Trial of Intravenous Immune Globulin in Dermatomyositis.

BACKGROUND: Intravenous immune globulin (IVIG) for the treatment of dermatomyositis has not been extensively evaluated. METHODS: We conducted a randomized, placebo-controlled trial involving patients with active dermatomyositis. The patients were assigned in a 1:1 ratio to receive IVIG at a dose of 2.0 g per kilogram of body weight or placebo every 4 weeks for 16 weeks. The patients who received placebo and those without confirmed clinical deterioration while receiving IVIG could enter an open-label extension phase for another 24 weeks. The primary end point was a response, defined as a Total Improvement Score (TIS) of at least 20 (indicating at least minimal improvement) at week 16 and no confirmed deterioration up to week 16. The TIS is a weighted composite score reflecting the change in a core set of six measures of myositis activity over time; scores range from 0 to 100, with higher scores indicating greater improvement. Key secondary end points included at least moderate improvement (TIS ≥40) and major improvement (TIS ≥60), and change in score on the Cutaneous Dermatomyositis Disease Area and Severity Index. RESULTS: A total of 95 patients underwent randomization: 47 patients were assigned to the IVIG group, and 48 to the placebo group. At 16 weeks, 79% of the patients in the IVIG group (37 of 47) and 44% of those in the placebo group (21 of 48) had a TIS of at least 20 (difference, 35 percentage points; 95% confidence interval, 17 to 53; P<0.001). The results with respect to the secondary end points, including at least moderate improvement and major improvement, were generally in the same direction as the results of the primary end-point analysis, except for the change in creatine kinase level (an individual core measure of the TIS), which did not differ meaningfully between the two groups. Over 40 weeks, 282 treatment-related adverse events occurred in the IVIG group, including headache (in 42% of patients), pyrexia (in 19%), and nausea (in 16%). A total of 9 serious adverse events that were considered to be related to IVIG occurred, including 6 thromboembolic events. CONCLUSIONS: In this 16-week trial involving adults with dermatomyositis, the percentage of patients with a response of at least minimal improvement based on a composite score of disease activity was significantly greater among those who received IVIG than among those who received placebo. IVIG was associated with adverse events, including thromboembolism. (Funded by Octapharma Pharmazeutika; ProDERM ClinicalTrials.gov number, NCT02728752.).

Treating fallopian tube occlusion with a manual pelvic physical therapy.

OBJECTIVE: To determine the efficacy of a non-invasive, manual soft-tissue physical therapy in opening completely blocked fallopian tubes in infertile women with confirmed bilateral occlusion and a history indicative of abdominopelvic adhesions. DESIGN: Retrospective analysis. SETTING: Clear Passage Therapies, Inc, clinic, Gainesville, Florida. PATIENTS: 28 infertile women (mean age = 35.2) with diagnosed complete tubal occlusion (proximal, midtubal, distal, or combination). The patients were being treated for various types of abdominopelvic pain and dysfunction (eg, intercourse and/or pelvic pain, menstrual cramps, endometriosis pain). INTERVENTION: A 20-hour series of manual physical therapy treatments (mean duration = 1 week) designed to address pain and restricted soft tissue mobility due to adhesions and micro-adhesions. The therapists accessed some of the deeper structures (such as the fallopian tubes) indirectly by manipulating the peritoneum, uterine and ovarian ligaments, and neighboring structures. MAIN OUTCOME MEASURES: (1) Unilateral or bilateral tubal patency confirmed by diagnostic test or natural intrauterine pregnancy; (2) natural intrauterine pregnancy rate achieved by patent patients within the 2-year follow-up period. RESULTS: Of the 28 patients, 17 (61%, 95% exact CI 41%-78%) demonstrated post-treatment unilateral or bilateral patency, as measured by hysterosalpingography or natural intrauterine pregnancy. The median interval between the last treatment date and patency confirmation was 1 month. Nine of the 17 (53%) patent patients reported a subsequent natural intrauterine pregnancy. CONCLUSION: Since truly occluded tubes are not known to reopen spontaneously, the results suggest this non-invasive therapy might be considered as an adjuvant to standard gynecological procedures in treating tubal occlusion.

Treating female infertility and improving IVF pregnancy rates with a manual physical therapy technique.

CONTEXT: Infertility and pregnancy. OBJECTIVE: To assess the effectiveness of site-specific manual soft tissue therapy in (1) facilitating natural fertility and (2) improving in vitro fertilization (IVF) pregnancy rates in women with histories indicating abdominopelvic adhesion formation. DESIGN AND INTERVENTION: Pursuant to 2 promising pilot studies, 53 infertile, premenopausal patients received a 10- to 20-hour series of site-specific manual physical therapy treatments. Seventeen patients hoped to achieve a natural pregnancy; 36 planned to undergo IVF within 15 months. The primary criteria for inclusion in the studies were the inability to conceive following a minimum of 12 months of unprotected intercourse and suspected or confirmed pelvic adhesions due to abdominal and/or pelvic surgery, infectious or inflammatory disease (eg, endometriosis, PID), or trauma. Treatments were specifically designed to address biomechanical dysfunctions of the pelvis, sacrum, and coccyx and restricted soft tissue and visceral mobility due to adhesions or microadhesions affecting the reproductive organs and adjacent structures. MAIN OUTCOME MEASURES: (1) Natural fertility group: pregnancy within 1 year of therapy and subsequent full-term delivery; (2) Pre-IVF group: pregnancy (via transfer of fresh embryos from nondonor eggs) within 15 months of the last manual treatment date. RESULTS: Natural fertility group: Of the 14 patients available for follow-up (ages 25 to 44; mean, 33.5 years), 10 (71.4%) became pregnant within 1 year, and 9 (64.3%) reported full-term deliveries. Three of the 9 women who delivered reported a subsequent pregnancy, suggesting that the treatment protocol might have lasting effects. Two women have had a second live birth delivery; and the third is still pregnant. Pre-IVF group: Of the 25 patients available for follow-up (ages 28 to 44; mean, 36 years), clinical pregnancies were documented in 22 of 33 embryo transfers vs the US Centers for Disease Control and Prevention (CDC) 2001 age-adjusted expected number of 12.7 (P < .001). The estimated odds ratio for a successful pregnancy in a cycle (manual treatment: no treatment) is 3.20 (95% confidence interval = 1.55-8.4). CONCLUSIONS: The data trend across these studies suggests that this innovative site-specific protocol of manual soft-tissue therapy facilitates fertility in women with a wide array of adhesion-related infertility and biomechanical reproductive organ dysfunction. The therapy, designed to improve function by restoring visceral, osseous, and soft-tissue mobility, is a nonsurgical, noninvasive manual technique with no risks and few, if any, adverse side effects or complications. As such, it should be considered a new adjunct to existing medical infertility treatments.