Equivalent endometrial safety and efficacy in the relief of the symptoms and signs of urogenital estrogen deficiency were demonstrated for the 12 months' use of a low-dose estradiol-releasing vaginal ring and a vaginal estradiol tablet.

Summary:suppression. Finally, culture conditions may be developed which could be applied to gene transduction protocols. We have previously demonstrated that CD34 + cells, Most investigators initiate stem/progenitor cell expansion selected from peripheral blood progenitor cells (PBPC), with CD34 + cells purified by positive selection since these can be expanded in ex vivo culture and can be infused cells appear to be superior to unselected material. In in tandem with unmanipulated PBPC with little or no addition, up to a 4.0 log depletion of contaminating tumour toxicity. In this study, four patients (two non-Hodgkin's cells can be obtained using CD34 selected starting populymphoma (NHL), two multiple myeloma (MM)) lations. 7 A recent study suggested that any remaining received myeloablative conditioning prior to stem cell tumour cells do not increase in number during ex vivo rescue using ex vivo expanded cells alone. The two expansion, and this may represent a further purging patients with NHL received cyclophosphamide and total effect. 8,9 The first clinical studies using progenitor cells body irradiation (CY/TBI) and the two patients with expanded ex vivo have now been reported. 5,6,10,11 In only MM, busulphan and melphalan (Bu/M). One case one of these studies, in a small number of patients, stem received an inadequate CFU-GM dose, despite expancell rescue was performed using only the expanded cells, sion, and in one case the expanded cells were contamiwithout unmanipulated 'back-up'. 5 Brugger et al 5 expanded nated. No definitive conclusions may therefore be drawn one tenth of a standard peripheral blood progenitor cell concerning engraftment in these two cases. However, (PBPC) product prior to infusion. Six patients were transthe other two cases received high doses of committed planted with expanded cells only, and five of six experiprogenitors. Following infusion of the expanded enced rapid engraftment following high-dose, but nonmaterial, all four patients failed to show sustained myeloablative, chemotherapy. The remaining patient died neutrophil engraftment and none showed evidence of prior to the anticipated time of engraftment. platelet engraftment. Back-up, unmanipulated PBPC In our previous study, we established the safety and were therefore infused on days 14, 34, 32 and 28 and feasibility of transfusing CD34 + cells which had been selecsubsequently all four cases achieved satisfactory ted from cryopreserved PBPC and then expanded ex vivo. 6 engraftment of both neutrophils and platelets. In conTen patients received у20 × 10 4 CFU-GM/kg unmanipclusion, we feel that, CD34 + cells, expanded ex vivo using ulated PBPC in addition to an aliquot of expanded cells the conditions described in this report, may not provide (range 33-279 × 10 4 CFU-GM/kg). There were no toxic durable engraftment following fully myeloablative effects from the progenitor cells which had been generated conditioning.ex vivo. 6 Keywords: ex vivo expansion; CD34 positive; PBPC;The primary objective of this second study was to det...

These data demonstrate that CD34 cells can successfully be selected from cryopreserved material, expanded ex vivo on a large scale, and safely reinfused following myeloablative conditioning regimens.

Objective To compare the safety, efficacy and acceptability of a continuous low dose oestradiol releasing vaginal ring with conjugated equine oestrogen vaginal cream in the treatment of postmenopausal urogenital atrophy. Design An open, parallel, comparative multicentre trial. Setting Sydney and Melbourne, Australia. Participants and Interventions One hundred and ninety‐four postmenopausal women with symptoms and signs of urogenital atrophy were randomised on a 2:1 basis to 12 weeks of treatment with an oestrogen vaginal ring versus an oestrogen cream. Main outcome measures and results Equivalence (95% CI) was demonstrated between the two treatments for relief of vaginal dryness and dyspareunia, resolution of atrophic signs, improvement in vaginal mucosal maturation indices and reduction in vaginal pH. No significant difference was demonstrated in endometrial response to a progestogen challenge test and equivalence was demonstrated in the incidence of intercurrent bleeding episodes. The vaginal ring was significantly more acceptable than the cream (P < 0.0001), and was preferred to the cream (P < 0.001). Conclusion With equivalent efficacy and safety and superior acceptability to vaginal cream, the low dose oestradiol vaginal ring is an advance in vaginal delivery systems for the treatment of urogenital atrophy.

Approximately 10% of women are severely affected by premenstrual syndrome (PMS) during their reproductive years. Several biological theories of causation have been proposed and each has provoked treatment attempts through medication to little sustained effect. As many of the reported complaints are psychological, a new treatment approach was considered using cognitive-behavioral therapy. A preliminary study which combined cognitive-behavioral therapy with drug treatment produced considerable symptom reduction. The present study examined the efficacy of cognitive-behavioral therapy alone in direct comparison with hormone treatment. Relaxation instructions were provided to a control group. Initial rapid responses to drug treatment and relaxation diminishes after 2 months, together with marked attrition in the control group. Significant positive benefits from cognitive-behavioral therapy were achieved after the first treatment month that continued throughout and were maintained at follow-up 3 months later. Implications for future management are discussed.