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Acupuncture for recurrent headaches: a systematic review of randomized controlled trials D Melchart’, K LindelJ, P FischerI, A White3, G Allais4, A Vickers5, B Berman6 Research Centre for Complementary Mediciru?, Department of Internal Medicine II, Klinikum rechts der Tsar, Technische Universitit, Germany; Institute for Occupational, Social Medicine and Epidemiologyr, Charitt Hospital, Humboldt-University, Berlin, Germany; Department of Complementary Medicines, School of Postgraduate Medicine and Health Sciences, University of Exeter, Exeter, UK; Woman’s Headache Center*, Department of Gynecology and Obstetrics, University of Turin, Turin, Italy; The Research Council fvr Complementary Medicines, London, UK; Division of Complementary Medicine6, Baltimore, MD, USA Department of Family Medicine, University of Mayland, G?phdd!! Melchart D, Linde K, Fischer P, White A, Allais G, Vickers A, Berman B. Acupuncture for recurrent -~ headaches: a systematic review of randomized controlled trials. Cephalalgia 1999;19:779-86. Oslo. ISSN 03331024 Objective: To assess whether there is evidence that acupuncture is effective in the treatment of recurrent headaches. Design: Systematic review. Study selection: Randomized or quasi-randomized clinical trials comparing acupuncture with any type of control intervention for the treatment of recurrent headaches. Data sources: Electronic databases (Medline, Embase, Cochrane Field for Complementary Medicine, Cochrane Controlled Trials Register), personal communications and bibliographies. Data collection and analysis: Information on patients, interventions, methods, and results were extracted by at least two independent reviewers using a pretested form. A pooled estimate of the responder rate ratio (responder rate in treatment group/responder rate in control group) was calculated as a crude indicator of trial results as meta-analysis of more specific outcome data was impossible due to heterogeneity and insufficient reporting. Results: Twenty-two trials, including a total of 1042 patients (median 36, range lo-150), met the inclusion criteria. Fifteen trials were in migraine patients, six in tension-headache patients, and in one trial patients with various headaches were included. The majority of the 14 trials comparing true and sham acupuncture showed at least a trend in favor of true acupuncture. The pooled responder rate ratio was 1.53 (95% confidence interval 1.11 to 2.11). The eight trials comparing acupuncture and other treatment forms had contradictory results. Conclusions: Overall, the existing evidence suggests that acupuncture has a role in the treatment of recurmnt headaches. However, the quality and amount of evidence is not fully convincing. There is urgent need for well-planned, large-scale studies to assess effectiveness and efficiency of acupuncture under real life conditions. 0 Acupuncture, migraine, randomized controlled trials, systematic review, tension-)ype headache K Linde, Research Centrefir Complementay Medicine, Department of Internal Medicine IL, Klinikum rechts der lsar, Technische Universitit, Raise&r. 9, 80802, M&&en, Germany. Tel. i-49 89 3304 1048, fax. +49 89 393484, email. [email protected] Received 15 July 1999, accepted 9 August 2999 Recurrent and chronic headaches are a major source of morbidity (l-4) and costs are substantial (5). Acupuncture is widely used for the treatment of headaches in industrialized countries and it may be applied as a single modality as well as part of a more complex treatment program (6-8). Despite this popularity there is still debate about whether acupuncture has “specific” effects, that is, effects over and above placebo. Systematic reviews on the use of acupuncture in the treatment of chronic pain in general (g-11), as well as on headaches in particular (12- 14), were published in 1989 and 1990. Since then a number of new trials have been performed and agreement has been reached on a classification of headaches (15). Therefore, an up-to-date review of the available clinical evidence was deemed necessary. The objective was to assess whether there is evidence that acupuncture is (i) more effective than no treatment; (ii) more effective than “sham” acupuncture; (iii) similarly effective as other inter- ventions in the treatment of recurrent headaches. Methods Selection criteria The review trials (i) had to be randomized or quasi-randomized (e.g., alternation); (ii) had to include patients with recurrent headaches (migraine, tension headache, cluster headache, not precisely classified chronic or recurrent headaches); (iii) had to compare acupuncture (needle insertion at acupunc- ture points, pain points, trigger points, or other methods of stimulating acupuncture points, such as laser acupuncture or electroacupuncture) with a control condition; (iv) had to report at least one clinical outcome related to headache (e.g., pain intensity, global assessment of headache, etc.). We excluded trials (a) focussing explicitly on patients with facial pain; (b) only comparing different forms of acupuncture; (cc) reporting physiological or laboratory parameters only; (d) with periods of less than 4 weeks from the start of the treatment phase to the end of the observation period.

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  • Acupuncture for recurrent headaches: a systematic review of randomized controlled trials

    D Melchart, K LindelJ, P FischerI, A White3, G Allais4, A Vickers5, B Berman6 Research Centre for Complementary Mediciru?, Department of Internal Medicine II, Klinikum rechts der Tsar, Technische Universitit, Germany; Institute for Occupational, Social Medicine and Epidemiologyr, Charitt Hospital, Humboldt-University, Berlin, Germany; Department of Complementary Medicines, School of Postgraduate Medicine and Health Sciences, University of Exeter, Exeter, UK; Womans Headache Center*, Department of Gynecology and Obstetrics, University of Turin, Turin, Italy; The Research Council fvr Complementary Medicines, London, UK; Division of Complementary Medicine6, Baltimore, MD, USA

    Department of Family Medicine, University of Mayland,

    G?phdd!! Melchart D, Linde K, Fischer P, White A, Allais G, Vickers A, Berman B. Acupuncture for recurrent -~ headaches: a systematic review of randomized controlled trials. Cephalalgia 1999;19:779-86. Oslo. ISSN 03331024

    Objective: To assess whether there is evidence that acupuncture is effective in the treatment of recurrent headaches. Design: Systematic review. Study selection: Randomized or quasi-randomized clinical trials comparing acupuncture with any type of control intervention for the treatment of recurrent headaches. Data sources: Electronic databases (Medline, Embase, Cochrane Field for Complementary Medicine, Cochrane Controlled Trials Register), personal communications and bibliographies. Data collection and analysis: Information on patients, interventions, methods, and results were extracted by at least two independent reviewers using a pretested form. A pooled estimate of the responder rate ratio (responder rate in treatment group/responder rate in control group) was calculated as a crude indicator of trial results as meta-analysis of more specific outcome data was impossible due to heterogeneity and insufficient reporting. Results: Twenty-two trials, including a total of 1042 patients (median 36, range lo-150), met the inclusion criteria. Fifteen trials were in migraine patients, six in tension-headache patients, and in one trial patients with various headaches were included. The majority of the 14 trials comparing true and sham acupuncture showed at least a trend in favor of true acupuncture. The pooled responder rate ratio was 1.53 (95% confidence interval 1.11 to 2.11). The eight trials comparing acupuncture and other treatment forms had contradictory results. Conclusions: Overall, the existing evidence suggests that acupuncture has a role in the treatment of recurmnt headaches. However, the quality and amount of evidence is not fully convincing. There is urgent need for well-planned, large-scale studies to assess effectiveness and efficiency of acupuncture under real life conditions. 0 Acupuncture, migraine, randomized controlled trials, systematic review, tension-)ype headache

    K Linde, Research Centrefir Complementay Medicine, Department of Internal Medicine IL, Klinikum rechts der lsar, Technische Universitit, Raise&r. 9, 80802, M&&en, Germany. Tel. i-49 89 3304 1048, fax. +49 89 393484, email. [email protected] Received 15 July 1999, accepted 9 August 2999

    Recurrent and chronic headaches are a major source of morbidity (l-4) and costs are substantial (5). Acupuncture is widely used for the treatment of headaches in industrialized countries and it may be applied as a single modality as well as part of a more complex treatment program (6-8). Despite this popularity there is still debate about whether acupuncture has specific effects, that is, effects over and above placebo.

    Systematic reviews on the use of acupuncture in the treatment of chronic pain in general (g-11), as well as on headaches in particular (12- 14), were published in 1989 and 1990. Since then a number of new trials have been performed and agreement has been reached on a classification of headaches (15). Therefore, an up-to-date review of the available clinical evidence was deemed necessary.

    The objective was to assess whether there is evidence that acupuncture is (i) more effective than no treatment; (ii) more effective than sham acupuncture; (iii) similarly effective as other inter- ventions in the treatment of recurrent headaches.

    Methods

    Selection criteria

    The review trials (i) had to be randomized or quasi-randomized (e.g., alternation); (ii) had to include patients with recurrent headaches (migraine, tension headache, cluster headache, not precisely classified chronic or recurrent headaches); (iii) had to compare acupuncture (needle insertion at acupunc- ture points, pain points, trigger points, or other methods of stimulating acupuncture points, such as laser acupuncture or electroacupuncture) with a control condition; (iv) had to report at least one clinical outcome related to headache (e.g., pain intensity, global assessment of headache, etc.). We excluded trials (a) focussing explicitly on patients with facial pain; (b) only comparing different forms of acupuncture; (cc) reporting physiological or laboratory parameters only; (d) with periods of less than 4 weeks from the start of the treatment phase to the end of the observation period.

  • 780 D Melchart et al. cEPHALAIGIA19 (1999)

    Search strategy

    To identify pbblished and unpublished eligible trials we searched (i) Medline 1966 to 1998 (search terms: acupuncture/acupressure/electroacupunc- ture and headache/migraine); (ii) Embase 1989 to 1998 (acupuncture/acupressure and headache/ migraine); (iii) the database of the Cochrane Field for Complementary Medicine; (iv) the Cochrane Controlled Trials Register; (v) individual trial collections and private databases; and (vi) biblio- graphies of articles obtained.

    All references identified by the literature search were screened by two reviewers. In a first step we tried to identify all articles on acupuncture treat- ment of recurrent headaches reporting orginal data. From 97 studies identified in that step, 40 were selected that mentioned a control condition. At least two reviewers then assessed whether eligibility criteria were met. Disagreements occurred in the case of three studies but were resolved by discus- sion.

    Assessment of methodological quality

    The quality of reports/methodological quality of included trials was assessed by at least two independent reviewers using two scales. The Jadad et al. (16) scale has items on random allocation, double-blinding, and reporting of drop- outs or exclusions. The maximum score is five. The second scoring method (the Internal Validity Scale) was developed by one of us and has been used in several systematic reviews of complementary med- icine (17-19). This instrument has six items: (a) method of allocation to groups; (b) concealment of allocation; (c) baseline comparability; (d) blinding of patients; (e) blinding of evaluators; (f) likelihood of selection bias after allocation to groups by drop- outs. The maximum score is six.

    When calculating scores, only the information provided in the publications or written reports was used. Disagreements between reviewers were resolved by discussion.

    Rata extraction and summarizing study results

    Information on patients, methods, interventions, outcomes, and results was extracted by at least two independent reviewers using a pretested form. We tried to contact the authors of 19 studies; 12 responded and one provided individual patient data. In summary, very little relevant additional information could be gathered.

    Trials were categorized by the different types of headache (migraine and migrainous disorders, tension-type headache, mixed [patients with differ- ent types of headache within one trial]) and by the

    type of control group intervention (sham acupunc- ture, other treatment, no treatment).

    A quantitative meta-analysis of data on frequency and intensity of headaches as well as medication was not possible owing to the heterogeneity of the trials (interventions, outcome measurement meth- ods) and insufficient reporting. In order to provide at least an exploratory quantitative s ummary of the results of the relatively large group of sham- controlled trials we extracted data on global response (improvement after treatment). If there was no global response data, data on frequency or headache indices were used (response was defined as at least 33% improvement). Rate ratios (propor- tion of responders in the true acupuncture group / proportion of responders in the sham acupuncture group), their 95% confidence intervals and a random effects summary estimate were calculated using the Cochrane Collaboration RevMan software. In addition, the results were summarized descrip- tively. We also performed a vote count with the following categories to get a crude estimator of the overall outcome of each study (at least two independent reviewers): -2 = control group better than acupuncture (statistically significant); -1= control group better than acupuncture (trend); 0 =no difference; 1 =acupuncture better than con- trol group (trend); 2 =acupuncture better than control group (statistically significant). Only in two studies did disagreements occur, and in both cases the less favorable vote was taken.

    Results Twenty-two studies on a total of 1042 patients (median 36, range lo- 150) met the inclusion criteria (see Table 1) (20-41). Fifteen trials were in migraine patients (20-34), six in tension-type headache patients (35 -40); and in one trial patients with various headaches were included (41). One of the migraine trials was in children (26). Five trials used the criteria of the International Headache Society @-IS) to classify headache syndromes (25,28,29,31, 38), three the Ad hoc Commitee criteria (23,37,40), and the pediatric trial the Prensky criteria (26).

    Fourteen trials compared true acupuncture and sham procedures (20-29, 35-38), five compared acupuncture with drug treatment (30- 33, 41), and two with physiotherapy (39, 40). One three-armed trial compared acupuncture with a no treatment group and a biobehavioral treatment program (34). The acupuncture interventions in the trials varied considerably. Basic information on the qualification and/or experience of the acupuncturists was provided only in nine trials (20. 23, 28, 29, 32, 34-36,38). All of the 14 sham-controlled trials tried to blind patients. At least five of these trials did not

  • Tab

    le 2

    . Cha

    ract

    eris

    tics

    of

    incl

    uded

    tr

    ials

    ,

    Firs

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    Patie

    nts

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    he

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    plet

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    plet

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    Fo

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    -up

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    atm

    ent

    Con

    ceal

    men

    t bl

    inde

    d tr

    eatm

    ent

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    riod

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    Con

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    Mig

    rain

    e B

    aust

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    44

    Cec

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    30

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    48

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    22

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    7)

    32

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    40

    Wei

    nsch

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    41

    Alla

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    **

    120

    Hes

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    85

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    150

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    63

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    30

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    22

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    0)

    62

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    55

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    no

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    no

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    am

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    (10)

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    e (1

    0 -

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    ed

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    (10)

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    e (6

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    ) fo

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    (8)

    indi

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    patie

    nts

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    uded

    an

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    ere

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    -out

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    ndle

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    an

    adeq

    uate

    w

    ay?

    **O

    ngoi

    ng

    tria

    l.

  • 782 D Melchart ef al. CEPHALALGIA 19 (1999)

    fully inform patients that one group would receive sham acupuncture (patients were told that two types of acupuncture were being compared) (20, 21, 25, 35, 38). In at least one further trial in which the placebo condition did not involve needling it seems very likely that this was done in the same way (otherwise it would not have been possible to blind patients) (22).

    The treatment period was on average 9 weeks (range 2- 17) with eight treatment sessions (range 6- 15). In the 15 trials which followed patients after therapy the median follow-up time was 28 weeks (range 3- 104). The most common outcome mea- sures were frequency (days with headache or number of headache attacks) and intensity.

    The majority of the trials had methodological and/or reporting shortcomings. Allocation conceal- ment was described in only three trials: in one, a central telephone call randomization was used (38), while in the other two sealed envelopes were used (22,40). For a fourth trial the author told us that he had used sealed envelopes (27). The median Jadad score was 2 (range l-5 from a maximum of 5); the median internal validity score was 2.5 (range 1 - 5 from a maximum of 6). The success of blinding was tested in two trials (suggesting successful blinding) (27, 38). The reporting of drop-outs and with- drawals was satisfactory in only half of the trials. Seven trials did not list inclusion criteria and 13 did not describe co-interventions. Reporting of the complex headache data was poor.

    We have particular doubts about three studies that were insufficiently reported and had extremely positive results (24,32,33). One trial, which seemed welI designed from a methodological perspective, failed completely on a practical level: a large proportion of patients dropped out at a very early phase of the trial (25).

    Of the 14 trials comparing acupuncture and sham acupuncture in migraine and tension-type headache patients, two (20, 22) found no effects over sham acupuncture, three trials (23,28,37) showed trends in favor of acupuncture, and in six trials (21,24,26, 27, 29, 35) the patients in the acupuncture groups did significantly better than those in the sham acupuncture group (see Table 2 for summary of results). Three trials were judged as uninterpretable by the reviewers: One trial (36) claimed significant results in favor of acupuncture, but did not present any actual data; in the second trial (25) a large proportion dropped out already in the early phase; the third trial (38) was a methodologically rigorous but very small pilot study with major baseline differences between the groups. The outcomes which seemed to be influenced the most were days with headache or frequency of attacks and intensity, although the findings were not always consistent. Duration of headache attacks and

    medication use were rarely reported in an inter- pretable way. Seven sham-controlled trials provided data on proportions of patients responding to treatment (20, 21, 23, 24, 28, 29, 37), and for three further trials such data were available either for frequency of headaches (22) or could be calculated from individual patient data on headache-free days (27) or headache indices (35); 117 of 182 acupunc- ture patients (64%) were classified as responders compared to 71 of 169 (42%) patients receiving sham acupuncture, resulting in a pooled random effects responder rate ratio of 1.53 (95% CI 1.11 to 2.11; test of heterogeneity: Chi square 19.38, z =2.59). The results for trials in aine and

    mrL tension-type were similar (see Table 3). eofthe trials included in this analysis (24) was one of the three trials where we had particular doubts about its validity. When this trial was excluded, the pooled responder rate ratio was 1.38 (95% CI 1.05 to 1.81; Chi square 12.34, z =2.30).

    The seven interpretable trials comparing acu- puncture and other treatments had highly contra- dictory results (see Table 2) (31-34, 39 -41). One trial is stilI ongoing, and an interim analysis was available as an abstract only (30).

    Eleven trials had follow-up periods of at least 6 months after therapy (22, 24, 25, 27-29, 32, 33, 37, 39,40), but the majority have to be interpreted with caution because of relevant loss to follow-up (25, 40), major reporting deficiencies (22, 28, 29, 39), or doubtful overall validity (24, 32, 33). The results of the two most rigorous trials (27, 37) suggest that improvements after acupuncture can last for longer periOdS.

    Discussion Overall, the existing evidence suggests that acu- puncture has a role in the treatment of recurrent headaches. The majority of trials comparing true and sham acupuncture in migraine and tension- headache patients show at least a trend in favor of true acupuncture. However, most trials were small and were either inadequately reported or had identifiable methodological flaws. Moreover, the trials varied greatly with respect to the precise nature of the acupuncture intervention and the method of outcome assessment.

    There is no evidence to assess how acupuncture compares to no treatment, and insufficient evidence whether it is as effective as other headache treatments.

    We searched a number of different sources to identify all trials relevant to our subject. We could not identify any unpublished studies (apart from one recently completed positive trial whose author told us that he plans to publish it as soon as

  • cEPHAL,ALGIA 19 (1999)

    Table 2. Narrative summary of the results of trials.

    First author (ref) vote count Outcomes and results

    Acupuncture for recurrent headaches 783

    comments

    Sham-controlled trials in migraine patients Baud (20) 0 Only responder data based on headache indices

    presented: 14/23 (acupuncture) vs 14/21 (sham)

    ceccherelli (21) ++ responders Hours with pain per week after treatment 11 (SD 11, acupuncture) vs 35 h (SD 28, sham), no effect

    Dowson (22) 0, on Sleep 33% relief in pain intensity after treatment: 14/25 (acupuncture) vs 7/23 (sham)

    Henry 6% +

    Heydenreich (24) ++

    Pintov (26) ++

    Vincent (2V ++

    weinschfitz (28) +

    Weinschtitz (29) ++

    Improvement rates after 3 months for frequency: 12/20 (acupuncture) vs 3/10 (sham), intensity: 11/20 vs 2/20 Improvement rates at 6-mo follow-up for frequency: 81% (acupuncture) vs 25% (sham); intensity: 39% vs 0% Migraine frequency after treatment: 1.4 (SD 0.6, acupuncture) vs 9.3 (SD 1.5, sham); intensity (VAS): 3.3 vs 6.2 Weekly pain scores at early follow-up: 15 (SD 12; acupuncture) vs 23 (SD 26, sham); less medication in acupuncture Improvement rates after treatment for intensity: lo/20 (acupuncture) vs 3/20 (sham); duration: 11/20 vs 3/20 Improvement rates after treatment for intensity: 9/20 (acupuncture) vs l/21 (sham); duration: 9/20 vs 3/21

    Sham4ontrolkd trials in patients with tension-type headaches Hansen WI -+ +

    Tavola (37) +

    Trials comparing acupuncture with Hesse (31)

    Heydenreich (32) ++

    L&mann (33) ++

    Doerr-Proske (34) -+

    Ahonen (39) 0

    Carlsson (40) -- +

    L+oh (41) +

    0

    Only data & headache indices available: mean reduction 31% (acupuncture) vs 21% (sham; p x0.05) Decrease in frequency at early follow-up: 44% (acupuncture) vs 21% (sham); medication: 58% vs 22%

    &her treatment or not treatment Frequency, intensity, and duration slightly better in metoproiol group but more side effects Response in 76% of acupuncture patients vs 84% of electr~acupuncture patients vs and 2096 in the medication group In&tsity reduction: 54% (acupuncture) vs 72% (electro-acupuncture) vs 8% propranolol Acupuncture vs behavioral program: frequency and medication use less in the behavioral group Acupuncture vs no treatment: frequency less in acupuncture group, medication use similar Improvement rates global response: 7/12 (acupunm) vs 3/10 (physiotherapy); frequency: 5/12 vs 2/10

    Pain intensity (VAS) at follow-up: 52 (SD 32, acupunchne) vs 29 (SD 22, physiotherapy)

    Response in 8/23 acupuncture patients vs 4/25 medication patients

    Variable observation period, no follow-up

    Follow-up only in responders

    Insufficient presentation of results No headache diary, incomplete follow-up

    Study of doubtful validity

    Probably alternate allocation

    Rigorous trial; no marked effect on frequency Probably rigorous, but insufficiently reported trials

    Cross-over trial of short duration Rigorous trial

    Rigomas trial, no follow-up Study of doubtful VCllidi~

    Untrustworthy study Insufficient sample size

    Insufficient sample size, no headache diary More intense intervention in physiotherapy group Only global responses presented

    Four studies were uninterpretable and excluded from this display as there were no data presented [30, 361, due to fundamental logistical problems (25) or major baseline differences (38).

    Vote count: - - = control better (statistically significant), - = control better (trend), 0 = no difference, + = acupuncture better (trend), + + =acupuncture better (statistically significant); *disagreement among reviewers (the vote less favorable for acupuncture is presented); **r&culafed based on individual patient data; SD = standard deviation; VAS =visual analog scale.

  • 784 D Melchart et al. CEPHALALGIA 19 (1999)

    Table 3. Response rates and responder rate ratios (=reIative risk) in 10 sham-controIIed trials of acupuncture for recurrent headaches.

    First author [ref.] Definition of response

    n responder/n randomized

    True Sham acupuncture acupuncture

    Rate ratio (95%CI)

    Rate ratio (95%CI)

    0.1 1 10 (sham (acup. better) better)

    Migraine

    Baust [20]

    CecchereIIi [21]

    Dowson [22]

    Henry WI Heydenreich [24]

    Vincent [271

    Weinschiitz [28]

    Weinschiitz [29]

    AII migraine trials

    >50% index reduction

    >50% index reduction

    >33% frequency reduction

    Overall patient assessment

    >50 symptom reduction

    >33% frequency reduction

    Single case time series

    Analysis (ARIMA)

    14/ 23

    13/ 15

    11 /25

    ll/ 20

    16/ 20

    7/ 15

    13/ 20

    15/ 20

    NO/158

    14/ 21

    5/ 15

    13/ 23

    3/ 10

    3/ 20

    6/ 15

    8/ 20

    8/ 21

    6w145

    0.91 (058,143) --I

    2.60 (1.24546)

    0.78 (044,138) --1

    1.83 (0665.12) -

    5.33 (l&&,15.49)

    1.17 (0.51266) -

    1.62 (0.87,3.04)

    1.97 (1.08359)

    1.55 (1.04,2.33)

    Tension-type headache

    Hansen [35] >33% index reduction

    TavoIa [371 >33% index reduction

    AII tension-type headache trials

    4/ 9

    13 /15

    17/ 24

    117/182

    2/ 9

    9 /15

    ll/ 24

    71/169

    2.00 (O&3,8.31) -

    1.44 (0.91,2.28)

    1.49 (0.96,2.30)

    possible). Also, our literature search did not identify eligible trials from China or Russia where acupunc- ture is widespread. As the literature from these countries is only partially covered by most data- bases it might be that unidentified eligible trials from these countries exist. Evidence from these countries has to be interpreted with caution, however, as it has been shown that researchers from Russia and China almost exclusively publish positive results (42).

    The insufficient reporting made both assessment of methodological quality and data extraction difficult and sometimes even impossible. Conceal- ment of allocation to groups was rarely described and reporting of drop-out and withdrawals was often incomplete. Only two of the blinded trials tested the success of blinding. Testing the success of blinding in sham-controlled trials is important, as a proportion of patients might find out to which group they have been allocated. The strategy to tell potential participants of a sham-controlled tial that two forms of acupuncture wilI be compared might help with recruitment and aid blinding. It is, however, ethically dubious. The quality scoring for blinding of evaluators proved difficult in our review. Evaluation was mostly done by the patients themselves in headache diaries. In consequence, a trial in which patients were blinded might be

    considered as double-blind (patients and evaluation blind). However, for our scoring methods at least those collecting the headache diaries had to be blinded for considering a trial as double-blind. ,

    Assessing chronic headaches in a clinically mean- ingful manner is a complex issue. Frequency, intensity, duration, medication needs, accompany- ing symptoms, mood, social functioning, daily activity, and workdays lost are aII relevant indica- tors. The heterogeneous outcome measurement methods and the lack of detail in the presentation of results precluded the calculation of effect size estimates for these outcomes. The results of our quantitative meta-analysis of responder rates have to be interpreted with extreme caution and should only be seen as a very crude indicator of the overall tendency of results. Response was not defined uniformly in the trials and such dichotomous outcomes are associated with very large confidence intervals in small trials indicating very low statis- tical power and precision. This also explains why our vote-counts and our narrative summary pro- vides a slightly more optimistic result than the analysis of responder rates.

    The widespread use of acupuncture, the promis- ing results, and the often insufficient quahty of the available studies warrant further research. Larger sham-controlled trials are needed to confirm (or

  • CEPHALALGIA 19 (1999) Acupuncture foT recurrent headaches 785

    refute) the available evidence that the effects of acupuncture in headache sufferers are truly specific. However, as sham acupuncture might have specific effects on its own or could be at least a more potent placebo than the provision of a pill (43), the evidence derived from such trials might under- estimate the benefits from acupuncture treatment. More pragmatic trials comparing acupuncture with no prophylactic treatment and other prophylactic interventions are needed to evaluate effectiveness and efficiency under real life conditions. Long-term observational studies would be useful to investigate how long the effects of acupuncture last and which patients are most likely to benefit. As acupuncture is applied in different ways by different acupunc- turists it is necessary to investigate practice patterns to ensure that future randomized trials truly invest the acupuncture strategies which are widespread in practice. Future randomized trials of acupuncture need much larger sample sizes. At present, sample size calculations for comparisons of acupuncture versus sham or no treatment could be based on the responder rates obtained in our study set. The pooled response rate in our study was about 60% in the treatment groups and about 40% in the sham groups. If such a difference is to be detected with 90% power (alpha level 0.05, two-sided test), 140 patients per group should be included in a trial. Smaller sample sizes could be possible if other outcomes (such as number of days with headache) are determined as primary outcome measures. Furthermore, future trials should follow specific guidelines for headache trials for inclusion criteria, classification of headaches, control of co-interven- tions and outcome measurement (44,45), as well as general guidelines for reporting (46).

    lished in the Cochrane Library. The work was partly funded by the NTAMS Grant No. 5 U24-AR-43346-02 and the Karl and Veronica Carstens Stiftung, Germany. We thank CA Vincent for providing individual patient data from his trial and the other authors who tried to answer our questions.

    Cmnpeting interests: Adrian White and Gianni Allais were involved in two trials included in this review. Both trials were assessed by other reviewers.

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    CEPHALALGIA 19 (1999)