Evaluation of individualized treatment of nonproliferative diabetic retinopathy: a multicenter, randomized, parallel-controlled study

doi:10.19852/j.cnki.jtcm.20210425.002

Abstract

Abstract:

OBJECTIVE: To evaluate the differences in the efficacy of stationary treatment and individualized treatment for patients with nonproliferative diabetic retinopathy (NPDR).

METHODS: This study was a randomized, controlled, multicenter clinical trial. Participants with NPDR were randomized into the stationary treatment group or the individualized treatment group. The stationary treatment group was given the basic treatment and Qiming granules, and the individualized treatment group was given the basic treatment, Qiming granules, and individualized Chinese herbal medicines over a 12-week period. The individualized therapeutic formula was also changed over time to adjust to the changes in the clinical presentation of the patient. We conducted observations of fundus retinal exudation and hemorrhage, visual acuity, Traditional Chinese Medicine symptom scores and other indicators.

RESULTS: A total of 140 participants with NPDR were randomized into the stationary treatment group or the individualized treatment group, and 132 participants completed this study. Following the 12-week treatment, significant improvements in both primary and secondary outcomes were observed in the stationary and individualized treatment groups. No remarkable difference in the primary outcomes between the two groups was observed. However, there was a significant difference in the Traditional Chinese Medicine symptom scores (18 ± 7 vs 15 ± 6; P < 0.05). There were no severe adverse effects.

CONCLUSION: Compared with stationary treatment, individualized treatment is more effective at relieving the Traditional Chinese Medicine symptoms and improving vision and fundus lesions at 12 weeks post treatment.

Key words: diabetic retinopathy, individualized treatment, randomized controlled trial, Qiming granules

Jian HUO, Junguo DUAN, Lisha LIU, Fuwen ZHANG, Keyu ZHU, Jiaqing SUI, Wenyuan JIAN. Evaluation of individualized treatment of nonproliferative diabetic retinopathy: a multicenter, randomized, parallel-controlled study[J]. Journal of Traditional Chinese Medicine, 2022, 42(1): 90-95.

Figures/Tables 4

References 24

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Characteristic		ST group (n = 64)	IT group (n = 68)	P value
Age (years)		62±9	59±10	0.052
Sex [n (%)]	Female	37 (57.8)	36 (52.9)	0.692
	Male	27 (42.2)	32 (47.1)
	Course of DM (years)	14±8	13±8	0.417
Staging of DR [n (%)]	Mild NPDR	20 (15.9)	18 (13.7)	0.826
	Moderate NPDR	83 (65.9)	86 (65.7)
	Severe NPDR	23 (18.2)	27 (20.6)

Characteristic		ST group (n = 64)	IT group (n = 68)	P value
Age (years)		62±9	59±10	0.052
Sex [n (%)]	Female	37 (57.8)	36 (52.9)	0.692
	Male	27 (42.2)	32 (47.1)
	Course of DM (years)	14±8	13±8	0.417
Staging of DR [n (%)]	Mild NPDR	20 (15.9)	18 (13.7)	0.826
	Moderate NPDR	83 (65.9)	86 (65.7)
	Severe NPDR	23 (18.2)	27 (20.6)

Characteristic		ST group (n = 56)	IT group (n = 54)	P value^b
RHA (pixel)	Baseline	19751±40588	15151±31621	0.701
	12 weeks	12885±31370	6493±11423	0.224
	RHA difference	6866±20659	8658±26057	0.384
	P value^a	0.002	0.044
REA (pixel)	Baseline	9436±22801	9071±23171	0.904
	12 weeks	5783±14832	4861±15065	0.442
	REA difference	3653±13349	4210±15629	0.710
	P value^a	0.007	0.047

Characteristic		ST group (n = 56)	IT group (n = 54)	P value^b
RHA (pixel)	Baseline	19751±40588	15151±31621	0.701
	12 weeks	12885±31370	6493±11423	0.224
	RHA difference	6866±20659	8658±26057	0.384
	P value^a	0.002	0.044
REA (pixel)	Baseline	9436±22801	9071±23171	0.904
	12 weeks	5783±14832	4861±15065	0.442
	REA difference	3653±13349	4210±15629	0.710
	P value^a	0.007	0.047

Characteristic		ST group (n = 64)	IT group (n = 68)	P value^b
HbA1c (%)	Baseline	7.49±1.20	7.69±1.12	0.354
	12 weeks	7.22±1.21	7.24±1.14	0.909
	HbA1c difference	0.27±0.91	0.44±1.05	0.370
	P value^a	0.024	0.001
VS	Baseline	70.94±11.31	70.09±12.53	0.719
	4 weeks	72.44±11.29	71.68±11.64	0.537
	8 weeks	72.80±11.68	72.37±11.72	0.765
	12 weeks	77.25±15.61	78.37±14.13	0.669
	VS difference	6.32±10.87	8.28±12.27	0.871
	P value^a	0.000	0.000
TCMSS	Baseline	24.16±8.37	23.74±8.08	0.855
	4 weeks	21.45±7.72	20.38±7.95	0.448
	8 weeks	19.67±7.54	18.51±7.33	0.360
	12 weeks	17.52±6.82	15.22±6.13	0.044
	TCMSS difference	6.64±5.78	8.51±6.39	0.080
	P value^a	0.000	0.000

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