Efficacy and safety of the Chinese herbal medicine shuganjieyu with
and without adjunctive repetitive transcranial magnetic stimulation (rTMS) for
geriatric depression: a randomized controlled trial |
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Authors: | Minmin XIE Wenhai JIANG Haibo YANG |
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Institution: | 1.Daqing Campus of Harbin Medical University, Daqing, Heilongjiang Province, China;2.The Third People’s Hospital of Daqing, Daqing, Heilongjiang Province, China |
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Abstract: | BackgroundPharmacological treatment of geriatric depression is often ineffective
because patients cannot tolerate adequate doses of antidepressant
medications. AimExamine the efficacy and safety of shuganjieyu – the first Chinese herbal
medicine approved for the treatment of depression by China’s drug regulatory
agency -- with and without adjunctive treatment with repetitive transcranial
magnetic stimulation (rTMS) in the treatment of geriatric depression.MethodsSixty-five inpatients 60 or older who met ICD-10 criteria for depression were
randomly assigned to an experimental group (shuganjieyu + rTMS) (n=36) or a
control group (shuganjieyu + sham rTMS)(n=29). All participants received 4
capsules of shuganjieyu daily for 6 weeks. rTMS (or sham rTMS) was
administered 20 minutes daily, five days a week for 4 weeks. Blinded raters
used the Hamilton Rating Scale for Depression (HAMD-17) and the Treatment
Emergent Symptom Scale to assess clinical efficacy and safety at baseline
and 1, 2, 4, and 6 weeks after starting treatment. Over the six-week trial,
there was only one dropout from the experimental group and two dropouts from
the control group.ResultsNone of the patients had serious side effects, but 40% in the experimental
group and 50% in the control group experienced minor side effects that all
resolved spontaneously. Both groups showed substantial stepwise improvement
in depressive symptoms over the 6 weeks. Repeated measures ANOVA found no
differences between the two groups. After 6 weeks, 97% of the experimental
group had experienced a 25% or greater drop in the level of depression, but
only 20% had experience a 50% or greater drop in the level of depression;
the corresponding values in the control group were 96% and 19%. There were
some minor, non-significant differences in the onset of the treatment effect
between the different types of depressive symptoms, but by the second week
of treatment all five HAMD-17 subscale scores had improved significantly in
both groupsConclusionThe Chinese herbal medicine shuganjieyu is effective and safe in the
treatment of geriatric depression, but only a minority of patients have
greater than 50% improvement in their depressive symptoms after 6 weeks of
treatment. Adjunctive use of rTMS with shuganjieyu does not improve the
overall outcome and does not significantly speed up the onset of action of
shuganjieyu. |
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Keywords: | shuganjieyu Chinese herbal medicine repetitive transcranial magnetic stimulation geriatric depression China |
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