple treatments for the condition, but failed to single out any one as the best approach. [3] A recent article by Brazilian researchers published a case series of 31 patients treated with CO2 laser quoted 17% recurrence after the procedure.[4]

The use of Word balloon catheter relieves pain immediately, well accepted and has low recurrence in the future. It is also cost effective in saving precious clinical time, healthcare resources and does not require anesthesia as compared to marsupialization.

Studies comparing the efficacy of both the procedures in terms of recurrence are few and not well designed. A Randomized Control Trial (RCT) by Kroese et al. published in the current issue of BJOG An International Journal Of Obstetrics and Gynecology compares the recurrence rate of both the procedures.

It was a multicentric, open-label, well designed randomized controlled trial conducted at eighteen hospitals in Netherlands and one in England between August 2010 and May 2014.

The study recruited 169 women with Bartholin cyst or abscess and allocated them to either receiving Word catheter (n = 82) or marsupialization (n = 79).

The investigators were primarily interested to study the difference in recurrence rate at the end of year. Other secondary outcomes studied were pain scores, use of analgesics and time to treatment from diagnosis.

Ten women (12%) suffered a recurrence in Word Catheter arm as compared to eight women (10%) in marsupialization arm. (RR) 1.1; P = 0.70. Pain scores were also comparable although patients in Word catheter arm used more analgesic in first 24 hours.

The authors stated “In our opinion, our data therefore favor treatment of a Bartholin cyst or abscess with a Word catheter since this is the fastest procedure, relieving pain sooner after diagnosis, with less cost than when marsupialization is performed.”

The study has several advantages of being generalizable to large population, robust follow-up of 1 year and being adequately powered.

The drawback is diabetes was not included as a confounding factor, which could have affected the recurrence rate in some patients.

  

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[1] Lee MY, Dalpiaz A, Schwamp R, Miao Y, Waltzer W, Khan A. Clinical pathology of Bartholin’s glands: a review of the literature. Curr Urol. 2015;8:22–25. doi: 10.1159/000365683.

[2] Kessous R, Aricha-Tamir B, Sheizaf B, Steiner N, Moran-Gilad J, Weintraub AY. Clinical and microbiological characteristics of Bartholin gland abscesses. Obstet Gynecol. 2013;122:794–799. doi: 10.1097/AOG.0b013e3182a5f0de

[3] https://www.ncbi.nlm.nih.gov/pubmed/19445813

[4] https://www.ncbi.nlm.nih.gov/pubmed/27074230#

Ulipristal acetate in medical management of fibroid

All symptomatic fibroid will eventually require treatment.

Absolute treatment is surgery consisting of  removing the myoma or the entire uterus, but there are patients  in whom Hysterectomy is not a feasible option, or patients who refuse surgery.

These patients have a choice between radiological or medical management. Radiological management consists of uterine artery embolization/ ultrasound ablation. All medical management offer short term relief and consists of progestin, aromatase inhibitors, GnRH analogues, and selective estrogen receptors modulators.  All these agents modify the hormonal milieu leading to shrinkage in size and decreasing the severity of symptoms.

Ulipristal acetate (UPA) is a possible option for medical therapy. It most common use is for preoperative shrinkage of fibroids in reproductive age group women.  It is a steroid that reversibly binds to the progesterone (P) receptor in its target tissue, acting as a potent orally active P receptor modulator. It belongs to the class of drugs known as elective P receptor modulators (SPRMs).

This study aims to investigate the long term intermittent use of UPA in relieving fibroid symptoms.  It was designed by the sponsor (PregLem S.A.) makers of ESMYA, with the involvement of academic investigators and a contract study statistician (CROS NT).

This is the first double blind RCT for UPA  by Donnez J et al published in the January issue of journal of  Fertlity  and Sterility.

Study subjects consist of premenopausal women with fibroid size between 3-12 mm in diameter, menorrhagia and uterine size less than 16 weeks. All study participants were aged between 18 and 50 years inclusive, with body mass index 18–40 (kg/m²) and regular menstrual cycles of 22–35 days with FSH ≤20 IU/L.

The subjects were assigned to receive UPA 5mg or 10 mg and matching placebos for four 12-week courses. A drug holiday was held after each course and the subsequent course was started on second menstruation during the drug free period.

The primary endpoints were percentage of subjects with amenorrhea at the end of four course treatments, the safety endpoint included number of women withdrawing from the treatment due to the adverse effects.

At the end of completion of the study, it was seen that:

• 75% of the subjects remained in the study for 20 months, demonstrating a very good compliance.
• UPA 5 and 10 mg both resulted in amenorrhea, ≥70% of subjects achieved it in a week and the average post-treatment menstrual bleeding was markedly less comparing with pretreatment bleeding.
• 73% of all subjects ended in amenorrhea with ≥25% reduction in fibroid volume at the end of treatment period.
• The endometrial changes were benign and returned to pretreatment levels in 3 months post treatment.
• Levels of E₂ remained well above postmenopausal levels, evading the fear of decreased bone mineral density.

It was concluded that treatment with four 12-week treatment courses of UPA at doses of 5 and 10 mg was well tolerated. No differences were observed between the 5 and 10 mg dosing groups. At the end of treatment cycle more than three fourth women achieved amenorrhea and a reduction in fibroid size. 

This study also showed that UPA 5 mg as an intermittent therapy can be a good medical alternative in those women with fibroid who wish to avoid surgery or surgery is contraindicated.

References:

http://www.fertstert.org/article/S0015-0282%2815%2901960-3/fulltext