The Role of Osteopathic Care in Gynaecology and Obstetrics: An Updated Systematic Review

Methods

• Articles analyzed: 35
• Stringa di ricerca: a combination of the following terms, free and as MeSH:
  • cranial sacral treat*, craniosacral, osteopath*, spinal manipul*, manipul*, osteopath* treat*, mobiliz*, OMT, somatic dysfunction, visceral treatment, myofascial release, cranial field;
  • dysmenorr*, female infertility, menopaus*, menstr*, childbirth, pelvic pain, pelvic floor, pregnan*, maternal-fetal, gravid*, labor, birth, climacteric, fertility, sterility*, fert*, hormon*, premenstrual, gynecol*, obstet*, perineum, puber* (puberty, puberal), incontinen* (incontinent, incontinence, post partum, ovulat* (ovulatory, ovulation), endometr* (endometrial, endometriosis), dyspareun*, PCOS, ovar* (ovary, ovarian).
• Criteria of inclusion:
  • Women with gynecological or obstetric conditions, including pregnancy, childbirth, infertility, dysmenorrhea, pelvic pain, and menopause;
  • all clinical trials – randomized controlled trials (RCTs), multi-RCTs, before-after controlled trials, interrupted time series, quasi RCTs, case controls, case reports, case series, observational,  published between May 2014 and December 2021;
  • any type of OMT (standardized, semi-standardized, or customized) on any area of the body, regardless of the techniques used; in control groups: sham  treatment, either manually or by technical instruments, waiting list, and other treatments;
  • studies in English, Italian, French, German and Spanish.
• Criteria of exclusion: literature reviews, protocols, commentaries, personal contributions, unpublished studies, and studies that applied manual therapies other than OMT to the experimental group.

Characteristics of the studies

• 11 case reports, 3 case series, 2 pilot observational studies, 1 retrospective observational study, 1 retrospective case-control study, 1 prospective cohort study, 1 before-after controlled study, 1 prospective controlled study, 1 pilot study, 13 RCTs.
• 9 studies on pregnancy
• 6 studies on childbirth
• 2 studies on infertility
• 2 studies on menopause
• 5 studies on dysmenorrhoea
• 2 studies on pelvic pain
• 1 study on PCOS
• 1 study on vulvodynia
• 5 studies on endometriosis
• 2 studies on postpartum
• RCTs evaluated according to Cochrane’s Risk of Bias (RoB): 10 low risk, 2 with some reservation, and 1 high risk.
• Other clinical studies evaluated according to the Methodological Index score for non-randomized studies (MINORS): 8 moderate and 3 low-quality studies.
• Given the high methodological and clinical heterogeneity, it was not possible to conduct a meta-analysis.

Participants

• Total number: 2,632 women (mean age 28.9 years)

Interventions and evaluations

• Assessment of any outcomes related to the gynecologic and obstetrical conditions under consideration.
• OMT:
  • see the Results section below, under Secondary Outcomes, sub-section Treatments.
• Control:
  • standard of care, sham treatment (manual or ultrasound), waiting list.

Results

• Primary outcomes:
  • Pregnancy: OMT showed greater reduction in low back pain and improved functional status compared with standard of care, but not compared with sham intervetion (placebo ultrasound). OMT also has the potential to improve the condition in high-risk pregnancies (polyhydramnios and fetal transfusion syndrome risk), promoting good health of the unborn child.
  • Delivery: OMT has been shown to reduce the duration of labor and the likelihood of high-risk pregnancies compared with standard care and sham (placebo ultrasound). No adverse effects on delivery were found from performing the fourth ventricle compression technique.
  • Postpartum: OMT reduced disability and pain in low back pain and postpartum pelvic pain, as well as improve conditions of rectus abdominis diastasis.
  • Pelvic pain: OMT reduced pelvic pain, disability and associated fear of movement.
  • Vulvodynia: OMT has the potential to improve conditions of vulvodynia, with accompanying mood decline, in the face of physical exertion where other therapies (eg, physiotherapy, antidepressants, and botox) have failed.
  • Endometriosis: OMT improved quality of life (ability to perform daily, physical and social activities, sense of energy) and reduce both pain and other symptoms (except urinary symptoms) related to endometriosis, even where drug treatment had failed. Potentially, OMT could also reduce the use of drugs to treat endometriosis and associated conditions (menorrhagia, leucorrhea, and pain)
  • Dysmenorrhea: OMT, either alone or in combination with a multidisciplinary approach (nutrition, exercise, meditation), reduced dysmenorrhea’s severity, pain, disability, and associated medication use. In addition, OMT appears to be able to promote proper positioning of the ovaries relative to the uterus.
  • PCOS: In women with PCOS, OMT may improve a number of autonomic nervous system-related parameters (lower post-exercise systolic blood pressure and better recovery of normal heart rate). No other findings emerged other than a slight reduction in free testosterone (although not statistically significant).
  • Menopause: in both the short and long term (9 months) OMT can improve symptoms and quality of life associated with menopause.
  • Infertility: there were no new studies since the previous review.
• Secondary outcomes:
  • Somatic dysfunction: 17 (19?) studies evaluated somatic dysfunction through the TART criteria, while 4 studies considered somatic dysfunction as regions.
  • Treatments: 14 studies performed individualized treatment based on patients’ needs, 7 studies semi-standardized treatment, and 15 studies standardized treatment according to a protocol.

In particular, myofascial, soft tissue, cranial, and articular techniques have been used, often in combination with each other. Especially, myofascial techniques were used in combination with high-velocity and low-amplitude, muscle, craniosacral, and soft tissue techniques. There were a few cases of exclusive use (1 study only applied high velocity and low amplitude techniques and 1 study only applied soft tissue techniques).

According to 16 studies, the treatment sessions lasted 32 minutes on average, while according to 30 studies, patients received 5.8 treatment sessions on average.

• • Adverse effects: only 5 out of 35 studies reported information on adverse effects. In general, OMT was well tolerated and, in the case of adverse effects, they were transitory or at least less than the standard treatment used as a control.
  • Economic impact: 3 studies investigated the economic impact of OMT but did not draw any conclusions.

Discussion

OMT has been shown to be able to reduce pain and disability and improve women’s quality of life in a variety of gynecologic and obstetrical conditions, although questions remain about some of its effects on outcomes such as the incidence of cesarean deliveries and some symptoms related to vulvodynia, endometriosis, and menopause.

The reason for these doubts comes mainly from two facts: many studies analyzed are case reports, and the studies are very heterogeneous in terms of protocol and outcomes analyzed.

Case reports are critical for the advancement of scientific research as they provide new hypotheses and show both  the importance of sharing one’s clinical experiences and the increased interest in osteopathy. However, they are precisely only the first step in building evidence of efficacy and safety.

Methodologically, we need more rigorous studies, with a thorough description of the control treatments, especially when they in the case of sham treatments. In fact, studies often describe them very sketchily. The same is true for adverse effects and the economic impact of OMT: while adverse effects are being reported more often, but always without particular attention, very few studies deal with the assessment of the economic impact of OMT, which is essential from the health system’s perspective.

Finally, the analysis of somatic dysfunction and type of treatment performed revealed great heterogeneity in both the osteopathic assessment and the treatment itself.

Although this is the first review intending to assess adverse effects and economic impact of OMT in gynecological and obstetrical conditions, it is possible that not all studies were included and, more importantly, that given the large extent of the subject matter, a scoping review would have been more suitable.