PURPOSE: This trial aimed to investigate the efficacy of Migu capsules in treating osteoporotic low back pain.
PATIENTS AND METHODS: In this single-center trial, we randomly assigned patients with osteoporotic low back pain that had lasted for 3 months in a 1:1 ratio to receive Migu capsules alongside Caltrate D in treatment group or to receive Caltrate D only in control group, both for 48 weeks. The primary outcome measure was the intensity of low back pain on a visual analog scale at 24 weeks after enrollment. Secondary outcome measures included the Roland-Morris Disability Questionnaire (RMDQ), bone turnover markers, and bone mineral density.
RESULTS: A total of 100 patients were enrolled, with 50 in each group. At baseline, the mean score for low back pain intensity was 6.2 in the treatment group and 6.1 in the control group. The primary outcome of the low back pain intensity score at 24 weeks was 2.9 in the treatment group and 4.7 in the control group (adjusted mean difference, -1.8; 95% confidence interval, -2.3 to -1.4; P<0.001). Secondary outcomes including the score on RMDQ and pain at 48 weeks were in the same direction as the primary outcome. Compared to the control group, the treatment group only showed a difference in bone density after continuous intervention for 48 weeks (P<0.05). Three patients experienced a mild adverse event associated with the intake of Migu capsules.
CONCLUSION: Migu capsules can alleviate bone pain and reduce functional disabilities caused by osteoporotic lower back pain.
| Discipline Area | Score |
|---|---|
| Physician |  |
Physician rater
As a Pain and Palliative care physician, I have not had experience with Chinese herbal medicine. The study methods are reasonable and the herbal medicine is safe per this study. More studies with this herbal medicine would be helpful.
Physician rater
Small study but fairly well designed. We would need to see a lot more data before even trying to find whether something like MIGU capsules would be available in the USA. I'm also unfamiliar with how this combination of herbal supplements would work. I'm definitely unfamiliar with how heat clearing traditional Chinese medicine would counteract side effects.
Physician rater
This is a study of 100 patients with osteoporotic back pain. Half received a Chinese herbal preparation and calcium/vitamin D and the other group received calcium/vitamin D alone. The herbal group showed more pain improvement but the difference was not deemed "minimally clinically important." The herbal supplement was dosed three times a day, and no placebo was used for this preparation. However, there is some clinical plausibility to some of the ingredients of the 7-herbal mix. This merits further study but not clinical adoption.
, McMaster University