Advertisement

Headache: the Placebo Effects in the Control Groups in Randomized Clinical Trials; an Analysis of Systematic Reviews

      Abstract

      Objective

      The purpose of this study is to describe the effects in the placebo and “no treatment” arms in trials with headache patients.

      Method

      This is a secondary analysis of randomized controlled trials from 8 systematic reviews and selected trials with a “no treatment” or placebo control group. The different types of “no treatment” and placebo interventions were assessed and classified into 6 subgroups. The analyses were carried out according to type of outcome variable.

      Results

      In total, 119 studies were included (7119 participants). The mean recovery rate in all control groups was 35.7%. Significantly more participants recovered in control groups of pharmacological studies than in nonpharmacological studies: 38.5% vs 15.0%, respectively. Adults were more likely to recover in nonpharmacological studies and children in pharmacological studies.

      Conclusions

      The mean recovery rate in the control groups was 36%. The recovery rate varied substantially between type of intervention and patients.

      Key Indexing Terms

      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to Journal of Manipulative & Physiological Therapeutics
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Mannix LK
        Epidemiology and impact of primary headache disorders.
        Med Clin North Am. 2001; 85: 887-895
        • Pinto A
        • Arava-Parastatidis M
        • Balasubramaniam R
        Headache in children and adolescents.
        J Can Dent Assoc. 2009; 75: 125-131
        • Silberstein SD
        • Lipton RB
        Headache epidemiology. Emphasis on migraine.
        Neurol Clin. 1996; 14: 421-434
        • Bille B
        A 40-year follow-up of school children with migraine.
        Cephalalgia. 1997; 17: 488-491
        • Speciali JG
        • Eckeli AL
        • Dach F
        Tension-type headache.
        Expert Rev Neurother. 2008; 8: 839-853
        • Headache Classification Committee of the International Headache Society
        The international classification of headache disorders.
        Cephalalgia. 2004; 24: 1-152
      1. Fernandes R., Ferreira J.J., Sampaio C. The placebo response in studies of acute migraine. J Pediatr 2008;152:527-33, 33e1.

        • Diener HC
        • Schorn CF
        • Bingel U
        • Dodick DW
        The importance of placebo in headache research.
        Cephalalgia. 2008; 28: 1003-1011
        • Verhagen A
        • Damen L
        • Berger M
        • Passchier J
        • Koes B
        Lack of benefit for prophylactic drugs of tension-type headache in adults: a systematic review.
        Fam Pract. 2010; 27: 151-165
        • Verhagen AP
        • Damen L
        • Berger MY
        • Passchier J
        • Merlijn V
        • Koes BW
        Is any one analgesic superior for episodic tension-type headache?.
        J Fam Pract. 2006; 55: 1064-1072
        • Verhagen A
        • Damen L
        • Berger M
        • Passchier J
        • Koes B
        Behavioral treatments of chronic tension-type headache in adults: are they beneficial?.
        CNS Neurosci Ther. 2009; 15: 183-205
        • Verhagen A
        • Damen L
        • Berger M
        • Passchier J
        • Merlijn V
        • Koes B
        Conservative treatments of children with episodic tension-type headache. A systematic review.
        J Neurol. 2005; 252: 1147-1154
        • Damen L
        • Bruijn J
        • Verhagen AP
        • Berger M
        • Passchier J
        • Koes BW
        Symptomatic treatment of migraine in children: a systematic review of medication trials.
        Paediatrics. 2005; 116: 295-302
        • Damen L
        • Bruijn J
        • Koes B
        • Berger M
        • Passchier J
        • Verhagen A
        Prophylactic treatment of migraine in children. Part 1. A systematic review of non-pharmacological trials.
        Cephalalgia. 2005; 26: 373-383
        • Damen L
        • Bruijn J
        • Verhagen A
        • Berger M
        • Passchier J
        • Koes B
        Prophylactic treatment of migraine in children. Part 2. A systematic review of pharmacological trials.
        Cephalalgia. 2005; 26: 497-505
        • Lenssinck ML
        • Damen L
        • Verhagen AP
        • Berger MY
        • Passchier J
        • Koes BW
        The effectiveness of physiotherapy and manipulation in patients with tension-type headache: a systematic review.
        Pain. 2004; 112: 381-388
        • Verhagen A
        • de Vet H
        • de Bie R
        • et al.
        The Delphi list: a criteria list for quality assessment of randomized clinical trials for conducting systematic reviews developed by Delphi consensus.
        J Clin Epidemiol. 1998; 51: 1235-1241
        • Bendtsen L
        • Mattsson P
        • Zwart JA
        • Lipton RB
        Placebo response in clinical randomized trials of analgesics in migraine.
        Cephalalgia. 2003; 23: 487-490
        • Rains JC
        • Penzien DB
        Behavioral research and the double-blind placebo-controlled methodology: challenges in applying the biomedical standard to behavioral headache research.
        Headache. 2005; 45: 479-486
        • Lewis DW
        • Winner P
        • Wasiewski W
        The placebo responder rate in children and adolescents.
        Headache. 2005; 45: 232-239
        • Hanten WP
        • Olson SL
        The effectiveness of CV-4 and resting position techniques on subjects with tension-type headaches.
        J Man Manip Ther. 1999; 7: 64-70
        • Hoyt WH
        • Shaffer F
        Osteopathic manipulation in the treatment of muscle-contraction headache.
        J Am Med Assoc. 1979; 78: 322-325
        • Vavrek D
        • Haas M
        • Peterson D
        Physical examination and self-reported pain outcomes from a randomized trial on chronic cervicogenic headache.
        J Manipulative Physiol Ther. 2010; 33: 338-348
        • Vernon H
        • Jansz G
        • Goldsmith CH
        • McDermaid C
        A randomized, placebo-controlled clinical trial of chiropractic and medical prophylactic treatment of adults with tension-type headache: results from a stopped trial.
        J Manipulative Physiol Ther. 2009; 32: 344-351
        • Knuistingh Neven A
        • Bartelink MEL
        • De Jongh TOH
        • Ongering JEP
        • Oosterhuis WW
        • et al.
        Huisarts Wet. 2004; 46: 411-422
        • Hershey AD
        Current approaches to the diagnosis and management of paediatric migraine.
        Lancet Neurol. 2010; 9: 190-204
        • Haas M
        • Aickin M
        • Vavrek D
        A preliminary path analysis of expectancy and patient-provider encounter in an open-label randomized controlled trial of spinal manipulation for cervicogenic headache.
        J Manipulative Physiol Ther. 2010; 33: 5-13