[Vertebroplasty compared with conservative method of integrated Chinese and Western Medicine in patients with osteoporotic vertebral compression fractures].

OBJECTIVE: To compare the effects of percutaneous vertebroplasty (PVP) versus conservative method of integrated Chinese and Western Medicine for pain relief and functional outcome in patients with painful osteoporotic vertebral fractures. New fractures and secondary adverse effects were also analyzed during a mid-long term follow-up period. METHODS: Patients were recruited to this prospective nonrandomized trial from a single hospital. Patients were aged 55 years or older, had vertebral compression fractures on spine radiograph (level of fracture at T6 or lower; bone oedema on MRI), with back pain for 6 weeks or less, and a visual analogue scale (VAS) score of 6 or more. Patients were nonrandomly assigned to PVP group or conservative treatment group according to their own desire. After 2 weeks, patients from the conservative group could change therapy to PVP. VAS for pain and Oswestry disability index (ODI) questionnaire scores were assessed before and 1 week, 1 month, 3, 6, 12, 24, 36, 48, and 60 months after the treatment. Other data included patients' baseline characteristics before the treatment, new fractures and secondary adverse effects were also recorded. RESULTS: A total of 181 consecutive patients were nonrandomly allocated to receive PVP (n=103) or conservative treatment (n=78) between December 2009 and August 2013. Six patients transferred to PVP group after 2 weeks conservative therapy. Pain relief and functional outcomes were significantly better in PVP group than in conservative group, as determined by VAS scores (3.67-1.13 vs 7.38-2.39) and ODI scores (23.55-5.83 vs 36.10-13.88) at 1 week, 1 month, 3 and 6 months (all P< 0.01). Both VAS and ODI scores decreased in PVP group showed no statistical significance at 1 year when compared with conservative group (P>0.05). However, pain relief and functional outcomes were significantly better at most of the subsequent follow-up points. The patients with complete pain relief (VAS<1) were significantly better in PVP group than in conservative group (P< 0.01) at all of the follow-up points. There were 17 patients died (PVP group: n=8) and 31 cases occurred secondary vertebral fractures (PVP group: n=19) during the follow-up periods. No serious complications or adverse events were related to PVP technique. CONCLUSION: PVP has immediate pain relief and functional improvement compared with conservative treatment. PVP should be considered as the treatment of first choice for symptomatic osteoporotic vertebral fractures. However, for patients with VAS < 5, conservative method of integrated Chinese and Western Medicine may perform well.