Effects of acupuncture and medical training therapy on depression, anxiety, and quality of life in patients with frequent tension-type headache: A randomized controlled study.

OBJECTIVES: To compare the effects of acupuncture and medical training therapy in combination or individually with usual care on quality of life, depression, and anxiety in patients with tension-type headache. METHODS: In this single-center, prospective, randomized, controlled, unblinded trial, 96 adults (38.7(+/-13.3) years of age; 75 females/20 males/one dropout) with frequent episodic or chronic tension-type headache were randomized to one of four treatment groups (n = 24). The treatment groups received six weeks of either acupuncture or medical training therapy as monotherapies or in combination (12 interventions each), or usual care. We assessed depressiveness (PHQ-9), anxiety (GAD-7), and health-related quality of life (SF-12) as secondary outcome parameters at baseline, six weeks, three months, and six months after initiation of treatment. Linear mixed models were calculated. RESULTS: Both, acupuncture (baseline to six-weeks change scores: mean: -2(standard deviation: 2.5 points), three months: -2.4(2.4), six-months -2.7(3.6)) and the combination of acupuncture and medical training therapy (-2.7(4.9), -2.2(4.0), -2.2(4.2)) (each within-group p < .05) significantly reduced depressiveness-scores (PHQ-9) to a greater extent than medical training therapy (-0.3(2.0), -0.5(1.6), -0.9(2.6)) or usual care alone (-0.8(2.9), 0.1(2.8), 0.2(3.6)). We found similar results with anxiety scores and the physical sum scores of the SF-12. No severe adverse events occurred. CONCLUSIONS: Acupuncture and the combination of acupuncture and medical training therapy elicit positive effects on depression, anxiety, quality of life, and symptom intensity in patients with episodic and chronic tension-type headache. Acupuncture appears to play a central role in mediating the therapeutic effects, underscoring the clinical relevance of this treatment. An additive benefit of the combination of both therapies does not appear to be relevant.Trial registration: Registered on 11 February 2019. German Clinical Trials Register, DRKS00016723.

Combination of acupuncture and medical training therapy on tension type headache: Results of a randomised controlled pilot study.

OBJECTIVES: The aim of this study was to compare the effects of acupuncture and medical training therapy alone and in combination with those of usual care on the pain sensation of patients with frequent episodic and chronic tension-type headache. DESIGN: This was a prospective single-centre randomised controlled trial with four balanced treatment arms. The allocation was carried out by pre-generated randomisation lists in the ratio 1:1:1:1 with different permutation block sizes. SETTING: The study was undertaken in the outpatient clinic of Rehabilitation Medicine of the Hannover Medical School.Participants and interventions: Ninety-six adult patients with tension-type headache were included and randomised into usual care (n = 24), acupuncture (n = 24), medical training (n = 24), and combination of acupuncture and medical training (n = 24). One patient was excluded from analysis because of withdrawing her/his consent, leaving 95 patients for intention to treat analysis. Each therapy arm consisted of 6 weeks of treatment with 12 interventions. Follow-up was at 3 and 6 months. MAIN OUTCOME MEASURES: Pain intensity (average, maximum and minimum), frequency of headache, responder rate (50% frequency reduction), duration of headache and use of headache medication.Clinical results: The combination of acupuncture and medical training therapy significantly reduced mean pain intensity compared to usual care (mean = -38%, standard deviation = 25%, p = 0.012). Comparable reductions were observed for maximal pain intensity (-25%, standard deviation = 20%, 0.014) and for minimal pain intensity (-35%, standard deviation = 31%, 0.03). In contrast, neither acupuncture nor medical training therapy differed significantly from usual care. No between-group differences were found in headache frequency, mean duration of headache episodes, and pain medication intake. At 3 months, the majority of all patients showed a reduction of at least 50% in headache frequency. At 6 months, significantly higher responder rates were found in all intervention groups compared to usual care. CONCLUSIONS: In contrast to monotherapy, only the combination of acupuncture and medical training therapy was significantly superior in reduction of pain intensity compared to usual care.Trial registration: Registered on 11 February 2019. German Clinical Trials Register, DRKS00016723.