Assessment of leech therapy for knee osteoarthritis: A randomized study

Figures & data

Table 1.  Inclusion and exclusion criteria

Inclusion criteria

Osteoarthritis of the knee

Persistent osteoarthritic symptoms for at least 6 months

Radiographic evidence of late-stage osteoarthritis of the knee (Kellgren/Lawrence stage III-IV)

History of nonoperative treatment including pain medication and physiotherapy

Exclusion criteria

Anticoagulant treatment or hemophilia

Rheumatic diseases leading to secondary osteoarthritis

Hematological, hepatological, renal, or immunological disease

Insulin-dependent diabetes mellitus

Intraarticular injections or systemic application of cortico-steroids during the previous 3 months

Surgery of the affected knee during the previous 3 months, or joint replacement

Previous leech therapy

Lack of informed consent

Table 2.  Patient demographics

	T group	C group	Total
No. of patients	73	40	113
Male (%)	44	26	70 (62)
Age, years (SD)	68 (10)	64 (9)	67 (10)
BMI (SD)	29 (4.8)	27 (3.8)	28 (4.5)
Weight, kg (SD)	83 (15)	79 (13)	81 (14)
Duration of osteoarthritis, years (SD)	8.3 (6.8)	7.1 (6.5)	7.9 (6.7)

Changes over time of medians and quartiles for Cumulative KOOS Score of the individual populations.

Table 3.  Changes over time of p-values determined with the paired Wilcoxon test for the individual populations

Group	1 week vs. Bl.	4 weeks vs. Bl.	6 weeks vs. Bl.	3 months vs. Bl.	6 months vs. Bl.	Score used
T1	< 0.001	< 0.001	0.003	< 0.001	0.02	Cumulative KOOS
	< 0.001	< 0.001	0.001	< 0.001	0.003	Cumulative WOMAC
	< 0.001	< 0.001	0.002	0.002	0.006	VAS
	< 0.001	< 0.001	< 0.001	< 0.001	< 0.001	Pain (WOMAC)
	0.12	0.01	0.05	0.02	0.03	Stiffness (WOMAC)
	< 0.001	< 0.001	0.005	0.004	0.02	Function (WOMAC
	< 0.001	< 0.001	< 0.001	< 0.001	< 0.001	Pain (KOOS)
	< 0.001	< 0.001	0.005	0.001	0.02	ADL (KOOS)
	0.008	0.002	0.002	0.001	0.001	RPM
T2	< 0.001	< 0.001	< 0.001	< 0.001	< 0.001	Cumulative KOOS
	< 0.001	< 0.001	< 0.001	< 0.001	< 0.001	Cumulative WOMAC
	< 0.001	< 0.001	< 0.001	< 0.001	< 0.001	VAS
	< 0.001	< 0.001	< 0.001	< 0.001	< 0.001	Pain (WOMAC)
	< 0.001	< 0.001	< 0.001	< 0.001	< 0.001	Stiffness (WOMAC)
	< 0.001	< 0.001	< 0.001	< 0.001	< 0.001	Function (WOMAC)
	< 0.001	< 0.001	< 0.001	< 0.001	< 0.001	Pain (KOOS)
	< 0.001	< 0.001	< 0.001	< 0.001	< 0.001	ADL (KOOS)
	< 0.001	< 0.001	< 0.001	0.003	0.04	RPM
C	0.02	0.003	< 0.001	0.002	0.05	CumulativeKOOS
	0.13	0.03	0.01	0.05	0.1	Cumulative WOMAC
	0.02	< 0.001	< 0.001	0.004	0.01	VAS
	0.13	0.008	0.01	0.01	0.2	Pain (WOMAC)
	0.95	0.6	0.6	0.9	1.0	Stiffness (WOMAC)
	0.11	0.009	0.003	0.03	0.03	Function (WOMAC)
	0.03	0.02	0.002	0.009	0.2	Pain (KOOS)
	0.11	0.008	0.003	0.03	0.02	ADL (KOOS)
	1.0	1.0	1.0	1.0	1.0	RPM

BI. = baseline

Table 4.  Evaluation of the differences obtained for various parameters over time, expressed as p-values, determined with the unpaired Wilcoxon-test for comparison of the individual populations

Group	1 week vs. Bl.	4 weeks vs. Bl.	6 weeks vs. Bl.	3 months vs. Bl.	6 months vs. Bl.	Score used
T1 vs. C	0.2	0.16	0.23	0.5	0.65	Cumulative KOOS
	0.04	0.02	0.03	0.2	0.20	Cumulative WOMAC
	0.06	0.07	0.01	0.07	0.35	VAS
	0.02	0.002	0.002	0.02	0.007	Pain (WOMAC)
	0.3	0.3	0.3	0.1	0.10	Stiffness (WOMAC)
	0.12	0.10	0.24	0.5	0.6	Function (WOMAC)
	0.05	0.005	0.006	0.03	0.05	Pain (KOOS)
	0.2	0.11	0.3	0.4	0.7	ADL (KOOS)
	0.01	0.005	0.006	0.005	0.001	RPM
T2 vs. C	0.002	0.009	< 0.001	0.007	0.02	Cumulative KOOS
	0.005	0.01	0.002	0.005	0.02	Cumulative WOMAC
	< 0.001	< 0.001	< 0.001	< 0.001	0.02	VAS
	0.03	0.008	< 0.001	0.002	0.001	Pain (WOMAC)
	0.002	< 0.001	< 0.001	< 0.001	< 0.001	Stiffness (WOMAC)
	0.02	0.04	0.008	0.02	0.04	Function (WOMAC)
	0.02	0.003	< 0.001	< 0.001	0.01	Pain (KOOS)
	0.02	0.04	0.008	0.007	0.04	ADL (KOOS)
	0.006	0.007	< 0.001	0.001	0.001	RPM
T2vs.T1	0.05	0.15	0.003	0.02	0.04	Cumulative KOOS
	0.3	0.8	0.4	0.05	0.2	Cumulative WOMAC
	0.4	0.05	0.005	0.03	0.07	VAS
	0.9	0.5	0.3	0.4	0.2	Pain (WOMAC)
	0.01	0.06	0.008	0.03	0.02	Stiffness (WOMAC)
	0.4	0.6	0.07	0.05	0.2	Function (WOMAC)
	0.4	0.7	0.1	0.2	0.1	Pain (KOOS)
	0.2	0.6	0.08	0.05	0.07	ADL (KOOS)
	0.9	0.6	0.8	0.8	0.2	RPM

Bl. = baseline