Objective

2

To observe the clinical efficacy and safety of

Xiaozheng Zhitong Gel

（消癥止痛凝胶） in the treatment of pain from bone metastasis.

Methods

2

The included patients were randomized into treatment group （52 cases） and control group （51 cases）. On the basis of routine anti-tumor treatment， the patients in the control group were administered with standardized or abandoned the three-step analgesic treatment according to the subjective needs of patients. The patients in the treatment group were additionally given

Xiaozheng Zhitong Gel

， 2 g for each pain site， three times daily， on the basis of the treatment given in the control group. Both groups were treated for one week. The primary outcomes were the effectiveness on the most severe pain and the average pain， for which subgroup analyses could be performed regarding whether three-step analgesic treatment is combined or not， traditional Chinese medicine （TCM） syndrome type， site of bone metastases， gender， and age. The secondary outcomes included the changes of the most severe pain， the average pain and the lightest pain measured by the numerical rating scale （NRS）， the impact of pain on activities of daily living measured by brief pain inventory （BPI）， the changes in the demand for three-step analgesics， and the local adverse reactions of the

Xiaozheng Zhitong Gel

.

Results

2

Totally， 49 cases were included in the treatment group and 48 cases in the control group for analysis. The total effective rate of

Xiaozheng Zhitong Gel

on the most severe pain was 61.22% （30/52） in the treatment group， significantly higher than 4.17% （2/51） of the control group （

P

＜0.05）. The total effective rate on average pain of bone metastasis was 34.69% （17/52） in the treatment group， significantly better than 0 （0/51） in the control group （

P

＜0.05）. Regarding whether three-step analgesic treatment was combined with， the treatment group with

Xiaozheng Zhitong Gel

had better effects on

the most severe pain and average pain than the control group （

P

＜0.05）， and the significant advantages on the most severe pain in favor of the treatment group were not associated with different TCM syndromes， site of bone metastases， gender and age （all

P

＜0.05）. In the treatment group， there was no significant difference among the subgroups with different pain severity， TCM syndromes， sites of bone metastases and gender （all

P

＞0.05）， except for age indicating best effect in people ≥ 65 years old （

P

＜0.05）. The NRS scores of the worst pain， average pain， and lightest pain， and the impact score of pain on activities of daily life function in the treatment group were significantly lower after treatment （

P

＜0.05）； the scores before and after treatment in the control group were not significantly different （

P

＞0.05）； and the changes of the scores were larger in the treatment group than the control group （

P

＜0.05）. There was no significant difference between groups in the demand for three-step analgesics （

P

＞0.05）. There were five cases of mild irritant dermatitis in the treatment group， which not interrupted the treatment and disappeared after treatment.

Conclusion

2

Xiaozheng Zhitong Gel

alone or in combination with three-step analgesics has a good analgesic effect in the treatment of bone metastasis pain， which are not associated to the pain severity， the site of bone metastasis， gender， age or TCM syndromes， and is safe.