Alavi, A.A., Eshraghi, M., Rahim, M.B., Meysami, A.P., Morteza, A., & Hajian, H. (2011). Povidone-iodine and bleomycin in the management of malignant pleural effusion. Acta Medica Iranica, 49(9), 584-587.

The objective of this study was to compare the effectiveness of bleomycin as a sclerosing agent with povidone-iodine with respect to efficacy, cost, accessibility, safety, ease of administration, and number of doses for complete response.        

Forty participants were assigned into two treatment groups of bleomycin treatment or povidone-iodine treatment via block randomization. A 28Fr. chest tube was placed in all patients at the bedside under local anesthesia with opioids given for pain. The following day, both groups had a sclerosing agent instilled in the chest tube for one hour; bleomycin at 1 mg/kg in 60 mL saline in the study group and povidone-iodine 10%, which was diluted to obtain a final concentration of 2.5% povidone-iodine in the control group. Both groups had 5 mL of 2% lidocaine solution added to the sclerosing agent. In both groups, the chest tubes were clamped for one hour and then connected to water seal. All patients were admitted to the same unit in the hospital and experienced the same post-pleurodesis respiratory and pain management protocols. The chest tube remained in place until output decreased to 200 mL; if high output persisted more than 10 days, a Heimlich valve was placed and patients were discharged from the hospital. Chest x-rays were obtained post-chest tube removal and at 30 days post-procedure to evaluate size of pleural effusions. Pain and dyspnea after drainage ratings were recorded at discharge and at 30 days post-op. 

The sample was comprised of 39 patients.

Key disease characteristics included

• Biopsy- or cytology-proven malignant pleural effusions with a variety of types of cancer
• Effusions previously treated with and showing improvement with thoracenteses but recurrent or symptomatic when entered in study.

Key sample characteristics included

• Symptomatic benefit from thoracenteses
• Chest radiograph confirming lung expansion of 90% or more after therapeutic thoracenteses
• Karnofsky performance status index greater than or equal to 70
• No one with comorbidities that would exclude them from general anesthesia
• No bleeding disorders, massive skin infiltration, or active infectious disease.
   

This single-site study was conducted in the inpatient unit at Valiasr Hospital in Tehran, Iran.

• Patients were undergoing long-term follow-up care.
• The study has clinical applicability for end-of-life and palliative care.
   

The study was a randomized clinical trial.

• Chest tube placement, +/- Heimlich valve    
• Numeric pain scale
• Chest x-ray
• Dyspnea scale (1–10)
   

• According to author reports, the groups were equivalent in demographic variables, but this data was not visible to the reviewer.
• No significant difference was seen between groups with respect to age, duration of thoracostomy, volume of pleural effusion, dyspnea score after drainage, fever, and pleural effusion after drainage, discharge, and one month later.
• Patients in the bleomycin group had significantly lower dyspnea scores at the one-month follow-up time compared to the povidone-iodine group.
• Complete pleurodesis occurred in 79% of the bleomycin group and 75% of the povidone-iodine group, which is not a significant difference in treatment results.

• Bleomycin is more effective at long-term dyspnea management based on one-month follow-up reports.
• No differences were observed between groups based on pain score following procedure, dyspnea at discharge, or reoccurrence of pleural effusion at the one-month follow-up visit. 
• Neither method demonstrated extremely superior results and appear similar in overall effects.

• The study had a small sample size of less than 100 patients.
• Groups were not matched by age and sex.
   

When compared with povidone-iodine, bleomycin offers the advantage of being more effective for dyspnea symptoms one month post-procedure. However, both methods appear similar in terms of pain scores, dyspnea at discharge, and recurrence of pleural effusions at one-month follow-up. For patients with concerns of iodine absorption or side effects, bleomycin would be a comparable sclerosing agent.