Efficacy and safety of Buyang Huanwu decoction (补阳还五汤) for diabetic peripheral neuropathy: a systematic review and Meta-analysis

doi:10.19852/j.cnki.jtcm.20230802.002

Abstract

Abstract:

OBJECTIVE: To evaluate the efficacy and safety of Buyang Huanwu decoction (BYHWD) in treating diabetic peripheral neuropathy (DPN).
METHODS: Eight electronic databases, including China National Knowledge Infrastructure Database, Wanfang Database, China Science and Technology Journal Database, Chinese Biomedical Literature Database, Cochrane Library, Embase, Web of Science, and PubMed, were searched for randomized controlled trials (RCTs) of BYHWD to treat DPN. We identified all RCTs related to BYHWD and those on the treatment of DPN with the combination of mecobalamin. RevMan software was used for the statistical analysis.
RESULTS: Twenty-one RCTs with a total of 1945 patients were included. The methodological quality of the literature included was low. Meta-analysis showed that the efficacy of the treatment group was significantly better than that of the control group in the treatment of DPN with BYHWD [risk ratio (RR) = 0.33, 95% CI (0.27, 0.40), Z = 11.25, P < 0.000 01]. The median nerve of median motor nerve conduction velocity (MNCV) [mean difference (MD) = 4.16, 95% CI (1.35, 6.98)] and median sensory NCV (SNCV) [(MD = 3.28, 95% CI (2.35, 4.22)] were improved in the treatment group. The MNCV in the common peroneal nerve [(MD = 1.63, 95% CI (0.39, 2.87)] and SNCV [(MD = 4.56, 95% CI (3.16, 5.97)] were significantly higher than those in the control group (P < 0.01). Plasma viscosity [(MD = －0.15, 95% CI (－0.20, －0.09), Z = 5.17, P < 0.01)], whole blood high shear [(MD = － 0.83, 95% CI (－1.56, －0.11), Z = 2.26, P = 0.02)]and whole blood low shear [(MD = － 1.61, 95% CI (－2.28, －0.94), Z = 4.68, P < 0.01)] decreased significantly after treatment. There was no significant difference in fasting blood glucose [(MD = －0.42, 95% CI (－ 0.89, 0.05), Z = 1.76, P = 0.08)] between the treatment and control groups; postprandial blood glucose [(MD = －0.62, 95% CI (－ 1.19, 0.05), Z = 2.12, P = 0.03)] decreased significantly. No significant difference was found in the blood lipid levels between the treatment and control groups, including triglycerides [(MD = －0.21, 95% CI (－0.52, 0.10), Z = 1.34, P = 0.18)] and cholesterol [(MD = －0.13, 95% CI (－ 0.27, 0.00), Z = 1.92, P = 0.06)]. Of the 21 RCTs, only five reported adverse reactions, and four studies reported the length of follow-up. No serious adverse events were reported. None of the studies reported the quality of life and economic conditions.
CONCLUSIONS: Our study suggests that BYHWD has a significant therapeutic effect on DPN. High-quality, large-scale RCTs are needed to provide more reliable evidence.

Key words: diabetic peripheral neuropathy, safety, treatment outcome, nerve conduction studies, hemorheology, randomized controlled trial, Meta-analysis, Buyang Huanwu decoction

ZHANG Meizhen, HAO Xiaohui, TANG Yiting, CHEN Yupeng, HE Puyu, ZHAO Liming, PANG Bing, NI Qing. Efficacy and safety of Buyang Huanwu decoction (补阳还五汤) for diabetic peripheral neuropathy: a systematic review and Meta-analysis[J]. Journal of Traditional Chinese Medicine, 2023, 43(5): 841-850.

Figures/Tables 4

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Source	Sample	Sex	Age (years)	Intervention			Treatment	DN	Outcome
	(T/C)	(male		Intervention			period	duration	measure
		/female)		Treatment group	Control group		(weeks)	(years)
Ning RZ et al 2020¹⁰	30/30	T:13/17	T:62.53±3.67	Modified BYHWD (150 mL, bid)+ Mecobalamine (500 μg tid, po)+BT		Mecobalamine (500 μg tid, po)+BT	12	T:1.83 ± 1.78	CER
Ning RZ et al 2020¹⁰	30/30	C:16/14	C:61.43±4.29			Mecobalamine (500 μg tid, po)+BT	12	C: 2.2 ± 1.17	CER
Han Y 2005¹⁸	30/20	Not reported	Not reported	Modified BYHWD (bid)+BT		Mecobalamin (500 μg, tid, po)+BT	14	Not reported	NCV+Hemorheology
Gong LZ et al 2017¹⁹	60/60	Not reported	Not reported	Modified BYHWD (200 mL, bid)		Mecobalamin (1 mg,qd, iv)+BT	8	Not reported	NCV
Gong LZ et al 2017¹⁹	60/60	Not reported	Not reported	+BT		Mecobalamin (1 mg,qd, iv)+BT	8	Not reported	NCV
Wu Y, Ma D 2015²⁰	60/60	T:27/33	T:45-75	Modified BYHWD+ BT		Mecobalamin (0.5-1 mg, qd, iv)+BT	12	T:0.25-3	CER+NCV
Wu Y, Ma D 2015²⁰	60/60	C: 32/28	C: 48-74	Mecobalamin (0.5-1 mg, qd, iv)		Mecobalamin (0.5-1 mg, qd, iv)+BT	12	C: 0.42-3	CER+NCV
Sun SZ, Wang YZ 2008²¹	42/42	T:23/19	T:44-73	BYHWD (250 mL, bid)+Mecobalamin		Mecobalamin (0.5 mL, qd, im)+BT	12	T:0.8-13.5	CER+NCV+ Hemorheology
Sun SZ, Wang YZ 2008²¹	42/42	C: 22/20	C: 45-72	(0.5 mL, qd, im)+BT		Mecobalamin (0.5 mL, qd, im)+BT	12	C: 0.6-13.6	CER+NCV+ Hemorheology
Zhang T 2008²²	60/60	T:34/26	T:54.6±5.9	Modified BYHWD (bid)+BT		Mecobalamin (500 μg, qd, im)+BT	12	T:0.5-3	CER+NCV
Zhang T 2008²²	60/60	C: 32/28	C: 54.8±5.8	Modified BYHWD (bid)+BT		Mecobalamin (500 μg, qd, im)+BT	12	C: 0.5-3	CER+NCV
Sun BX, Li LQ 2017²³	47/47	T:24/23	T:59.64±10.51	Modified BYHWD (bid)+BT		Mecobalamin (0.5 mg, qd, im)+BT	12	T:6.87±3.41	CER
Sun BX, Li LQ 2017²³	47/47	C: 22/25	C: 59.35±10.33	Modified BYHWD (bid)+BT		Mecobalamin (0.5 mg, qd, im)+BT	12	C: 7.05±3.81	CER
Yang YQ, Xing DZ 2019²⁴	38/38	T:19/19	T:67.91±2.18	Modified BYHWD (250 mL, bid) + Mecobalamin (0.5-1 mg, qd,im)		Mecobalamin (0.5-1 mg, qd, im)	12	Not reported	CER
Yang YQ, Xing DZ 2019²⁴	38/38	C: 18/20	C: 68.59±2.12			Mecobalamin (0.5-1 mg, qd, im)	12	Not reported	CER
Liu B 2018¹¹	41/41	T:22/19	T:59.85±2.82	Modified BYHWD (200 mL, bid)+ Mecobalamine (0,5 mg, tid, po) + BT		Mecobalamine (0.5 mg, tid, po)+BT	8	Not reported	CER+NCV
Liu B 2018¹¹	41/41	C: 21/20	C: 59.35±2.76			Mecobalamine (0.5 mg, tid, po)+BT	8	Not reported	CER+NCV
Pan XJ 2017¹²	30/30	T:13/17	T:50.74±9.25	Modified BYHWD (150 mL, bid) +		Mecobalamine (500 μg, tid, po)+BT	12	T:8.45±1.26	CER+NCV+Hemorheology
Pan XJ 2017¹²	30/30	C: 16/14	C: 49.62±9.83	Meco-balamine (500 μg, tid, po) + BT		Mecobalamine (500 μg, tid, po)+BT	12	C: 8.72±1.35	CER+NCV+Hemorheology
Li YF 2009¹³	36/36	T:20/16	T:42-69	Modified BYHWD (bid) + BT		Mecobalamine (500 μg, tid, po)+BT	8	Not reported	CER+NCV+Hemorheology
Li YF 2009¹³	36/36	C: 16/20	C: 41-	Modified BYHWD (bid) + BT		Mecobalamine (500 μg, tid, po)+BT	8	Not reported	CER+NCV+Hemorheology
Peng H 2009¹⁴	30/30	T:18/12	T:52.7±11.5	Modified BYHWD (200 mL, bid) +Mecobalamine (0.5 mg, tid, po)+BT		Mecobalamine (0.5 mg, tid, po)+BT	12	T:6.52±1.21	CER+ NCV+Hemorheology
Peng H 2009¹⁴	30/30	C: 14/16	C: 50.8±12.4			Mecobalamine (0.5 mg, tid, po)+BT	12	C: 6.46±1.12	CER+ NCV+Hemorheology
Luo XY 2007¹⁵	40/40	T:22/18	T:66.68±9.82	BYHWD (100 mL, bid)+Mecobalamine (		Mecobalamine (500 μg, tid, po)+BT	8	Not reported	CER +NCV+Hemorheology
Luo XY 2007¹⁵	40/40	C: 21/19	C: 66.9±10.53	500 μg, tid, po)+BT		Mecobalamine (500 μg, tid, po)+BT	8	Not reported	CER +NCV+Hemorheology
Wang SX et al 2005¹⁶	130/78	T:78/52	T:56.6±6.3	Modified BYHWD (bid)+BT		Mecobalamine (500 μg, tid, po)+BT	8	T:2.3±1.2	CER+ NCV+Hemorheology
Wang SX et al 2005¹⁶	130/78	C: 45/33	C: 55.8±6.5	Modified BYHWD (bid)+BT		Mecobalamine (500 μg, tid, po)+BT	8	C: 2.3±1.5	CER+ NCV+Hemorheology
Liu CH et al 2003¹⁷	42/26	T:22/10	T:55.6±4.5	Modified BYHWD (100 mL, bid)+BT		Blank+BT	8	Not reported	CER+ NCV+Hemorheology
Liu CH et al 2003¹⁷	42/26	C: 14/12	C: 57.8± 3.4	Modified BYHWD (100 mL, bid)+BT		Blank+BT	8	Not reported	CER+ NCV+Hemorheology
CuiY, Pan MX 2004²⁵	100/92	T:58/42	T:39-73	Modified BYHWD (200 mL, bid)+ Meco-		Mecobalamine (500 μg, qod, im) +BT	8	T:0.25-10	CER+ NCV+Hemorheology
CuiY, Pan MX 2004²⁵	100/92	C: 52/40	C: 37-70	balamine (500 μg, qod, im) +BT		Mecobalamine (500 μg, qod, im) +BT	8	C: 0.25-11	CER+ NCV+Hemorheology
Luo XY 2007¹⁵	40/40	T:22/18	T:66.68±9.82	BYHWD (100 mL, bid)+Mecobalamine		Mecobalamine (500 μg, tid, po)+BT	8	Not reported	CER +NCV+Hemorheology
Luo XY 2007¹⁵	40/40	C: 21/19	C: 66.9±10.53	500 μg, tid, po)+BT		Mecobalamine (500 μg, tid, po)+BT	8	Not reported	CER +NCV+Hemorheology
Zhuang HZ 2011²⁶	30/30	T:14/16	T:54.1±3.7	Modified BYHWD (bid)+Mecobalamine		Mecobalamine (500 μg, qd, im)+BT	8	T:4.8±2.2	CER
Zhuang HZ 2011²⁶	30/30	C:16/14	C:55.1±3.9	(500 μg,qd, im) +BT		Mecobalamine (500 μg, qd, im)+BT	8	C:5.1±3.3	CER
Liu JG 2015²⁷	54/54	T:28/26	T:62.07±6.93	Modified BYHWD (200 mL, bid)+Mecob-		Mecobalamine (0.5 mg, tid, po)+BT	12	T:5.45±2.81	CER
Liu JG 2015²⁷	54/54	C:29/25	C:61.58±6.52	alamine (0.5 mg, tid, po) +BT		Mecobalamine (0.5 mg, tid, po)+BT	12	C:5.16±2.70	CER
Ji TC 2014²⁸	32/31	T:18/14	T:40-73	Modified BYHWD (bid)+ Mecobalamine (500 μg, tid)+BT		Mecobalamine (500 μg, tid)+BT	6	T:1-15	CER
Ji TC 2014²⁸	32/31	C:16/15	C:41-74	Modified BYHWD (bid)+ Mecobalamine (500 μg, tid)+BT		Mecobalamine (500 μg, tid)+BT	6	C:1-14	CER
Jiao FE et al 2013²⁹	56/52	T:30/26	T:40-72	Modified BYHWD (bid)+ Mecobalamine (500 μg, tid)+BT		Mecobalamine (500 μg, tid,)+BT	8	T:0.33-8.5	CER
Jiao FE et al 2013²⁹	56/52	C:31/21	C:42-70	Modified BYHWD (bid)+ Mecobalamine (500 μg, tid)+BT		Mecobalamine (500 μg, tid,)+BT	8	C:0.25-8	CER
Jiang ZS et al 2005³⁰	30/30	T:18/12	T:48.6±9	Modified BYHWD (200 mL, bid) + Mecobalamine (first four weeks, im;		Mecobalamine (first four weeks, im; last four weeks, po)+BT	8	T:13.6± 8.3^a	CER+NCV
Jiang ZS et al 2005³⁰	30/30	C:16/14	C:50±10.8	last four weeks, po)+BT		Mecobalamine (first four weeks, im; last four weeks, po)+BT	8	C:13± 9.8^a	CER+NCV

Source	Sample	Sex	Age (years)	Intervention			Treatment	DN	Outcome
	(T/C)	(male		Intervention			period	duration	measure
		/female)		Treatment group	Control group		(weeks)	(years)
Ning RZ et al 2020¹⁰	30/30	T:13/17	T:62.53±3.67	Modified BYHWD (150 mL, bid)+ Mecobalamine (500 μg tid, po)+BT		Mecobalamine (500 μg tid, po)+BT	12	T:1.83 ± 1.78	CER
Ning RZ et al 2020¹⁰	30/30	C:16/14	C:61.43±4.29			Mecobalamine (500 μg tid, po)+BT	12	C: 2.2 ± 1.17	CER
Han Y 2005¹⁸	30/20	Not reported	Not reported	Modified BYHWD (bid)+BT		Mecobalamin (500 μg, tid, po)+BT	14	Not reported	NCV+Hemorheology
Gong LZ et al 2017¹⁹	60/60	Not reported	Not reported	Modified BYHWD (200 mL, bid)		Mecobalamin (1 mg,qd, iv)+BT	8	Not reported	NCV
Gong LZ et al 2017¹⁹	60/60	Not reported	Not reported	+BT		Mecobalamin (1 mg,qd, iv)+BT	8	Not reported	NCV
Wu Y, Ma D 2015²⁰	60/60	T:27/33	T:45-75	Modified BYHWD+ BT		Mecobalamin (0.5-1 mg, qd, iv)+BT	12	T:0.25-3	CER+NCV
Wu Y, Ma D 2015²⁰	60/60	C: 32/28	C: 48-74	Mecobalamin (0.5-1 mg, qd, iv)		Mecobalamin (0.5-1 mg, qd, iv)+BT	12	C: 0.42-3	CER+NCV
Sun SZ, Wang YZ 2008²¹	42/42	T:23/19	T:44-73	BYHWD (250 mL, bid)+Mecobalamin		Mecobalamin (0.5 mL, qd, im)+BT	12	T:0.8-13.5	CER+NCV+ Hemorheology
Sun SZ, Wang YZ 2008²¹	42/42	C: 22/20	C: 45-72	(0.5 mL, qd, im)+BT		Mecobalamin (0.5 mL, qd, im)+BT	12	C: 0.6-13.6	CER+NCV+ Hemorheology
Zhang T 2008²²	60/60	T:34/26	T:54.6±5.9	Modified BYHWD (bid)+BT		Mecobalamin (500 μg, qd, im)+BT	12	T:0.5-3	CER+NCV
Zhang T 2008²²	60/60	C: 32/28	C: 54.8±5.8	Modified BYHWD (bid)+BT		Mecobalamin (500 μg, qd, im)+BT	12	C: 0.5-3	CER+NCV
Sun BX, Li LQ 2017²³	47/47	T:24/23	T:59.64±10.51	Modified BYHWD (bid)+BT		Mecobalamin (0.5 mg, qd, im)+BT	12	T:6.87±3.41	CER
Sun BX, Li LQ 2017²³	47/47	C: 22/25	C: 59.35±10.33	Modified BYHWD (bid)+BT		Mecobalamin (0.5 mg, qd, im)+BT	12	C: 7.05±3.81	CER
Yang YQ, Xing DZ 2019²⁴	38/38	T:19/19	T:67.91±2.18	Modified BYHWD (250 mL, bid) + Mecobalamin (0.5-1 mg, qd,im)		Mecobalamin (0.5-1 mg, qd, im)	12	Not reported	CER
Yang YQ, Xing DZ 2019²⁴	38/38	C: 18/20	C: 68.59±2.12			Mecobalamin (0.5-1 mg, qd, im)	12	Not reported	CER
Liu B 2018¹¹	41/41	T:22/19	T:59.85±2.82	Modified BYHWD (200 mL, bid)+ Mecobalamine (0,5 mg, tid, po) + BT		Mecobalamine (0.5 mg, tid, po)+BT	8	Not reported	CER+NCV
Liu B 2018¹¹	41/41	C: 21/20	C: 59.35±2.76			Mecobalamine (0.5 mg, tid, po)+BT	8	Not reported	CER+NCV
Pan XJ 2017¹²	30/30	T:13/17	T:50.74±9.25	Modified BYHWD (150 mL, bid) +		Mecobalamine (500 μg, tid, po)+BT	12	T:8.45±1.26	CER+NCV+Hemorheology
Pan XJ 2017¹²	30/30	C: 16/14	C: 49.62±9.83	Meco-balamine (500 μg, tid, po) + BT		Mecobalamine (500 μg, tid, po)+BT	12	C: 8.72±1.35	CER+NCV+Hemorheology
Li YF 2009¹³	36/36	T:20/16	T:42-69	Modified BYHWD (bid) + BT		Mecobalamine (500 μg, tid, po)+BT	8	Not reported	CER+NCV+Hemorheology
Li YF 2009¹³	36/36	C: 16/20	C: 41-	Modified BYHWD (bid) + BT		Mecobalamine (500 μg, tid, po)+BT	8	Not reported	CER+NCV+Hemorheology
Peng H 2009¹⁴	30/30	T:18/12	T:52.7±11.5	Modified BYHWD (200 mL, bid) +Mecobalamine (0.5 mg, tid, po)+BT		Mecobalamine (0.5 mg, tid, po)+BT	12	T:6.52±1.21	CER+ NCV+Hemorheology
Peng H 2009¹⁴	30/30	C: 14/16	C: 50.8±12.4			Mecobalamine (0.5 mg, tid, po)+BT	12	C: 6.46±1.12	CER+ NCV+Hemorheology
Luo XY 2007¹⁵	40/40	T:22/18	T:66.68±9.82	BYHWD (100 mL, bid)+Mecobalamine (		Mecobalamine (500 μg, tid, po)+BT	8	Not reported	CER +NCV+Hemorheology
Luo XY 2007¹⁵	40/40	C: 21/19	C: 66.9±10.53	500 μg, tid, po)+BT		Mecobalamine (500 μg, tid, po)+BT	8	Not reported	CER +NCV+Hemorheology
Wang SX et al 2005¹⁶	130/78	T:78/52	T:56.6±6.3	Modified BYHWD (bid)+BT		Mecobalamine (500 μg, tid, po)+BT	8	T:2.3±1.2	CER+ NCV+Hemorheology
Wang SX et al 2005¹⁶	130/78	C: 45/33	C: 55.8±6.5	Modified BYHWD (bid)+BT		Mecobalamine (500 μg, tid, po)+BT	8	C: 2.3±1.5	CER+ NCV+Hemorheology
Liu CH et al 2003¹⁷	42/26	T:22/10	T:55.6±4.5	Modified BYHWD (100 mL, bid)+BT		Blank+BT	8	Not reported	CER+ NCV+Hemorheology
Liu CH et al 2003¹⁷	42/26	C: 14/12	C: 57.8± 3.4	Modified BYHWD (100 mL, bid)+BT		Blank+BT	8	Not reported	CER+ NCV+Hemorheology
CuiY, Pan MX 2004²⁵	100/92	T:58/42	T:39-73	Modified BYHWD (200 mL, bid)+ Meco-		Mecobalamine (500 μg, qod, im) +BT	8	T:0.25-10	CER+ NCV+Hemorheology
CuiY, Pan MX 2004²⁵	100/92	C: 52/40	C: 37-70	balamine (500 μg, qod, im) +BT		Mecobalamine (500 μg, qod, im) +BT	8	C: 0.25-11	CER+ NCV+Hemorheology
Luo XY 2007¹⁵	40/40	T:22/18	T:66.68±9.82	BYHWD (100 mL, bid)+Mecobalamine		Mecobalamine (500 μg, tid, po)+BT	8	Not reported	CER +NCV+Hemorheology
Luo XY 2007¹⁵	40/40	C: 21/19	C: 66.9±10.53	500 μg, tid, po)+BT		Mecobalamine (500 μg, tid, po)+BT	8	Not reported	CER +NCV+Hemorheology
Zhuang HZ 2011²⁶	30/30	T:14/16	T:54.1±3.7	Modified BYHWD (bid)+Mecobalamine		Mecobalamine (500 μg, qd, im)+BT	8	T:4.8±2.2	CER
Zhuang HZ 2011²⁶	30/30	C:16/14	C:55.1±3.9	(500 μg,qd, im) +BT		Mecobalamine (500 μg, qd, im)+BT	8	C:5.1±3.3	CER
Liu JG 2015²⁷	54/54	T:28/26	T:62.07±6.93	Modified BYHWD (200 mL, bid)+Mecob-		Mecobalamine (0.5 mg, tid, po)+BT	12	T:5.45±2.81	CER
Liu JG 2015²⁷	54/54	C:29/25	C:61.58±6.52	alamine (0.5 mg, tid, po) +BT		Mecobalamine (0.5 mg, tid, po)+BT	12	C:5.16±2.70	CER
Ji TC 2014²⁸	32/31	T:18/14	T:40-73	Modified BYHWD (bid)+ Mecobalamine (500 μg, tid)+BT		Mecobalamine (500 μg, tid)+BT	6	T:1-15	CER
Ji TC 2014²⁸	32/31	C:16/15	C:41-74	Modified BYHWD (bid)+ Mecobalamine (500 μg, tid)+BT		Mecobalamine (500 μg, tid)+BT	6	C:1-14	CER
Jiao FE et al 2013²⁹	56/52	T:30/26	T:40-72	Modified BYHWD (bid)+ Mecobalamine (500 μg, tid)+BT		Mecobalamine (500 μg, tid,)+BT	8	T:0.33-8.5	CER
Jiao FE et al 2013²⁹	56/52	C:31/21	C:42-70	Modified BYHWD (bid)+ Mecobalamine (500 μg, tid)+BT		Mecobalamine (500 μg, tid,)+BT	8	C:0.25-8	CER
Jiang ZS et al 2005³⁰	30/30	T:18/12	T:48.6±9	Modified BYHWD (200 mL, bid) + Mecobalamine (first four weeks, im;		Mecobalamine (first four weeks, im; last four weeks, po)+BT	8	T:13.6± 8.3^a	CER+NCV
Jiang ZS et al 2005³⁰	30/30	C:16/14	C:50±10.8	last four weeks, po)+BT		Mecobalamine (first four weeks, im; last four weeks, po)+BT	8	C:13± 9.8^a	CER+NCV

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