According to the authors of this study, research is lacking regarding osteopathic approaches in treating polycystic ovary syndrome (PCOS), one of the prevailing endocrine abnormalities in reproductive-aged women. Limited movement of pelvic organs can result in functional and structural deficits, which can be resolved by applying visceral manipulation (VM). Already with these two introductory sentences, I have problems. But for the moment, we can leave this aside and have a look at their trial.
The study was aimed at analyzing the effect of VM on dysmenorrhea, irregular, delayed, and/or absent menses, and premenstrual symptoms in PCOS patients.
Thirty Egyptian women with PCOS, with menstruation-related complaints and free from systematic diseases and/or adrenal gland abnormalities, prospectively participated in a single-blinded, randomized controlled trial. They were recruited from the women’s health outpatient clinic in the faculty of physical therapy at Cairo University, with an age of 20-34 years, and a body mass index (BMI) ≥25, <30 kg/m2. Patients were randomly allocated into two equal groups (15 patients); the control group received a low-calorie diet for 3 months, and the study group received the same hypocaloric diet plus VM to the pelvic organs and their related structures, according to assessment findings, for eight sessions over 3 months. Evaluations for body weight, BMI, and menstrual problems were done by weight-height scale, and menstruation-domain of Polycystic Ovary Syndrome Health-Related Quality of Life Questionnaire (PCOSQ), respectively, at baseline and after 3 months of treatments.
A total of 30 patients were included, with baseline mean age, weight, BMI, and menstruation domain score of 27.5 ± 2.2 years, 77.7 ± 4.3 kg, 28.6 ± 0.7 kg/m2, and 3.4 ± 1.0, respectively, for the control group, and 26.2 ± 4.7 years, 74.6 ± 3.5 kg, 28.2 ± 1.1 kg/m2, and 2.9 ± 1.0, respectively, for the study group. Of the 15 patients in the study group, uterine adhesions were found in 14 patients (93.3%), followed by restricted uterine mobility in 13 patients (86.7%), restricted ovarian/broad ligament mobility (9, 60%), and restricted motility (6, 40%). At baseline, there was no significant difference (p>0.05) in any of the demographics (age, height), or dependent variables (weight, BMI, menstruation domain score) among both groups. Post-study, there was a statistically significant reduction (p=0.000) in weight, and BMI mean values for the diet group (71.2 ± 4.2 kg, and 26.4 ± 0.8 kg/m2, respectively) and the diet + VM group (69.2 ± 3.7 kg; 26.1 ± 0.9 kg/m2, respectively). For the improvement in the menstrual complaints, a significant increase (p<0.05) in the menstruation domain mean score was shown in the diet group (3.9 ± 1.0), and the diet + VM group (4.6 ± 0.5). On comparing both groups post-study, there was a statistically significant improvement (p=0.024) in the severity of menstruation-related problems in favor of the diet + VM group.
The authors concluded that VM yielded greater improvement in menstrual pain, irregularities, and premenstrual symptoms in PCOS patients when added to caloric restriction than utilizing the low-calorie diet alone in treating that condition.
VM involves the manual manipulation by a therapist of internal organs, blood vessels and nerves (the viscera) mostly from outside the body, but sometimes, the therapist also puts his/her fingers into the patient’s vagina. It was developed by the osteopath Jean-Piere Barral. He stated that through his clinical work with thousands of patients, he created this modality based on organ-specific fascial mobilization. And through work in a dissection lab, he was able to experiment with visceral manipulation techniques and see the internal effects of the manipulations. According to its proponents, visceral manipulation is based on the specific placement of soft manual forces looking to encourage the normal mobility, tone, and motion of the viscera and their connective tissues. The idea is that these gentle manipulations may potentially improve the functioning of individual organs, the systems the organs function within, and the structural integrity of the entire body.
I don’t see any reason to believe the concepts of VM are plausible. Thus I find the hypothesis of this trial extremely far-fetched. The results are equally unconvincing. As we have often discussed, the ‘A+B vs B’ design cannot prove a causal relationship between the intervention and the outcome.
The most likely explanation for the findings is that the patients receiving VM experienced or merely reported improvements because the extra attention of mildly invasive treatments produced a powerful placebo effect. To put it bluntly: this is a poor, arguably unethical study where over-enthusiastic researchers reach a conclusion that is not supported by the data.