Pleural effusion: pleurodesis using bleomycin and tetracycline was better than either alone.

Clinical bottom line (level 1b)

  1. A combination of tetracycline and bleomycin used for pleurodesis was better than either alone at preventing recurrence of malignant pleural effusions (NNT = 3 at 6 months) .
  2. There was no clear difference in the side effects between combination or single therapy.
  3. Malignant pleural effusions commonly recurred following pleurodesis - over half by 6 months.
Emad and Rezaian: Cancer 1996; 78: 2498-2501
Expires October 2003

The study

Unblinded ?concealed randomised trial with intention-to-treat
Setting: university hospital, Iran

60 patients (aged range 30 to 68 years; mean 54, 55% female) histologically- or cytologically-proven massive malignant pleural effusions. All patients were receiving chemotherapy, but were still symptomatic, so were going to have pleurodesis.
Control Group: (n = 20, 20 analysed): single installation of tetracycline (20mg/kg to a maximum of 2g in 50 ml of normal saline)
Experimental Group: (n = 20, 20 analysed): single installation of bleomycin (1 unit/kg to a maximum of 60 units in 50 ml of normal saline)
Experimental Group: (n = 20, 20 analysed): single installation of bleomycin and tetracycline
All patients had a 28-French thoracostomy tube inserted into the sixth intercostal space. Complete removal of fluid was allowed over several hours and was confirmed by subsequent X-ray. Then patients had 10-15 ml of intrapleural 1% lidocaine before installation of the suspension. Patients were repositioned every 15 minutes for two hours. The chest tube was reconnected after 24 hours and removed once drainage was < 5- ml per 8 hours and chest x-ray showed full expansion of the lungs.
100% followed for 6 months
Outcome notes:
  • recurrence of effusion : determined by x-ray

The evidence

bleomycin vs tetracycline
Outcome Time to outcome CEREERRRR
(95% CI)		ARR
(95% CI)		NNT
(95% CI)
recurrence of effusion 6 months 11
(55.0%)		 14
(70.0%)		 -27%
(-108% to 22%)		 -15.0%
(-44.6% to 14.6%)		 -7
(NNT = 7 to infinity;
NNH = 2 to infinity)
side effects 6 months 5
(25.0%)		 4
(20.0%)		 20%
(-155% to 75%)		 5.00%
(-20.8% to 30.8%)		 20
(NNT = 3 to infinity;
NNH = 5 to infinity)

combination vs tetracycline
Outcome Time to outcome CEREERRRR
(95% CI)		ARR
(95% CI)		NNT
(95% CI)
recurrence of effusion 6 months 11
(55.0%)		 3
(15.0%)		 73%
(17% to 91%)		 40.0%
(13.2% to 66.8%)		 3
(1 to 8)
side effects 6 months 5
(25.0%)		 5
(25.0%)		 0%
(-193% to 66%)		 0.00%
(-26.8% to 26.8%)		 inf
(NNT = 4 to infinity;
NNH = 4 to infinity)

Comments

  1. The study is too small to show any clear differences between tetracycline and bleomycin alone.

Citation

  1. Emad A, and Rezaian GR: treatment of malignant pleural effusions with a combination of bleomycin and tetracycline: a comparison of bleomycin or tetracycline alone versus a combination of bleomycin and tetracycline. Cancer 1996; 78: 2498-2501
Search Terms: pleural effusion in Cochrane
Contributor: Chris Ball and Clare Wotton, October 2000
Reviewer:

Clinical Question.
Patient malignant pleural effusions
Intervention or Exposure tetracycline
Comparison bleomycin with and without tetracycline
Outcome recurrence, side effects