Clinical Trials in Venous Disease: With Particular Reference to Life Table Analysis

Abstract

Over recent years surgeons have adopted an increasingly scientific approach to determine the best treatment for their patients. For venous disease there have been trials comparing surgery with sclerotherapy,¹⁻³ the use of stockings to relieve symptoms,⁴ therapeutic benefits of drugs^5,6 and dressings for ulcer healing.^7,8

The term ‘trial’ is often used in reporting medical research, but frequently it is used inappropriately. This paper gives an overview of the considerations necessary to run a meaningful clinical trial and some of the common pitfalls in trials of venous disease.

Keywords

clinical trials venous disease life table analysis

Get full access to this article

View all access options for this article.

References

Hobbs

J.T.

Surgery and sclerotherapy in the treatment of varicose veins. A random trial. Arch Surg 1974; 109: 793–6.

Piachaud

Weddell

J.M.

The economics of treating varicose veins. Int J Epidemiol 1972; 1: 287.

Doran

F.S.A.

White

A clinical trial designed to discover if the primary treatment of varicose veins should be by Fegan's method or by an operation. Br J Surg 1975; 62: 72–6.

Dinn

Henry

Value of lightweight elastic tights in standing occupations. Presented to the Venous Forum of the Royal Society of Medicine, London 1988

Layer

G.T.

Stacey

M.C.

Burnand

K.G.

Stanozolol and the treatment of venous ulceration – an interim report. Phlebology 1986; 1: 197–203.

Pulvertaft

T.B.

Paroven in the treatment of chronic venous insufficiency. The Practitioner 1979; 223: 838–41.

Steward

A.J.

Leaper

D.J.

Treatment of chronic leg ulcers in the community: A comparative trial of Scherisorb and Iodosorb. Phlebology 1987; 2: 115–21.

Blair

S.D.

Backhouse

C.M.

Wright

D.D.I.

Riddle

McCollum

C.N.

Do dressings influence the healing of chronic venous ulcers?

Phlebology 1988; 3: 129–34.

Bulpitt

C.J.

Randomised controlled clinical trials. The Hague: Martinus Nyerhoff Publishers, 1983.

10.

McFarland

R.J.

Scott

H.J.

Kay

D.N.

Scott

R.A.P.

High injection sclerotherapy for varicose veins in the presence of femoro-saphenous reflux. Phlebology 1988; 3, 49–54.

11.

Friedman

L.M.

Furberg

C.D.

DeMets

D.L.

Fundamentals of clinical trials, Boston: John Wright, PSG Inc, 1981.

12.

Weitgasser

The use of pentoxyifylline (Trental 400) in the treatment of leg ulcers: Results of a double-blind trial. Pharmatherapeutica 1983, 3 (Suppl. 1): 143–51.

13.

Warlow

Organise a multicenre trial. Br Med J 1990; 300: 180–3.

14.

Kahn

H.A.

An introduction to epidemiologic methods, Oxford: Oxford University Press, 1983.

15.

Armitage

Berry

Statistical methods in medical research, Oxford: Blackwell Scientific Publishing, 1987.