Management of peripheral arterial disease in primary care

EDITORS: Burns et al. (1) reviewed the current knowledge on the
management of peripheral arterial disease (PAD). They did not even
mentioned ozonated autohemotherapy (O3-AHT), the therapeutic modality used
in symptomatic treatment of lower limbs ischemia in some countries from
several decades. In this method, a known volume of blood is exposed ex
vivo to an oxygen-ozone mixture with strict ozone concentration,
afterwards reinfused back to the patient. Given the fact that ozone, a
strong oxidant may be toxic, this medical approach has encountered
skepticism, if not outright objection in a big part of medical community.

In-depth studies of Bocci and coworkers, performed in the last decade
helped to improve the understanding of biological mechanism of ozone
activity. They gave also precise recommendations on the use of O3-AHT in
PAD, and established the range of ozone concentrations in which it does
not induce oxidative cell damage (2).

The other important issue is the clinical effectiveness of O3-AHT.
Despite the some uncontrolled reports showing clinical improvement after
O3-AHT in patients with symptomatic PAD, a strict evidence was not
provided to date (3). To shed light on this point, we performed a
prospective, placebo-controlled study to evaluate the impact of O3-AHT on
the walking distance in patients on maintenance HD with PAD (II-III stage
according to Fontain) (4). 10 subjects received 9 sessions of O3-AHT with
ozone concentration of 50 ìg/ml and 9 sessions of oxygen autohemotherapy
as a control in a cross-over, single-blind manner. Intermittent
claudication distance was measured using a march test on a treadmill.
Significant prolongation in walking distance after O3-AHT was found, as
compared to the baseline (by 30.5%) and to the oxygen control (by 22.7%)
[p<_0.04 and="and" p0.02.="p0.02." thus="thus" we="we" demonstrated="demonstrated" to="to" our="our" best="best" knowledge="knowledge" for="for" the="the" first="first" time="time" in="in" a="a" placebo-controlled="placebo-controlled" manner="manner" that="that" o3-aht="o3-aht" may="may" attenuate="attenuate" clinical="clinical" symptoms="symptoms" of="of" lower="lower" limbs="limbs" ischemia.="ischemia." p="p"/> The rationale for these beneficial effects may come from several
possible mechanisms of ozone activity leading to an improvement of blood
flow in hypoxic areas. These include a decrease in blood viscosity and
coagulation, vasorelaxation and alterations in prostanoids production. The
influence of ozone on the increase of 2,3-diphosphoglycerate levels,
responsible for enhanced oxygen delivery to ischemic tissues has also been
postulated but not substantiated in all studies (2,3). Despite our
encouraging results, a wide use of O3-AHT should be preceded by large-
scale clinical trials, which could finally confirm or deny the
effectiveness of this modality.

Leszek Tylicki, Bogdan Biedunkiewicz, Tomasz Neweglowski, Boleslaw
Rutkowski

From Department of Nephrology, Transplantology and Internal Medicine.
Medical University of Gdansk. Poland.

REFERENCES

1. Burns P, Gough S, Bradbury A. Management of peripheral arterial disease
in primary care. BMJ 2003; 326: 584-588.

2. Bocci V: Biological and clinical effects of ozone. Has ozone therapy a
future in medicine? Br J Biomed Sci 1999; 56: 270-279.

3. Tylicki L, Nieweglowski T, Biedunkiewicz B, Burakowski S, Rutkowski B:
Beneficial clinical effects of ozonated autohemotherapy in chronically
dialyzed patients with atherosclerotic ischemia of the lower limbs. Int J
Artif Organs 2001; 24: 79-82.

4. Biedunkiewicz B, Tylicki L, Nieweglowski T, Burakowski S, Chamienia A,
Debska-Slizien A, Rutkowski B: Beneficial effects of ozonated
autohemotherapy in hemodialyzed patients with atherosclerotic ischemia of
lower limbs. Nephrol Dial Tansplant 2002; 17(Suppl. 12): 260(abstract).

Competing interests:  
None declared