[Treatment of diabetic nephropathy by integrative medicine: a multi-center prospective cohort study].

OBJECTIVE

To assess the efficacy and safety of integrative medicine (IM) treatment for diabetic nephropathy (DN), and to explore the medication laws by Chinese medicine (CM) syndrome typing.

METHODS

One hundred and seventy outpatients or inpatients with DN at Dongfang Hospital of Beijing University of Chinese Medicine, Xiyuan Hospital of China Academy of Chinese Medical Sciences, and China-Japan Friendship Hospital of the Ministry of Health were recruited from March 2008 to July 2009. They were allocated into the IM group (116 cases) or the Western medicine group (54 cases) according to whether or not they were willing to receive CM syndrome typing. The incidence of endpoint events and secondary outcome measures [such as body mass index (BMI), systolic blood pressure (SBP), diastolic blood pressure (DBP), urinary albumin excretion rate (UAER), 24 h urinary protein (24 hU), serum creatinine (SCr), fasting blood glucose (FBG), and glycosylated hemoglobin (HbA1c)] of two groups were observed at 3, 6, 12, 18, and 24 months respectively during the follow-ups. Patients in the IM group were syndrome typed. The CM recipes were collected to calculate the frequency of Chinese materia medica used. The liver function, blood routines, and ECG were observed and compared during the follow-ups.

RESULTS

The follow-up period was 3 to 24 months with the mean of 14 months. Data suitable for analysis mainly covered the 3rd, 6th, 12th and 18th month of the follow-up. Both PPS and FAS analysis showed that there were no significant difference in the incidence of endpoint between two groups (11.2% vs 7.4%, P>0.05). The level of body mass index (BMI) [(25.0 +/- 3.1) kg/m2] and fasting blood glucose (FBG) [(7.9 +/- 1.5) mmol/L] in the IM group were lower than those of the Western medicine group [(28.6 +/- 4.4) kg/m2 and (8.8 +/- 2.9) mmol/L respectively] at the 6-month follow-up (P<0.05). The levels of FBG [(7.9 +/- 1.4) mmol/L] and HbA1c [(7.8 +/- 1.4)%] in the IM group were lower than those of the Western medicine group [(9.6 +/- 2.8) mmol/L and (8.5 +/- 1.6)% respectively] at the 12-month follow-up (P<0.05). There was no significant difference in other indices between the two groups at the 3- or 12-month follow-ups. The level of SCr in the IM group and the Western medicine group before follow-up were (96.8 +/- 35.2) micromol/L and (80.5 +/- 24.6) micromol/L respectively, showing statistical difference (P<0.01). There were no significance difference in SCr between the two groups at 3, 6, 12, 18-month follow-ups for center 2 (Xiyuan Hospital of China Academy of Chinese Medical Sciences) and center 3 (China-Japan Friendship Hospital of the Ministry of Health), while the level of SCr in the IM group [(82.4 +/- 25.7) micromol/L, (78.1 +/- 25.9) micromol/L, (80.3 +/- 24.0) micromol/L, respectively] were lower than that of the Western medicine group [(101.4 +/- 37.2) micromol/L, (96.5 +/- 34.1) micromol/L, (93.9 +/- 25.9) micromol/L, respectively] for center 1 (Dongfang Hospital of Beijing University of Chinese Medicine) at 3, 6, 12-month follow-ups (P<0.05). The top ten drugs used most frequently in the 237 prescriptions collected was astragali (68.4%), ophiopogonis tube (67.5%), rehmannia dried rhizome (67.1%), danshen root (49.4%), Codonopsis pilosula (41.8%), figwort root (35.4%), Chinese magnolia-vine fruit (29.5%), safflower (27.9%), peach seed (26.2%), and angelica root (25.3%). There was no abnormal liver function, blood abnormalities, and serious adverse events in two groups during the follow-ups.

CONCLUSIONS

CM treatment based on syndrome typing in combination with routine Western medicine for DN could reduce the levels of BMI, FBG, HbA1c, and SCr at partial time points, showing favorable safety. Chinese medicinals applied in treatment based on syndrome typing for DN covered mainly supplementing qi, nourishing yin, and activating blood circulation to remove blood stasis.